Efficacy And Safety Of Sofosbuvir/Velpatasvir Fixed Dose Combination With Ribavirin in Chronic HCV Infected Adults Who Participated in a Prior Gilead Sponsored HCV Treatment Study

• Status: Completed
• Trial end date: 2016-09-15
• Target enrollment: 0
• Participant gender: All

Summary

The primary objective of this study is to evaluate the efficacy, safety and tolerability of treatment with sofosbuvir/velpatasvir (Epclusa®; SOF/VEL) with ribavirin (RBV) for 24 weeks in adults with chronic hepatitis C virus (HCV) infection who participated in a prior Gilead sponsored study and did not achieve sustained virologic response (SVR).

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

Details

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

Criteria

Key Inclusion Criteria:

• Willing and able to provide written informed consent

• HCV genotype determined by the Central Laboratory

• HCV RNA > LLOQ at screening

• Participated and completed a Gilead sponsored HCV treatment study of direct acting antiviral (DAA) containing regimens.

• Male and female of childbearing potential must agree to use protocol specified method(s) of contraception

Key Exclusion Criteria:

• Current or prior history: Clinically-significant illness (other than HCV) or any other major medical disorder that may interfere with treatment, assessment or compliance with the protocol; individuals currently under evaluation for a potentially clinically-significant illness (other than HCV) are also excluded.

• Screening ECG with clinically significant abnormalities

• Laboratory results outside of acceptable ranges at screening

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

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