HEPATITIS C CLINICAL TRAINING

Simplified Algorithm for Management of Hepatitis C Infection for Primary Care ProvidersPaul Gaglio, MDDirector: Hepatology OutreachProfessor of Medicine (in Surgery)Columbia University College of Physicians and SurgeonsCenter for Liver Disease and TransplantationNY Presbyterian Hospital-Columbia University Medical Center

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Disclosures

Learning Objectives

By the end of this presentation, participants will be able to:• Identify patients appropriate for hepatitis C (HCV) screening• Recall the simplified algorithm for assessing patients for and

initiating HCV therapy• Assess patient's risk for HBV reactivation• Explain the role of fibrosis testing in HCV treatment• Recognize potential drug-drug interactions of HCV therapies

Increase in Acute HCV Incidence – USA

Centers for Disease Control. Viral Hepatitis Surveillance United States, 2015. Available at: https://www.cdc.gov/hepatitis/statistics/2015surveillance/pdfs/2015HepSurveillanceRpt.pdf (accessed June 2018);Suryaprasad AG. Clin Infect Dis 2014:15;59:1411–9; Zibbell JE, et al. MMWR Morb Mortal Wkly Rep 2015;64:453–8; Centers for Disease Control unpublished data

Year2000 2003 2006 2009 2012 2015

1.6

1.4

1.2

1.0

0.8

0.6

0.4

0.2

0

Rat

e pe

r 100

,000 Male

Female

• ~33,900 new HCV infections in 2015• 1:1 male: female ratio, predominantly white race• Highest incidence: 20–29 years, non-metropolitan areas

Age Distribution of Reported Chronic HCV Infections in the NYC, 2008 and 2018

www1.nyc.gov. Accessed March 28, 2020

0

10 0

20 0

30 0

40 0

50 0

0 5 10 15 20 25 30 35 40 45 50 55 60 65 70 75 80 85 90 95

2005

Female Male

0

50

10 0

15 0

20 0

0 5 10 15 20 25 30 35 40 45 50 55 60 65 70 75 80 85 90 95

2012

Female Male

0

50

10 0

15 0

20 0

0 6 12 18 24 30 36 42 48 54 60 66 72 78 84 90 97

2015

Female Male

0

50

10 0

15 0

20 0

1 5 9 13 17 21 25 29 33 37 41 45 49 53 57 61 65 69 73 77 81 85 89 93 97

2016

Female Male

Slide courtesy of NYS DOH Bureau of Viral Hepatitis.

Total HCV by Age, Sex, and Year, New York State (Excluding NYC)

1. Zibbell JE, et al. Am J Public Health. 2018;108(2):175-181. 2. CDC. https://www.cdc.gov/nchhstp/newsroom/2017/hepatitis-c-and-opioid-injection-press-release.html. December 21, 2017. Accessed August 9, 2019.

0

5

10

15

20

25

30

2004

2005

2006

2007

2008

2009

2010

2011

2012

2013

2014

Dru

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ent A

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ting

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2.5

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(per

100

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)

Any opioid injection (18-29)Any opioid injection (30-39)HCV rate (18-29)HCV rate (30-39)

The national increase in acute HCV infection is associated with the nation’s opioid epidemic.1

Among people aged 30-39 years1:

Among people aged 18-29 years1:

400%622%

Rate of acute HCV

Admission for opioid injection

325%83%

Rate of acute HCV

Admission for opioid injection

CDC, Centers for Disease Control and Prevention.

