Randomised Study of Interferon-free Treatment for Recently Acquired Hepatitis C in PWID and People With HIV Coinfection.
REACT
A Randomised Study of Interferon-free Treatment for Recently Acquired Hepatitis C in People Who Inject Drugs and People With HIV Coinfection.
1 other identifier
interventional
222
8 countries
25
Brief Summary
The aim of the study is to determine if treatment for recently acquired hepatitis C infection (with or without HIV coinfection) can be shortened when treating with the interferon-free therapy sofosbuvir/velpatasvir (SOF/VEL). SOF/VEL is a new treatment for hepatitis C called direct acting antiviral which targets the hepatitis C virus replication cycle and has been shown in phase II studies in chronic HCV to be highly effective (SVR12 \>95%) when given for 12 weeks. Data has shown that treatment can be shortened when treating recently acquired HCV with interferon containing treatments. It is not known whether treatment with SOF/VEL can be shortened. This study aims to find out if treatment for 6 weeks with open-label SOF/VEL is equivalent to treatment for 12 weeks with SOF/VEL in participants with recently acquired hepatitis C infection. The project is a randomised study where both participants and investigators would not find out the treatment duration of the participants until week 6 of treatment.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for phase_3
Started Mar 2017
Typical duration for phase_3
25 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
December 7, 2015
CompletedFirst Posted
Study publicly available on registry
December 9, 2015
CompletedStudy Start
First participant enrolled
March 9, 2017
CompletedPrimary Completion
Last participant's last visit for primary outcome
March 23, 2020
CompletedStudy Completion
Last participant's last visit for all outcomes
March 23, 2020
CompletedResults Posted
Study results publicly available
November 24, 2021
CompletedNovember 24, 2021
November 1, 2021
3 years
December 7, 2015
September 15, 2021
November 22, 2021
Conditions
Outcome Measures
Primary Outcomes (1)
Number of Participants With Undetectable HCV RNA at 12 Weeks Post End of Treatment (SVR12) Following SOF/VEL for 6 Weeks as Compared With 12 Weeks in People With Recent HCV Infection- Among Intention-to-treat (ITT) Population
To evaluate the proportion of participants with HCV RNA below the level of quantification at 12 weeks post treatment following SOF/VEL for 6 weeks as compared with 12 weeks in people with recent HCV infection- among intention-to-treat (ITT) population The ITT population included all randomized participants, with loss to follow-up deemed treatment failure.
12 weeks post treatment
Secondary Outcomes (3)
Number of Participants With Undetectable HCV RNA at 12 Weeks Post End of Treatment (SVR12) Following SOF/VEL for 6 Weeks as Compared With 12 Weeks in People With Recent HCV Infection- Among Modified Intention-to-treat (ITT) Population
12 Weeks Post End of Treatment
Number of Participants With Undetectable HCV RNA at End of Treatment (ETR) of SOF/VEL for 6 Weeks as Compared With 12 Weeks in People With Recent HCV Infection- Among Intention-to-treat (ITT) Population
End of treatment - week 6 of the shortened treatment duration arm, and week 12 of the standard treatment duration arm
Number of Participants With Undetectable HCV RNA at 12 Weeks Post End of Treatment (SVR12) Following SOF/VEL for 6 Weeks as Compared With 12 Weeks in People With Recent HCV Infection- Among Per Protocol (PP) Population
12 weeks post treatment
Study Arms (2)
Drug: SOF/VEL for 6 weeks
EXPERIMENTALOpen-label SOF/VEL 400mg/100mg co-formulated tablet once daily will be given to participants who are randomised into the short treatment duration arm (A) for 6 weeks.
Drug: SOF/VEL for 12 weeks
EXPERIMENTALOpen-label SOF/VEL 400mg/100mg co-formulated tablet once daily will be given to participants who are randomised into the standard treatment duration arm (B) for 12 weeks.
Interventions
Open-label SOF/VEL 400mg/100mg once daily to be given to participants randomised to Arm A (6 weeks short treatment duration).
