This study will enroll subjects who are at high risk for nonadherence (including active alcohol and/drug use, recent hospitalization for a psychiatric condition, previous nonadherence or missed clinic visits, or transportation issues). This study is evaluating the use of a digital medicines program to help sustain adherence and hopefully increase the chance of a cure. Study subjects will be compensated for their time in the study.
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The study will enroll well-compensated cirrhotic as well as non-cirrhotic subjects treatment experienced with an NS5a Inhibitor + sofosbuvir and will include patients who did not complete the prescribed duration due to adverse event or any reason other than for non/poor compliance. Subjects will be randomized to 12 or 16 weeks of treatment.
Mavyret: A Phase 3b, single arm, open-label, multicenter study to evaluate the safety and to demonstrate the non-inferiority of the sustained virologic response 12 weeks post dosing (SVR12) rates of 8 weeks of treatment with the glecaprevir (GLE)/pibrentasvir (PIB) combination regimen to the historical SVR12 rate of 12 weeks of treatment with the GLE/PIB in treatment-naïve adults with chronic HCV GT 1, 2, 4, 5, or 6 infection and compensated cirrhosis.
The study is evaluating the treatment of HCV genotype 1 with the Viekira regime in people coinfected with hepatitis C and HIV. Viekira regime is approved by the Food and Drug Administration (FDA) to treat people mono-infected with HCV and in people coinfected with HCV and HIV. Previous studies have achieved cure rates of 95% to 100%.
Evaluating the Safety and Effectiveness of Interferon-Free Treatment of Hepatitis C Virus Infection in HIV-Coinfected Adults on Antiretroviral Therapy (C_ASCENT)
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Pediatric patients infected with HCV genotypes 1, 3, 4, 5, and 6 will be treated with ledipasvir and sofosbuvir (with and without ribavirin). There will also be a placebo arm. A lead-in phase is testing the safe and effective dose. After the lead-in phase, the same patients will be treated with the combinations. There are different arms based on the ages of the children.
Safety and Efficacy of Ledipasvir/Sofosbuvir Fixed Dose Combination +/-Ribavirin in Adolescents and Children With Chronic HCV-Infection
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