Efficacy and Safety of Ledipasvir/Sofosbuvir Fixed-Dose Combination and Sofosbuvir + Ribavirin for Subjects With Chronic Hepatitis C Virus (HCV) and Inherited Bleeding Disorders
Condition: Chronic HCV Infection
MeSH terms: Hepatitis C; Hepatitis C, Chronic; Hemostatic Disorders; Blood Coagulation Disorders
Intervention: LDV/SOF; SOF; RBV
Intervention description: 90/400 mg FDC tablet administered orally; 400 mg tablet administered orally once daily; Ribavirin (RBV) tablets administered orally in a divided daily dose according to package insert weight-based dosing recommendations (< 75 kg = 1000 mg and ≥ 75 kg = 1200 mg)
Intervention MeSH terms: Sofosbuvir
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 122.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No

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.
    

Eligibility 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