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Marina B Klein,1â 4 Jim Young,2 David Ortiz-Paredes,3 Shouao Wang,3 Sharon Walmsley,4,5 Alexander Wong,6 Valérie Martel-Laferrière,7 Neora Pick,8 Brian Conway,9 Jonathan Angel,10 Jean-Guy Baril,11 Chris Fraser,12 Bertrand Lebouché,3,13 Darrell HS Tan,14 Roger Sandre,15 Sylvie Trottier,16 Hansi Peiris,3 Jayamarx Jayaraman,4 Joel Singer4 On behalf of the CTN 286 Study Investigators1Division of Infectious Diseases and Chronic Viral Illness Service, Department of Medicine, McGill University Health Centre, Montreal, Canada; 2Department of Epidemiology, Biostatistics and Occupational Health, McGill University, Montreal, Canada; 3Centre for Outcomes Research and Evaluation, Research Institute of the McGill University Health Centre, Montreal, Canada; 4Canadian Institutes of Health Research, Canadian HIV Trials Network, Vancouver, Canada; 5University Health Network, University of Toronto, Toronto, Canada; 6Department of Medicine, University of Saskatchewan, Regina, Canada; 7Department of Microbiology and Infectious Diseases, Centre de recherche du Centre hospitalier de lâUniversité de Montréal, Montreal, Canada; 8Department of Medicine, Division of Infectious Diseases, University of British Columbia, Vancouver, Canada; 9Vancouver Infectious Diseases Centre, Vancouver, Canada; 10Ottawa Hospital Research Institute, Ottawa, Canada; 11Clinique de Médecine Urbaine du Quartier Latin, Montreal, Canada; 12Cool Aid Community Health Centre, Victoria, Canada; 13Department of Family Medicine, McGill University, Montreal, Canada; 14Toronto General Hospital Research Institute, University Health Network, Toronto, Canada; 15HAVEN Program, Health Sciences North, Sudbury, Canada; 16Centre de Recherche du CHU de Québec, Department of Microbiology, Infectiology and Immunology, Université Laval, Quebec, CanadaCorrespondence: Marina B Klein, Division of Infectious Diseases and Chronic Viral Illness Service, McGill University Health Centre, 1001 Decarie Boulevard, D02.4110, Montréal, H4A 3J1, Canada, Tel +1-514-843-2090, Fax +1-514-843-2092, Email marina.klein@mcgill.caBackground: Many people living with HIV struggle to consistently adhere to antiretroviral therapy, fail to achieve long-term virologic control and remain at risk for HIV-related disease progression, development of resistance and may transmit HIV infection to others.Objective: To determine if switching from current multi-tablet (curART) to single-tablet antiretroviral therapy (abacavir/lamivudine/dolutegravir; ABC/3TC/DTG), both combined with individualized adherence support, would improve HIV suppression in non-adherent vulnerable populations.Methods: TriiADD was an investigator-initiated randomized, multicentre, open label study. HIV+ adults with documented non-adherence on curART were randomized in a 1:1 ratio to immediately switch to ABC/3TC/DTG or to continue curART. Both arms received adherence support. The primary outcome was the proportion of participants in each arm with HIV RNA < 50 copies/mL 24 weeks after randomization.Results: In total, 50 people were screened and 27 randomized from 11 sites across Canada before the trial was stopped early due to slow recruitment. Participants were predominantly from ethnocultural communities, Indigenous people and/or had a history of injection drug use. The proportion achieving HIV RNA < 50 copies/mL at week 24 was 4/12 (33%) in the curART arm vs 7/13 (54%) in the ABC/3TC/DTG arm; median Bayesian risk difference, 5% (95% CrI, â 17 to 28%) higher for those randomized to ABC/3TC/DTG. We encountered difficulties with recruitment of participants without prior drug resistance, retention despite intensive support, reliably measuring adherence and in overcoming entrenched adherence barriers.Conclusion: Results of our trial are consistent with a slight improvement in viral suppression in a vulnerable population when a single tablet regimen is combined with patient-level adherence support. Beyond treatment simplicity and tolerability, tailored interventions addressing stigma and social determinants of health are still needed. The numerous challenges we encountered illustrate how randomised trials may not be the best approach for assessing adherence interventions in vulnerable populations.Keywords: adherence interventions, human immunodeficiency virus, HIV, antiretroviral therapy, single tablet regimen, vulnerable populations |
