Study to Investigate the Efficacy and Safety of Sofosbuvir/Velpatasvir Fixed-Dose Combination for 12 Weeks in Adults With Chronic HCV Infection and Compensated Cirrhosis

Gilead Sciences

Status and phase: Completed; Phase 3

Conditions: Hepatitis C Virus Infection

Treatments: Drug: SOF/VEL

Study type: Interventional

Funder types: Industry

Identifiers

NCT04112303

GS-US-342-5531

JapicCTI-194989 (Registry Identifier)

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) in adults with chronic hepatitis C virus (HCV) infection and compensated cirrhosis.

Enrollment: 37 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion criteria

Key Inclusion Criteria:

• Chronic HCV-infected males and non-pregnant/non-lactating females
• Treatment-naïve or treatment-experienced individuals
• Compensated cirrhosis at Screening

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

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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37 participants in 1 patient group

SOF/VEL

Experimental group

Description:

Participants received SOF/VEL (400/100 mg) orally once daily for up to 12 weeks.

Treatment:

Drug: SOF/VEL