Efficacy and Safety of Sofosbuvir/Velpatasvir ± Ribavirin for 12 Weeks in Adults With Chronic HCV Infection and Decompensated Cirrhosis

Gilead Sciences

Status and phase: Completed; Phase 3

Conditions: Hepatitis C Virus Infection

Treatments: Drug: RBV; Drug: SOF/VEL

Study type: Interventional

Funder types: Industry

Identifiers

NCT02996682

GS-US-342-4019

Details and patient eligibility

About

The primary objectives of this study are to evaluate the antiviral efficacy, safety, and tolerability of sofosbuvir/velpatasvir (SOF/VEL) fixed-dose combination (FDC) with or without ribavirin (RBV) for 12 weeks in adults with chronic hepatitis C virus (HCV) infection and decompensated cirrhosis.

Enrollment: 102 patients

Sex: All

Ages: 20+ 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
• Child-Pugh-Turcotte Score 7-12 at screening

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

---

102 participants in 2 patient groups

SOF/VEL

Experimental group

Description:

SOF/VEL for 12 weeks

Treatment:

Drug: SOF/VEL

SOF/VEL + RBV

Experimental group

Description:

SOF/VEL + RBV for 12 weeks

Treatment:

Drug: SOF/VEL

Drug: RBV