Ledipasvir/Sofosbuvir Fixed-Dose Combination and Vedroprevir With or Without Ribavirin in Treatment-Experienced Participants With Chronic Genotype 1 HCV Infection and Cirrhosis

Phase 2

Completed

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

• Registration Number: NCT02226549
• Lead Sponsor: Gilead Sciences

Brief Summary

This study is to evaluate the antiviral efficacy, safety, and tolerability of combination therapy with ledipasvir/sofosbuvir (LDV/SOF) fixed-dose combination (FDC) + vedroprevir (VDV) ± ribavirin (RBV) for 8 weeks in treatment-experienced adults with chronic genotype 1 hepatitis C virus (HCV) infection and cirrhosis.

Detailed Description

Not available

Study Timeline

• Study Start: 2014-07
• Study First Submitted: 2014-08-25
• Study First Submitted QC: 2014-08-25
• Study First Posted: 2014-08-27
• Primary Completion: 2015-02
• Study Completion: 2015-02
• Status Verified: 2016-02
• Results First Submitted: 2016-02-05
• Results First Submitted QC: 2016-02-05
• Results First Posted: 2016-03-04
• Last Update Submitted: 2018-10-19
• Last Update Posted: 2018-11-16

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 47

Inclusion Criteria

• Age ≥ 18 years, with chronic HCV genotype 1 infection
• Documentation as treatment-experienced having received pegylated interferon (Peg-IFN) + RBV ≥ 4 weeks of duration without an additional agent in the regimen without achieving sustained viral response (SVR)
• Presence of compensated cirrhosis
• Screening laboratory values within defined thresholds
• Must use specific contraceptive methods if female of childbearing potential or sexually active male
• Not pregnant or a nursing female

Exclusion Criteria

• Co-infection with HIV or hepatitis B virus (HBV)
• Current or prior history of clinical hepatic decompensation
• Chronic use of systemic immunosuppressive agents
• History of clinically significant illness or any other medical disorder that may interfere with subject treatment, assessment or compliance with the protocol

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
LDV/SOF+VDV	LDV/SOF	Participants will receive LDV/SOF+VDV for 8 weeks.
LDV/SOF+VDV	VDV	Participants will receive LDV/SOF+VDV for 8 weeks.
LDV/SOF+VDV+RBV	LDV/SOF	Participants will receive LDV/SOF+VDV+RBV for 8 weeks.
LDV/SOF+VDV+RBV	VDV	Participants will receive LDV/SOF+VDV+RBV for 8 weeks.
LDV/SOF+VDV+RBV	RBV	Participants will receive LDV/SOF+VDV+RBV for 8 weeks.

Primary Outcome Measures

Name	Time	Method
Percentage of Participants With Sustained Virologic Response (SVR) 12 Weeks After Discontinuation of Therapy (SVR12)	Posttreatment Week 12	SVR12 was defined as HCV RNA \< the lower limit of quantitation (LLOQ; ie, 15 IU/mL) at 12 weeks after stopping study treatment.
Percentage of Participants Who Permanently Discontinued Any Study Drug Due to an Adverse Event	Up to 8 weeks

Secondary Outcome Measures

Name	Time	Method
Percentage of Participants With SVR at 4 Weeks After Discontinuation of Therapy (SVR4)	Posttreatment Week 4	SVR4 was defined as HCV RNA \< LLOQ at 4 weeks after stopping study treatment.