From 2004-2014, HCV and Opioid Injection Drug Use Increased Significantly Among People Aged 18-39 Years1,2

HCV Screening Recommendations

2020 CDC Recommendations HCV ScreeningAmong Adults in the US

1. Universal ScreeningScreen at least once in a lifetime for all adults ≥18 years(except in settings where HCV RNA-positivity is <0.1%)

2. Pregnancy Screening all pregnant women during each pregnancy(except in settings where HCV RNA-positivity is <0.1%)

3. ExposureOne-time testing among people with recognized conditions or exposures (more info on https://www.cdc.gov/hepatitis/hcv/guidelinesc.htm), regardless of age or setting prevalence

4. Periodic testingRoutine periodic testing for people with on-going risk factors

2020 USPSTF HCV Screening Recommendations

• Screen all adults (including pregnant persons) aged 18 to 79 years• One-time screening for most adults

– Periodically screen persons with continuous risk (history of or current injection drug use)

JAMA. Published online March 02, 2020. doi:10.1001/jama.2020.1123

Read the full recommendations at https://jamanetwork.com/journals/jama/fullarticle/2762186

Recommendations For HCV Screening In Persons Less Than 18 Years Of Age

• One-time testing should be performed for all persons less than 18 years of age with behaviors, exposures or risk factors or circumstances associated with an increased risk of HCV exposure

Hcvguidelines.org. Accessed March 28, 2020

Re-testing for Patients at Risk for HCV

• Periodic repeat HCV testing should be offered to all persons with behaviors, exposures or risk factors associated with HCV

• Annual HCV testing is recommended for all persons who inject drugs and for HIV-infected men who have unprotected sex with men

AASLD, IDSA, IAS-USA. Recommendations for testing, managing, and treating hepatitis C. http://www.hcvguidelines.org. Accessed March 28, 2020.

Summary: 2020 HCV Screening Recommendations

Adults Under 18 years

One-time HCV screening

• All adults 18 to 79 years of age• All pregnant women during each

pregnancy

(CDC, USPSTF)

• All children born to women infected with HCV

• People under 18 with HCV risk factors

(AASLD, IDSA, IAS-USA)

Repeat HCV testing (e.g. annual)

Adults with HCV risk factors, including:• People with a history of or active

injection drug use• HIV-positive men who have

unprotected sex with men

(CDC, USPSTF, AASLD, IDSA, IAS-USA)

Inner coat

Outer coat

Virus genes

Significant Progress Has Been Made In HCV Understanding And Management

Adapted from Sahoo SS. Epidemiology of hepatitis B and C. Available at: https://www.slideshare.net/drswaroopsoumya/epidemiology-of-hepatitis-b-and-c (accessed June 2018);Yau AHL, Yoshida EM. Can J Gastroenterol Hepatol 2014;288:445–51; Seifert LL, et al. World J Hepatol 2015;7:2829–33 PEG-IFN: pegylated interferon; RBV: ribavirin

Hepatitis C virus

1960 20051965 1980 1990 201020001995 20151970 1975 1985 2020

1975: Description of non-A, non-B hepatitis

1989: HCV identified

1993: HCV genomedelineation

1996: 3D structure of HCV enzymes: HCV protease

1997: Infectious clone of HCV constructed

1999: Replicon system established

2005: Recombinant infectious HCV

1998: IFN + RBV

2003: PIs developed

2011: First all-oral DAA data presented

2014: Launch of first all-oral DAA regimen

2001: PEG-IFN + RBV

Rapid Therapeutic Advances In HCV

Gilead Sciences Ltd. SOVALDI▼ (sofosbuvir), SmPC, September 2017; WHO. Patent situation of key products for treatment of hepatitis C: Simeprevir Working Paper; June 2016; Bristol-Myers Squibb Pharmaceuticals Ltd. DAKLINZA▼ (daclatasvir), SmPC, January 2018; Gilead Sciences Ltd. HARVONI▼ (ledipasvir/sofosbuvir), SmPC, December 2017; AbbVie Ltd. VIEKIRAX▼ (ombitasvir//paritaprevir/ritonavir), SmPC, January 2018; Gilead Sciences Ltd. EPCLUSA▼ (sofosbuvir/velpatasvir), SmPC, March 2018; Merck Sharp & Dohme Ltd. ZEPATIER▼

(elbasvir/grazoprevir), SmPC, July 2017; Gilead Sciences Ltd. VOSEVI▼ (sofosbuvir/velpatasvir/voxilaprevir), SmPC, August 2017; AbbVie Ltd. MAVIRET▼ (glecaprevir/pibrentasvir), SmPC, May 2018

