Treatments of Genotype 2, 3,and 4: Now and in the future

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Treatments of Genotype 2, 3,and 4: Now and in the future THERAPY FOR THE TREATMENT OF GENOTYPE 2 1

GT 2 and GT 3 Treatment-Naïve: SOF+RBV vs PEG-IFN+RBV FISSION Study Design HCV GT 2 and GT 3 Treatment-naïve N=499 Stratified by HCV genotype, HCV RNA, and cirrhosis Randomized 1:1 Study Week SOF + RBV*, n=256 SVR12 *RBV dose 12 mg/d PEG-IFN + RBV (SOC), n=243 SVR12 8 mg/d for PEG-IFN+RBV 12 24 36 No response guided therapy HCV RNA analyzed by COBAS TaqMan HCV Test v2. HPS, with LLOQ of 25 IU/mL Lawitz E, et al. N Engl J Med. 213; 368: 1878-1887 FISSION SVR 12 for Genotype 2: TREATMENT NAIVE 8 4 SOF/RBV 12 wks 97 98 82 78 PEG/RBV 24 wks 91 62 2 Overall No cirrhosis Cirrhosis Lawitz E, et al. N Engl J Med. 213;368:1878-1887 2

FUSION STUDY: Genotype 2 and 3 Treatment Experienced HCV GT 2 and GT 3 Treatmentexperienced N=21 Stratified by HCV genotype and cirrhosis Randomized 1:1 Study Week SVR12 SOF + RBV, n=13 Placebo SVR12 SOF + RBV, n=98 SOF dose 4 mg QD; RBV dose 12 mg/d 12 16 24 28 No response guided therapy HCV RNA analyzed by COBAS TaqMan HCV Test v2. HPS, with LLOQ of 25 IU/mL Nelson DR, et al. EASL 213. Amsterdam, The Netherlands. Oral #6 Jacobson IM, et al. N Engl J Med. 213 Apr 23 FUSION SVR 12 for Genotype 2: TREATMENT EXPERIENCED 8 86 94 SOF/RBV 12 wks 96 SOF/RBV 16 wks 78 4 2 Overall No cirrhosis Cirrhosis Nelson et al. EASL 213 Amsterdam 3

FUSION SVR 12 for Genotype 2: TREATMENT EXPERIENCED 8 86 94 SOF/RBV 12 wks 96 SOF/RBV 16 wks 78 4 2 Overall No cirrhosis Cirrhosis Nelson et al. EASL 213 Amsterdam SOF + RBV for 12 Weeks: SVR12 in Interferon- Intolerant, Ineligible or Unwilling Patients (POSITRON) 94.5 Genotype 2 94 94 SVR12 (%) 93.5 93 92.5 92 91.5 92 85/92 16/17 91 No Cirrhosis Cirrhosis Lawitz et al., N Engl J Med 213, 368: 1867-1877. 4

LONESTAR-2: Sofosbuvir + P/R for 12 Wks in Treatment-Exp d GT2/3 HCV Pts Single-arm trial of pts with treatment failure on P/R Approximately 5% with compensated cirrhosis Pts with GT2 or GT3 HCV and previous treatment failure with P/R (N = 47) SOF 4 mg QD + PegIFN wkly + RBV mg or 12 mg Lawitz E, et al. AASLD 213. Abstract LB-4. Wk 12 SVR12 (% %) 8 4 2 n/n = 96 GT2 All 93 GT2 F4 22/23 13/14 9/9 GT2 F-3 FUTURE THERAPY FOR GENOTYPE 2 5

Treatment of Naïve Genotype 2 with Sofosbuvir + Daclatasvir (NS5A): 24 weeks Not FDA approved 98 96 92 89 8 SVR (%) 4 2 126 41 41 18 GT 1 Naive GT 1 Experienced GT 2 GT 3 GT 3: 1 lost to f/u 1 viral failure Sulkowski M et al. N Engl J Med. 214;37:211-21. SOF + GS-5816 for 12 weeks in Treatment- Naive Non-cirrhotic Patients With GT2 Open-label phase II study N = 154 patients t randomized d to 12 wks of SOF + GS-5816 25 mg or mg/day GS-5816: investigational NS5A inhibitor 8 91 SOF + GS-5816 25 mg SOF + GS-5816 mg SVR12 (%) 4 2 n/n = 1/11 1/1 Genotype 2 Everson GT, et al. EASL 214. Abstract O111. 6

RETREATMENT OF GENOTYPE 2 SOFOSBUVIR FAILURES Retreatment of Genotype 2 SOF/RBV Failures G 2 8 5 4 G 2 2 PEG/SOF/R 12 SOF/R 24 wks wks N= 4 n=2 Esteban et al. EASL 214 Abstract 8 7

