Drug Interaction Potentiation Clinical Trial
Official title:
The Real World Analysis of Drug-Drug Interactions of Grazoprevir/Elbasvir in Treatment of Chronic Hepatitis C Patients in Taiwan
Co-morbid diseases often present in a substantial proportion of patients with chronic hepatitis C (CHC) and require drugs to treat and control. Grazoprevir/elbavir is metabolized by cytochrome P-450 enzyme of liver. Drug-drug interactions (DDIs) are important issue before commencing direct acting antiviral agents (DAA) treatment for CHC patients. Few studies from Western countries reported that the percentages of DDIs of grazoprevir/elbasvir are limited.In Asia, real-world analysis of DDIs of grazoprevir/elbasvir is lacking and needs to be clarified.
This is a multi-center, retrospective study. Five hospitals in Taiwan and 400 patients
Patients treated with grazoprevir/elbasvir during August 2017 to July 2018 are candidates of
study subjects. All the required study information will be recorded with detailed chart
review.
DDI will be evaluated by HEP Drug Interactions (www.hep-druginteractions.org) assessment of
comidications: Category 0: Classification not possible due to lack of information; Category
1: No clinical interaction possible; Category 2: May require dose adjustment/closer
monitoring; Category 3: Coadministration not recommended or contraindicated.
The assessment of DDI will be evaluated and recorded according to the suggested categories,
the number of patients at risk for a clinically relevant DDI, and the ratio of patients with
at least one predicted DDI between medication of grazoprevir/elbasvir will be calculated.
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