SOF/VEL ± RBV in genotype 3 with compensated cirrhosis

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Presentation transcript:

SOF/VEL ± RBV in genotype 3 with compensated cirrhosis Randomisation * 1:1 Open label Design W12 HCV genotype 3 Treatment-naïve or treatment-experienced (including NS3/4 or NS5B inhibitors) Compensated cirrhosis (defined by biopsy or Fibroscan > 12.5 kPa or the combination of Fibrotest > 0.75 AND APRI > 2) Patients with HIV co-infection eligible N = 101 SOF/VEL SVR12 SOF/VEL + RBV N = 103 * Stratification by treatment experience SOF/VEL: 400/100 mg 1 tablet QD Patients enrolled in 29 sites in Spain Primary endpoint SVR12 (HCV < 15 IU/mL) SOF/VEL + RBV G3 cirrhosis Esteban R. Gastroenterology. 2018;155:1120-7 1

SOF/VEL ± RBV in genotype 3 with compensated cirrhosis Baseline characteristics SOF/VEL 12W N = 101 SOF/VEL + RBV 12W N = 103 Median age, years (range) 51 (31-70) 51 (31-85) Male, N (%) 75 (74) 87 (85) Race: White, N (%) 84 (83) 95 (92) Median BMI, kg/m2 (range) 27 (18-40) 27 (18-47) HIV co-infection, N (%) 16 (16) 14 (14) Median HCV RNA, log10 IU/mL (range) 6.2 (4-7.5) 6.3 (4.8-7.5) Treatment-experienced, N (%) 27 (27) 28 (27) SOF/VEL + RBV G3 cirrhosis SOF/VEL + RBV G3 cirrhosis Esteban R. Gastroenterology. 2018;155:1120-7 2

SOF/VEL ± RBV in genotype 3 with compensated cirrhosis Primary Endpoint (SVR12) 101 103 91 96 % N = Relapse 5 2 Non-responder 1 Lost to follow-up 2 ( 1 for AE) Discontinuation due to AE NS5A RAS: 19% in SOF/VEL (SVR12: 84%), 22% in SOF/VEL + RBV (SVR12: 96%) Patients with Y93H: N = 4 in SOF/VEL (SVR12: 50%), N = 9 in SOF/VEL + RBV (SVR12: 88.9%) SOF/VEL + RBV G3 cirrhosis SOF/VEL + RBV G3 cirrhosis Esteban R. Gastroenterology. 2018;155:1120-7 3

SOF/VEL ± RBV in genotype 3 with compensated cirrhosis Primary Endpoint (SVR12) by prior treatment 28 27 75 74 Treatment naive (N = 149) Treatment experienced (N = 55) 89 96 % N = Relapse 4 1 Non-responder Lost to follow-up 2 Discontinuation due to AE SOF/VEL + RBV G3 cirrhosis SOF/VEL + RBV G3 cirrhosis Esteban R. Gastroenterology. 2018;155:1120-7 4

SOF/VEL ± RBV in genotype 3 with compensated cirrhosis Adverse events (AE) and laboratory abnormalities, N (%) SOF/VEL 12W N = 101 SOF/VEL + RBV 12W N = 103 Any AE / grade 3-4 AE 48 (48%) / 2 (2%) 77 (75%) / 1 (1%) Serious AE (all unrelated to treatment) 4 (4%) 2 (2%) AE leading to discontinuation of SOF/VEL 1 (1%) AE leading to discontinuation of RBV - AE > 10% in either group Asthenia Headache Insomnia 12 (12%) 8 (8%) 28 (27%) 25 (24%) Laboratory abnormalities Grade 3-4 Hemoglobin < 10 g/dL Hemoglobin < 8.5 g/dL 7 (7%) 16 (16%) 5 (5%) SOF/VEL + RBV G3 cirrhosis SOF/VEL + RBV G3 cirrhosis Esteban R. Gastroenterology. 2018;155:1120-7 5

SOF/VEL ± RBV in genotype 3 with compensated cirrhosis Conclusion High rates of SVR12 were observed with 12 weeks of SOF/VEL ± RBV in patients with GT3 and compensated cirrhosis Adding RBV reduced the relapse rate from 5% to 2% Treatment was well-tolerated SOF/VEL + RBV G3 cirrhosis SOF/VEL + RBV G3 cirrhosis Esteban R. Gastroenterology. 2018;155:1120-7 6