TARGET3D
Research type
Research Study
Full title
An open-label, multicentre, international pilot study of paritaprevir/ritonavir, ombitasvir, dasabuvir with or without ribavirin for people with recently acquired hepatitis C virus infection with or without HIV co-infection.
IRAS ID
188893
Contact name
Mark Nelson
Contact email
Sponsor organisation
University of New South Wales
Eudract number
2015-005084-16
Clinicaltrials.gov Identifier
Duration of Study in the UK
3 years, 1 months, 24 days
Research summary
Summary of research
This study is a prospective 2-arm study examining a new treatment regimen of direct acting antivirals (DAA) in people with recently acquired hepatitis C genotype 1 infection. The safety, efficacy and feasibility of the new AbbVie "3D" regimen paritaprevir/ritonavir/ombitasvir, dasabuvir with or without ribavirin will be explored for 8 (and then potentially) 6 weeks.The study consists of a screening phase (4 to 12 weeks), a treatment phase (6 or 8 weeks), an early follow-up phase (1, 3 and 6 months after the end of treatment) and a long term follow-up phase (yearly visits for 4 years).
The effectiveness of the treatment will be assessed by looking at the proportion of participants who clear the virus (have no virus detectable in their blood) 4 weeks following the commencement of treatment, at the end of treatment, 1, 3 (study primary objective), 6 months. Reinfection will be evaluated annually through to the end of study follow-up.
Summary of Results
: Currently, people who are newly infected with Hepatitis C (HCV) are treated for the same amount of time as people who have been infected for a long time, despite previous research showing shortened treatment courses (when using older style drugs such as interferon) may be sufficient. It is not known whether a shorter course with the new HCV drugs would cure people who have been recently infected with HCV.TARGET3D Cohort 3 looked at whether four weeks of the new HCV drugs, glecaprevir-pibrentasvir, was just as good as the usual course of treatment for everyone with HCV, regardless of how long they’ve been infected for. People had to have been infected for a year or less. People with HIV were all able to participate.
The study enrolled a total 23 of 30 people from Australia, England, and New Zealand from December 2018 to December 2020. The study was stopped early because the impact of COVID-19 pandemic on recruitment and study activities.
Of the 23 people enrolled:
• 96% were male
• 70% had HIV
• 78% had hepatitis C genotype 1 infection
• At time of starting treatment, most had been infected with HCV for between six and 12 months (61%).Study Key Findings:
• All people completed four weeks of treatment with glecaprevir-pibrentasvir, and 78% (18 of 23) were cured.
• People with a low amount of virus detected in their blood on starting treatment had higher cure rates (HCV RNA <1,000,000 IU/mL; 100%; 15/15).
• Of those people who were not cured, four people relapsed after treatment (this means they had virus detectable in their blood after not having virus detected while on treatment). Three people were retreated outside the study, of which two were cured.
• Treatment was safe and well tolerated. Treatment did not cause any serious side effects or problems.Conclusion:
The TARGET3D Cohort 3 study was the first to look at shortening treatment with glecaprevir-pibrentasvir for people with new HCV infection. While many people were cured, it wasn’t enough to make four weeks of treatment with glecaprevir-pibrentasvir the standard practice for people with recently infected with HCV.Study Publications:
An abstract was presented at the Conference on Retroviruses and Opportunistic Infections (CROI) 2023. A publication is being prepared for submission to Hepatology.REC name
London - Riverside Research Ethics Committee
REC reference
16/LO/0952
Date of REC Opinion
8 Jul 2016
REC opinion
Further Information Favourable Opinion