Drug-Drug Interactions of Grazoprevir/Elbasvir in Taiwan

Completed

• Conditions: Drug Interaction Potentiation
• Interventions: Drug: elbasvir/grazoprevir

• Registration Number: NCT03706222
• Lead Sponsor: National Cheng-Kung University Hospital

Brief Summary

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

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.

Study Timeline

• Study First Submitted: 2018-10-08
• Study First Submitted QC: 2018-10-10
• Study First Posted: 2018-10-15
• Study Start: 2018-10-22
• Primary Completion: 2019-02-25
• Study Completion: 2019-02-25
• Status Verified: 2019-03
• Last Update Submitted: 2019-03-12
• Last Update Posted: 2019-03-13

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 400

Inclusion Criteria

• Patients treated with grazoprevir/elbasvir are candidates of study subjects.

Exclusion Criteria

• none

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Drug interaction of Elbasvir/Grazoprevir	elbasvir/grazoprevir	Patients treated with elbasvir/grazoprevir will be enrolled. DDI will be evaluated.

Primary Outcome Measures

Name	Time	Method
the potential drug drug interaction of elbasvir/grazoprevor	DDI will be assessed before and through the 12 weeks or 16 weeks of elbasvir/grazoprevir treatment	the ratio of patients with at least one predicted DDI will be analyzed.

Secondary Outcome Measures

Name	Time	Method
the comorbid diseases of CHC patients in Taiwan	Comorbid diseases will be assessed before elbasvir/grazoprevir treatment.	Comorbid diseases will be recorded and categorized by involved organ systems before elbasvir/grazoprevir treatment.

Trial Locations

Locations (1)

National Cheng Kung University Hospital; 🇨🇳 Tainan, Taiwan