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

Gilead Sciences

Status and phase

Completed

Phase 2

Conditions

Hepatitis C Virus Infection

Treatments

Drug: RBV

Drug: SOF/VEL

Study type

Interventional

Funder types

Industry

Identifiers

NCT02300103

GS-US-342-1553

Details and patient eligibility

About

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).

Enrollment

69 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

Inclusion and exclusion 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.