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

• Status: Completed
• Trial end date: 2016-06-15
• 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/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.

• 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

• 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.