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CURRICULUM VITAE
Eric J. Lawitz, M.D.
OFFICE ADDRESS: Texas Liver Institute
American Research Corporation
607 Camden
SanAntonio, Texas 78215
Phone: (210)253-3426
Fax: (210)227-6951
EDUCATION: B.S. Degree in Biology, June 1989
University of Illinois at Chicago
Chicago, IL.
M.D. June 1993
Rush Medical College
Chicago, IL
INTERNSHIP: Internal Medicine
Brooke Army Medical Center
1 July 93 to 30 June 94
RESIDENCY: Internal Medicine
Brooke Army Medical Center
1 July 94 - 30 June 96
FELLOWSHIP: Gastroenterology/Hepatology
Brooke Army Medical Center
1 July 96 - 30 June 99
2
CURRENT POSITION:
Texas Liver Institute
American Research Corporation
VP, Scientific and Research Development
Professor of Medicine
University of Texas Health Science Center, San Antonio
2013 to Present
HOSPITAL
APPOINTMENTS: Baptist Medical Center
SanAntonio, Texas
Staff Gastroenterology/Hepatology
2004-Present
Metropolitan Methodist Hospital
SanAntonio, Texas
Staff Gastroenterology/Hepatology
2004-Present
Santa Rosa Hospital
SanAntonio, Texas
Staff Gastroenterology/Hepatology
2004-Present
Nix Hospital
SanAntonio, Texas
Staff Gastroenterology/Hepatology
2004-Present
PAST POSITIONS:
Alamo Medical Research
Chief Executive Officer
Professor of Medicine
University of Texas, San Antonio
2004 to 2013
Chief of Clinical Services
Associate Program Director, SanAntonio Uniformed Health
Services Education Consortium Gastroenterology Fellowship
Medical Director Viral Hepatitis Clinic
Department of Gastroenterology
Brooke Army Medical Center
3
2001-2004
Staff Gastroenterologist
Medical Director Viral Hepatitis Clinic
Brooke Army Medical Center
2000 to 2001
Staff Gastroenterologist
Fellowship Education Coordinator
Medical Director Viral Hepatitis Clinic
Brooke Army Medical Center
1999 to 2000
CERTIFICATION: Diplomat, National Board of Medical
Examiners, 1993
Diplomat, American Board of Internal Medicine, Gastroenterology,
2009- Decile 10 (upper 10%), #167681
CCTI/CPI, Association of Clinical Research Professionals Clinical
Investigator Certification, November 2012
LICENSURE: State of Texas, #L6486
PROFESSIONAL SOCIETY
MEMBERSHIPS:
American College of Physicians
American Gastroenterology Association
American Association For The Study Of Liver Disease
American College of Gastroenterology
Association of Clinical Research Professionals
European Association for the Study of the Liver
COMMITTEES:
Co-Course Director: The Seventh Annual Gastroenterology
Symposium, Wilford Hall Medical Center, 6 March 98
Medical Director: Hepatitis C Awareness Week
NBC (KMOL), SanAntonio, TX, January 22-28, 2001
Course Director: American College of Physicians, Army Chapter,
Gastroenterology Section, November 2001
4
AWARDS/ HONORS:
June 1987 Phi Kappa Phi (National Honor Society)
June 1987 Alpha Lamda Delta (National Honor Society)
July 1988 Golden Key National Honor Society
July 1995- June 1996 Outstanding Resident Teacher, Dept. Of Medicine, Brooke Army
Medical Center
July 1995- June 1996 Outstanding Resident Research Project, Dept. Of Medicine,
Brooke Army Medical Center
July 1997- June 1998 Outstanding Fellow Teacher, Dept. Of Medicine, Brooke Army
Medical Center
May 1999 ASGE 20th
Annual Fellow Essay Award Titled:
“Prevalence of Colonic Adenomas in Average Risk
Asymptomatic Patients on Daily Aspirin”
July 2000 Listed in The National Registry Of Who’s Who Lifetime Member
(134229)
November 2001 Recognizing Discover and Innovation in 2001: Milestone Award in
Hepatitis C, Dallas, Texas -Awarded Milestone Award for
Recognition Of Investigator-Initiated Research
March 2002 Featured on the Cover of periodical “Hepatitis” 2002 Vol.4 (2)
November 2002 William Beaumont Clinical Research Award
EDITORIAL POSITIONS:
Reviewer for:
American Journal of Gastroenterology
Gastroenterology and Clinical Gastroenterology and Hepatology
Journal of Hepatology
Gastroenterology
Therapeutic Advances in Gastroenterology
The LANCET
Antiviral Research
PRESENTATIONS:
1. Utility of preoperative fiberoptic flexible sigmoidoscopy in the evaluation of patients with
suspected gynecologic malignancy. Second place podium presentation at South Texas Regional
American College of Physicians meeting, San Antonio, Texas, October 1995
2. Utility of preoperative fiberoptic flexible sigmoidoscopy in the evaluation of
patients with suspected gynecologic malignancy. Poster presentation, Digestive Disease
5
Week, San Francisco, California, May 1996
3. Utility of preoperative fiberoptic flexible sigmoidoscopy in the evaluation of patients with
suspected gynecologic malignancy. Podium presentation, American College of Physicians, Army
Chapter meeting, Reston, Virginia, October 1996
4. Prevalence of colonic adenomas in average risk asymptomatic patients with and without daily
aspirin, Podium presentation, American College of Physicians, Army Chapter meeting, Reston,
Virginia, October 1998
5. Intron A and Ribavirin for Treatment of Patients with Interferon Relapsed or Interferon
refractory Chronic Hepatitis C, Podium presentation, American College of Physicians, Army
Chapter meeting, Reston, Virginia, October 1998
6. Intron A and Ribavirin for Treatment of Patients Chronic Hepatitis C not Previously
Treated with Interferon Podium presentation, American College of Physicians, Army Chapter
meeting, Reston, Virginia, October 1998
7. Intron A and Ribavirin for Treatment of Patients with Interferon Relapsed or Interferon
refractory Chronic Hepatitis C, American Association for the Study of Liver Disease, Chicago,
IL., November 1998
8. Intron A and Ribavirin for Treatment of Patients Chronic Hepatitis C not Previously Treated
with Interferon, American Association for the Study of Liver Disease, Chicago, IL., November
1998
9. Prevalence of Colonic Adenomas in Average Risk Asymptomatic Patients on Daily Aspirin,
American College of Physicians, Society of Airforce Physicians, accepted for the Jay P. Sanford
competition, Berkley, CA. , April 1999
10. Prevalence of Colonic Adenomas in Average Risk Asymptomatic Patients on Daily Aspirin,
Podium presentation, Young Investigators conference sponsored by the ASGE, Atlanta, GA.,
April 1999.
11. Prevalence of Colonic Adenomas in Average Risk Asymptomatic Patients on Daily Aspirin,
Podium presentation, Digestive Disease Week, Orlando, Florida, May 1999
12. A Multicenter Randomized Trial Comparing Daily Induction Dose Interferon Alpha 2b Plus
Ribavirin Followed by Daily Interferon Alpha 2b Plus Ribavirin Versus Standard Interferon
Alpha 2b Plus Ribavirin in patients with Chronic Hepatitis C Who Have Not been Previously
Been Treated With Interferon, Podium presentation, American College of Physicians, Army
Chapter meeting, SanAntonio, Texas November 1999
13. Comparison Of Daily Dose Interferon Alpha 2b Plus Ribavirin Followed By Daily
Combination Therapy Versus Standard Interferon Alpha 2b Plus Ribavirin in patients with
Chronic Hepatitis C Who Have Not been Previously Been Treated With Interferon, Podium
6
presentation, American College of Physicians, Army Chapter meeting, Restin, Virginia
November 2000
14. A Multi-Center Trial Using Daily Induction Dose Interferon Alpha 2B Plus Ribavirin
Followed By Daily Combination Therapy Versus Standard Combination Therapy In Patients
With Chronic Hepatitis C, Podium presentation, American College of Physicians, Army Chapter
meeting, Restin, Virginia November 2000
15. The Impact Of Body Mass Index On 12 Week Response Rates With Varying Regimens Of
Combination Therapy For Hepatitis C, American College of Physicians, Army Chapter meeting,
Restin, Virginia November 2000
16. Clinical Depression In Chronic Hepatitis C Patients Receiving Daily Versus Three Times A
Week Interferon Alfa 2b And Ribavirin, American College of Physicians, Army Chapter
meeting, Restin, Virginia November 2000
17. Continuous Combination Therapy Has Superior Viral Clearance Compared To Standard
Combination Therapy-A Multicenter Randomized Trial, Digestive Disease Week, Atlanta, GA,
May 2001
18. The Effect Of Hepatic Steatosis On Hepatic Iron Concentration In Fresh And Paraffin-
Embedded Tissue, American College of Gastroenterology 66th
Annual Scientific Meeting, Las
Vegas, Nevada, October 2001
19. Pegylated Interferon Alfa 2b And Ribavirin For Hepatitis C Patients Who Were Previous
Nonresponders To Standard Combination Therapy: 24 Week Viral Clearance, American
Association for the Study of Liver Disease, Dallas, TX., November 2001
20. African Americans Have A Lower Viral Clearance Rate With Combination Interferon And
Ribavirin Therapy For Hepatitis C: Results Of Two Multi-Center Trials, American Association
for the Study of Liver Disease, Dallas, TX., November 2001
21. Pegylated Interferon Alfa 2b (PEG-IFN) and Ribavirin for Hepatitis C Patients who Were
Nonresponders to Previous Therapy, Digestive Disease Week, SanFrancisco, CA; May 2002
22. Alpha Feto-Protein Levels in Hepatitis C Subjects Treated with Combination Therapy:
Abnormal Levels Decline with Therapy, Digestive Disease Week, SanFrancisco, CA; May 2002
23. Triple Therapy Compared to Standard Pegylated Interferon Alfa 2b + Weight Based
Ribavirin for Treatment Naive Patients with Chronic Hepatitis C: 24 Week Viral Clearance
[TRI-STAR Trial], Digestive Disease Week, SanFrancisco, CA; May 2002
24. Effect of Interferon-Ribavirin Therapy on Hepatitis A and B Vaccination in Patients Infected
with Hepatitis C Virus. In: Programs and Abstracts, the 40th Annual Meeting of the Infectious
Diseases Society of America. Chicago, October 2002
7
25. Pegylated Interferon Alfa 2b and Ribavirin for Hepatitis C Patients Who Were
Nonresponders to Previous Therapy, Digestive Disease Week, Orlando FL, May 2003.
26. Interleukin-11 In Patients With Chronic Hepatitis C And Advanced Liver Disease Who Have
Been Nonresponsive To Antiviral Therapy, Digestive Disease Week, Orlando FL, May 2003.
27. Hepatic Steatosis on Ultrasound: Associated Factors and Relationship with Steatosis on Liver
Biopsy, Digestive Disease Week, Orlando FL, May 2003.
28. The Outcome of Hepatitis C Therapy in African Americans and Hispanics with Persistently
Normal Transaminases. Digestive Disease Week, New Orleans LA, May 2004.
29. The Effect of Amantadine on Sustained Virologic Response When Added to Pegylated
Interferon Alfa 2b + Weight Based Ribavirin in Previous Nonresponders and Relapsers.
Digestive Disease Week, New Orleans LA, May 2004.
30. The Effect of Induction Pegylated Interferon Alfa 2b and Ribavirin on Early Virologic
Response in Genotype 1 Chronic Hepatitis C. Digestive Disease Week, New Orleans LA, May
2004.
31. 28 Days Of The Hepatitis C Protease Inhibitor VX-950, In Combination With PEG-
Interferon-Alfa-2a And Ribavirin, Is Well-Tolerated And Demonstrates Robust Antiviral Effects.
Digestive Disease Week, Los Angeles CA, May 2006.
32. Clearance of HCV RNA with Valopicitabine (NM283) plus PEG-Interferon in Treatment-
Naive Patients with HCV-1 Infection: results at 24 and 48 Weeks. European Association For The
Study Of The Liver, Barcelona Spain, April 2007
33. Multiple dose safety and pharmacokinetic study of bavituximab in patients with chronic
hepatitis C virus (HCV) infection. American Association for the Study of Liver Disease, Boston,
MA., November 2007
34. Treatment week 24 results of weight-based Taribavirin versus weight-based Ribavirin, both
with Peginterferon Alfa-2B, in naïve chronic Hepatitis C, genotype 1 patients. American
Association for the Study of Liver Disease, San Francisco, CA., November 2008
35. Interim results from a phase 1B dose-escalation study of 4 weeks of Peg-Interferon Lambda
(PEG-rIL-29) treatment in subjects with Hepatitis C virus (HCV) genotype 1 with prior virologic
response and relapse to Peginterferon Alfa and Ribavirin. American Association for the Study of
Liver Disease, San Francisco, CA., November 2008
36. Safety, tolerability and antiviral activity of MK-7009, a novel inhibitor of the hepatitis C
virus NS3 / 4A protease, in patients with chronic HCV genotype 1 infection. American
Association for the Study of Liver Disease, San Francisco, CA., November 2008
8
37. Safety, tolerability and antiviral activity of VCH-916, a novel non-nucleoside HCV
polymerase inhibitor in patients with chronic HCV genotype-1 infection. European Association
for the Study of the Liver Congress, Copenhagen, Denmark, April 2009.
38. GI-5005 Immunotherapy plus Peg-IFN/Ribavirin versus Peg-IFN/Ribavirin in genotype 1
chronic HCV subjects; preliminary phase 2 EVR analyses. European Association for the Study
of the Liver Congress, Copenhagen, Denmark, April 2009.
39. Randomized trial comparing systemic and local reactions to controlled-release Interferon
Alpha 2B in hepatitis C patients who failed prior treatment. European Association for the
Study of the Liver Congress, Copenhagen, Denmark, April 2009.
40. Safety and antiviral efficacy of 14 days of the cycophilin inhibitor NIM811 in combination
with Pegylated Interferon a2a in relapsed genotype 1 HCV infected patients. European
Association for the Study of the Liver Congress, Copenhagen, Denmark, April 2009.
41. Antiviral activity of ANA598, a potent non-nucleoside polymerase inhibitor, in chronic
hepatitis C patients. European Association for the Study of the Liver Congress, Copenhagen,
Denmark, April 2009.
42. Potent Antiviral Activity Observed with PSI-7851, a Novel Nucleotide Polymerase Inhibitor
for HCV, Following Multiple Ascending Oral Doses for 3 Days in Patients with Chronic HCV
Infection. HepDart, Kohala Coast, HI, December 2009
43. Early viral response of controlled-release Interferon Alpha2B and Ribavirin vs. Pegylated-
Interferon Alpha2B and Ribavirin in treatment-naïve genotype 1 hepatitis C: 12 week results
(Select-2 trial). European Association for the Study of the Liver Congress, Vienna, Austria, April
2010.
44. Safety and antiviral activity of ANA598 in combination with Pegylated Interferon a2A plus
Ribavirin in treatment-Naïve genotype-1 chronic HCV patients. European Association for the
Study of the Liver Congress, Vienna, Austria, April 2010.
45. Dose-ranging, three-day monotherapy study of the HCV NS3 protease inhibitor GS-9256.
European Association for the Study of the Liver Congress, Vienna, Austria, April 2010.
46. Clinical Synergy of an Anti-HCV Nucleoside Analog with SOC: Viral Kinetics of PSI-7977
with SOC. American Association for the Study of Liver Disease, Boston, MA November 2010.
47. Initial Antiviral activity of the HCV NS3 Protease Inhibitor ABT-450 when given with low
dose Ritonavir as 3-Day Monotherapy: Preliminary results of study M11-602 in Genotype-1
(GT1) HCV-Infected Treatment-Naïve subjects. American Association for the Study of Liver
Disease, Boston, MA November 2010.
9
48. 4-Week Virologic Response and Safety of ABT-450 given with low-dose Ritonavir (ABT-
450/R) in combination with Pegylated Interferon Alpha-2A and Ribavirn (SOC) after 3-Day
Monotherapy in Genotype 1 (GT1) HCV-Infected Treatment-Naïve Subjects. American
Association for the Study of Liver Disease, Boston, MA November 2010.
49. Three-Day, Dose-Ranging Study of the HCV NS3 Protease Inhibitor GS-9451. American
Association for the Study of Liver Disease, Boston, MA November 2010.
50. High Rapid Virologic Response (RVR) with PSI-7977 QD plus Peg-IFN / RBV in a 28-Day
phase 2A trial. American Association for the Study of Liver Disease, Boston, MA November
2010.
51. Safety and Antiviral Activity of ANA598 in combination with Pegylated Interferon a2A plus
Ribavirin in Treatment-Naïve Genotype-1 HCV Patients. American Association for the Study of
Liver Disease, Boston, MA November 2010.
52. SVR for controlled-release Interferon Alpha-2B (CR2B) + Ribavirin compared to Pegylated
Interferon Alpha-2B (PEG2B) + Ribavirin in treatment-naïve genotype-1 (G1) Hepatitis C: Final
results from Select-2. European Association for the Study of the Liver Congress, Berlin,
Germany, April 2011.
53. A Phase 2B trial comparing 24 to 48 weeks treatment with Tegobuvir (GS-9190)/Peg/RBV to
48 weeks treatment with Peg/RBV for chronic genotype 1 HCV infection. European Association
for the Study of the Liver Congress, Berlin, Germany, April 2011.
54. Three-Day, Dose-Ranging study of the HCV NS5A Inhibitor GS-5885. European Association
for the Study of the Liver Congress, Berlin, Germany, April 2011.
55. ABT-450/Ritonavir (ABT-450/R) combined with Pegylated Interferon Alpha-2A and
Ribavirin (SOC) after 3-day monotherapy in genotype 1 HCV-infected treatment-naïve subjects:
12 week interim efficacy and safety results. European Association for the Study of the Liver
Congress, Berlin, Germany, April 2011.
56. Once daily dual-nucleotide combination of PSI-938 and PSI-7977 provides 94% HCV RNA
<LOD at Day 14: First Purine/Pyrimidine clinical combination data (The Nuclear Study).
European Association for the Study of the Liver Congress, Berlin, Germany, April 2011.
57. ABT-450/Ritonavir (ABT-450/R) combined with Peglayted Interferon Alpha- 2A/Ribavirin
after 3-day monotherapy in Genotype 1 (GT1) HC- infected treatment- naïve subjects 12-week
sustained viologic response (SVR12) and safety results. European Association for the Study of
the Liver Congress, Barcelona, Spain, April 2012.
58. GS-6620 , A Liver- Targeted Nucleotide Prodrug,, exhibits antiviral activity and favorable
safety profile over 5 days in treatment naïve chronic HCV genotype 1 subjects. European
Association for the Study of the Liver Congress, Barcelona, Spain, April 2012.
10
59. GS-9669, A novel NS5B Non-Nucleotide Site II inhibitor, demonstrates potent antiviral
activity, favorable profile and potential for once-daily dosing. European Association for the
Study of the Liver Congress, Barcelona, Spain, April 2012.
60. PSI-7977 Proton and Electron: 100% Concordance of SVR4 with SVR24 in HCV GT1,
GT2, & GT3. European Association for the Study of the Liver Congress, Barcelona, Spain, April
2012.
61. A 12 week Interferon- free regiment of ABT-450/R, ABT-072, and ribavirin was well
tolerated and achieved sustained virologic response in 91% treatment naïve HCV I L28B-CC
Genotype-1 infected subjects. European Association for the Study of the Liver Congress,
Barcelona, Spain, April 2012.
62. Safety and Antiviral activity of ABT-267, A Novel NS5A Inhibitor, During 3-Day
Monotherapy: First study in HCV genotype-1 (GT-1) infected treatment- naïve subjects.
European Association for the Study of the Liver Congress, Barcelona, Spain, April 2012.
63. The Effect of Hepatic Impairment on the Pharmacokinetics and Antiviral Activity of PSI-
7977 in Hepatitis C Infected Subjects Treated for Seven Days. European Association for the
Study of the Liver Congress, Barcelona, Spain, April 2012.
64. SVR4 results of a once daily regimen of simeprevir (TMC435) plus sofosbuvir (GS-7977)
with or without ribavirin in HCV genotype 1 null responders. 20th Conference on Retroviruses
and Opportunistic Infections, Atlanta, GA, March 2013
65. 12 Weeks of ABT-450/Ritonavir, Non-nucleoside Inhibitor and Ribavirin Achieved SVR24
in >90% of Treatment-naïve Hepatitis C Virus GT1 Patients and 47% of Prior Non-responders
20th Conference on Retroviruses and Opportunistic Infections, Atlanta, GA, March 2013
66. ACH-2684 Demonstrates Potent Viral Suppression in Genotype 1 Hepatitis C Patients with
and without Cirrosis: Safety, Pharmacokinetic, and Viral Kinetic Analysis. European
Association for the Study of the Liver Congress, Amsterdam, Netherlands, April 2013.
67. High Concordance of SVR4, SVR12 and SVR 24 in Patients with HCV Infection with have
received Treatment with Sofosbuvir. European Association for the Study of the Liver Congress,
Amsterdam, Netherlands, April 2013.
68. Pharmacodynamics of Oral TLR-7 Agonist GS-9620 in Treatment-Naïve Patients with
Chronic Hepatitis C. European Association for the Study of the Liver Congress, Amsterdam,
Netherlands, April 2013.
69. Sofosbuvir + Peginterferon + Ribavirin for 12 Weeks Achieves 90% SVR12 in Genotype
1,4,5 or 6 HCV Infected Patients: The Neutrino Study. European Association for the Study of
the Liver Congress, Amsterdam, Netherlands, April 2013.
11
70. Interferon and Ribavirin-Free Regimen of ABT-450/r + ABT-267 in HCV Genotype 1b-
infected Treatment naïve Patients and Prior Null Responders. American Association for the
Study of Liver Disease, Washington DC, November 2013.
71. High Efficacy and Safety of the All-Oral Combination Regimen, MK-5172/MK-8742 +/-
RBV for 12 Weeks in HCV Genotype 1 Infected Patients: The C-WORTHY Study. American
Association for the Study of Liver Disease, Washington DC, November 2013.
72. Once Daily Sofosbuvir/Ledipasvir Fixed Dose Combination with or without Ribavirin
Resulted in >95% Sustained Virologic Response in Patients with HCV Genotype 1, Including
Patients with Cirrhosis: the LONESTAR trial. American Association for the Study of Liver
Disease, Washington DC, November 2013.
73. GS-5816, a Once Daily NS5A Inhibitor, Demonstrates Potent Antiviral Activity in Patients
with Genotype 1, 2, 3 or 4 HCV Infection in a 3-Day Monotherapy Study.. American Association
for the Study of Liver Disease, Washington DC, November 2013.
74. Once Daily Sofosbuvir/Ledipasvir Fixed Dose Combination is Highly Effective in Subjects
with Baseline NS5A Inhibitor andNS3 Protease Inhibitor Resistance-Associated Variants: The
Lonestar Trial. American Association for the Study of Liver Disease, Washington DC, November
2013.
75. A Fixed-Dose Combination of Sofosbuvir and Ledipasvir Is Highly Effective in Treatment-
Naïve and Treatment-Experienced Genotype 1 HCV-Infected Patients: Results from the
LONESTAR and ELECTRON Phase 2 Studies. HepDart 2013, Big Island, HI, December 2013
76. High Efficacy and Safety of the All-Oral Combination Regimen, MK-5172/MK-8742 +/-
RBV for 12 Weeks in HCV Genotype 1 Infected Patients: The C-WORTHY Study. Asia Pacific
Association for the Study of The Liver, Brisbane, Australia March 2014 .
77. Once Daily Sofosbuvir/Ledipasvir Fixed Dose Combination with or without Ribavirin
Resulted in >95% Sustained Virologic Response in Patients with HCV Genotype 1, Including
Patients with Cirrhosis: the LONESTAR trial. Asia Pacific Association for the Study of The
Liver, Brisbane, Australia March 2014
PUBLICATIONS:
1. Lawitz E, Kadakia SC. Utility of preoperative fiberoptic flexible sigmoidoscopy in the
evaluation of patients with suspected gynecologic malignancy. Gastrointestinal Endoscopy Vol.
47(5) 1998.
2. Lawitz E, Meier N, Kadakia SC. Prevalence of colonic adenomas in average risk
asymptomatic patients on daily aspirin. Gastointestinal Endoscopy Vol 49(4), part 2 AB63, 1999.
12
3. Lawitz E, Kadakia SC. Response to a Letter to the Editor. Gastointestinal Endoscopy Vol 49
(6) 1999.
4. Lawitz E, Kadakia SC, Cantu NS, Jeffries MA, Schutz SM, Matossian H, Jolley J, Sheinbaum
AJ, Meadows JG. Comparison Of Daily Induction Dose Interferon Alpha 2b Plus Ribavirin
Followed By Daily Combination Therapy In Treatment Naïve Patients With Chronic Hepatitis C.
Gastroenterology 2000;Vol. 118(4), suppl 2, part 2, A6624.
5. Lawitz E, Kadakia SC, Cantu NS, Nader P, Cox J, Ganeshappa KP, Reddy G, Nguyen TT,
Diamond K, Lindner M, Osterower V, Vemura R. Treatment Of Hepatitis C With Daily
Induction Dose Interferon Alpha 2b Plus Ribavirin Followed By daily Combination Therapy in
Patients Who Are Treatment Naïve Or Have Previously Failed An Interferon Based Therapy.
Gastroenterology 2000;Vol. 118(4), suppl 2, part 2, A6625.
6. Sjogren MH, Holtzmuller KC, Sjogren RW, Kadakia SC, Lawitz EJ, Deguide J. Failure Of
Interferon Induction Dosing To Alter Sustained Response Rates In Patients With Chronic
Hepatitis C. Gastroenterology 2000;Vol. 118(4), suppl 2, part 2, A6739.
7. Wong PW, Lawitz EJ, Cantu N, Kadakia SC, Maydonovitch C. Screening And Treatment Of
Depression In Chronic Hepatitis C Patients Receiving Interferon Alpha 2b And Ribavirin
Therapy. Gastroenterology 2000;Vol. 118(4), suppl 2, part 2, A6781.
8. Sjogren MH, Holtzmuller KC, Sjogren RW, Kadakia SC, Lawitz EJ, Loughney T, Deguide J..
Management of Chronic Hepatitis C: Effect of Duration of Retreatment After Monotherapy
Failure Gastroenterology 2000;Vol. 118(4), suppl 2, part 2, A232.
9. Lawitz E, Cantu N, Kadakia SC. Outcome Of Rescreening Patients Referred For Open Access
Flexible Fiberoptic Sigmoidoscopy Gastrointestinal Endoscopy 2000; Vol. 51(4) Part 2, AB233,
6969.
10. Lawitz E, Cantu N, Kadakia SC, Nader P, Diamond K, Ganeshappa KP, Cox J, Reddy G,
Nguyen T, Lindner M, Fixelle AM, Goodpasture H. A Multi-Center Trial Using Daily Induction
Dose Interferon Alpha 2B Plus Ribavirin Followed By Daily Interferon Alpha 2B+ Ribavirin In
Patients With Chronic Hepatitis C Who Are Treatment Naïve. Hepatology 2000; VOL 32(4), Pt2
AB# 15885, 556A.
11. Lawitz E, Cantu N, Kadakia SC, Jeffries MA, Schutz SM, Sheinbaum A, Torivara N, Jolley
JJ, Matossian H, Moulis H, Glombiki A, Galen E. A Multi-Center Randomized Trial Comparing
Daily Induction Dose Interferon Alpha 2B Plus Ribavirin Followed By Daily Combination
Therapy Versus Standard Combination Therapy In Treatment Naïve Patients With Chronic
Hepatitis C. Hepatology 2000; VOL 32(4), Pt2 AB# 1587, 556A.
12. Lawitz E, Cantu N, Kadakia SC, Nader P, Diamond K, Ganeshappa KP, Mehta N, Reddy G,
Nguyen T, Lindner M, Fixelle AM, Goodpasture H. A Multi-Center Trial Using Daily Induction
Dose Interferon Alpha 2B Plus Ribavirin Followed By Daily Interferon Alpha 2B+ Ribavirin In
13
Patients With Chronic Hepatitis C Who Previously Failed An Interferon Based Therapy.
Hepatology 2000; VOL 32(4), Pt2 AB# 1597, 559A.
13. Wong PW, Lawitz EJ, Cantu N, Kadakia SC. Clinical depression In Chronic Hepatitis C
Patients Receiving Two Different Interferon Alfa-2B/ Ribavirin Combination Regimens.
Hepatology 2000; VOL 32(4), Pt2 AB# 1606, 561A.
14. Wong PW, Lawitz EJ, Torgerson S, Goodman Z, Centeno J. The Effect Of Hepatic Steatosis
On Hepatic Iron Concentration In Fresh And Paraffin-Embedded Tissue. American Journal of
Gastroenterology 2001; VOL 96(9) AB#437, S139.
15. Lawitz EJ, Kadakia SC, Jeffries MA, Aggarwal A, Bilir B, Galen EA, Diamond K, James D,
Jolley J, Matossian H, Nguyen T, Warfield P. Continuous Combination Therapy Has Superior
Viral Clearance Compared To Standard Combination Therapy-A Multicenter Randomized Trial,
Gastroenterology 2001; VOL 120(5), suppl.1 AB#1954, A381.
