10/4/2016. Management of Hepatitis C Virus Genotype 2 or 3 Infection
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1 Management of Hepatitis C Virus Genotype 2 or 3 Infection Kenneth E. Sherman, MD, PHD Gould Professor of Medicine Director, Division of Digestive Diseases University of Cincinnati Cincinnati, Ohio FORMATTED: 09/22/16 Learning Objectives After attending this presentation, participants will be able to: Select treatment for hepatitis C virus (HCV) genotype 2-infected patients who do not have cirrhosis Select treatment for HCV genotype 3-infected patients who do not have cirrhosis Describe investigational treatment options on the horizon Slide 2 of 23 Case 58 y.o. man with HCV/HIV co-infection HCV diagnosed 06, never treated HIV well controlled on raltegravir + tenofovir/emtricitabine Feels generally well except for mild fatigue No history of hepatic decompensation Occasional current EtOH Remote IDU Slide 3 of 23 1
2 Case Physical Exam Vital signs normal, BMI 29 Well-appearing Anicteric Abdomen with normal liver edge, no hepatosplenomegaly No lower extremity edema No spider nevi, palmar erythema, rash Labs Wbc 7.8, hgb 14.9, plt 285 Creatinine 0.9 T.bili 0.4, AST 57, ALT 51, Alk phos 73, albumin 4.8 INR 1.0 CD4 752, HIV RNA < HBsAg negative, HBsAb positive, HBcAb total positive Hepatitis A Ab total positive Slide 4 of 23 Case HCV RNA 1,235,000 IU/mL HCV genotype 2a Fibrosure: fibrosis score of 0.42 = F1-F2 FIB-4: 1.43 APRI: Liver biopsy in 13: Grade 2, stage 1 disease Multiple cores of hepatic parenchyma with overall intact architecture. Approximately 15 portal areas. Some of the portal areas have a mild predominantly lymphocytic infiltrate. There is minimal interface activity. The lobules show mild, scattered lymphocytic infiltrates and rare small clusters of lymphocytes, associated with minimal hepatocyte injury. The trichrome stain demonstrates fibrous portal expansion. Iron stain is negative. Reticulin stain demonstrates conserved hepatic architecture Abdominal ultrasound is normal Slide 5 of 23 The best treatment for this patient is 7% 1. ELBASVIR/GRAZOPREVIR 0% 2. PEG-IFN/RIBA/SOFOSBUVIR 93% 3. SOFOSBUVIR/VELPATASVIR 0% 4. DACLATASVIR/PRO 0% 5. PEG-IFN/RIBA Slide 6 of 23 2
3 Treatment Recommendations - HCV genotype 2 Non-Cirrhotic & Compensated Cirrhotic patients Treatment naïve or PEG-IFN/RBV experienced Treatment naïve or PEG-IFN/RBV experienced Daily sofosbuvir (0 mg)/velpatasvir ( mg) x 12 weeks (IA) Daily daclatasvir ( mg*) + sofosbuvir (0 mg) (IIaB) Daily sofosbuvir (0 mg)/velpatasvir ( mg) x 12 weeks (IA) Daily daclatasvir ( mg*) + sofosbuvir (0 mg) x weeks (IIaB) *Daclatasvir dose may need to be increased or decreased when used with cytochrome P450 3A/4 inducers and inhibitors, respectively WBR = weight-based ribavirin, RBV = ribavirin; Strength of recommendation provided by Class (I, IIa/b, III) and Level (A, B, C), PEG-IFN= pegylated interferon Slide 