Will infants finally have access to a highly effective HIV drug?

A new study has found the right dosage to administer a highly effective HIV treatment to newborns who are at risk of getting HIV. Dolutegravir is one of the most effective and safest HIV medicines, and the preferred drug treatment recommended by the World Health Organization. It has been in use for more than a decade as an HIV treatment by millions of adults and adolescents living with HIV in over 100 countries. But there’s no specific drug formulation for newborns. While many pregnant women have been taking dolutegravir for years to prevent mother-to-child transmission of HIV, this is not the case for everyone. “There are still some moms that, unfortunately, [are] not on antiretroviral therapy … or they are on antiretroviral therapy, but they don’t always adhere well to their regimen,” Dr. Adrie Bekker, a professor at Stellenbosch University in South Africa and one of the study authors, told Devex. “This can cause viral blips in their HIV, and if that happens at a time when the baby is delivered, or even when a mom is breastfeeding afterwards … it can pose a risk to the baby of developing HIV,” she added. An estimated 1.4 million children are living with HIV. According to 2023 figures, most of these children live in sub-Saharan Africa and were infected through transmission from their HIV-positive mothers during pregnancy, childbirth, or breastfeeding. For this reason, antiretroviral medications are also given to newborns to protect them from getting HIV. But newborns are given older HIV drugs — most commonly nevirapine or zidovudine — which while effective have some downsides. They come in syrup form that have short shelf lives, “taste poorly,” and may need refrigeration, said Bekker. Zidovudine also has to be given twice daily, and has some side effects, such as bone marrow suppression. In addition, because the market is small, these drugs often are out of stock. “Therefore it is important to use existing pediatric [antiretroviral] formulations and see how they can be adapted for neonates,” Bekker said. But there was a need to determine the right dosage of dolutegravir to be considered for newborns. In their study, researchers from Chiang Mai University in Thailand and Stellenbosch University first gave 16 newborns the same dose given to children — a single dose of 5 milligrams of dolutegravir — on top of existing HIV prophylaxis drugs, and tested the drug levels in the babies’ blood. Seeing it’s safe, the researchers then went ahead with the second phase of their study where they enrolled 43 babies to receive 5 milligrams of dolutegravir every second day for the first two weeks of life, and then every day by the third and fourth week. The babies were at low risk of developing HIV, but the researchers decided to give them an HIV prevention drug on top of giving them dolutegravir for four weeks to ensure they had at least one existing drug already proven to work and in use for newborns. Thirty-nine babies completed the study, while four mothers withdrew their babies from the study. All the babies tested negative for HIV at the end of the study. The drug was given in two forms: A dispersible tablet and a thin, micro film that dissolves on a baby’s tongue. Bekker said the mothers liked the film. However, it’s not yet out in the market. Based on the study results presented this week at the 2025 Conference on Retroviruses and Opportunistic Infections in San Francisco, USA, Bekker said they are recommending that dolutegravir be added as one of the HIV drug options for newborns. But it will be up to WHO and other guideline committees to determine whether to recommend its use for HIV prevention or treatment. While the study helps support the use of dolutegravir in newborns, she hopes that the newer long-acting antiretrovirals, such as cabotegravir and lenacapavir, would also eventually be used in children and newborns. She said it won’t be easy to study these new drugs in newborns, as babies’ weight and physiology change rapidly during their first weeks of life, which can affect the amount of drug to administer. “But I think it’s important to highlight that just because it's difficult, it doesn’t mean that it cannot be done and that it should not be done. And one can imagine a mother just after birth … little sleep happening, trying to drink her own medication and still give her baby medications, that it may be much easier if one could just potentially give the baby an injection, which could cover the baby and protect against HIV for the first month or two of life,” she said. She is concerned however that the recent U.S. aid funding freezes on HIV programs and research may affect care for all populations, especially newborns. “We are very fortunate that Unitaid supported us to be able to do this study. But one is definitely worried that in future, it's going to become more difficult to do these types of studies if the funding cuts are not reversed,” she said.