Ledipasvir/Sofosbuvir Fixed-Dose Combination for 12 Weeks in Participants With Chronic Genotype 2 HCV Infection

Gilead Sciences

Status and phase: Completed; Phase 3

Conditions: Hepatitis C Virus Infection

Treatments: Drug: SOF; Drug: LDV/SOF; Drug: RBV

Study type: Interventional

Funder types: Industry

Identifiers

NCT02738333

GS-US-337-1903

Details and patient eligibility

About

The primary objectives of this study are to evaluate the antiviral efficacy of therapy with ledipasvir/sofosbuvir (LDV/SOF) fixed-dose combination (FDC) and to evaluate the safety and tolerability of LDV/SOF FDC and sofosbuvir (SOF) + ribavirin (RBV) in participants with chronic genotype 2 hepatitis C virus (HCV) infection.

Enrollment: 239 patients

Sex: All

Ages: 20+ years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion criteria

Key Inclusion Criteria:

• Chronic genotype 2 HCV-infected males and non-pregnant/non-lactating females
• Aged 20 years or older
• Treatment naive or treatment experienced
• At least 20 subjects will have Child-Pugh-A compensated cirrhosis. In Cohort 2, participants must be ineligible or intolerant of RBV.

Key Exclusion Criteria:

• Previous exposure to an NS5A or NS5B inhibitor
• Infection with hepatitis B virus (HBV) or human immunodeficiency virus (HIV)
• Pregnant or nursing female or male with pregnant female partner

Note: Other protocol defined Inclusion/Exclusion criteria may apply.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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239 participants in 3 patient groups

LDV/SOF (Cohort 1)

Experimental group

Description:

LDV/SOF FDC for 12 weeks

Treatment:

Drug: LDV/SOF

SOF+RBV (Cohort 1)

Experimental group

Description:

SOF+RBV for 12 weeks

Treatment:

Drug: RBV

Drug: SOF

LDV/SOF (Cohort 2)

Experimental group

Description:

Participants who are ineligible for or intolerant to RBV therapy will receive LDV/SOF FDC for 12 weeks.

Treatment:

Drug: LDV/SOF