For HIV-Positive Babies, New Evidence Favors Starting Drug Treatment Just After Birth

Every day, as many as 500 babies in sub-Saharan Africa are born with HIV. Standard practice in many of these countries is to give them treatment if they test positive, but not for weeks or even months after they’re born. The concern is that newborns can’t tolerate the powerful drugs.

In the last few years, researchers have suspected that treating right at birth is better. Dr. Deborah Persaud, a virologist at Johns Hopkins Children’s Center, co-wrote a paper six years ago about a baby girl in Mississippi with HIV who was treated 30 hours after birth.

“That baby was known to be infected and went off drugs,” she says. At 18 months, the girl’s family took her off antiretroviral drugs. For infected individuals who stop treatment, it usually takes two to four weeks for the virus to resurge, but “for 27 months, there were no signs of HIV.” The girl later relapsed and went back on antiretroviral drugs around age 4.

Still, doctors thought the “Mississippi baby’s” two years of drug-free healthy living were the result of getting treatment so early. Since then, it has become standard practice in the U.S. to treat babies at high risk of being born with HIV soon after birth — but doctors think more clinical evidence is needed that the treatment can be safe and more effective than delaying treatment.

Now, results from a clinical trial in Botswana support that hunch. In Science Translational Medicine, researchers report on 10 HIV-positive babies who were started on a drinkable three-drug cocktail of conventional antiretrovirals within their first days. After they had two years of antiretroviral drugs, the virus was almost undetectable in their bodies. By contrast, kids who started antiretroviral therapy a few months after birth had 200 times more virus in their blood.

Daniel Kuritzkes, a study co-author and chief of the Division of Infectious Diseases at Brigham and Women’s Hospital in Boston, says the early-treated kids aren’t cured yet, “but it’s likely that we may have set them up for the possibility of long-term remission of their HIV.”

Kuritzkes thinks there are two main reasons that treating so early is helpful. First, in people of any age, treating as soon as someone becomes infected helps keep the virus from taking firm hold in their bodies. And second, in babies, their immune system is just beginning to develop.

“By intervening very early, we’re able to protect the immune system much more effectively from any damage from HIV,” he says.

Kuritzkes says his study adds evidence that very early treatment is safe and tolerated well by babies.

Persaud, who was not involved in the Botswana study, says that when HIV first infects someone, it establishes itself in certain cells where it can hide out for years. Current HIV drugs can’t get at these reservoirs. Very early treatment, which prevents the virus from replicating when babies’ immune systems are just developing, seems to work by keeping the hidden stock of HIV very small.

The Botswana trial is one of three major ongoing clinical trials looking at very early treatment of HIV in infants — and the first to publish some results, says Ted Ruel, an infectious disease pediatrician at UCSF Benioff Children’s Hospital. A second study is ongoing in South Africa, and a third, called the P1115 study (which Ruel and Persaud are both involved with), has multiple sites around the world, including in Brazil, India and Thailand. The ultimate goal of this work, Ruel says, “is to get it so that people with HIV can forget about it, so they can not [have to] take medicine every day and not worry about infecting other people and not feel any side effects from it.”

According to Kuritzkes, the next step in the Botswana trial is to introduce an experimental treatment using broadly neutralizing antibodies, which have been promising in adults, to children.

“The idea is to replace daily or twice daily oral dosing with antibody infusions that might be administered every three months or less frequently,” he wrote in an email. Persaud says that the P1115 study plans, with the consent of the families, to stop antiretroviral treatment in healthy-seeming children and to see if their bodies will continue to suppress the virus on their own.

While treating HIV very early looks promising, one of the biggest hurdles will be getting drugs to babies who need them.

“You really need the kind of infrastructure that exists in Botswana or in a country like the United States in order to be able to identify and rapidly intervene in these children,” says Kuritzkes. Faced with one of the world’s highest HIV rates, Botswana developed a nationwide treatment plan — the first in eastern and southern Africa to give free access to HIV drugs for anyone who needs them.

Last year, 160,000 kids worldwide were infected with HIV through pregnancy, birth or breastfeeding. Almost 90% of them live in sub-Saharan Africa, and half of them don’t have access to antiretroviral drugs. Obstacles to treatment abound. The parents might not know their children have HIV, the drugs can be hard to get or there’s often stigma around being an HIV carrier in their communities.

Researchers involved in these studies agree that preventing kids from getting HIV in the first place is key. But for those who fall through the cracks, they say that giving treatment very early offers a second chance for good health.

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