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

Gilead Sciences

Status and phase: Completed; Phase 2

Conditions: HCV Infection

Treatments: Drug: RBV; Drug: LDV/SOF

Study type: Interventional

Funder types: Industry

Identifiers

NCT01987453

GS-US-337-1118

2014-001245-24 (EudraCT Number)

Details and patient eligibility

About

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).

Enrollment: 100 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion criteria

Key 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 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.

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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100 participants in 3 patient groups

LDV/SOF+RBV 12 weeks (Group 1)

Experimental group

Description:

Participants who failed a prior SOF+RBV ± pegylated interferon (Peg-IFN) regimen will receive LDV/SOF FDC plus RBV for 12 weeks.

Treatment:

Drug: RBV

Drug: LDV/SOF

LDV/SOF 24 weeks (Group 2)

Experimental group

Description:

Participants who failed a prior LDV/SOF ± RBV regimen will receive LDV/SOF FDC for 24 weeks.

Treatment:

Drug: LDV/SOF

LDV/SOF+RBV 24 weeks (Group 3)

Experimental group

Description:

Participants with advanced compensated or decompensated cirrhosis who failed a prior SOF+RBV regimen will receive LDV/SOF FDC plus RBV for 24 weeks.

Treatment:

Drug: RBV

Drug: LDV/SOF