Mortality under early access to antiretroviral therapy vs. Eswatini's national standard of care: the MaxART clustered randomized stepped-wedge trial.

Autor: Chao A; Department of Biostatistics, Yale School of Public Health, Center for Methods in Implementation and Prevention Science (CMIPS), New Haven, CT, USA., Spiegelman D; Department of Biostatistics, Yale School of Public Health, Center for Methods in Implementation and Prevention Science (CMIPS), New Haven, CT, USA., Khan S; Clinton Health Access Initiative (CHAI), Mbabane, Eswatini., Walsh F; Clinton Health Access Initiative (CHAI), Boston, MA, USA., Mazibuko S; Eswatini National ART program (SNAP), Ministry of Health, Mbabane, Eswatini., Pasipamire M; Eswatini National ART program (SNAP), Ministry of Health, Mbabane, Eswatini., Chai B; Department of Nutrition, Harvard T.H. Chan School of Public Health, Boston, MA, USA., Reis R; Leiden University Medical Center, Leiden University, Leiden, Netherlands.; Amsterdam Institute for Social Science, University of Amsterdam, Amsterdam, Netherlands.; Children's Institute, University of Cape Town, Cape Town, South Africa., Mlambo K; Clinton Health Access Initiative (CHAI), Mbabane, Eswatini., Delva W; The South African Department of Science and Technology - National Research Foundation (DST-NRF) Centre of Excellence in Epidemiological Modelling and Analysis (SACEMA), Stellenbosch University, Stellenbosch, South Africa.; Center for Statistics, Hasselt University, Diepenbeek, Belgium.; International Centre for Reproductive Health, Ghent University, Gent, Belgium.; Rega Institute for Medical Research, KU Leuven, Leuven, Belgium., Khumalo G; Eswatini National Network of People Living with HIV (SWANNEPHA), Mbabane, Eswatini., Zwane M; SAfAIDS, Manzini, Eswatini., Fleming Y; Aidsfonds, Amsterdam, Netherlands., Mafara E; Clinton Health Access Initiative (CHAI), Mbabane, Eswatini., Hettema A; Clinton Health Access Initiative (CHAI), Mbabane, Eswatini., Lejeune C; Clinton Health Access Initiative (CHAI), Mbabane, Eswatini., Bärnighausen T; Heidelberg Institute of Public Health, University of Heidelberg, Heidelberg, Germany., Okello V; Directorate Office, Ministry of Health, Mbabane, Eswatini.
Jazyk: angličtina
Zdroj: HIV medicine [HIV Med] 2020 Aug; Vol. 21 (7), pp. 429-440. Date of Electronic Publication: 2020 May 26.
DOI: 10.1111/hiv.12876
Abstrakt: Objectives: Current WHO guidelines recommend the treatment of all HIV-infected individuals with antiretroviral therapy (ART) to improve survival and quality of life, and decrease infection of others. MaxART is the first implementation trial of this strategy embedded within a government-managed health system, and assesses mortality as a secondary outcome. Because primary findings strongly supported scale-up of the 'treat all' strategy (hereafter Treat All), this analysis examines mortality as an additional indicator of its impact.
Methods: MaxART was conducted in 14 Eswatinian health clinics through a clinic-based stepped-wedge design, by transitioning clinics from then-national standard of care (SoC) to the Treat All intervention. All-cause, disease-related, and HIV-related mortality were analysed using the Cox proportional hazards model, censoring SoC participants at clinic transition. Median follow-up time among study participants was 292 days. There were 36/2034 deaths in SoC (1.77%) and 49/1371 deaths in Treat All (3.57%).
Results: Between September 2014 and August 2017, 3405 participants were enrolled. In SoC and Treat All interventions, respectively, the multivariable-adjusted 12-month all-cause mortality rates were 1.42% [95% confidence interval (CI): 0.66-2.17] and 1.60% (95% CI: 0.78-2.40), disease-related mortality rates were 1.02% (95% CI: 0.40-1.64) and 1.10% (95% CI: 0.46-1.73), and HIV-related mortality rates were 1.03% (95% CI: 0.40-1.65) and 0.99% (95% CI: 0.40-1.58). Treat All had no impact on all-cause [hazard ratio (HR) = 1.12, 95% CI: 0.58-2.18, P = 0.73], disease-related (HR = 1.04, 95% CI: 0.52-2.11, P = 0.90), or HIV-related mortality (HR = 0.93, 95% CI: 0.46-1.87, P = 0.83).
Conclusion: There was no immediate benefit of the Treat All strategy on mortality, nor evidence of harm. Longer follow-up of participants is needed to establish long-term consequences.
(© 2020 British HIV Association.)
Databáze: MEDLINE
Externí odkaz:
Nepřihlášeným uživatelům se plný text nezobrazuje