Phase II Trial of Retreatment Strategies for Difficult-to-Treat Hepatitis C Virus (HCV)-Infected Individuals Who Have Failed Prior Direct Acting Antiviral (DAA)-Based Regimens
People who are infected with Hepatitis C Virus (HCV) have a great chance of being cured of the infection when they are treated with sofosbuvir. However, in some instances, treatment with sofosbuvir-containing therapy does not work. It is not known if people respond to retreatment with sofosbuvir, after it did not work the first time. There is an important need to understand retreatment options in those instances. This clinical trial was done to study the response to two different regimens, ledipasvir/sofosbuvir and ledipasvir/sofosbuvir with ribavirin, and to see if they are safe and well-tolerated in HCV-infected persons whose previous treatment with sofosbuvir had failed.
• Willing and able to provide written informed consent
• Documentation of non-cirrhotic or cirrhotic status
• HIV-1 infection
• HIV antiretroviral treatment status (ART), CD4+ T-cell (CD4) count and HIV-1 RNA as follows: (1) not on ART with CD4 count \>500 cells/mm\^3 within 42 days of study entry, (2) elite controller not on ART with CD4 \>200 cells/mm\^3 within 42 days of study entry and HIV-1 RNA \<500 copies/mL on all measurements within 48 weeks prior to study entry, (3) on a stable protocol-approved ART with CD4 count \>200 cells/mm\^3 and HIV-1 RNA \<50 copies/mL within 42 days of study entry
• HCV GT-1 within 12 months prior to study entry
• Prior virologic treatment failure with SOF-containing regimen (SOF/RBV, SOF/PEG/RBV, and SOF/SIM)
• Body mass index (BMI) ≥18 kg/m\^2 within 42 days prior to study entry
• Certain laboratory values obtained within 42 days prior to study entry
• Hemoglobin ≥12.0 g/dL for male, ≥11.0 g/dL for female participants
• Aspartate aminotransferase (AST) (SGOT) and Alanine aminotransferase (ALT) (SGOT) \<10 x ULN
• For female participants of reproductive potential, a negative serum pregnancy test with a sensitivity of at least 25 mIU/mL performed at screening and within 48 hours prior to study entry
• Agreement to use at least two reliable forms of contraceptive simultaneously while receiving study treatment and for 6 months afterward
• Intention to comply with the dosing instructions and study schedule of assessments