Sofosbuvir/Velpatasvir Fixed-Dose Combination in Adults With Chronic HCV Infection

Gilead Sciences

Status and phase

Completed

Phase 3

Conditions

Hepatitis C Virus Infection

Treatments

Drug: SOF/VEL

Study type

Interventional

Funder types

Industry

Identifiers

NCT02346721

2014-003898-42 (EudraCT Number)

GS-US-342-1446

Details and patient eligibility

About

The primary objectives of this study are to evaluate the efficacy, safety, and tolerability of treatment with sofosbuvir/velpatasvir (SOF/VEL) in participants with chronic genotype 1, 2, 4, 6 or indeterminate HCV infection who received placebo in the Gilead-sponsored study GS-US-342-1138.

Enrollment

111 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
Chronic HCV infection (≥ 6 months) documented by prior medical history or liver biopsy
Was administered placebo to match SOF/VEL in Gilead study GS-US-342-1138
HCV RNA ≥ 10^4 IU/mL at screening
Classification as treatment naive or treatment experienced
Males and females of childbearing potential who engage in heterosexual intercourse must agree to use protocol specified method(s) of contraception

Key Exclusion Criteria:

Current or prior history of 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 electrocardiogram (ECG) with clinically significant abnormalities
Laboratory results outside of acceptable ranges at screening
Prior exposure to SOF or other nucleotide analogue HCV NS5B inhibitor or any HCV NS5A inhibitor
Infection with hepatitis B virus (HBV) or human immunodeficiency virus (HIV)

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