Treating Infants with HAART within 3 Weeks of Birth Dramatically Reduces Progression to AIDS and Death

By Ronald Baker, PhD

HIV positive Infants who receive antiretroviral therapy within 3 months of birth have a significantly reduced risk of death or progression to AIDS, according to results of study published in the March 13, 2009 issue of AIDS.

Since use of antiretroviral drugs has significantly lowered the rate of mother-to-child HIV transmission in industrialized countries, most recent research on HIV treatment in children has been done in resource-poor areas.

About 20% of infants born in developed countries who do not receive HAART will develop AIDS or die within their first year of life, the authors of the current study noted as background(1). A recent randomized, controlled trial of 375 HIV-infected infants in South Africa, called CHER (CHildren with HIV Early antiRetroviral therapy),showed a 76% reduction in mortality in asymptomatic babies who started HAART before 12 weeks of age compared with those who received deferred therapy when they showed signs of disease progression(2).

Because the clinical benefits of treating HIV-infected infants very early has not yet been evaluated in a large patient population in high-income countries, the authors conducted a collaborative cohort study to evaluate the impact of early antiretroviral therapy in vertically (mother-to-child) infected infants before 3 months of age.

Children born to HIV-infected mothers between September 1996 and December 2004 who were diagnosed with HIV infection but free of AIDS before 3 months were eligible for the study. Data on demographics, pregnancy outcomes, details of antiretroviral therapy, and clinical outcome were collected for more than 200 infants from 11 European countries participating in the European Infant Collaborative study.

The risk of AIDS or death, according to whether or not an infant started treatment before 3 months of age, was estimated using Kaplan-Meier survival analysis and Cox proportional hazards models.

Results

Among 210 children analyzed, 21 developed AIDS and 3 died.

Baseline characteristics of the 124 infants treated before 3 months were similar to those of the 86 infants treated later.

The risk of developing AIDS or death at 1 year was 1.6% in the early treatment group compared with 11.7% in the deferred therapy group (P < 0.001).

In multivariate models adjusting for cohort, deferred treatment was associated with a significantly increased risk of HIV disease progression (adjusted hazard ratio 3.0; P = 0.021).

Based on the results from this first analysis of infants in the European Infant Collaborative study, the study authors stated, "Antiretroviral therapy initiated before the age of 3 months has a dramatic effect in reducing progression to AIDS and death in high income countries."
They also noted that their findings concurred with those of the randomized CHER trial conducted in South Africa.

Finally, they concluded, "Deferring treatment in infected infants is no longer an option and guidelines for industrialized and poor-income countries are being updated."

Pediatric Department, CHU St Pierre, Brussels, Belgium; Inserm, U822, Le Kremlin-Bicêtre, France; AP-HP, Hôpital Trousseau, Service d'Hématologie et d'oncologie pédiatrique, Paris, France; Collaborative HIV Pediatric Study (CHIPS), MRC Clinical Trials Unit, London, UK; Italian Register, Department of Pediatrics, University of Florence, Italy; Hospital Universitario de Getafe, Madrid, Spain; Department of Pediatrics, University of Padova, Padova, Italy; Université Paris-Sud, Faculté de Médecine Paris-Sud, Le Kremlin-Bicêtre, France; AP-HP, Hôpital Bicêtre, Epidemiology and Public Health Service, France.

3/17/09

Reference
T Goetghebuer, E Haelterman, J Le Chenadec, and others (for the European Infant Collaboration group). Effect of early antiretroviral therapy on the risk of AIDS/death in HIV-infected infants. AIDS 23(5): 597-604. March 13, 2009. (Abstract).

Other Citations

1. Natural history of vertically acquired human immunodeficiency virus-1 infection. The European Collaborative Study. Pediatrics 94: 815-819. 1994.

2. A Violari, MF Cotton, DM Gibb, and others. Early antiretroviral therapy and mortality among HIV-infected infants. New England Journal of Medicine 359(21): 2233-2244. 2008.