Clareo Health | Efficacy and Safety of Ledipasvir/Sofosbuvir Fixed-Dose Combination and Sofosbuvir + Ribavirin for Subjects With Chronic Hepatitis C Virus (HCV) and Inherited Bleeding Disorders
Efficacy and Safety of Ledipasvir/Sofosbuvir Fixed-Dose Combination and Sofosbuvir + Ribavirin for Subjects With Chronic Hepatitis C Virus (HCV) and Inherited Bleeding Disorders
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Lead
Gilead Sciences
Age
18–any
Sex
ALL
Healthy volunteers
Not accepted
You may be eligible if
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
You may not be if
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
