The New York Times - November 19, 2008
Donald G. McNeil Jr.

The study prompted the World Health Organization to change its guidelines, which had recommended delaying therapy until symptoms became apparent.

It found giving antiretroviral therapy (ART) straight after diagnosis cut the risk of death from Aids by 76%.

The study appears in the New England Journal of Medicine.

The study, of 377 HIV-positive South African babies, found that babies given treatment immediately after they were diagnosed with HIV cut their risk of dying from the infection to just 4%.

In comparison, the risk of death for those whose treatment was delayed until their levels of key immune system CD4 cells began to fall, or other symptoms emerged, was 16%.

Immediate treatment also cut the chance of disease progressing measurably by 75%, from 26% to 6%.

The findings were so conclusive that treatment for all babies was re-assessed at the preliminary stage of the trial.

Unexpected findings

Professor Diana Gibb, from the Medical Research Council clinical trials unit worked on the study.

She said: "We did not expect to see differences so soon between the infants receiving early treatment and those in the group where treatment started only when immunity was falling or symptoms developed."

Lead researcher Dr Avy Violari, from the Comprehensive International Program of Research on Aids (CIPRA-SA) said: "Our results reinforce the view that there are no reliable predictors for small infants as to how their disease is progressing.

"CD4 counts do not tell us with enough accuracy if babies under a year of age are becoming sick.

"What was alarming was the speed of disease progression; some infants could seem fine in the morning and get sick and die by nightfall. Some did not even make it to the hospital.

"When these early data were analysed, it became clear that treating all infants at the earliest opportunity after diagnosis was the best course of action."

Saving lives

Her CIPRA-SA colleague Professor Mark Cotton, who also played a key role in the study, said he was delighted that the study had led to changes in the WHO guidelines.

He said: "It is to be hoped that this will save countless babies across the world, especially in low-income countries where mother-to-child transmission is still common.

"However, in order to start ART early, it is important to undertake HIV viral diagnosis very early in life which does require a programme with both manpower and resources."

Professor Gibb also stressed that avoiding mother-to-child transmission in the first place was the top priority.

She said: "These drug regimens are no picnic for these babies and even with improved outcomes in early life, there is still no cure for Aids."

The WHO issued a statement in which it confirmed the study had been instrumental in its decision to revise its guidelines.

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