South African children will have to wait until next year for the rollout of the child friendly, ‘sweet-tasting’ antiretroviral (ARV) treatment, despite this new 4-in-1 combination receiving the green light.

The South African Health Products Regulatory Authority (SAHPRA) approved the combo, which includes abacavir, lamivudine, lopinavir, and ritonavir in June. But the National Department of Health isn’t ready to roll out the treatment especially designed for infants and young children.

Currently, the same combination is given to children in pill form, that’s hard to swallow.

Department of Health spokesperson, Foster Mohale, told Health-e News the new child friendly treatment might only be available at public facilities towards the end of the year. He added that the department doesn’t envisage widespread use of the 4-in-1 combination.

Long road ahead 

“It is anticipated that most young children using the current combination will be transitioned to a dolutegravir-containing regime, and not the 4-in-1 combination.  A sweet tasting, dispersible (paediatric dolutegravir) DTG tablet has also been registered in SA,” said Mohale.

Dolutegravir is considered a ‘better medicine for children weighing between 3kg and 20kg’, who can now benefit from an age appropriate formulation of the drug in tablet form that can dissolve in water or other liquids.

The department is updating treatment guidelines to introduce paediatric dolutegravir.  

“With regards to timelines, several steps need to unfold. Registration is only the first step as guidelines need to be updated, and health care workers trained. The manufacturers also need to ensure adequate supply and provide information on the costs,” Mohale added.

He further indicated government procurement procedures also need to be followed. 

A sense of urgency required

Dr Amanda Skepu from the Council for Scientific and Industrial Research (CSIR), says it’s important that the country rolls out the new 4-in-1 combination quickly to improve adherence to treatment among children. 

“The new 4-in-1 fixed-dose ARV treatment is child-friendly, does not require refrigeration and has a sweet taste. The new formulation is in the form of granules in capsules which can be added to liquids and food, while the current treatment regimen requires refrigeration and has a bitter taste”, said Skepu. 

She added that South Africa has done well in terms of ‘providing ARV access to at least 72%  of people living with HIV’. “But only half of the children living with HIV are on treatment. Without access, these children are at risk of dying. And since the new treatment is child-friendly, treatment adherence will increase as well as chances of survival”, she said.

A welcome relief

Having witnessed children and infants struggle to take their HIV treatment for over a decade, a caregiver has described the new ARV treatment as a welcome relief. 

Khathutshelo Nemafhohoni from the Vhutshilo Mountain School said children won’t suffer anymore. 

“For many years, I have seen infants and young children struggle to take their HIV treatment due to the unpleasant taste. It is therefore very difficult to persuade children to adhere to the treatment,” she said.  

Situated just outside Louis Trichardt in Limpopo, the school has become a refuge for young people living with HIV.

South Africa's approval of the 4-in-1 combination ARV treatment for children is a big win in availing optimal treatment options for infants & children living with #HIV.

Read more here 👉🏾https://t.co/aEZOCqu2ui pic.twitter.com/qwA9ln8s8p

— Prof Sam Kariuki, BVM, MSc, PhD, DSc (Hons, LSTM) (@EADirectorDNDi) June 14, 2022

“The moment I heard that a new combination of treatments will soon be at our disposal, I was so excited. They say the new treatment is sweeter and more appealing to children,” said Nemafhohoni.

She further noted that since the new HIV treatment can be sprinkled on soft food, parents and caregivers will have a much easier time. 

Decline in HIV treatment for children

According to UNAIDS, the number of children on treatment globally has declined since 2019, leaving almost 800 000 children (aged 0 to 14 years) living with HIV, and not on antiretroviral therapy in 2020. In South Arica, where an estimate 238 000 children have HIV, only 40% have suppressed viral loads, compared to 67% of adults.

South African National Aids Council (SANAC) spokesperson, Nelson Dlamini, said that the current regimen is very unpleasant.

“The main difference is that the previous regimen was not child-friendly at all. But this new formulation is nice on the palate,” said Dlamini.  

Improved adherence among children

Dlamini is hopeful that the new treatment will help to improve treatment adherence among children. The country has a high rate of people defaulting on their treatment for a number of reasons.

Nemafhohoni further pleaded with parents and caregivers to do everything they can to keep their children on treatment so that they can grow up healthy and strong. 

“It is our duty as parents and caregivers to ensure that our children adhere to their treatment all the time. We have to do almost everything within our powers to make sure that they continue to take their treatments,” said Nemafhohoni. – Health-e News