16. Lawitz EJ, Cantu NS, Kadakia SC, Jeffries MA and The ALAMO Study Group. Pegylated
Interferon Alfa 2B And Ribavirin For Hepatitis C Patients Who Were Previous Nonresponders to
Standard Combination Therapy: 24 Week Viral Clearance. Hepatology 2001; VOL 34(4), Pt2
AB# 664, 338A.
17. Lawitz EJ, Hepburn M, Cantu NS, Hepburn LM, Kadakia SC and The ALAMO Study
Group. African Americans Have A Lower Viral Clearance Rate With Combination Interferon
And Ribavirin Therapy For Hepatitis C: Results Of Two Multi-Center Trials. Hepatology 2001;
VOL 34(4), Pt2 AB# 1000, 422A.
18. Lawitz EJ, Kadakia SC, Kelly R, Chalumeau BE. Prevelence Of Hepatitis C In Cap Haitian,
Haiti. Hepatology 2001; VOL 34(4), Pt2 AB# 1579, 567A.
19. Lawitz EJ, Cantu NS, Kadakia SC, and The ALAMO Study Group. Continuous
Combination Therapy Induces Viral Clearance In Hepatitis C Patients Who Were Previous
Nonresponders to Standard Combination Therapy. Hepatology 2001; VOL 34(4), Pt2 AB #
1644, 583A
20. Jacobson I, Brown R, Bernstein D, Bruno C, Spivey J, Lawitz E, Afdhal N, Flamm S,
Freilich B, Pizov O, Russo M, Brass C. Pegylated Interferon Alfa-2B And Fixed Versus Weight-
Based Ribavirin Dosing For Treatment Naive Patients With Chronic Hepatitis C. Hepatology
2001; VOL 34(4), Pt2 AB# 1648, 584A.
21. Lawitz EJ, Cantu NS, Kadakia SC, and The ALAMO Study Group. Continuous
Combination Therapy In Treatment Naive Patients With Chronic Hepatitis C. Hepatology 2001;
VOL 34(4), Pt2 AB# 1651, 585A.
22. Lawitz EJ, Cantu NS, Becker S, Dhar R, Li J, Bala NS, Gordon S, Davis M, Nader P,
Holtzmuller K, Rosenfield T, Monsour H, and The ALAMO Study Group. Pegylated Interferon
14
Alfa 2b and Ribavirin for hepatitis C Patients who Were Nonresponders to Previous Therapy.
Gastroenterology 2002; VOL 122(4), AB#80, A-626.
23. Hepburn M, Lawitz EJ, and The ALAMO Study Group. Alfa Feto-Protein Levels in
Hepatitis C Subjects Treated with Combination Therapy: Abnormal Levels Decline with
Therapy. Gastroenterology 2002; VOL 122(4), AB#119, A-630.
24. Lawitz EJ, Cantu NS, Adams F, Davis M, Sperling R, Fein S, Glombicki AP, Tsai N, Gasic
A, Sanders B, Kothari T, Cox J, and The ALAMO Study Group. Triple Therapy Compared to
Standard Pegylated Interferon Alfa 2b+ Weight Based Ribavirin for Treatment Naïve Patients
withChronic Hepatitis C: 24 Week Viral Clearance [TRI-STAR Trial]. Gastroenterology 2002;
VOL 123(1), AB#T1384, 75.
25. Lawitz EJ, Adams F, Davis M, Fein S, Sperling R, Glombicki A, Tsai N, Gasic A,
Ganeshappa KP, Cox J, Jeffries MA, Kadakia SC, Sanders B, Buckelew D, Silverman B,
Ghandour E, Medoff J and the ALAMO Study Group. Triple Therpay Compared to Standard
Pegylated Interferon + Weight Based Ribavirin For Treatment Naïve Patients With Chronic
Hepatitis C: 24 Week Viral Clearance. Hepatology 2002; VOL 36(4), Pt 2, 580A,1668.
26. Lawitz EJ, Nader P, Cox J, Diamond K, Cox J, Ganeshappa KP, Reddy G, Fixelle A,
Nguyen T, Vemura R. Daily Combination Therapy In Treatment Naïve and Previous
Nonresponders With Chronic Hepatitis C. Hepatology 2002; VOL 36(4), Pt 2, 580A,1670 .
27. Lawitz EJ, Cantu NS, Lapeer GM, Dalton C. Interleukin-11 In Patients With Chronic
Hepatitis C With Advanced Liver Disease Who Have Been Nonresponsive To Antiviral Therapy-
A Pilot Study. Hepatology 2002; VOL 36(4), Pt 2, 581A,1672.
28.Lawitz EJ, Cantu NS, Matossian H, Buckelew D, James D, Jolley J, Bilir B, Li J, Warfield P,
Galen E, Ganeshappa KP. Daily Combination Therapy Is Superior To Standard Combination
Therapy: Final Analysis. Hepatology 2002; VOL 36(4), Pt 2, 581A,1673.
29. Lawitz EJ, Adams F, Davis M, Fein S, Sperling R, Glombicki A, Tsai N, Gasic A,
Ganeshappa KP, Cox J, Jeffries MA, Kadakia SC, Sanders B, Buckelew D, Silverman B,
Ghandour E, Medoff J and the ALAMO Study Group. Triple Therpay Compared to Standard
Pegylated Interferon + Weight Based Ribavirin In Previous Interferon Based Therapy
Nonresponders And Relpasers. Hepatology 2002; VOL 36(4), Pt 2, 581A,1674
30. Hepburn M, Lawitz EJ, Torgerson S. Hepatic Steatosis In Hepatitis C Patients: Steatosis
Decreases With Combination Therapy. Hepatology 2002; VOL 36(4), Pt 2, 605A,1769.
31. Hepburn M, Lawitz EJ. Immunologic Markers In Chronic Hepatitis C Infection And Their
Relationship To Combination Therapy. Hepatology 2002; VOL 36(4), Pt 2, 605A,1770.
32. Hepburn MJ, Lawitz EJ. Effect of Interferon-Ribavirin Therapy on Hepatitis A and B
Vaccination in Patients Infected with Hepatitis C Virus. In: Programs and Abstracts, the 40th
15
Annual Meeting of the Infectious Diseases Society of America. Chicago, October 23-27, 2002,
#800, p. 118.
33. Dantzler TE, Lawitz EJ. Treatment of Chronic Hepatitis C in Nonresponders to Previous
Therapy. Current Gastroenterology Reports 2003; VOL 5(1), 78-85.
34. Lawitz EJ, Bala NS, Becker S, Brown G, Davis M, Dhar R, Ganeshappa KP, Gordon SC,
Holtzmuller K, Jeffries M, Li J, Monsour H, Nader P, Rosenfield T, Tolman K, Kadakia S, and
the ALAMO Study Group. Pegylated Interferon Alfa 2b and Ribavirin for Hepatitis C Patients
Who Were Nonresponders to Previous Therapy. Gastroenterology 2003; VOL 124(4), suppl. 1,
A783.
35. Hepburn MJ, Torgerson SJ, Lawitz EJ. Hepatic Steatosis on Ultrasound: Associated Factors
and Relationship with Steatosis on Liver Biopsy. Gastroenterology 2003; VOL 124(4), suppl. 1,
A-691.
36. Lawitz EJ, Casey T, Cantu NS. Interleukin-11 In Patients With Chronic Hepatitis C And
Advanced Liver Disease Who Have Been Nonresponsive To Antiviral Therapy.
Gastroenterology 2003; VOL 124(4), suppl. 1, A-768.
37. Lawitz EJ, Cantu NS, Davis M, Afdahl N, Curry M, Mailliard M, Adams F, Tsai N, Gasic
A, Kothari T, Ganeshappa KP, Cox J, Silverman B, Kadakia SC and the ALAMO Study Group.
Triple Therapy Compared to Standard Pegylated Interferon Alfa 2B + Weight Based Ribavirin
for Treatment Naïve Chronic Hepatitis C [TriStar Trial]: Final Results. Hepatology 2003VOL
38(4), suppl.1, 636A.
38. Hurley S, Lawitz EJ. Hepatitis C Treatment Practice Patterns in the Untied States: A
National Survey. Hepatology 2003VOL 38(4), suppl.1, 695A.
39. Lawitz EJ, Cantu NS, Davis M, Afdahl N, Curry M, Mailliard M, Adams F, Tsai N, Gasic
A, Kothari T, Ganeshappa KP, Cox J, Silverman B, Kadakia SC and the ALAMO Study Group.
Triple Therapy Compared To Standard Pegylated Interferon Alfa 2B + Weight Based Ribavirin
for Previous Nonresponders and Relapsers with Chronic Hepatitis C. Hepatology 2003VOL
38(4), suppl.1, 742A.
40. Ahmed F, Jacobson IM, Hargrave T, Lawitz EJ, Migicovsky B, Reddy V, Terrault N, Brown
R, Brass C. Diabetes Mellitus of New Onset During Pegylated Interferon and Ribavirin Therapy
for Chronic Hepatitis C: Observations from the WIN-R Trial. Hepatology 2003VOL 38(4),
suppl.1, 730A.
41. Lawitz EJ, Hoyumpa A. Emerging Therapeutic Strategies for Advanced Liver Disease in
Chronic Hepatitis C. Scientific Conference and Abstract News 2004, March, 1-18.
42. Lawitz EJ, Cantu NS, Harrison SA, Kadakia S, Adams F, Davis M, Sperling R, Tsai N,
Gasic A, Kothari T, Ganeshappa KP, Cox J, Sanders B, Silverman B, Ghandour E, Medoff J,
16
Afdhal N, Maillard, Curry M for the Alamo Study Group. The Outcome of Hepatitis C Therapy
in African Americans and Hispanics with Persistently Normal Transaminases. Gastroenterology
2004; VOL 126(4) suppl 2, A696.
43. Lawitz EJ, Cantu NS, Harrison SA, Kadakia S, Adams F, Davis M, Sperling R, Tsai N,
Gasic A, Kothari T, Ganeshappa KP, Cox J, Sanders B, Silverman B, Ghandour E, Medoff J,
Afdhal N, Maillard, Curry M for the Alamo Study Group. The Effect of Amantadine on
Sustained Virologic Response When Added to Pegylated Interferon Alfa 2b + Weight Based
Ribavirin in Previous Nonresponders and Relapsers. Gastroenterology 2004; VOL 126(4) suppl
2, A697.
44. Hepburn MJ, Cantu NS, Lapeer MG, Lawitz EJ. Estrogen Replacement Does Not Effect
Therapeutic Outcome in Post-Menopausal Women Infected with hepatitis C. Gastroenterology
2004; VOL 126(4) suppl 2, A722.
45. Lawitz EJ, Cantu NS, Harrison SA, Davis M, Perkel M, Vemura R, Nguyen T, Kadakia SC,
Diamond K, Matossian H, Box TD, Ganeshappa KP, Ghandour E for the Alamo Study Group.
The Effect of Induction Pegylated Interferon Alfa 2b and Ribavirin on Early Virologic Response
in Genotype 1 Chronic Hepatitis C. Gastroenterology 2004; VOL 126(4) suppl 2, A723.
46. Hurley SP, Hepburn M, Russo M, Lawitz EJ. Hepatitis C Therapeutic Management Patterns
Among Gastroenterologists in the United States: A National Survey. Gastroenterology 2004;
VOL 126(4) suppl 2, A430.
47. Hurley SP, Hepburn M, Russo M, Lawitz EJ. Assessment of patients Infected with hepatitis
C among Gastroenterologists in the United States: A National Survey. Gastroenterology 2004;
VOL 126(4) suppl 2, A430.
48. Hepburn MJ, Hepburn LM, Cantu NS, Lapeer MG, Lawitz EJ. Differences in treatment
outcome for hepatitis C among ethnic groups. American Journal of Medicine 2004; 117(03) 163-
168.
49. Lawitz EJ, Cantu NS, Hepburn MJ, Casey TJ. A Pilot Study of Interleukin-11 in Subjects
with Chronic Hepatitis C and Advanced Liver Disease Nonresponsive to Antiviral Therapy.
American Journal of Gastroenterology 2004; 99(12) 2359-2364.
50. Lawitz EJ, Hepburn MJ. Seroprevalence of hepatitis C and associated risk factors among an
urban population in Haiti. BMC Gastroenterology 2004; 4:31 (14 Dec 2004).
51. Hepburn MJ, Vos, Fillman
EP, Lawitz EJ. The accuracy of the report of hepatic steatosis on
ultrasonography in patients infected with hepatitis C in a clinical setting: A retrospective
observational study. BMC Gastroenterology 2005, 5:14.
17
52. T. Cassidy, E. Lawitz, P. Kobes, R. Shaffer, E. Sutton, L. Johnson, D. Predictors of Oxygen
Desaturation During Routine Gastrointestinal Endoscopy. Gastrointestinal Endoscopy, Volume
59, Issue 5, Page P128 .
53. O’Brien C, Godohsky E, Rodriguez-Torres M, Afdahl N, Pappas SC, Pokros P, Lawitz E,
Bzowej N, Rustgi V, Sulkowski M, Sherman K, Jacobson I, Chao G, Knox S, Pietropaolo K,
Brown N. Randomized trial of Valopictiabine (NM 283), alone or with PEG-Interferon, VS.
Retreatment with PEG-Interferon plus Ribavirin (PEGIFN/RBV) in Hepatitis C patients with
previous Nonresponse to PEGIFN/RBV: First Interim Results. Hepatology 2005 VOL 42(4),
suppl.1, 234A.
54. McHutchison J, Bacon B, Gordon S, Lawitz E, Shiffman M, Afdahl N, Jacobson I, Muir A,
Efler S, Al-Adhami M, Davis H, Schmalbach T. Relationships of HCV RNA Responses to CPG
10101, A TLR9 Agonist: Pharmacodynamics and Patient Characteristics. Hepatology 2005 VOL
42(4), suppl.1, 249A.
55. McHutchison J, Bacon B, Gordon S, Lawitz E, Shiffman M, Afdahl N, Jacobson I, Muir A,
Efler S, Vicari A, Mette K, Ahluwalia N, Lipford G, , Schmalbach T, Hrieg AM, , Davis H.
Immunophenotyping Profile of CPG 10101, A New TLR Agonist Antiviral For Hepatitis C.
Hepatology 2005 VOL 42(4), suppl.1, 539A.
56. Zhou XJ, Rodriguez-Torres M, Lawitz E, Godofsky E, Afdahl N, Constance BF, Knox S,
Brown NA. Absence of Effect of Pegylated Interferon Alfa-2B on the Pharmacokinetics of
Valopicitabine (NM 283) in Patients with Chronic Hepatitis C. Hepatology 2005 VOL 42(4),
suppl.1, 540A.
57. D Dieterich, E Lawitz, T Nguyen, Z Younes, J Santoro, N Gitlin, D McEniry, R Chasen, J
Goff, S Knox, K Kleber, B Belanger K, N Brown and the Valopicitabine 006 Study Group. Early
Clearance of HCV RNA with Valopicitabine (NM283) plus Peg-Interferon in Treatment-Naïve
Patients with HCV-1 infection: First Results from a Phase IIb Trial. J. of Hepatology 2006.
58. N. Afdhal, C. O’Brien, E. Godofsky, M. Rodriguez-Torres, S. Pappas, P. Pockros, E. Lawitz,
N. Bzowej, V. Rustgi, M. Sulkowski, K. Sherman,I. Jacobson, G. Chao, S. Knox,
K. Pietropaolo, and N. Brown . Randomized Trial of Valopicitabine (NM283)
Alone and in Combination with Peg-Interferon vs. Retreatment with Peg-Interferon plus
Ribavirin (PegIFN/RBV) in Hepatitis C Patients with Previous Non-Response to PegIFN/RBV:
Second Interim Results. J. of Hepatology 2006.
59. J.G. McHutchison, B.R. Bacon1, S.C. Gordon, E. Lawitz, M. Shiffman, N.H. Afdhal, I.M.
Jacobson, A. Muir A, Vicari, S. Efler, M. Al-Adhami, M.L. Morris, H.L. Davis. Final Results of
a Multi-Center Phase 1b Randomized, Placebo-Controlled, Dose-Escalation Trial of CPG 10101
in Patients with Chronic Hepatitis C Virus. J. of Hepatology 2006.
60. McHutchison JG, Ghalib R, Lawitz E, Freilich B, Kwo P, Masciari F, Himes JL, Al-adhami
M, Bacon B. Early Viral Response to Cpg 10101, a New Investigational Antiviral Tlr9 Agonist,
18
in Combination with Pegylated Interferon and/or Ribavirin, in prior relapse HCV Responders:
Preliminary Report of a Randomized Phase 1 Study. Gastroenterology 2006; VOL 130(4) suppl
2, S1062.
61. Pockros; C. O'Brien; E. Godofsky; M. Rodriguez-Torres; N. Afdhal; S. Pappas; E. Lawitz;
N. Bzowej; V. Rustgi; M. Sulkowski; K. Sherman; I. Jacobson; G. Chao; S. Knox; K.
Pietropaolo; N. Brown. Valopicitabine (NM283), Alone or with Peg-Interferon, Compared to Peg
Interferon/Ribavirin (pegIFN/RBV) Retreatment in Hepatitis C Patients with Prior Non-
Response to PegIFN/RBV: Week 24 Results. Gastroenterology 2006; VOL 130(4) suppl 2,
62. E. J. Lawitz; M. Rodriguez-Torres; A. Muir; J. Keane; T. Kieffer; L. McNair; J. G.
McHutchison. 28 Days Of The Hepatitis C Protease Inhibitor VX-950, In Combination With
PEG-Interferon-Alfa-2a And Ribavirin, Is Well-Tolerated And Demonstrates Robust Antiviral
Effects. Gastroenterology, VOL 131( 3), September 2006, Pages 950-951.
63. E. Lawitz; T. Nguyen; Z. Younes; J. Santoro; N. Gitlin; D. McEniry; R. Chasen; J. Goff; S.
Knox; K. Kleber; B. Belanger; N. A. Brown; D. Dieterich. Valopicitabine (NM 283) Plus PEG
Interferon in Treatment- Naïve Hepatitis C Patients With HCV Genotype-1 Infection: HCV RNA
Clearance During 24 Weeks of Treatment. Hepatology 2006 VOL 44(4), suppl.1, 223A.
64. I. M. Jacobson; R. Ghalib; E. Lawitz; B. Freilich; S. C. Gordon; P. Kwo; T. R. Riley; D.
Bright; M. L. Morris; M. Al-Adhami; J. L. Himes; F. E. Massari; J. G. McHutchison. Early Viral
Response and On Treatment Response to CPG 10101 (ACTILONTM
), in combination with
pegylated interferon and/or ribavirin, in chronic HCV genotype 1 infected patients with prior
relapse response. Hepatology 2006 VOL 44(4), suppl.1, 224A.
65. M. Rodriguez-Torres; E. Lawitz; A. Muir; J. Keane; T. Kieffer; L. McNair; J. G.
McHutchison. Current status of subjects receiving Peg-Interferon-Alfa-2a (Peg-IFN) and
Ribavirin (RBV) Follow-on therapy after 28-Day treatment with the hepatitis C protease inhibitor
Telaprevir (VX-950), Peg Interferon and Ribavirin. Hepatology 2006 VOL 44(4), suppl.1, 532A.
66. E. Lawitz , T. Nguyen , Z. Younes , J. Santoro , N. Gitlin , D. McEniry , R. Chasen , J. Goff ,
D. Dieterich , S. Knox , K. Kleber , B. Belanger , N.A. Brown , The 006 Investigator Group.
Clearance of HCV RNA with Valopicitabine (NM283) plus PEG-Interferon in Treatment-Naive
Patients with HCV-1 Infection: results at 24 and 48 Weeks. Journal of Hepatology 2007 VOL
46, suppl 1, S9.
67. N. Afdhal , C. OBrien , E. Godofsky , M. Rodriguez-Torres , S.C. Pappas , E. Lawitz , P.
Pockros , M. Sulkowski , I. Jacobson , G. Chao , S. Knox , K. Pietropaolo , N.A. Brown , The
Valopiticitabine 04 Study Group. Valopicitabine (NM283), Alone or with PEG-Interferon,
Compared to PEG interferon/Ribavirin (PEGIFN/RBV) Retreatment in Patients with HCV-1
Infection and Prior Non-Response to PEGIFN/RBV: One-Year Results. Journal of Hepatology
2007 VOL 46, suppl 1, S5.
19
68. J.C. Pottage, Jr , E. Lawitz , D. Mazur , D. Wyles , H. Vargas , R. Ghalib , R. Gugliotti , M.
Donohue , H. Robison. Short-Term Antiviral Activity and Safety of ACH-806 (GS-9132), an
NS4A Antagonist, in HCV genotype 1 Infected Individuals. Journal of Hepatology 2007 VOL
46, suppl 1, S294.
69. M.L. Shiffman, R. Ghalib, E. Lawitz, B. Freilich, S.C. Gordon, P.Y. Kwo, T.R. Riley, E.
Schiff , S. Flamm , I.M. Jacobson, N.N. Zein, A. Reuben, M. Swaim, D. Bright, M. Al-Adhami,
J. Lekstrom-Himes, F.E. Massari, J.G. McHutchison. CPG 10101 (Actilon) in Combination with
Pegylated Interferon and/or Ribavirin in chronic HCV Genotype 1 Infected Patients with Prior
relapsed Response: Week 48 Data. Journal of Hepatology 2007 VOL 46, suppl 1, S245.
70. M. Rodriguez-Torres, N.H. Afdhal, E. Lawitz, E. Godofsky, B. Belanger, B.F. Constante, S.
Knox, J. Leone, N.A. Brown. Final Results from a Phase Ia Pharmacokinetic Study of
Valopicitabine (NM283) and PEG-IFN 2b in Patients with Genotype 1 Chronic Hepatitis C.
Gastroenterology 2007; VOL 132(4) suppl 2, A-778.
71. N. Gitlin, E. Lawitz, T. Nguyen, Z. Younes, J. Santoro, D. McEniry, R. Chasen, J. Goff, D.
Dieterich, S. Knox, K. Kleber, J. Leone, B. Belanger, N.A. Brown. Valopicitabine (NM283) Plus
PEG-Interferon Alfa-2a (PEG-IFN) in Treatment-Naïve Patients with HCV-1 Infection:
Preliminary Results At Weeks 24 and 48. Gastroenterology 2007; VOL 132(4) suppl 2, A-780
72. A. Khunvichai, H.M. Chu, V. Garg, J.G. McHutchinson, E. Lawitz, M. Rodriguez, T.
Kieffer, J. Alam. Predicting HCV Treatment Duration With An HCV Protease Inhibitor Co-
Administered With PEG-IFN/RBV By Modeling Both Wild-Type Virus and Low Level
Resistant Variant Dynamics. Gastroenterology 2007; VOL 132(4) suppl 2, A-740
73. E. J. Lawitz, E. W. Godofsky, J. S. Shan. Multiple dose safety and pharmacokinetic study of
bavituximab in patients with chronic hepatitis C virus (HCV) infection. Hepatology 2007 VOL
46(4), suppl.1, 257A.
74. L. Bavisotto, C. C. Wang, I. M. Jacobson, P. Marcellin, S. Zeuzem, E. J. Lawitz, M. Lunde,
P. Sereni, C. O'Brien, D. W. Oldach, G. Rhodes. Antiviral, Pharmacokinetic and Safety Data for
GS-9190, a Non-nucleoside HCV NS5b Polymerase Inhibitor, in a Phase-1 Trial in HCV
Genotype 1 Infected Subjects. Hepatology 2007 VOL 46(4), suppl.1, 255A.
75. M. Rodriguez-Torres, E. J. Lawitz, J. G. McHutchison. Final Results of Patients Treated
with Peg-Interferon-Alfa-2a (Peg-IFN) and Ribavirin (RBV) Follow-on Therapy After 28-Day
Treatment with the Hepatitis C Protease Inhibitor Telaprevir (VX-950), Peg-IFN and RBV.
Hepatology 2007 VOL 46(4), suppl.1, 314A.
76. C. Cooper, E. J. Lawitz, P. Ghali, M. Rodriguez-Torres, F. H. Anderson, S. S. Lee, L.
Proulx. Antiviral activity of the non-nucleoside polymerase inhibitor, VCH-759, in chronic
Hepatitis C patients:Results from a randomized, double-blind, placebo -controlled, ascending
multiple dose study. Hepatology 2007 VOL 46(4), suppl.1, 864A.
20
77. F. Poordad, E. J. Lawitz, N. Gitlin, M. Rodriguez-Torres, T. Box, T. Nguyen, K.
Pietropaolo, W. Liu, B. A. Fielman, D. Mayers. Efficacy and Safety of Valopicitabine in
Combination with Pegylated Interferon-α (Peg IFN) and Ribavirin (RBV) in Patients with
Chronic Hepatitis C. Hepatology 2007 VOL 46(4), suppl.1, 866A.
78. J.G. McHutchison, B.R. Bacon, S.C. Gordon, E. Lawitz, M. Shiffman, N.H. Afdhal, I.M.
Jacobson, A. Muir A, M. Al-Adhami, M.L. Morris, J A Lekstrom-Himes, S M Efler, and H.L.
Davis. Phase 1b Randomized, Double Blind Dose-Escalation Trial of CPG 10101 in Patients
with Chronic Hepatitis C Virus. Hepatology 2007 VOL 46(5), 1341-1349.
79. E. Schiff, F. Poordad, I. Jacobson, S. Flamm, B. Bacon, E. Lawitz, S. Gordon, J.
McHutchison, R. Ghalib, T. Poynard, M. Sulkowski, C. Trepo, M. Rizzetto, S. Zeuzem, P.
Marcellin, P. Mendez, C. Brass, J.K. Albrecht. Boeprevir (B) Combination therapy in Null
Responders (NR): Response Dependent on interferon Responsiveness. Journal of Hepatology
2008 VOL 48, suppl 2, S46.
80. Kwo P, Lawitz E, McCone J, Schiff E, Vierling J, Pound D, Davis M, Galati J, Gordon S,
Ravendhran N, Rossaro L, Anderson F, Jacobson I, Rubin R, Mukhopadhyay P, Chaudhri E,
Pedicone L, Albrecht J. Interim Results from HCV SPRINT-1: RVR/EVR from Phase 2 study of
Boceprevir Plus PEGINTRONTM
(Peginterferon alfa-2b)/Ribavirin in Treatment-Naïve Subjects
with Genotype-1 CHC. Journal of Hepatology 2008 VOL 48, suppl 2, S372.
81. Sulkowski M, Lawitz E, Shiffman ML, Muir AJ, Galler G, McCone J, Nyberg L, Lee WM,
Ghalib R, Schiff E, Galati J, Bacon B, Davis M, Mukhopadhay P, Noviello S, Pedicone L,
Algrecht J, McHutchison J. Final Results of the Ideal (Individualized Dosing Efficacy Versus
Flat Dosing To Assess Optimal Pegylated Interferon Therapy) Phase IIIB Study. Journal of
Hepatology 2008 VOL 48, suppl 2, S370-371.
82. F. Poordad, E. Lawitz, E. Chun, J. Hammond. Treatment Week 12 Results Of Weight-Based
Taribavirin Versus Weight-Based Ribavirin, Both With Peginterferon Alfa-2B, In Naïve Chronic
Hepatitis C, Genotype 1 Patients. Journal of Hepatology 2008 VOL 48, suppl 2, S373.
83. Lawitz E, Rodriguez-Torres M, Muir AJ, Kieffer TL, McNair l, Khunvichai A, McHutchison
JG. Antiviral effects and safety of telaprevir, peginterferon alfa-2a, and ribavirin for 28 days in
hepatitis C patients. Journal of Hepatology 2008 VOL 48 (2) 163-169.
84. Eric Lawitz, Atif Zaman, Andrew J. Muir, Mitchell L. Shiffman, Boris Yoffe, Tracy Zhang,
Sherri Souza, Diana F. Hausman. Interim results from a phase 1B dose-escalation study of 4
weeks of Peg-Interferon Lambda (PEG-rIL-29) treatment in subjects with Hepatitis C virus
(HCV) genotype 1 with prior virologic response and relapse to Peginterferon Alfa and Ribavirin.
Hepatology 2008 VOL 48(4), 385A.
85. Daniel E. Brady, Jong W. An, Eric Lawitz, Stephen Harrison. Does induction Pegylated
Interferon Alfa-2B in combination with Ribavirin enhance the sustained response rates in
21
patients with genotype 1 and 4 chronic Hepatitis C? Results from a prospective, randomized,
multi-center, open-label treatment study. Hepatology 2008 VOL 48(4), 402A.
86. Eric Lawitz, Mark S. Sulkowski, Ira M. Jacobson, Shaban Faruqui, Walter K. Kraft,
Benedict Maliakkal, Mohamed Allbrahim, Reem H. Ghalib, Stuart C. Gordon, Paul Kwo,
Juergen Rockstroh, Michelle Miller, Peggy Hwang, Jacqueline Gress, Erin Quirk. Safety,
tolerability and antiviral activity of MK-7009, a novel inhibitor of the hepatitis C virus NS3 / 4A
protease, in patients with chronic HCV genotype 1 infection. Hepatology 2008 VOL 48(4),
403A.