Not all regimens are approved in all patient populations and/or in all countries. Please refer to your local country authorisation. The addition of RBV is recommended in some patient

populations; HCPs should refer to the respective SmPCs.DCV: daclatasvir; DSV: dasabuvir; EBR: elbasvir; GLE: glecaprevir; GZR: grazoprevir;

HCP: healthcare professional; LDV: ledipasvir; OBV: ombitasvir; PIB: pibrentasvir; PTV: paritaprevir; RTV: ritonavir; SMV: simeprevir; SOF: sofosbuvir;

VEL: velpatasvir; VOX: voxilaprevir

SOF + RBV

SOF + SMV ±RBV

LDV/SOF ± RBV

SOF + DCV ±RBV

OBV/PTV/RTV ±DSV ± RBV

SOF/VEL ±RBV

EBR/GZR ± RBV GLE/PIB

SOF/VEL/VOX

Jan 2014 Nov 2014 Aug 2014 Nov 2014 Jan 2015 July 2016 July 2017

OO N

NH

O

O

PO

HN

O

O

OH3C

H3C

CH3HO F

CH3

SOF VELLDV

SMV DCV

VOX

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PTV DSV

OBV

O

O

NN

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O

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FF

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NNH

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GLEGZR

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HCV elimination?

Case Study 1

• 46 year-old African-American female diagnosed with HCV two months ago– Complains of fatigue– PMH: Hypertension– She has a history of intravenous drug use who last used 10 years ago– ALT 45, AST 56, total bilirubin 1.1, platelet count 165,000– HCV RNA 6,680,056, genotype 1a– Transient elastography with F2, S2

Think about what you would do next. We will review at end of presentation.

A Simplified Algorithm for Management of HCV Infection

Simplified Algorithm: Background

• WHO objective: HCV elimination by 2030

• Treatment access limited by availability of specialists

• Current guidelines are comprehensive and most appropriate for experienced treaters, but non-specialists may consider them too complex

• A simplified treatment algorithm targeting non-traditional HCV treaters to drive HCV elimination is needed

20Dieterich et al, Gastroenterology & Hepatology; volume 15, issue 5, supplement 3, May 2019HCV guidance: recommendations for testing, managing, and treating hepatitis C. Available at: http://www.hcvguidelines.org/ (accessed March 2020)

HCVGuidelines.org: Treatment is recommended for ALL patients with chronic HCV infection

Simplified Algorithm: Method of Development

• Authors participated in a consensus meeting in September 2018 to develop a simplified HCV treatment algorithm

• A committee of 13 expert members from various settings was formed, including FQHCs and ID practices

• Meeting and manuscript funded by Gilead Sciences– Funder’s role limited to attendance at meeting and review of the

manuscript for medical accuracy

21Dieterich et al, Gastroenterology & Hepatology; volume 15, issue 5, supplement 3, May 2019

Test for HBV Before Initiating HCV DAA Therapy

ESAL: Patients commencing DAA-based treatment for hepatitis C should be tested for HBs antigen, anti-HBc antibodies and anti-HBs antibodies (B1)

Anti-HBc test resultNegative Positive

HBsAgtest result

Negative No risk of HBV reactivation Very low risk of HBV reactivation

Positive Moderate risk of HBV reactivation(depending on HBV DNA)

AASLD: All patients initiating HCV DAA therapy should be assessed for HBV coinfection with HBsAg, anti-HBs, and anti-HBc (B1)

Boxed Warning: Risk Of HBV Reactivation with DAA Use in HCV/HBV Coinfected Patients1

1. Test all patients for HBV before initiating treatment with any HCV DAA therapy• HBV reactivation has been reported in HCV/HBV coinfected patients undergoing or completed

HCV DAA treatment and not receiving HBV antiviral therapy

• Some cases have resulted in fulminant hepatitis, hepatic failure, and death

• Cases have been reported in patients who:• Are HBsAg positive • Have serologic evidence of resolved HBV• Receive certain immunosuppressant or chemotherapeutic agents

2. Monitor HCV/HBV coinfected patients for hepatitis flare or HBV reactivation during HCV treatment and post-treatment follow-up

3. Initiate appropriate patient management for HBV infection as clinically indicated

231. https://www.hcvguidelines.org. accessed April 20, 2020

How Simple Can Treatment Be For Most Patients?