Open-label SOF/VEL 400mg/100mg once daily to be given to participants randomised to Arm B (12 weeks standard treatment duration).
Eligibility Criteria
You may qualify if:
- Participants have voluntarily signed the informed consent form.
- years of age or older.
- Detectable HCV RNA at screening (\>10,000 IU/ml), and in the opinion of the investigator is unlikely to demonstrate spontaneous viral clearance
- HCV genotypes 1-6.
- HBsAg negative
- Compensated liver disease (Child-Pugh A)
- Negative pregnancy test at baseline (females of childbearing potential only).
- Medically stable on the basis of physical examination, medical history and vital signs
- Adequate English to provide reliable responses to the study questionnaires
- All fertile males and females must be using effective contraception during treatment and during the 30 days after treatment end.
- Recently acquired HCV infection (estimated duration of infection ≤12 months)\*
- Recently acquired HCV infection as defined by:
- A) i) First anti-HCV Ab or HCV RNA positive within the previous 3 months and ii) Documented anti-HCV Ab negative within the 12 months prior to anti-HCV antibody positive result
- B) i) First anti-HCV Ab or HCV RNA positive within the previous 3 months and ii) Acute clinical hepatitis \[jaundice or alanine aminotransferase (ALT)\] \> 10 X ULN) within the previous 6 months prior to first positive HCV antibody or HCV RNA, with no other cause of acute hepatitis identifiable
- C) For cases of recent HCV reinfection the following criteria are required:
- +16 more criteria
You may not qualify if:
- History of any of the following:
- Clinically significant illness (other than HCV) or any other major medical disorder that may interfere with the participant treatment, assessment or compliance with the protocol; participants currently under evaluation for a potentially clinically significant illness (other than HCV) are also excluded.
- History of chronic pulmonary disease associated with functional limitation, severe cardiac disease, major organ transplantation or other evidence of severe illness, malignancy, or any other conditions which would make the patient, in the opinion of the investigator, unsuitable for the study
- Solid organ transplant
- Malignancy within 5 years prior to screening, with exception of specific cancers that may have been cured by surgical resection (basal cell skin cancer, etc.). Subjects under evaluation for possible malignancy are also excluded.
- Significant drug allergy (such as anaphylaxis or hepatotoxicity).
- Subject shows evidence of significant liver disease in addition to hepatitis C, which may include but is not limited to drug- or alcohol-related cirrhosis, autoimmune hepatitis, hemochromatosis, Wilson's disease, non-alcoholic steatohepatitis (NASH), or primary biliary cirrhosis
- Subject has known cirrhosis
- Any of the following lab parameters at screening:
- Direct bilirubin \> 1.5 x ULN
- Platelets \< 50,000/μL
- Creatinine clearance (CLcr) \< 60 mL/min
- Haemoglobin \< 11 g/dL for females ; \< 12 g/dL for males
- Albumin \< 30g/L
- Pregnant or nursing female.
