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

• Status: Terminated
• Trial end date: 2017-05-29
• Target enrollment: 0
• Participant gender: All

Summary

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.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Gilead Sciences
• Treatments: Ledipasvir; Ledipasvir, sofosbuvir drug combination; Ribavirin; Sofosbuvir

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.