Drug-Drug Interactions of Grazoprevir/Elbasvir in Taiwan

N

National Cheng-Kung University

Status

Completed

Conditions

Drug Interaction Potentiation

Treatments

Drug: elbasvir/grazoprevir

Study type

Observational

Funder types

Other
Industry

Identifiers

NCT03706222
MISP#57751

Details and patient eligibility

About

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.

Full 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.

Enrollment

400 patients

Sex

All

Ages

20+ years old

Volunteers

No Healthy Volunteers

Inclusion criteria

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

Exclusion criteria

none

Trial design

400 participants in 1 patient group

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

Trial documents
1

Trial contacts and locations

0

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Data sourced from clinicaltrials.gov

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