Efficacy and Safety of Ledipasvir/Sofosbuvir Fixed-Dose Combination and Sofosbuvir + Ribavirin for Subjects With Chronic Hepatitis C Virus (HCV) and Inherited Bleeding Disorders

• Status: Completed
• Trial end date: 2015-08-01
• Target enrollment: 0
• Participant gender: All

Summary

The primary objectives of this study are to evaluate the antiviral efficacy, safety, and tolerability of treatment with ledipasvir/sofosbuvir (LDV/SOF) fixed-dose combination (FDC) in participants with genotypes 1 and 4 hepatitis C virus (HCV) infection and sofosbuvir (SOF) plus ribavirin (RBV) in participants with genotypes 2 and 3 HCV infection. Participants with an inherited bleeding disorder and chronic HCV infection (either monoinfected or HIV-1/HCV coinfected) will be enrolled.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Gilead Sciences
• Treatments: Ledipasvir; Ribavirin; Sofosbuvir

Criteria

Inclusion Criteria:

• Hemophilia A, B or C, or Von Willebrand's disease

• Chronic genotype 1, 2, 3 or 4 HCV infection

• HCV RNA ≥ 1000 IU/mL at screening

• Use of protocol specified method(s) of contraception if female of childbearing potential or sexually active male

• Screening laboratory values within defined thresholds

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

• Suppressed HIV-1 RNA on an antiretroviral (ARV) regimen for at least 6 months prior to screening

• Stable protocol-approved ARV regimen for > 8 weeks prior to screening

• CD4 T-cell count > 200 cells/mm^3 at screening

Exclusion Criteria:

• Clinically-significant illness (other than HCV, inherited bleeding disorder or HIV-1) or any other major medical disorder that may interfere with subject treatment, assessment or compliance with the protocol

• Current or prior history of any of the following:

• Hepatic decompensation

• Chronic liver disease of a non-HCV etiology

• Hepatocellular carcinoma (HCC)

• Infection with hepatitis B virus (HBV)

• Pregnant or nursing female

• Prior treatment with inhibitors of nonstructural protein 5A (NS5A) or the NS5B polymerase

• Chronic use of systemically administered immunosuppressive agents

• 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