2017 Bruce Lucas Hepatology and Liver Transplant Symposium October 13th 2017 Management of Hepatitis C in Pre- and Post-Transplant Patients

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1 2017 Bruce Lucas Hepatology and Liver Transplant Symposium October 13th 2017 Management of Hepatitis C in Pre- and Post-Transplant Patients Jens Rosenau, MD Associate Professor of Medicine Acting Director of Hepatology Division of Digestive Diseases and Nutrition University of Kentucky

2 Disclosure Nothing to disclose

3 Learning Objectives

4 Principles of HCV Treatment

5 Where HCV Therapy Stands Now Interferon is gone in the US; ribavirin... not completely SVR in > 95% of patients Difficult-to-cure populations no longer difficult Black race Cirrhosis Renal failure and kidney transplant HIV coinfection Older age Liver transplant Persons who inject drugs (PWID) Genotype 3 remains more challenging (but not by much) Cost and access issues persist but improving

6 Nearly Everyone With HCV Can Now Be Treated Successfully Very high SVR rates; therapies highly tolerable All-oral therapy for almost every pt Treatment generally just 12 wks Standard Interferon IFN 6 Mos 16 IFN 12 Mos Ribavirin IFN/RBV 6 Mos IFN/RBV 12 Mos Peginterferon PegIFN 12 Mos 55 PegIFN/ RBV 12 Mos Direct- Acting Antivirals PegIFN/ RBV + DAA DAA + RBV ± PegIFN All-Oral Therapy Current 95+ All Oral DAA± RBV Slide credit: clinicaloptions.com

7 Approved DAAs From Multiple Classes: Basis of 2017 Combination HCV Regimens Structural Domain Nonstructural Domain 5 UTR Core E1 E2 P7 NS2 NS3 4A NS4B NS5A NS5B 3 UTR Protease Polymerase Ribavirin (RBV) NS3 Protease Inhibitors NS5A Replication Complex Inhibitors NS5B NUC Inhibitors NS5B Non-NUC Inhibitors Simeprevir (SMV) Paritaprevir (PTV/RTV) Grazoprevir (GZR) Voxilaprevir (VOX) Glecaprevir (GLE) Ledipasvir (LDV) Daclatasvir (DCV) Ombitasvir (OBV) Elbasvir (EBR) Velpatasvir (VEL) Pibrentasvir (PIB) Sofosbuvir (SOF) Dasabuvir (DSV) Slide credit: clinicaloptions.com

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9 Treatment Options for Genotype 1

10 Recommended for GT1 Treatment-Naive or IFN- Experienced Pts Without Cirrhosis HCV GT Recommended Regimens (All 12 Wks Except as Noted) 1a 1b SOF/LDV (Harvoni ) 8 wks if tx naive, nonblack, no HIV, and HCV RNA < 6 million IU/mL SOF/VEL (Epclusa ) 12 wks GLE/PIB (Mavyret ) 8 wks GZR/EBR (Zepatier ) 12 wks only if no baseline NS5a EBR RAS/16 if NS5a EBR RAS SOF (Sovaldi ) + DCV (Daklinza ) 12 SOF (Sovaldi ) + SMV (Olysio ) 12 OBV/PTV/RTV/DSV extended release (Viekira XR ) + RBV (Ribavirin) 12 or OBV/PTV/RTV + DSV BID (Viekira Pak ) + RBV (Ribavirin) 12 SOF/LDV 8 wks if tx naive, nonblack, no HIV, and HCV RNA < 6 million IU/mL SOF/VEL 12 GLE/PIB 8 GZR/EBR 12 SOF + DCV 12 SOF + SMV 12 OBV/PTV/RTV/DSV extended release or OBV/PTV/RTV + DSV BID 12 AASLD/IDSA. HCV guidance. October Slide credit: clinicaloptions.com

11 Recommended for GT1 Treatment-Naive or IFN- Experienced Pts With Compensated Cirrhosis HCV GT 1a Treatment Naive SOF/VEL 12 GLE/PIB 12 GZR/EBR* 12/16 SOF/LDV 12 Recommended Regimens (All 12 Wks) IFN/RBV Experienced SOF/VEL 12 GLE/PIB 12 GZR/EBR* 12/16 SOF/LDV + RBV 12 1b SOF/VEL 12 GLE/PIB 12 GZR/EBR 12 LDV/SOF 12 OBV/PTV/RTV+ DSV BID 12 SOF/VEL 12 GLE/PIB 12 GZR/EBR 12 LDV/SOF + RBV 12 OBV/PTV/RTV+ DSV BID 12 *12 weeks only if no baseline NS5A elbasvir RASs detected. AASLD/IDSA. HCV guidance. October Slide credit: clinicaloptions.com

