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New guidelines and ARVs for SA children with HIV

Several sessions at the recent 11th SA AIDS conference held in Durban highlighted the worrying fact that key HIV numbers – like treatment coverage – are much lower in children than in adults, but it’s hoped new treatments and guidelines might narrow the gap, writes Elri Voigt in Spotlight.

According to Dr Sandile Buthelezi, DG of the National Department of Health, on UNAIDS’ 95-95-95 targets, children with HIV in South Africa are at 81-65-68 – meaning 81% of them have been diagnosed, 65% are on antiretroviral treatment, and 68% of those on treatment are virally suppressed.

For the South African population as a whole, the numbers are at 94-76-92.

Throughout the conference, various speakers expressed concern that only 65% of children who have been diagnosed are on treatment. To reach UNAIDS’ target of 95%, an additional 88 000, at least, need to start treatment.

Professor Lee Fairlie, director of Maternal and Child Health at Wits RHI, said only 52% of children under 14 with HIV are on treatment, that children lagged behind substantially when it comes to viral suppression, which is particularly challenging in the youngest age groups.

Not all bad news

The good news was that new and more child-friendly antiretroviral formulations are being rolled out in South Africa, making it easier for children to start and stay on treatment.

The National Department of Health recently updated the antiretroviral treatment guidelines to allow the use of several of these new formulations and better HIV treatment regimens for youngsters. Most notable is a new regimen comprising the medicines abacavir, lamivudine and dolutegravir (ALD).

Dr Leon Levin, a paediatrician who has been treating infants, children and adolescents with HIV for almost three decades, told delegates the new formulations had had a major impact on the updated treatment guidelines.

One is a 120/60mg dispersible tablet of abacavir and lamivudine that can be taken in patients weighing between 3kg and 25kg. It is given once daily and two generics are registered with the South African regulatory authority (Sahpra). “It’s going to literally replace all other paediatric Abacavir+3TC formulations. You can swallow it, chew it, crush it, or dissolve it in water. So (it’s) very versatile,” he said.

Also important is a paediatric formulation of the antiretroviral dolutegravir – which forms the backbone of HIV treatment in adults.

Levin said the child-friendly version is not available to everyone yet, and many clinicians still need to undergo training on how to use it. It is a 10mg dispersible, scored tablet given once daily that can be used at 3kg and higher and from four weeks of age onward.

Two generic versions are registered with Sahpra.

The introduction of paediatric dolutegravir is likely to overshadow the introduction of a four-in-one formulation of abacavir, lamivudine, lopinavir/ritonavir, a four-in-one combination taken twice daily, which is strawberry flavoured and in powder form.

“Unfortunately, through nobody’s fault, this was launched at the same time as paediatric dolutegravir, meaning paediatric dolutegravir will take centre stage and this product unfortunately is not going to be used much,” Levin said.

Updated guidelines

Levin said the changes to South Africa’s treatment guidelines focused on two main points relating to children with HIV. The first is to implement an optimised regimen – the ALD regimen – and the second is to create an “enabling environment to support engagement in care and adherence”.

He said that with the new guidelines, we can expect “much improved (viral) suppression, optimised regimens, improved synchronisation of clinic visits, and happier patients”.

A big change is that now children who weigh 3kg and are four weeks old should be started on the ALD regimen, instead of the abacavir, lamivudine, and lopinavir/ritonavir previously recommended. “This is a major change…a well-tolerated regimen,” Levin said.

Once the children on this regimen get to 30kg, they will be switched to a regimen containing tenofovir, dolutegravir, and lamivudine (TLD for short). TLD is also what’s offered to adults with HIV when starting treatment for the first time.

For children already on treatment, the new guidelines recommend that those four weeks and older, who weigh 3kg or more, should be transitioned to a dolutegravir-containing regimen. For children with suppressed viral loads, the switch to ALD or TLD is straightforward, while for those without viral suppression, it can get more complicated.

Another important change is that children older than five are now eligible for Repeat Prescription Collection Strategies (RPCs) if they are virally suppressed and have had an age-appropriate disclosure – meaning their HIV status has been explained to them in a way that is appropriate for their age, as outlined in the guidelines. Children under five can be given three months’ supply at a time, providing they are at least six months old.

Levin said whenever RCPs or a three-month supply is considered for children, it is essential to look at where and how the parents may be receiving their own ARV treatment so that it can be co-ordinated, and parents don’t have visit two different places for medications.

New options in pipeline

While the paediatric formulations in the new guidelines are a step forward, there are experimental treatments in the pipeline that may make treatment even more convenient for children.

Fairlie said the paediatric market was extremely small “and then one has to maintain enthusiasm for manufacturers to actually continue to look at this population”.

“And so, merging of treatments and prophylaxis regimens is really what would work.”

She specifically referred to long-acting formulations of cabotegravir (CAB-LA) and rilpivirine (RPV). CAB-LA has already been approved by Sahpra for HIV prevention in adults and pilot projects evaluating how to best provide this injection in South Africa will start soon.

The combination of CAB-LA and rilpivirine injections has been approved for the treatment of HIV in adults by the US Food and Drug Administration, but not yet by Sahpra. The injections are administered every two months.

Fairlie said there were several studies either ongoing or starting soon for the use of these agents in the paediatric and adolescent age groups. There are also trials planned to test another long-acting medication – lenacapavir – in adolescents and broadly neutralising antibodies (bNAbs) in children.

Several improved delivery methods are on the drawing board for paediatrics. These include a mechanism that doesn’t require water, like oro-dispersible tablets, also known as fast melts, which dissolve in the mouth, as well as oral films that stick to the mouth, disintegrate there, and dissolve.

And there are various tablet options small enough for children to swallow easily. Mini-tablets are also a prospect – compressed tablets no larger than 4ml.

Finally, there are novel mechanisms like long-acting oral drug delivery systems and micro-array patches.

Fairlie said long-acting oral drugs are where a drug is stored in the centre of a capsule with a number of “arms”, which keep the capsule in the stomach and slowly dissolve and release it into the stomach. This allows for slow-release dosing. The “arms” tend to break down after about seven days.

National ART Clinical Guideline 2023_06_06 version 3 Web

Spotlight article – SA AIDS 2023: New treatments and guidelines to benefit kids, with more advances on the horizon (Creative Commons Licence)

 

See more from MedicalBrief archives:

 

New hope for HIV+ children thanks to delicious new ARVs

 

New combo HIV drug treatment for children approved in SA

 

A strategy for the millions of HIV-exposed but uninfected children

 

 

 

 

 

 

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