Study to Evaluate the Pharmacokinetics of Velpatasvir in Participants With Normal Renal Function and Severe Renal Impairment

A Phase 1, Open-Label, Parallel-Group, Single-Dose Study to Evaluate the Pharmacokinetics of GS-5816 in Subjects With Normal Renal Function and Severe Renal Impairment

The primary objective of the study is to evaluate the single-dose pharmacokinetics (PK) of velpatasvir (formerly GS-5816) in participants with severe renal impairment using matched healthy participants as a control group.

Key Inclusion Criteria:

• General good health with stable chronic kidney disease in Severe Renal Impairment Group
• Screening labs within defined thresholds
• Creatinine clearance must be < 30 mL/min for Severe Renal Impairment group, and ≥ 90 mL/min for Normal Renal Function group

Key Exclusion Criteria:

• Females who are pregnant or nursing, or males who have a pregnant partner
• Infection with hepatitis B virus (HBV), hepatitis C virus (HCV) or HIV
• History of clinically significant illness (including psychiatric or cardiac) or any other medical disorder that may interfere with participant treatment and/or adherence to the protocol

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