87. John G. McHutchison, Eric Lawitz, John M. Vierling, Gregory T. Everson, Ira M. Jacobson,
Mitchell L. Shiffman, Thomas D. Boyer, Eugene R. Schiff, Scott Cruickshank, Timothy C.
Rodell, David Apelian. GI5005 immunotherapy plus PEG-IFN / Ribavirin in genotype 1 chronic
Hepatitis C patients compared to PEG-IFN / Ribavirin alone in naïve and non-responder patients;
preliminary RVR and viral kinetic analysis from the GI 5005-02 phase 2 study. Hepatology 2008
VOL 48(4), 1023A.
88. Paul Kwo, Eric Lawitz, Jonathan McCone, Eugene R. Schiff, John M Vierling, David
Pound, Mitchell Davis, Joseph S. Galati, Stuart C. Gordon, Natarajan Ravendhran, Lorenzo
Rossaro, Frank H. Anderson, Ira M. Jacobson, Raymond Rubin, Kenneth Koury, Eirum I.
Chaudhri, Janice K. Albrecht. HCV Sprint-1: Boceprevir plus Peginterferon Alfa-2B / Ribavirin
for treatment of genotype 1 chronic Hepatitis C in previously untreated patients. Hepatology
2008 VOL 48(4), 1027A.
89. Andrew J. Muir, Eric Lawitz, John G. McHutchison, Stuart C. Gordon, Ira M. Jacobson,
Bambang S. Adiwijaya, Leif Bengtsson, Lindsay McNair, Maribel Rodriguez-Torres. Viral
responses in African-Americans, Latinos and Caucasians in the US phase 2 study (Prove 1) of
Telaprevir with Peginterferon Alfa-2A and Ribavirin in treatment naïve genotype 1 infected
subjects with Hepatitis C. Hepatology 2008 VOL 48(4), 1131A.
90. Lisa M. Nyberg, Mitchell L. Shiffman, Hector Bonilla, Ke-Qin Hu, Timothy R. Morgan,
Robert A. Levine, Eric Lawitz, John G. McHutchison, Andrew J. Muir, Greg Wayne Galler,
Jonathan McCone, William M. Lee, Reem H. Ghalib, Eugene R. Schiff, Joseph S. Galati, Bruce
R. Bacon, Mitchell Davis, Steven K. Herrine, Alexandra L. Gibas, Bradley Freilich, John W.
King, Lorenzo Rossaro, Mark S. Sulkowski, Pabak Mukhopadhyay, Stephanie Noviello, Janice
K. Albrecht, Fred Poordad. Predicting the ability to achieve a sustained virologic response (SVR)
in the first 12 weeks: results from the ideal study. Hepatology 2008 VOL 48(4), 1134A.
91. Fred Poordad, Norbert Brau, Eric Lawitz, Mitchell L. Shiffman, John G. McHutchison,
Andrew J. Muir, Greg Wayne Galler, Jonathan McCone, Lisa Marie Nyberg, William M. Lee,
Reem H. Ghalib, Eugene R. Schiff, Joseph S. Galati, Bruce R. Bacon, Mitchell Davis, Steven K.
Herrine, Alexandra L. Gibas, Bradley Freilich, John W. King, Lorenzo Rossaro, Pabak
Mukhopadhyay, Stephanie Noviello, Clifford A. Brass, Janice K. Albrecht, Mark S. Sulkowksi .
Hematologic safety data from the ideal trial: Neutropenia, Anemia and Thrombocytopenia
profiles of Peginterferon Alfa / Ribavirin. Hepatology 2008 VOL 48(4), 1145A.
22
92. Eric Lawitz, Andrew J. Muir, Fred Poordad, Eric Chun, Janet Hammond. Treatment week
24 results of weight-based Taribavirin versus weight-based Ribavirin, both with Peginterferon
Alfa-2B, in naïve chronic Hepatitis C, genotype 1 patients. Hepatology 2008 VOL 48(4), 433A.
93. P. Kwo, E. Lawitz, J. McCone, E. Schiff, J. Vierling, D. Pound, M. Davis, J. Galati, S.
Gordon, N. Ravendhran, L. Rossaro, F. Anderson, I. Jacobson, R. Rubin, K. Koury, C.
Brass, E.Chaudhri, J. Albrecht. HCV Sprint-1 Final Results: SVR 24 from a phase 2 study of
Boceprevir plus Pegintron (Peginterferon Alfa-2B)/Ribavirin in treatment- naïve subjects with
genotype-1 chronic hepatitis C. Journal of Hepatology 2009 Vol 50, suppl 1, S4.
94. F. Poordad, E. Lawitz, R. Pozza, M. Shiffman, B. Bacon, E. Godofsky, D. Halliman, J.
Heise, E. Chun, J. Hammond. Efficacy and safety of weight-based regimens of Taribavirin or
Ribavirin, given with Peginterferon Alfa-2B, at 12 weeks after treatment (SVR12) in naïve
patients with genotype 1 chronic-hepatitis C. Journal of Hepatology 2009 Vol 50, suppl 1, S8.
95. E. Lawitz, C. Cooper, M. Rodriguez-Torres, R. Ghalib, R. Lalonde, A. Sheikh, B.
Bourgault, N. Chauret, L. Proulx, J. Hutchison. Safety, tolerability and antiviral activity of
VCH-916, a novel non-nucleoside HCV polymerase inhibitor in patients with chronic HCV
genotype-1 infection. Journal of Hepatology 2009 Vol 50, suppl 1, S37.
96. J. Ke, E. Lawitz, R. Rozier, T. Marbury, N. Nguyen, D. Serra, K. Doyle, J.
Praestgaard, M. Huang, T. Evans. Safety and tolerability of NIM811, a novel cyclophilin
inhibitor for HCV, following single and multiple ascending doses in healthy volunteers and
HCV-infected patients. Journal of Hepatology 2009 Vol 50, suppl 1, S229.
97. E. Lawitz, T.D. Boyer, G.T. Everson, I.M. Jacobson, W. Lee, J.G. McHutchison, P.J.
Pockros, M.L. Shiffman, J.M. Vierling, S. Cruickshank, T.C. Rodell, D. Apelian. GI-5005
Immunotherapy plus Peg-IFN/Ribavirin versus Peg-IFN/Ribavirin in genotype 1 chronic HCV
subjects; preliminary phase 2 EVR analyses. Journal of Hepatology 2009 Vol 50, suppl 1,
S230.
98. E. Lawitz, Z.M. Younossi, M. Shiffman, S. Gordon, R. Ghalib, W. Long, A. Muir, J.
Hutchison. Randomized trial comparing systemic and local reactions to controlled-release
Interferon Alpha 2B in hepatitis C patients who failed prior treatment. Journal of Hepatology
2009 Vol 50, suppl 1, S231.
99. M. Shiffman, E. Lawitz, A. Zaman, J. Vierling, B. Yoffe, J. Freeman, T. Gray, D.
Hausman, A. Muir. Peg-IFN Lambda: Antiviral activity and safety profile in a 4-week phase
1B study in relapsed genotype 1 hepatitis C infection. Journal of Hepatology 2009 Vol 50,
suppl 1, S237.
100. S. Zeuzem, M. Sulkowski, E. Lawitz, V. Rustgi, Y. Lurie, M. Grigorescu, A. Muir, P.
Cronin, E. Pulkstenis, M. Subramanian, J. McHutchison. Efficacy and safety of Albinterferon
23
Alfa-2B in combination with Ribavirin in treatment- naïve, chronic hepatitis C genotype 1
(CHC G1) patients. Journal of Hepatology 2009 Vol 50, suppl 1, S277.
101. D. Nelson, Y. Benhamou, W.L. Chuang, E. Lawitz, R. Flisiak, M. Rodriguez-Torres,
V. Bain, K. Patel, P.W. Cronin, E. Pulkstenis, G.M. Subramanian, J.G. McHutchison.
Efficacy and safety results of Albinterferon Alfa-2B in combination with Ribivirin in
Interferon-Alfa treatment naïve patients with genotype 2 or 3 chronic hepatitis C. Journal of
Hepatology 2009 Vol 50, suppl 1, S378.
102. E. Lawitz, R. Rouzier, T. Nguyen, M. Huang, J. Ke, J. Praestgaard, D. Serra,M.
Koziel, T. Evans. Safety and antiviral efficacy of 14 days of the cycophilin inhibitor NIM811
in combination with Pegylated Interferon a2a in relapsed genotype 1 HCV infected patients.
Journal of Hepatology 2009 Vol 50, suppl 1, S379.
103. I Jacobson, P. Pockros, J. Lalezari, E. Lawitz, M. Rodriguez-Torres, E. DeJesus, F.
Haas, C. Martorell, R. Pruitt, K. Durham,S. Srinivasan, M. Rosario, S. Jagannatha, J.
Hammond. Antiviral activity of filibuvir in combination with Pegylated Interferon Alfa-2A and
Ribavirin for 28 days in treatment naïve patients chronically infected with HCV genotype 1.
Journal of Hepatology 2009 Vol 50, suppl 1, S382.
104. E. Lawitz, M. Rodriguez-Torres, M. DeMicco, T. Nguyen, E. Godofsky, J. Appleman,
M. Rahimy, C. Crowley, J. Freddo. Antiviral activity of ANA598, a potent non-nucleoside
polymerase inhibitor, in chronic hepatitis C patients. Journal of Hepatology 2009 Vol 50,
suppl 1, S384.
105. C. Cooper, E. J. Lawitz, P. Ghali, M. Rodriguez-Torres, F. H. Anderson, S. S. Lee, J.
Bedard, N. Chauret, R. Thibert, L. Proulx. Evaluation of VCH-759 monotherapy in Hepatitis C
infection. Journal of Hepatology 2009 VOL 51(1), 39-46.
106. Nezam H. Afdhal, Bruce R. Bacon, Keyur Patel, Eric J. Lawitz, Stuart C. Gordon, David
R. Nelson, Tracy Challies, Imad Nasser and John McHutchison. United States Multicenter Study
of Ultrasonic TRANSIENT ELASTOGRAPHY (FibroScan) for the Diagnosis of Cirrhosis and
Fibrosis in Patients with Hepatitis B and C. Gastroenterology 2009 Volume 136, Issue 5,
Supplement 1, May 2009, Pages A806.
107. McHutchison JG, Lawitz EJ, Shiffman ML, Muir AJ, Galler GW, McCone J, Nyberg
LM, Lee WM, Ghalib RH, Schiff ER, Galati JS, Bacon BR, Davis MN, Mukhopadhyay P,
Koury K, Noviello S. Peginterferon alfa-2b or alfa-2a with ribavirin for treatment of hepatitis
C infection. The New England Journal of Medicine 2009 VOL 361(6):580-93.
108. P. Kwo, E. Lawitz, J. McCone, E. Schiff, J. Vierling, D. Pound, M. Davis, J. Galati,
S. Gordon, N. Ravendhran, L. Rossaro, F. Anderson, I. Jacobson, R. Rubin, K. Koury, N.
Boparai, E. Chaudhri, C. Brass, J. Albrecht. High sustained virologic response (SVR) in
genotype 1 (G1) null responders to peg-interfeon Alfa-2B (P) plus ribavirin (R) when treated
with boceprevir (BOC) combination therapy. Hepatology 2009 VOL 50(4)(suppl), 331A.
24
109. M. Sulkowski, S. Zeuzem, E. Lawitz, M. Grigoresci, A. Tice, V. Rustgi, M.
Rodriguez-Torres, Y. Lurie, J. Cianciara, B. Bacon, V. Bain, W. Kryczka, E. Pulkstenis, G.
Subramanian, J. McHutchison. Efficacy and safety of Albinterferon Alfa-2B in combination
with ribavirin in treatment naïve patients with chronic hepatitis C genotype 1. Hepatology 2009
VOL 50(4)(suppl), 333A.
110. F. Poordad, E. Lawitz, T. Hassanein, M. Shiffman, B. Bacon, A. Muir, J. Heise, D.
Halliman, E. Chun, J. Hammond. Sustained virologic response (SVR) results for weight-
based-Taribavirin versus weight-based-Ribavirin, in naïve chronic hepatitis C, genotype 1
patients. Hepatology 2009 VOL 50(4)(suppl), 334A.
111. J. Vierling, F. Poordad, E. Lawitz, R. Ghalib, W. Lee, N. Ravendhran, J. Galati, B.
Bacon, S. Flamm, L. Balart, B. Freilich, E. Schiff, I. Jacobson, P. Kwo, S. Gordon, M.
Sulkowski, N. Bopapai, E. Chaudhri, C. Brass, E. Hughes, J. Albrecht. Once daily
Narlaprevir (SCH900515) in combination with Peginteron (Peginterferon Alfa-2B) / Ribavirin
for treatment-naïve subjects with genotype 1 CHC: interim results from Next-1, a phase 2A
study. Hepatology 2009 VOL 50(4)(suppl), 90A.
112. M. Rodriguez-Torres, E. Lawitz, D. Cohen, L. Larsen , R. Menon, C. Collins, T.
Marsh, S. Gibbs, B. Bernstein. Treatment-naïve, HCV genotype 1 infected subjects show
significantly greater HCV RNA deceases when treated with 28 days of ABT-333 plus
Peginterferon and Ribavirin compared to Peginterferon and Ribavirin alone. Hepatology 2009
VOL 50(4)(suppl), 91A.
113. C. Pasquinelli, T. Eley, C. Villegas, K. Sandy, E. Mathias, P. Wendelburg, S. Liao,
F. McPhee, P. Scola, L. Sun, T. Marbury, E. Lawitz, R. Goldwater, M. Rodriguez-Torres,
M. DeMicco, M. Abada, D. Wright, M. Charlton, W. Kraft, J. Lopez-Talavera, D. Grasela.
Safety, tolerability pharmacokinetics and antiviral activity following single and multiple dose
administration of BMS-650032, a novel HCV NS3 inhibitor, in subjects with chronic genotype
1 HCV infection. Hepatology 2009 VOL 50(4)(suppl), 411A.
114. J. Hutchison, I. Jacobson, T. Boyer, E. Schiff, G. Everson, W. Lee, P. Pockros, R.
Chasen, J. Vierling, E. Lawitz, M. Kuglemas, N. Tsai, B. Armstrong, T. Rodell, D.
Apelian. GI-5005 therapeutic vaccine plus Peg-IFN/Ribavirin improves end of treatment
response at 48 weeks versus Peg-IFN/Ribavirin in naïve genotype 1 chronic HCV patients.
Hepatology 2009 VOL 50(4)(suppl), 228A.
115. M. Rodriguez-Torres, E. Lawitz, S. Flach, J. Denning, E. Albanis, W. Symonds, M.
Berrey. Antiviral activity, pharmacokinetics, safety, and tolerability of PSI-7851, a novel
nucleotide polymerase inhibitor for HCV, following single and 3 day multiple ascending oral
doses in healthy volunteers and patients with chronic HCV infection. Hepatology 2009 VOL
50(4)(suppl), 228A.
25
116. Y. Benhamou, D. Nelson, W. Chuang, E. Lawitz, R. Flisiak, J. Rasenack, W. Kryczka,
C. Lee, M. Rodriguez-Torres, V. Bain, E. Schiff, M. Cho, E. Janczewski-Kazek, C. Peng, E.
Pulkstenis, G M. Subramanian, J. McHutchinson. Efficacy and safety results of Albinterferon
Alfa-2B in combination with Ribavirin in treatment naïve subjects with chronic hepatitis C
genotype 2 or 3. Hepatology 2009 VOL 50(4)(suppl), 1026A.
117. P. Kwo, E. Lawitz, J. McCone, E. Schiff, J. Vierling, D. Pound, M. Davis, J. Galati,
S. Gordon, N. Ravendhran, L. Rossaro, F. Anderson, I. Jacobson, R. Rubin, K. Koury, N.
Bobarai, E. Chaudhri, C. Brass, J. Albrecht. Response-guided therapy (RGT) for boceprevir
(BOC) combination treatment?- Results from HCV Sprint-1. Hepatology 2009 VOL
50(4)(suppl), 1035A.
118. A. Muir, M. Shiffman, A. Zaman, B. Yoffe, J. Lopez-Talavera, S. Souza, D. Hausman,
E. Lawitz. A phase 1B dose ranging study of 4 weeks of Peg-Interferon (IFN) Lambda (PEG-
RIL-29) in combination with Ribavirin (RBV) in patients with chronic genotype 1 hepatitis C
virus (HCV) infection. Hepatology 2009 VOL 50(4)(suppl), 1039A.
119. K. Patel, S. Lim, C. Cheng, E. Lawitz, H. Tillmann, N. Chopra, J. Randle, J.
McHutchison. Open-label phase 1B pilot study to evaluate the antiviral efficacy of co-
administration of simvastatin and sertraline in chronic hepatitis C (CHC) patients. Hepatology
2009 VOL 50(4)(suppl), 1048A.
120. Vinod K. Rustgi, William M. Lee, Eric Lawitz, Stuart C. Gordon, Nezam Afdhal, Fred
Poordad, Herbert L. Bonkovsky, Leif Bengtsson, Gurudatt Chandorkar, Matthew Harding,
Lindsay McNair, Molly Aalyson, John Alam, Robert Kauffman, Shahin Gharakhanian and John
G. McHutchison. Merimepodib, Pegylated Interferon, and Ribavirin in Genotype 1 Chronic
Hepatitis C Pegylated Interferon and Rivavirin Nonresponders. Hepatology 2009 VOL 50(6), ppg
1719-1726.
121. Daniel E. Brady, Dawn M. Torres, Jong W. An, John A. Ward, Eric Lawitz, Stephen A.
Harrison. Induction Pegylated Interferon Alfa-2b in Combination With Ribavirin in Patients
With Genotypes 1 and 4 Chronic Hepatitis C: A Prospective, Randomized, Multicenter, Open-
Label Study. Clinical Gastroenterology and Hepatology 2010 Volume 8(1), ppg 66-71.e1.
122. M. Rodrigues-Torres, E. Lawitz, B. Conway, K. Kaita, A.M. Sheikh, R. Ghalib, R.
Adrover, C. Cooper, M. Silva, M. Rosario, B. Bourgault, L. Proulx, J.G. McHutchison. Safety
and antiviral activity of the HCV non-nucleoside polymerase inhibitor VX-222 in treatment-
Naïve genotype 1 HCV-infected patients. Journal of Hepatology 2010 Vol 52 (1),S14
123. A.Muir, R. Ghalib, E. Lawitz, K. Patel, M. Rodriguez-Torres, A. Sheikh, S. Sapp, R.
Taylor, A. Bexon, T. Sullivan, A. Dovholuk, J. McHutchison. A phase 1, multi-center,
randomized, placebo-controlled, dose-escalation study of IMO-2125, a TLR9 agonist, in hepatitis
C-non responders. Journal of Hepatology 2010 Vol 52 (1), S14
26
124. I.M. Jacobson, P.J. Pockros, J. Lalezari, E. Lawitz, M. Rodriguez-Torres, E. DeJesus, F.
Hass, C. Martorell, R. Pruitt, V. Purohit, S. Srinivasan, S. Jagannatha, K. Rana, J. Hammond.
Virologic response rates following 4 weeks of filibuvir in combination with pegylated Interferon
Alfa-2A and Ribavirin in chronically-infected HCV genotype-1 patients. Journal of Hepatology
2010 Vol 52 (1),S465.
125. I.M. Jacobson, J.G. McHutchison, T.D. Boyer, E.R. Schiff, G.T. Everson, P.J. Pockros,
R.M. Chasen, J.M. Vierling, E. J. Lawitz, M. Kugelmas, N.C. Tsai, M.L. Shiffman, R. J.
Buynak, A.M. Sheikh, B. Armstrong, T.C. Rodell, D. Apelian. GI-5005 Therapeutic vaccine plus
Peg-IFN/Ribavirin significantly improves virologic response an ALT normalization at end-of-
treatment and improves SVR24 compared to Peg-IFN/Ribavirin in genotype-1 chronic HCV
patients. Journal of Hepatology 2010 Vol 52 (1),S465.
126. E.J. Lawitz, T.C. Marbury, B.D. Vince, N. Grunenberg, M. Rodriguez-Torres, M.P.
DeMicco, J.N. Tarro, M.J. Shelton, S. West, J. Zong, A. Bae, K. Wong, H.M. Mo, D. Oldach, W.
W. Delaney, F. Rousseau. Dose-ranging, three-day monotherapy study of the HCV NS3 protease
inhibitor GS-9256. Journal of Hepatology 2010 Vol 52 (1),S466.
127. E. Lawitz, M. Rodriguez-Torres, V.K. Rustgi, T. Hassanein, M.H Rahimy, C.A. Crowley,
J.L. Freddo, A. Muir, J. McHutchison. Safety and antiviral activity of ANA598 in combination
with Pegylated Interferon a2A plus Ribavirin in treatment-Naïve genotype-1 chronic HCV
patients. Journal of Hepatology 2010 Vol 52 (1),S467.
128. W.A. Long, D. Takov, K. Tehernev, I. Kotzev, A. Rigney, Z. Krastev, S. Stoynov, R.
Balabanska, E. Lawitz, Z. Younossi, R. Ghalib, E. Zuckerman, R. Safadi, R. Tur-Kaspa, N.
Assy, Y. Lurie. Q2week controlled-release-Interferon-Alpha2B+Ribavirin reduces flu-like
symptoms >50% and provides equivalent efficacy in comparison to weekly Pegylated-Interferon-
Alpha2B+Ribavirin in treatment-Naïve-genotype-1-chronic-hepatitis C: Results from empower,
a randomized-open-label-12-week-comparison in 133 patients. Journal of Hepatology 2010 Vol
52 (1), S467.
129. A.J. Thompson, J. Fellay, D. Ge, T. Urban, K. Shianna, M. Sulkowski, A. Muir, N. Afdhal,
I. Jacobson, R. Esteban, F. Poordad, E. Lawitz, J. McCone, M. Shiffman, G. Galler, W. Lee, R.
Reindollar, J. King, P. Kwo, R. Ghalib, B. Freilich, L. Nyberg, K. Patel, H. Tillmann, S.
Noviello, N. Bopari, K. Koury, L. Pedicone, C. Brass, J.K. Albrecht, D. Goldstein, J.G.
McHutchison. Genome wide analysis of patients from the ideal study identifies a causal role for
ITPA genetic variation in Ribavirin-induced hemolytic anemia. Journal of Hepatology 2010 Vol
52 (1),S470.
130. J.M. Vierling, R. Ralston, E.J. Lawitz, J. McCone, S. Gordon, D. Pound, M. Davis, J.
Galati, I. Jacobson, L. Rossaro, F.H. Anderson, J. King, W. Cassidy, M. Bourliere, R. Esteban-
Mur, N. Ravendhran, G. Galler, P. Mendez, C.A. Brass, J.K. Albrecht. Long-term outcomes
following combination treatment with Boceprevir plus Peg-Intron/Ribavirin (P/R) in patients
with chronic hepatitis C, genotype 1 (CHC-G1). Journal of Hepatology 2010 Vol 52 (1),S470.
27
131. E. Lawitz, Z. Younossi, P. Mehra, A. Rigney, Z. Krastev, K. Tchernev, D. Takov, W.
A.Long. Early viral response of controlled-release Interferon Alpha2B and Ribavirin vs.
Pegylated-Interferon Alpha2B and Ribavirin in treatment-naïve genotype 1 hepatitis C: 12 week
results (Select-2 trial). Journal of Hepatology 2010 Vol 52 (1),S114.
132. M.P. Manns, E. Lawitz, A.I.M. Hoepelman, H.J. Choi, J. Y. Lee, M. Cornporpst, W. Liang.
B. King, K.R. Hirsch, D. Oldach, F.S. Rousseau. Short term safety, tolerability, pharmacokinetics
and preliminary activity of GS-9450, a selective caspase inhibitor, in patients with chronic HCV
infection. Journal of Hepatology 2010 Vol 52 (1), S114.
133. J.G. McHutchison, Z.D, Goodman, G.T. Everson, I.M. Jacobson, T.D. Boyer, E.R. Schiff,
W.M. Lee, R.M. Chasen, J.M.Vierling, E.J. Lawitz, M. Kugelmas, N.C. Tsai, R.J. Buynak,
A.M. Sheikh, B. Armstrong, T.C. Rodell, D. Apelian. GI-5005 Therapeutic vaccine plus Peg-
IFN/Ribavirin improves biopsy necro-Inflammatory scores and ALT normalization at 4 weeks
versus Peg-IFN/Ribavirin in genotype 1 chronic HCV patients. Journal of Hepatology 2010 Vol
52 (1),S116
134. M.S. Sulkowski, J.W. King, S.A. Harrison, L. Rossaro, K.Q. Hu, E.J. Lawitz, M.L.
Shiffman, A.J. Muir, G.W. Galler, J. McCone, L.M. Nyberg, W.M. Lee, R. Ghalib, J.G.
McHutchison, S. Noviello, V.S. Gotei, J.K. Albrecht, C.A. Brass. Metabolic syndrome (MS) is a
negative predictor of treatment outcome in patients with chronic hepatitis C: Results from the
ideal study. Journal of Hepatology 2010 Vol 52 (1),S127.
135. Alexander J. Thompson, Andrew J. Muir, Mark S. Sulkowski, Dongliang Ge, Jacques
Fellay, Kevin V. Shianna, Thomas Urban, Nezam H. Afdhal, Ira M. Jacobson, Rafael Esteban,
Fred Poordad, Eric J. Lawitz, Jonathan McCone, Mitchell L. Shiffman, Greg W. Galler,
William M. Lee, Robert Reindollar, John W. King, Paul Y. Kwo, Reem H. Ghalib, Bradley
Freilich, Lisa M. Nyberg, Stefan Zeuzem, Thierry Poynard, David M. Vock, Karen S. Pieper,
Keyur Patel, Hans L. Tillmann, Stephanie Noviello, Kenneth Koury, Lisa D. Pedicone, Clifford
A. Brass, Janice K. Albrecht, David B. Goldstein, John M. McHutchinson . Interleukin-28B
Polymorphism Improves Viral Kinetics and Is the Strongest Pretreatment Predictor of Sustained
Virologic Response in Genotype 1 Hepatitis C Virus. Gastroenterology 2010 Vol 139(1), pp 120-
129.
136. Paul Y Kwo, Eric J Lawitz, Jonathan McCone, Eugene R Schiff, John M Vierling, David
Pound, Mitchell N Davis, Joseph S Galati, Stuart C Gordon, Natarajan Ravendhran, Lorenzo
Rossaro, Frank H Anderson, Ira M Jacobson, Raymond Rubin, Kenneth Koury, Lisa D Pedicone,
Clifford A Brass, Eirum Chaudhri, Janice K Albrecht. Efficacy of boceprevir, an NS3 protease
inhibitor, in combination with peginterferon alfa-2b and ribavirin in treatment-naive patients with
genotype 1 hepatitis C infection (SPRINT-1): an open-label, randomised, multicentre phase 2
trial . Lancet 2010 Vol. 376 No. 9742 pp 705-716.
137 Andrew J Muir, Mitchell L Shhiffman, Atif Zaman, Boris Yoffe, Andrew de la Torre, Steven
Flamm, Stuart C Gordon, Paul Marotta, John M Vierling, Juan Carlos Lopez-Talavera, Kellly
28
Byrnes-Blake, David Fontana, Jeremy Freeman, Todd Gray, Diana Hausman, Naomi N Hunder,
and Eric Lawitz. Phase 1b study of pegylated interferon lambda 1 with or without ribavirin in
patients with chronic genotype 1 hepatitis C virus infection. Hepatology 2010. Vol 52, Number 3,
pgs 822-832.
138. Virologic response rates of weight-based taribavirin versus ribavirin in treatment-naive
patients with genotype 1 chronic hepatitis C. Fred Poordad, Eric Lawitz
, Mitchell L. Shiffman
,
Tarek Hassanein, Andrew J. Muir
, Bruce R. Bacon
, Jamie Heise,
Deanine Halliman
, Eric Chun,
Janet Hammond. Hepatology 2010. Volume 52(4), pgs 1208–1215.
139. Eric Lawitz, Maribel Rodriguez-Torres, Vinod K. Rustgi, Tarek Hassanein, Mohamad H.
Rahimy, Consance A. Crowley, James L. Freddo, Andrew J. Muir, John G. McHutchinson.
Safety and Antiviral Activity of ANA598 in combination with Pegylated Interferon a2A plus
Ribavirin in Treatment-Naïve Genotype-1 HCV Patients. Hepatology 2010. Volume 52(4) ppg
334A.
140. Norah Terrault, Curtis Cooper, Luis A. Balart, Dominique G. Larrey, Terry D. Box , Erick
M. Yoshida, Eric Lawitz, Peter Buggisch, Peter Ferenci, Martin Weltman, Emily Labriola-
Tompkins, Ying Zhang, Mercidita T. Navarro, Chin Yin Lim, Ellen S. Yetzer, Patrick Marcellin.
Phase II Randomised Partially-Blind, Parallel-Group Study of Oral Danoprevir (RG7227) with
PEGIFNa-2A (Pegasys) plus Ribavirin in Treatment-Naïve Genotype 1 Patients with CHC:
Results of planned week 12 Interim analysis of the Atlas Study.Hepatology 2010. Volume 52(4)
ppg 335A.
