Efficacy And Safety Of Sofosbuvir/Velpatasvir Fixed Dose Combination With Ribavirin in Chronic HCV Infected Adults Who Participated in a Prior Gilead Sponsored HCV Treatment Study

Phase 2

Completed

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

• Registration Number: NCT02300103
• Lead Sponsor: Gilead Sciences

Brief Summary

The primary objective of this study is to evaluate the efficacy, safety and tolerability of treatment with sofosbuvir/velpatasvir (Epclusa®; SOF/VEL) with ribavirin (RBV) for 24 weeks in adults with chronic hepatitis C virus (HCV) infection who participated in a prior Gilead sponsored study and did not achieve sustained virologic response (SVR).

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2014-11-20
• Study First Submitted QC: 2014-11-20
• Study First Posted: 2014-11-24
• Study Start: 2014-12-01
• Primary Completion: 2016-07-02
• Study Completion: 2016-09-15
• Status Verified: 2017-06
• Results First Submitted: 2017-06-30
• Results First Submitted QC: 2017-06-30
• Results First Posted: 2017-07-28
• Last Update Submitted: 2018-10-19
• Last Update Posted: 2018-11-16

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 69

Inclusion Criteria

• Willing and able to provide written informed consent
• HCV genotype determined by the Central Laboratory
• HCV RNA > LLOQ at screening
• Participated and completed a Gilead sponsored HCV treatment study of direct acting antiviral (DAA) containing regimens.
• Male and female of childbearing potential must agree to use protocol specified method(s) of contraception

Key

Exclusion Criteria

• Current or prior history: Clinically-significant illness (other than HCV) or any other major medical disorder that may interfere with treatment, assessment or compliance with the protocol; individuals currently under evaluation for a potentially clinically-significant illness (other than HCV) are also excluded.
• Screening ECG with clinically significant abnormalities
• Laboratory results outside of acceptable ranges at screening
• Infection with hepatitis B virus (HBV) or human immunodeficiency virus (HIV)

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
SOF/VEL+RBV	SOF/VEL	Participants will receive SOF/VEL fixed dose combination (FDC) and RBV for 24 weeks.
SOF/VEL+RBV	RBV	Participants will receive SOF/VEL fixed dose combination (FDC) and RBV for 24 weeks.

Primary Outcome Measures

Name	Time	Method
Percentage of Participants With Sustained Virologic Response 12 Weeks After Discontinuation of Therapy (SVR12)	Posttreatment Week 12	SVR12 is defined as HCV RNA \< the lower limit of quantitation (LLOQ) 12 weeks following the last dose of study drug.
Percentage of Participants Who Permanently Discontinued Any Study Drug Due to an Adverse Event	Up to 24 weeks

Secondary Outcome Measures

Name	Time	Method
Percentage of Participants With Sustained Virologic Response 4 and 24 Weeks After Discontinuation of Therapy (SVR4 and SVR24)	Posttreatment Weeks 4 and 24	SVR4 and SVR24 are defined as HCV RNA \< LLOQ at 4 and 24 weeks following the last dose of study drug.
Percentage of Participants With HCV RNA < LLOQ On-treatment	Baseline to Week 24
HCV RNA Change From Baseline	Baseline to Week 24
Percentage of Participants With Virologic Failure	Up to Posttreatment Week 24	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