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

Gilead Sciences

Status and phase: Completed; Phase 2

Conditions: Chronic HCV Infection

Treatments: Drug: GS-9669; Drug: LDV/SOF; Drug: RBV

Study type: Interventional

Funder types: Industry

Identifiers

NCT01984294

GS-US-337-0133

Details and patient eligibility

About

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).

Enrollment: 101 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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101 participants in 3 patient groups

LDV/SOF+RBV

Experimental group

Description:

Participants will receive LDV/SOF plus RBV for 8 weeks.

Treatment:

Drug: LDV/SOF

Drug: RBV

LDV/SOF + GS-9669 250 mg

Experimental group

Description:

Participants will receive LDV/SOF plus GS-9669 250 mg for 8 weeks.

Treatment:

Drug: LDV/SOF

Drug: GS-9669

LDV/SOF + GS-9669 500 mg

Experimental group

Description:

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

Treatment:

Drug: LDV/SOF

Drug: GS-9669