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Antiretroviral therapy initiated before 12 weeks of age reduces early mortality in young HIV-infected infants: evidence from the Children with HIV Early Antiretroviral Therapy (CHER) Study
Presented by Avy Violari, South Africa.
Violari A.1, Cotton M.2, Gibb D.3, Babiker A.3, Steyn J.1, Jean-Phillip P.4, McIntyre J.1, on behalf of the CHER Study Team
1Perinatal HIV Research Unit, University of Witwatersrand, Witwatersrand, South Africa, 2Children's Infectious Diseases Clinical Research Unit, Faculty of Health Sciences, Stellenbosch University, Stellenbosch, South Africa, 3MRC-Clinical Trials Unit, London, United Kingdom, 4Division of AIDS, NIAID, NIH, Bethesda, United States
Objectives: There are no randomized trials on antiretroviral therapy (ART) started before 12 weeks of age.
Methods: Infants aged 6-12 weeks with CD4% ³ 25 were randomised to three arms: ART when the CD4% declined to <20% (25% if <1year; based on WHO guidelines) (Arm 1); ART with planned interruption at age 1year (Arm2) or 2years (Arm3). Infants with CD4% < 25 started ART following WHO guidelines and were not included in these randomisations. PMTCT regimens included Nevirapine (62%), ZDV+NVP (20%), none (11%) and HAART (2%). Following a recent DSMB review, we report early outcome of infants randomized to Arm 1 compared with early ART (Arms 2 and 3 combined).
Results: 252 infants were randomized to start ART (LPV/r, ZDV, 3TC) before 12 weeks (Arms 2 and 3) and 125 to Arm 1. Median age at randomisation was 7.4 weeks; 59% female; 95% CDC N or A; median (IQR) CD4% 35 (29 to 41)%. Over a median follow-up of 32 (20-48) weeks, a total of 30 infants died: 10 (4%) in Arms 2/3 and 20 (16%) in Arm 1 (HR 0.24 [95% CI 0.11 – 0.52]; p = 0.0002). 10 infants died at home; Among 20 infants dying in hospital, causes of death were gastroenteritis (7), sepsis/pneumonia (5), PCP/CMV (3), SIDS (1), other (4). By May 2007, 61% had initiated ART in Arm 1. Follow-up of all infants in CHER continues, with the aim of evaluating the long term benefits of early limited ART. Initiation of ART is being considered in all untreated children in Arm 1.
Conclusions: Early identification of HIV and initiation of ART results in a 75% reduction in early mortality in a resource-limited setting. These results will inform guidelines for ART management of young HIV-infected infants.
Sponsor: Comprehensive Program for Research in AIDS (CIPRA) Division of AIDS CIPRA-SA. Drugs provided by GSK and Department of Health, South Africa
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