Official Title
Simplifying Hepatitis C Antiviral Therapy in Rwanda for Elsewhere in the Developing World
Phase
Phase 4Lead Sponsor
Partners in HealthStudy Type
InterventionalStatus
Completed No Results PostedIndication/Condition
Chronic Hepatitis CIntervention/Treatment
ledipasvir sofosbuvir ...Study Participants
300The main purpose of the study is to evaluate the efficacy, safety and tolerability of a medication, ledipasvir/sofosbuvir (LDV/SOF), used to treat individuals with chronic hepatitis C virus (HCV) in Rwandan adults. A sub-cohort of participants will have limited laboratory monitoring to determine the minimum laboratory tests necessary.
This is an open-label single arm study that will evaluate the antiviral efficacy, safety and tolerability of ledipasvir/sofosbuvir fixed dose combination administered for 12 weeks in HCV treatment-naive and treatment-experienced participants with chronic genotype 1 or 4 HCV infection. Approximately 240 participants will be enrolled and treated with sofosbuvir (SOF) 400 mg/LDV 90 mg fixed dose combination (FDC) one tablet once daily for 12 weeks in the SHARED 1 study. Sixty additional participants will be enrolled in the SHARED 2 sub-cohort with laboratory monitoring blinded to study clinicians.
Inclusion Criteria: patients that are willing and able to provide written informed consent age ≥ 18 years HCV RNA ≥ 103 IU/mL HCV genotype 1 or 4 screening ultrasound excluding hepatocellular carcinoma (HCC) acceptable laboratory values (hemoglobin ≥8.0 g/dL, platelet count ≥40,000/mm3; AST, ALT, and alkaline phosphatase ≤10 × ULN; creatinine clearance ≥30 mL/min) general good health ability to comply with study procedures HIV-infected patients must have completed at least 6 months of any approved HIV antiretroviral therapy (ART) per Rwanda National Guidelines 2013, have been taking for at least 2 weeks prior to screening ART compatible with SOF/LDV (efavirenz, rilpivirine, raltegravir, dolutegravir, emtricitabine, lamivudine, zidovudine, tenofovir), have screening HIV RNA < 200 copies/mL, and have screening CD4 T-cell count of ≥100 cells/µL Exclusion Criteria: current or history of clinical hepatic decompensation (i.e., ascites, encephalopathy or variceal hemorrhage) active tuberculosis other clinically-significant illness (except HCV and/or HIV) or any other major medical disorder active Hepatitis B infection difficulty with blood collection and/or poor venous access for the purposes of phlebotomy any IFN-containing regimen within 8 weeks prior to screening or any prior exposure to HCV-specific direct-acting antiviral agent (other than a NS3/4A protease inhibitor and SOF), current pregnancy or breastfeeding, and active drug or alcohol use or dependence
