Safety and Efficacy of Ledipasvir/Sofosbuvir Fixed-Dose Combination (FDC) With and Without Ribavirin for the Treatment of HCV

Gilead Sciences

Status and phase: Completed; Phase 3

Conditions: Chronic Hepatitis C Virus

Treatments: Drug: RBV; Drug: LDV/SOF

Study type: Interventional

Funder types: Industry

Identifiers

NCT01701401

2012-003387-43 (EudraCT Number)

GS-US-337-0102

Details and patient eligibility

About

The purpose of this study is to evaluate the safety, tolerability, and antiviral efficacy of ledipasvir (LDV)/sofosbuvir (SOF) fixed-dose combination (FDC) tablets with or without ribavirin (RBV) administered for 12 and 24 weeks in treatment-naive subjects with chronic genotype 1 HCV infection.

Enrollment: 870 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Age ≥ 18, with chronic genotype 1 HCV infection
• HCV treatment-naive
• HCV RNA > 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
• Co-infection with HIV or hepatitis B virus (HBV)
• 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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870 participants in 4 patient groups

LDV/SOF 12 weeks

Experimental group

Description:

LDV/SOF administered for 12 weeks

Treatment:

Drug: LDV/SOF

LDV/SOF+RBV 12 weeks

Experimental group

Description:

LDV/SOF+RBV administered for 12 weeks.

Treatment:

Drug: LDV/SOF

Drug: RBV

LDV/SOF 24 weeks

Experimental group

Description:

LDV/SOF administered for 24 weeks

Treatment:

Drug: LDV/SOF

LDV/SOF+RBV 24 weeks

Experimental group

Description:

LDV/SOF+RBV administered for 24 weeks.

Treatment:

Drug: LDV/SOF

Drug: RBV