Assess for cirrhosis with platelets (>150x109/L)

SOF/VEL 1 tab daily w/ or w/o food for 12 weeks

GLE/PIB 3 tabs daily w/ food for 8 or 12 weeks

History, exam, labs* *Assessment Labs: CBC, AST, ALT, bilirubin, albumin, creatinine, HBV, HIV, HAV; eGFR

HCV viremia

Assess for DDI

Dieterich et al, Gastroenterology & Hepatology; volume 15, issue 5, supplement 3, May 2019

Simplified Algorithm for Management of HCV Infection

HCV antibody test with reflex to PCR

2. Pretreatment assessment and testing

3. Treatment and monitoring

Positive (+) PCR

Active HCV infection

Initial assessment: physical exam, stigmata of cirrhosis,

clinical and prior treatment history, extrahepatic manifestations

Blood testsCBC, AST, ALT, bilirubin, albumin,

creatinine; HBV, HIV, HAV; eGFR

Platelets >150x109/L

Assess for potential DDI

Treatment with pan-genotypic therapy: GLE/PIB or SOF/VEL

Assessment of cure (SVR12)HCV RNA, ALT

Negative (-) HCV RNA

Cured

1. Screening and diagnosis

Universal screening optimalor

Risk factors/age screening

Refer to post-cure managementPlatelets <150 refer to specialist

Dieterich et al, Gastroenterology & Hepatology; volume 15, issue 5, supplement 3, May 2019

High SVR Rates Achieved Across Patient Types

*Safety and efficacy of SOF/VEL has not been assessed in patients with CTP class C cirrhosis; †As approved in the Canadian Product Monograph. These are not head-to-head studies and direct comparisons cannot be made;CTP: Child–Turcotte–Pugh; GLE/PIB: glecaprevir/pibrentasvir; GT: genotype; RBV: ribavirin; SOF/VEL: sofosbuvir/velpatasvir;

Agarwal K, et al. ILC 2016 Poster #SAT-195; Gane E, et al. AASLD 2017; Oral #74; Puoti M, et al. ILC 2017 Poster #SAT-233; AbbVie Corporation. MAVIRET (glecaprevir/pibrentasvir) Product Monograph, August 2017; Gilead Sciences Canada Inc. EPCLUSA (sofosbuvir/velpatasvir) Product Monograph, April 2018

GT 1 GT 2 GT 3 GT 4 GT 5 GT 6

GLE/PIB8, 12 or

16 weeks†

SOF/VEL 12 weeks

98%323/328

99%237/238

95%264/277

100%116/116

97%34/35

100%41/41

98%502/513

98%228/232

96%289/302

96%65/68

100%4/4

94%16/17

F0–F4 & CTP A CTP B–C*

GT1–6

94%82/87

X

+ RBV

Liver Disease Stage Considerations

DAA-naïve patientsAbbVie Corporation. MAVIRET (glecaprevir/pibrentasvir) Product Monograph, August 2017; Gilead Sciences Canada Inc. EPCLUSA (sofosbuvir/velpatasvir) Product Monograph, April 2018

GLE/PIB

SOF/VEL 12 weeks

8 weeks 8 weeks

F 0 F 1 F 2 F 3 F 4 CTP A CTP B CTP C

Fibrosis stage CTP score

12 weeks + RBV

Contraindicated Contra-indicated

XX

Why Is Fibrosis Staging Still Important?

• Uncover undiagnosed cirrhosis• In some states, there are still fibrosis requirements to treat• Most importantly any stage 3 or 4 fibrosis requires (for now)

lifelong screening for HCC • Protease inhibitors should not be used in Childs B or C patients

Assess Cirrhosis and HCC Risk with Platelet Count

• Thrombocytopenia is a surrogate for cirrhosis and a marker for the identification of patients at high-risk for hepatocellular carcinoma (HCC)

• The best cutoff platelet count was 150,000/mm for a diagnosis of cirrhosis.

