Safety and Efficacy of Ledipasvir/Sofosbuvir Fixed-Dose Combination ± Ribavirin in Treatment-Experienced Subjects With Genotype 1 HCV Infection (ION-2)

Gilead Sciences

Status and phase: Completed; Phase 3

Conditions: Chronic Hepatitis C Virus

Treatments: Drug: LDV/SOF; Drug: RBV

Study type: Interventional

Funder types: Industry

Identifiers

NCT01768286

GS-US-337-0109

Details and patient eligibility

About

This study is to evaluate the safety, tolerability, and antiviral efficacy of ledipasvir/sofosbuvir fixed dose combination (FDC) with or without ribavirin (RBV) administered for 12 or 24 weeks in treatment-experienced subjects with chronic genotype 1 hepatitis C virus (HCV) infection.

Enrollment: 441 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Age > 18, with chronic genotype 1 HCV infection
• HCV treatment-experienced, including patients who have previously failed a nonstructural protein (NS)3/4A protease inhibitor plus pegylated interferon (PEG)/RBV regimen
• 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
• Coinfection with HIV or hepatitis B virus
• Current or prior history of clinical hepatic decompensation
• Hepatocellular carcinoma 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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441 participants in 4 patient groups

LDV/SOF 12 Weeks

Experimental group

Description:

Participants will receive LDV/SOF FDC for 12 weeks.

Treatment:

Drug: LDV/SOF

LDV/SOF+RBV 12 Weeks

Experimental group

Description:

Participants will receive LDV/SOF FDC plus RBV for 12 weeks.

Treatment:

Drug: LDV/SOF

Drug: RBV

LDV/SOF 24 Weeks

Experimental group

Description:

Participants will receive LDV/SOF FDC for 24 weeks.

Treatment:

Drug: LDV/SOF

LDV/SOF+RBV 24 Weeks

Experimental group

Description:

Participants will receive LDV/SOF FDC plus RBV for 24 weeks.

Treatment:

Drug: LDV/SOF

Drug: RBV