Sofosbuvir/Velpatasvir Fixed-Dose Combination in HCV-Infected Adults Who Are Undergoing Liver Transplantation

Phase 2

Completed

• Conditions: Hepatitis C Virus Infection
• Interventions: Drug: SOF/VEL

• Registration Number: NCT02728206
• Lead Sponsor: Gilead Sciences

Brief Summary

The primary objectives of this study are to evaluate the antiviral efficacy, safety, and tolerability of sofosbuvir/velpatasvir (SOF/VEL) fixed-dose combination (FDC) in hepatitis C virus (HCV)-infected adults who are undergoing liver transplantation.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2016-03-31
• Study First Submitted QC: 2016-03-31
• Study First Posted: 2016-04-05
• Study Start: 2016-06-12
• Primary Completion: 2018-01-16
• Study Completion: 2018-01-16
• Results First Submitted: 2019-01-07
• Status Verified: 2019-02
• Results First Submitted QC: 2019-02-05
• Last Update Submitted: 2019-02-05
• Results First Posted: 2019-02-06
• Last Update Posted: 2019-02-06

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 9

Inclusion Criteria

• HCV-infected, male and non-pregnant/non-lactating females, who are undergoing liver transplantation

Key

Exclusion Criteria

• Receiving an HCV-infected liver
• HIV or hepatitis B virus (HBV) co-infected

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
SOF/VEL	SOF/VEL	SOF/VEL FDC for 4 weeks starting on the day of or day after the participant's liver transplant

Primary Outcome Measures

Name	Time	Method
Percentage of Participants Who Permanently Discontinued Any Study Drug Due to an Adverse Event	Up to Week 4
Percentage of Participants With Sustained Virologic Response (SVR) 12 Weeks After Discontinuation of Therapy (SVR12)	Posttreatment Week 12	SVR12 was defined as HCV RNA \< the lower limit of quantitation (LLOQ; ie, 15 IU/mL) at 12 weeks after stopping study treatment.

Secondary Outcome Measures

Name	Time	Method
Percentage of Participants With SVR at 4 Weeks After Discontinuation of Therapy (SVR4)	Posttreatment Week 4	SVR4 was defined as HCV RNA \< LLOQ at 4 weeks after stopping study treatment.
Percentage of Participants With HCV RNA < LLOQ On Treatment	Days 3, 5, 7, 14, 21, and 28
Percentage of Participants With Overall Virologic Failure	Up to Posttreatment Week 12	Virologic failure was defined as 1) End of Treatment Virologic Failure: HCV RNA ≥ 15 IU/mL at last observed HCV RNA measurement on or prior to last dose date of SOF/VEL + 3 days after completion of 28 ± 3 days of SOF/VEL treatment, or 2) Relapse: HCV RNA ≥ 15 IU/mL during the posttreatment follow-up period having achieved HCV RNA \< 15 IU/mL at the end of treatment, confirmed with 2 consecutive values or last available posttreatment measurement.