Efficacy and Safety of Sofosbuvir/Velpatasvir Fixed Dose Combination for 12 Weeks in Participants With Chronic HCV

• Status: Completed
• Trial end date: 2018-03-27
• Target enrollment: 0
• Participant gender: All

Summary

The primary objectives of this study are to evaluate the efficacy, safety, and tolerability of treatment with sofosbuvir (SOF)/velpatasvir (VEL; GS-5816) fixed-dose combination (FDC) for 12 weeks in participants with chronic hepatitis C virus (HCV) infection.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

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

Criteria

Key Inclusion Criteria:

• Willing and able to provide written informed consent

• HCV RNA ≥ 10^4 IU/mL at screening

• Chronic HCV infection (≥ 6 months) documented by prior medical history or liver biopsy

• Any HCV genotype (1, 2, 3, 4, 5, 6 or indeterminate)

• HCV treatment-naive or treatment-experienced

• Liver imaging within 6 months of Day 1 is required in cirrhotic patients only to exclude hepatocellular carcinoma (HCC)

Key Exclusion Criteria:

• Current or prior history of clinically-significant illness (other than HCV), gastrointestinal disorder, clinical hepatic decompensation, or post-operative condition that could interfere with the absorption of the study drug

• Pregnant or nursing female or male with pregnant female partner

• Chronic liver disease of a non HCV etiology

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

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