Safety and Efficacy of LDV/SOF Fixed-Dose Combination (FDC) ± Ribavirin in HCV Genotype 1 Subjects

Gilead Sciences

Status and phase: Completed; Phase 2

Conditions: Chronic Hepatitis C Virus

Treatments: Drug: RBV; Drug: LDV/SOF

Study type: Interventional

Funder types: Industry

Identifiers

NCT01726517

GS-US-337-0118

Details and patient eligibility

About

This study is to evaluate the safety, tolerability, and antiviral efficacy of ledipasvir/sofosbuvir (LDV/SOF) fixed-dose combination (FDC) with or without ribavirin (RBV), administered for 8 or 12 weeks of treatment in participants with chronic genotype 1 hepatitis C virus (HCV) infection who are treatment-naive, and for 12 weeks in participants who had previously received a regimen containing a protease inhibitor for the treatment of HCV.

Enrollment: 100 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Age ≥ 18 years, with chronic genotype 1 HCV infection
• HCV RNA equal to or greater than 10,000 IU/mL at screening
• Cirrhosis determination; a liver biopsy may be required
• Screening laboratory values within defined thresholds
• Use of two effective contraception methods if female of childbearing potential or sexually active male

Exclusion criteria

• Pregnant or nursing female or male with pregnant female partner
• Current or prior history of clinical hepatic decompensation
• Hepatocellular carcinoma (HCC) or other malignancy (with exception of certain resolved skin cancers)
• 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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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100 participants in 5 patient groups

LDV/SOF 8 Weeks (TN)

Experimental group

Description:

Treatment-naive (TN) participants will be randomized to receive LDV/SOF for 8 weeks.

Treatment:

Drug: LDV/SOF

LDV/SOF+RBV 8 Weeks (TN)

Experimental group

Description:

Treatment-naive participants will be randomized to receive LDV/SOF plus RBV for 8 weeks.

Treatment:

Drug: RBV

Drug: LDV/SOF

LDV/SOF 12 Weeks (TN)

Experimental group

Description:

Treatment-naive participants will be randomized to receive LDV/SOF for 12 weeks.

Treatment:

Drug: LDV/SOF

LDV/SOF 12 Weeks (TE)

Experimental group

Description:

Treatment-experienced (TE) participants (had virologic failure following prior therapy with a protease-inhibitor \[PI\]+pegylated interferon \[PEG\]+RBV regimen) will be randomized to receive LDV/SOF for 12 weeks.

Treatment:

Drug: LDV/SOF

LDV/SOF+RBV 12 Weeks (TE)

Experimental group

Description:

Treatment-experienced participants (had virologic failure following prior therapy with a PI+PEG+RBV regimen) will be randomized to receive LDV/SOF plus RBV for 12 weeks.

Treatment:

Drug: RBV

Drug: LDV/SOF