141. Maribel Rodriguez-Torres, Reem H. Ghalib, Stuart C. Gordon, Eric Lawitz, Keyur Patel,
Ronald Pruitt, Aasim M. Sheikh, Robert D. Arbiet, Alice S. Bxon, Ekambar R. Kamimalla,
Melissa Precopio, Tim Sullivan, Andrew J. Muir, John G. McHutchinson. IMO-2125, A TLR9
Agonist, induces immune Responses which correlate with reduction in viral load in null
responder HCV Patients. Hepatology 2010. Volume 52(4) ppg 336A.
142. Alexander J. Thompson, Abanish Singh, Jacques Fellay, Donglinag Ge, Mark S. Sulkowski,
Andrew J. Muir, Hans L. Tillmann, Keyur Patel, Susanna Naggie, Kevin Shianna, Nezam H.
Afdhal, Ira M. Jacobson, Rafael Esteban, Fred Poordad, Eric Lawitz, Jonathan McCone,
Mitchell L. Shiffman, Greg Wayne Galler, John W. King, Paul Y. Kwo, Lisa M. Nyberg,
Stephanie Noviello, Navdeep Boparai, Kenneth J. Koury, Lisa Pedicone, Clifford A. Brass,
Janice K. Albrecht, David B. Goldstein, John G. McHutchison. Genome-Wide Association Study
identifies an association between ITPA Gene Varients and IFN-Induced Thrombocytopenia in
Chronic Hepatitis C patients from the Ideal Study. Hepatology 2010. Volume 52(4) ppg 362A.
29
143. Paul Packros, Ira Jacobson, Thomas D. Boyer, Eugene R. Schiff, Gregory T. Everson,
William M. Lee, John M. Vierling, Eric Lawitz, Marcelo Kugelmas, Naoky Tsai, Mitchell L.
Shiffman, Robert S. Brown, Brian R. Armstrong, Alicia Mattson, Timothy C. Rodell, David
Apelian. GI-5005 Therapeutic Vaccine plus Peg-IFN/Ribavirin improves sustained Virologic
response versus Peg IFN/Ribavirin in prior Non-Responders with Genotype 2 Chronic HCV
Infection. Hepatology 2010. Volume 52(4) ppg 404A.
144. Bruce R. Bacon, Stuart C. Gordon, Eric Lawitz, Patrick Marcellin, John M. Vierling,
Stefan Zeuzem, Fred Poordad, Navdeep Boparai, Margaret Burroughs, Clifford A. Brass, Janice
K. Albrecht, Rafael Esteban. HCV Respond-2 Final Results: High Sustained Virologic response
among Genotype 1 previous Non-Responders and Relapsers to Peginterferon/Ribavirin when re-
treated with Boceprevir plus Pegintron (Peginterferon Alfa-2B)/Ribavirin. Hepatology 2010.
Volume 52(4) ppg 430A.
145. Alexander J. Thompson, Paul J. Clark, Jacques Fellay, Andrew J. Muir, Hans L. Tillmann,
Keyur Patel, Susanna Naggie, Nezam H. Afdhal, Ira M. Jacobson, Rafael Esteban, Fred Poordad,
Eric Lawitz, Jonathan McCone, Mitchell L. Shiffman, Greg Wayne Galler, John W. King, Paul
Y. Kwo, Lisa M. Nyberg, Zachary Goodman, Stephanie Noviello, Navdeep Boparai, Kenneth J.
Koury, Lisa Pedicone, Clifford A. Brass, Janice K. Albrecht, David B. Goldstein, John G.
McHutchison, Mark S. Sulkowski. IL28B Genotype is not associated with Advanced Hepatic
Fibrosis in Chronic Hepatitis C Patients enrolled in the Ideal Study. Hepatology 2010. Volume
52(4) ppg 437A.
146. Paul J. Clark, Alexander J. Thompson, Mingfu Zhu, Qianqian Zhu, Dongliang Ge, Mark S.
Sulkowski, Hans L. Tillmann, Keyur Patel, Susanna Naggie, Andrew J. Muir, Nezam H. Afdhal.
Ira M. Jacobson, Rafael Esteban, Eric Lawitz, Fred Poordad, Mitchell L. Shiffman, Greg Wayne
Galler, Stephen Harrison, John W. King, Paul Y. Kwo, Lisa M. Nyberg, Jonathan McCone,
William M. Lee, Robert Reindollar, Reem H. Ghalib, Bradley Freilich, Zachary Goodman,
Navdeep Boparai, Kenneth J. Koruy, Stephanie Noviello, Lisa Pedicone, Clifford A. Brass,
Janice K. Albrecht, David B. Goldstein, John G. McHutchison. IL28B Genetic Polymorphism
has Genome Wide significant associations with Serum Low Density Lipoprotein Levels and
Hepatic Steatosis in Patients with Genotype 1 Chronic Hepatitis C (CHC). Hepatology 2010.
Volume 52(4) ppg 439A.
147. John M. Vierling, Paul Y, Kwo, Eric Lawitz, Jonathan McCone, Eugene R. Schiff, David
Pound, Mitchell Davis, Joseph S. Galati, Stuart C. Gordon, Natarajan Ravendhran, Lorenzo
Rossaro, Frank Anderson, Ira M. Jacobson, Raymond Rubin, Lisa Pedicone, Eirum I. Chaudhri,
Xiao Tong, Ping Qiu, Richard J. Barnard, Clifford A. Brass, Janice K. Albrecht, Patricia
Mendez, Robert Ralston. Frequencies of Resistance-Associated Amino Acid Variants following
Combination Treatment with Boceprevir plus Pegintron (Peginterferon Alfa-2B)/Ribavirin in
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patients with Chronic Hepatits C (CHC), Genotype 1 (G1). Hepatology 2010. Volume 52(4) ppg
702A.
148. Eric Lawitz, Jacob P. Lalezari, Maribel Rodriguez-Torres, Kris V. Kowdley, David Nelson,
Edwin DeJesus, John G. McHutichson, Michael Mader, Efsevia Albanis, William Symonds,
Michelle Berrey. High Rapid Virologic Response (RVR) with PSI-7977 QD plus Peg-IFN / RBV
in a 28-Day phase 2A trial. Hepatology 2010. Volume 52(4) ppg 706A.
149. John G. McHutichson, David Goldstein, Kevin Shianna, Eric Lawitz, Jacob P. Lalezari,
Maribel Rodriguez-Torres, Kris V. Kowdley, David Nelson, Edwin DeJesus, William Symonds,
Michael Mader, Efsevia Albanis, William Symonds, Michelle Berrey. IL28B SNP Geographical
Distribution and Antiviral Reponses in a 28-Day Phase 2A trial of PSI-7977 daily dosing plus
PEG-IFN/RBV. Hepatology 2010. Volume 52(4) ppg 711A.
150. Mark S. Sulkowski, Stephen A. Harrison, Lorenzo Rossaro, Ke Qin Hu, Eric Lawitz,
Mitchell L. Shiffman, Andrew J. Muir, Greg Wayne Galler, Jonathan McCone, Lisa Marie
Nyberg, William M. Lee, Reem H. Ghalib, Jianmin Long, Stephanie Noviello, Clifford A. Brass,
Lisa Pedicone, Janice K. Albrecht, John G. McHutchison, John W. King. Impaired Fasting
Glucose is associated with lower rates of Sustained Virologic Response (SVR) in patients with
Genotype 1 analysis of the Ideal Study. Hepatology 2010. Volume 52(4) ppg 712A.
151. Eric Lawitz, John Hill, Thomas Marbury, Maribel Rodriguez-Torres, Michael DeMicco,
J.Quesada, Paula Shaw, Stuart Gordon, Mark Shelton, Derek Coombs, Jian Zong, Andrew Bae,
Kelly Wong, Hongmei Mo, Elsa Mondou, Kenneth Hirsch, William Delaney. Three-Day, Dose-
Ranging Study of the HCV NS3 Protease Inhibitor GS-9451. Hepatology 2010. Volume 52(4)
ppg 714A.
152. Andrew Muir, Eric Lawitz, Reem Ghalib, Norman Sussman, Frank Anderson, Gregory
Everson, Ira Jocobson, Juan Carlos Lopez-Talavera, Jan Hillson, Todd Gray, David Fontana,
Eleanor Ramos, Maribel Rodriguez-Torres. Pegylated Interferon Lambda (PEG-IFN) Phase 2
Dose-Ranging, Active-Controlled Study in Combination with Ribavirin (RBV) for treatment-
naïve HCV patients (Genotypes 1, 2, 3 or 4): Safety, Viral Response, and impact of IL-28B host
genotype through week 12. Hepatology 2010. Volume 52(4) ppg 715A.
153. Alexander Thompson, Paul Clark, Abanish Singh, Dongliang Ge, Jacques Fellay, Mark
Sulkowski, Andrew Muir, Hans Tillmann, Keyur Patel, Susanna Naggie, Kevin Shianna, Nezam
Afdhal, Ira Jacobson, Rafael Esteban, Fred Poordad, Eric Lawitz, Jonathan McCone, Mitchell
Shiffman, Greg Wayne Galler, John King, Paul Kwo, Lisa Nyberg, Stephanie Noviello, Navdeep
Boparai, Kenneth Koury, Lisa Pedicone, Clifford Brass, Janice Albrecht, David Goldstein, John
MCHutchinson. Common Genetic Variants do not associate with IFN-Induced Neutropenia in a
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Genome-Wide Association Study of Chronic Hepatitis C patients in the Ideal Study. Hepatology
2010. Volume 52(4) ppg 764A.
154. Anna Lok, David Gardiner, Eric Lawitz, Claudia Martorell, Gregory Everson, Reem
Ghalib, Robert Reindollar, Vinod Rustgi, Pamela Wendelberg, Kurt Zhu, Vaishali Shah, Diane
Sherman, Fiona McPhee, Megan Wind-Rotolo, Marc Bifano, Timothy Eley, Tong Guo, A.
Persson, Robert Hindes, Dennis Grasela, Claudio Pasquinelli. Combination Therapy with BMS-
790052 and BMS-650032 alone or with PEGIFN/RBV results in undetectable HCV RNA
through 12 weeks of therapy in HCV Genotype 1 Null responders. Hepatology 2010. Volume
52(4) ppg 877A.
155. Eric Lawitz, Isabelle Gaultier, Fred Poordad, Edwin DeJesus, Kris Kowdley, Gladys
Sepulveda, Diane Cohen, Rajeev Menon, Lois Larsen, Thomas Podsadecki, Barry Bernstein. 4-
Week Virologic Response and Safety of ABT-450 given with low-dose Ritonavir (ABT-450/R)
in combination with Pegylated Interferon Alpha-2A and Ribavirn (SOC) after 3-Day
Monotherapy in Genotype 1 (GT1) HCV-Infected Treatment-Naïve Subjects. Hepatology 2010.
Volume 52(4) ppg 878A.
156. Walker Long, Eric Lawitz, Yoav Lurie, Zahary Krastev, Dimitar Takov, Konstantin
Tchernev, Amy Rigney, Nimer Assy, Zobair Younossi. Adverse Event Reporting during HCV
Treatment via weekly clinic visits substantially underestimates flu frequency & severity
compared to daily Epro: results from 133 patients in Empower. Hepatology 2010. Volume 52(4)
ppg 881A.
157. Andrew Muir, Eric Lawitz, Maribel Rodriguez-Torres, Vinod Rustgi, Tarek Hassanein,
James Appleman, Constance Crowley, James Freddo, John McHutchison. IL28B Polymorphism
and Kinetics of Antiviral activity for ANA598 in combination with Pegylated Interferon a2A plus
Ribavirin in Treatment-Naïve Genotype-1 Chronic HCV patients. Hepatology 2010. Volume
52(4) ppg 1200A.
158. Eric Lawitz, Isabelle Gaultier, Fred Poordad, Daniel Cohen, Rajeev Memon, Lois Larsen,
Thomas Podsadecki, Barry Bernstein. Initial Antiviral activity of the HCV NS3 Protease
Inhibitor ABT-450 when given with low dose Ritonavir as 3-Day Monotherapy: Preliminary
results of study M11-602 in Genotype-1 (GT1) HCV-Infected Treatment-Naïve subjects.
Hepatology 2010. Volume 52(4) ppg 1202A.
159. Richard Nettles, Ziaodong Wang, Syed Quadri, Yaoshi Wu, Min Gao, Makonen Belema,
Eric Lawitz, R. Goldwater, Michael DeMicco, Thomas Marbury, Apinya Bee Vutikullird,
Ernesto Fuentes, A. Pearson, Dennis Grasela. BMS-824393 is a potent Hepatitis C Virus NS5A
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Inhibitor with Substantial Antiviral activity with given as Monotherapy in subjects with Chronic
G1 HCV Infection. Hepatology 2010. Volume 52(4) ppg 1203A.
160. Eric Lawitz, Jacob Lalezari, Maribel Rodriguez-Torres, Kris Kowdley, David Nelson,
Edwin DeJesus, John McHutchinson, Abel De La Rosa, William Symonds, Michelle Barrey.
Clinical Synergy of an Anti-HCV Nucleoside Analog with SOC: Viral Kinetics of PSI-7977
with SOC. Hepatology 2010. Volume 52(4) ppg 1205A.
161. Richard Nettles, Heather Sevinsky, Ellen Chung, David Burt, Hong Xiao, Thomas Marbury,
R. Goldwater, Michael DeMicco, Maribel Rodriguez-Torres, Ernesto Fuentes, Apinya Bee
Vutikullird, Eric Lawitz, A. Persson, Marc Bifano, Dennis Grasela. BMS-790052, A First-In
Class Potent Hepatitis C Virus NS5A Inhibitor, demonstrates multiple-dose Proof-Of-Concept in
subjects with Chronic GT1 HCV Infection. Hepatology 2010. Volume 52(4) ppg 1214A.
162. Alexander Thompson, Paul Clark, Mingfu Zhu, Qianqian Zhu, Dongliang Ge, Mark
Sulkowski, Andrew Muir, Hans Tillmann, Keyur Patel, Susanna Naggie, Nezam Afdhal, Ira
Jacobson, Rafael Esteban, Fred Poordad, Eric Lawitz, Jonathan McCone, Mitchell Shiffman
Greg Wayne Galler, John King, Paul Kwo, Lisa Nyberg, Zachary Goodman, Stephanie Noviello,
Navdeep Boparai, Kenneth Koury, Lisa Pedicone, Clifford Brass, Janice Albrecht, David
Goldstein, John McHutchison. Genome Wide-Association Study identifies IL28B
Polymorphism to be associated with baseline ALT and Hepatic Necro-Inflammatory activity in
Chronic Hepatitis C patients enrolled in the Ideal Study. Hepatology 2010. Volume 52(4) ppg
1220A.
163. John Vierling, John McHutchison, Ira Jacobson, Thomas Boyer, Eugene Schiff, William
Lee, Mitchell Shiffman, Naoky CS C. Tsai, Eric Lawitz, Claire Coeshott, Jean Boyer, Daniel
Schullery, Casey Krebs, Brian Armstrong, Timothy Rodell, David Apelian. GI-5005 Therapeutic
Vaccine improves deficit in Cellular Immunity in IL28B Genotype T/T, Treatment-Naïve
patients with Chronic Hepatitis C Genotype 2 when added to standard of care (SOC) PEG-IFN-
ALFA-2A/Ribavirin. Hepatology 2010. Volume 52(4) ppg 1258A.
164. S. Zeuzem, M.S. Sulkowski, E. J. Lawitz, V.K. Rustgi. M. Rodriguez-Torres, B.R. Bacon,
M. Grigorescu, A.D. Tice, Y. Lurie, J. Cianciara, A.J. Muir, P. W. Cronin, E. Pulkstenis, G. M.
Subramanian, J. G. McHutchison. Albinterferon Alfa-2b Was Not Inferior to Pegylated
Interferon in a Randomized Trial of Patients With Chronic Hepatitis C Virus Genotype 1.
Gastroenterology 2010 Volume 139(4), ppg1257-1266.
165. D. R. Nelson, Y. Benhamou, W. L. Chuang, E. J. Lawitz, M. Rodriguez-Torres, R. Flisiak,
J. W. F. Rasenack, W. Kryczka, C. M. Lee, V. G. Bain, S. Pianko, K. Patel, P. W. Cronin, E.
Pulkstenis, G. M. Subramanian, J. G. McHutchinson. Albinterferon Alfa-2b Was Not Inferior to
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Pegylated Interferon in a Randomized Trial of Patients With Chronic Hepatitis C Virus Genotype
2 or 3. Gastroenterology2010 Volume 139(4), ppg1267-1276.
166. Eric Lawitz, Eliot Godofsky, Regine Rouzier, Thomas Marbury, Tuan Nguyen, June Ke,
MeiMei Huang, Jens Praestgaard, Denise Serra, Thomas G. Evans. Safety, pharmacokinetics, and
antiviral activity of the cyclophilin inhibitor NIM811 alone or in combination with pegylated
interferon in HCV-infected patients receiving 14 days of therapy. Antiviral Research 2010
Volume 89(3), ppg 238-245.
167. Alexander J Thompson,Andrew J. Muir, Mark S Sulkowski, Dongliang GE, Jacques Fellay,
Kevin V. Shianna, Thomas Urban, Nezam Afdhal, Ira M. Jacobson, Rafael Esteban, Fred
Poordad, Eric J. Lawitz, Jonathon McCone, Mitchell L. Shiffman, Greg W. Galler, William M.
Lee, Robert Reindollar, John W. King, Paul Y. Kwo, Reem H. Ghalib, Bradley Freilich, Lisa M.
Nyberg, Stefan Zeuzam, Thierrt Ponyard, David M. Vock, Karen Pieper, Keyur Patel, Hans L.
Tillmann, Stephanie Noviello, Henneth Koury, Lisa D. Pedicone, Clifford A. Brass, Janice
Albrecht, David Goldstein and John G McHutchison. Interleukin-28B Polymorphism Improves
Viral Kinetics and Is the Strongest Pretreatment Predictor of Sustained Virologic Response in
Genotype 1 Hepatitis C Virus. Gastroenterology 2010;139:120–129.
168. Bruce R Bacon, Stuart C. Gordon, Eric Lawitz, Patrick Marcellin, John M. Veirling, Stefan
Zeuzem, Fred Poordad, Zachary D. Goodman, Heather L. Sings, Navdeep Boparai, Margaret
Burroughs, Clifford A Brass, Janice K. Albrecht, Rafael Estaban. Boceprevir for Previously
Treated Chronic HCV Genotype 1 Infection. New England of Journal of Medicine
2011;364:1207-17.
169. J. Lalezari, E. Lawitz, M. Rodriguez-Torres, A. Seikh, B. Freilich, D.R. Nelson, T.
Hassanein, M. Mader, E. Albanis, W. Symonds, M.M. Berrey. Once daily PSI-7977 plus
PEGIFN/RBV in phase 2B trial: Rapid virologic suppression in treatment-naïve patients with
HCV GT2/GT3. Journal of Hepatology 2011 Vol 54 (supp1),S28.
170. P.J. Clark, A.J. Thompson, M. Zhu, D. Ge, K. Shianna, H.L. Tillmann, K. Patel, T. Urban,
A. Singh, M. Sulkowski, N. Afdhal, I. Jacobson, E. Esteban, F. Poordad, E. Lawitz, J. McCone,
M.L. Shiffman, G. Galler, W.M. Lee, R. Reindollar, J. King, P. Kwo, R. Ghalib, B. Freilich, L.
Nyberg, S. Noviello, N. Bopari, K. Koury, L.D. Pedicone, C. Bass, J.K. Albrecht, D. Goldstein,
J.G. McHutchinson. Phosphodiesterase Polymorphisms may be associated with baseline thyroid
stimulating hormone (TSH) and Peginterferon treatment induced hypothyroidism in patients with
chronic Hepatitis C. Journal of Hepatology 2011 Vol 54 (supp1),S56.
171. R. Esteban, S. Gordon, E. Lawitz, P. Marcellin, J. Vierlin, S. Zeuzem, F. Poordad, N.
Boparai, M. Burroughts, J. Albrecht, C. Brass, B. Bacon. Utility of historical data compared to
lead-in response in predicting sustained virologic response to non-responders and relapsers to
Peginterferon/Ribavirin when re-treated with Boceprevir + Peginterferon Alfa-2B/Ribavirin
(P/R). Journal of Hepatology 2011 Vol 54 (supp1),S168.
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172. E. Lawitz, Z. Younossi, P. Mehra, A. Rigney, Z. Krastev, K. Tcernev, D. Takov. W.A.
Long. SVR for controlled-release Interferon Alpha-2B (CR2B) + Ribavirin compared to
Pegylated Interferon Alpha-2B (PEG2B) + Ribavirin in treatment-naïve genotype-1 (G1)
Hepatitis C: Final results from Select-2. Journal of Hepatology 2011 Vol 54 (supp1),S180.
173. E. Lawitz, I. Jacobson, E. Godofsky, G.R. Foster, R. Flisiak, M. Bennett, M. Ryan, J.
Hinkle, J. Simpson, J. McHutchison, D. Oldach. A Phase 2B trial comparing 24 to 48 weeks
treatment with Tegobuvir (GS-9190)/Peg/RBV to 48 weeks treatment with Peg/RBV for chronic
genotype 1 HCV infection. Journal of Hepatology 2011 Vol 54 (supp1),),S181.
174. W.A. Long, Z. Younossi, E. Lawitz, I. Kotsev, D. Takov, K. Tchernev, A. Rigney, R.
Ghalib, S. Stoinov, R. Balabanska, P. Mehra, Z. Krastev. Timing and frequency of depression
during HCV-treatment with controlled-release-IFNA2B (CR2B) vs. Pegylated-IFNA2B
(PEG2B): Results from Select-2, A randomized-open-label-72-week-comparison in 116
treatment-naïve patients with genotype-1 HCV. Journal of Hepatology 2011 Vol 54
(supp1),),S181.
175. V. Sekar, A. Simion, M. Peeters, K. Spittaels, E. Lawitz, T.C. Marbury, D. DeSmedt.
Pharmacokinetics of TMC435 in subjects with moderate Hepatic Impairment. Journal of
Hepatology 2011 Vol 54 (supp1),S193.
176. E. Lawitz, D. Gruener, J. Hill, T. Marbury, S. Komjathy, M. DeMicco, A. Murillo, F.
Jenkin, K. Kim, J. Simpson, M. Aycock, A. Mathias, C. Yang, E. Dowdy, M. Liles, G. Cheng, E.
Mondou, J. Link, D. Brainard, J. McHutchinson, C. Ohmstede, R. Bannister. Three-Day, Dose-
Ranging study of the HCV NS5A Inhibitor GS-5885. Journal of Hepatology 2011 Vol 54
(supp1),S481.
177. E. Lawitz, I. Gaultier, F. Poordad, D.E. Cohen, R. Menon, L.M. Larsen, T. Podsadecki, B.
Bernstein. ABT-450/Ritonavir (ABT-450/R) combined with Pegylated Interferon Alpha-2A and
Ribavirin (SOC) after 3-day monotherapy in genotype 1 HCV-infected treatment-naïve subjects:
12 week interim efficacy and safety results. Journal of Hepatology 2011 Vol 54 (supp1),S482.
178. M. Rodriguez-Torres, E. Lawitz, J. Denning, M. Cornpropst, E. Albanis, W. Symonds,
M.M. Berrey. PSI-352938, a novel Purine Nucleotide Analog, exhibits potent antiviral activity
and no evidence of resistance in patients with HCV genotype 1 over 7 days. Journal of
Hepatology 2011 Vol 54 (supp1),S488.
179. A.Lok, D. Gardiner, E. Lawitz, C. Martorell, G. Everson, R. Ghalib, R. Reindollar, V.
Rustgi, F. McPhee, M. Wind-Rotolo, A. Persson, K. Zhu, D. Dimitrova, T. Eley, T. Guo, D.
Grasela, C. Pasquinelli. Quadruple therapy with BMS-790052, BMS-650032 and PEG-IFN/RBV
for 24 weeks results in 100% SVR12 in HCV genotype 1 null responders. Journal of Hepatology
2011 Vol 54 (supp1),S536.
180. S. Zeuzem, S. Arora, B. Bacon, M. Charlton, M. Diago, D. Dieterich, R. Esteban Mur, G.
Everson, M. Fallon, P. Ferenci, R. Flisiak, J. George, R. Ghalib, N. Gitlin, A. Gladysz, S.
35
Gordon, S. Greenbloom, T. Hassanein, I. Jacobson, L. Jeffers, K. Kowdley, E. Lawitz, S. Lee, B.
Leggett, S. Lueth, D. Nelson, P. Pockros, M. Rodriguez-Torres, V. Rustgi, L. Serfaty, M.
Sherman, M. Shiffman, R. Sola, M. Sulkowski, H. Vargas, J. Vierling, B. Yoffe, L. Ishak, D.
Fontana, D. Xu, J. Lester, T. Gray, A. Horga, J. Hillson, E. Ramos, J.C. Lopez-Talavera, A.
Muir. Pegylated Interferon-Lambda (PEGIFN- ) shows superior viral response with improved
safety and tolerability versus PEGIFNa-2A in HCV patients (G1/2/3/4): Emerge phase IIB
through week 12. Journal of Hepatology 2011 Vol 54 (supp1),S538.
181. S. Flamm, E. Lawitz, I. Jacobson, R. Rubin, M. Bourliere, C. Hezode, J. Vierling, C.
Niederau, M. Sherman, V. Gotei, R. Vilchez, C. Brass, J. Albrecht, F. Poordad. High sustained
virologic response (SVR) among genotype 1 previous non-responders and relapsers to
Peginterferon/Ribavirin with re-treated with Boceprevir (BOC) plus Peginterferon Alfa-
2A/Ribavirin. Journal of Hepatology 2011 Vol 54 (supp1),S541.
182. E. Lawitz, M. Rodriguez-Torres, J. Denning, M. Cornpropst, D. Clemons, L. Mnair, M.M.
Berrey, W. Symonds. Once daily dual-nucleotide combination of PSI-938 and PSI-7977 provides
94% HCV RNA <LOD at Day 14: First Purine/Pyrimidine clinical combination data (The
Nuclear Study). Journal of Hepatology 2011 Vol 54 (supp1),S543.
183. D.R. Nelson, J. Lalezari, E. Lawitz, T. Hassanein, K. Kowdley, F. Poordad, A. Sheikh, N.
Afdhal, D. Bernstein, E. Dejesus, B. Freilich, D. Dieterich, I. Jacobson, D. Jensen, G.A.Abrams,
J. Darling, M. Rodriguez-Torres, R. Reddy, M. Sulkowski, N. Bzowej, M. Demicco, J.
Strohecker, R. Hyland, M. Mader, E. Albanis, W.T. Symonds, M.M. Berrey. Once daily PSI-
7977 plus PEG-IFN/RBV in HCV GT1: 98% rapid virologic response, complete early virologic
response: The Proton Study. Journal of Hepatology 2011 Vol 54 (supp1),S544.
184. S. Zeuzem, P. Andreone, S. Pol, E. Lawitz, M. Diago, S. Roberts, R. Focaccia, Z.M.
Younossi, G.R. Foster, A. Horban, P.J. Pockros, R. Van Heeswijk, S. de Meyer, D. Luo, G.
Picchio, M. Beumont. Realize trail final results: Telaprevir-Based regimen for genotype 1
Hepatitis C Virus infection in patients with prior null response, partial response or relapse to
Peginterferon/Ribavirin. Journal of Hepatology 2011 Vol 54 (supp1),S3.
185. G.R. Foster, S. Zeuzem, P. Anderone, S. Pol, E. Lawitz, M. Diego, S. Roberts, J. Pockros,
Z. Younossi, I. Lonjon-Domanec, R. Van Heeswijk, S. de Meyer, D. Luo, S. George, M.
Beumont, G. Picchio. Subanalyses of theTeleprevir lead-in arm in the Realize Study: Response
at week 4 is not a substitute for prior null response categorization. Journal of Hepatology 2011
Vol 54 (supp1),S3.
186. S. Pol, J. Aarssens, S. Zeuzem, P. Andreone, E. Lawitz, S. Roberts, Z. Younossi, G. R.
Foster, R. Focaccia, A. Horban, P. Pockros, R. Van Heeswijk, S. de Meyer, D. Luo, M. Botfield,
M. Beumont, G. Picchio. Similar SVR rates in IL28B CC, CT or TT prior relapsers, partial-or
null-responder patients treated with Telaprevir/Peginterferon/Ribavirin: Retrospective analysis
of the realize study. Journal of Hepatology 2011 Vol 54 (supp1),S6.
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187. S.C. Gordon, E. Lawitz, B. Bacon, M. Sulkowski, E. Yoshida, M. Davis, N. Boparai, V.
Sniukiene, M. Burroughs, C. Brass, J. Albrecht, K. R. Reddy. Adherence to assigned dosing
regimen and sustained virologic response among Hepatitis C genotype 1 treatment-naïve and
Peg-Ribivirin treatment-failures treated with Boceprevir plus Peginterferon Alfa-2B/Ribavirin.
Journal of Hepatology 2011 Vol 54 (supp1),S173.