• The proportion of thrombocytopenia was significantly greater in patients with HCV-related HCC(63%) than in patients with HBV-related HCC (42%).

Cancer Volume107, Issue91 November 2006

Does This Patient With Liver Disease Have Cirrhosis?

• Meta-analysis of 86 studies of adequate quality that evaluated the accuracy of clinical findings for identifying histologically proven cirrhosis

• 19,533 patients were included in this meta-analysis, among whom 4,725 had biopsy-proven cirrhosis

• a platelet count <160 x 103/μL (LR, 6.3; 95% CI, 4.3-8.3)

JAMA. 2012 Feb 22;307(8):832-842. doi: 10.1001/jama.2012.186

FDA Drug Safety Communication on the Use of PI-Containing DAA Regimens for HCV

• On August 28, 2019, the FDA issued a safety announcement about the rare occurrence of serious liver injury with the use of protease-inhibitor (PI)-containing regimens for HCV, including glecaprevir/pibrenasvir, elbasvir/grazoprevir and ledipasvir/velpatasvir/voxilaprevir

­Using these drugs to treat chronic hepatitis C in patients with moderate to severe liver impairment has resulted in rare cases of worsening liver function or liver failure.

­These medicines are not indicated for use in patients with moderate to severe liver impairment.

https://www.fda.gov/drugs/drug-safety-and-availability/fda-warns-about-rare-occurrence-serious-liver-injury-use-hepatitis-c-medicines-mavyret-zepatier-andAccessed on August 28, 2019

FDA Drug Safety Communication: Serious Liver Injury with PI-Containing DAA Regimens

• FDA received reports of 63 cases of worsening liver function, including liver failure and 8 deaths, in HCV patients treated with PI-containing DAA regimens:

https://www.fda.gov/drugs/drug-safety-and-availability/fda-warns-about-rare-occurrence-serious-liver-injury-use-hepatitis-c-medicines-mavyret-zepatier-andAccessed on August 28, 2019

46

143

Mavyret Zepatier Vosevi

Serious Liver Injury per PI-Containing Regimen (n)

21

29 33

17

No Cirrhosis CC DC Unknown

Baseline Liver Function (%)

1363

1163

1863

2163

• More than half of the cases with no cirrhosis or compensated cirrhosis (CC) were misclassified and had evidence of advanced liver disease or risk factors for decompensation (low platelets, portal hypertension, alcohol abuse, other liver comorbidities)

Glecaprevir/Pibrenasvir

Elbasvir/Grazoprevir

Ledipasvir/Velpatasvir/Voxilaprevir

FDA Drug Safety Communication Recommendations

• Perform liver chemistries at baseline and as clinically indicated

• Monitor for clinical signs and symptoms of hepatic decompensation (e.g. jaundice, ascites, hepatic encephalopathy, and variceal hemorrhage

• Encourage patients to read the prescribing information

• Discontinue glecaprevir/pibrenasvir, elbasvir/grazoprevir, ledipasvir/velpatasvir/voxilaprevir in patients who develop hepatic decompensation or as clinically indicated

• Report adverse events involving glecaprevir/pibrenasvir, elbasvir/grazoprevir, ledipasvir/velpatasvir/voxilaprevir or other medicines to the FDA MedWatch program: call 1-800-332-1088 or access https://www.accessdata.fda.gov/scripts/medwatch/

https://www.fda.gov/drugs/drug-safety-and-availability/fda-warns-about-rare-occurrence-serious-liver-injury-use-hepatitis-c-medicines-mavyret-zepatier-andAccessed on August 28, 2019

Assess for Potential Drug-Drug Interactions

35

SOF/VEL GLE/PIB

Key DDI

anticonvulsants, rifampicin, efavirenz, St. John’s wort§ amiodarone§ proton pump inhibitors § statins

§ dabigatran§ ethinyl estradiol-containing contraceptives§ atazanavir§ darunavir§ ritonavir§ statins§ cyclosporine

Common drugs without interactions

ARBs, methadone, buprenorphine, calcium channel blockers, lamotrigine, omeprazole, progestin-only contraceptives

HCPs should consult prescribing information, their local pharmacist and/or online tools (eg, HEP Drug Interactions; http://www.hep-druginteractions.org) to confirm interaction or lack of interaction for specific drugs within a class, as exceptions may exist.

