Safety and Efficacy of Sofosbuvir/Velpatasvir/Voxilaprevir in Adults With Chronic HCV Infection Who Have Previously Received Treatment With Direct-Acting Antiviral Therapy



Status:Completed
Conditions:Infectious Disease, Hepatitis
Therapuetic Areas:Immunology / Infectious Diseases
Healthy:No
Age Range:18 - Any
Updated:3/7/2019
Start Date:November 11, 2015
End Date:June 21, 2017

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A Phase 3, Global, Multicenter, Randomized, Double-Blind, Placebo-Controlled Study to Investigate the Safety and Efficacy of Sofosbuvir/Velpatasvir/GS-9857 Fixed-Dose Combination for 12 Weeks in Direct-Acting Antiviral-Experienced Subjects With Chronic HCV Infection

The primary objectives of this study are to evaluate the safety and efficacy of treatment
with sofosbuvir/velpatasvir/voxilaprevir (SOF/VEL/VOX) in adults with chronic hepatitis C
virus (HCV) infection who have previously received treatment with direct-acting antiviral
therapy.

Participants randomized to placebo may be eligible for deferred treatment with active
SOF/VEL/VOX.


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 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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