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Efficacy and Tolerability of Grazoprevir and Elbasvir in Patients With Chronic Genotype 1 HCV and HIV Co-infection

Chronic Hepatitis C Clinical Trial

Official title:
Efficacy and Tolerability of Grazoprevir and Elbasvir in Peginterferon Alfa Plus Ribavirin Experienced Patients With Chronic Genotype 1 HCV and HIV Co-infection: a Non-randomised, Open-label Clinical Trial

Clinical Trial Summary

This clinical study will evaluate whether grazoprevir and elbasvir is efficacious, safe, and well-tolerated in peginterferon alfa plus ribavirin experienced patients who inject drugs (PWID) and men who sex with men (MSM) with genotype 1 HCV and HIV co-infection.

Clinical Trial Description

Primary Objective •To assess the efficacy of grazoprevir 100mg and elbasvir 50mg by determining the proportion of sustained virological response 12 weeks after the end of therapy (SVR12; HCV RNA concentration less than 10 IU/ mL at follow-up week 12) in peginterferon alfa plus ribavirin experienced patients with genotype 1 HCV and HIV co-infection, compared with treatment-naïve patients with 1 HCV and HIV co-infection.

Secondary Objective

•To assess the tolerability of grazoprevir 100mg and elbasvir 50mg in peginterferon alfa plus ribavirin experienced patients by measuring frequency of SAEs and AEs leading to discontinuation. ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT03098121
Study type Interventional
Source Taoyuan General Hospital
Contact
Status Completed
Phase Phase 4
Start date October 20, 2017
Completion date November 30, 2018
View Details
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