HEPATITIS C: UPDATE AND MANAGEMENT
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1 HEPATITIS C: UPDATE AND MANAGEMENT José Franco, MD Professor of Medicine Associate Dean for Educational Improvement Associate Director, Kern Institute STAR Center Director
2 José Franco, MD Disclosures I have no disclosures relevant to this presentation I will only be speaking regarding FDAapproved therapies
3 HEPATITIS C UPDATE AND MANAGEMENT: OBJECTIVES Explain the prevalence and natural history of hepatitis C Identify which cohorts should be tested for hepatitis C Recognize the currently available therapies for the treatment of hepatitis C
4 HEPATITIS C TREATMENT: PREDICTION The majority of non-cirrhotic patients and compensated cirrhotics will be treated by primary care physicians.
5 Nearly Everyone With HCV Can Now Be Treated Successfully Very high SVR rates; therapies highly tolerable All-oral therapy for almost every patient Treatment generally just 12 weeks Standard Interferon 1991 Ribavirin Peginterferon Direct- Acting Antivirals All-Oral Therapy Current IFN 6 Mos 16 IFN 12 Mos IFN/RBV 6 Mos IFN/RBV 12 Mos PegIFN 12 Mos PegIFN/ RBV 12 Mos PegIFN/ RBV + DAA DAA + RBV ± PegIFN All Oral DAA± RBV References in slidenotes. Slide credit: clinicaloptions.com
6 CHRONIC VIRAL HEPATITIS IN USA: 2013 Hepatitis B 1.2 MILLION Hepatitis C 3.2 MILLLION CDC
7 CDC
8 WISCONSIN HCV REPORTING Reported cases: % in Milwaukee county 10% Correctional institutions 43% female (up from 30% in 2003) 27% now in those under 30 (up from 5% in 2003)
9 HEPATITIS C RISK FACTORS Risk behaviors Current or past injection drug use Intranasal illicit drug use Risk exposures Long-term hemodialysis Unregulated percutaneous/parenteral exposure Healthcare providers with needlesticks or mucosal exposures to HCV-infected blood Children born to HCV-infected women Transfusions prior to 1992, clotting factors prior to 1987 Incarcerated individuals
10 HEPATITIS C TESTING One time testing also recommended for individuals born between , without prior ascertainment of risk
11
12 HCV INFECTION: WORLDWIDE GENOTYPE DISTRIBUTION 1a,1b 2a, 2b, 3a 1b 2a, 2b, 2c, 3a 4 1b,3a 2a 1b, 6 1b 4 3b 5a 1b,3a Simmonds P. Curr Stud Hematol Blood Transfus. 1998;62:38-63.
13 HEPATITIS C GENOTYPES IN U.S. Genotype 1A 37% Genotype 1B 30% Genotype 2 10% Genotype 3 6% Other or mixed 9% Indeterminate 5%
14 NATURAL HISTORY OF HCV INFECTION Exposure Acute Phase Chronic 85% Cirrhosis 20% Resolved 15% ESLD 6%/yr HCC 4%/yr Transplantation 3-4%/yr 0 yrs 10 yrs 20 yrs 30 yrs Di Bisceglie
15 FACTORS ASSOCIATED WITH MORE ADVANCED DISEASE Host Factors Viral Factors Non-Modifiable Co-infection with HBV or HIV Fibrosis stage Inflammation grade Older age at time of infection Male sex Organ Transplant Modifiable Alcohol consumption Nonalcoholic fatty liver disease Obesity Insulin resistance AASLD Guidelines 2014
16 STAGES OF FIBROSIS Stage 0 Stage 2 Stage 3 Stage 4 CIRRHOSIS
17 FIBROSCAN
18 FIBROSCAN SCORING
19 HCV in the US: Gaps in Current Practice % 80 Pts (%) % 43% 27% 20 17% 16% 9% 0 Chronic HCV Infected Diagnosed and Aware Access to Care HCV RNA Confirmed Liver Biopsy Prescribed HCV Treatment Achieved SVR n = 3,500,000 1,743,000 1,514, , , , ,859 Yehia BR, et al. PLoS One. 2014;9:e
20 WHO SHOULD PRIMARY CARE PHYSICIANS NOT TREAT? Decompensated cirrhosis HIV/HCV co-infection Patients with renal impairment Acute HCV Recurrent HCV after liver transplant
21
22 HEPATITIS C ERADICATION: DEFINITION Absence of hepatitis C viral RNA at least 12 weeks following completion of antiviral therapy (SVR-sustained virological response)
23 HEPATITIS C VIRUS5 UT C E1 E2 NS2 NS3 NS4b NS5a NS5b Structural Non-structural Neumann, Science, 1998 Rosenberg, J Mol Biology, 2001 Lauer, NEJM, 2001
