August 26, 2013
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Early time-limited ART showed better outcomes than deferred therapy

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Less overall antiretroviral therapy was seen when infants with HIV were treated with early time-limited antiretroviral therapy compared with deferred treatment, according to recent study findings published in The Lancet.

“This important finding indicates we may be able to temporarily stop treatment and spare infants from some of the toxic effects of continuous ART for a while, if we can monitor them carefully,” Mark Cotton, MD, PhD, of Stellenbosch University in South Africa, said in a press release. “With ART coverage in children currently at just 28%, our findings highlight the urgency of increasing early (within the first 3 months of life) testing and treatment of HIV-infected infants.”

The study included 377 infants younger than 12 weeks with a percentage of CD4+ T lymphocytes of 25% or higher. Participants were assigned to either deferred ART (ART-Def); immediate ART for 40 weeks (ART-40W); or immediate ART for 96 weeks (ART-96W), with subsequent treatment interruption.

Researchers found that the median time for ART initiation in the ART-Def group was 20 weeks; time to restarting ART after interruption was 33 weeks in the ART-40W group and 70 weeks in the ART-96W group. Nineteen percent of participants in ART-40W and 32% in ART-96W remained off ART after the end of the trial.

“Early treatment followed by a break is definitely better and more cost-effective than delaying starting infants on treatment,” Avy Violari, MD, of the University of the Witwatersrand in South Africa, said in a press release. “But we do not know if a longer initial period of treatment, or early continuous treatment, might be even better.”

 

Robert Colebunders

In an accompanying editorial, Robert Colebunders, MD, PhD, of the University of Antwerp in Belgium, and Victor Musiime, PhD, of the Makerere University College of Health Sciences in Kampala, Uganda, said treatment interruptions require children to be closely monitored, which may not be feasible in sub-Saharan Africa.

“However, in the future, straightforward point-of-care tests, such as a combined RNA-DNA test, will probably become available for very early infant diagnosis,” they wrote. “Together with new methods to monitor the infection, cessation of ART after a prolonged course of a highly effective treatment regimen could become an option. Certainly, children will benefit from an improved, drug-free quality of life, but we will need to be sure that this approach will not cause them any harm.”

Disclosure: The study was funded in part by NIH.