Study Provides Support for Early ART in HIV-Infected Infants

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Babies born with HIV benefit from beginning ART with days—not weeks—of birth.

Antiretroviral therapy (ART) is as crucial a tool for infants with HIV as it is for older people who contract the virus. But how early is early enough when it comes to introducing ART? A study conducted in Botswana bolsters the argument for immediate initiation of ART for optimum health outcomes.

The Early Infant Treatment Study, carried out by the Botswana-Harvard AIDS Institute Partnership, enrolled 40 HIV-positive newborns who were given ART (a combination of nevirapine, zidovudine, and lamivudine) within a week of their birth, at a median age of 2 days. Their blood levels of medication were tested at weeks 1 and 2, after which the babies were started on a different ART regimen, lopinavir/ritonavir, anywhere from weeks 2 through 5. The babies were then followed for 24 weeks.

At 2 weeks, blood tests showed only about half the babies had therapeutic levels of ART in their systems. However, by 12 weeks, viral levels were below 40 copies/mL of HIV RNA in 55% of the babies. By 24 weeks, 71% of the babies had fewer than 40 copies/mL of HIV RNA. Even more—84%—had HIV RNA levels below 400 copies/mL by 24 weeks, indicating that a high proportion had achieved viral suppression.

“Our study found that very early treatment of HIV in children leads to a rapid viral load reduction and a decrease in the total amount of virus in the baby’s body,” Kenneth Maswabi, MD, a clinical coordinator at the Botswana-Harvard AIDS Institute in Botswana and an author of the study, told Contagion®. “[This work] has highlighted the importance of early infant testing—especially birth testing—in the global fight against HIV in children.”

This fight is particularly difficult in locales where HIV is prevalent and treatment uptake has not kept pace. In the Botswana study, almost none of the mothers took ART during pregnancy for more than 8 weeks, a length of time not nearly long enough to prevent transmission to their babies. “There were many issues that led to mothers not taking ART during pregnancy, including young age, very low socioeconomic [status], very little education, lack of proper identification documents, religious beliefs, etc,” Maswabi said.

Some of those barriers to treatment can be mitigated with the help of local health care groups. “Community nursing is vital, as it can be used to identify pregnant mothers early so that they can access antenatal care (ANC) services early, including HIV testing and commencement of ART,” Maswabi noted. “Also, community nursing in association with social workers can help very low socioeconomic [status] pregnant mothers to get all the required documents needed for registration into ANC and HIV treatment services,”

For high-risk babies, Maswabi asserted that early HIV testing, and follow-up testing, is vital. Babies who test positive at birth and are started on ART may later test negative due to effective viral suppression; however, stopping ART will allow viral levels to bounce back up. “It is critical to have a good follow-up plan for the HIV-affected children on ART for up to 5 years to reduce morbidity and mortality, especially in resource-limited settings,” he said. He attributed the high rate of viral suppression in the babies in Botswana study to retention of all subjects, effective counseling on ART adherence, and—possibly—the fact that they began ART so early in life.

Maswabi’s team continues to follow the children in the study, the oldest of whom is now turning 5, he said. But because ART is evolving, with newer therapies introduced regularly, future studies are planned that will examine babies’ responses to different HIV drugs than were used in the current trial.

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