NCT02940691

Scale-up of Treatment of Hepatitis C Infection Among People Who Inject Drugs

A Phase IV, Open-label, Single Arm, Multicentre Trial of Grazoprevir/Elbasvir for Genotype 1 or 4 in People With Chronic Hepatitis C Virus Infection and Recent Injecting Drug Use or Receiving Opioid Substitution Therapy

• Status: Terminated
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 32 (actual)
• Sponsor: Kirby Institute · Other Government
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

This study is a phase IV, open-label, single arm, multicentre study whose aim is to assess whether interferon-free and ribavirin-free Direct Acting Antiviral (DAA) Hepatitis C Virus (HCV) therapy with grazoprevir/elbasvir, will be feasible for the treatment of People who inject drugs (PWID) with recent injecting drug use or people receiving opioid substitution therapy and chronic HCV genotype 1 or 4 infection.

Detailed description

A prospective, observational cohort design will be used to enrol patients attending tertiary, drug and alcohol and primary health care services in Sydney, Australia. The study consists of a treatment phase (12 weeks) and a follow-up phase (up to 3 years) where participants will be followed every 3 months for the first year and every 6 months in years 2-3 to evaluate treatment response and reinfection. The effectiveness of the treatment will be assessed by looking at the proportion of patients with undetectable HCV RNA at 12 weeks post end of treatment (SVR12) following therapy with grazoprevir/elbasvir and evaluate demographic and clinical predictors of non-response.

Conditions

• Hepatitis C

Interventions

Type	Name	Description
DRUG	Grazoprevir/elbasvir	Grazoprevir/elbasvir (100mg/50mg) once daily for 12 weeks.

Timeline

• Start date: 2017-05-01
• Primary completion: 2018-11-01
• Completion: 2018-11-01
• First posted: 2016-10-21
• Last updated: 2020-03-09
• Results posted: 2019-12-30

Locations

5 sites across 1 country: Australia