12 Adjust EBR/GZR Duration Based on Baseline NS5A RASs in GT1a C-EDGE Treatment Naive: 12 Wks of Elbasvir/Grazoprevir SVR12 (%) n/n = 144/ /135 11/19 129/131 0 All No BL NS5A RASs BL NS5A RASs All GT1a GT1b If NS5A RASs in GT1a, treat with EBR/GZR + RBV for 16 wks (alternative) No baseline RAS testing needed in GT1b pts 58 Zeuzem Z, et al. Ann Intern Med. 2015;163:1-13. Kwo P, et al. J Hepatol. 2015;62(suppl 2):S674-S675. Slide credit: clinicaloptions.com

13 Resistance Considerations Which classes are prone to resistance? Barrier to PI and NS5A resistance Protease, NS5A, and nonnucleotide NS5B inhibitors Higher for GT1b vs GT1a Most pts with failure of current DAAs have emergent resistance-associated substitutions (RASs) NS5A RASs persist much longer than PI RASs 15% of pts have baseline NS5A RASs with variable effects on GT1a response Second-generation drugs designed to cover RASs Slide credit: clinicaloptions.com

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15 Glecaprevir/ Pibrentasvir (Mavyret ) in Noncirrhotic Patients: ENDURANCE Studies

16 ENDURANCE-1, -2, -3: GLE/PIB for Treatment of GT1, 2, 3 HCV ENDURANCE-1: randomized, open-label phase III trial [1] Noncirrhotic pts with GT1 HCV with or without IFN experience or HIV coinfection (N = 703; 38% tx-experienced ) GLE/PIB* (n = 351) GLE/PIB* (n = 352) ENDURANCE-2: randomized, double-blind, placebo-controlled phase III trial [2] Wk 8 Wk 12 Noncirrhotic pts with GT2 HCV with or without IFN experience (N = 302; 29% to 30% tx-experienced ) GLE/PIB* (n = 202) Placebo (n = 100) *Dosing: GLE/PIB given as 3 coformulated 100/40-mg tablets QD for a total dose of 300/120 mg. Treatment experience permitted: IFN or pegifn ± RBV or SOF + RBV ± pegifn. Slide credit: clinicaloptions.com

17 ENDURANCE-1, -2 Studies: Efficacy of GLE/PIB for Treating GT1, 2, 4, 5, 6 HCV * 99.7* 99 SVR12 (%) n/n = 0 332/ / Wks 12 Wks 195/ Wks 1 case of on-treatment virologic failure at Day 29 in pt with GT1a HCV infection ENDURANCE-1 (GT1) [1] ENDURANCE-2 (GT2) [2] *ITT-PS analysis: included all pts receiving 1 dose of study drug; excluded pts with HIV coinfection or SOF experience. ITT analysis: excluded pts with SOF experience. ITT analysis. 1. Zeuzem S, et al. AASLD Abstract Kowdley KV, et al. AASLD Abstract Asselah T, et al. AASLD Abstract 114. Slide credit: clinicaloptions.com

18 ENDURANCE-1, -2 Studies: Safety of GLE/PIB for Treating GT1, 2, 4, 5, 6 HCV Outcome, % ENDURANCE-1 [1] ENDURANCE-2 [2] GLE/PIB 8 Wks (n = 351) GLE/PIB 12 Wks (n = 352) GLE/PIB 12 Wks (n = 202) PBO 12 Wks (n = 100) Any AE D/c for AE 0 < Serious AE Death 0 < AE in 10% of pts Fatigue Headache AST grade 3* 0 < ALT grade 3* 0 0 < 1 2 Total bilirubin grade 3 < 1 < 1 < 1 0 *> 5 times ULN times ULN. 1. Zeuzem S, et al. AASLD Abstract Kowdley KV, et al. AASLD Abstract Asselah T, et al. AASLD Abstract 114. Slide credit: clinicaloptions.com