Dieterich et al, Gastroenterology & Hepatology; volume 15, issue 5, supplement 3, May 2019

†Treatment duration of SOF/VEL for treatment-experienced patients is 12 weeks.‡GLE/PIB is also indicated for patients with HCV GT 1 infection with no cirrhosis or compensated cirrhosis (Child-Pugh A) who have been treated with a regimen containing an HCV NS5A inhibitor or NS3/4A protease inhibitor, but not both. Duration of treatment for patients with prior NS5A inhibitor experience or NS3/4A protease inhibitor experience is 16 weeks or 12 weeks, respectively. §Prescribing information in the EU, but not the US, states that addition of RBV may be considered for patients with HCV GT 3 and compensated cirrhosis. ¶For patients with decompensated cirrhosis, SOF/VEL is indicated in combination with ribavirin.

Treatment Options

36

SOF/VEL† GLE/PIB‡

Treatment duration, wkNo cirrhosisCompensated cirrhosisDecomp. cirrhosis

1212§

12¶

88

Contraindicated

Dosage

1 tablet (400 mg SOF + 100 mg VEL)

Once daily With or without food

3 tablets (100 mg GLE + 40 mg PIB per tablet)

Once dailyFood required

Common side effects (≥ 5%)

Headache, fatigue, nausea, asthenia, insomnia Headache, fatigue, nausea

Dieterich et al, Gastroenterology & Hepatology; volume 15, issue 5, supplement 3, May 2019

sofosbuvir/velpatasvir/voxilaprevirPrescribing Information

Indicated for treatment of adults with chronic HCV without cirrhosis or with compensated cirrhosis (Child-Pugh A) who have:• Genotype 1, 2, 3, 4, 5, or 6 infection and

previously treated with an HCV regimen containing an NS5A inhibitor

• Genotype 1a or 3 infection and previously been treated with HCV regimen containing sofosbuvir without an NS5A inhibitor

Additional benefit of sofosbuvir/velpatasvir/voxilaprevir over sofosbuvir/velpatasvir was not shown in adults with genotype 1b, 2, 4, 5, or 6 infection previously treated with sofosbuvir without an NS5A inhibitor.

• Take once daily with food for 12 weeks• Safety and efficacy unknown for patients

with eGFR <30 mL/min/1.73 m2 or ESRD requiring hemodialysis due to higher exposures (up to 20-fold) of the predominant sofosbuvir metabolite

• Not recommended in patients with moderate or severe hepatic impairment (Child-Pugh B or C) due to higher exposures of voxilaprevir (up to 6-fold in non-HCV infected subjects)

37VOSEVI US Full Prescribing Information, Gilead Sciences Inc, Foster City CA. November 2017.

Monitoring Recommendations

• Advise patients, particularly those with prior HBV infection, to contact their HCP if they experience unexpected or severe symptoms

• At least 12 weeks after treatment completion, confirm cure by assessing HCV RNA by PCR– Refer patients with detectable HCV RNA to a specialist

• At least 12 weeks after treatment completion, obtain ALT level– If ALT remains abnormal on repeated measure, refer the patient to a specialist

Dieterich et al, Gastroenterology & Hepatology; volume 15, issue 5, supplement 3, May 2019

Case Study 1

• 46 year-old African-American female diagnosed with HCV 2 months ago– Complains of fatigue– PMH: Hypertension– She has a history of intravenous drug use who last used 10 years ago– ALT 45, AST 56, total bilirubin 1.1, platelet count 165,000– HCV RNA 6,680,056, genotype 1a– Transient elastography with F2, S2

• What would you do for this patient?

