Safety And Efficacy of Sofosbuvir/Velpatasvir/Voxilaprevir Fixed-Dose Combination for 12 Weeks in Adults Who Participated in a Prior Gilead-Sponsored HCV Treatment Study

Phase 3

Completed

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

• Registration Number: NCT03118843
• Lead Sponsor: Gilead Sciences

Brief Summary

The primary objectives of this study are to determine the efficacy, safety, and tolerability of treatment with sofosbuvir/velpatasvir/voxilaprevir (SOF/VEL/VOX) fixed-dose combination (FDC) for 12 weeks in participants with chronic hepatitis C virus (HCV) infection with or without cirrhosis, who did not achieve sustained viral response (SVR) after receiving prior treatment in a Gilead-sponsored HCV treatment study of direct-acting antiviral (DAA)-containing regimens.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2017-04-13
• Study First Submitted QC: 2017-04-17
• Study First Posted: 2017-04-18
• Study Start: 2017-04-25
• Primary Completion: 2018-03-19
• Study Completion: 2018-03-19
• Status Verified: 2019-03
• Results First Submitted: 2019-03-08
• Results First Submitted QC: 2019-03-08
• Last Update Submitted: 2019-03-08
• Results First Posted: 2019-04-03
• Last Update Posted: 2019-04-03

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 31

Inclusion Criteria

• Chronically HCV-infected males and non-pregnant/non-lactating females aged 18 years or older who did not achieve sustained virologic response (SVR) in a prior Gilead-sponsored HCV treatment study

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

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

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

Primary Outcome Measures

Name	Time	Method
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.
Percentage of Participants Who Permanently Discontinued Any Study Drug Due to an Adverse Event	Up to Week 12

Secondary Outcome Measures

Name	Time	Method
Percentage of Participants With HCV RNA < LLOQ On Treatment	Weeks 2, 4, 8, and 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 2 consecutive HCV RNA \< LLOQ), or; * Rebound (confirmed \> 1 log10 IU/mL increase in HCV RNA from nadir while on treatment), or; * Non-response (HCV RNA persistently ≥ LLOQ through 8 weeks of treatment); * Virologic relapse: Confirmed HCV RNA ≥ LLOQ during the posttreatment period having achieved HCV RNA \< LLOQ at last on-treatment visit
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.
Change From Baseline in HCV RNA	Baseline; Weeks 2, 4, 8, and 12

Trial Locations

Locations (27)

Ruane Clinical Research Group Inc.; 🇺🇸 Los Angeles, California, United States

Stanford Hospital and Clinics; 🇺🇸 Palo Alto, California, United States

Kaiser Permanente; 🇺🇸 San Diego, California, United States

University of Colorado Denver (Leprino Building); 🇺🇸 Aurora, Colorado, United States

Emory Hospital Midtown Infectious Disease Clinic; 🇺🇸 Atlanta, Georgia, United States

Saint Louis University, Gastroenterology & Hepatology, Clinical Research Unit; 🇺🇸 Saint Louis, Missouri, United States

Gastrointestinal Specialists of Georgia; 🇺🇸 Marietta, Georgia, United States

Center for Liver Diseases, Oakland; 🇺🇸 Pittsburgh, Pennsylvania, United States

Columbia University Medical Center/ New York Presbyterian; 🇺🇸 New York, New York, United States

University Gastroenterology; 🇺🇸 Providence, Rhode Island, United States

New Orleans Center for Clinical Research; 🇺🇸 Knoxville, Tennessee, United States

Royal Prince Alfred Hospital; 🇦🇺 Camperdown, New South Wales, Australia

University of Washington/Harborview Medical Center; 🇺🇸 Seattle, Washington, United States

Translational Research Centre; 🇦🇺 Darlinghurst, New South Wales, Australia

Kay Edmonton Clinic; 🇨🇦 Edmonton, Canada

Toronto Centre for Liver Disease (TCLD), Toronto General Hospital; 🇨🇦 Toronto, Canada

Leber- and Studienzentrum am Checkpoint; 🇩🇪 Berlin, Germany

Universitatsklinikum Bonn; 🇩🇪 Bonn, Germany

Auckland Clinical Studies Ltd; 🇳🇿 Grafton, Auckland, New Zealand

Christchurch Clinical Studies Trust, Ltd; 🇳🇿 Christchurch, New Zealand

Kings College Hospital NHS Trust; 🇬🇧 London, United Kingdom

Orlando Immunology Center; 🇺🇸 Orlando, Florida, United States

Cedars Sinai Medical Center; 🇺🇸 Los Angeles, California, United States

NYU Langone Medical Center; 🇺🇸 New York, New York, United States

Gastro One; 🇺🇸 Germantown, Tennessee, United States

Centre Hospitalier Universitaire de Rouen; 🇫🇷 Rouen cedex, France

Inland Empire Liver Foundation; 🇺🇸 Rialto, California, United States