Retreatment of Genotype 2 & 3 patients SOF/RBV failures Regimen #ofpatients SVR 12 SOF/LDV 14 % 13/14 were African-Americans Osinusi et al. EASL 214 Abstract 11 Treatment of HIV/HCV: The Photon Study: Genotype 2 SOF/RBV for 12 weeks Patients with HCV RNA <LLOQ (%) 8 4 2 96 96 88 88 25/26 22/23 23/26 23/26 24/24 23/23 22/24 22/24 25/26 22/23 23/26 23/26 24/24 23/23 22/24 22/24 Week 4 EOT SVR12 SVR24 Week 4 EOT SVR12 SVR24 Treatment Naïve 12 Weeks SOF + RBV 92 92 Treatment Experienced Sulkowski MS, et al. AASLD 213. Washington, DC. Oral #212 24 Weeks SOF + RBV 8

Treatment of HIV/HCV: The Photon Study: Genotype 2 SOF/RBV for 12 weeks Patients with HCV RNA <LLOQ (%) 8 4 2 96 96 88 88 25/26 22/23 23/26 23/26 24/24 23/23 22/24 22/24 25/26 22/23 23/26 23/26 24/24 23/23 22/24 22/24 Week 4 EOT SVR12 SVR24 Week 4 EOT SVR12 SVR24 Treatment Naïve 12 Weeks SOF + RBV 92 92 Treatment Experienced Sulkowski MS, et al. AASLD 213. Washington, DC. Oral #212 24 Weeks SOF + RBV AASLD/IDSA Recommendations for Genotype 2 HCV Treatment-Naive Pts Population Recommended Regimen Duration Treatment naive and previous Sofosbuvir 4 mg + 12 wks relapsers, genotype 2 RBV -12 mg/day Alternative regimens: none Regimens specifically not recommended: PegIFN/RBV x 24 wks Monotherapy with pegifn, RBV, or DAA TVR-, BOC-, SMV-based regimens http://www.hcvguidelines.org/full-report/initial-treatment-hcv-infection-patients-starting-treatment accessed September 7, 214. 9

AASLD/IDSA Recommendations for Genotype 2 HCV Treatment-Exp d Pts Population Recommended Regimen Duration Nonresponse to previous treatment with pegifn/rbv Sofosbuvir 4 mg + RBV -12 mg/day *Pts with cirrhosis may benefit by extension of therapy to 16 wks. 12 wks but may extend to 16 wks if cirrhotic Population Alternative Regimen Duration Nonresponse to previous treatment with pegifn/rbv Sofosbuvir 4 mg + pegifn + RBV -12 mg/day 12 wks with IFN eligibility Regimens specifically not recommended: PegIFN/RBV ± TVR or BOC Monotherapy with pegifn, RBV, or DAA http://www.hcvguidelines.org/full-report/initial-treatment-hcv-infection-patients-starting-treatment accessed September 7, 214. THERAPY FOR GENOTYPE 3 1

FISSION SVR 12 for Genotype 3: TREATMENT NAIVE SOF/RBV 12 wks PEG/RBV 24 wks 8 56 63 61 71 4 2 34 3 Overall No cirrhosis Cirrhosis Lawitz E, et al. N Engl J Med. 213;368:1878-1887 FUSION SVR 12 for Genotype 3: TREATMENT EXPERIENCED SOF/RBV 12 wks SOF/RBV 16 wks 8 62 63 61 4 2 3 37 19 Overall No cirrhosis Cirrhosis Nelson et al. EASL 213 Amsterdam 11

SOF + RBV for 12 Weeks: SVR12 in Interferon- Intolerant, Ineligible or Unwilling Patients (POSITRON) SVR12 (%) 8 Genotype 3 7 68 5 4 3 2 21 1 57/ 84 3/14 No Cirrhosis Cirrhosis Lawitz et al, N Engl J Med 213;368:1867-1877. Genotype 3: Longer duration in Treatment experienced patients: the VALENCE Study Wk Wk 12 Wk 24 SVR4, SVR12, SVR24 Sofosbuvir + Ribavirin (n = 25) * Zeuzem et al AASLD 213 12

SVR12 in GT 3 Patients Treated for 24 Weeks 92 93 8 85 4 2 Naïve, noncirrhotic Naïve, cirrhotic Experienced, noncirrhotic Experienced, cirrhotic Zeuzem et al AASLD 213 Impact of Duration on Efficacy of SOF in Treatment-Experienced GT3 Pts SVR12 (%) 8 4 37 63 87 FISSION: 12 wks of SOF/RBV FUSION: 16 wks of SOF/RBV VALENCE: 24 wks of SOF/RBV 61 93 2 n/n = 14/ 38 25/ 4 No Cirrhosis 87/ 19 5/ 26 14/ 23 Cirrhosis 27/ 45 TE Naive Genotype 3 Jacobson IM, et al. N Engl J Med. 213;368:1867-1877. Zeuzem S, et al. N Engl J Med. 214 13

