Efficacy and Safety of Ledipasvir/Sofosbuvir, With or Without Ribavirin, in HCV Infected Participants Who Have Failed Prior Treatment With Sofosbuvir-based Therapies

Gilead Sciences

Status and phase: Terminated; Phase 3

Conditions: Hepatitis C Virus Infection

Treatments: Drug: LDV/SOF; Drug: RBV

Study type: Interventional

Funder types: Industry

Identifiers

NCT02600351

GS-US-337-1746

Details and patient eligibility

About

The primary objective of this study is to evaluate the efficacy, safety, and tolerability of ledipasvir/sofosbuvir (LDV/SOF) fixed dose combination (FDC) for 12 weeks with or without ribavirin (RBV) in participants without cirrhosis, and LDV/SOF FDC for 12 weeks with RBV or LDV/SOF FDC for 24 weeks without RBV in participants with cirrhosis.

Enrollment: 87 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion criteria

Key Inclusion Criteria:

• HCV RNA > 15 IU/mL at screening
• HCV genotype 1 or 4
• Chronic HCV infection (≥ 6 months)
• Prior virologic failure after treatment with SOF in combination with simeprevir (SMV) ± RBV or with RBV ± pegylated interferon (PEG)
• Cirrhotic and non-cirrhotic as determined by standard methods
• Male and female individuals of childbearing potential who engage in heterosexual intercourse must agree to use protocol specified method(s) of contraception

Key Exclusion Criteria:

• Prior exposure to approved or experimental non-structural protein (NS5A) inhibitors
• Prior exposure to nucleos(t)ide polymerase inhibitors, other than SOF
• 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 individual's treatment, assessment or compliance with the protocol

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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87 participants in 4 patient groups

LDV/SOF 12 weeks, without cirrhosis

Experimental group

Description:

LDV/SOF for 12 weeks

Treatment:

Drug: LDV/SOF

LDV/SOF + RBV 12 weeks, without cirrhosis

Experimental group

Description:

LDV/SOF + RBV for 12 weeks

Treatment:

Drug: RBV

Drug: LDV/SOF

LDV/SOF + RBV 12 weeks, with compensated cirrhosis

Experimental group

Description:

LDV/SOF + RBV for 12 weeks

Treatment:

Drug: RBV

Drug: LDV/SOF

LDV/SOF 24 weeks, with compensated cirrhosis

Experimental group

Description:

LDV/SOF for 24 weeks

Treatment:

Drug: LDV/SOF