Study to Investigate the Efficacy and Safety of Sofosbuvir/Velpatasvir (SOF/VEL) Fixed-Dose Combination (FDC) and Sofosbuvir/Velpatasvir/Voxilaprevir (SOF/VEL/VOX ) FDC for 12 Weeks in Adults With Chronic Hepatitis C Virus (HCV) Infection

Gilead Sciences

Status and phase: Completed; Phase 3

Conditions: Hepatitis C Virus Infection

Treatments: Drug: SOF/VEL/VOX; Drug: SOF/VEL

Study type: Interventional

Funder types: Industry

Identifiers

NCT04211909

GS-US-342-5532

Details and patient eligibility

About

The primary objectives of this study are to evaluate the antiviral efficacy, safety, and tolerability of therapy with Sofosbuvir/Velpatasvir (SOF/VEL) Fixed-Dose Combination (FDC) and Sofosbuvir/Velpatasvir/Voxilaprevir (SOF/VEL/VOX ) FDC in participants with chronic HCV infection.

Enrollment: 87 patients

Sex: All

Ages: 19+ years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion criteria

Key Inclusion Criteria:

• Chronic HCV infected males and non-pregnant/non-lactating females
• Treatment-naive or treatment-experienced individuals
• Non-cirrhosis or compensated cirrhosis at screening

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

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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87 participants in 2 patient groups

SOF/VEL

Experimental group

Description:

Participants with chronic HCV infection (genotype 1 or 2), who are treatment-naive or treatment-experienced with interferon (IFN)-based treatments will receive SOF/VEL for 12 weeks.

Treatment:

Drug: SOF/VEL

SOF/VEL/VOX

Experimental group

Description:

Participants with chronic HCV infection (genotype 1), who are treatment-experienced with nonstructural protein 5A (NS5A) direct-acting antiviral (DAA)-based treatments of at least 4 weeks duration will receive SOF/VEL/VOX for 12 weeks.

Treatment:

Drug: SOF/VEL/VOX