7 of 23 AASLD/IDSA HCV Guidance ASTRAL-2: Sofosbuvir/Velpatasvir in HCV GT 2 Sofosbuvir/velpatasvir Sofosbuvir + RBV 99%* 99% % 96% 94% % 93% % % 81% SVR12 (%) 0 Overall (n= ) No Cirrhosis (n= 96) Cirrhosis (n=15 15) No Cirrhosis (n=15 16) Cirrhosis (n=4 4) Treatment-Naïve Treatment Experienced Slide 8 of 23 Foster GR, et al. N Engl J Med. 15; Nov 17. [Epub ahead of print]. ASTRAL-2: SOF/VEL STR for 12 Weeks in GT 2 HCV-Infected Patients Resistance Analysis (1% cut-off) Total, n=133 SVR12 (%) % SVR12 % % No BL BL NS5A NS5A RAVs RAVs N=53 N= % SVR /53 / Slide 9 of 23 Sulkowski, AASLD, 15, 5. Foster GR, et al. New Engl J Med. 15. DOI: /NEJMoa
4 Daclatasvir plus sofosbuvir x 24 weeks for genotype 2 HCV, treatment-naïve patients: A144 Patients with SVR12 (%) GT2 = 9 88 GT2 = 8 GT2 = 9 14/16 11/11 14/14 5/6 12/14 2/2 0 SOF x 7d DCV + SOF DCV + SOF + RBV DCV + SOF 24 wk 24 wk x 23 wk Treatment-Naïve: GT 2 or 3 DCV = daclatasvir; SOF = sofosbuvir Sulkowski et al, NEJM 14 Figure adapted from University of Washington Hepatitis Web Study Slide 10 of Daclatasvir plus sofosbuvir x 12 weeks for genotype 2 HCV, treatment-naïve patients: ALLY-2 (HIV/HCV) Patients with SVR12 (%) /11 5/6 2/2 Treatment Naïve Treatment Naïve Treatment Experienced *Daclatasvir (DCV)/sofosbuvir (SOF) not FDA-approved for genotype 2 HCV treatment Slide 11 of 23 Wyles et al, NEJM 15. Figure from University of Washington Hepatitis Web Study TREATMENT OF HCV GENOTYPE 3 INFECTION in NON-CIRRHOTIC PATIENTS TREATMENT-NAÏVE TREATMENT-EXPERIENCED (PEG-IFN/RBV OR SOF/RBV) Slide 12 of
5 Treatment recommendations - HCV genotype 3 Non-cirrhotic/Cirrhotic patients Non-Cirrhotic Treatment naïve and PEG-IFN/RBV experienced Cirrhotic Treatment Naïve and PEG-IFN/RBV Experienced Daily daclatasvir ( mg*) + sofosbuvir (0 mg) x 12 weeks (IA) Daily sofosbuvir (0 mg)/velpatasvir ( mg) (IA) Daily sofosbuvir (0 mg)/velpatasvir ( mg) x 12 weeks (IA) Daily daclatasvir ( mg*) + sofosbuvir (0 mg) + WBR x 24 weeks (IIaB) *Daclatasvir dose may need to be increased or decreased when used with cytochrome P450 3A/4 inducers and inhibitors, respectively WBR = weight-based ribavirin, RBV = ribavirin; Strength of recommendation provided by Class (I, IIa/b, III) and Level (A, B, C), PEG-IFN= pegylated interferon Slide 13 of 23 AASLD/IDSA HCV Guidance High response rates with sofosbuvir/daclatasvir in non-cirrhotic HCV genotype 3 infection: ALLY-3 Study Open-label, 12 week treatment course Slide 14 of 23 Nelson et al, Hepatology 15 (%) with SVR12 Optimal duration of treatment for genotype 3 HCV with compensated cirrhosis is not known: ALLY-3+ Advanced Fibrosis Cirrhosis Treatment-Experienced Cirrhosis /14 31/36 26/30 6/6 15/18 14/16 8/8 16/18 12/14 0 Overall 12 weeks 16 weeks No difference between 12 vs 16 weeks of daclatasvir+sofosbuvir+ribavirin for GT3 and advanced fibrosis Slide 15 of 23 Leroy, Hepatology 16; Figure from University of Washington Hepatitis Web Study 5