SOF + RBV for 12 vs 24 Weeks: SVR12 in HCV/HIV Coinfected Patients Based on Genotype SVR12 (%) 8 4 GT 1 GT 2 GT 3 76 88 92 94 67 2 87/114 23/26 22/24 Treatment Naive, 24 Weeks Treatment Naive, 12 Weeks Treatment Experienced, 24 Weeks 28/42 Treatment Naïve, 12 Weeks 16/17 Treatment Experienced, 24 Weeks Sulkowski MS, et al. JAMA. 214;312:353-61. FUTURE THERAPY FOR GENOTYPE 3 14

LONESTAR-2: Sofosbuvir + P/R for 12 Wks in Treatment-Experienced GT3 HCV Pts Single-arm trial of pts with treatment failure on P/R Approximately 5% with compensated cirrhosis Pts with GT2 or GT3 HCV and previous treatment failure with P/R (N = 47) Sofosbuvir 4 mg QD + PegIFN + RBV -12 mg Wk 12 SVR12 (%) 8 4 2 n/n = 83 GT3 All 83 83 2/24 1/12 1/12 GT3 F4 GT3 F-3 Similar rates of SVR12 in pts with and without cirrhosis Lawitz E, et al. AASLD 213. Abstract LB-4. Retreatment in Genotype 3 Patients With Previous SOF + RBV Failure Open-label, nonrandomized trial 34% to 41% compensated cirrhosis 91 12 wks of SOF + pegifn/rbv 24 wks of SOF/RBV SVR12 (% %) 8 4 2 n/n = 63 2/22 24/38 Genotype 3 Esteban R, et al. EASL 214. Abstract O8. 15

ELECTRON 2: SOF/LDV FDC ± RBV in Diverse Hard-to-Treat Patients Partially randomized, d open-label l phase IIt trial Wk 12 SVR12, % Treatment-naive patients with GT3 HCV (N = 51) SOF/LDV FDC (n = 25) SOF/LDV FDC + RBV* (n = 26) 64 *Sofosbuvir/ledipasvir 4/9 mg FDC tablet once daily; weight-based RBV -12 mg/day. Additional nonrandomized arms conducted in patients with GT1 HCV not shown. Gane EJ, et al. EASL 214. Abstract O6. Sofosbuvir + Daclatasvir (NS5A): 24 weeks 98 96 92 Not FDA approved 89 8 SVR (%) 4 2 126 41 41 18 GT 1 Naive GT 1 Experienced GT 2 GT 3 GT 3: 1 lost to f/u 1 viral failure Sulkowski M et al. N Engl J Med. 214;37:211-21. 16

SOF + GS-5816 for 12 weeks in Treatment- Naive Non-cirrhotic Patients With G3 Open-label phase II study N = 154 patients randomized to 12 wks of SOF + GS-5816 25 mg or mg daily GS-5816: investigational NS5A inhibitor ) SVR12 (%) 8 4 2 93 93 25/27 25/27 Genotype 3 SOF + GS-5816 25 mg SOF + GS-5816 mg Everson GT, et al. EASL 214. Abstract O111. AASLD/IDSA Recommendations for Genotype 3 HCV Treatment-Naive Pts Population Recommended Regimen Duration Regardless of IFN eligibility Sofosbuvir 4 mg + 24 wks RBV -12 mg/day Population Alternative Regimen Duration Only consider if eligible for IFN Sofosbuvir 4 mg + pegifn + RBV -12 mg/day 12 wks Not recommended: PegIFN/RBV for 24-48 wks Monotherapy with pegifn, RBV, or a DAA Telaprevir, boceprevir, simeprevir AASLD/IDSA treatment recommendations. 17

AASLD/IDSA Recommendations for Genotype 3 HCV Treatment-Experienced Population Recommended Regimen Duration Regardless of IFN eligibility Sofosbuvir 4 mg + RBV -12 mg/day 24 wks Population Alternative Regimen Duration Consider only if eligible for IFN Sofosbuvir 4 mg + pegifn + RBV -12 mg/day Not recommended: PegIFN/RBV ± telaprevir, boceprevir, simeprevir Monotherapy with pegifn, RBV, or a DAA 12 wks http://www.hcvguidelines.org/full-report/initial-treatment-hcv-infection-patients-starting-treatment Accessed September 7, 214. Daclatasvir for Genotype 3: EU Approval 8/27/214 Regimen Treatment Duration Treatment experienced DAC/SOF/RBV 24 weeks Compensated cirrhosis DAC/SOF/RBV 24 weeks 18

