Sofosbuvir/Velpatasvir Fixed-Dose Combination and Ribavirin for 12 or 24 Weeks in Participants With Chronic Genotype 1 or 2 Hepatitis C Virus Infection Who Have Previously Failed a Direct-Acting Antiviral-Containing Regimen

A Phase 3, Multicenter, Randomized, Open-Label Study to Investigate the Efficacy and Safety of Sofosbuvir/Velpatasvir Fixed-Dose Combination and Ribavirin for 12 or 24 Weeks in Subjects With Chronic Genotype 1 or 2 HCV Infection Who Have Previously Failed a Direct-Acting Antiviral-Containing Regimen

The primary objective of this study is to evaluate the antiviral efficacy, safety, and tolerability of therapy with sofosbuvir/velpatasvir (SOF/VEL) fixed-dose combination (FDC) and ribavirin (RBV) in participants with chronic genotype 1 or 2 hepatitis C virus (HCV) infection who have previously failed a direct-acting antiviral (DAA)-containing regimen.

Study Overview

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

• Study Type: Interventional
• Enrollment (Actual): 117
• Phase: Phase 3

Contacts and Locations

Study Locations

• Japan
  • Ehime, Japan
  • Hiroshima, Japan
  • Ichikawa-shi, Japan
  • Iruma-gun, Japan
  • Kashihara, Japan
  • Kurume-shi, Japan
  • Kyoto, Japan
  • Maebashi, Japan
  • Musashino-shi, Japan
  • Nagoya, Japan
  • Nishinomiya, Japan
  • Ogaki City, Japan
  • Okayama, Japan
  • Omura, Japan
  • Sapporo, Japan
  • Suita, Japan
  • Takamatsu-shi, Japan
  • Yamagata, Japan

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 20 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Key Inclusion Criteria:

• Genotype 1 or 2 HCV infection
• Chronic HCV infection (≥ 6 months prior to screening) documented by prior medical history or liver biopsy
• Previously treated with a DAA-containing regimen of at least 4 week duration

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: SOF/VEL FDC + RBV 12 weeks; SOF/VEL FDC + RBV for 12 weeks in participants with genotype 1 or 2 HCV infection	Drug: SOF/VEL; 400/100 mg tablet administered orally once daily; Other Names: Epclusa®; GS-7977/GS-5816; Drug: RBV; Capsules administered orally in a divided daily dose according to package insert weight-based dosing recommendations (≤ 60 kg = 600 mg, > 60 kg to ≤ 80 kg = 800 mg, and ≥ 80 kg = 1000 mg); Other Names: REBETOL®
Experimental: SOF/VEL FDC + RBV 24 weeks; SOF/VEL FDC + RBV for 24 weeks in participants with genotype 1 or 2 HCV infection	Drug: SOF/VEL; 400/100 mg tablet administered orally once daily; Other Names: Epclusa®; GS-7977/GS-5816; Drug: RBV; Capsules administered orally in a divided daily dose according to package insert weight-based dosing recommendations (≤ 60 kg = 600 mg, > 60 kg to ≤ 80 kg = 800 mg, and ≥ 80 kg = 1000 mg); Other Names: REBETOL®

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 24 weeks

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
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 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
Percentage of Participants With HCV RNA < LLOQ at Week 1		Week 1
Percentage of Participants With HCV RNA < LLOQ at Week 6		Week 6
Percentage of Participants With HCV RNA < LLOQ at Week 16		Week 16
Percentage of Participants With HCV RNA < LLOQ at Week 20		Week 20
Percentage of Participants With HCV RNA < LLOQ at Week 24		Week 24
Percentage of Participants With Overall Virologic Failure	Virologic failure was defined as: On-treatment virologic failure:Breakthrough (confirmed HCV RNA ≥ LLOQ after having previously had HCV RNA < LLOQ while on treatment), 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 24
Change From Baseline in HCV RNA at Week 1		Baseline; Week 1
Change From Baseline in HCV RNA at Week 6		Baseline; Week 6
Percentage of Participants With SVR at 24 Weeks After Discontinuation of Therapy (SVR24)	SVR 24 was defined as HCV RNA < LLOQ at 24 weeks after stopping study treatment.	Posttreatment Week 24
Percentage of Participants With HCV RNA < LLOQ at Week 3		Week 3
Percentage of Participants With HCV RNA < LLOQ at Week 5		Week 5
Percentage of Participants With HCV RNA < LLOQ at Week 10		Week 10
Change From Baseline in HCV RNA at Week 3		Baseline; Week 3
Change From Baseline in HCV RNA at Week 5		Baseline; Week 5
Change From Baseline in HCV RNA at Week 10		Baseline; Week 10
Change From Baseline in HCV RNA at Week 16		Baseline; Week 16
Change From Baseline in HCV RNA at Week 20		Baseline; Week 20
Change From Baseline in HCV RNA at Week 24		Baseline; Week 24

Collaborators and Investigators

• Sponsor: Gilead Sciences

Study record dates

Study Major Dates

• Study Start (Actual): July 25, 2016
• Primary Completion (Actual): June 2, 2017
• Study Completion (Actual): August 25, 2017

Study Registration Dates

• First Submitted: June 30, 2016
• First Submitted That Met QC Criteria: June 30, 2016
• First Posted (Estimate): July 4, 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; Molecular Mechanisms of Pharmacological Action; Anti-Infective Agents; Antiviral Agents; Antimetabolites; Sofosbuvir; Sofosbuvir-velpatasvir drug combination; Velpatasvir; Ribavirin
• Other Study ID Numbers: GS-US-342-3921

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; 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