A child-friendly version of the antiretroviral drug dolutegravir was registered in South Africa in 2022. (Photo: Tina Floersch/Unsplash)News & Features
4th September 2025 | Elri Voigt
A child-friendly formulation of the antiretroviral drug dolutegravir was first included in the country’s HIV treatment guidelines in 2023. New estimates suggest that most children aged one to four living with HIV have now been switched to the drug.
The potent antiretroviral (ARV) drug dolutegravir has become the backbone of South Africa’s HIV treatment programme. The drug was first included in South Africa’s ARV tender in 2019 and was rolled out in phases in the public health sector. By 2023, more than 4.7 million adults living with HIV were taking treatment that contains dolutegravir.
A child-friendly version of dolutegravir, along with several new ARVs formulated for kids, was registered in South Africa in 2022. A year later, South Africa’s HIV treatment guidelines were updated to include a new regimen consisting of the medicines abacavir, lamivudine and dolutegravir (ALD).
This was good news as this meant regimens of the highly effective drug would be available to children, a group among whom reductions in HIV rates have been slowing down. In mid-2024, there were around 157 000 children aged 15 and younger living with HIV in South Africa, according to the latest figures from Thembisa, the leading mathematical model of HIV in South Africa. It is estimated that around one in three of these children are not getting the HIV drugs they need.
Of those children who are getting the HIV treatment they need, based on data presented on 20 August at the Southern African HIV Clinicians Society conference in Cape Town, the majority of those aged one to four are now taking dolutegravir.
Massive switch to dolutegravir
Since 2023, the number of children living with HIV, aged one to four, who are on a dolutegravir-based regimen has “increased considerably”, said presenter Dr Ahmad Haeri Mazanderani. He is a joint researcher in the Department of Paediatrics and Child Health in Wits University and the National Institute for Communicable Diseases (NICD).
In June 2023, about 1 000 (8%) of children in this age group were taking treatment that contained dolutegravir, while 12 000 (92%) were on a regimen that didn’t contain the drug.
Two years later, as of June 2025, the situation has essentially flipped, with 11 000 (94%) of one-to-four-year-olds taking dolutegravir and only 734 (6%) not on a regimen that includes dolutegravir.
In other words, for the one-to-four-year-olds we have data for, there are very few who have not been switched to dolutegravir-based treatment.
The figures are derived from a combination of routine data from the National Health Laboratory Service, estimates from the Thembisa model, and Health Information Centre data, accessed through a platform called TIER.Net.
The new figures should be regarded as only a rough estimate of what is going on. This is because we do not have data for all children in this age range – for both the 2023 and 2025 estimates it is thought that over 20% of children were not reflected in the available data.
“[T]here are challenges with monitoring the paediatric HIV programme using routine data, there are data quality issues principally … due to the fact that we do not have a unique patient identifier in the country,” Mazanderani told delegates.
While the data didn’t include those outside of the one-to-four-year age group, based on information contained in the newest ARV tender, it seems likely that most children living with HIV will take dolutegravir-based treatment in the coming years. The tender, set to run from 1 July 2025 to 30 June 2028, shows an expected demand for around 1.4 million monthly packs of the dolutegravir 10mg scored dispersible tablets. It also shows an expected demand of around three million monthly packs of a paediatric version of ALD (dolutegravir 5mg, abacavir 60mg, lamivudine 30mg), sometimes referred to as pALD, which was only recently registered in the country. Since dosing for kids is dependent on a child’s weight, it is not straight-forward to calculate how many children would be covered by the above quantities, but our back-of-the-envelope calculations suggests that these amounts would be sufficient to cover the need.
Kids are doing better on dolutegravir
A reliable way of checking how well HIV treatment is working is to measure something called a viral load, which basically shows how much virus is present in a blood sample. The fewer copies of the virus there are, the less the virus is actively replicating and causing havoc in the body. Someone living with HIV is considered to be virologically suppressed when the amount of virus in the blood is below a very low threshold.
The increase in the use of dolutegravir for the one-to-four-year-old age group since 2023 has been associated with an increase in viral suppression, said Mazanderani. Using rolling 12-month data on viral suppression, based on tests done by the NICD that has been deduplicated, it gives a picture that should be “fairly representative of what is truly happening”, he said.
The improvement is substantial. Viral suppression in children aged one to four and on treatment increased from 58% in June 2023 to 76% in June 2025 – an increase of over 30%, or 18 percentage points. For these figures, a cut-off for viral suppression of less than 1 000 copies/ml were used. Using the much stricter cut-off of 50 copies/ml, viral suppression was 34% in June 2023 and 54% in June 2025.
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Mazanderani noted that girls consistently had higher rates of virologic suppression than boys. This is true at both the less than 1 000 or less than 50 copies/ml cut off. For the former, in June 2025, there was a 3% higher suppression rate in girls aged one to four, compared to boys in the same age group. For the latter, this was even higher, with a 7% higher viral suppression rate in girls compared to boys.