19 Sofosbuvir/ Velpatasvir/ Voxilaprevir (Vosevi ): POLARIS Studies

20 POLARIS-1 and -4: SOF/VEL/VOX in DAA- Experienced Pts POLARIS-1: randomized, double-blind, placebo-controlled phase III trial [1,2] DAA-experienced pts with GT1-6 HCV and NS5A inhibitor experience with or without cirrhosis (pts with GT1 HCV randomized between arms; pts with GT2-6 assigned to SOF/VEL/VOX) (N = 415) Stratified by cirrhosis status (yes or no) SOF/VEL/VOX 400/100/100 mg PO QD (n = 263) Placebo PO QD (n = 152) POLARIS-4: randomized, open-label, active-controlled phase III trial [1,3] DAA-experienced pts with GT1-6 HCV and no NS5A inhibitor experience with or without cirrhosis (pts with GT1-3 HCV randomized between arms; pts with GT4-6 assigned to SOF/VEL/VOX) (N = 333) References in slidenotes. Stratified by HCV genotype, cirrhosis status (yes vs no) SOF/VEL/VOX 400/100/100 mg PO QD (n = 182) SOF/VEL 400/100 mg PO QD (n = 151) Wk 12 Subsequently received deferred SOF/VEL/VOX Slide credit: clinicaloptions.com

21 FDA approval for adults with genotype 1, 2, 3, 4, 5 or 6 previously treated with an NS5A inhibitor-containing regimen, or with genotype 1a or 3 previously treated with a sofosbuvir-containing regimen without an NS5A inhibitor

22 POLARIS-2, -3: Safety of SOF/VEL/VOX for 8 Wks Outcome, % SOF/VEL/VOX 8 Wks (n = 501) POLARIS-2 SOF/VEL 12 Wks (n = 440) SOF/VEL/VOX 8 Wks (n = 110) POLARIS-3 SOF/VEL 12 Wks (n = 109) Any AE Serious AE D/c for AE 0 < Death AE in > 10% of pts Headache Fatigue Diarrhea Nausea Jacobson IM, et al. Gastroenterology. 2017;[Epub ahead of print]. Slide credit: clinicaloptions.com

23 Treatment of Hepatitis C Pre- and Post Liver Transplantation - Treatment of Decompensated Cirrhosis - Special Considerations for post-transplant treatment

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32 MAGELLAN-2: GLE/PIB in GT1-6 HCV With Liver or Renal Transplant SVR12 With GLE/PIB by ITT or mitt No deaths during study, 1 pt with transplant rejection (unrelated to DAA) SVR12 (%) n/n = / 100 ITT 98/ 99 mitt 1 relapse in pt with GT3a HCV; 1 pt LTFU GT 1 n=57, GT 2 n=13, GT3 n=24, all non-cirrhotic, F0-1 80%, Tx naïve 66%, Liver Transplant 80% Reau N, et al. EASL Abstract LBO-03. Reproduced with permission. Safety Outcome, % GLE/PIB (N = 100) Any AE 85 Serious AE DAA related AEs leading to d/c DAA related AEs in 10% of pts Headache Fatigue Nausea Pruritus Grade 3 abnormality AST ALT Total bilirubin CrCl Slide credit: clinicaloptions.com

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34 Linkage to Care

35 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

36 University of Kentucky: Treatment Uptake after Referral to Care 1,049 new consults for HCV (ICD-9 codes) Confirmed HCV (RNA positive) RNA undetectable RNA unavailable (Did not complete lab) Enrolled (n=881) Excluded (n=136) Excluded (n=32) Racho et al., DDW 2017

37 Patient Characteristics Summary of cohort, n=881 Avg age 43 +/- 12 Born after 1965 (64%) Male (53%) White (93%) Genotype 1 (68%) Low fibrosis (F0-F2) (64%) Medicaid insurance (73%) Lifetime injection drug use (73%) Age 30y 30% Age 31-40y 39% Age >40y 30% Racho et al., DDW 2017

38 Geographic Distribution of UK HCV referrals 5-year period from 7/2010 to 6/2015 Abdelwadoud et al. AASLD 2017

39 Moving Knowledge Instead of Patients Project ECHO (Extension for Community Health Outcomes)

40 Treatment Uptake by Insurance Type and Liver Fibrosis Stage Total n = 881 Treatment Initiation Rate 25% 3% 33% 6% n = 198 n = 448 Racho et al., DDW 2017

41 Psychosocial Readiness Evaluation and Preparation for Hepatitis C Treatment: PREP-C - Motivation: Reasons pat. wants to start HCV treatment, concerns about treatment, importance of treatment. - Information: Knowledge about HCV treatment and one s own HCV disease status. - Medication Adherence: Current prescribed medications and adherence to them in prior month. - Self-Efficacy: Self-confidence about adhering to HCV treatment. - Social Support and Stability: Stability of financial, housing, and social support resources. - Alcohol and Substance Use: Alcohol and substance use behaviors and current treatment. - Psychiatric Stability: Current psychiatric status, previous and current treatment. - Energy Level: Sleep and fatigue. - Cognitive Functioning: Perceived difficulty with communication, problem-solving ability, and memory.

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44 Drug-Drug- Interactions with Calcineurin Inhibitors

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