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Abstract Details |
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Sofosbuvir/velpatasvir for 12 vs. 6 weeks for the treatment of recently acquired hepatitis C infection |
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J Hepatol. 2021 May 20;S0168-8278(21)00336-6. doi: 10.1016/j.jhep.2021.04.056.Online ahead of print.
Gail V Matthews 1, Sanjay Bhagani 2, Marc Van der Valk 3, Juergen Rockstroh 4, Jordan J Feld 5, Andri Rauch 6, Christine Thurnheer 6, Julie Bruneau 7, Arthur Kim 8, Margaret Hellard 9, David Shaw 10, Ed Gane 11, Mark Nelson 12, Patrick Ingiliz 13, Tanya L Applegate 14, Jason Grebely 14, Phillipa Marks 14, Marianne Martinello 14, Kathy Petoumenos 14, Gregory J Dore 15, REACT study group; Protocol Steering Committee; Marc van der Valk 16, Margaret Hellard 17, Ed Gane 11, Andri Rauch 18, Julie Bruneau 7, Arthur Kim 19, Sanjay Bhagani 20, Greg Dore 21, Pip Marks 22, Gail Matthews 22, Jason Grebely 22, Kathy Petoumenos 22, Marianne Martinello 22, Tanya Applegate 22, Jordan Feld 23, Jürgen Rockstroh 4, Coordinating Centre; Site Principal Investigators
Collaborators
- Gail Matthews 24, Pip Marks 24, Sophia Amjad 24, Elise Tu 24, Kathy Petoumenos 24, Mahshid Tamaddoni 24, Marc van der Valk 16, Margaret Hellard 17, Ed Gane 11, Maria Christine Thurnheer 18, Yvonne Gilleece 25, Julie Bruneau 7, Mark Nelson 26, Chris Fraser 27, Alberto Moriggia 28, Thomas Lutz 29, Juhi Moon 30, Phillip Read 31, Arthur Y Kim 19, Andrew Ustianowski 32, Christiane Cordes 33, David Shaw 10, Sanjay Bhagani 20, Joe Sasadeusz 34, Mark Hull 35, Greg Dore 21, Jordan Feld 23, Jürgen Rockstroh 4, Dominique Braun 36, Patrick Ingiliz 13
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Author information
- 1Kirby Institute, UNSW Sydney, Sydney, Australia; St Vincent's Hospital, Sydney, Australia. Electronic address: gmatthews@kirby.unsw.edu.au.
- 2Royal Free Hospital, London, United Kingdom.
- 3Amsterdam University Medical Centers, Academic Medical Center, University of Amsterdam, Department of Infectious Diseases, Amsterdam Infection & Immunity Institute, Amsterdam, the Netherlands.
- 4University Clinic Bonn, Bonn, Germany.
- 5Toronto Centre for Liver Diseases, Toronto General Hospital, Toronto, Canada.
- 6Department of Infectious Diseases, Inselspital, Bern, Switzerland.
- 7Centre Hospitalier de l'Université de Montréal, Montréal, Canada.
- 8Division of Infectious Diseases, Massachusetts General Hospital, Boston, United States.
- 9The Alfred Hospital, Melbourne, Australia; The Burnet Institute, Melbourne, Australia.
- 10Royal Adelaide Hospital, Adelaide, Australia.
- 11Auckland City Hospital, Auckland, New Zealand.
- 12Chelsea & Westminster Hospital, London, United Kingdom.
- 13Zentrum für Infektiologie Berlin-Prenzlauer Berg, Berlin, Germany.
- 14Kirby Institute, UNSW Sydney, Sydney, Australia.
- 15Kirby Institute, UNSW Sydney, Sydney, Australia; St Vincent's Hospital, Sydney, Australia.
- 16Amsterdam University medical Centers, The Netherlands.
- 17The Alfred Hospital and Burnet Institute, Melbourne, Australia.
- 18Bern Inselspital, Bern, Switzerland.
- 19Massachusetts General Hospital, Boston, USA.
- 20Royal Free Hospital, London, UK.
- 21St Vincent's Hospital, Sydney, Australia.
- 22The Kirby Institute, Sydney, Australia.
- 23Toronto General Hospital, Toronto, Canada.
- 24The Kirby Institute, UNSW Sydney, Sydney, Australia.
- 25Brighton and Sussex University Hospitals, Brighton, UK.
- 26Chelsea and Westminster Hospital, London, UK.
- 27Cool Aid Community Health Centre, Victoria, Canada.
- 28Fondazione Epatocentro Ticino, Lugano, Switzerland.
- 29Infektio-Research GmbH, Frankfurt, Germany.
- 30Johns Hopkins University, Baltimore, USA.
- 31Kirketon Road Centre, Sydney, Australia.
- 32Pennine Acute Hospitals, Manchester, UK.
- 33Praxis Dr Cordes, Berlin, Germany.
- 34Royal Melbourne Hospital, Melbourne, Australia.
- 35St Paul's Hospital, Vancouver, Canada.
- 36University Hospital Zurich, Zurich, Switzerland.
Abstract
Background and aims: Shortened duration therapy for acute and recent hepatitis C virus (HCV) infection has been shown to be highly effective in several small non-randomised studies with direct-acting antiviral regimens, however large randomised studies are lacking.
Methods: REACT was an NIH-funded multicentre international, open-label, randomised, phase 4 non-inferiority trial examining the efficacy of short course (6 weeks) versus standard course (12 weeks) therapy with sofosbuvir-velpatasvir for recent HCV infection (estimated duration of infection <= 12 months). Randomisation occurred at week 6. The primary endpoint was SVR12 in the intention-to treat (ITT) population. A total of 250 participants were planned for enrolment. On advice of the data safety and monitoring board the study was halted early.
Results: Primary analysis population consisted of 188 randomised participants at termination of study enrolment; short arm (n=93), standard arm (n=95). Ninety seven percent were male and 69% HIV positive. ITT SVR12 was 76/93, 81.7% (95% CI 72.4-89.0) in the short arm and 86/95, 90.5% (95% CI 82.7-95.6) in the standard arm. The difference between the arms was -8.8 (95% CI: -18.6, 1.0). By modified ITT analysis in which non-virological reasons for failure were excluded (death, reinfection, lost to follow-up) SVR12 was 76/85, 89.4% (95% CI 80.8-95.0) in the short arm and 86/88, 97.7% in the standard arm (95% CI 92.0-99.7; difference -8.3%, p=0.025).
Conclusions: In this randomised study in recent HCV infection, 6 weeks sofosbuvir-velpatasvir did not meet the criteria for non-inferiority to standard 12 weeks duration.
Lay summary: In this randomised trial one hundred and eighty people with recently acquired hepatitis C infection were randomly assigned to treatment using either a short 6-week course (93 people) or standard 12-week course (95 people) of the hepatitis C treatment sofosbuvir/velpatasvir. There were nine cases of relapse after treatment in the short course and two using the standard course. A shortened course of 6 weeks therapy for hepatitis C infection was considered not as effective as a standard twelve week course in people with recently acquired hepatitis C infection.
Trial registration: Clinicaltrials.gov Identifier: NCT02625909.
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