While any improvement in rates of virologic suppression are good, these rates are still far from ideal. Mazanderani noted that these figures show despite the increased rollout of dolutegravir and new child-friendly formulations being available, “we’re still very far from achieving the third [UNAIDS] 95 target for young children”. This target is for 95% of children on treatment to have viral suppression.
Room for improvement
As Spotlight reported in May this year, viral suppression rates in children living with HIV are lower than those for adults living with HIV, for a number of interesting reasons. The issue was again under the spotlight at the Cape Town conference.
“[T]he younger you are, the more likely you are to have virological failure,” said Dr Moherndran Archary. He is a professor of paediatric infectious diseases based at the University of KwaZulu-Natal and Victoria Mxenge Hospital and researcher at the Africa Health Research Institute.
He was speaking in the context of data from 381 children enrolled in the Odyssey trial. The results, presented in July at IAS 2025, showed that being less than six years of age, having a low BMI and low CD4 count when starting treatment was associated with lower rates of viral suppression.
This is in part due to the difficulty in giving HIV medications in children, he explained, since it can involve multiple different medications and formulations that don’t always taste good. “But [virological failure] also relates to the complexity of the social fabric in these families,” Archary added. Things like poor social circumstances, having different caregivers, and being unable to go for multiple clinic visits. Spotlight previously reported on this here.
Dosing details
Treating children living with HIV is much more complicated than treating adults, because of the regimens and formulations available as well as different dosing requirements based on weight and age.
Associate Professor James Nuttall, a paediatric infectious diseases sub-specialist at the Red Cross War Memorial Children’s Hospital and the University of Cape Town, broke down the details for Spotlight.
Children younger than 10 years and weighing less than 30kgs are dosed according to the World Health Organization’s weight bands, he explained, meaning that instead of having to calculate the exact milligram or millilitre of a drug that should be given per kilogram, a dosage is calculated based more broadly on weight. It starts at a weight band of 3kg to 5.9 kg, then 6kg to 9.9 kg and so forth.
Those older than 10 and weighing more than 30kgs are eligible for adult HIV treatment – commonly referred to as TLD – a tablet containing the ARVs dolutegravir, tenofovir disoproxil fumarate, and lamivudine.
The Southern African HIV Clinicians Society, the health department together with the Medicines Information Centre at the University of Cape Town have produced a helpful breakdown of the different treatment regimens and dosages. These will be updated soon, according to Nuttall, since the newest ARV tender, with some new regimens like the paediatric formulation of ALD is set to come into effect at the end of the year.
For now, most children living with HIV who are older than four weeks and weigh more than 3kg are taking ALD, which consists of a tablet containing the drugs abacavir and lamivudine and a tablet of just dolutegravir. Both the tablets are dispersible, meaning they can be dissolved in water and taste “pretty good”, according to Nuttall.
A child who weighs 10kg, Nuttall said, would take two of the abacavir and lamivudine tablets and two of the dolutegravir dispersible tablets. “So, four tablets, pop them in a bit of water, swirl them around and then the child would swallow that … and for most of them it’s doable and manageable,” he said.
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For children who weigh less than 3kgs and are younger than four weeks, the regimens and dosing get more complicated. For newborns to one-month olds, a combination of Lamivudine, Zidovudine – both of which are available in tablet form or in an oral solution – as well as Nevirapine is recommended. But this may soon change to dolutegravir as well following good safety results for a novel formulation of the drug in newborns from the PETITE study.
Before ALD, children had to take three drugs, a combination of abacavir and lamivudine as well as lopinavir/ritonavir. The latter, which was a liquid that had to be given twice a day was poorly tolerated in children, because of its strong smell and terrible taste. “We had a lot of problems with children spitting, vomiting, refusing [the liquid], battles happening between caregivers and children and just … poor tolerance to the drug, they just can’t tolerate it basically,” said Nuttall. However, very few children are still on this regimen.
Treatment could get even simpler with the introduction of the paediatric formulation of ALD, which contains all three drugs in one tablet. This formulation is now only available in the private healthcare sector but has been included on the new ARV tender, said Nuttall.
Archary was hopeful that the paediatric formulation of ALD, once it becomes more widely available in the country, will replace having to use the two different tablets and simplify treatment.
He added that having more treatment options, like we have recently seen in the HIV prevention space, would be beneficial for the families that struggle to give daily oral treatment.
“[W]e do need to find simpler regimens and alternative ways in which you can deliver these treatments. We need to work closer together, both as a community of people living with HIV and a community of treatment [providers] to realise this option of optimising paediatric treatment options.”
One option that could potentially help is long-acting HIV treatment. Archary said the long-acting treatment that is furthest along the pipeline is an injection of the ARVs cabotegravir and rilpivirine, but at this stage is only recommended for adolescents over the age of 12 who are virologically suppressed. A phase I/II study, called CRAYON is currently evaluating the use of cabotegravir and rilpivirine in children between the ages of two and 12, weighing between 10 and 40kg.
In short, while the switch to child-friendly dolutegravir has had a substantial impact, experts are clear that there is still much more to be done to improve HIV treatment for children.
