By Gift Briton
For the first time, infants younger than 28 days (neonates) can safely receive Dolutegravir (DTG), one of the most effective and widely used HIV drugs worldwide.
Since the World Health Organization (WHO) approved it in 2013, DTG has been the go-to treatment for over 22 million people across 110 low-and middle-income countries. Yet, until now, there is no official dosing guidelines for neonates.
For years, neonates exposed and infected by HIV have faced an uphill battle. Prevention and treatment options have been limited, outdated, and sometimes even toxic. But thanks to a new research, that is about to change.
The new research is led by Dr. Adrie Bekker, a neonatologist at Stellenbosch University in South Africa and Dr. Tim R. Cressey of Chiang Mai University in Thailand and aimed to fill this gap by testing two baby-friendly DTG options: a dissolvable 5 mg tablet and a quick-melting oral film. Based on the findings, both antiretroviral formulations proved safe, effective, and easy for mothers to administer.
“The easier we can make it for a child to take their medicines regularly, the more likely it is that they will complete their treatment successfully,” said Cherise Scott, Senior Technical Manager at Unitaid, which funded the study under the BENEFIT-KIDS project.
HIV transmission from mother to child has declined significantly over the years, thanks to improved prevention methods. However, about 120,000 infants still develop HIV each year either during pregnancy, at delivery or via breastfeeding.
“Some of the antiretrovirals that are currently being given to neonates are of older drug classes that even adults no longer use. They often require twice-daily dosing, which is challenging for new mothers, especially right after childbirth,” Dr. Bekker explains.
The new DTG formulations for neonates are set to eliminate these problems. The dispersible tablet can be dissolved in water, while the oral film simply melts on the baby’s tongue within seconds.
Mothers who participated in the study said that they preferred the film because it was easy to administer and mess-free. “As soon as I put the film on his tongue, it dissolved in seconds—he even enjoyed it,” one mother shared.
The study established a clear DTG dosing strategy for neonates: 5 mg DTG every 48 hours from birth to Day 14 of life, followed by 5 mg every day until four weeks of age.
This dosing schedule, as Dr. Bekker explains, ensures that drug levels in the baby’s body remain comparable to those in adults, making it both safe and effective. Importantly, the study found no safety concerns among the 41 infants who received at least one dose of DTG.
The study findings will be presented to the WHO, which will review the data and decide whether to include DTG in global neonatal HIV treatment guidelines, which Dr. Bekker notes might take a couple of months.
“If WHO approves it, national health agencies will then decide whether to adopt the recommendation. But in the meantime, individuals can review our study and decide on an individual basis whether they are happy to use the drug based on the available evidence,” adds Dr. Bekker.
With the DTG dispersible tablet already available and used in many clinics worldwide, if WHO updates its guidelines, it would simply mean extending its use to neonates.
The oral film, however, is not yet commercially available. While a generic manufacturer in India has developed it, further negotiations are needed before it can be widely distributed.
“This is a giant leap forward in the fight against paediatric HIV. It has the potential to give babies access to the strongest and latest medications available,” notes Dr. Bekker.
