Trial of Simplified Treatment Monitoring for 8 Weeks Glecaprevir/Pibrentasvir in Chronic Hepatitis C Patients
Status:
Completed
Trial end date:
2018-12-19
Target enrollment:
Participant gender:
Summary
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.
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 timepoint (SVR12).