Rapid treatment best for infants infected with HIV: study

Treating babies infected with HIV rapidly with drug treatments dramatically reduces their risk of death, according to a study that has already prompted officials to recommend immediate treatment.

In Thursday's New England Journal of Medicine, researchers in South Africa who studied 377 babies concluded that giving newborns drug therapy right away instead of delaying it until symptoms emerge reduced early infant mortality by 76 per cent and HIV progression by 75 per cent.

Preliminary results of the trial last year prompted officials in the U.S., Europe and the World Health Organization to recommend immediate treatment with antiretroviral therapy, or ART as it is known,for children under one year of age after diagnosis, rather than waiting until signs of illness appeared the standard of care when the study started in 2005.

"HIV attacked the developing immune system extremely quickly," said Dr. Avy Violari of the University of Witwatersrand in Johannesburg, who led the study.

"The decline was so rapid, short of seeing the babies every day, you won't be able to pick up any meaningful changes that would prompt a doctor to start treatment."

No warning signs for parents

More than one-third of the deaths recorded happened at home and were "unexpected and rapid," the study's authors said. In two of the 12 deaths, the cause of death was determined; gastroenteritis in one case and disseminated tuberculosis in the other.

"The other thing is that the signs [of trouble] are so subtle, they don't give a good warning for the parent," Violari said.

When the study began, the infants were randomly assigned to one of three groups:

• Start antiretroviral therapy immediately and continue for 40 weeks.
• Start the drug therapy and continue for 96 weeks.
• Defer the drug therapy until signs of clinical or immune system progression to AIDS appeared

The antiretroviral therapy was typically started at seven weeks of age for babies in the immediate treatment groups, who were infected by their mothers during birth or while nursing.

After an average of 48 weeks, 10 of 252 infants or four per cent in the immediate treatment groups had died, as had 20 of 125 or 16 per cent of theinfants in the deferred treatment group, the researchers said.

Challenge of treating infants quickly

Those in the deferred treatment group originally received treatment when their immune system's CD4 T-cells dropped to low levels. When the preliminary results were announced, all babies in the deferred group were assessed for drug treatment.

The results are "are a clarion call to scale up widespread early HIV testing of at-risk infants and to make ART immediately accessible to all infants who test positive," said Dr. Anthony Fauci, director of the U.S. National Institute of Allergy and Infectious Diseases or HIAID.

It is exciting to now know the best time to begin treating infants infected with HIV, agreed Dr. Ed Handelsman, chief of the pediatric medicine branch in NIAID's Division of AIDS.

"The challenge now for the global community is to ensure that all HIV-infected infants who need ART receive it soon enough," Handelsman said.

The ART treatment included three drugs,ritonavir-boosted lopinavir, zidovudine and lamivudine, that were provided by GlaxoSmithKline PLC of Britain and the South African Department of Health.