- +9 more criteria
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Kirby Institutelead
Study Sites (25)
Johns Hopkins University
Baltimore, Maryland, 21287, United States
Massachusetts General Hospital
Boston, Massachusetts, 02114-2621, United States
Kirketon Road Centre
Sydney, New South Wales, 1340, Australia
St. Vincent's Hospital
Sydney, New South Wales, 2010, Australia
The Kirby Institute, University of New South Wales Australia
Sydney, New South Wales, 2052, Australia
Royal Adelaide Hospital
Adelaide, South Australia, 5000, Australia
The Alfred Hospital
Melbourne, Victoria, 3004, Australia
Royal Melbourne Hospital
Melbourne, Victoria, 3050, Australia
St Paul's Hospital
Vancouver, British Columbia, V6Z 1Y6, Canada
Cool Aid Community Health Centre
Victoria, British Columbia, V8W 1M8, Canada
Toronto General Hospital
Toronto, Ontario, ON M57 2S8, Canada
Centre Hospitalier de l' Universite de Montreal
Montreal, Quebec, QC H2X 1P1, Canada
Praxis Dr Cordes
Berlin, 10243, Germany
Zentrum für Infektiologie Berlin-Prenzlauer Berg
Berlin, 10439, Germany
University Hospital of Bonn
Bonn, 53105, Germany
Infektio-Research GmbH
Frankfurt, 60596, Germany
Academic Medical Centre, University of Amsterdam
Amsterdam, 1105 AZ, Netherlands
Auckland City Hospital
Auckland, 1142, New Zealand
University Hospital Zurich
Zurich, Canton of Zurich, 8091, Switzerland
Bern University Hospital
Bern, 3010, Switzerland
Fondazione Epatocentro Ticino
Lugano, 6900, Switzerland
Brighton & Sussex University Hospitals NHS Trust
Brighton, Brigton and Hove, BN2 1ES, United Kingdom
Pennine Acute Hospitals NHS Trust
Manchester, Lancashire, M8 5RB, United Kingdom
Royal Free Hospital
London, NW3 2QG, United Kingdom
Chelsea & Westminster Hospital
London, SW10 9NH, United Kingdom
Related Publications (2)
Carson JM, Barbieri S, Cunningham E, Mao E, van der Valk M, Rockstroh JK, Hellard M, Kim A, Bhagani S, Feld JJ, Gane E, Thurnheer MC, Bruneau J, Tu E, Dore GJ, Matthews GV, Martinello M; REACT study group. Sexual and drug use risk behaviour trajectories among people treated for recent HCV infection: the REACT study. J Int AIDS Soc. 2023 Sep;26(9):e26168. doi: 10.1002/jia2.26168.
PMID: 37675828DERIVEDMatthews GV, Bhagani S, Van der Valk M, Rockstroh J, Feld JJ, Rauch A, Thurnheer C, Bruneau J, Kim A, Hellard M, Shaw D, Gane E, Nelson M, Ingiliz P, Applegate TL, Grebely J, Marks P, Martinello M, Petoumenos K, Dore GJ; REACT study group; Protocol Steering Committee; Coordinating Centre; Site Principal Investigators. Sofosbuvir/velpatasvir for 12 vs. 6 weeks for the treatment of recently acquired hepatitis C infection. J Hepatol. 2021 Oct;75(4):829-839. doi: 10.1016/j.jhep.2021.04.056. Epub 2021 May 21.
PMID: 34023350DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Results Point of Contact
- Title
- Pip Marks, Clinical Trials Manager
- Organization
- The Kirby Institute
Study Officials
- PRINCIPAL INVESTIGATOR
Gail V Matthews, MbChB, PhD
The Kirby Institute, University of New South Wales Australia, Sydney, New South Wales, Australia, NSW 2052
Publication Agreements
- PI is Sponsor Employee
- No
- Restrictive Agreement
- No
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- OTHER GOV
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
December 7, 2015
First Posted
December 9, 2015
Study Start
March 9, 2017
Primary Completion
March 23, 2020
Study Completion
March 23, 2020
Last Updated
November 24, 2021
Results First Posted
November 24, 2021
Record last verified: 2021-11
Data Sharing
- IPD Sharing
- Will share
- Shared Documents
- STUDY PROTOCOL, SAP, ICF, CSR, ANALYTIC CODE
- Time Frame
- Available following publication of the primary manuscript, indefinitely
- Access Criteria
- Submission of a research concept sheet proposal to the study Principal Investigator for review and approval by the protocol steering committee,
No individual participant data will be shared. The results of the project will be presented at scientific meetings, and published in peer reviewed scientific literature. Sharing of data generated by this project is an essential part of our proposed activities and will be carried out in several different ways. We plan to make our results available to the community of scientists interested in recently acquired hepatitis C, community organisations representing the affected communities and participants. We also welcome collaboration with others who could make use of data and samples.