24 Approved DAAs From Multiple Classes: Basis of 2016 Combination HCV Regimens Structural Domain Nonstructural Domain P 5 UTR Core E1 E2 NS2 NS3 4A NS4B NS5A NS5B 7 3 UTR Protease Polymerase Ribavirin (RBV) NS3 Protease Inhibitors NS5A Replication Complex Inhibitors NS5B NUC Inhibitors NS5B Non-NUC Inhibitors *Possible approval in Grazoprevir (GZR) Paritaprevir/Ritonavir (PTV/RTV) Simeprevir (SMV) Voxilaprevir (VOX)* Glecaprevir (GLE)* Daclatasvir (DCV) Elbasvir (EBR) Ledipasvir (LDV) Ombitasvir (OBV) Velpatasvir (VEL) Pibrentasvir (PIB)* Sofosbuvir (SOF) Dasabuvir (DSV) Slide credit: clinicaloptions.com
25 HCVGuidelines.org, 2017
26 LEDISPAVIR/SOFOSBUVIR First approved 11/2014 Can be used in - compensated cirrhosis - decompensated cirrhosis - post-liver transplant Well tolerated Few drug-drug interactions
27 Approved DAAs From Multiple Classes: Basis of 2016 Combination HCV Regimens Structural Domain Nonstructural Domain P 5 UTR Core E1 E2 NS2 NS3 4A NS4B NS5A NS5B 7 3 UTR Protease Polymerase Ribavirin (RBV) NS3 Protease Inhibitors NS5A Replication Complex Inhibitors NS5B NUC Inhibitors NS5B Non-NUC Inhibitors *Possible approval in Grazoprevir (GZR) Paritaprevir/Ritonavir (PTV/RTV) Simeprevir (SMV) Voxilaprevir (VOX)* Glecaprevir (GLE)* Daclatasvir (DCV) Elbasvir (EBR) Ledipasvir (LDV) Ombitasvir (OBV) Velpatasvir (VEL) Pibrentasvir (PIB)* Sofosbuvir (SOF) Dasabuvir (DSV) Slide credit: clinicaloptions.com
28 Ledipasvir-Sofosbuvir for 8 or 12 Weeks in Treatment-Naïve HCV GT 1 ION-3 Study: Results Patients with SVR 12 (%) ION-3: SVR 12* by Treatment Duration and Regimen / / /216 LDV-SOF LDV-SOF +RBV LDV-SOF 8-Week Regimen 12-Week Regimen Abbreviations: LDV-SOF= ledipasvir-sofosbuvir; RBV = ribavirin *Primary end-point by intention-to-treat analysis Source: Kowdley, K, et al. N Engl J Med. 2014;370:
29 Elbasvir/Grazoprevir (Zepatier) All-oral, once-daily regimen Approved 1/2016 for GT 1 and 4 1. Summa V, et al. Antimicrobial Agents Chemother. 2012;56(8): Coburn CA, et al. ChemMedChem. 2013;8(12): Harper S, et al. ACS Med Chem Lett. 2012;3(4): Yeh WW, et al. Hepatology. 2014;60(suppl 4):1940.
30 Approved DAAs From Multiple Classes: Basis of 2016 Combination HCV Regimens Structural Domain Nonstructural Domain P 5 UTR Core E1 E2 NS2 NS3 4A NS4B NS5A NS5B 7 3 UTR Protease Polymerase Ribavirin (RBV) NS3 Protease Inhibitors NS5A Replication Complex Inhibitors NS5B NUC Inhibitors NS5B Non-NUC Inhibitors *Possible approval in Grazoprevir (GZR) Paritaprevir/Ritonavir (PTV/RTV) Simeprevir (SMV) Voxilaprevir (VOX)* Glecaprevir (GLE)* Daclatasvir (DCV) Elbasvir (EBR) Ledipasvir (LDV) Ombitasvir (OBV) Velpatasvir (VEL) Pibrentasvir (PIB)* Sofosbuvir (SOF) Dasabuvir (DSV) Slide credit: clinicaloptions.com
31 SVR12: Immediate and Deferred Treatment Groups
32 PTV/r/OBV+DSV (Viekira Pak) Approved 12/2014 for GT 1 GT 1a and cirrhotics require Ribavirin which increases pill Burden and side effects Contraindicated in advanced cirrhosis
33 Approved DAAs From Multiple Classes: Basis of 2016 Combination HCV Regimens Structural Domain Nonstructural Domain P 5 UTR Core E1 E2 NS2 NS3 4A NS4B NS5A NS5B 7 3 UTR Protease Polymerase Ribavirin (RBV) NS3 Protease Inhibitors NS5A Replication Complex Inhibitors NS5B NUC Inhibitors NS5B Non-NUC Inhibitors *Possible approval in Grazoprevir (GZR) Paritaprevir/Ritonavir (PTV/RTV) Simeprevir (SMV) Voxilaprevir (VOX)* Glecaprevir (GLE)* Daclatasvir (DCV) Elbasvir (EBR) Ledipasvir (LDV) Ombitasvir (OBV) Velpatasvir (VEL) Pibrentasvir (PIB)* Sofosbuvir (SOF) Dasabuvir (DSV) Slide credit: clinicaloptions.com
34 Ombitasvir-Paritaprevir-Ritonavir and Dasabuvir +/- RBV in GT1 PEARL-III and PEARL-IV: Results Patients with SVR12 (%) / / / /209 3D + RBV 3D 3D + RBV 3D Genotype 1a Genotype 1b 3D = Ombitasvir-Paritaprevir-Ritonavir and Dasabuvir RBV = Ribavirin Source: Ferenci P, et al. N Engl J Med. 2014;370:
