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.
Phase 1 of this study will compare the effectiveness of 3 approved HCV treatment regimens to learn whether they work equally well under real-world conditions. Phase 2 of this study will begin early 2017 and will compare the effectiveness of 2 FDA approved HCV treatments. Patients receiving HCV therapy in community and academic clinics will be offered the opportunity to consent to be randomly assigned to one of three regimens and then observed for outcomes. Once randomized, all medical care, laboratory testing, and any disease or side effect management will be assumed by usual care conditions, and patient-reported outcomes will be collected outside clinic in keeping with pragmatic design principles.
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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