HIV Treatment Interruptions for Children

Studies presented to the conference produced conflicting results about the safety and advisability of structured treatment interruptions for children who start HIV treatment in infancy.

Taking breaks from HIV treatment is generally not recommended, as large studies with adults – including the SMART trial – have shown that the risks of stopping treatment, even temporarily, outweigh potential benefits.

Treatment for children with HIV poses particular challenges, but early treatment dramatically reduces the risk of illness and death. Treatment guidelines recommend that HIV-positive infants start treatment as soon as possible

Unplanned treatment breaks in children have been shown to result in rapid increases in viral load, decreases in CD4 count and increased risk of disease progression, but a number of trials are investigating managed treatment interruptions in children.

One study in Kenya, OPH03, followed children who had started antiretroviral treatment (ART) during their first year of life. Children were randomised to either take ART continuously or to stop treatment and restart if their CD4 percentage went below 25% or if their growth rate deteriorated.

Of the 21 children in the stopping-treatment arm, 14 needed to restart treatment based on CD4 criteria in the first three months. As a result the data and safety monitoring board recommended that the trial be stopped. The researchers concluded that treatment interruption was not a feasible strategy for this group.

The CHER study, in South Africa, randomised children to three groups.

In one group the children didn’t start treatment until there was clinical progression or a drop in CD4 percentage to below 20%; in the second group the children took ART until 40 weeks, then stopped until progression or CD4 drop; in the third group the children took ART until 96 weeks, then stopped until progression or CD4 drop.

It’s important to note that this study did not directly compare treatment interruptions to continuous treatment.

Immediate treatment, as has previously been reported and in line with current guidelines, significantly reduced infant mortality.

When the two immediate treatment arms were compared, there was no significant difference between them. However, the time that children could safely remain off treatment was only 33 or 70 weeks, depending on the arm of the trial. The researchers noted that treatment interruption in this study appeared safe, but so was treatment, suggesting that the strategy was at best cost-saving.

Both presenters concluded that further research and analyses would be needed.

A heated debate at the conference on the ethics of treatment interruption in children suggests that further studies are likely to remain controversial.

The Friends of AIDS Foundation is dedicated to enhancing the quality of life for HIV positive individuals and empowering people to make healthy choices to prevent the spread of the HIV virus. To learn more about The Friends of AIDS Foundation, please visit: http://www.friendsofaids.org.

TOGETHER WE REMAIN STRONG!