Ledipasvir/Sofosbuvir Fixed-Dose Combination With Ribavirin or GS-9669 in Subjects With Chronic Genotype 1 HCV Infection

Phase 2

Completed

• Conditions: Chronic HCV Infection
• Interventions: Drug: LDV/SOF; Drug: GS-9669; Drug: RBV

• Registration Number: NCT01984294
• Lead Sponsor: Gilead Sciences

Brief Summary

This study will evaluate the antiviral efficacy of ledipasvir/sofosbuvir (LDV/SOF) fixed-dose combination (FDC) plus ribavirin (RBV) or LDV/SOF plus GS-9669 in treatment-naive or treatment-experienced participants with chronic genotype 1 hepatitis C virus (HCV) infection. A total of 90 participants are planned to be enrolled in the study for 8 weeks of treatment, approximately 60 having had prior treatment with a regimen containing pegylated interferon (PEG) and RBV for ≥ 12 weeks. Randomization will be stratified by treatment-naive versus treatment-experienced and by HCV genotype (1a versus 1b).

Detailed Description

Not available

Basic Information
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Recruitment & Eligibility
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Study & Design

Study Timeline

• Study Start: 2013-10
• Study First Submitted: 2013-11-08
• Study First Submitted QC: 2013-11-08
• Study First Posted: 2013-11-14
• Primary Completion: 2014-04
• Study Completion: 2014-07
• Status Verified: 2015-04
• Results First Submitted: 2015-04-30
• Results First Submitted QC: 2015-04-30
• Results First Posted: 2015-05-21
• Last Update Submitted: 2018-10-19
• Last Update Posted: 2018-11-19

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 101

Inclusion Criteria

• Age ≥ 18, with chronic genotype 1 HCV infection
• Documented HCV treatment-naïve or treatment-experienced subjects who failed previous PEG+RBV regimen
• HCV RNA > 10,000 IU/mL at Screening
• Presence of compensated cirrhosis
• Screening laboratory values within defined thresholds
• Use of two effective contraception methods if female of childbearing potential or sexually active male

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Exclusion Criteria

• Pregnant or nursing female or male with pregnant female partner
• 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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
LDV/SOF + GS-9669 500 mg	GS-9669	Participants will receive LDV/SOF plus GS-9669 500 mg (2 x 250 mg) for 8 weeks.
LDV/SOF + GS-9669 500 mg	LDV/SOF	Participants will receive LDV/SOF plus GS-9669 500 mg (2 x 250 mg) for 8 weeks.
LDV/SOF+RBV	LDV/SOF	Participants will receive LDV/SOF plus RBV for 8 weeks.
LDV/SOF + GS-9669 250 mg	LDV/SOF	Participants will receive LDV/SOF plus GS-9669 250 mg for 8 weeks.
LDV/SOF + GS-9669 250 mg	GS-9669	Participants will receive LDV/SOF plus GS-9669 250 mg for 8 weeks.
LDV/SOF+RBV	RBV	Participants will receive LDV/SOF plus RBV for 8 weeks.

Primary Outcome Measures

Name	Time	Method
Percentage of Participants Permanently Discontinuing Any Study Drug Due to an Adverse Event	Up to 8 weeks
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) 12 weeks following the last dose of study drug.

Secondary Outcome Measures

Name	Time	Method
Percentage of Participants With Sustained Virologic Response at 2, 4, 8, and 24 Weeks After Discontinuation of Therapy (SVR2, SVR4, SVR8, and SVR24)	Posttreatment Weeks 2, 4, 8, and 24	SVR2, SVR4, SVR8, and SVR24 was defined as HCV RNA \< LLOQ at 2, 4, 8, and 24 weeks following the last dose of study drug, respectively.
Percentage of Participants Experiencing Viral Relapse	Up to Posttreatment Week 24	Viral relapse was defined as having achieved undetectable HCV RNA levels (HCV RNA \< LLOQ) at end of treatment, but did not achieve an SVR.
Percentage of Participants Experiencing On-treatment Virologic Failure	Up to 8 weeks	On-treatment virologic failure was defined as; * 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)