Drug-Drug Interactions of Grazoprevir/Elbasvir in Taiwan

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.

Study Overview

• Status: Completed
• Conditions: Drug Interaction Potentiation
• Intervention / Treatment: Drug: elbasvir/grazoprevir

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 Type: Observational
• Enrollment (Actual): 400

Contacts and Locations

Study Locations

• Taiwan
  • Tainan, Taiwan, 704
    • National Cheng Kung University Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 20 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

Patients infected with genotype 1 or 4 hepatitis C virus and treated with elbasvir/grazoprevir during August 2017 to July 2018 in Taiwan.

Description

Inclusion Criteria:

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

Exclusion Criteria:

• none

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Drug interaction of Elbasvir/Grazoprevir; Patients treated with elbasvir/grazoprevir will be enrolled. DDI will be evaluated.	Drug: elbasvir/grazoprevir; Comedications during elbasvir/grazoprevir will be recorded and analyzed for potential drug-drug interaction.; Other Names: Zepatier

What is the study measuring?

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.

Collaborators and Investigators

• Sponsor: National Cheng-Kung University Hospital
• Collaborators: Merck Sharp & Dohme LLC
• Investigators: Principal Investigator: Pin-Nan Cheng, M.D., National Cheng-Kung University Hospital

Publications and helpful links

General Publications

• Liu CJ, Tseng KC, Lo CC, Tseng IH, Cheng PN. Limited drug-drug interaction of elbasvir/grazoprevir for chronic hepatitis C. J Formos Med Assoc. 2020 May;119(5):933-940. doi: 10.1016/j.jfma.2019.09.011. Epub 2019 Oct 5.

Study record dates

Study Major Dates

• Study Start (Actual): October 22, 2018
• Primary Completion (Actual): February 25, 2019
• Study Completion (Actual): February 25, 2019

Study Registration Dates

• First Submitted: October 8, 2018
• First Submitted That Met QC Criteria: October 10, 2018
• First Posted (Actual): October 15, 2018

Study Record Updates

• Last Update Posted (Actual): March 13, 2019
• Last Update Submitted That Met QC Criteria: March 12, 2019
• Last Verified: March 1, 2019

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Anti-Infective Agents; Antiviral Agents; Grazoprevir; Elbasvir-grazoprevir drug combination
• Other Study ID Numbers: MISP#57751

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No