Simplifying Hepatitis C Antiviral Therapy in Rwanda for Elsewhere in the Developing World

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