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).
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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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 goal of this study is to evaluate the effectiveness of a brief, computerized behavioral intervention for promoting screening for hepatitis C and reducing risky behavior for people who inject drugs (PWID).