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GS-US Study: SOF/VEL + GS in genotype 2, 3, 4 or 6 - Phase II

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Presentation on theme: "GS-US Study: SOF/VEL + GS in genotype 2, 3, 4 or 6 - Phase II"— Presentation transcript:

1 GS-US-367-1169 Study: SOF/VEL + GS-9857 in genotype 2, 3, 4 or 6 - Phase II
Design Open-label W6 W8 W12 No cirrhosis SOF/VEL + GS-9857 N = 33 > 18 years Genotype 2, 3, 4, 5 or 6 HCV RNA > IU/mL Treatment-naive or treatment-experienced (with or without DAA) Compensated cirrhosis allowed Creatinine clearance > 60 mL/min No HBV or HIV co-infection Naive N = 30 SOF/VEL + GS-9857 Cirrhosis No cirrhosis SOF/VEL + GS-9857 N = 36 Treatment- experienced N = 29 SOF/VEL + GS-9857 Cirrhosis SOF/VEL: 400/100 mg FDC QD ; GS-9857: 100 mg QD Objective SVR12 (HCV RNA < 15 IU/mL), by ITT, with 2-sided 95% CI (no inferential statistics) GS-US Gane EJ, Gastroenterology 2016; 151:

2 Baseline characteristics Treatment-experienced
GS-US Study: SOF/VEL + GS in genotype 2, 3, 4 or 6 - Phase II Baseline characteristics Treatment-naive Treatment-experienced No cirrhosis Cirrhosis SOF/VEL + GS-9857 6W N = 33 8W N = 30 12W N = 36 N = 29 Age, years, mean 53 56 57 58 Female, % 64 30 28 White, % 82 80 81 79 HCV RNA, log10 IU/mL, mean 6.2 6.1 6.3 6.4 IL28B CC, % 33 37 42 35 Genotype 1b / 2 / 3 / 4 / 6, N 1 / 6 / 21 / 5 / 0 0 / 6 / 18 / 5 / 1 0 / 13 / 18 / 4 / 1 0 / 8 / 17 / 3 / 1 DAA experience, N None SOF + RBV + PEG-IFN Other DAAs - 10 17 2 GS-US Gane EJ, Gastroenterology 2016; 151:

3 Treatment-experienced
GS-US Study: SOF/VEL + GS in genotype 2, 3, 4 or 6 - Phase II SVR12, ITT, % (95% CI) Treatment-experienced 20 40 60 80 100 88 ( 72-97) 33 (90-100) 36 % N= 97 (82-99) 29 Naive No cirrhosis 93 ( 78-99) 30 Cirrhosis SOF/VEL + GS-9857 6W 8W 12W GS-US Gane EJ, Gastroenterology 2016; 151:

4 SVR12 and relapse by genotype Treatment-experienced
GS-US Study: SOF/VEL + GS in genotype 2, 3, 4 or 6 - Phase II SVR12 and relapse by genotype Treatment-naive Treatment-experienced No cirrhosis Cirrhosis SOF/VEL + GS-9857 6W N = 33 8W N = 30 12W N = 36 N = 29 SVR12, N (%) Genotype 1b 1 (100) Genotype 2 4/6 (67) 6/6 (100) 13/13 (100) 8/8 (100) Genotype 3 21/21 (100) 17/18 (94) 18/18 (100) 16/17 (94) Genotype 4 3/5 (60) 4/5 (80) 4/4 (100) 3/3 (100) Genotype 6 1/1 (100) Relapse, N (%) 4 (12) 2 (7) 1 (3) GS-US Gane EJ, Gastroenterology 2016; 151:

5 SVR12 according to presence or absence of baseline RASs
GS-US Study: SOF/VEL + GS in genotype 2, 3, 4 or 6 - Phase II Resistance analysis (1% deep sequencing) At baseline, presence of class RASs (NS3, NS5A or NS5B) 32/63 (51%) treatment-naïve patients 6/27 (22%) IFN-experienced, DDA-naïve 20/38 (53%) DDA-experienced patients SVR12 according to presence or absence of baseline RASs Population Duration of SOF/VEL + GS-9857 SVR12 Baseline RASs Yes No Naive, no cirrhosis 6 weeks 11/14 (79%) 18/19 (95%) Naive, cirrhosis 8 weeks 11/12 (92%) 17/18 (94%) DAA-experienced 12 weeks 23/24 (96%) 41/41 (100%) At relapse, N = 7 Emergence of RAS in 1 patient with genotype 3a: Y93H at baseline and relapse, emergence of Q80R GS-US Gane EJ, Gastroenterology 2016; 151:

6 Treatment-experienced
GS-US Study: SOF/VEL + GS in genotype 2, 3, 4 or 6 - Phase II Adverse events, % Treatment-naive Treatment-experienced No cirrhosis Cirrhosis SOF/VEL + GS-9857 6W N = 33 8W N = 30 12W N = 36 N = 29 Serious adverse event 3 AE leading to discontinuation 7 Death AE in ≥ 5% of patients Headache Diarrhea Fatigue Nausea Constipation Dizziness Dry mouth Abdominal pain, upper Nasopharyngitis Upper respiratory tract infection GS-US Gane EJ, Gastroenterology 2016; 151:

7 Laboratory abnormalities, N (%) Treatment-experienced
GS-US Study: SOF/VEL + GS in genotype 2, 3, 4 or 6 - Phase II Laboratory abnormalities, N (%) Treatment-naive Treatment-experienced No cirrhosis Cirrhosis SOF/VEL + GS-9857 6W N = 34 8W N = 33 12W N = 31 N = 32 Hemoglobin 7-9 g/dl 1 (3) Neutrophils /mm3 Platelets /mm3 Creatine kinase > 20 x ULN Glycemia 3-4 g/L Lipase < 3 x ULN 3 (10) GS-US Gane EJ, Gastroenterology 2016; 151:

8 GS-US-367-1169 Study: SOF/VEL + GS-9857 in genotype 2, 3, 4 or 6 - Phase II
Summary In this phase 2 open-label trial, SOF/VEL + GS (8 weeks in treatment-naïve patients or 12 weeks in treatment- experienced patients) was safe and effective for patients with HCV genotype 2, 3, 4, or 6 infections, with or without compensated cirrhosis GS-US Gane EJ, Gastroenterology 2016; 151:

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