THE TREATMENT OF GENOTYPE 4 NEUTRINO: SVR12 With Sofosbuvir + P/R According in Genotype 4 96 8 SVR12 (%) S 4 2 27/28 GT 4 Lawitz E, et al. NEJM 213 19

FUTURE THERAPY FOR GENOTYPE 4 Genotype 4 Wk Wk 12 Wk 24 Wk 36 Wk 48 SOF+RBV (n=31)* SVR4 SVR12 SVR24 SOF+RBV (n=29)* SVR4 SVR12 SVR24 Single-center, open-label, USA study patients with chronic HCV GT 4 Born in Egypt and dboth parents of fegyptian ancestry Treatment-naïve or -experienced Up to 2% with compensated cirrhosis Treatment assignment stratified by prior treatment experience and presence/absence of cirrhosis Ruane et al EASL 214 *SOF 4 mg/d; RBV 12 mg/d. 2

IFN-free therapy of GT 4 infection with SOF + RBV Egyptian Ancestry Study Treatment-naïve Treatment-experienced 2 (%) 8 79 59 87 SVR1 4 2 11/14 14/14 1/17 13/15 12 weeks 24 weeks 12 weeks 24 weeks Ruane PJ, et al. EASL 214. Abstract #694. ABT-45/RTV + Ombitasvir ± RBV in Tx- Naive Noncirrhotic Genotype 4 Open-label, nonrandomized phase II trial Primary endpoint: SVR12 Interim results, SVR12 available for Tx-naive arms only Wk 12 SVR12, % Noncirrhotic, treatment-naive patients with GT4 HCV ABT-45/RTV + Ombitasvir (n = 44) 9.9 Noncirrhotic, treatment-naive patients with GT4 HCV Noncirrhotic, partial or null responder, or relapser with GT4 HCV ABT-45/RTV + Ombitasvir + RBV (n = 42) ABT-45/RTV + Ombitasvir + RBV (n = 49) Not reached ABT-45/RTV 15/ mg once daily; ombitasvir 25 mg once daily; RBV -12 mg/day. Hezode C, et al. EASL 214. Abstract O58. Reproduced with permission. 21

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DCV/ASV/791325 for 12 weeks in genotype 4, naïve patients Regimen # of patients On treatment End of treatment SVR 12 week 2 viral viral loss loss DCV 3 11 % % % mg/asv 2mg/BMS- 791325 75 mg BID DCV 3 1 % % % mg/asv 2mg/BMS- 791325 15 mg BID Daclatasvir NS5a inhibitor Asunaprevir NS3 protease inhibitor BMS-791325 non-nucleotide polymerase inhibitor Hassanein et al. EASL 214 AASLD/IDSA Recommendations for HCV Genotype 4 Treatment-Naive Patients Yes Genotype 4 Treatment Naive IFN Eligible? No Sofosbuvir 4 mg/d + PEG + RBV x 12 wks Sofosbuvir 4 mg/d + RBV x 24 wks Alternative Regimens Simeprevir 15 mg/d + PEG + RBV x 24-48 wks RBV dose: -12 mg/day http://www.hcvguidelines.org/full-report/initial-treatment-hcv-infection-patients-starting-treatment Accessed September 7, 214 23

AASLD/IDSA Recommendations for HCV Genotype 4 Treatment-Experienced Pts Genotype 4 Treatment Experienced Sofosbuvir 4 mg/d + PEG + RBV x 12 wks Alternative Regimens RBV dose: -12 mg/day Sofosbuvir 4 mg/d + RBV x 24 wks http://www.hcvguidelines.org/full-report/initial-treatment-hcv-infection-patients-starting-treatment Accessed September 7, 214. Daclatasvir for Genotype 4: EU Approval 8/27/214 Regimen Duration Options No cirrhosis SOF/DAC 12 weeks Consider 24 weeks if previously treated Compensated cirrhosis SOF/DAC 24 weeks Consider 12 weeks for untreated patients of those with CC and/or low baseline viral load Compensated PEG/RBV/DAC 24/48 If HCV-RNA negative at week 4 cirrhosis/noncirrhotics weeks and 12, 24 weeks of therapy If HCV-RNA positive at either week 4 or 12, additional 24 weeks of PEG/RBV 24

Summary of Treatments for Genotype 2, 3,and 4 Now Future G2 G2 SOF/DAC SOF/RBV SOF/GS5816 G3 SOF/LDV SOF/RBV G3 PEG/RBV/SOF G4 SOF/LDV + RBV PEG/RBV/SOF / SOF/DAC SOF/GS-5816 G4 SOF/RBV ABT-45/R/Ombitasvir + RBV DAV/ASV/BMS-791325 25

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