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
To view the entire clinical trial description, click here