188. M. Melia, N. Brau, F. Poordad, E. Lawitz, M. Shiffman, J. McHutchison, A. Muir, G.
Galler, J. McCone, L. Nyberg, W. Lee, R. Ghalib, E. Schiff, J. Long, S. Noviello, C. Brass, L.
Pedicone, J. Albrecht, M. Sulkowski. Infections during Peginterferon (PEGIFN)/Ribavirin
(RBV) Therapy are associated with the magnitude of decline in the Lymphocyte count: Results
of the Ideal Study. Journal of Hepatology 2011 Vol 54 (supp1),),S195.
189. J. Vierling, E. Lawitz, F. Poordad, M. Sulkowski, M. Bourliere, M. Buti, C. Cooper, J.
Galati, J. Albrecht, N. Boparai, C. Brass, M. Burroughts, V. Sniukiene, S. Bruno . Four-week
therapy with Peginterferon Alfa-2B/Ribavirin effectively predicts sustained virologic response in
treatment-naïve and previous-treatment-failure patients with HCV-1 treated with Boceprevir plus
Peginterferon Alfa-2B/Ribavirin. Journal of Hepatology 2011 Vol 54 (supp1),S197.
190. Stefan Zeuzem, Pietro Andreone, Stanislas Pol, Eric Lawitz, Moises Diago, Stuart Roberts,
Roberto Focaccia, Zobair Younossi, Graham R. Foster, Andrzej Horban, Peter Ferenci, Frederik
Nevens, Beat Müllhaupt, Paul Pockros, Ruben Terg, Daniel Shouval, Bart van Hoek Ola
Weiland, Rolf Van Heeswijk, Sandra De Meyer, Don Luo, Griet Boogaerts, Ramon Polo, Gaston
Picchio, and Maria Beumont. Telaprevir for Retreatment of HCV Infection. New England of
Journal of Medicine 2011;364:2417-28.
191. Eric Lawitz. Advances in Hepatology: Diagnosis and Management of Telaprevir-
Associated Rash. Gastroenterology and Hepatology 2011; 7(7); 469-471.
192. C. Hezode; G. M. Hirschfield; W. Ghesquiere; W. Sievert; M. Rodriguez-Torres; S. D.
Shafran; P. J. Thuluvath; H. A. Tatum; I. Waked; G. E. Esmat; E. Lawitz; V. K. Rustgi; S. Pol;
N. Weis; P. Pockros; M. Bourliere; L. Serfaty; J. M. Vierling; M. W. Fried ; O. Weiland; M. R.
Brunetto; G. T. Everson; S. Zeuzem; P. Y. Kwo; M. S. Sulkowski; P. D. Yin; U. A. Diva; E. A.
Hughes; M. Wind-Rotolo; S. M. Schnittman. BMS-790052, A NS5A Replication Complex
Inhibitor, Combined with Peginterferon Alfa-2a and Ribivirin in Treatment-Naive HCV-
Genotype 1 or 4 Patients: Phase 2b AI444010 Study Interim Week 12 Results. Hepatology 2011.
Volume 54(4) ppg 474A.
193. E. Lawitz; J. P. Lalezari; T. Hassanein; K. V. Kowdley; F. Poordad; A. M. Sheikh; N. H.
Afdhal; D. Bernstein; E. DeJesus; B. Freilich; D. R. Nelson; D. T. Dieterich; I. M. Jacobson; D.
M. Jensen ; G. A. Abrams; J. M. Darling; M. Rodriguez-Torres; K. Reddy; M. S. Sulkowski; N.
H. Bzowej; M. p. DeMicco; J. S. Strohecker; R. H. Hyland; M. Mader; E. Albanis; W. T.
Symonds; M. Berrey. Once-Daily PSI-7977 Plus Peg/RBV in Treatment-naïve Patients with
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HCV GT1: Robust End of Treatment Response Rates are Sustained Post-treatment. Hepatology
2011. Volume 54(4) ppg 472A.
194. M. Rodriguez-Torres; E. Lawitz; L. Hazan; A. N. Barry; E. D. Wenzel; J. Alam; G. W.
Henson; J. Patti. Antiviral Activity and Safety of INX-08189, a Nucleotide Polymerase Inhibitor,
Following 7-Days of Oral Therapy in Naïve Genotype-1 Chronic HCV Patients. Hepatology
2011. Volume 54(4) ppg 534A.
195. A. Jazwinski; P. J. Clark; A. J. Thompson; S. C. Gordon; E. Lawitz; J. McCone; S.
Noviello; C. A. Brass; L. Pedicone; J. K. Albrecht; M. S. Sulkowski; A. J. Muir. Predictors of
consent to pharmacogenomics testing in the IDEAL study. Hepatology 2011. Volume 54(4) ppg
554A.
196. S. Zeuzem; G. R. Foster; P. Andreone; S. Pol; E. Lawitz; M. Diago; S. K. Roberts; P.
Pockros; Z. M. Younossi; I. Lonjon-Domanec; R. van Heeswijk; S. De Meyer; R. Polo; D. Luo;
S. George; J. Witek; G. Picchio. Different likelihood of achieving SVR on a telaprevir-
containing regimen among null responders, partial responders and relapsers irrespective of
similar responses after a peginterferon/ribavirin 4-week lead-in phase: REALIZE study
subanalysis. Hepatology 2011. Volume 54(4) ppg 986A.
197. J. P. Lalezari; L. Hazan; M. Kankam; E. Lawitz; F. Poordad; V. Araya; R. Ghalib; B. R.
Bacon; S. L. Flamm; E. Godofsky; F. Hinestrosa; E. Olek; H. Robison; L. Robarge. High Rapid
Virologic Response(RVR) with ACH-1625 Daily Dosing plus PegIFN-alpha 2a/RBV in a 28-day
Phase 2a Trial . Hepatology 2011. Volume 54(4) ppg 992A.
198. S. K. Roberts; P. Andreone; S. Pol; Z. M. Younossi; M. Diago; E. Lawitz; R. Focaccia; G.
R. Foster; A. Horban; I. Lonjon-Domanec; R. DeMasi; R. van Heeswijk; G. Picchio; J. Witek; S.
Zeuzem. Impact of anemia and ribavirin dose reduction on SVR to a telaprevir-based regimen in
patients with HCV genotype 1 and prior peginterferon/ribavirin treatment failure in the Phase III
REALIZE study. Hepatology 2011. Volume 54(4) ppg1007A.
199. Z. M. Younossi; F. Negro; L. Serfaty; S. Pol; M. Diago; S. Zeuzem; P. Andreone; E.
Lawitz; S. K. Roberts; R. Focaccia; G. R. Foster; A. Horban; I. Lonjon-Domanec; B. Coate; R.
DeMasi; G. Picchio; J. Witek. Impact of insulin resistance on virologic response to a telaprevir-
based regimen in patients with HCV genotype 1 and prior peginterferon/ribavirin treatment
38
failure: post-hoc analysis of the REALIZE Phase III study. Hepatology 2011. Volume 54(4) ppg
1008A.
200. A. Rabiee; H. L. Tillmann; F. Poordad; E. Lawitz; M. L. Shiffman; A. J. Muir; S.
Noviello; C. A. Brass; L. Pedicone; J. K. Albrecht; M. S. Sulkowski; I. M. Jacobson. Influence of
hepatitis C virus (HCV) genotype-1 (G1) subtype, baseline viral load and IL28B genotype on
peginterferon (PEG)/ribavirin (RBV) treatment response: Results of the IDEAL study.
Hepatology 2011. Volume 54(4) ppg 998A.
201. M. Rodriguez-Torres; J. L. Hillson; B. R. Bacon; T. D. Box; T. Hassanein; S. Greenbloom;
E. Lawitz; H. E. Vargas; J. M. Vierling; M. Horga; E. Ramos; D. Fontana; J. A. Freeman; T. E.
Gray; R. Bittner; D. Xu; L. Ishak; J. Lopez-Talavera. Safety and Efficacy of Pegylated Interferon
Lambda (peg-lambda) Compared to Pegylated Interferon α-2a (peg-alfa) in HCV-Infected
Patients (G1/2/3) With Compensated Cirrhosis: EMERGE Phase IIB Efficacy and Safety Results
through Week 12. Hepatology 2011. Volume 54(4) ppg 994A.
202. F. Poordad; E. Lawitz; S. C. Gordon; M. Bourlière; J. M. Vierling; T. Poynard; A. Craxi;
M. P. Manns ; A. Alberti; L. Pedicone; M. Burroughs; R. M. Lambert; C. A. Brass; J. K.
Albrecht; S. Bruno. Concomitant Medication Use in Patients with Hepatitis C Genotype 1
Treated with Boceprevir (BOC) Combination Therapy. Hepatology 2011. Volume 54(4)
ppg799A.
203. S. C. Gordon; K. Reddy; J. McCone; I. M. Jacobson; R. Esteban; L. Pedicone; J. Shen; M.
Burroughs; C. A. Brass; J. K. Albrecht; E. Lawitz. Effect of Baseline Viral Load (VL) on
Response to Boceprevir (BOC) Plus Peginterferon Alfa-2b/Ribavirin (PR) in Patients Infected
with HCV Genotype 1. Hepatology 2011. Volume 54(4) ppg 812A.
204. J. M. Vierling; S. L. Flamm; S. C. Gordon; E. Lawitz; J. Bronowicki; M. Davis; E. M.
Yoshida; L. Pedicone; W. Deng; M. A. Treitel; C. A. Brass; J. K. Albrecht; I. M. Jacobson.
Efficacy of Boceprevir in Prior Null Responders to Peginterferon/Ribavirin: the PROVIDE
Study. Hepatology 2011. Volume 54(4) ppg 796A.
205. N. Terrault; C. Cooper; L. A. Balart; D. G. Larrey; T. D. Box; E. Yoshida; E. Lawitz; P.
Buggisch; P. Ferenci; M. Weltman; E. Labriola-Tompkins; D. N. Thomas; G. Hooper; N.
Shulman; Y. Zhang; M. T. Navarro; C. Lim; E. S. Yetzer; P. Marcellin. High sustained virologic
39
response (SVR24) rates with response-guided danoprevir (DNV; RG7227) plus PegIFN α-2a
(40KD) and ribavirin (P/R) in treatment-naive HCV genotype 1 (G1) patients: Results from the
ATLAS study. Hepatology 2011. Volume 54(4) ppg 398A.
206. S. L. Flamm; E. Lawitz; I. M. Jacobson; M. Bourliere; C. Hezode; J. M. Vierling; C.
Niederau; M. Sherman; B. R. Bacon; L. Pedicone; V. S. Goteti; M. Burroughs; C. A. Brass; J. K.
Albrecht; F. Poordad. Overall Safety Profile of Boceprevir (BOC) Plus Peginterferon alfa-
2a/Ribavirin in Genotype 1 Previous Non-Responders and Relapsers to Peginterferon/Ribavirin .
Hepatology 2011. Volume 54(4) ppg 838A.
207. E. Lawitz; F. Poordad; J. Bronowicki; P. Marcellin; V. S. Feinman; P. Y. Kwo; D.
Guyader; M. Davis; S. A. Harrison; L. Pedicone; W. Deng; M. Burroughs; C. A. Brass; J. K.
Albrecht; S. Zeuzem. The Effect of Using Lower Limit of Quantitation (LLQ) vs Lower Limit of
Detection (LLD) for the Definition of Undetectable HCV RNA: Data from the RESPOND-2 and
SPRINT-2 Trials. Hepatology 2011. Volume 54(4) ppg 442A.
208. A. J. Thompson; P. J. Clark; H. L. Tillmann; K. Patel ; S. Naggie; F. Poordad; E. Lawitz;
B. R. Bacon; J. M. Vierling; S. Noviello; C. A. Brass; J. K. Albrecht; D. B. Goldstein; J. G.
McHutchison; M. S. Sulkowski; A. J. Muir. IL28B C/C genotype is predictive of ≥ 1 log10
IU/mL reduction in plasma HCV RNA after 4 weeks of peginterferon (pegIFN) and ribavirin
(RBV) therapy: implications for the use of the lead-in strategy for direct-acting antiviral-based
treatment regimens. Hepatology 2011. Volume 54(4) ppg436A.
209. S. Pol; S. K. Roberts; P. Andreone; Z. M. Younossi; M. Diago; E. Lawitz; R. Focaccia; G.
R. Foster; A. Horban; I. Lonjon-Domanec; R. DeMasi; R. van Heeswijk; S. De Meyer; G.
Picchio; J. Witek; S. Zeuzem. Efficacy and safety of telaprevir-based regimens in cirrhotic
patients with HCV genotype 1 and prior peginterferon/ribavirin treatment failure: subanalysis of
the REALIZE Phase III study. Hepatology 2011. Volume 54(4) ppg 374A
210. T. Berg; P. Andreone; S. Pol; S. K. Roberts; Z. M. Younossi; M. Diago; E. Lawitz; R.
Focaccia; G. R. Foster; A. Horban; I. Lonjon-Domanec; R. DeMasi; G. Picchio; J. Witek; S.
Zeuzem. Predictors of virologic response with telaprevir-based combination treatment in HCV
genotype 1-infected patients with prior peginterferon/ribavirin treatment failure: post-hoc
analysis of the Phase III REALIZE study. Hepatology 2011. Volume 54(4) ppg 375A
211. H. L. Janssen; H. W. Reesink; S. Zeuzem; E. Lawitz; M. Rodriguez-Torres; A. Chen; C.
Davis; B. King; A. A. Levin; M. R. Hodges. A Randomized, Double-blind, Placebo (PLB)
Controlled Safety and Anti-viral Proof of Concept Study of Miravirsen (MIR), an
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Oligonucleotide Targeting miR-122, In Treatment Naïve Patients with Genotype 1 (GT1)
Chronic HCV Infection. Hepatology 2011. Volume 54(4) ppg 1430A
212. N. Afdhal; G. Dusheiko; E. G. Giannini; P. Chen; K. Han; A. Moshin; M. Rodriguez-
Torres; S. Rugina; E. Lawitz; M. L. Shiffman; G. Tayyab; F. Poordad; Y. Mostafa Kamel; A.
Brainsky; J. Geib; S. Y. Vasey; R. Patwardhan; F. M. Campbell; D. Theodore. Final Results of
ENABLE 1, a Phase 3, Multicenter Study of Eltrombopag as an Adjunct for Antiviral Treatment
of Hepatitis C Virus-Related Chronic Liver Disease Associated With
Thrombocytopenia. Hepatology 2011. Volume 54(4) ppg 1427A.
213. E. Lawitz; M. Rodriguez-Torres; A. Stoehr; E. J. Gane; L. Serfaty; S. Bhanja; R. J.
Barnard; D. An; J. Gress; P. Hwang; N. Mobashery. A Phase 2b study of MK-7009 (vaniprevir)
in patients with genotype 1 HCV infection who have failed previous pegylated interferon and
ribavirin treatment. Hepatology 2011. Volume 54(4) ppg1434A.
214. J. M. Vierling; F. Poordad; E. Lawitz; R. H. Ghalib; W. M. Lee; N. Ravendhran; J. S.
Galati; B. R. Bacon; S. L. Flamm; L. A. Balart; B. Freilich; E. R. Schiff; I. M. Jacobson; P. Y.
Kwo; S. C. Gordon; M. S. Sulkowski; R. Jiang ; N. Boparai; E. I. Chaudhri; M. A. Treitel; E. A.
Hughes; C. A. Brass; J. K. Albrecht. Once Daily Narlaprevir (NVR; SCH 900518) and Ritonavir
(RTV) in Combination with Peginterferon alfa-2b/Ribavirin (PR) for 12 weeks plus 12 weeks PR
in Treatment-Naïve Patients with HCV Genotype 1 (G1): SVR Results from NEXT-1, a Phase 2
Study. Hepatology 2011. Volume 54(4) ppg 1437A.
215. Fernando E. Membreno; Eric J Lawitz. Hepatitis C Direct Acting Antivirals: The New
Standard of Care; The HCV NS5B Nucleoside and Non Nucleoside Inhibitors. Clinics In Liver
Disease August 2011 Volume 15(3); ppg 611-627.
216. Peter Varunok,Eric Lawitz, Kimberly L Beavers,Gary Matusow, Ruby Leong, Nathalie
Lambert, Coen Bernaards, Jonathan Solsky, Barbara J Brennan,Cynthia Wat, Anne Bertasso.
Evaluation of pharmacokinetics, user handling, and tolerability of peginterferon alfa-2a (40 kDa)
delivered via a disposable autoinjector device. Patient Preference and Adherence 2011:5 587–
599.
217. Richard Nettles, Min Gao, Marc Bifano, Ellen Chung, Anna Persson, Thomas C Marbury,
Ronald Goldwater, Michael P DiMicco, Maribel Rodriguez-Torres, Apinya Vutikullird, Ernesto
Fuentes, Eric Lawitz, Juan Carlos Lopez-Talavera, Dennis M Grasela. Multiple Ascending dose
study of BMS-790052, a nonstructural protein 5A replication complex inhibitor, in patients
infected with Hepatitis C Virus genotype 1. Hepatology 2011; Vol 54(6) ppg 1956-1965.
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218. Keyur Patel, Seng G Lim, Chow W Cheng, Eric Lawitz, Hans L Tillmann, Narinder
Chopra, Ralf Altmeyer, John Cr Randle, John G McHutchison. Open-label Phase 1b pilot study
to assess the antiviral efficacy of simvastatin combined with sertraline in chronic hepatitis C
patients. Antiviral Therapy 2011;16: 1351-55.
219. Alexander J. Thompson, Paul J. Clark, Abanish Singh, Dongliang Ge, Jacques Fellay,
Mingfu Zhu, Qianqian Zhu, Thomas J. Urban, Keyur Patel, Hans L. Tillmann, Susanna Naggie,
Nezam H. Afdhal, Ira M. Jacobson, Rafael Esteban, Fred Poordad, Eric J. Lawitz, Jonathan
McCone, Mitchell L. Shiffman, Greg W. Galler, John W. King, Paul Y. Kwo, Kevin V. Shianna,
Stephanie Noviello, Lisa D. Pedicone, Clifford A. Brass, Janice K. Albrecht, Mark S. Sulkowski,
David B. Goldstein, John G. McHutchison, Andrew J. Muir. Genome-wide association study of
interferon-related cytopenia in chronic hepatitis C patients . Journal of Hepatology 2012; Vol 56
(2) ppg 313-319.
220. Anna S. Lok, David F. Gardiner, Eric Lawitz, Claudia Martorell, Gregory T. Everson,
Reem Ghalib, Robert Reindollar, Vinod Rustgi, Fiona McPhee, Megan Wind-Rotolo, Anna
Persson, Kurt Zhu, Dessislava I. Dimitrova, Timothy Eley, Tong Guo, Dennis M. Grasela,
Pharm.D, and Claudio Pasquinelli. Preliminary Study of Two Antiviral Agents for Hepatitis C
Genotype 1. N Engl J Med 2012; 366:ppg.216-224.
221. Alexander J Thompson,Keyur Patel, Wan-Long Chuang, Eric J Lawitz, Maribel
Rodriguez-Torres, Vinod K Rustgi,Robert Flisiak, Stephen Pianko, Moises Diago, Sanjeev
Arora, Graham R Foster, Michael Torbenson, Yves Benhamou, David R Nelson, Mark S
Sulkowski, Stefan Zeuzem, Erik Pulkstenis, G Mani Subramanian, John G McHutchison. Viral
clearance is associated with improved insulin resistance in genotype 1 chronic hepatitis C but not
genotype 2/3. Gut 2012;61:128-134
222. Thompson AJ, Clark PJ, Singh A, Ge D, Fellay J, Zhu M, Zhu Q, Urban TJ, Patel K,
Tillmann HL, Naggie S, Afdhal NH, Jacobson IM, Esteban R, Poordad F, Lawitz EJ, McCone J,
Shiffman ML, Galler GW, King JW, Kwo PY, Shianna KV, Noviello S, Pedicone LD, Brass CA,
Albrecht JK, Sulkowski MS, Goldstein DB, McHutchison JG, Muir AJ. Genome-wide
association study of interferon-related cytopenia in chronic hepatitis C patients. Journal of
Hepatology 2012 Feb;56(2):313-9.
223. Lawitz E, Rodriguez-Torres M, Cornpropst M.T, Denning J.M, Clemons D, McNair L,
Fang L, Berrey M.M, Symonds W.T. The Effect of Hepatic Impairment on the Pharmacokinetics
and Antiviral Activity of PSI-7977 in Hepatitis C Infected Subjects Treated for Seven Days.
Journal of Hepatology 2012, Volume 56 (suppl), ppg 445
224. Lawitz E., Poordad F, DeJesus E, Kowdley K, Gaultier I, Cohen D, Xie W, Larsen L, Pilot-
Maitias T, Menon R.M, Podsadecki T, Bernstien B. ABT-450/Ritonavir (ABT-450/R) combined
with Peglayted Interferon Alpha- 2A/Ribavirin after 3-day monotherapy in Genotype 1 (GT1)
42
HC- infected treatment- naïve subjects 12-week sustained viologic response (SVR12) and safety
results. Journal of Hepatology 2012. Volume 56 (suppl), ppg 470
225. Lawitz E, Hill J, Marbury T, Hazan L, Gruener D, Webster L, Majuskas R, Morrison R,
DiMicco M, German P, Stefanidis D, Savroskaia E, Jain A, Arterburn S, Ray A, Rossi S,
McHutchison J, Rodriguez-Torres M. GS-6620 , A Liver- Targeted Nucleotide Prodrug,, exhibits
antiviral activity and favorable safety profile over 5 days in treatment naïve chronic HCV
genotype 1 subjects. Journal of Hepatology 2012. Volume 56 (suppl), ppg 470
226. Lawitz E, Hazan L, Gruener D, Hack H, Backonja M, Hill J, German P, Dvory-Sobol H,
Jain A, Arterburn S, Watkins W. J, Rossi S, McHutchison J, Rodriguez-Torres M. GS-9669, A
novel NS5B Non-Nucleotide Site II inhibitor, demonstrates potent antiviral activity, favorable
profile and potential for once-daily dosing. Journal of Hepatology 2012. Volume 56 (suppl), ppg
471
227. Lawitz E, Hazan L, Gruener D, Hack H, Backonja M, Hill J, German P, Dvory-Sobol H,
Jain A, Arterburn S, Watkins W.J, Rossi S, McHutchison J, Rodriguez-Torres M, Reddy K.R,
Sulkowski M.S, Bzowej N, H, DeMicco M.P, Strohecker J.S, Hyland R.H, Anderson J.K, Baker
C, Kirven S, Hindes R.G, Albanis E, Symonds W.T, Berrey M.M. PSI-7977 Proton and
Electron: 100% Concordance of SVR4 with SVR24 in HCV GT1, GT2, & GT3. Journal of
Hepatology 2012, Volume 56, (suppl), ppg 4
228. Lawitz E, Poordad F, Kowdley K.V, Jensen D, Cohen D.E, Siggelkow S, Wikstrom K,
Larsen L, Menon R. M, Podsadecki T, Bernstein B. A 12 week Interferon- free regiment of
ABT-450/R, ABT-072, and ribavirin was well tolerated and achieved sustained virologic
response in 91% treatment naïve HCV I L28B-CC Genotype-1 infected subjects. Journal of
Hepatology 2012. Volume 56 (suppl), ppg 7
229. Tatum H, Thuluvath P, Lawitz E, Martorell C.T, DeMicco M, Cohen S, Rustgi V,
Ravendhran N, Ghalib R, Hanson J, Zamparo J, Yang R, Hughes E, Cooney E. A Phase 2A
study of BMS-791325, An NS5B Polymerase Inhibitor, with PegInterferon ALFA-2A and
Ribavirin in treatment-naïve patients with genotype 1 chronic Hepatitis C infection. Journal of
Hepatology 2012. Volume 56 (suppl), ppg 460
230. Poordad F, Lalezari J, Lawitz E, Van Vlierberghe H, Shiffman M, Jacobson I, Kankam M,
Araya V, Ghalib R, Ryan M, Bacon B, Flamm S, Godofsky E, Hazan L, Hinestrosa F, Michielsen
P, Deltenre P, Robison H, Robarge L, Olek E. Continued High Virologic Response Rates with
ACH-1625 daily dosing plus PEGIFN-ALPHA 2A in a 28 day and 12 –week phase 2A trial.
Journal of Hepatology 2012. Volume 56 (suppl), ppg 455
231. Rodriguez-Torres M, Lawitz E, Cornpropst M.T, Denning J.M, Clemons D, McNair L,
Fang L, Berrey M.M, Symonds W.T. The Effect of Hepatic Impairment on the safety
pharmacokinetics and antiviral activity of PSI-938 in Hepatitis C infected subjects treated for
seven days. Journal of Hepatology 2012. Volume 56 (suppl), ppg 456
43
232. Marcellin P, Cooper C, Balart L.A, Larrey D.G, Box T.D, Yoshida E, Lawitz E, Buggisch
P, Ferenci P, Weltman M, Labriola-Tompkins E, Le Pogam S, Najera I, Thomas D.N, Hooper G,
Shulman N, Zhang Y, Navarro M.T, Lim C.Y, Brunda M, Yetzer E. S, Terrault N. High
sustained virological response rates with response-guided Danoprevir plus PegInterferon Alpha-
2A (40KD) and Ribavirin in treatment-naïve Genotype 1 patients: atlas study final results.
Journal of Hepatology 2012. Volume 56 (suppl), ppg 472
233. Poordad F, Lawitz E, DeJesus E, Kowdley K.V, Gaultier I, Cohen D.E, Xie W, Larsen L,
Pilot-Maitias T, Koev G, Dumas E, Podsadecki T, Bernstein B. ABT-072 or ABT-333 combined
with Peglayted Interferon/ Ribavirin after 3- day monotherapy in HCV genotype 1 (GT1)-
infected treatment naïve subjects: 12 week sustained virological response (SVR12) and safety
results. Journal of Hepatology 2012. Volume 56 (suppl), ppg 478
234. Sullivan G.J, Rodriguez-Torres M, Lawitz E, Poordad F, Kapoor M, Campbell A, Setze C,
Xie W, Khatri A, Dumas E, Kirshnan P, Pilot- Matias T, Williams L, Bernstien B. ABT-267
combined with Pegylated Interferon Alpha-2A/ Ribavirin in genotype HCV –infected treatment-
naïve subjects: 12 week antiviral and safety analysis. Journal of Hepatology 2012. Volume 56
(suppl), ppg480
235. Vince B, Lawitz E, Searie S, Marbury T, Robison H, Robarge L, Olek E. Novel NS5A
Inhibitor ACH-2928 Phase 1 Results in HCV GT-1 Patients. Journal of Hepatology 2012.
Volume 56 (suppl), ppg 480
236. Wong K.A, Worth A, Brainard D.M, Lawitz E, Miller M.D, Mo H. Persistence of NS5A
GS-5885 Drug Resistance mutations following 3 days of monotherapy in Genotype-1 HCV
patients is dependent on the HCV subtype and specific mutation. Journal of Hepatology 2012.