6 Daclatasvir + sofosbuvir +/- RBV for 24 weeks HCV genotype 3 European real-world compassionate use cohort Daclatasvir + sofosbuvir x 24 weeks recommended Addition of RBV or shorter course at provider s discretion 7 deaths, 44 (9.4%) serious AEs, 2 (0.4%) treatmentrelated, 3 (0.6%) discontinuations for AEs Slide 16 of 23 Hezode, AASLD November 13-17, 15, Abstract 6 Sofosbuvir/velpatasvir for Genotype 3 HCV: ASTRAL-3 12 wks 24 wks Baseline NS5A SVR12 resistance profile RAVs present 88% (including A30K, L31M, Y93H), n=43 (16%) Y93H, n=25 84% No RAVs 97% Genotype 2 HCV (ASTRAL-2): 99% SVR12 vs 94% with SOF/RBV x 12 wks Slide 17 of 23 Foster, NEJM 15 RETREATMENT OF GENOTYPE 2 TREATMENT FAILURES PEG-IFN/RIBA Failures Non-cirrhotic Sofosbuvir/Velpatasvir x 12 weeks (Recommended) Sofosbuvir/Daclatasvir x 12 weeks (Alternative) Cirrhotic Sofosbuvir/Velpatasvir x 12 weeks (Recommended) Sofosbuvir/Daclatasvir x weeks (Alternative) SOFOSBUVIR + PEG-IFN/RIBA Failures With or without Cirrhosis Sofosbuvir + Daclatasvir x 24 weeks (Recommended) Sofosbuvir/Velpatasvir x 12 weeks (Recommended) Slide 18 of 23 6
7 RETREATMENT OF GENOTYPE 3 TREATMENT FAILURES PEG-IFN/RIBA Failures Non-cirrhotic Sofosbuvir/Velpatasvir x 12 weeks (Recommended) Sofosbuvir/Daclatasvir x 12 weeks (Recommended) Cirrhotic Sofosbuvir/Velpatasvir/Riba x 12 weeks (Recommended) Sofosbuvir/Daclatasvir/Riba x 24 weeks (Recommended) SOFOSBUVIR + PEG-IFN/RIBA Failures With or without Cirrhosis Sofosbuvir/Daclatasvir/Riba x 24 weeks (Recommended) Sofosbuvir/Velpatasvir/Riba x 12 weeks (Recommended) Slide 19 of 23 TREATMENT OF HCV GENOTYPE 2 AND 3 INFECTION PROMISING NEW REGIMENS Slide of ABT-493 plus ABT-530 +/- RBV for Genotype 3 HCV: SURVEYOR-II Treatment naïve, compensated cirrhotics (Child-Pugh A) No discontinuations due to adverse events Few serious AEs ABT-530 with activity against common NS3 and NS5A RAVs RAV = Resistance-associated variant Slide 21 of participants with baseline NS3 or NS5A RAVs Kwo, EASL, April 13-17, 16 7
8 ELBASVIR/GRAZOPREVIR + SOFOSBUVIR C-SWIFT Treatment Naïve Genotype 3 Treated 8-12 Weeks With Cirrhosis Without Cirrhosis SVR Non-cirrhotic 93% (14/15) with 8 weeks of therapy % (14/14) with 12 weeks of therapy Cirrhotic 91% (10/11) with 12 weeks of therapy Poordad F et al., J HEPATOL, Abs. O Slide 22 of 23 Summary Good treatment options are currently available for non-cirrhotic genotype 2 and 3 HCV infection Role of ribavirin in treatment of genotype 3 cirrhotics is unclear Presence of baseline NS5A RAVs has been associated with lower SVR rates with treatment of genotype 3 infection using SOF + an NS5A inhibitor Slide 23 of 23 Management of Hepatitis C Virus Genotype 2 or 3 Infection Kenneth E. Sherman, MD, PHD Gould Professor of Medicine Director, Division of Digestive Diseases University of Cincinnati Cincinnati, Ohio FORMATTED: 09/22/16 8
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