Clinical trial NCT02185794
Conditions: Hepatitis C Virus Infection
Keywords: Sustained Virologic Response Direct Acting Antiviral Combination Therapy Liver Diseases Digestive System Diseases Hepatitis, Viral, Human Enterovirus Infections Picornaviridae Infections RNA Virus Infections Flaviviridae Infections Antiviral Agents Anti-Infective Agents Therapeutic Uses Pharmacologic Actions Antimetabolites Molecular Mechanisms of Pharmacological Action
Sponsor: Gilead Sciences
Start date: 2014-06-13; Completion date: 2015-09-28
Enrollment: 101 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The primary objective of the study is to evaluate the safety and tolerability of voxilaprevir (formerly GS-9857) alone or with sofosbuvir (SOF)/velpatasvir (VEL) fixed dose combination (FDC) and antiviral activity of voxilaprevir in adults with genotype 1, 2, 3, 4 hepatitis C virus (HCV) infection. All participants will be monitored for up to 48 weeks after the last dose.

Detailed description:

Arms: arm 1: Participants with genotype (GT) 1a HCV infection will receive placebo once daily for 3 days under fasted conditions. arm 2: Participants with GT 1a HCV infection will receive voxilaprevir 50 mg once daily for 3 days under fasted conditions. arm 3: Participants with GT 1a HCV infection will receive voxilaprevir 100 mg once daily for 3 days under fasted conditions. arm 4: Participants with GT 1a HCV infection will receive voxilaprevir 300 mg once daily for 3 days under fasted conditions. arm 5: Participants with GT 3 HCV infection will receive placebo once daily for 3 days under fasted conditions. arm 6: Participants with GT 3 HCV infection will receive voxilaprevir 50 mg once daily for 3 days under fasted conditions. arm 7: Participants with GT 3 HCV infection will receive voxilaprevir 100 mg once daily for 3 days under fasted conditions. arm 8: Participants with GT 3 HCV infection will receive voxilaprevir 300 mg once daily for 3 days under fasted conditions. arm 9: Participants with GT 2 HCV infection will receive placebo once daily for 3 days under fasted conditions. arm 10: Participants with GT 2 HCV infection will receive voxilaprevir 100 mg once daily for 3 days under fasted conditions. arm 11: Participants with GT 4 HCV infection will receive voxilaprevir 100 mg once daily for 3 days under fasted conditions. arm 12: Participants with GT 1b HCV infection will receive voxilaprevir 100 mg once daily for 3 days under fasted conditions. arm 13: Participants with GT 3a HCV infection will receive voxilaprevir 100 mg once daily for 3 days under fed conditions. arm 14: Participants with genotypes 1a, 1b, 2, 3, or 4 HCV infection will receive voxilaprevir up to 600 mg under fasted or fed conditions for 3 days. arm 15: Participants with any GT HCV infection received voxilaprevir 100 mg on Day 1 after moderate fat meal and voxilaprevir 100 mg plus sofosbuvir (SOF)/velpatasvir (VEL) (400/100 mg) fixed-dose combination (FDC)on Days 2 and 3 after either a light or moderate-fat meal. arm 16: Participants with any GT HCV infection received voxilaprevir 100 mg on Day 1 and voxilaprevir 100 mg plus SOF/VEL (400/100 mg) FDC on Days 2 and 3 after moderate fat meal.
Interventions: intervention 1: Voxilaprevir intervention 2: Placebo to match voxilaprevir intervention 3: SOF/VEL
Intervention descriptions: intervention 1: Voxilaprevir tablets administered orally once daily intervention 2: Placebo to match voxilaprevir tablets administered orally once daily intervention 3: 400 mg/100 mg FDC tablet administered orally once daily

Protocol documents: