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

Hepatitis C Virus Infection Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02822794
• Other study ID #: GS-US-342-3921
• Status: Completed
• Phase: Phase 3
• Start date: July 25, 2016
• Est. completion date: August 25, 2017

Study information

• Verified date: July 2018
• Source: Gilead Sciences
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 117
• Est. completion date: August 25, 2017
• Est. primary completion date: June 2, 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 20 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Communicable Diseases
• Hepatitis
• Hepatitis C
• Hepatitis C Virus Infection
• Infection
• Virus Diseases

Intervention

Drug:
• SOF/VEL
400/100 mg tablet administered orally once daily
• 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)

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Gilead Sciences

Country where clinical trial is conducted

Japan, 

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 24 weeks
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 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
Secondary	Percentage of Participants With HCV RNA < LLOQ at Week 1		Week 1
Secondary	Percentage of Participants With HCV RNA < LLOQ at Week 2		Week 2
Secondary	Percentage of Participants With HCV RNA < LLOQ at Week 3		Week 3
Secondary	Percentage of Participants With HCV RNA < LLOQ at Week 4		Week 4
Secondary	Percentage of Participants With HCV RNA < LLOQ at Week 5		Week 5
Secondary	Percentage of Participants With HCV RNA < LLOQ at Week 6		Week 6
Secondary	Percentage of Participants With HCV RNA < LLOQ at Week 8		Week 8
Secondary	Percentage of Participants With HCV RNA < LLOQ at Week 10		Week 10
Secondary	Percentage of Participants With HCV RNA < LLOQ at Week 12		Week 12
Secondary	Percentage of Participants With HCV RNA < LLOQ at Week 16		Week 16
Secondary	Percentage of Participants With HCV RNA < LLOQ at Week 20		Week 20
Secondary	Percentage of Participants With HCV RNA < LLOQ at Week 24		Week 24
Secondary	Change From Baseline in HCV RNA at Week 1		Baseline; Week 1
Secondary	Change From Baseline in HCV RNA at Week 2		Baseline; Week 2
Secondary	Change From Baseline in HCV RNA at Week 3		Baseline; Week 3
Secondary	Change From Baseline in HCV RNA at Week 4		Baseline; Week 4
Secondary	Change From Baseline in HCV RNA at Week 5		Baseline; Week 5
Secondary	Change From Baseline in HCV RNA at Week 6		Baseline; Week 6
Secondary	Change From Baseline in HCV RNA at Week 8		Baseline; Week 8
Secondary	Change From Baseline in HCV RNA at Week 10		Baseline; Week 10
Secondary	Change From Baseline in HCV RNA at Week 12		Baseline; Week 12
Secondary	Change From Baseline in HCV RNA at Week 16		Baseline; Week 16
Secondary	Change From Baseline in HCV RNA at Week 20		Baseline; Week 20
Secondary	Change From Baseline in HCV RNA at Week 24		Baseline; Week 24
Secondary	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), 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 24