Case Study 1

• Screen for hepatitis B• Review for drug-drug interactions• Inquire about OTC’s and herbal products• Start DAA therapy

– Either• GLE/PIB for 8 weeks

• SOF/VEL for 12 weeks

Post-Cure Recommendations

• Inform patients who are cured that they are susceptible to reinfection

• Provide patients with appropriate HCV harm-reduction resources such as buprenorphine and a prescription for naloxone to help patients stay safe and to minimize the possibility of reinfection

41Dieterich et al, Gastroenterology & Hepatology; volume 15, issue 5, supplement 3, May 2019

Renal Impairment Labeling Updates for Sofosbuvir-Based HCV Therapies 11/20/2019

• FDA has approved updated labeling for in renal disease for: – sofosbuvir/velpatasvir– ledipasvir/sofosbuvir – sofosbuvir/velpatasvir/voxilaprevir

• Prescribing information now states that no dosage adjustment is recommended in patients with any renal impairment including patients on dialysis – Results showed the pharmacokinetics of sofosbuvir, GS-331007 (the predominant

circulating metabolite of sofosbuvir), velpatasvir, and ledipasvir were consistent with those observed in HCV-negative patients with ESRD requiring dialysis

– While not studied in ESRD patients, voxilaprevir exposure is not expected to be meaningfully altered in HCV patients with ESRD requiring dialysis

42

Things to Remember when Treating HCV

• Screen for HBV: HBsAg, HBsAb, HBcAb– Treat if HBsAg+ or DNA +

• Vaccinate for HAV and HBV where indicated• Platelet count < 150,000 concerning for advanced fibrosis • Stage fibrosis: Fibroscan most convenient > 9.5 kPA =HCC screen for life

(F3)– >12.5 kPA needs screening for varices (or platelets < 125,000) (F4)– >12.5 kPA needs CT or MRI screening. US often not adequate

• DO NOT use Protease Inhibitors in Child’s B or C patients

Conclusions

• HCV is curable with readily available combination therapies• Elimination will require a multifactorial approach to diagnose, link to care,

treat and cure HCV • The Simplified Algorithm provides a roadmap for non-specialists to treat

HCV• Costs of treatments have come down drastically • Risk of HCC in cured patients with cirrhosis is decreased but patients still

need to be screened for life• The biggest issue we have now is getting people tested and treated • To eliminate HCV, we need to broaden our treater base• Patients with advanced disease should be referred to a liver specialist

Resources

• NYS HCV Clinical Consultation Hotline: (866) 637-2342

• HCV referrals: www.nyc.gov/health/hepc– Free or low-cost care – Programs with supportive services

• www.HepFree.NYC– CME HCV Training – NYC Hep C Task Force and HepCX

Contact Us

For CMEs or educational opportunities, contact:

Meg Chappell, MPHProgram Manager

Empire Liver Foundationmegchappell@empireliverfoundation.org

www.empireliverfoundation.org

For questions about resources, contact:

Nirah Johnson, LCSWDirector, Capacity Building

Viral Hepatitis ProgramNew York City Health Department

njohnso2@health.nyc.govwww.hepfree.nyc

HCV Provider Training Series

• May 7, 2020:

• May 14, 2020:

• May 21, 2020:

• May 28, 2020:

Hepatitis C : Epidemiology, Natural History and Diagnosis with Dr. Arun Jesudian

Simplified Algorithm for Management of Hepatitis C Infection for Primary Care Providers with Dr. Gaglio

Management of Hepatitis C Complications with Dr. Wolf

Hepatitis C Treatment in Persons Who Inject Drugs (PWID) with Dr. Taki

Hepatitis clinical care can continue during COVID-19 via telemedicine

• New NYC Health Department Weekly telehealth implementation support webinars

• New Hep Free NYC Telehealth Capacity Building Webpage

• Rapid Implementation of Telemedicine in response to COVID-19 with Su Wang, MD - May 13 (4:30 - 5:30 PM)