Efficacy and Safety of Sofosbuvir/Velpatasvir Fixed Dose Combination for 12 Weeks in Adults With Chronic Hepatitis C Virus (HCV) and Human Immunodeficiency Virus (HIV)-1 Coinfection

• Status: Completed
• Trial end date: 2016-06-22
• 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) for 12 weeks in participants with chronic HCV infection who were coinfected with HIV-1.

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

Details

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

Criteria

Key Inclusion Criteria:

• HCV RNA ≥ 10^4 IU/mL at screening

• HCV genotype 1, 2, 3, 4, 5, 6

• Cirrhosis determination, a fibroscan or liver biopsy may be required

• HIV-1 infection

• Use of protocol specified method(s) of contraception

• Screening laboratory values within defined thresholds

Key Exclusion Criteria:

• Clinically-significant illness (other than HCV or HIV) or any other major medical disorder that may interfere with individual's treatment, assessment or compliance with the protocol

• Current or prior history of clinical hepatic decompensation, hepatocellular carcinoma (HCC) or other malignancy (with the exception of certain resolved skin cancers)

• Screening ECG with clinically significant abnormalities

• Pregnant or nursing female or male with pregnant female partner

• Infection with hepatitis B virus (HBV)

• Use of any prohibited concomitant medications as described in the protocol

• Chronic use of systemically administered immunosuppressive agents

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