Sofosbuvir/Velpatasvir Fixed Dose Combination in Participants With Chronic Hepatitis C Virus Infection Who Have Received a Liver Transplant

Gilead Sciences

Status and phase: Completed; Phase 2

Conditions: Hepatitis C Virus Infection

Treatments: Drug: SOF/VEL

Study type: Interventional

Funder types: Industry

Identifiers

NCT02781571

GS-US-342-2104

2016-000416-15 (EudraCT Number)

Details and patient eligibility

About

The primary objectives of this study are to evaluate the efficacy, safety, and tolerability of sofosbuvir /velpatasvir (SOF/VEL) fixed-dose combination (FDC) in participants with chronic hepatitis C virus (HCV) who have received a liver transplant.

Enrollment: 79 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion criteria

Key Inclusion Criteria:

• History of chronic HCV infection (≥ 6 months)
• HCV genotype 1, 2, 3, 4, 5, 6, or indeterminate
• Liver transplant ≥ 3 months prior to screening
• Male and nonpregnant/ non-lactating female individuals without cirrhosis or with compensated cirrhosis

Key Exclusion Criteria:

• History of clinically significant illness or any other medical disorder that may interfere with individual's treatment, assessment or compliance with the protocol,
• Co-infection with HIV or hepatitis B virus
• Known hypersensitivity to study medication,
• Use of any prohibited concomitant medications as within with window before the Day 1 visit.
• De novo or recurrent hepatocellular carcinoma posttransplant

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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79 participants in 1 patient group

SOF/VEL

Experimental group

Description:

SOF/VEL FDC for 12 weeks

Treatment:

Drug: SOF/VEL