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

An Open-Label Study to Evaluate the Safety And Efficacy of Sofosbuvir/Velpatasvir/Voxilaprevir Fixed-Dose Combination for 12 Weeks in Subjects Who Participated in a Prior Gilead-Sponsored HCV Treatment Study

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.

Study Overview

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

• Study Type: Interventional
• Enrollment (Actual): 31
• Phase: Phase 3

Contacts and Locations

Study Locations

• Australia
  • New South Wales
    • Camperdown, New South Wales, Australia, 2050
      • Royal Prince Alfred Hospital
    • Darlinghurst, New South Wales, Australia, 2010
      • Translational Research Centre
• Canada
  • Edmonton, Canada, T6G IZI
    • Kay Edmonton Clinic
  • Toronto, Canada, M5G 2C4
    • Toronto Centre for Liver Disease (TCLD), Toronto General Hospital
• France
  • Rouen cedex, France, 76031
    • Centre Hospitalier Universitaire de Rouen
• Germany
  • Berlin, Germany, 10969
    • Leber- and Studienzentrum am Checkpoint
  • Bonn, Germany, 53127
    • Universitätsklinikum Bonn
• New Zealand
  • Christchurch, New Zealand, 8011
    • Christchurch Clinical Studies Trust, Ltd
  • Auckland
    • Grafton, Auckland, New Zealand, 1010
      • Auckland Clinical Studies Ltd
• United Kingdom
  • London, United Kingdom, SE5 9RS
    • Kings College Hospital NHS Trust
• United States
  • California
    • Los Angeles, California, United States, 90048
      • Cedars Sinai Medical Center
    • Los Angeles, California, United States, 90036
      • Ruane Clinical Research Group Inc.
    • Palo Alto, California, United States, 94304
      • Stanford Hospital and Clinics
    • Rialto, California, United States, 92377
      • Inland Empire Liver Foundation
    • San Diego, California, United States, 92154
      • Kaiser Permanente
  • Colorado
    • Aurora, Colorado, United States, 80045
      • University of Colorado Denver (Leprino Building)
  • Florida
    • Orlando, Florida, United States, 32803
      • Orlando Immunology Center
  • Georgia
    • Atlanta, Georgia, United States, 30308
      • Emory Hospital Midtown Infectious Disease Clinic
    • Marietta, Georgia, United States, 30060
      • Gastrointestinal Specialists of Georgia
  • Missouri
    • Saint Louis, Missouri, United States, 63104
      • Saint Louis University, Gastroenterology & Hepatology, Clinical Research Unit
  • New York
    • New York, New York, United States, 10016
      • NYU Langone Medical Center
    • New York, New York, United States, 10032
      • Columbia University Medical Center/ New York Presbyterian
  • Pennsylvania
    • Pittsburgh, Pennsylvania, United States, 15213
      • Center for Liver Diseases, Oakland
  • Rhode Island
    • Providence, Rhode Island, United States, 02905
      • University Gastroenterology
  • Tennessee
    • Germantown, Tennessee, United States, 38138
      • Gastro One
    • Knoxville, Tennessee, United States, 37920
      • New Orleans Center for Clinical Research
  • Washington
    • Seattle, Washington, United States, 98104
      • University of Washington/Harborview Medical Center

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:

• 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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: NA
• Interventional Model: SINGLE_GROUP
• Masking: NONE

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
EXPERIMENTAL: SOF/VEL/VOX; SOF/VEL/VOX for 12 weeks	Drug: SOF/VEL/VOX; 400/100/100 mg FDC tablet administered orally once daily with food; Other Names: Vosevi®; GS-7997/GS-5816/GS-9857

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 12

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
Change From Baseline in HCV RNA		Baseline; Weeks 2, 4, 8, and 12
Percentage of Participants With HCV RNA < LLOQ On Treatment		Weeks 2, 4, 8, and 12
Percentage of Participants With Virologic Failure	Virologic failure was defined as: On-treatment virologic failure:Breakthrough (confirmed HCV RNA ≥ LLOQ after 2 consecutive HCV RNA < LLOQ), orRebound (confirmed > 1 log10 IU/mL increase in HCV RNA from nadir while on treatment), orNon-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	Up to Posttreatment Week 12

Collaborators and Investigators

• Sponsor: Gilead Sciences

Publications and helpful links

General Publications

• Ruane P, Strasser SJ, Gane EJ, Hyland RH, Shao J, Dvory-Sobol H, et al. Retreatment with Sofosbuvir/Velpatasvir/Voxilaprevir for 12 weeks is safe and effective for patients who have previously received Sofosbuvir/Velpatasvir or Sofosbuvir/Velpatasvir/Voxilaprevir [Abstract LBO-06]. 16th International Symposium on Viral Hepatitis and Liver Diseases (ISVHLD); 2018 14-17 June; Toronto, Canada

Study record dates

Study Major Dates

• Study Start (ACTUAL): April 25, 2017
• Primary Completion (ACTUAL): March 19, 2018
• Study Completion (ACTUAL): March 19, 2018

Study Registration Dates

• First Submitted: April 13, 2017
• First Submitted That Met QC Criteria: April 17, 2017
• First Posted (ACTUAL): April 18, 2017

Study Record Updates

• Last Update Posted (ACTUAL): April 3, 2019
• Last Update Submitted That Met QC Criteria: March 8, 2019
• Last Verified: March 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; Velpatasvir
• Other Study ID Numbers: GS-US-367-4181; 2017-000179-98 (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 https://www.gilead.com/about/ethics-and-code-of-conduct/policies.
• 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; 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