35 Sofosbuvir/Velpatasvir (Epclusa) Velpatasvir, an NS5A inhibitor and Sofosbuvir, an NSEB inhibitor, once daily single tablet regimen FDA approval 2016 Pangenotypic
36 Approved DAAs From Multiple Classes: Basis of 2016 Combination HCV Regimens Structural Domain Nonstructural Domain P 5 UTR Core E1 E2 NS2 NS3 4A NS4B NS5A NS5B 7 3 UTR Protease Polymerase Ribavirin (RBV) NS3 Protease Inhibitors NS5A Replication Complex Inhibitors NS5B NUC Inhibitors NS5B Non-NUC Inhibitors *Possible approval in Grazoprevir (GZR) Paritaprevir/Ritonavir (PTV/RTV) Simeprevir (SMV) Voxilaprevir (VOX)* Glecaprevir (GLE)* Daclatasvir (DCV) Elbasvir (EBR) Ledipasvir (LDV) Ombitasvir (OBV) Velpatasvir (VEL) Pibrentasvir (PIB)* Sofosbuvir (SOF) Dasabuvir (DSV) Slide credit: clinicaloptions.com
37 Sofosbuvir/Velpatasvir: SVR12 by Genotype 37 ASTRAL-1: SOF/VEL STR for 12 Weeks in GT 1, 2, 4, 5, 6 HCV-Infected Patients SVR12 (%) relapse 2 LTFU 1 WC 1 relapse 1 death /624 Total 206/ / / /116 34/35 41/41 1a 1b LTFU=lost to follow up; WC=withdrew consent Feld, AASLD, 2015, LB-2. Feld JJ, et al. N Engl J Med DOI: /NEJMoa Genotype
38 HCVGuidelines.org, 2017
39 HCVGuidelines.org, 2017
40 HCVGuidelines.org, 2017
41 HCVGuidelines.org, 2017
42 HCVGuidelines.org, 2017
43 HCVGuidelines.org, 2017
44 HCVGuidelines.org, 2017
45 HCVGuidelines.org, 2017
46 Healthline, 2016
47 WHAT DRUGS ARE CHOSEN FOR HCV THERAPY? Medicaid coverage guidelines: Genotype 1: Zepatier or Viekira XR Genotype 2 & 3: Epclusa Genotype 4: Zepatier or Technivie Medicare Part D and Commercial Insurance trends (each plan has a different formulary): Genotype 1: Harvoni Genotype 2: Epclusa Genotype 3: Epclusa or Daklinza+Sovaldi Genotype 4: Harvoni
48 HCV THERAPY: RECENT MEDICAID CHANGES Summary of major updates: -Treatment coverage will be available to stage 0 & 1 fibrosis patients -Fibroscan/fibrosis staging is not required unless advanced fibrosis/cirrhosis is suspected -Patients with recent (not defined in guideline) drug use must be participating in a recovery program and must no longer be actively using IV drugs for at least 3 months prior to and during HCV therapy -Medicaid will now provide approval for the full course of HCV therapy, and not require renewals/labs throughout treatment as before
49 HEPATITIS C TREATMENT: SUMMARY Hepatitis C treatment is highly effective with greater than 95% sustained virological response Hepatitis C treatment is well tolerated Current treatment options are costly Multiple barriers to therapy persist including identifying infected individuals and performing appropriate testing
50
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Pharmacy Coverage Guidelines are subject to change as new information becomes available.
DIRECT ACTING ANTIVIRAL AGENTS FOR HEPATITIS C VIRUS (HCV): DAKLINZA (daclatasvir) oral tablet EPCLUSA (velpatasvir, sofosbuvir) oral tablet HARVONI (ledipasvir, sofosbuvir) oral tablet MAVYRET (glecaprevir,
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Treatment of Hepatitis C with sofosbuvir/ledipasvir (Harvoni )
Applies to all products administered or underwritten by Blue Cross and Blue Shield of Louisiana and its subsidiary, HMO Louisiana, Inc.(collectively referred to as the Company ), unless otherwise provided
PHARMACY PRIOR AUTHORIZATION Hepatitis C Clinical Guideline
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See Important Reminder at the end of this policy for important regulatory and legal information.
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Length of Authorization: 8-16 weeks. Requires PA: All direct-acting antivirals for treatment of Hepatitis C. Approval Criteria
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HEPATITIS C. Whitney Dickson, PharmD, BCPS October 12 th, 2017
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