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

A Phase 3, Open-Label Study to Investigate the Efficacy and Safety of Sofosbuvir/GS-5816 Fixed Dose Combination for 12 Weeks in Subjects With Chronic Hepatitis C Virus (HCV) and Human Immunodeficiency Virus (HIV)-1 Coinfection

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.

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.