Efficacy and Safety of Sofosbuvir/Ledipasvir ± Ribavirin in Japanese Participants With Chronic Genotype 1 HCV Infection

Gilead Sciences

Status and phase: Completed; Phase 3

Conditions: Chronic HCV Infection

Treatments: Drug: LDV/SOF; Drug: RBV

Study type: Interventional

Funder types: Industry

Identifiers

NCT01975675

GS-US-337-0113

Details and patient eligibility

About

This study will evaluate the antiviral efficacy of sofosbuvir (SOF)/ledipasvir (LDV) fixed-dose combination (FDC) tablet with or without ribavirin (RBV) in treatment-naive or treatment-experienced Japanese participants with chronic genotype 1 HCV infection. Participants receive 12 weeks of treatment and continue assessments during a 24-week posttreatment follow-up period.

Enrollment: 341 patients

Sex: All

Ages: 20+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Body weight ≥ 40 kg
• HCV RNA ≥ 10^5 IU/mL at screening

Exclusion criteria

• Current or prior history of any clinically-significant illness (other than HCV)
• Pregnant or nursing female or male with pregnant female partner
• Chronic liver disease of a non-HCV etiology
• Infection with hepatitis B virus (HBV) or human immunodeficiency virus (HIV)

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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341 participants in 4 patient groups

LDV/SOF (treatment naive)

Experimental group

Description:

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

Treatment:

Drug: LDV/SOF

LDV/SOF+RBV (treatment naive)

Experimental group

Description:

Treatment-naive participants will receive LDV/SOF plus RBV for 12 weeks.

Treatment:

Drug: RBV

Drug: LDV/SOF

LDV/SOF (treatment experienced)

Experimental group

Description:

Treatment-experienced participants will receive LDV/SOF for 12 weeks.

Treatment:

Drug: LDV/SOF

LDV/SOF+RBV (treatment experienced)

Experimental group

Description:

Treatment-experienced participants will receive LDV/SOF plus RBV for 12 weeks.

Treatment:

Drug: RBV

Drug: LDV/SOF