Volume 56 (suppl), ppg 482
237. Lok A, Gardiner D, Hezode C, Lawitz E, Bourliere M, Everson G, Marcellin P, Rodriguez-
Torres M, Pol S, Serfaty L, Eley T, Huang S.-P, Wind-Rotolo M, McPhee F, Grasela D,
Pasquinelll C. Confirmation that quadruple therapy with Daclatasvir (NS5A Inhibitor),
Asunaprevir (NS3 Inhibitor) and Peginterferon/Ribavirin results in high rate of SVR4 in HCV
genotype 1 null responders. Journal of Hepatology 2012. Volume 56 (suppl), ppg 557
238. Poordad F.F, Lawitz E.J, Reddy K.R, Afdhal N.H, Hezode, Zeuzem S, Lee S.S, Calleja J.L,
Jr. Brown R.S, Crazi A, Wedemeyer H, Deng W, Koury K, Boparai N, Pedicone L.D, Burroughs
M, Wahl J, Brass C.A, Albrecht J.K, Sulkowski M.S. A randomized trial comparing Ribavirin
dose reduction versus Erythropoietin for anemia management in previously untreated patients
with Chronic Hepatitis C receiving Boceprevir plus Peginterferon/ Ribavirin. Journal of
Hepatology 2012. Volume 56 (suppl), ppg 559
239. Sulkowski M, Rodriguez-Torres M, Lawitz E, Shiffman M, Pol S, Herring R, McHutchison
J, Pang P, Brainard D, Wyles D, Habersetzer F. High Sustained virological response rate in
44
treatment naïve HCV genotype 1A and 1B treated for 12 weeks with Interferon-Free all- oral
quad regimen Interim results. Journal of Hepatology 2012. Volume 56 (suppl), ppg 560
240. Sulkowski M, Gardiner D, Lawitz E, Hinestrosa F, Nelson D, Thuluvath P, Rodriguez-
Torres M, Lok A, Schwartz H, Reddy K.R, Eley T, Wind-Rotolo M, Huang S.P, Gao M, McPhee
F, Hindes R, Symonds B, Pasquinelli C, Grasela D. Potent Viral Suppression with all-oral
combination of Daclatasvir (NS5A Inhibitor) and GS-7977 (NS5B Inhibitor), +/Ribavirin in
treatment- naïve patients with chronic HCV GT 1, 2, or 3. Journal of Hepatology 2012. Volume
56 (suppl)
241. Kowdley K.V, Lawitz E, Crespo I, Hassanein T, David M, DeMicco M, Nelson D.R,
Bernstein D, Afdhal N.H, Jacobson I, Vierling J, Gordon S, Anderson J.K, Hyland R.H, Hindes
R.G, Baker C, Sorensen R, Albanis E, Symonds W.T, Berrey M.M. Atomic 97% RVR for PSI-
7977 PEG/RBV x 12 week regimen in HCV GT1: an end response-guided therapy. Journal of
Hepatology 2012. Volume 56 (suppl), ppg 1
240. Poordad F, Lawitz E, Kowdley K.V, Everson G.T, Freilich B, Cohen D, Siggelkow S,
Heckaman M, Menon R, Pilot-Matias T, Podsadecki T, Bernstein B. 12 week Interferon-free
regimen of ABT-450/R+ABT-333+Ribavirin achieved SVR12 in more than 90% of treatment-
naïve HCV genotype-1 infected subjects and 47% of previous non-responders. Journal of
Hepatology 2012. Volume 56 (suppl), ppg 549
241. Zeuzem S, Arora S, Bacon B, Box T, Charlton M, Diago M, Dieterich D, Mur R.E, Everson
G, Fallon M, Ferenic P, Flisiak R, George J, Ghalib R, Gitlin N, Gladysz A, Gordon S,
Greenbloom S, Hassanein T, Jacobson I, Jeffers L, Kowdley K, Lawitz E, Lee S.S, Leggett B,
Lueth S, Nelson D, Pockros P, Rodriguez-Torres M, Rustgi V, Serfaty L, Sherman M, Shiffman
M, Sola R, Sulkowski M, Vargas H, Vierling J, Yoffe B, Ishak L, Fontana D, Xu D, Gray T,
Horga A, Hillson J, Lopez-Talavera J.C, Muir A. Peginterferon Lambda-1A (Lambda)
compared to Peginterferon ALFA-2A (Alpha) in treatment- naïve patients with HCV genotypes
(G) 2 or 3: first SVR24 results from emerge phase IB. Journal of Hepatology 2012. Volume 56
(suppl), ppg 5
242. Bronowicki J, David M, Flamm S, Gordon S, Lawitz E, Yoshida E, Galati J, Luketic V,
McCone J, Jabobson I, Marcellin P, Muir A, Poordad F, Pedicone L.D, Deng W, Treitel M, Wahl
J, Vierling J. Sustained Virologic response (SVR) in prior Peginterferon/Ribavirin (PR)
treatment failures after retreatment with Boceprevir (BOC) + PR: The provide study interim
results. Journal of Hepatology 2012. Volume 56 (suppl), ppg 6
243. Nelson D.R, Lawitz E, Bain V, Gitlin N, Hawkins T, Marotta P, Workowski K, Flamm S,
Pang P.S, McHutchison J.G, McNally J, Urbanek P, Yoshida E.M. High SVR12 with 16 weeks
of Tegobuvir and GS-9256 with Peginterferon- Alfa 2A and Ribavirin in treatment-naïve
genotype 1 HCV patients. Journal of Hepatology 2012. Volume 56 (suppl), ppg 6
45
244. Resesink H.W, Janssen H.L.A, Zeuzem S, Lawitz E, Rodriguez-Torres M, Patel K, Chen
A, David C, King B, Levin A, Hodges M.R. Final Results- randomized, double-blinded,
placebo- controlled safety, anti-viral proof- of- concept study of Miravirsen and Oligonucelotide
targeting MIR-122, in treatment-naïve patients with genotype 1 chronic HCV infection. Journal
of Hepatology 2012. Volume 56 (suppl), ppg 26
245. Dushieiko G, Afdhal N, Giannini E.G, Chen P.J, Han K.H, Rodriguez-Torres M, Rugina S,
Lawitz E, Streinu-Cercel A, Shiffman M.L, Poordad F, Mostafa Kamel Y, Brainsky A, Geib J,
Vasey S.Y, Patwardhan R, Campbell F, Theodore D. Results of enable 2, A Phase 3, Multicenter
study of Eltrombopag and Peginterferon Alfa-2B treatment in patients with Hepatitis C and
Thrombocytopenia. Journal of Hepatology 2012. Volume 56 (suppl), ppg 27
246. Lawitz E, Marbury T, Campbell A, Dumas E, Kapoor M, Pilot-Maitias T, Krishnan P,
Setze C, Xie W, Podsadecki T, Bernstien B, Williams L. Safety and Antiviral activity of ABT-
267, A Novel NS5A Inhibitor, During 3-Day Monotherapy: First study in HCV genotype-1 (GT-
1) infected treatment- naïve subjects. Journal of Hepatology 2012. Volume 56 (suppl), ppg 469
247. Jacobson I , Lawitz E, Lalezari J, Crespo I, David M, Hassanein T, DeMicco M, Arora S,
Gitlin N, Herring R, Nelson D.R, Anderson J.K, Hyland R.H, Mader M, Hindes R, Albanis E,
Symonds W.T, Berrey M.M. PSI-7977 400 MG QD safety and tolerability in the first 450
patients treated for 12 weeks. Journal of Hepatology 2012. Volume 56 (suppl), ppg 441
248. Lawitz E, Marbury T, Campbell A, Dumas E, Kapoor M, Pilot-Maitias T, Krishnan P,
Setze C, Xie W, Podsadecki T, Bernstien B, Williams L. Safety and Antiviral activity of ABT-
267, A Novel NS5A Inhibitor, During 3-Day Monotherapy: First study in HCV genotype-1 (GT-
1) infected treatment- naïve subjects. Journal of Hepatology 2012. Volume 56 (suppl), ppg 44
249. Claudio Pasquinelli, Fiona McPhee, Timothy Eley, Criselda Villegas, Katrina Sandy,
Pamela Wendelburg, Anna Persson, Shu-Pang Huang, Dennis Hernandez, Amy Sheaffer, Paul
Scola, Thomas Marbury, Eric Lawitz, Ronald Goldwater, Maribel Rodriguez-Torres, Michael
DeMicco, David Wright, Michael Charlton, Walter Kraft, Juan-Carlos Lopez-Talavera, and
Dennis Grasela. Antimicrobial Agents Chemother. April 2012 56:1838-1844.
250. Eric J. Lawitz, Daniel Gruener, John M. Hill, Thomas Marbury, Lisa Moorehead,
Anita Mathias, Guofeng Cheng, John O. Link, Kelly A. Wong, Hongmei Mo,
John G. McHutchison, Diana M. Brainard. A phase 1, randomized, placebo-controlled, 3-day,
dose-ranging study of GS-5885, an NS5A inhibitor, in patients with genotype
1 hepatitis C. Journal of Hepatology 2012 vol. 57; 24–31.
251. Eric Lawitz, Stefan Zeuzem, Lisa Nyberg, David Nelson, Lorenzo Rossaro, Luis Balart, K.
Ranjender Reddy, Timothy Morgan, Weiping Deng, Kenneth Koury, Katia Alves, Frank Dutko,
Janice Wahl, Lisa Pedicone, Fred Poordad. Boceprevir (BOC) combined with Peginterferon alfa-
2b/ribavirin (P/RBV) in treatment naïve chronic HCV genotype 1 patients with compensated
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cirrhosis: Sustained Virologic Response (SVR) and safety subanalyses for the Anemia
Management Study. Hepatology 2012. Volume 56(4) ppg 216A.
252. Anna Lok, David Gardiner, Christophe Hezode, Eric Lawitz, Marc Bourliere, Gregory
Everson, Patrick Marcellin, Maribel Rodriguez-Torres, Stanislas Pol, Lawrence Serfaty, Timothy
Eley, Shu-Pang Huang, Megan Wind-Rotolo, Fiona McPhee, Dennis Grasela, Claudio
Pasquinelli. Sustained Virologic Response in chronic HCV genotype (GT) 1-Infected Null
Responders with combination of Daclatasvir (DCV; NS5A Inhibitor) and Asunaprevir (ASV;
NS3 Inhibitor) with or without Pegionterferon Alfa-2a/Ribavirin (PEG/RBV). Hepatology 2012.
Volume 56(4) ppg 230A.
253. Adriaan van der Meer, Andra Boonstra, Hendrik Reesink, Stefan Zeuzem, Eric Lawitz,
Maribel Rodriguez-Torres, Alice Chen, Arthur Levin, Sakari Kauppinen, Bettina Hansen,
Thomas Vanwolleghem, Michael Hodges, Harry Janssen. Miravirsen, an oligonucleotide
targeting microRNA-122, induces a decline of interferon-gamma inducible protein-10 in
treatment naïve chronic hepatitis C genotype 1 patients. Hepatology 2012. Volume 56(4) ppg
237A.
254. Fred Poordad, Eric Lawitz, K. Rajender Reddy, Nezam Afdhal, Christophe Hezode, Stefan
Zeuzem, Samuel Lee, Jose Calleja, Robert Brown, Antonio Craxi, Heiner Wedemeyer, Bruce
Bacon, Steven Flamm, Weiping Deng, Kenneth Koury, Lisa Pedicone, Frank Dutko, Margaret
Burroughts, Katia Alves, Janice Wahl, Clifford Brass, Janice Albrecht, Mark Sulkowski. Timing
and magnitude of ribavirin dose reduction (RBV DR) do not impact sustained virologic response
(SVR) rates with boceprevir (BOC) + peginterferon alfa-2b / ribavirin (P/RBV) in the Anemia
Management Study in chronic HCV genotype 1 patients. Hepatology 2012. Volume 56(4) ppg
269A.
255. Mark Sulkowski, Maribel Rodriguez Torres, Eric Lawitz, Mitchell Shiffman, Stanislas Pol,
Robert Herring, John McHutchison, Benedetta Massetto, Diana Brainard, Phil Pang, David
Wyles, Francois Habersetzer. Complete SVR4 Rates in treatment-naïve HCV genotype 1a and 1b
patients who achieved vRVR with an interferon-free all oral regimen. Hepatology 2012. Volume
56(4) ppg 298A.
256. Tarek Hassanein, Eric Lawitz, Israel Crespo, Mitchell Davis, Michael DeMIcco, David
Nelson, David Eric Bernstein, Nezam Afdhal, Ira Jacobson, John Vierling, Stuart Gordon, Jane
Anderson, Robert Hyland, Robert Hindes, William Symonds, Efsevia Albanis, Sanjeev Arora,
Kris Kowdley. Once daily Sofosbuvir (GS-7977) plus PEG/RBV: High early response rates are
maintained during post-treatment follow-up in treatment naïve patients with HCV genotype 1,4,6
infection in the Atomic study. Hepatology 2012. Volume 56(4) ppg 307A.
257. Evguenia Svarovskaia, HAdas Dvory-Sobol, Viktoria Gontcharova, Sophia Chiu, Christy
Hebner, Robert Hyland, Kris Kowdley, Eric Lawitz, Edward Gane, William Symonds, John
McHutchison, Michael Miller, Hongmei Mo. Comprehensive Resistance Testing in patients who
relapsed after treatment with Sofosbuvir (GS-7977)- Containing regimes in phase 2 studies.
Hepatology 2012. Volume 56(4) ppg 551A.
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258. Christophe Hezode, Gideon Hirschfield, Wayne Ghesquiere, William Sievert, Maribel
Rodriguez Torres, Stephen Shafran, Paul Thuluvath, Harvey Tatum, Imam Waked, Gamal
Esmat, Eric Lawitz, Vinod Rustgi, Stanislas Pol, Nina Weis, Paul Pockros, Marc Bourliere,
Lawrence Serfaty, John Vierling, Michael Fried, Ola Weiland, Maurizia Brunetto, Gregory
Everson, Stefan Zeuzem, Paul Kwo, Mark Sulkowski, Norbert Nrau,Megan Wind-Rotolo,
Zhaohui Liu, Eric Hughes, Steven Schnittman, Philip Yin. Daclatsvir, an NS5A Replication
Complex Inhibitor, combined with Peginterferon Alfa-2a and Ribavirin in treatment-naïve HCV-
Genotype 1 or 4 subjects: Phase 2b COMMAND-1 SVR 12 results. Hepatology 2012. Volume
56(4) ppg 553A.
259. Amit Khatri, Isabelle Gaultier, Rajeev Menon, Thomas Marbury, Eric Lawitz, Thomas
Podsadecki, Victoria Mullally, Walid Awni, Barry Bernstein, Sandeep Dutta. Pharmacokinetics
and safety of co-administered ABT-450 plus Ritonavir (ABT-450/r), ABT-267 and ABT-333 as
a single dose in subjects with normal hepatic function and in subjects with mild, moderate and
severe hepatic impairment. Hepatology 2012. Volume 56(4) ppg 555A.
260. Gregory Dore, Eric Lawitz, Christophe Hezode, Stephen Shafran, Alnoon Ramji, Harvey
Tatum, Gloria Taliani, Albert Strasser, Nina Weis, Wayne Ghesquiere, Samuel Lee, Dominique
Larrey, Stanislas Pol, Hugh Harley, Jacob George, Scott Fung, Victor de Ledinghen, Peggy
Hagens, David Cohen, Eric Hughes, Elizabeth Cooney. Twelve- or 16-week treatment with
Daclatasvir combined with Peginterferon Alfa and Ribavirin for Hepatitis C virus genotype 2 or
3 infection: Command GT 2/3 study. Hepatology 2012. Volume 56(4) ppg 558A.
261. Gregory Everson, Eric Lawitz, Alexander Thompson, Mark Sulkowski, Yanni Zhu, Diana
Brainard, Laura Mendelson, John McHutchison, Phil Pang, Jenny Yang, Patrick Marcellin,
Nezam Afdhal. The NS5A Inhibitor GS-5885 is safe and well-tolerated in over 1000 patients
treated in phase 2 studies. Hepatology 2012. Volume 56(4) ppg 572A.
262. Eric Lawitz, Mark Swain, Aasim Sheikh, Rajender Reddy, Marion Chojkier, William
Towner, Diana Brainard, Phillip Pang, John McNally, John McHuchison, Paul Pockros, Eugene
Shiff. Characteristics of the Interferon-Ineligible and Interferon-Intolerant Hepatitis C patients
enrolled in a large phase 2 clinical study. Hepatology 2012. Volume 56(4) ppg 573A
263. David Nelson, Eric Yoshida, Dongliang Ge, John McNally, Phil Pang, Matthew Paulson,
Mani Subramanian, John McHutchison, Kevin Shianna, David Goldstein, Petr Urbanek, Eric
Lawitz, Thomas Urban. Genome-wide association study to characterize potential determinants
of Bilirubin elevations in HCV patients receiving the HCV NS3 Serine Protease Inhibitor GS-
9256. Hepatology 2012. Volume 56(4) ppg 585A.
264. Eric Lawitz, Terry Box, Ronald Pruitt, Maribel Rodriguez Torres, Tuan Nguyen, Jacob
Lalezari, Hugo Vargas, John Goff, Federico Hinestrosa, Velimir Luketic, Purvi Mehra, Gloria
Dubuc-Patric, Eileen Donovan, Jie Chen, Keith Pietropaolo, Xiao-Jian Zhou, John Sullivan-
Bolyai, Douglas Mayers. High rates of Rapid Virologic Response (RVR) and complete Early
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Virologic Response (cEVR) with IDX 184, Pegylated Interferon and Ribavirin in genotype 1
HCV infected subjects: Interim Results. Hepatology 2012. Volume 56(4) ppg 1006A.
265. Douglas Mayers, Bradley Vince, John Hill, Eric Lawitz, William O’Riordan, Lynn
Webster, Daniel Gruener, Ricky Mofsen, Abel Murillo, Eileen Donovan, Jie Chen, John
Sullivan-Bolyai, Xiao-Jian Zhou. IDX719, HCV NS5A Inhibitor, demonstrates Pan-Geotypic
activity after three days of monotherapy in genotype 1,2,3 or 4 HCV-infected subjects.
Hepatology 2012. Volume 56(4) ppg 1020A.
266. Fernando E. Membreno and Eric J. Lawitz. Non-Interferon Therapies for Hepatitis C.
Current Hepatitis Reports 2012. Vol 11; PPG 146-152.
267. Fernando E. Membreno, Jennifer C. Espinales, Eric J. Lawitz. Cyclophilin Inhibitors for
Hepatitis C Therapy. Clinics in Liver Disease 2013 Vol. 17 ; PPG 129–139.
268. Fred Poordad, M.D., Eric Lawitz, M.D., Kris V. Kowdley, M.D., Daniel E. Cohen, M.D.,
Thomas Podsadecki, M.D., Sara Siggelkow, R.N., Michele Heckaman, M.S., Lois Larsen, Ph.D.,
Rajeev Menon, Ph.D., Gennadiy Koev, Ph.D., Rakesh Tripathi, M.S., Tami Pilot-Matias, Ph.D.,
and Barry Bernstein, M.D. Exploratory Study of Oral Combination Antiviral Therapy for
Hepatitis C. New England Journal of Medicine 2013. Vol 368; ppg 45-53
269. Alexander J Thompson; Hans L Tillmann; Thomas J Urban; Mingfu Zhu; Qianqian Zhu;
Susanna Naggie; Stephanie Noviello; Keyur Patel; Lisa Pedicone; F Fred Poordad; Kevin V
Shianna; Mitchell L Shiffman; Abanish Singh; Mark S Sulkowski; Nezam H Afdhal; Janice K
Albrecht; Clifford A Brass; Paul J Clark; Rafael Esteban; Jacques Fellay; Greg W Galler;
Dongliang Ge; David B Goldstein; Ira M Jacobson; John W King; Paul Y Kwo; Eric J Lawitz;
Jonathan McCone; John G McHutchison; Andrew J Muir. Journal of hepatology 2012.
56(2):313-9.
270. Eric J Lawitz. Diagnosis and management of telaprevir-associated rash. Gastroenterology
& Hepatology 2011 7(7):469-71
271. Eric J Lawitz; John O Link; Thomas Marbury; Anita Mathias; John G McHutchison;
Hongmei Mo; Lisa Moorehead; Kelly A Wong; Guofeng Cheng; Daniel Gruener; John M Hill;
Diana M Brainard. A phase 1, randomized, placebo-controlled, 3-day, dose-ranging study of GS-
5885, an NS5A inhibitor, in patients with genotype 1 hepatitis C. Journal of
Hepatology 2012;57(1):24-31.
272. Hadas Dvory-Sobol; Jeanette Harris; Karin S Ku; Eric J Lawitz; Michael D Miller; Phillip
S Pang; Kelly A Wong; Andrew S Bae; Hongmei Mo. Characterization of resistance to the
protease inhibitor GS-9451 in hepatitis C virus-infected patients. Antimicrobial agents and
chemotherapy 2012;56(10):5289-95.
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273. Steven L Flamm; Venkata Goteti; Christophe Hezode; John A Howe; Ira Jacobson; Eric J
Lawitz ; Claus Niederau; Lisa D Pedicone; Janice K Albrecht; Bruce R Bacon; Richard O
Barnard; Marc Bourlière; Clifford A Brass; Margaret H Burroughs; Morris Sherman; Heather L
Sings; John M Vierling; F Fred Poordad. Boceprevir with peginterferon alfa-2a-ribavirin is
effective for previously treated chronic hepatitis C genotype 1 infection. Clinical
Gastroenterology and Hepatology 2013. 2013;11(1):81-87
274. Graham R Foster; Shelley George; Eric J Lawitz; Isabelle Lonjon-Domanec; Don Luo;
Pietro Andreone; Maria Beumont; Sandra De Meyer; Moises Diago; Paul J Pockros; Stanislas
Pol; Stuart Roberts; Zobair Younossi; Stefan Zeuzem; Gaston Picchio. Sustained virologic
response rates with telaprevir by response after 4weeks of lead-in therapy in patients with prior
treatment failure. Journal of Hepatology 2013;58(3):488-94.
275. Eric J Lawitz; Maribel Rodriguez-Torres; Efsevia Albanis; Michelle M Berrey; Melanie
Cornpropst; Jill M Denning; William T Symonds. Pharmacokinetics, Pharmacodynamics, and
Tolerability of GS-9851, a Nucleotide Analog Polymerase Inhibitor, following Multiple
Ascending Doses in Patients with Chronic Hepatitis C Infection. Antimicrobial Agents and
Chemotherapy 2013;57(3):1209-17.
276. Harry L.A. Janssen, Hendrik W. Reesink, Eric J. Lawitz, Stefan Zeuzem, Maribel
Rodriguez-Torre, Keyur Patel, Adriaan J. van der Meer, Amy K. Patick, Alice Chen,
Yi Zhou., Robert Persson., Barney D. King,Sakari Kauppinen., Arthur A. Levin, and Michael R.
Hodges. Treatment of HCV Infection by Targeting MicroRNA. New England Journal
of Medicine 2013.
277. K.V. Kowdley, E. Lawitz, F. Poordad, D.E. Cohen, D. Nelson, S. Zeuzem, G.T. Everson, P.
Kwo, G.R. Foster, M. Sulkowski, W. Xie, L. Larsen, A. Khatri, T. Podsadecki, B. Berstein.
Safety and Efficacy of Interferon-Free Regimens of ABT-450/r, ABT-267, ABT-333 +/-
Ribavirin in Patient with Chronic HCV GT1 Infection: Results from the Aviator Study. Journal
of Hepatology 2013. Volume 58 (suppl l), ppg S2.
278. E. Gane, E. Lawitz, M. Rodriguez-Torres, S. Gordon, H. Dvory-Sobol, S. Arterburn, J.
McNally, D.M. Brainard, W.T. Symonds, J.G. McHutchison, A. Sheikh, A. Mangia. Phase 3
Randomized Controlled Trial of All-Oral Treatment with Sofosbuvir + Ribavirin for 12 weeks
Compared to 24 weeks of Peg + Ribivirin in Treatment Naïve GT2/3 HCV-Infected Patients
(Fission). Journal of Hepatology 2013. Volume 58 (suppl l), ppg S3.
279. M. Rodriguez-Torres, A. Stoehr, E. Gane, L. Serfaty, E. Lawitz, M. Bourque, S. Bhanja, R.
Barnard, P. Hwang, N. Mobashery. Sustained Viral Response and Safety of MK-7009 in
Cirrhotic Treatment-Experienced Patients with Genotype 1 HCV Infection who have failed
previous Pegylated Interferon and Ribavirin Treatment. Journal of Hepatology 2013. Volume 58
(suppl l), ppg S47.
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280. K. V. Kowkley, T. Hassanein, E.J. Gane, R.H. Hyland, J. Ma, W.T. Symonds, J. Lalezari, E.
Lawitz. Sofosbuvir safety and Toleravility in 741 Patients Treated for up to 24 Weeks. Journal
of Hepatology 2013. Volume 58 (suppl l), ppg S345.
281. E. Lawitz, J. Hill, B. Vince, A. Murillo, D. Gruener, T. Marbury, M. Demicco, A. Agarwal,
H. Robison, M. Huang, L. Robarge, J. Hui, E. Olek, M. Deshpande, H. Kocinsky. ACH-2684
Demonstrates Potent Viral Suppression in Genotype 1 Hepatitis C Patients with and without
Cirrosis: Safety, Pharmacokinetic, and Viral Kinetic Analysis. Journal of Hepatology 2013.
Volume 58 (suppl l), ppg S347.
282. E. Lawitz, E.J. Gane, J. Lalezari, R.H. Hyland, J. Ma, W.T. Symonds, T. Hassanein, K.V.
Kowdley. High Concordance of SVR4, SVR12 and SVR 24 in Patients with HCV Infection with
have received Treatment with Sofosbuvir. Journal of Hepatology 2013. Volume 58 (suppl l), ppg
S348.
283. Muir, J. Hill, E. Lawitz, T. Marbury, L. Robarge, H. Robison, J. Hui, M. Huang, A.
Agarwal, A. Perelson, M. Deshapande, H. Kocinsky. ACH-3102, A Second Generation NS5A
Inhibitor, Demonstrates Potent Antiviral Activity in Patients with Genotype 1a HCV Infection
Despite the Presence of Baseline NS5A-Resistant Variants. Journal of Hepatology 2013. Volume
58 (suppl l), ppg S360.
284. Q. Huang, N. Huang, A. Hug, M. Lau, E. Peng, J. Larezari, G. Farrell, P. Shah, E. Lawitz,
P. Vig, N. Brown, R. Colonno. Vast Majority of Detected NS5A Resistant Variants are not
Amplified in HCV Patients During 3-Day Monotherapy with the Optimized NS5A Inhibitor PPI-
668. Journal of Hepatology 2013. Volume 58 (suppl l), ppg S485.
285. J. Guedj, P.S. Pang, E. Lawitz, M. Rodriguez-Torres, B. symonds, A.S. Perelson. Analysis
of the Kinetics of Viral Decline During 14 Days of Administration of Sofosbuvir and GS-0938.
Journal of Hepatology 2013. Volume 58 (suppl l), ppg S486.
286. E. Lawitz, D. Gruener, T. Marbury, J. Hill, L. Webster, D. Hassman, S. Pflanz, B.
Massetto, M. Subramanian, J. McHutchison, I.M. Jacobson, B. Freilich, M. Rodriguez-Torres.
Pharmacodynamics of Oral TLR-7 Agonist GS-9620 in Treatment-Naïve Patients with Chronic
Hepatitis C. Journal of Hepatology 2013. Volume 58 (suppl l), ppg S490.
287. E. Lawitz, D. Wyles, M. Davis, M. Rodriguez-Torres, K.R. Reddy, K.V. Kowdley, E.
Svarovskaia, D. Jiang, J. McNally, D. M. Brainard, W. T. Symonds, J. G. McHutchison, L.
Nyberg, Z. Younossi. Sofosbuvir + Peginterferon + Ribavirin for 12 Weeks Achieves 90%
SVR12 in Genotype 1,4,5 or 6 HCV Infected Patients: The Neutrino Study. Journal of
Hepatology 2013. Volume 58 (suppl l), ppg S567
288. M.S. Sulkowski, D.F. Gardiner, M. Rodriguez-Torres, K. R. Reddy, T. Hassanein, I.
Jacobson, E. Lawitz, A.S. Lok, F. Hinestrosa, P.J. Thuluvath, H. Schwartz, D.R. Nelson, G.T.
Everson, T. Eley, M. Wind-Rotolo, S. P. Huang, M. Gao, F. McPhee, D. hernandez, D. Sherman,
R. Hindes, W. Symonds, C. Pasquinelli, D. M. Grasela. Sustained Virologic Rsponse with
51
Daclatasvir plus Sofosbuvir + Ribavirin (RBV) in Chronic HCV Genotype (GT) 1-Infected
Patients who Previously Failed Telaprevir (TVR) or Boceprevir (BOC). Journal of Hepatology
2013. Volume 58 (suppl l), ppg S570.
289. G. J. Dore, E. Lawitz, C. Hezode, S. Shafran, A. Ramji, H. Tatum, G. Taliani, A. Tran, M.
Brunetto, S. Zaltron, S. Strasser, N. Weis, W. Ghesquiere, S. Lee, Dr. Larrey, S. Pol, H. Harley,
J. George, S. Fung, V. de Ledinghen, P. Hagens, D. Cohen, E. Cooney,S. Noveillo, E. Hughes.
Declatasvir Combined with Peginterferon ALFA-2A and Ribavirin for 12 or 16 Weeks in
Patients with HCV Genotype 2 or 3 Infection: Command GT /23 Study. Journal of Hepatology
2013. Volume 58 (suppl l), ppg S570.
290. G. T. Everson, K.D. Sims, M. Rodriguez-Torres, C. Hezode, E. Lawitz, M. Bourliere, V.
Loustaud-Ratti, V. Rustgi, H. Schwartz, H. Tatum, P. Marcellin, S. Pol, P. J. Thuluvath, T. Eley,
X. wang, S.P. Huang, F. McPhee, M. Wind-Rotolo, E. chung, C. Pasquinelli, D.M. Grasela, D.F.
Gardiner. Interim Analysis of an Interferon (IFN)-and Ribavirin (RBV)-Free Regimen of
Daclatsvir (DCV), Asunaprevir (ASV), and BMS-791325 in Treatment-Naïve, Hepatitis C Virus
Genotype 1-Infected Pateints. Journal of Hepatology 2013. Volume 58 (suppl l), ppg S573.
291. J. C. Lin, N. Afdhal, E.J. Lawitz, M.S. Paulson, Y. Zhu, G. M. Subrmanian, J. G.
McHutchison, M. Sulkowski, D.L. Wyles, R.T. Schooley. Changes in Interferon-Gamma
Inducible Protein-10 in treatment-Naïve Versus Treatment-Experienced Patients Given All-Oral
Anti-HCV Regimen. Journal of Hepatology 2013. Volume 58 (suppl l), ppg S193
292. J.P. Lalezari, D.R. Nelson, R.H. Hyland, M. Lin, S.J. Rossi, W.T. Symonds, M. Rodriguez-
Torres, E.J. Lawitz. Once Daily Sofosbuvir Plus Ribavirin for 12 and 24 Weeks in Treatment-
Naïve Patients with HCV Infection: The Quantum Study. Journal of Hepatology 2013. Volume
58 (suppl l), ppg S346.
