Safety and Efficacy of SOF/VEL/VOX FDC for 12 Weeks and SOF/VEL for 12 Weeks in DAA-Experienced Adults With Chronic HCV Infection Who Have Not Received an NS5A Inhibitor
Safety and Efficacy of SOF/VEL/VOX FDC for 12 Weeks and SOF/VEL for 12 Weeks in DAA-Experienced Adults With Chronic HCV Infection Who Have Not Received an NS5A Inhibitor
The primary objectives of the study are to evaluate the efficacy, safety, and tolerability of
 treatment with sofosbuvir/velpatasvir/voxilaprevir (Vosevi®; SOF/VEL/VOX) fixed-dose
 combination (FDC) for 12 weeks and of sofosbuvir/velpatasvir (Epclusa®; SOF/VEL) FDC for 12
 weeks in direct-acting antiviral (DAA)-experienced adults with chronic hepatitis C virus
 (HCV) infection with or without cirrhosis who have not received prior treatment with a
 regimen containing an inhibitor of the HCV NS5A protein.
Key Inclusion Criteria:

 -  Willing and able to provide written informed consent

 -  HCV RNA ≥ 10^4 IU/mL at screening

 -  Chronic HCV infection (≥ 6 months)

 -  Treatment experienced with a direct acting antiviral medication not including a NS5A
 Inhibitor for HCV

 -  Use of protocol specified methods of contraception

 Key Exclusion Criteria:

 -  Current or prior history of clinically significant illness that may interfere with
 participation in the study

 -  Screening ECG with clinically significant abnormalities

 -  Laboratory results outside of acceptable ranges at screening

 -  Pregnant or nursing female

 -  Chronic liver disease not caused by HCV

 -  Infection with hepatitis B virus (HBV) or human immunodeficiency virus (HIV)

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