Safety and Efficacy of Ledipasvir/Sofosbuvir (LDV/SOF) Fixed Dose Combination Tablet With Ribavirin for 12 Weeks in Treatment-naive Adults With Chronic HCV Genotype 3 Infection

Phase 2

Completed

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

• Registration Number: NCT02413593
• Lead Sponsor: Gilead Sciences

Brief Summary

This study will evaluate the antiviral efficacy, safety, and tolerability of ledipasvir/sofosbuvir (LDV/SOF) fixed dose combination (FDC) plus ribavirin (RBV) in treatment-naive adults with chronic genotype 3 hepatitis C virus (HCV) infection.

Detailed Description

Not available

Study Timeline

• Study Start: 2015-04
• Study First Submitted: 2015-04-07
• Study First Submitted QC: 2015-04-07
• Study First Posted: 2015-04-10
• Primary Completion: 2015-12
• Study Completion: 2016-01
• Status Verified: 2016-12
• Results First Submitted: 2016-12-22
• Results First Submitted QC: 2016-12-22
• Results First Posted: 2017-02-14
• Last Update Submitted: 2018-10-19
• Last Update Posted: 2018-11-16

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 111

Inclusion Criteria

• Chronic genotype 3 HCV infection
• HCV treatment-naive
• HCV RNA > 10,000 IU/mL at screening
• Absence of cirrhosis or compensated cirrhosis
• Screening laboratory values within defined thresholds
• Use of two effective contraception methods if female of childbearing potential or sexually active male

Key

Exclusion Criteria

• Pregnant or nursing female or male with pregnant female partner
• Coinfection 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 the individual's treatment, assessment, or compliance with the protocol

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
LDV/SOF+RBV	LDV/SOF	LDV/SOF FDC plus RBV for 12 weeks
LDV/SOF+RBV	RBV	LDV/SOF FDC plus RBV for 12 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 12 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.
Percentage of Participants With HCV RNA < LLOQ at Weeks 1, 2, 4, 8 and 12	Weeks 1, 2, 4, 8, and 12
Percentage of Participants With Virologic Failure	Up to Posttreatment Week 12	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.
Change From Baseline in HCV RNA at Weeks 1, 2, 4, 8, and 12	Baseline; Weeks 1, 2, 4, 8, and 12