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Phase 3. Treatment Naïve, Chronic HCV and HIV. PEG alfa-2a + RBV versus PEG alfa- 2a versus INF + RBV APRICOT STUDY. Torriani FJ, et. al. N Engl J Med. 2004;351:438-50. . PEG + RBV versus PEG versus INF + RBV in HCV & HIV APRICOT Study: Features. - PowerPoint PPT Presentation
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Hepatitisweb study
Hepatitisweb study
PEG alfa-2a + RBV versus PEG alfa-2a versus INF + RBV APRICOT STUDY
Phase 3
Treatment Naïve, Chronic HCV and HIV
Torriani FJ, et. al. N Engl J Med. 2004;351:438-50.
Hepatitisweb study
PEG + RBV versus PEG versus INF + RBV in HCV & HIV APRICOT Study: Features
• Study- Randomized, placebo-controlled trial- Conducted at 95 centers in 19 countries in U.S., Canada, & Europe
• Subjects- N = 868 chronically infected with both HCV and HIV - Treatment naïve; 61% genotype 1- CD4 >200 cells/mm3 or CD4 = 100-200 cells/mm3 + HIV RNA level <5,000 copies/ml
• Regimens (48 Week Treatment)- Peginterferon alfa-2a 180 µg 1x/week + Ribavirin 800 mg/day - Peginterferon alfa-2a 180 µg 1x/week + Placebo- Interferon alfa-2a: 3 million IU 3x/week + Ribavirin 800 mg/day
• Primary Endpoint- Undetectable HCV RNA (< 50 IU/ml) 24 weeks after stopping Rx
Source: Torriani FJ, et. al. N Engl J Med. 2004;351:438-50.
Hepatitisweb study
Peginterferon alfa-2a + Ribavirin
Interferon alfa-2a + Ribavirin
Peginterferon alfa-2a + Placebo
48 720Week
Source: Torriani FJ, et. al. N Engl J Med. 2004;351:438-50.
PEG + RBV versus PEG versus INF + RBV in HCV & HIVAPRICOT Study: Design
Drug DosingPeginterferon alfa-2a 180 µg 1x/weekRibavirin (divided bid): 800 mg/dayInterferon alfa-2a 3 million IU 3x/week
SVR24
SVR24
SVR24
N = 286
N = 289
N = 285
Hepatitisweb study
End of Treatment Response Sustained Virologic Response-240
20
40
60
80
47
40
31
2014 12
Peginterferon + Ribavirin
Peginterferon + Placebo
Interferon + Ribavirin
Patie
nts
(%)
PEG + RBV versus PEG versus INF + RBV in HCV & HIV APRICOT Study: Results
APRICOT Study: Virologic Responses by Treatment Regimen
Source: Torriani FJ, et. al. N Engl J Med. 2004;351:438-50.
90/286136/289 40/285 58/286116/289 33/285
Hepatitisweb study
All Genotype 1 Genotype 2 or 30
20
40
60
80
100
40
29
62
2014
36
127
20
Peginterferon + Ribavirin Peginterferon + Placebo Interferon + Ribavirin
Patie
nts
with
SVR
(%
)PEG + RBV versus PEG versus INF + RBV in HCV & HIV
APRICOT Study: Results
APRICOT Study: SVR24 by Treatment Regimen and Genotype
Source: Torriani FJ, et. al. N Engl J Med. 2004;351:438-50.
58/286116/289 33/285 24/17551/176 12/171 32/9059/95 18/89
Hepatitisweb study
SVR
N = 90(44%)
N = 114(56%)
N = 85(29%)
N = 204(71%)
2-log drop or undetectable
HCV RNA
Yes
No
Week 12
HCV RNA(N = 289)
N = 83(98%)
N = 2(2%)
No SVR
SVR
No SVR
PEG + RBV versus PEG versus INF + RBV in HCV & HIV APRICOT: Predictive Value of Early Virologic Response
Peginterferon alfa-2a + Ribavirin
Source: Torriani FJ, et. al. N Engl J Med. 2004;351:438-50.
Hepatitisweb studySource: Torriani FJ, et. al. N Engl J Med. 2004;351:438-50.
PEG + RBV versus PEG versus INF + RBV in HCV & HIV APRICOT Study: Conclusions
Conclusions: “Among patients infected with both HIV and HCV, the combination of peginterferon alfa-2a plus ribavirin was significantly more effective than either interferon alfa-2a plus ribavirin or peginterferon alfa-2a monotherapy.”
Hepatitisweb study
Hepatitisweb study
This slide deck is from the University of Washington’s Hepatitis C Online and Hepatitis Web Study projects.
Hepatitis C Onlinewww.hepatitisc.uw.edu
Hepatitis Web Studyhttp://depts.washington.edu/hepstudy/
Funded by a grant from the Centers for Disease Control and Prevention.
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