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

A Phase 2, Open-Label Study to Investigate the Safety and Efficacy of Sofosbuvir/Velpatasvir Fixed Dose Combination Administered for Four Weeks in Patients Infected With Chronic HCV in the Peri-Operative Liver Transplantation Setting

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.

Study Overview

• Status: Completed
• Conditions: Hepatitis C Virus Infection
• Intervention / Treatment: Drug: SOF/VEL

• Study Type: Interventional
• Enrollment (Actual): 9
• Phase: Phase 2

Contacts and Locations

Study Locations

• New Zealand
  • Auckland, New Zealand

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Key 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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: SOF/VEL; SOF/VEL FDC for 4 weeks starting on the day of or day after the participant's liver transplant	Drug: SOF/VEL; 400/100 mg FDC tablet administered orally once daily; Other Names: Epclusa®; GS-7977/GS-5816

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Percentage of Participants With SVR at 4 Weeks After Discontinuation of Therapy (SVR4)	SVR4 was defined as HCV RNA < LLOQ at 4 weeks after stopping study treatment.	Posttreatment Week 4
Percentage of Participants With HCV RNA < LLOQ On Treatment		Days 3, 5, 7, 14, 21, and 28
Percentage of Participants With Overall Virologic Failure	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.	Up to Posttreatment Week 12

Collaborators and Investigators

• Sponsor: Gilead Sciences

Study record dates

Study Major Dates

• Study Start (Actual): June 12, 2016
• Primary Completion (Actual): January 16, 2018
• Study Completion (Actual): January 16, 2018

Study Registration Dates

• First Submitted: March 31, 2016
• First Submitted That Met QC Criteria: March 31, 2016
• First Posted (Estimate): April 5, 2016

Study Record Updates

• Last Update Posted (Actual): February 6, 2019
• Last Update Submitted That Met QC Criteria: February 5, 2019
• Last Verified: February 1, 2019

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Digestive System Diseases; RNA Virus Infections; Virus Diseases; Infections; Blood-Borne Infections; Communicable Diseases; Liver Diseases; Flaviviridae Infections; Hepatitis, Viral, Human; Hepatitis; Hepatitis C; Anti-Infective Agents; Antiviral Agents; Sofosbuvir; Sofosbuvir-velpatasvir drug combination; Velpatasvir
• Other Study ID Numbers: GS-US-342-2083

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: Yes
• IPD Plan Description: Qualified external researchers may request IPD for this study after study completion. For more information, please visit our website at http://www.gilead.com/research/disclosure-and-transparency.
• IPD Sharing Time Frame: 18 months after study completion
• IPD Sharing Access Criteria: A secured external environment with username, password, and RSA code.
• IPD Sharing Supporting Information Type: Study Protocol; Statistical Analysis Plan (SAP)

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: Yes