Safety and Efficacy of Voxilaprevir Plus Sofosbuvir/Velpatasvir Fixed Dose Combination in Adults With Chronic Genotype 1 HCV Infection

• Status: Completed
• Trial end date: 2016-04-12
• Target enrollment: 0
• Participant gender: All

Summary

This primary objectives of the study are to evaluate the safety, tolerability, and efficacy of voxilaprevir (VOX) plus sofosbuvir/velpatasvir (SOF/VEL) fixed dose combination (FDC) ± ribavirin (RBV) in adults with chronic genotype 1 hepatitis C virus (HCV) infection.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Gilead Sciences
• Treatments: Sofosbuvir; Sofosbuvir-velpatasvir drug combination; Velpatasvir

Criteria

Key Inclusion Criteria:

• Individuals with chronic HCV infection

• HCV RNA ≥10^4 IU/mL at screening

• HCV genotype 1

• Cirrhosis determination; a liver biopsy may be required

• Screening laboratory values within defined thresholds

• Use of two contraception methods if female of childbearing potential or sexually active male

Key Exclusion Criteria:

• Pregnant or nursing female

• Current or prior history of hepatic decompensation

• Hepatocellular carcinoma (HCC) or other clinically significant malignancy

• Infection with hepatitis B virus (HBV) or human immunodeficiency virus (HIV)

• History of clinically significant illness or any other medical disorder that may interfere with the individual's treatment, assessment or compliance with the protocol

NOTE: Other protocol defined Inclusion/Exclusion criteria may apply.