Safety and Efficacy of Sofosbuvir/Velpatasvir/Voxilaprevir Fixed-Dose Combination With or Without Ribavirin in Participants With Chronic Genotype 1 HCV Infection Previously Treated With a Direct Acting Antiviral Regimen
| Status: | Completed |
|---|---|
| Conditions: | Infectious Disease, Infectious Disease, Hepatitis |
| Therapuetic Areas: | Immunology / Infectious Diseases |
| Healthy: | No |
| Age Range: | 18 - Any |
| Updated: | 2/27/2019 |
| Start Date: | July 29, 2015 |
| End Date: | June 28, 2016 |
A Phase 2, Open-Label Study to Investigate the Safety and Efficacy of Sofosbuvir/GS-5816/GS-9857 Fixed-Dose Combination With or Without Ribavirin in Subjects With Chronic Genotype 1 HCV Infection Previously Treated With a Direct Acting Antiviral Regimen
The primary objective of this study is to evaluate the efficacy, safety, and tolerability of
the treatment with sofosbuvir/velpatasvir/voxilaprevir (SOF/VEL/VOX) fixed dose combination
(FDC) ± ribavirin (RBV) in participants with chronic genotype 1 hepatitis C virus (HCV)
infection and prior treatment experience with a direct acting antiviral (DAA).
the treatment with sofosbuvir/velpatasvir/voxilaprevir (SOF/VEL/VOX) fixed dose combination
(FDC) ± ribavirin (RBV) in participants with chronic genotype 1 hepatitis C virus (HCV)
infection and prior treatment experience with a direct acting antiviral (DAA).
Key Inclusion Criteria:
- Individuals with chronic HCV genotype 1 infection
- Documented as treatment experienced with a direct acting antiviral-containing regimen
without achieving sustained viral response
- Absence of cirrhosis or presence of compensated cirrhosis
- Screening laboratory values within defined thresholds
- Must use specific contraceptive methods if female of childbearing potential or
sexually active male
Key Exclusion Criteria:
- Co-infection with HIV or hepatitis B virus (HBV)
- Current or prior history of clinical hepatic decompensation
- Chronic use of systemic immunosuppressive agents
- History of clinically significant illness or any other medical disorder that may
interfere with individual's treatment, assessment or compliance with the protocol
- Pregnant or a nursing female
Note: Other protocol defined Inclusion/Exclusion criteria may apply.
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