293. H. Dvory-Sobol, E.S. Svarovskaia, V. Gontcharova, S. Rossi, E.J. Lawitz, M.D. Miller, H.
Mo. Resistance analyses Using Deep and Population Sequencing After 3 Day Monotherapy with
GS-9669, a Novel Non-Nucleoside NS5B Inhibitor in Genotype 1 HCV Patients. Journal of
Hepatology 2013. Volume 58 (suppl l), ppg S485.
294. M Rodriguez-Torres, E. Lawitz, KV Kowdley, DR Nelson, E Dejesus, JG
McHutchison,MT Crornprost, M Mader, A Albanis, D Jiang, CM Hebner, WT Symonds, MM
Berrey, J Lalezari. Sofosbuvir (GS 7977) plus peginterferon/ribavirin in treatment naïve patietns
with HCV genotype 1: A randomized, 28 day, dose-ranging trial. Journal of Hepatology 2013.
Volume 58(4), ppg 663-668.
295. Eric J. Lawitz, John M. Hill, Thomas Marbury, Michael P. DeMicco, William Delaney,
Jenny Yang, Lisa Moorehead, Anita Mathias, Hongmei Mo, John G. McHutchinson, Maribel
Rodriguez-Torres, Stuart C. Gordon. A Phase 1, randomized, placebo-controlled, 3-day,
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ascending-dose study of GS-9451, an NS3/4A protease inhibitor, in genotype 1 hepatitis C
patients. Antiviral Therapy 2013. Volume ppg 1359-6535.
296. E.J. Lawitz, M. Rodriguez-Torres, J. Denning, A. Mathias, H. Mo, B. Gao, M.T.
Cornpropst, M.M. Berrey, W.T. Symonds. All-oral therapy with nucleotide inhibitors sofosbuvir
and GS-0938 for 14 days in treatment-naïve genotpe 1 hepatitis C (NUCLEAR). Journal of Viral
Hepatitis 2013 Vol .ppgs 1-9.
297. Gardiner D, Lalezari J, Lawitz E, Dimicco M, Ghalib R, Reddy KR, Chang KM, Sulkowski
M, Marro SO, Anderson J, He B, Kansra V, McPhee F, Wind-Rotolo M, Grasela D, Selby M,
Korman AJ, Lowy I. A Randomized, Double-Blind, Placebo-Controlled Assessment of BMS-
936558, a Fully Human Monoclonal Antibody to Programmed Death-1 (PD-1), in Patients with
Chronic Hepatitis C Virus Infection. PLoS One. 2013 May 22;8(5):e63818.
298. SC Gordon, EM Yoshida, EJ Lawitz, BR Bacon, MS Sulkowski, M Davis, F Poordad, JP
Bronowicki, R Estaban, V Sniukiene, MH Burroughs, W Denf, FJ Dutko, CA Brass, JK
Albrecht, K Rajender Reddy. Adherence to Assigned Dosing Regimen and Sustained Virologic
Response Among Hepatitis C Genotype 1 Treatment-NaïVE and PEG/Ribavirin Treatment-
Failures Treated With Boceprevir Plus Peginterferon Alfa-2B/Ribavirin. Alimentary
Pharmacology and Therapeutics 2013 Vol 38 (1) ppg16-27.
299. Eric Lawitz, Mark Sulkowski, Ira Jacobson, William K Kraft, Benedict Maliakkal,
Moamed Al-Ibrahim, Stuart Gordon, Paul Kwo, Juergren Kurt Rockstroh, Paul Panorchan,
Michelle Miller, Luzelena Caro, Richard Barnard, Peggy May Hwang, Jaqueline Gress, Erin
Quirck, Niloufar Mobashery. Characterization of vaniprevir, a hepatitis C virus NS3/4A protease
inhibitor, in patients with HCV genotype 1 infection: Safety, antiviral activity, resistance, and
pharmacokinetics. Antiviral Research 2013 Vol. 99 ppg 214-220.
300. Eric Lawitz, Fred Poordad, Kris V. Kowdley, Daniel E. Cohen, Thomas Podsakecki, Sara
Siggelkow, Lois Larsen, Rajeev Menon, Gennadiy Koev, Rakesh Tripathi, Tami Pilot-Matias,
Barry Bernstein. A Phase 2a trial of 12-week interferon-free therapy with two direct-acting
antivirals (ABT-450/r, ABT-072) and ribavirin in IL28B C/C patients with chronic hepatitis C
genotype 1. Journal of Hepatology 2013 Volume 59(1) ppg 18-23.
301. Eric Lawitz, Maribel Rodriguez-Torres, Albrecht Stoehr, Edward J. Gane, Lawrence
Serfaty, Sanhita Bhanja, Richard J. Barnard, Di An, Jacqueline Gress, Peggy Hwang, Niloufar
Mobashery. A phase 2B study of MK-7009 (vaniprevir) in patients with genotype 1 HCV
infection who have failed previous pegylated interferon and ribavirin treatment . Journal of
Hepatology 2013 Volume 59(1) ppg 11-17.
302. Eric Lawitz, Christophe Hezode, Peter Varunok, Paul Thuluvath, Tolga Baykal, Mudra
Kapoor, Sandra Lovell, Tianli Wang, Tami Pilot-Matias, Regis Vilchez, Barry Bernstein.
Interferon and Ribavirin-Free Regimen of ABT-450/r + ABT-267 in HCV Genotype 1b-infected
Treatment naïve Patients and Prior Null Responders. Hepatology 2013. Volume 58(4,S1) ppg
244A.
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303. Eric Lawitz, John Vieling, Abel Murillo, Marcelo Kugelmas, Jan Gerstoft, Peter Winkle,
Luis Balart, Peer Christensen, Reem Ghalib, Ronald Nahass, Melissa Shaughnessy, Xiao Sun,
Peggy Hwang, Janice Wahl, Michael Robertson, Barbara Haber. High Efficacy and Safety of the
All-Oral Combination Regimen, MK-5172/MK-8742 +/- RBV for 12 Weeks in HCV Genotype 1
Infected Patients: The C-WORTHY Study. Hepatology 2013. Volume 58(4,S1) ppg 244A.
304. Nezam Afdhal, Bruce Bacon, Keyur Patel, Eric Lawitz, Stuart Gordon, David Nelson,
Tracy Challies, Imad Nasser, Lee jen Wei, John McHutchison. Diagnostic accuracy of liver
stiffness (Fibroscan) in patients with chronic viral hepatitis: results of a large USA cohort,
Hepatology 2013. Volume 58(4,S1) ppg 278A.
305. Eric Lawitz, Fred Poordad, Robert Hyland, Xiao Ding, Christy Hebner, Phil Pang, William
Symonds, John McHutchison, Fernando Membreno. Once Daily Sofosbuvir/Ledipasvir Fixed
Dose Combination with or without Ribavirin Resulted in >95% Sustained Virologic Response in
Patients with HCV Genotype 1, Including Patients with Cirrhosis: the LONESTAR trial.
Hepatology 2013. Volume 58(4,S1) ppg 315A.
306. Zobair Younossi, Maria Stepanova, Eric Lawitz, David R. Nelson, Ira Jacobson, Edward
Gane, Fatema Nader, Sharon Hunt. Health Utilities in Patients with Chronic Hepatitis C Treated
with Sofosbuvir (SOF) Containing Regimens: Results for POSITRON, FISSON, FUSION
andNEUTRINO studies. Hepatology 2013. Volume 58(4,S1) ppg 385A.
307. Christy Hebner, Viktoria Gontcharova, Ramakrishna Chodavarapu, Maribel Rodriguez-
Torres, Eric Lawitz, Chris Yang, John McNally, John Link, Hongmei Mo. Deep Sequencing of
HCV NS5A From a 3-Day Study of GS-5816 Monotherapy Confirms the Potency of GS-5816
Against Pre-Existing Genotype 1-3 NS5A Resistance-Associated Variants. Hepatology 2013.
Volume 58(4,S1) ppg 433A.
308. Eric Lawitz, Steven Glass, Daniel Gruener, Bradley Freilich, John Hill, John Link, Polina
German, Christy Hebner, Lingling Han, Diana Brainard, John McNally, William Smith, Suzanne
Kim, Thomas Marbury, Jon Ruckle, Maribel Rodriguez-Torres. GS-5816, a Once Daily NS5A
Inhibitor, Demonstrates Potent Antiviral Activity in Patients with Genotype 1, 2, 3 or 4 HCV
Infection in a 3-Day Monotherapy Study. Hepatology 2013. Volume 58(4,S1) ppg 731A.
309. Eric Yoshida, Mark Sulkowski, Edward Gane, Robert Herring, Juile Ma, John McNally,
Diana Brainard, William Symonds, John McHutchison, Kimberly Beavers, Ira Jacobson, K.
Rajender Reddy, Eric Lawitz. The Concordance between SVR4, SVR12, and SVR24 in Patients
with Chronic HCV Infection who Received Treatment with Sofosbuvir in Phase 3 Clinical Trials.
Hepatology 2013. Volume 58(4,S1) ppg 734A.
310. Xaiver Forns, Eric Lawitz, Stefan Zeuzem, Edward Gane, Jean-Pierre Bronowicki, Pietro
Andreone, Andrzej Horban, Ashley Brown, Monika Peeters, Oliver Lenz, Sivi Ouwerkerk
Mahadevan, Jane Scott, Ronald Kalmeijer, Guy De La Rosa, Rekha Sinha, Maria Beumont-
Mauviel. Simeprevir (TM435) with peg-interferon a-2a/ribavirin for treatment of chronic HCV
54
genotype 1 infection in patients who relapsed after previous interferon-based therapy: efficacy
and safety in patient sub-populations in the PROMISE phase III trial, Hepatology 2013. Volume
58(4,S1) ppg 737A.
311. Alessandra Mangia, Marcelo Kugelmas, Gregory Everson, Federico Hinestrosa, Julie Ma,
John McNally, Diana Brainard, William Symonds, John McHutchison, Edward Gane, Stephen
Shafran, Raymond Chung, Eric Lawitz. Virologic Response Rates to Sofosbuvir-Containing
Regimens are Similar in Patients With and Without Traditional Negative Predictive Factors: A
Retrospective Analysis of Phase 3 Data. Hepatology 2013. Volume 58(4,S1) ppg 752A.
312. B. Nebiyou Bekele, David Nelson, Stuart Gordon, Jordan Feld, Keyur Patel, Eric Lawitz,
Aasim Sheikh, Diana Brainard, William Symonds, John McHutchison, Alessandra Mangia,
Edward Gane. A Bayesian Bridging Model Using Phase 3 Data in Treatment-Experienced HCV
Genotype 3 Patients Demonstrates Extending Sofosbuvir+Ribavirin Treatment from 12-16
Weeks in Treatment-Naïve Genotype 3 Patients May Significantly Increase SVR Rates.
Hepatology 2013. Volume 58(4,S1) ppg 754A.
313. Harvey Tatum, Paul Thuluvath, Eric Lawitz, Claudia Martorell, Stanley Cohen, Vinod
Rustgi, Natarajan Ravendhran, Reem Ghalib, John Hanson, Joann Zamparo, Jing Zhao, Michelle
Treitel, Eric Hughes. Safety and Efficacy of BMS-791325, a Non-Nucleoside NS5B Polymerase
Inhibitor, Combined with Peginterferon Alfa-2a and Ribavirin in Treatment-Naïve Patients
Infected with Hepatitis C Virus Genotype 1. Hepatology 2013. Volume 58(4,S1) ppg 759A.
314. Evguenia Svarovskaia, Hadas Dvory, Christy Hebner, Brian Doehle, Viktoria Gontcharova,
Ross Martin, Edward Gane, Ira Jacobson, David Nelson, Eric Lawitz, B. Nebiyou Bekele, Diana
Brainard, William Symonds, John McHutchison, Michael Miller, Hongmei, Mo. No Resistance
Detected in four Phase 3 Clinical Studies in HCV Genotype 1-6 of Sofosbuvir + Ribavirin with
or without Peginterferon. Hepatology 2013. Volume 58(4,S1) ppg 1091A.
315. Eric Lawitz, Christy Hubner, Phil Pang, Robert Hyland, Michael Miller, Hongmei Mo,
Fred Poordad, Fernando Membreno. Once Daily Sofosbuvir/Ledipasvir Fixed Dose Combination
is Highly Effective in Subjects with Baseline NS5A Inhibitor andNS3 Protease Inhibitor
Resistance-Associated Variants: The Lonestar Trial. Hepatology 2013. Volume 58(4,S1) ppg
1092A.
316. Zobair Younossi, Maria Stepanova, Eric Lawitz, David Nelson, Kelly Kaita, Fatema Nader,
Spencer Frost, Sharon Hunt. Successful Treatment with Sofosbuvir Regimen Improves Fatigue
Scores in Patients with Chronic Hepatitis C (CH-C). Hepatology 2013. Volume 58(4,S1) ppg
1277A.
317. Zobair Younossi, Maria Stepanova, Eric Lawitz, David Nelson, Curtis Cooper, Fatema
Nader, Mariam Afendy, Sharon Hunt. Minimal Impact of Sofosbuvir + Ribavirin (SOF + RBV)
on Work Productivity of Patients with Chronic Hepatitis C (CH-C). Hepatology 2013. Volume
58(4,S1) ppg 244A.
55
318. Fred Poordad, Eric Lawitz, K Rajender Reddy, Nezam H Afdhal, Christophe Hézode,
Stefan Zeuzem, Samuel S Lee, Jose Luis Calleja, Robert S Brown, Antonio Craxi, [......],
Weiping Deng, Kenneth J Koury, Lisa D Pedicone, Frank J Dutko, Margaret H Burroughs, Katia
Alves, Janice Wahl, Clifford A Brass, Janice K Albrecht, Mark S Sulkowski. Effects of Ribavirin
Dose Reduction vs Erythropoietin for Boceprevir-Related Anemia in Patients with Chronic HCV
Genotype 1 Infection-a Randomized Trial. Volume 145 (5), ppg 1035-1044.
319. Kelly A Wong, Angela Worth, Ross Martin, Evguenia Svarovskaia, Diana M Brainard, Eric
Lawitz, Michael D Miller, Hongmei Mo. Characterization of Hepatitis C Virus Resistance from a
Multiple Dose Clinical Trial of the novel NS5A Inhibitor GS-5885. Antimicrobial Agents and
Chemotherapy 2013
320. P Marcellin, C Cooper, L Balart, D Larrey, T Box, E Yoshida, E Lawitz, P Buggisch, P
Ferenci, M Weltman, I Nájera, D Thomas, G Hooper, N S Shulman, Y Zhang, M T Navarro, C Y
Lim, M Brunda, N A Terrault, E S Yetzer. Randomized Controlled Trial of Danoprevir Plus
Peginterferon Alfa-2a and Ribavirin in Treatment-Naive Patients with HCV Genotype 1
Infection. Gastroenterology 2013 Vol 145 (4), ppgs 790-800.
321. Eric Lawitz, Mark Sulkowski, Ira Jacobson, Walter K Kraft, Benedict Maliakkal,
Mohamed Al-Ibrahim, Stuart C Gordon, Paul Kwo, Juergen Kurt Rockstroh, Paul Panorchan,
Michelle Miller, Luzelena Caro, Richard Barnard, Peggy May Hwang, Jacqueline Gress, Erin
Quirk, Niloufar Mobashery. Characterization of Vaniprevir, a Hepatitis C Virus NS3/4A
Protease Inhibitor, in Patients With HCV Genotype 1 Infection: Safety, Antiviral Activity,
Resistance, and Pharmacokinetics. Antiviral Research 2013
322. Maribel Rodriguez-Torres, Albrecht Stoehr, Edward J Gane, Lawrence Serfaty, Eric
Lawitz, Amy Zhou, Michael Bourque, Sanhita Bhanja, Julie Strizki, Richard J O Barnard, Peggy
M T Hwang, Mark J Dinubile, Niloufar Mobashery Combination of Vaniprevir with
Peginterferon and Ribavirin Significantly Increases the Rate of Sustained Viral Response in
Treatment-Experienced Patients with Chronic HCV Genotype 1 Infection and Cirrhosis. Clinical
Gastroenterology and Hepatology 2013
323. Nezam H Afdhal, Geoffrey M Dusheiko, Edoardo G Giannini, Pei-Jer Chen, Kwang-Hyub
Han, Aftab Mohsin, Maribel Rodriguez-Torres, Sorin Rugina, Igor Bakulin, Eric Lawitz,
Mitchell L Shiffman, Ghias-Un-Nabi Tayyab, Fred Poordad, Yasser Mostafa Kamel, Andres
Brainsky, James Geib, Sandra Y Vasey, Rita Patwardhan, Fiona M Campbell, Dickens Theodore.
Eltrombopag Increases Platelet Numbers in Thrombocytopenic Patients with HCV Infection and
Cirrhosis, Allowing for Effective Antiviral Therapy. Gastroenterology 2013
324. Ira M Jacobson, Stuart C Gordon, Kris V Kowdley, Eric M Yoshida, Maribel Rodriguez-
Torres, Mark S Sulkowski, Mitchell L Shiffman, Eric Lawitz, Gregory Everson, Michael
Bennett, Di An, Ming Lin, John McNally, Diana Brainard, William T Symonds, John G
McHutchison, Keyur Patel, Jordan Feld, Stephen Pianko, David R Nelson. Sofosbuvir for
Hepatitis C Genotype 2 or 3 in Patients without Treatment Options. New England Journal of
Medicine 2013 Vol 368. 1867-1877.
56
325. Eric Lawitz, Alessandra Mangia, David Wyles, Maribel Rodriguez-Torres, Tarek
Hassanein, Stuart C Gordon, Michael Schultz, Mitchell N Davis, Zeid Kayali, K Rajender
Reddy, Robert H Hyland, Sarah Arterburn, Deyuan Jiang, John McNally, Diana Brainard,
William T Symonds, John G McHutchison, Aasim M Sheikh, Zobair Younossi, Edward J Gane.
Sofosbuvir for Previously Untreated Chronic Hepatitis C Infection. New England Journal of
Medicine 2013 Vol 368. 1878-1887.
326. Kris V Kowdley, Eric Lawitz, Israel Crespo, Tarek Hassanein, Mitchell N Davis, Michael
Demicco, David E Bernstein, Nezam Afdhal, John M Vierling, Stuart C Gordon, Jane K
Anderson, Robert H Hyland, Hadas Dvory-Sobol, Di An, Robert G Hindes, Efsevia Albanis,
William T Symonds, M Michelle Berrey, David R Nelson, Ira M Jacobson. Sofosbuvir with
pegylated interferon alfa-2a and ribavirin for treatment-naive patients with hepatitis C genotype-1
infection (ATOMIC): an open-label, randomised, multicentre phase 2 trial. The Lancet 2013. Vol
381,(9883), Ppg 2100 – 2107.
327. Eric Lawitz, Jay P Lalezari, Tarek Hassanein, Kris V Kowdley, Fred F Poordad, Aasim M
Sheikh, Nezam H Afdhal, David E Bernstein, Edwin Dejesus, Bradley Freilich, [......], Natalie H
Bzowej, Robert H Hyland, Hongmei Mo, Ming Lin, Michael Mader, Robert Hindes, Efsevia
Albanis, William T Symonds, Michelle M Berrey, Andrew Muir. Sofosbuvir in combination with
peginterferon alfa-2a and ribavirin for non-cirrhotic, treatment-naive patients with genotypes 1,
2, and 3 hepatitis C infection: a randomised, double-blind, phase 2 trial. The Lancet Infectious
Diseases 2013. Vol 13: 401–08.
328. Robert A Ogert, John A Howe, John M Vierling, Paul Y Kwo, Eric J Lawitz, Jonathan
McCone, Eugene R Schiff, David Pound, Mitchell N Davis, Stuart C Gordon, Ira M Jacobson,
Robert Ralston, Eirum Chaudhri, Ping Qiu, Lisa D Pedicone, Clifford A Brass, Janice K
Albrecht, Richard Jo Barnard, Daria J Hazuda, Anita Ym Howe. Resistance-associated amino
acid variants associated with boceprevir plus pegylated interferon-α2b and ribavirin in patients
with chronic hepatitis C in the SPRINT-1 Trial. Antiviral Therapy 2013. Vol 18(3):387-97.
329. Fernando E Membreno, Jennifer C Espinales, Eric J Lawitz. Cyclophilin inhibitors for
hepatitis C therapy. Clinics in Liver Disease 2013. Vol 17(1):129-39.
330. Stanislas Pol, Jeroen Aerssens, Stefan Zeuzem, Pietro Andreone, Eric J Lawitz, Stuart
Roberts, Zobair Younossi, Graham R Foster, Roberto Focaccia, Andrzej Horban, Paul J Pockros,
Rolf P G Van Heeswijk, Sandra De Meyer, Don Luo, Martyn Botfield, Maria Beumont, Gaston
Picchio. Limited impact of IL28B genotype on response rates in telaprevir-treated patients with
prior treatment failure. Journl of Hepatology 2013. Vol 58(5):883-9.
331. S C Gordon, E M Yoshida, E J Lawitz, B R Bacon, M S Sulkowski, M Davis, F Poordad,
J-P Bronowicki, R Esteban, V Sniukiene, M H Burroughs, W Deng, F J Dutko, C A Brass, J K
Albrecht, K Rajender Reddy . Adherence to assigned dosing regimen and sustained virological
57
response among chronic hepatitis C genotype 1 patients treated with boceprevir plus
peginterferon alfa-2b/ribavirin. Alimentary Pharmacology & Therapeutics 2013
332. Eric Lawitz, Mark Sulkowski, Ira Jacobson, Walter K Kraft, Benedict Maliakkal,
Mohamed Al-Ibrahim, Stuart C Gordon, Paul Kwo, Juergen Kurt Rockstroh, Paul Panorchan,
Michelle Miller, Luzelena Caro, Richard Barnard, Peggy May Hwang, Jacqueline Gress, Erin
Quirk, Niloufar Mobashery. Characterization of Vaniprevir, a Hepatitis C Virus NS3/4A
Protease Inhibitor, in Patients With HCV Genotype 1 Infection: Safety, Antiviral Activity,
Resistance, and Pharmacokinetics. Antiviral Research 2013
333. P Marcellin, C Cooper, L Balart, D Larrey, T Box, E Yoshida, E Lawitz, P Buggisch, P
Ferenci, M Weltman, E Labriola-Tompkins, S Le Pogam, I Nájera, D Thomas, G Hooper, N S
Shulman, Y Zhang, M T Navarro, C Y Lim, M Brunda, N A Terrault, E S Yetzer. Randomized
Controlled Trial of Danoprevir Plus Peginterferon Alfa-2a and Ribavirin in Treatment-Naive
Patients with HCV Genotype 1 Infection. Gastroenterology 2013
334. Kelly A Wong, Angela Worth, Ross Martin, Evguenia Svarovskaia, Diana M Brainard, Eric
Lawitz, Michael D Miller, Hongmei Mo . Characterization of Hepatitis C Virus Resistance from
a Multiple Dose Clinical Trial of the novel NS5A Inhibitor GS-5885.
Antimicrobial Agents and Chemotherapy 2013
335. Fred Poordad, Eric Lawitz, K Rajender Reddy, Nezam H Afdhal, Christophe Hézode,
Stefan Zeuzem, Samuel S Lee, Jose Luis Calleja, Robert S Brown, Antonio Craxi, Heiner
Wedemeyer, Lisa Nyberg, David Nelson, Lorenzo Rossaro, Luis Balart, Timothy Morgan, Bruce
R Bacon, Steven L Flamm, Kris V Kowdley, Weiping Deng, Kenneth J Koury, Lisa D Pedicone,
Frank J Dutko, Margaret H Burroughs, Katia Alves, Janice Wahl, Clifford A Brass, Janice K
Albrecht, Mark S Sulkowski. Effects of Ribavirin Dose Reduction vs Erythropoietin for
Boceprevir-Related Anemia in Patients with Chronic HCV Genotype 1 Infection-a Randomized
Trial. Gastroenterology 2013
336. Alison B Jazwinski, Paul J Clark, Alexander J Thompson, Stuart C Gordon, Eric J Lawitz,
Stephanie Noviello, Clifford A Brass, Lisa D Pedicone, Janice K Albrecht, Mark S Sulkowski,
Andrew J Muir. Predictors of consent to pharmacogenomics testing in the IDEAL study.
Pharmacogenetics and Genomics 2013
337. E J Lawitz, M Rodriguez-Torres, J Denning, A Mathias, H Mo, B Gao, M T Cornpropst, M
M Berrey, W T Symonds. All-oral therapy with nucleotide inhibitors sofosbuvir and GS-0938
for 14 days in treatment-naive genotype 1 hepatitis C (NUCLEAR). Journal of Viral Hepatitis
2013 Vol 20(10):699-707.
338. Maribel Rodriguez-Torres, Albrecht Stoehr, Edward J Gane, Lawrence Serfaty, Eric
Lawitz, Amy Zhou, Michael Bourque, Sanhita Bhanja, Julie Strizki, Richard J O Barnard, Peggy
M T Hwang, Mark J Dinubile, Niloufar Mobashery . Combination of Vaniprevir with
58
Peginterferon and Ribavirin Significantly Increases the Rate of Sustained Viral Response in
Treatment-Experienced Patients with Chronic HCV Genotype 1 Infection and Cirrhosis. Clinical
gastroenterology and Hepatology 2013
339. Nezam H Afdhal, Geoffrey M Dusheiko, Edoardo G Giannini, Pei-Jer Chen, Kwang-Hyub
Han, Aftab Mohsin, Maribel Rodriguez-Torres, Sorin Rugina, Igor Bakulin, Eric Lawitz,
Mitchell L Shiffman, Ghias-Un-Nabi Tayyab, Fred Poordad, Yasser Mostafa Kamel, Andres
Brainsky, James Geib, Sandra Y Vasey, Rita Patwardhan, Fiona M Campbell, Dickens Theodore.
Eltrombopag Increases Platelet Numbers in Thrombocytopenic Patients with HCV Infection and
Cirrhosis, Allowing for Effective Antiviral Therapy. Gastroenterology 2014, Vol146(2) ppg 442-
451.
340. Stuart C Gordon, K Rajender Reddy, Ira M Jacobson, Fred Poordad, Jean-Pierre
Bronowicki, Bruce Bacon, Maria Buti, Ke-Qin Hu, Lisa D Pedicone, Margaret Burroughs,
Clifford A Brass, Janice K Albrecht, Eric J Lawitz. Boceprevir Plus Peginterferon α-
2b/Ribavirin in Chronic Hepatitis C Genotype 1: Impact of Baseline Viral Load on Sustained
Virologic Response. Journal of Clinical Gastroenterology 2014
341. Gregory T Everson, Karen D Sims, Maribel Rodriguez-Torres, Christophe Hézode, Eric
Lawitz, Marc Bourlière, Veronique Loustaud-Ratti, Vinod Rustgi, Howard Schwartz, Harvey
Tatum, Patrick Marcellin, Stanislas Pol, Paul J Thuluvath, Timothy Eley, Xiaodong Wang, Shu-
Pang Huang, Fiona McPhee, Megan Wind-Rotolo, Ellen Chung, Claudio Pasquinelli, Dennis M
Grasela, David F Gardiner. Efficacy of an Interferon- and Ribavirin-free Regimen of Daclatasvir,
Asunaprevir, and BMS-791325 in Treatment-naïve Patients with HCV Genotype 1 Infection.
Gastroenterology 2013
342. Hope Hubbard and Eric Lawitz. Real World Experience in the Era of First Generation
Protease Inhibitors in the Treatment of Hepatitis C. Current Hepatitis Reports 2013; 12(4).
343. Zobair M Younossi, Maria Stepanova, Linda Henry, Edward Gane, Ira M Jacobson, Eric
Lawitz, David Nelson, Lynn Gerber, Fatema Nader, Sharon Hunt. Effects of Sofosbuvir-based
Treatment, With and Without Interferon, on Outcome and Productivity of Patients With Chronic
Hepatitis C. Clinical gastroenterology and Hepatology 2013
344. Zobair M Younossi, Maria Stepanova, Linda Henry, Edward Gane, Ira M Jacobson, Eric
Lawitz, David Nelson, Fatema Nader, Sharon Hunt. Minimal Impact of Sofosbuvir and
Ribavirin on Health Related Quality of Life in Chronic Hepatitis C (CH-C). Journal of
Hepatology 2013
345. John M Vierling, Mitchell Davis, Steven Flamm, Stuart C Gordon, Eric Lawitz, Eric M
Yoshida, Joseph Galati, Velimir Luketic, Jonathan McCone, Ira Jacobson, Patrick Marcellin,
Andrew J Muir, Fred Poordad, Lisa D Pedicone, Janice Albrecht, Clifford Brass, Anita Y M
Howe, Lynn Y Colvard, Frans A Helmond, Weiping Deng, Michelle Treitel, Janice Wahl, Jean-
Pierre Bronowicki. Boceprevir for Chronic HCV Genotype 1 Infection in Patients with Prior
59
Treatment Failure to Peginterferon/Ribavirin, including Prior Null Response. Journal of
Hepatology 2013
346. Eric Lawitz, Fred F Poordad, Phillip S Pang, Robert H Hyland, Xiao Ding, Hongmei Mo,
William T Symonds, John G McHutchison, Fernando E Membreno . Sofosbuvir and ledipasvir
fixed-dose combination with and without ribavirin in treatment-naive and previously treated
patients with genotype 1 hepatitis C virus infection (LONESTAR): an open-label, randomised,
phase 2 trial. The Lancet 2013
347. Kowdley KV, Lawitz E, Crespo I, Hassanein T, Davis M, De Mico DR, et al. ATOMIC:
97% RVR for PSI-7977 + PEG/RBV × 12 week regimen in HCV GT1: an end to response-
guided therapy?. Journal of Hepatology 2012;56:1
348. Thomas Marbury, Eric Lawitz, Robert Stonerock, Martha Gonzalez, James Jiao, Jim
Breeding, Christopher Haqq, Peter Verboven, Hans Stieltjes, Margaret Yu, Arturo Molina, Milin
Acharya, Caly Chien, Namphuong Tran. Single-dose pharmacokinetic studies of abiraterone
acetate in men with hepatic or renal impairment. The Journal of Clinical Pharmacology 2013
349. Zobair Younossi, Francesco Negro, Lawrence Serfaty, Stanislas Pol, Moises Diago, Stefan
Zeuzem, Pietro Andreone, Eric J. Lawitz, Stuart Roberts, Roberto Focaccia, Graham R. Foster,
Andrzej Horban, Isabelle Lonjon-Domanec, Bruce Coate, Ralph DeMasi, Gaston Picchio, James
Witek. Homeostasis model assessment of insulin resistance does not seem to predict response to
telaprevir in chronic hepatitis C in the REALIZE trial. Hepatology 12/2013; 58(6).
