Trial of Simplified Treatment Monitoring for 8 Weeks Glecaprevir/ Pibrentasvir (Mayret) in Chronic Hepatitis C Patients (SMART-C)
Data has shown that direct-acting antiviral (DAA) regimen of glecaprevir (300mg)/pibrentasvir (120mg), a protease inhibitor and NS5A inhibitor respectively, provides key features for HCV treatment simplification.
Eligible participants (naïve pre-cirrhosis chronic HCV patients) will be randomized (1:2) to the standard or simplified monitoring arm and will receive treatment for 8 weeks.
One post-treatment visit will be conducted 12 weeks after the final dose of study medication to evaluate the proportion of patients with undetectable HCV RNA at this time point (SVR12).
DAA Treatment in Donor HCV-positive to Recipient HCV-negative Liver Transplant
This is a single center study for the donation of HCV-positive livers to HCV negative recipient patients, with preemptive, interventional treatment of Epclusa to prevent HCV transmission upon transplantation.
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Approximately fifty HIV/HCV coinfected patients with decompensated liver disease will be enrolled in the study. Ten (up to twenty) subjects will be treated with FDC SOF/LDV (Harvoni) pre or post liver transplant and followed prospectively. Forty + subjects will be enrolled retrospectively with the intent to capture all patients who have been exposed to sofosbuvir based DAA therapies at participating sites since 1/2014, and to mirror the population being enrolled prospectively.
In the medical literature, there are case reports that Harvoni improves symptoms in patients with PCT. However, this has never been systematically tested. Therefore, the purpose of this study is to assess whether Harvoni alone is an effective therapy of active PCT in patients with Chronic Hepatitis C
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.
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.
Trial of Simplified Treatment Monitoring for 8 Weeks Glecaprevir/Pibrentasvir in Chronic Hepatitis C Patients (SMART-C)
The aim of this study is to determine if treatment monitoring schedule for chronic HCV patients treated with glecaprevir (300mg)/pibrentasvir (120mg) can be simplified. There will be two arms – one arm will have two on-treatment clinic visits; the other arm will have no on-treatment clinic visits.
Effectiveness, Safety and Clinical Outcomes of Elbasvir/Grazoprevir: Results From a Spanish Real World Cohort
This is a multicentre, descriptive, observational and ambispective (also known as a historical prospective) study carried out in patients who are treated with Zepatier (Elbasvir/Grazoprevir) in hospitals that included their data in Hepa-C Registry (directed by the Spanish Association for the Study of the Liver and the Networked Biomedical Research Centre for Hepatic and Digestive Diseases).