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

Hepatitis C Virus Infection Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03118843
• Other study ID #: GS-US-367-4181
• Secondary ID: 2017-000179-98
• Status: Completed
• Phase: Phase 3
• Start date: April 25, 2017
• Est. completion date: March 19, 2018

Study information

• Verified date: March 2019
• Source: Gilead Sciences
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 31
• Est. completion date: March 19, 2018
• Est. primary completion date: March 19, 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Hepatitis C
• Hepatitis C Virus Infection
• Virus Diseases

Intervention

Drug:
• SOF/VEL/VOX
400/100/100 mg FDC tablet administered orally once daily with food

Locations

Country	Name	City	State
Australia	Royal Prince Alfred Hospital	Camperdown	New South Wales
Australia	Translational Research Centre	Darlinghurst	New South Wales
Canada	Kay Edmonton Clinic	Edmonton
Canada	Toronto Centre for Liver Disease (TCLD), Toronto General Hospital	Toronto
France	Centre Hospitalier Universitaire de Rouen	Rouen cedex
Germany	Leber- and Studienzentrum am Checkpoint	Berlin
Germany	Universitatsklinikum Bonn	Bonn
New Zealand	Christchurch Clinical Studies Trust, Ltd	Christchurch
New Zealand	Auckland Clinical Studies Ltd	Grafton	Auckland
United Kingdom	Kings College Hospital NHS Trust	London
United States	Emory Hospital Midtown Infectious Disease Clinic	Atlanta	Georgia
United States	University of Colorado Denver (Leprino Building)	Aurora	Colorado
United States	Gastro One	Germantown	Tennessee
United States	New Orleans Center for Clinical Research	Knoxville	Tennessee
United States	Cedars Sinai Medical Center	Los Angeles	California
United States	Ruane Clinical Research Group Inc.	Los Angeles	California
United States	Gastrointestinal Specialists of Georgia	Marietta	Georgia
United States	Columbia University Medical Center/ New York Presbyterian	New York	New York
United States	NYU Langone Medical Center	New York	New York
United States	Orlando Immunology Center	Orlando	Florida
United States	Stanford Hospital and Clinics	Palo Alto	California
United States	Center for Liver Diseases, Oakland	Pittsburgh	Pennsylvania
United States	University Gastroenterology	Providence	Rhode Island
United States	Inland Empire Liver Foundation	Rialto	California
United States	Saint Louis University, Gastroenterology & Hepatology, Clinical Research Unit	Saint Louis	Missouri
United States	Kaiser Permanente	San Diego	California
United States	University of Washington/Harborview Medical Center	Seattle	Washington

Sponsors (1)

Lead Sponsor	Collaborator
Gilead Sciences

Countries where clinical trial is conducted

United States,  Australia,  Canada,  France,  Germany,  New Zealand,  United Kingdom, 

References & Publications (1)

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/Voxi

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	Percentage of Participants Who Permanently Discontinued Any Study Drug Due to an Adverse Event		Up to Week 12
Secondary	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
Secondary	Percentage of Participants With HCV RNA < LLOQ On Treatment		Weeks 2, 4, 8, and 12
Secondary	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), 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	Up to Posttreatment Week 12
Secondary	Change From Baseline in HCV RNA		Baseline; Weeks 2, 4, 8, and 12