Background:Antiretroviral treatment (ART) reduces HIV infectiousness but the effect of early ART on sexual behaviour is unclear.Methods:We assessed, within the START randomized trial that enrolled HIV-positive adults with CD4+ cell count greater than 500cells/μl, the effect of early (immediate) versus deferred ART on: condomless sex with HIV-serodifferent partners (CLS-D); all condomless sex (CLS); HIV transmission-risk sex (CLS-D-HIV risk, defined as CLS-D and: not on ART or started ART <6 months ago or viral load greater than 200 copies/ml or no viral load in past 6 months), during 2-year follow-up. Month-12 CLS-D (2010-2014) was the primary outcome.Results:Among 2562 MSM, there was no difference between immediate and deferred arms in CLS-D at month 12 [12.6 versus 13.1%; difference (95% CI):-0.4% (-3.1 to 2.2%), P=0.75] or month 24, or in CLS. Among 2010 heterosexual men and women, CLS-D at month 12 tended to be higher in the immediate versus deferred arm [10.8 versus 8.3%; difference:2.5% (-0.1 to 5.2%), P=0.062]; the difference was greater at month 24 [9.3 versus 5.6%; difference: 3.7% (1.0 to 6.4%), P=0.007], at which time CLS was higher in the immediate arm (20.7 versus 15.7%, P=0.013). CLS-D-HIV risk at month 12 was substantially lower in the immediate versus deferred arm for MSM [0.2 versus 11%; difference:-10.7% (-12.5 to-8.9%), P<0.001] and heterosexuals [0.6% versus 7.7%; difference:-7.0% (-8.8 to-5.3%), P<0.001], because of viral suppression on ART.Conclusion:A strategy of early ART had no effect on condomless sex with HIV-serodifferent partners among MSM, but resulted in modestly higher prevalence among heterosexuals. However, among MSM and heterosexuals, early ART resulted in a substantial reduction in HIV-Transmission-risk sex, to a very low absolute level.
Bibliographical noteFunding Information:
Funding: The START study was primarily funded by the National Institute of Allergy and Infectious Diseases of the National Institutes of Health under Award numbers: UM1-AI068641 and UM1-AI120197. START was supported by the National Institutes of Health Clinical Center, National Cancer Institute, National Heart, Lung, and Blood Institute, Eunice Kennedy Shriver National Institute of Child Health and Human Development, National Institute of Mental Health, National Institute of Neurological Disorders and Stroke, National Institute of Arthritis and Musculoskeletal and Skin Diseases, Agence Nationale de Recherches sur le SIDA et les Hépatites Virales (France), National Health and Medical Research Council (Australia), National Research Foundation (Denmark), Bundes ministerium für Bildung und Forschung (Germany), European AIDS Treatment Network, Medical Research Council (United Kingdom), National Institute for Health Research, National Health Service (United Kingdom), and University of Minnesota. Antiretroviral drugs were donated to the central drug repository by AbbVie, Bristol-Myers Squibb, Gilead Sciences, GlaxoSmithKline/ViiV Healthcare, Janssen Scientific Affairs and Merck.
G.M.C. has done paid consultancy work for Gilead Sciences, ViiV Healthcare and Mylan. J.M.M has received grants from Gilead and honoraria for advisory boards with Gilead, Merck and ViiV. J. Ga. has received honoraria for lectures and advisory boards, and has institution (Hospital Clinic de Barcelona) research grants from ViiV, Gilead, Janssen and MSD. Since May 2018 J Ga is a full time employee of ViiV Healthcare. F.C.L., A.J. R., W.B., A.G., G.F., W.E.S.,J.N., S.E.,C.O., J. Ge., K.R., A.N.P have no conflicts of interest.
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- Antiretroviral therapy
- Condomless sex