Safety and Efficacy of Ledipasvir/Sofosbuvir in Adults With Chronic HCV Infection

Gilead Sciences

Status and phase: Completed; Phase 3

Conditions: Hepatitis C Virus Infection

Treatments: Drug: LDV/SOF; Drug: RBV

Study type: Interventional

Funder types: Industry

Identifiers

NCT02472886

GS-US-337-1463

2015-000690-13 (EudraCT Number)

Details and patient eligibility

About

The primary objectives of this study are to evaluate the antiviral efficacy, safety, and tolerability of ledipasvir/sofosbuvir (LDV/SOF) fixed dose combination (FDC) with or without ribavirin (RBV) in adults with chronic hepatitis C virus (HCV) infection.

Enrollment: 153 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion criteria

Key Inclusion Criteria:

• Participants who failed treatment in Study GS-US-334-0119 who meet relevant inclusion/exclusion criteria are eligible for retreatment in this study
• Chronic genotype 1 HCV infection
• HCV treatment-naive
• HCV RNA > 10,000 IU/mL at screening
• Absence of cirrhosis
• Screening laboratory values within defined thresholds
• Use of two effective contraception methods if female of childbearing potential or sexually active male

Key Exclusion Criteria:

• Pregnant or nursing female or male with pregnant female partner

• Infection with 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 the individual's treatment, assessment, or compliance with the protocol

• For HIV-1/HCV co-infected individuals:

  • Opportunistic infection within 6 months prior to screening
  • Active, serious infection (other than HIV-1 or HCV) requiring parental antibiotics, antivirals or antifungals within 30 days prior to baseline
  • Treatment with an antiretroviral (ARV) regimen other than one of those listed in the study protocol

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

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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153 participants in 3 patient groups

LDV/SOF

Experimental group

Description:

Treatment-naive participants with genotype 1 HCV infection without cirrhosis will receive LDV/SOF FDC for 8 weeks.

Treatment:

Drug: LDV/SOF

LDV/SOF Coinfected with HIV-1

Experimental group

Description:

Treatment-naive participants with genotype 1 HCV infection without cirrhosis and who are coinfected with HIV-1 will receive LDV/SOF FDC for 8 weeks.

Treatment:

Drug: LDV/SOF

LDV/SOF+RBV Retreatment

Experimental group

Description:

Participants with genotype 1 or 3 HCV infection who failed to achieve SVR12 in Gilead Study GS-US-334-0119 will receive LDV/SOF FDC + RBV for 12 weeks.

Treatment:

Drug: LDV/SOF

Drug: RBV