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

Phase 2

Completed

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

• Registration Number: NCT02781571
• Lead Sponsor: Gilead Sciences

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2016-05-20
• Study First Submitted QC: 2016-05-20
• Study First Posted: 2016-05-24
• Study Start: 2016-07-27
• Primary Completion: 2017-07-28
• Study Completion: 2017-07-28
• Status Verified: 2018-07
• Results First Submitted: 2018-07-25
• Results First Submitted QC: 2018-07-25
• Results First Posted: 2018-08-21
• Last Update Submitted: 2018-10-19
• Last Update Posted: 2018-11-14

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 79

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
SOF/VEL	SOF/VEL	SOF/VEL FDC for 12 weeks

Primary Outcome Measures

Name	Time	Method
Percentage of Participants Who Prematurely Discontinued Study Drug Due to Any Adverse Event	Up to 12 weeks
Percentage of Participants With Sustained Virologic Response (SVR) 12 Weeks After Cessation of Therapy (SVR12)	Posttreatment Week 12	SVR12 was defined as HCV RNA \< the lower limit of quantitation (LLOQ) at 12 weeks after stopping study treatment.

Secondary Outcome Measures

Name	Time	Method
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	Up to Posttreatment Week 12	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
Percentage of Participants With HCV RNA < LLOQ at Week 2	Week 2
Percentage of Participants With Sustained Virologic Response 4 Weeks After Cessation 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 at Week 4	Week 4
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
Percentage of Participants With HCV RNA < LLOQ at Week 8	Week 8

Trial Locations

Locations (15)

Hospital Ramón Y Cajal; 🇪🇸 Madrid, Spain

La Fe Hospital; 🇪🇸 Valencia, Spain

Hospital Clínic de Barcelona; 🇪🇸 Barcelona, Spain

Hospital General Universitario Gregorio Maranon; 🇪🇸 Madrid, Spain

Hospital Universitari Vall d'Hebron; 🇪🇸 Barcelona, Spain

Hospital Clinico Zaragoza; 🇪🇸 Zaragoza, Spain

Royal Infirmary of Edinburgh; 🇬🇧 Edinburgh, United Kingdom

St James University Hospital; 🇬🇧 Leeds, United Kingdom

Hospital Universitario Virgen del Rocío; 🇪🇸 Sevilla, Spain

Reina Sofía University Hospital; 🇪🇸 Córdoba, Spain

Royal Free Hampstead NHS Trust; 🇬🇧 London, United Kingdom

Cambridge University Hospitals NHS Foundation Trust; 🇬🇧 Cambridge, United Kingdom

Kings College Hospital; 🇬🇧 London, United Kingdom

Universität Bern; 🇨🇭 Bern, Switzerland

University Hospital Zurich; 🇨🇭 Zürich, Switzerland