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



Status:Completed
Conditions:Infectious Disease, Infectious Disease, Hepatitis
Therapuetic Areas:Immunology / Infectious Diseases
Healthy:No
Age Range:18 - Any
Updated:3/7/2019
Start Date:December 23, 2015
End Date:January 18, 2017

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A Phase 3, Global, Multicenter, Randomized, Open-Label Study to Investigate the Safety and Efficacy of Sofosbuvir/Velpatasvir/GS-9857 Fixed-Dose Combination for 12 Weeks and Sofosbuvir/Velpatasvir for 12 Weeks in Direct-Acting Antiviral-Experienced Subjects 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.
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47
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