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Publication Details
AFRICAN RESEARCH NEXUS
SHINING A SPOTLIGHT ON AFRICAN RESEARCH
medicine
Early antiretroviral therapy and mortality among HIV-infected infants
New England Journal of Medicine, Volume 359, No. 21, Year 2008
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Description
BACKGROUND: In countries with a high seroprevalence of human immunodeficiency virus type 1 (HIV-1), HIV infection contributes significantly to infant mortality. We investigated antiretroviral-treatment strategies in the Children with HIV Early Antiretroviral Therapy (CHER) trial. METHODS: HIV-infected infants 6 to 12 weeks of age with a CD4 lymphocyte percentage (the CD4 percentage) of 25% or more were randomly assigned to receive antiretroviral therapy (lopinavir-ritonavir, zidovudine, and lamivudine) when the CD4 percentage decreased to less than 20% (or 25% if the child was younger than 1 year) or clinical criteria were met (the deferred antiretroviral-therapy group) or to immediate initiation of limited antiretroviral therapy until 1 year of age or 2 years of age (the early antiretroviral-therapy groups). We report the early outcomes for infants who received deferred antiretroviral therapy as compared with early antiretroviral therapy. RESULTS: At a median age of 7.4 weeks (interquartile range, 6.6 to 8.9) and a CD4 percentage of 35.2% (interquartile range, 29.1 to 41.2), 125 infants were randomly assigned to receive deferred therapy, and 252 infants were randomly assigned to receive early therapy. After a median follow-up of 40 weeks (interquartile range, 24 to 58), antiretroviral therapy was initiated in 66% of infants in the deferred-therapy group. Twenty infants in the deferred-therapy group (16%) died versus 10 infants in the early-therapy groups (4%) (hazard ratio for death, 0.24; 95% confidence interval [CI], 0.11 to 0.51; P<0.001). In 32 infants in the deferred-therapy group (26%) versus 16 infants in the early-therapy groups (6%), disease progressed to Centers for Disease Control and Prevention stage C or severe stage B (hazard ratio for disease progression, 0.25; 95% CI, 0.15 to 0.41; P<0.001). Stavudine was substituted for zidovudine in four infants in the early-therapy groups because of neutropenia in three infants and anemia in one infant; no drugs were permanently discontinued. After a review by the data and safety monitoring board, the deferred-therapy group was modified, and infants in this group were all reassessed for initiation of antiretroviral therapy. CONCLUSIONS: Early HIV diagnosis and early antiretroviral therapy reduced early infant mortality by 76% and HIV progression by 75%. (ClinicalTrials.gov number, NCT00102960.) Copyright © 2008 Massachusetts Medical Society.
Authors & Co-Authors
Violari, Avy
South Africa, Johannesburg
University of the Witwatersrand
Cotton, Mark Fredric
South Africa, Cape Town
Stellenbosch University, Faculty of Medicine and Health Sciences
Gibb, Diana M.
United Kingdom, London
Medical Research Council
Babiker, Abdel G.A.G.
United Kingdom, London
Medical Research Council
Steyn, Jan G.
South Africa, Johannesburg
University of the Witwatersrand
Madhi, Shabir A.
South Africa, Johannesburg
University of the Witwatersrand
Jean-Philippe, Patrick
United States, Bethesda
National Institute of Allergy and Infectious Diseases Niaid
McIntyre, James Alasdair
South Africa, Johannesburg
University of the Witwatersrand
Statistics
Citations: 1,280
Authors: 8
Affiliations: 4
Identifiers
Doi:
10.1056/NEJMoa0800971
ISSN:
00284793
e-ISSN:
15334406
Research Areas
Environmental
Infectious Diseases
Maternal And Child Health
Study Design
Cohort Study