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

NCT ID: NCT02940691

Last Updated: 2020-03-09

Basic Information

• Recruitment Status: TERMINATED
• Clinical Phase: PHASE4
• Total Enrollment: 32 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2017-05-01
• Study Completion Date: 2018-11-01

Brief 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

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Grazoprevir/elbasvir

Grazoprevir/elbasvir (100mg/50mg) daily taken orally for 12 weeks.

Group Type: EXPERIMENTAL

Grazoprevir/elbasvir

Intervention Type: DRUG

Grazoprevir/elbasvir (100mg/50mg) once daily for 12 weeks.

Interventions

Grazoprevir/elbasvir

Grazoprevir/elbasvir (100mg/50mg) once daily for 12 weeks.

Intervention Type: DRUG

Other Intervention Names

Zepatier

Eligibility Criteria

Inclusion Criteria

• Participants have voluntarily signed the informed consent form.
• Be ≥18 years of age on day of signing informed consent form.
• Have chronic HCV genotype 1 or 4 infection (defined as detectable HCV RNA).
• Recent injecting drug use (previous 6 months) or receiving opioid substitution therapy.
• HIV-1 infected subjects enrolled in the study must meet the following criteria:

• Have HIV infection documented by any licensed rapid HIV test or HIV enzyme or chemiluminescence immunoassay (E/CIA) test kit at any time prior to study entry (Baseline) and confirmed by a licensed Western blot or a second antibody test by a method other than the initial rapid HIV and/or E/CIA, or by HIV-1 p24 antigen, or plasma HIV-1 RNA viral load
• b) Be on HIV Antiretroviral Therapy (ART) for at least 4 weeks prior to study entry using an ART regimen that is allowable with the intended DAA regimen as determined by the current PI and the Liverpool drug interaction website (http://www.hiv-druginteractions.org/) or current prescribing guidelines for elbasvir/grazoprevir OR be naive to treatment with any antiretroviral therapy (ART) with a baseline CD4 count of >200 and have no plans to initiate ART treatment while participating in this study and through to at least Follow-up Week 4.
• Negative pregnancy test at screening and baseline (females of childbearing potential only).
• All fertile males and females must be using effective contraception during treatment and during 14 days after treatment end.

Exclusion Criteria

• Is taking or plans to take any prohibited medications as per DAA Product Information or herbal supplements, including but not limited to St. John's Wort (Hypericum perforatum) within 2 weeks of Baseline.
• Is currently using or intends to use barbiturates.
• Is a female and is pregnant or breast-feeding, or expecting to conceive or donate eggs from Baseline and continue throughout treatment, and after the last dose of study medication (as per the regimen requirements), or longer if dictated by local regulations.
• Has any condition or pre-study laboratory abnormality, ECG abnormality or history of any illness, which, in the opinion of the investigator, might confound the results of the study or pose additional risk in administering the study drugs to the subject.
• Had a life-threatening SAE during the screening period.
• Has exclusionary laboratory values as listed below:

• Haemoglobin < 9.5 g/dL for both males and females
• Platelets < 50 x 10^3 /µL
• Serum albumin < 3.0 g/dL
• Patients with Child Pugh-B or C decompensated cirrhosis
• Previous HCV treatment-experience.
• Ongoing severe psychiatric disease as judged by the treating physician.
• Frequent injecting drug use that is judged by the treating physician to compromise treatment safety.
• Inability or unwillingness to provide informed consent or abide by the requirements of the study.
• Is Hepatitis B surface antigen (HBsAg) positive

NOTE: Sanger sequencing will be performed on a pre-treatment sample on all participants.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Kirby Institute

OTHER_GOV

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Greg Dore, MBBS

Role: PRINCIPAL_INVESTIGATOR

Kirby Institute

Locations

Kirketon Road Centre

Darlinghurst, New South Wales, Australia

St Vincent's Hospital

Darlinghurst, New South Wales, Australia

The Langton Centre

Darlinghurst, New South Wales, Australia

Nepean Hospital

Kingswood, New South Wales, Australia

Drug and Alcohol Clinical Services (Hunter)

Newcastle, New South Wales, Australia

Countries

Australia

References

Grebely J, Read P, Cunningham EB, Weltman M, Matthews GV, Dunlop A, Montebello M, Martinello M, Gilliver R, Marks P, Applegate TL, Dore GJ; DARLO-C Study Group. Elbasvir and grazoprevir for hepatitis C virus genotype 1 infection in people with recent injecting drug use (DARLO-C): An open-label, single-arm, phase 4, multicentre trial. Health Sci Rep. 2020 Mar 15;3(2):e151. doi: 10.1002/hsr2.151. eCollection 2020 Jun.

Reference Type: DERIVED

PMID: 32270056 (View on PubMed)

Provided Documents

Document Type: Study Protocol and Statistical Analysis Plan

View Document

Other Identifiers

VHCRP1510

Identifier Type: -

Identifier Source: org_study_id