Ledipasvir/Sofosbuvir Fixed-Dose Combination ± Ribavirin in Participants With Chronic Genotype 1 HCV Who Participated in a Prior Gilead-Sponsored HCV Treatment Study

Phase 2

Completed

• Conditions: HCV Infection
• Interventions: Drug: LDV/SOF; Drug: RBV

• Registration Number: NCT01987453
• Lead Sponsor: Gilead Sciences

Brief Summary

The primary objectives of this study are to evaluate the efficacy, safety, and tolerability of ledipasvir/sofosbuvir (LDV/SOF) fixed-dose combination (FDC) with or without ribavirin (RBV) in participants with chronic genotype 1 hepatitis C virus (HCV) infection who have participated in a prior Gilead-sponsored HCV treatment study, and who did not achieve sustained virologic response (SVR24), defined as HCV RNA \< lower limit of quantification (LLOQ) 24 weeks after last dose of study drug (SVR24).

Detailed Description

Not available

Basic Information
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Recruitment & Eligibility
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Study & Design

Study Timeline

• Study First Submitted: 2013-11-12
• Study First Submitted QC: 2013-11-12
• Study First Posted: 2013-11-19
• Study Start: 2014-07
• Primary Completion: 2015-11
• Study Completion: 2015-11
• Status Verified: 2016-11
• Results First Submitted: 2016-11-11
• Results First Submitted QC: 2016-11-11
• Results First Posted: 2017-01-10
• Last Update Submitted: 2018-10-19
• Last Update Posted: 2018-11-19

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 100

Inclusion Criteria

• Willing and able to provide written informed consent
• Infection with HCV genotype 1
• HCV RNA > LLOQ at screening
• Participation in a prior Gilead-sponsored study
• Screening laboratory values within defined thresholds
• Use of two effective contraception methods if female of childbearing potential or sexually active male
• Must be of generally good health, with the exception of chronic HCV infection, as determined by the Investigator
• Must be able to comply with the dosing instructions for study drug administration and able to complete the study schedule of assessments

Key

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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 (Groups 1 and 2 only)
• Hepatocellular carcinoma (HCC)
• History of clinically significant illness or any other medical disorder that may interfere with subject treatment, assessment or compliance with the protocol

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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
LDV/SOF+RBV 12 weeks (Group 1)	LDV/SOF	Participants who failed a prior SOF+RBV ± pegylated interferon (Peg-IFN) regimen will receive LDV/SOF FDC plus RBV for 12 weeks.
LDV/SOF+RBV 12 weeks (Group 1)	RBV	Participants who failed a prior SOF+RBV ± pegylated interferon (Peg-IFN) regimen will receive LDV/SOF FDC plus RBV for 12 weeks.
LDV/SOF 24 weeks (Group 2)	LDV/SOF	Participants who failed a prior LDV/SOF ± RBV regimen will receive LDV/SOF FDC for 24 weeks.
LDV/SOF+RBV 24 weeks (Group 3)	LDV/SOF	Participants with advanced compensated or decompensated cirrhosis who failed a prior SOF+RBV regimen will receive LDV/SOF FDC plus RBV for 24 weeks.
LDV/SOF+RBV 24 weeks (Group 3)	RBV	Participants with advanced compensated or decompensated cirrhosis who failed a prior SOF+RBV regimen will receive LDV/SOF FDC plus RBV for 24 weeks.

Primary Outcome Measures

Name	Time	Method
Percentage of Participants With Sustained Virologic Response 12 Weeks After Discontinuation of Therapy (SVR12)	Post-treatment Week 12	SVR12 was defined as HCV RNA \< the lower limit of quantitation (LLOQ) 12 weeks following the last dose of study treatment.
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 (SVR) at 4 and 24 Weeks After Discontinuation of Therapy (SVR4 and SVR24)	Posttreatment Weeks 4 and 24	SVR4 and SVR24 were defined as HCV RNA \< LLOQ at 4 and 24 weeks following the last dose of study treatment, respectively.
Percentage of Participants With HCV RNA < LLOQ While on Treatment	Baseline to Week 24
Change in HCV RNA From Baseline	Baseline to Week 8
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 confirmed with 2 consecutive values or last available posttreatment measurement