Safety and Efficacy of Sofosbuvir/Velpatasvir/Voxilaprevir and Sofosbuvir/Velpatasvir in Adults With Chronic HCV Infection Who Have Not 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 16, 2015
End Date:January 11, 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 8 Weeks Compared to Sofosbuvir/Velpatasvir for 12 Weeks in Direct-Acting Antiviral-Naïve Subjects With Chronic HCV Infection

The primary objectives of this study are to compare the efficacy, safety, and tolerability of
treatment with sofosbuvir/velpatasvir/voxilaprevir (SOF/VEL/VOX) fixed dose combination (FDC)
for 8 weeks with that of SOF/VEL FDC for 12 weeks in direct-acting antiviral-naive
participants with chronic hepatitis C virus (HCV) infection.


Key Inclusion Criteria:

- Willing and able to provide written informed consent

- HCV RNA ≥ 10^4 IU/mL at screening

- Chronic HCV infection (≥ 6 months)

- HCV treatment naive or treatment experienced with an interferon (IFN)-based regimen

- 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 parameters outside the acceptable range 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.
We found this trial at
48
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