New medicines should make life easier for kids living with HIV

New medicines should make life easier for kids living with HIVTop South African HIV clinicians are setting their sights on different approaches to finding an HIV vaccine after the "disappointing" news that the Mosaico trial was stopped early because the vaccine did not show any efficacy.
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In 2019, only 53% of the estimated 1.8 million children living with HIV world-wide were diagnosed and on treatment. That means that over 800 000 children living with HIV are not receiving the treatment they need to stay healthy.

So, UNAIDS has a point when it suggests children living with HIV are being left behind in the HIV response.

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Children living with HIV are being left behind particularly in sub-Saharan Africa. More than half of the over 800 00 children not on treatment are in just five countries—the Democratic Republic of the Congo, Kenya, Mozambique, Nigeria and South Africa. Globally there were around 150 000 new HIV infections in children younger than 15 in 2019.

Doctor Leon Levin, head of the Paediatric HIV programme at Right to Care (an NGO), says there are different treatment combinations for different aged children based on availability of different formulations.

“In first line, very young children will get a three-drug combination containing a drug called lopinavir/ritonavir (LPV/r), while older children will get a three drug combination containing a drug called dolutegravir. Then of course there are second and third line regimens when the first and second line treatments stop working,” says Levin. “The very young children will take their medicines in [the] form of a syrup or little pellets that are sprinkled on porridge, and as they get older, we teach them to swallow small tablets.”

Bitter taste

A mother of two Sinethemba Jali says it is very difficult to give her child medication.

“The Kaletra (lopinavir/ritonavir) syrup is bitter and he can’t even take it. Most of the time he spits it out [and] sat time he even vomits. I have discussed this with my doctors and I was told to give him peanut butter first then the medication. This is really a challenge because he doesn’t like peanut butter and this makes it difficult for him to take his medication. This means most of the time he is not getting the medication as he is supposed to,” she says.

The lopinavir/ritonavir oral solution also contains 42% alcohol and 15% propylene glycol.

Levin agrees that the taste of HIV medicines is a problem for children. “Yes, some of them taste absolutely terrible for example the lopinavir/ritonavir syrup. Others have to be taken twice daily and other regimens consist of many tablets a day. All these things impact on adherence. In younger children the taste of the LPV/r is a big factor,” he says.

The challenges facing the caregivers of children living with HIV are multi-pronged, says Nelson Dlamini, acting communications manager at the South African National AIDS Council (SANAC).

“[These include] having to cope with their own HIV status as mothers to the kids. This could be social, emotional and economical, especially if they are unemployed,” he says. “In most cases, a positive child might not be the only child they are caring for. They might have multiple children. Juggling economic needs and caregiving responsibilities with minimal support, if any at all.”

Dlamini also points out that the lopinavir/ritonavir oral solution must be kept refrigerated. “This assumes that all caregivers with HIV-positive children have access to refrigeration,” he says. “Loadshedding and prolonged power cuts are likely to affect the effectiveness of syrups even for families with refrigerators, especially during summer months.”

He says in South Africa, children are among the most vulnerable and disproportionately affected populations in the HIV epidemic. “The lack of optimal antiretroviral medicines with suitable paediatric formulations has been a longstanding barrier to improving health outcomes for children living with HIV, contributing towards low treatment coverage, and poor virological suppression,” he says.

New formulations

Pharmaceutical company Cipla recently launched a new, more child-friendly product called Lopimune, in which lopinavir/ritonavir is formulated as pellets rather than a syrup. Unlike the syrup, the pellets do not require refrigeration.

According to Dr Precious Garnett, marketing manager and medical advisor at Cipla, Lopimune is easy to take. “A caregiver can put it in the child’s favourite food be it porridge, yoghurt or anything and the child eats it. That way we know children are not vomiting or spitting out the medication and they stay on treatment. Even if it is mixed with food we know it is still effective,” she says. The pellets do however become bitter if left in food for too long.

In addition to Lopimune, Cipla will also soon launch a product called quadrimune which combines lopinavir/ritonavir with the ARVs abacavir and lamivudine in strawberry-flavoured granules. Quadrimune was developed together with the Drugs for Neglected Diseases Initiative (a non-profit drug developer).

Long time coming

“All the new formulations that are in the pipeline will go a long way to solve the adherence issues we are experiencing with our current formulations, but some are better than others,” says Levin.

“The major advantages these products bring are better tolerability but also being stable at room temperature is a big plus. Even the new products vary in [its] tolerability which is why we are still waiting for newer products to be registered. It is amazing that we will finally be spoiled for choice in treating young children. It has been a long time coming and we still have a pretty long way to go.”

Developing child-friendly formulations is one thing, getting them registered so they can be made widely available presents another set of challenges.

“It takes years for new paediatric formulations to be registered in South Africa. Apart from last year, the previous time that we updated our paediatric dosage chart was in 2013,” say Levin. “That means no new paediatric formulations [were] registered for six years. Sadly, the MCC/SAHPRA (South African Health Products Regulatory Authority) has had a role to play in a lot of the delays. Taking three years to register a product is just not acceptable. True there have been changes and improvements but we are still hardly feeling them in paediatrics,” he says.

Sahpra had not responded to questions from Spotlight by time of publication.

PMTCT success

Levin says prevention of mother-to-child transmission of HIV has been a huge success. “Wow! It’s absolutely dramatic,” he says. “The transmission rate has gone down from around 40% to under 2% at birth, due to mothers taking ARVs throughout pregnancy (preferably starting before they conceive),” says Levin.

“We are pretty good at preventing transmission from mother to baby at birth. Obviously, there is always room for improvement but what we really still need to work on is HIV transmission during breast feeding. That is still high. Added to this are the numbers of moms who become HIV positive while breastfeeding and then transmit HIV to their babies through breastfeeding. Because these moms have early HIV infection, they are highly infectious,” Levin explains.

“We encourage HIV negative women to take all measures to prevent themselves contracting HIV while they are pregnant or breastfeeding. Pre-exposure prophylaxis (PrEP) (one tablet daily) can be used to reduce the risk of getting HIV by over 90%. HIV positive women must make sure they are on the correct ARVs, that they take them every day, and that their blood viral load is suppressed,” says Levin.

Vital to track progress

Facilitating a paediatric HIV treatment webinar earlier in November, Coceka Nogoduka from Sanac said it is vital to track progress as a country and look at things according to the goal and plans of the National Strategic Plan (NSP) of 2017 to 2022. Among others, the NSP endorses the UNAIDS 90-90-90 targets–which states that 90% of people living with HIV should know their status, 90% of people who know their status should be on treatment, and 90% of people on treatment should be virally suppressed.

Speaking at the same webinar, Dr Lesley Bamford, Acting Chief Director for Child and Youth Health in the National Department of Health, says South Africa is currently at 77-63-63 in terms of its performance against the 90-90-90 targets in children younger than 15.

Bamford admits the country is not doing well especially for children under 15 years, and work is being done to ensure that children are at the forefront when it comes to the HIV response.

“South Africa is currently providing sub-optimal treatment through use of non-essential and dated ARVs that most other high-burden countries have deprioritised and phased out,” she says. “The current paediatric ARV formulary is not providing children with the best medication for HIV treatment. The sub-optimal formulations have been found to negatively impact adherence in children resulting in poor outcomes such as reduced retention in care and treatment failure,” says Bamford.

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