350. Mark S. Sulkowski, M.D., David F. Gardiner, M.D., Maribel Rodriguez-Torres, M.D., K.
Rajender Reddy, M.D., Tarek Hassanein, M.D., Ira Jacobson, M.D., Eric Lawitz, M.D., Anna S.
Lok, M.D., Federico Hinestrosa, M.D., Paul J. Thuluvath, M.D., Howard Schwartz, M.D., David
R. Nelson, M.D., Gregory T. Everson, M.D., Timothy Eley, Ph.D., Megan Wind-Rotolo, Ph.D.,
Shu-Pang Huang, Ph.D., Min Gao, Ph.D., Dennis Hernandez, Ph.D., Fiona McPhee, Ph.D.,
Diane Sherman, M.S., Robert Hindes, M.D., William Symonds, Pharm.D., Claudio Pasquinelli,
M.D., Ph.D., and Dennis M. Grasela, Pharm.D., Ph.D. Daclatasvir plus Sofosbuvir for Previously
Treated or Untreated Chronic HCV Infection. N Engl J Med 2014; 370:211-221.
351. Kris V. Kowdley, M.D., Eric Lawitz, M.D., Fred Poordad, M.D., Daniel E. Cohen, M.D.,
David R. Nelson, M.D., Stefan Zeuzem, M.D., Gregory T. Everson, M.D., Paul Kwo, M.D.,
Graham R. Foster, F.C.R.P., Mark S. Sulkowski, M.D., Wangang Xie, Ph.D., Tami Pilot-Matias,
Ph.D., George Liossis, B.A., Lois Larsen, Ph.D., Amit Khatri, Ph.D., Thomas Podsadecki, M.D.,
and Barry Bernstein, M.D. Phase 2b Trial of Interferon-free Therapy for Hepatitis C Virus
Genotype 1. N Engl J Med 2014; 370:222-232.
352. Michael T. Melia; Norbert Brau; Fred Poordad; Eric J. Lawitz; Mitchell L. Shiffman; John
G. McHutchison; Andrew J. Muir; Greg W. Galler; Lisa M. Nyberg; W. M. Lee; Eugene Schiff;
Jianmin Long; Stephanie Noviello; Clifford A. Brass; Lisa D. Pedicone; Mark S. Sulkowski.
Infections during peginterferon/ribavirin therapy are associated with the magnitude of decline in
absolute lymphocyte count: Results of the IDEAL study. Clinical Infectious Diseases 2014.
60
353. Bradley Vince, John M Hill, Eric J Lawitz, William O'Riordan, Lynn R Webster, Daniel M
Gruener, Ricky S Mofsen, Abel Murillo, Eileen Donovan, Jie Chen, Joseph F McCarville, John Z
Sullivan-Bólyai, Douglas Mayers, Xiao-Jian Zhou . A randomized, double-blind, multiple-dose
study of the pan-genotypic NS5A inhibitor samatasvir in patients infected with hepatitis C virus
genotype 1, 2, 3 or 4. Journal of Hepatology 1/2014.
354. Jeremie Guedj, Phillip S Pang, Jill Denning, Maribel Rodriguez-Torres, Eric Lawitz,
William Symonds, Alan S Perelson. Analysis of the hepatitis C viral kinetics during
administration of two nucleotide analogues: sofosbuvir (GS-7977) and GS-0938. Antiviral
therapy 01/2014.
355. David L Wyles, Maribel Rodriguez-Torres, Eric Lawitz, Mitchell L Shiffman, Stanislas
Pol, Robert W Herring, Benedetta Massetto, Bittoo Kanwar, James D Trenkle, Phil S Pang,
Yanni Zhu, Hongmei Mo, Diana M Brainard, G Mani Subramanian, John G McHutchison,
François Habersetzer, Mark S Sulkowski. All-Oral Combination of Ledipasvir, Vedroprevir,
Tegobuvir, and Ribavirin in Treatment-Naive Patients with Genotype 1 HCV Infection.
Hepatology 02/ 2014
356. David Nelson, Eric M Yoshida, Matthew S Paulson, Paul N Hengen, Dongliang Ge, Bittoo
Kanwar, John McNally, Phil S Pang, G Mani Subramanian, John G McHutchison, Petr Urbanek,
Eric Lawitz, Thomas J Urban. Genome-wide association study to characterize serum bilirubin
elevations in patients with HCV treated with GS-9256, an HCV NS3 serine protease inhibitor.
Antiviral Therapy 02/2014.
357. Anna S. Lok, David F. Gardiner, Christophe Hézode, Eric J. Lawitz, Marc Bourlière,
Gregory T. Everson, Patrick Marcellin, Maribel Rodriguez-Torres, Stanislas Pol, Lawrence
Serfaty, Timothy Eley, Shu-Pang Huang, Jianling Li, Megan Wind-Rotolo, Fei Yu, Fiona
McPhee, Dennis M. Grasela, Claudio Pasquinelli. Randomized trial of daclatasvir and
asunaprevir with or without PegIFN/RBV for hepatitis C virus genotype 1 null responders.
Journal of Hepatology 2014. Vol 60 (3) , Pages 490-499.
358. G.T. Everson, K.D. Sims, M. Rodriguez-Torres, C. Hezode, E. Lawitz, M. Bourliere, V.
Loustaud-Ratti, V. Rustgi, H. Schwartz, H. Tatum, P. Marcellin, S. Pol, P.J. Thuluvath, T. Eley,
X. Wang, S.-P. Huang, F. McPhee, M. Wind-Rotolo, E. Chung, C. Pasquinelli, D.M. Grasela,
and D.F. Gardiner. Efficacy of an Interferon- and Ribavirin- Free Regimen of Daclatasvir,
Asunaprevir, and BMS- 791325 in Treatment-Naïve Patients With HCV Genotype 1 Infection.
Gastroneterology February 2014. Volume 146(2), Pages 420-429.
359. Xavier Forns, Eric Lawitz, Stefan Zeuzem, Ed Gane, Jean Pierre Bronowicki, Pietro
Andreone, Andrzej Horban, Ashley Brown, Monika Peeters, Oliver Lenz, Sivi Ouwerkerk-
Mahadevan, Jane Scott, Guy De La Rosa, Ronald Kalmeijer, Rekha Sinha, Maria Beumont-
Mauviel Simeprevir with Peginterferon and Ribavirin Leads to High Rates of SVR in Patients
with HCV Genotype 1 Who Relapsed After Previous Therapy: a Phase 3 Trial
Gastroneterology June 2014 Vol 146(7), 1669-1679.
61
360. A.S. Lok, D.F. Gardiner, C. Hezode, E.J. Lawitz, M. Bourliere, G.T. Everson, P. Marcellin,
M. Rodriguez-Torres, S. Pol, L. Serfaty, T. Eley, S.-P. Huang, J. Li, M. Wind-Rotolo, F. Yu, F.
McPhee, D.M. Grasela and C. Pasquinelli. Randomized trial of daclatasvir and asunaprevir with
or without PeglFN/RBV for hepatitis C virus genotype 1 null responders. Journal of Hepatology
April 2014. 3, April 2014, Pages 490-499.
361. Zobair M. Younossi, Maria Stepanova, Linda Henry
, Edward Gane
, Ira M. Jacobson
, Eric
Lawitz, David Nelson
, Fatema Nader
, Sharon Hunt. Minimal impact of sofosbuvir and ribavirin
on health related quality of life in Chronic Hepatitis C (CH-C). Journal of Hepatology April
2014. Volume 60, Issue 4, April 2014, Pages 741–747.
362. John M. Vierling, Mitchell Davis, Steven Flamm, Stuart C. Gordon, Eric Lawitz, Eric
M. Yoshida, Joseph Galati, Velimir Luketic, Jonathan McCone, Ira Jacobson, Patrick Marcellin,
Andrew J. Muir, Fred Poordad, Lisa D. Pedicone, Janice Albrecht, Clifford Brass, Anita
Y.M. Howe, Lynn Y. Colvard, Frans A. Helmond, Weiping Deng, Michelle Treitel, Janice Wahl,
Jean-Pierre Bronowicki. Boceprevir for chronic HCV genotype 1 infection in patients with prior
treatment failure to peginterferon/ribavirin, including prior null response. Journal of Hepatology
April 2014. Volume 60, Issue 4 , Pages 748-756.
363. Zobair M. Younossi, Maria Stepanova, Fatema Nader, Ira M. Jacobson, Ed Gane, David
Nelson, Eric Lawitz, Sharon L. Hunt. Patient-reported outcomes in chronic hepatitis C patients
with cirrhosis treated with sofosbuvir-containing regimens. Hepatology 2014 Vol59(6), ppg
2161-2170.
364. Nezam Afdhal, K Rajender Reddy, David R Nelson, Eric Lawitz, Stuart C Gordon, Eugene
Schiff, Ronald Nahass, Reem Ghalib, Norman Gitlin, Robert Herring, Jacob Lalezari, Ziad H
Younes, Paul J Pockros, Adrian M Di Bisceglie, Sanjeev Arora, G Mani Subramanian, Yanni
Zhu, Hadas Dvory-Sobol, Jenny C Yang, Phillip S Pang, William T Symonds, John G
McHutchison, Andrew J Muir, Mark Sulkowski, Paul Kwo. Ledipasvir and Sofosbuvir for
Previously Treated HCV Genotype 1 Infection. New England Journal of Medicine 2014;
370:1483-1493.
365. Kris V Kowdley, Stuart C Gordon, K Rajender Reddy, Lorenzo Rossaro, David E Bernstein,
Eric Lawitz, Mitchell L Shiffman, Eugene Schiff, Reem Ghalib, Michael Ryan, Vinod Rustgi,
Mario Chojkier, Robert Herring, Adrian M Di Bisceglie, Paul J Pockros, G Mani Subramanian,
Di An, Evguenia Svarovskaia, Robert H Hyland, Phillip S Pang, William T Symonds, John G
McHutchison, Andrew J Muir, David Pound, Michael W Fried. Ledipasvir and Sofosbuvir for 8
or 12 Weeks for Chronic HCV without Cirrhosis. New England Journal of Medicine 2014; 370
366. Karen Sims, Julie Lemm, Timothy Eley, Menping Liu, Anna Berglind, Diane Sherman,
Eric Lawitz, Apinya B Vutikullird, Pablo Tebas, Min Gao, Claudio Pasquinelli, Dennis M
62
Grasela. A Randomized, Placebo-Controlled, Single Ascending Dose Study of BMS-791325, a
Hepatitis C Virus NS5B Polymerase Inhibitor, in Genotype 1 Infection. Antimicrobial Agents
and Chemotherapy April 2014.
367. Eric Lawitz, Fernando Membreno. Response-Guided Therapy in Patients with Genotype 1
HCV: Current Status and Future Prospects. Journal of Gastroenterology and Hepatology. May
2014.
368. Jennifer Lin, Francois Habersetzer, Maribel Rodriguez Torres, Nazam Afdahl, Eric Lawitz,
Mathew Paulson. IP-10 Kinetics in Treatment-Naïve Versus -Experienced Patients Receiving
Interferon-Free Hepatitis C Virus Therapy: Implications for the Innate Immune Response. The
Journal of infectious diseases 06/2014; DOI: 10.1093/infdis/jiu325
369. Eric Lawitz, Mark S Sulkowski, Reem Ghalib,Maribel Rodriguez-Torres, Zobair M
Younossi, Ana Corregidor, Edwin DeJesus, Brian Pearlman, Mordechai Rabinovitz, Norman
Gitlin, Joseph K Lim, Paul J Pockros , John D Scott, Bart Fevery, Tom Lambrecht, Sivi
Ouwerkerk-Mahadevan, Katleen Callewaert, William T Symonds, Gaston Picchio, Karen L
Lindsay, Maria Beumont, Ira M Jacobson. Simeprevir plus sofosbuvir, with or without ribavirin,
to treat chronic infection with hepatitis C virus genotype 1 in non-responders to pegylated
interferon and ribavirin and treatment-naive patients: the COSMOS randomised study. The
LANCET 2014, Volume 384, Issue 9956, Pages 1756 - 1765, 15 November 2014
370. Hézode C, Hirschfield GM, Ghesquiere W, Sievert W, Rodriguez-Torres M, Shafran SD,
Thuluvath PJ, Tatum HA, Waked I, Esmat G, Lawitz EJ, Rustgi VK, Pol S, Weis N, Pockros
PJ, Bourlière M, Serfaty L, Vierling JM, Fried MW, Weiland O, Brunetto MR, Everson GT,
Zeuzem S, Kwo PY, Sulkowski M, Bräu N, Hernandez D, McPhee F, Wind-Rotolo M, Liu Z,
Noviello S, Hughes EA, Yin PD, Schnittman S. Daclatasvir plus peginterferon alfa and ribavirin
for treatment-naive chronic hepatitis C genotype 1 or 4 infection: a randomised study. Gut. 2014
Jul 30. pii: gutjnl-2014-307498. doi: 10.1136/gutjnl-2014-307498.
371. Dvory-Sobol H, Voitenleitner C, Mabery E, Skurnac T, Lawitz EJ, McHutchison J,
Svarovskaia ES, Delaney W, Miller MD, Mo H . Clinical and In Vitro Resistance to GS-9669, a
Thumb Site II Nonnucleoside Inhibitor of the Hepatitis C Virus NS5B Polymerase.
Antimicrobial Agents and Chemotherapy 08/2014 2014 pii: AAC.02815-14
372. Eric Lawitz, Daniel Gruener, Thomas Marbury, John Hill, Lynn Webster, David Hassman,
Anh-Hoa Nguyen, Stefan Pflanz, Erik Mogalian, Anuj Gaggar, Benedetta Massetto, G Mani
Subramanian, John G McHutchison, Ira M Jacobson, Bradley Freilich, Maribel Rodriguez-
Torres. Safety, pharmacokinetics and pharmacodynamics of the oral Toll-like receptor 7 agonist
GS-9620 in treatment-naive patients with chronic hepatitis C. Antiviral Therapy 2014, doi:
10.3851/IMP2845
373. van der Ree MH, van der Meer AJ, de Bruijne J, Maan R, van Vliet A, Welzel TM, Zeuzem
S, Lawitz EJ, Rodriguez-Torres M Kupcova V, Wiercinska-Drapalo A, Hodges MR, Janssen
63
HL, Reesink HW. Long-term safety and efficacy of microRNA-targeted therapy in chronic
hepatitis C patients. Antiviral Research. 2014 Sep 8. pii: S0166-3542(14)00252-6.
doi:10.1016/j.antiviral.2014.08.015.
374. Eric Lawitz, Greg Sullivan, Maribel Rodriguez-Torres, Michael Bennett, Fred Poordad,
Mudra Kapoor, Prajakta Badri, Andrew Campbell, Lino Rodrigues Jr, Yiran Hu, Tami Pilot-
Matias, Regis A. Vilchez. Exploratory Trial of Ombitasvir and ABT-450/r With or Without
Ribavirin for HCV Genotype 1, 2, and 3 Infection. Journal of Infection 2014. available online:
22-SEP-2014 DOI information: 10.1016/j.jinf.2014.09.008.
375. Svarovskaia ES, Dvory-Sobol H, Parkin N, Hebner C, Gontcharova V, Martin R, Ouyang
W, Han B, Xu S, Ku K, Chiu S, Gane E, Jacobson IM, Nelson DR, Lawitz E, Wyles DL, Bekele
N, Brainard D, Symonds WT, McHutchison JG, Miller MD, Mo H. Infrequent Development of
Resistance in Genotype 1-6 Hepatitis C Virus-Infected Subjects Treated With Sofosbuvir in
Phase 2 and 3 Clinical Trials. Clin Infect Dis. 2014 Sep 28. pii: ciu697
376. Thomas Berg, Pietro Andreone, Stanislas Pol, Stuart Roberts, Zobair Younossi, Moises
Diago, Eric J. Lawitz, Roberto Focaccia, Graham R. Foster, Andrzej Horban, Isabelle Lonjon-
Domanec, Ralph DeMasi, Gaston Picchio, Donghan Luo, Sandra De Meyer and Stefan Zeuzem.
Low-density lipoprotein and other predictors of response with telaprevir-based therapy in
treatment-experienced HCV genotype 1 patients: REALIZE study. Liver International 15 OCT
2014 08:40AM EST | DOI: 10.1111/liv.12703.
377. Gregory J. Dore, Eric Lawitz, Christophe Hézode, Stephen D. Shafran, Alnoor Ramji,
Harvey A. Tatum, Gloria Taliani,Albert Tran, Maurizia R. Brunetto, Serena Zaltron, Simone I.
Strasser, Nina Weis,Wayne Ghesquiere, Samuel S. Lee, Dominique Larrey, Stanislas Pol,Hugh
Harley, Jacob George,Scott Fung, Victor de Lédinghen, Peggy Hagens, Fiona McPhee,Dennis
Hernandez, David Cohen,Elizabeth Cooney, Stephanie Noviello, Eric A. Hughes. Daclatasvir
plus Peginterferon and Ribavirin is Non-inferior to Peginterferon and Ribavirin Alone, and
Reduces Duration of Treatment for HCV Genotype 2 or 3 Infection. Gastroenterology 2014 DOI:
http://dx.doi.org/10.1053/j.gastro.2014.10.007
378. Eric Lawitz, Fred Poordad, Diana M. Brainard, Robert H. Hyland, Di An, William T.
Symonds, John G. McHutchison, Fernando E. Membreno. Sofosbuvir with peginterferon-
ribavirin for 12 weeks in previously treated patients with hepatitis C genotype 2 or 3 and
cirrhosis. Hepatology October, 2014, DOI: 10.1002/hep.27567.
379. Eric Lawitz, Edward Gane, Brian Pearlman, Edward Tam, Wayne Ghesquiere, Dominique
Guyader, Laurent Alric, Jean-Pierre Bronowicki,Laura Lester, William Sievert, Reem Ghalib,
Luis Balart, Fredrik Sund, Martin Lagging, Frank Dutko, Melissa Shaughnessy, Peggy Hwang,
Anita Y M Howe, Janice Wahl, Michael Robertson, Eliav Barr, Barbara Haber. Efficacy and
safety of 12 weeks versus 18 weeks of treatmentwith grazoprevir (MK-5172) and elbasvir (MK-
8742) with orwithout ribavirin in patients infected with hepatitis Cgenotype 1 with cirrhosis or
previous null response (C-WORTHY): a randomised, factorial open-label phase 2 trial. The
LANCET, November 11, 2014 http://dx.doi.org/10.1016/S0140-6736(14)61795-5.
64
380. Tarek Hassanein, Karen D. Sims, Michael Bennett, Norman Gitlin, Eric Lawitz,
Tuan Nguyen, Lynn Webster, Zobair Younossi, Howard Schwartz, Paul J.
Thuluvath, Helen Zhou, Bhaskar Rege, Fiona McPhee, Nannan Zhou, Megan
Wind-Rotolo, Ellen Chung, Amber Griffies, Dennis M. Grasela, David F.
Gardiner. A Randomized Trial of Daclatasvir in Combination With Asunaprevir and
Beclabuvirin Patients With Chronic Hepatitis C Virus Genotype 4 Infection. Journal of
Hepatology 2014; DOI: http://dx.doi.org/10.1016/j.jhep.2014.12.025.
381.Eric M. Yoshida, Mark S. Sulkowski, Edward J. Gane, Robert W. Herring Jr., Vlad Ratziu,
Xiao Ding, Jing Wang, Shu-Min Chuang, Julie Ma, John McNally, Luisa M. Stamm, Diana M.
Brainard, William T. Symonds, John G. McHutchison, Kimberly L. Beavers, Ira M. Jacobson, K.
Rajender Reddy and Eric Lawitz. Concordance of sustained virological response 4, 12, and 24
weeks post-treatment with sofosbuvir-containing regimens for hepatitis C virus (pages 41–45).
Hepatology 24 NOV 2014 | DOI: 10.1002/hep.27366.
382. Afdhal NH, Bacon BR, Patel K, Lawitz EJ, Gordon SC, Nelson DR, Challies TL, Nasser I,
Garg J, Wei LJ, McHutchison JG. Accuracy of Fibroscan, Compared with Histology, in Analysis
of Liver Fibrosis in Patients with Hepatitis B or C: A US Multi-center Study. Clin Gastroenterol
Hepatol. 2014 Dec 17. pii: S1542-3565(14)01823-0. doi: 10.1016/j.cgh.2014.12.014.
383. Eric Lawitz , Greg Sullivan , Maribel Rodriguez-Torres ,Michael Bennett , Fred Poordad ,
Mudra Kapoor ,Prajakta Badri , Andrew Campbell , Lino Rodrigues Jr.,Yiran Hu, Tami Pilot-
Matias , Regis A. Vilchez. Exploratory trial of ombitasvir and ABT-450/r with or without
ribavirin for HCVgenotype 1, 2, and 3 infection. Journal of Infection (2015) 70, 197-205.
384. Nelson DR, Cooper JN, Lalezari JP, Lawitz E, Pockros PJ, Gitlin N, Freilich BF, Younes
ZH, Harlan W, Ghalib R, Oguchi G, Thuluvath PJ, Ortiz-Lasanta G, Rabinovitz M, Bernstein D,
Bennett M, Hawkins T, Ravendhran N, Sheikh AM, Varunok P, Kowdley KV, Hennicken D,
McPhee F, Rana K, Hughes EA. All-Oral 12-Week Treatment With Daclatasvir Plus Sofosbuvir
in Patients With Hepatitis C Virus Genotype 3 Infection: ALLY-3 Phase 3 Study. Hepatology.
2015 Jan 23. doi: 10.1002/hep.27726.
385. David Wyles, Paul Pockros,Giuseppe Morelli,Ziad Younes, Evguenia Svarovskaia, Jenny C.
Yang, Phillip Pang,Yanni Zhu, John G. McHutchison,Steven Flamm, Eric Lawitz. Ledipasvir-
sofosbuvir plus ribavirin for patients with genotype 1 HCV previously treated in clinical trials of
sofosbuvir regimens. Hepatology 2015. DOI: 10.1002/hep.27814.
386. K. Rajender Reddy, Marc Bourlière, Mark Sulkowski, Masao Omata, Stefan Zeuzem,
Jordan J. Feld, Eric Lawitz, Patrick Marcellin, Tania M. Welzel, Robert Hyland, Phillip Pang,
Hadas Dvory‐Sobol, Mani Subramanian, William Symonds, John G. McHutchison, Alessandra
Mangia, Edward Gane, Masashi Mizokami, Stanislas Pol, Nezam Afdhal. Ledipasvir and
Sofosbuvir in Patients with Genotype 1 HCV and Compensated Cirrhosis: An Integrated Safety
and Efficacy Analysis. Hepatology 2015. DOI: 10.1002/hep.27826.
65
387. Z.M. Younossi, M. Stepanova, D. Nelson, E. Lawitz, F. Nader, S. Hunt. Health-Related
Quality of Life (HRQL) in Chronic Hepatitis C (CH-C) Patients Treated with Sofosbuvir
Containing Interferon-Free Regimens. Value in Health 2013. DOI:
http://dx.doi.org/10.1016/j.jval.2013.08.1133.
388. Xavier Forns, Stuart Gordon, Eli Zuckerman, Eric Lawitz, Jose L. Calleja, Harald Hofer,
Christopher Gilbert, John Palcza, Anita Y.M. Howe, Mark J. DiNubile, Michael N. Robertson,
Janice Wahl, Eliav Barr, Maria Buti. Grazoprevir/Elbasvir plus Ribavirin For Chronic HCV
Genotype-1 Infection After Failure of Combination Therapy Containing a Direct-Acting
Antiviral Agent. Journal of Hepatology 2015. DOI: http://dx.doi.org/10.1016/j.jhep.2015.04.009.
389. JA Gutierrez, E Lawitz, F Poordad. Interferon-free, direct-acting antiviral therapy for
chronic hepatitis C. Journal of Viral Hepatitis June 2015. DOI: 10.1111/jvh.12422.
390. Amit Khatri, Rajeev Menon, Thomas C. Marbury, Eric Lawitz, Thomas J. Podsadecki,
Victoria Mullally, Bifeng Ding, Walid M. Awni,Barry Bernstein,.Sandeep Dutta.
Pharmacokinetics and Safety of Coadministered Paritaprevir plus Ritonavir (Paritaprevir/r),
Ombitasvir, and Dasabuvir in Hepatic Impairment. Journal of Hepatology 2015.
DOI: http://dx.doi.org/10.1016/j.jhep.2015.05.02.
391. Eric Lawitz, Mihály Makara, Ulus Salih Akarca, Paul J Thuluvath,Liliana Lucia
Preotescu, Peter Varunok, Rosa M Morillas, Coleen Hall, Niloufar Mobashery, Rebecca
Redman, Tami Pilot-Matias,Regis A Vilchez, Christophe Hézode. Efficacy and Safety of
Ombitasvir, Paritaprevir, and Ritonavir in an Open-label Study of Patients With Genotype 1b
Chronic Hepatitis C Virus, With and Without Cirrhosis. Gastroenterology July 2015. DOI:
10.1053/j.gastro.2015.07.001.
392. E Lawitz, B Freilich, J Link, P German, H Mo, L Han, D M Brainard,J McNally, T
Marbury, M Rodriguez-Torres. A phase 1, randomized, dose-ranging study of GS-5816, a once-
daily NS5A inhibitor, in patients with genotype 1-4 hepatitis C virus.Journal of Viral
Hepatitis, JULY 2015 DOI: 10.1111/jvh.1243.
393. Eric Lawitz, Ira M Jacobson , David R Nelson, Stefan Zeuzem, Mark S Sulkowski , Rafael
Esteban , Diana Brainard , John McNally, William T Symonds, John G McHutchison ,Douglas
Dieterich, Edward Gane. Development of sofosbuvir for the treatment of hepatitis C virus
infection. Annals of the New York Academy of Sciences. July 2015, DOI: 10.1111/nyas.12832.
394. Amit Khatri, Rajeev M. Menon, Thomas C. Marbury, Eric J. Lawitz, Thomas J.
Podsadecki, Victoria M. Mullally, Bifeng Ding, Walid M. Awni, Barry M. Bernstein, Sandeep
Dutta. Pharmacokinetics and safety of co-administered paritaprevir plus ritonavir, ombitasvir,
and dasabuvir in hepatic impairment. Journal of Hepatology Oct-2015.. Vol 63 (4), ppg 805-812.
66
395. Everson GT, Sims KD, Thuluvath PJ, Lawitz E, Hassanein T, Rodriguez-Torres M, Desta
T, Hawkins T, Levin JM, Hinestrosa F, Rustgi V,Schwartz H, Younossi Z, Webster L, Gitlin
N, Eley T, Huang SP, McPhee F, Grasela DM, Gardiner DF. Daclatasvir + Asunaprevir +
Beclabuvir ± Ribavirin for Chronic HCV Genotype 1-Infected Treatment-Naive Patients. Liver
Int. 2015 Oct 16. doi: 10.1111/liv.12964
396. Donna Skee, Jan De Jong, Peter Hellemans, Dominique Swerts ,Deborah
Conover,Christopher Jones, Eric Lawitz ,Thomas Marbury ,William Smith ,Vijay
Chauhan, Juhui James Jiao,Juthamas Sukbuntherng , Erik Mannaert. Pharmacokinetics of
ibrutinib in subjects with varying degrees of hepatic impairment: Results from an open-label,
multicenter study. Clinical Cancer Research 21(17):B20-B20 · August 2015.
397. Jennifer T. Wells,Carmen Landaverde,Julio Gutierrez, Eric Lawitz. Management of
patients with hepatitis C virus resistance–associated variants to NS5A inhibitors: Where are we
now? Clinical Liver Disease. Volume 6, Issue 4, pages 82–85, October 2015.
