Drug-Drug Interactions of Grazoprevir/Elbasvir in Taiwan

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

Official Title
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The Real World Analysis of Drug-Drug Interactions of Grazoprevir/Elbasvir in Treatment of Chronic Hepatitis C Patients in Taiwan

Conditions
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Drug Interaction Potentiation

Intervention / Treatment
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* Drug: elbasvir/grazoprevir


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Patients treated with grazoprevir/elbasvir are candidates of study subjects. Exclusion Criteria: none

Ages Eligible for Study
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Minimum Age: 20 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Drug interaction of Elbasvir/Grazoprevir<br>Patients treated with elbasvir/grazoprevir will be enrolled. DDI will be evaluated. | Drug: elbasvir/grazoprevir<br>* Comedications during elbasvir/grazoprevir will be recorded and analyzed for potential drug-drug interaction.<br>* Other names: Zepatier;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| the potential drug drug interaction of elbasvir/grazoprevor | the ratio of patients with at least one predicted DDI will be analyzed. | DDI will be assessed before and through the 12 weeks or 16 weeks of elbasvir/grazoprevir treatment | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| the comorbid diseases of CHC patients in Taiwan | Comorbid diseases will be recorded and categorized by involved organ systems before elbasvir/grazoprevir treatment. | Comorbid diseases will be assessed before elbasvir/grazoprevir treatment. |