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

A Phase 2, Multicenter, Open-Label Study to Evaluate the Efficacy and Safety of Sofosbuvir/Velpatasvir Fixed Dose Combination in Subjects With Chronic HCV Infection Who Have Received a Liver Transplant

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.

Study Overview

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

• Study Type: Interventional
• Enrollment (Actual): 79
• Phase: Phase 2

Contacts and Locations

Study Locations

• Spain
  • Barcelona, Spain
    • Hospital Clinic De Barcelona
  • Barcelona, Spain
    • Hospital Universitari Vall d'Hebron
  • Córdoba, Spain
    • Reina Sofia University Hospital
  • Madrid, Spain
    • Hospital General Universitario Gregorio Marañon
  • Madrid, Spain
    • Hospital Ramón y Cajal
  • Sevilla, Spain
    • Hospital Universitario Virgen del Rocío
  • Valencia, Spain
    • La Fe Hospital
  • Zaragoza, Spain
    • Hospital Clinico Zaragoza
• Switzerland
  • Bern, Switzerland
    • Universität Bern
  • Zürich, Switzerland
    • University Hospital Zurich
• United Kingdom
  • Cambridge, United Kingdom
    • Cambridge University Hospitals NHS Foundation Trust
  • Edinburgh, United Kingdom
    • Royal Infirmary of Edinburgh
  • Leeds, United Kingdom
    • St James University Hospital
  • London, United Kingdom
    • Kings College Hospital
  • London, United Kingdom
    • Royal Free Hampstead NHS Trust

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:

• 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.

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 12 weeks	Drug: SOF/VEL; 400/100 mg 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 Cessation of Therapy (SVR12)	SVR12 was defined as HCV RNA < the lower limit of quantitation (LLOQ) at 12 weeks after stopping study treatment.	Posttreatment Week 12
Percentage of Participants Who Prematurely Discontinued Study Drug Due to Any Adverse Event		Up to 12 weeks

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Percentage of Participants With Sustained Virologic Response 4 Weeks After Cessation 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 at Week 2		Week 2
Percentage of Participants With HCV RNA < LLOQ at Week 4		Week 4
Percentage of Participants With HCV RNA < LLOQ at Week 8		Week 8
Percentage of Participants With HCV RNA < LLOQ at Week 12		Week 12
HCV RNA at Week 2		Week 2
HCV RNA at Week 4		Week 4
HCV RNA at Week 8		Week 8
HCV RNA at Week 12		Week 12
Change From Baseline in HCV RNA at Week 2		Baseline; Week 2
Change From Baseline in HCV RNA at Week 4		Baseline; Week 4
Change From Baseline in HCV RNA at Week 8		Baseline; Week 8
Change From Baseline in HCV RNA at Week 12		Baseline; Week 12
Percentage of Participants With Virologic Failure	Virologic failure was defined as On-treatment virologic failure: Breakthrough (confirmed HCV RNA ≥ LLOQ after having previously had HCV RNA < LLOQ on 2 consecutive measurements while on treatment), or; Rebound (confirmed > 1 log10 IU/mL increase in HCV RNA from nadir while on treatment), or; Non-response (HCV RNA persistently ≥ LLOQ through 12 weeks of treatment) Virologic relapse: HCV RNA ≥ LLOQ during the post-treatment period having achieved HCV RNA < LLOQ at end of treatment, confirmed with 2 consecutive values or last available post-treatment measurement	Up to Posttreatment Week 12

Collaborators and Investigators

• Sponsor: Gilead Sciences

Publications and helpful links

General Publications

• Agarwal K, Castells L, Mullhaupt B, Rosenberg WMC, McNabb B, Arterburn S, Camus G, McNally J, Stamm LM, Brainard DM, Mani Subramanian G, Marino Z, Dufour JF, Forns X. Sofosbuvir/velpatasvir for 12 weeks in genotype 1-4 HCV-infected liver transplant recipients. J Hepatol. 2018 Sep;69(3):603-607. doi: 10.1016/j.jhep.2018.05.039. Epub 2018 Jun 8.

Study record dates

Study Major Dates

• Study Start (Actual): July 27, 2016
• Primary Completion (Actual): July 28, 2017
• Study Completion (Actual): July 28, 2017

Study Registration Dates

• First Submitted: May 20, 2016
• First Submitted That Met QC Criteria: May 20, 2016
• First Posted (Estimate): May 24, 2016

Study Record Updates

• Last Update Posted (Actual): November 14, 2018
• Last Update Submitted That Met QC Criteria: October 19, 2018
• Last Verified: July 1, 2018

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Digestive System Diseases; Pathologic Processes; RNA Virus Infections; Blood-Borne Infections; Disease Attributes; Liver Diseases; Flaviviridae Infections; Hepatitis, Viral, Human; Enterovirus Infections; Picornaviridae Infections; Infections; Communicable Diseases; Hepatitis; Hepatitis A; Hepatitis C; Virus Diseases; Anti-Infective Agents; Antiviral Agents; Sofosbuvir; Sofosbuvir-velpatasvir drug combination; Velpatasvir
• Other Study ID Numbers: GS-US-342-2104; 2016-000416-15 (EudraCT Number)

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