Sahpra approves new combo drug to revolutionise HIV treatment for children

A new sweet-tasting combination treatment designed for infants and young children with HIV has been approved for use in SA.

The “4-in-1" formulation approved by the SA Health Products Regulatory Authority (Sahpra) has been developed by the non-profit Drugs for Neglected Diseases initiative (DNDi) and pharmaceutical firm Cipla. It does not require refrigeration.

“It is significant that this first regulatory approval of the 4-in-1 formulation is from a country that has a high-burden of HIV among children,” said Dr Irene Mukui, DNDi's head of HIV.

“Sahpra’s accelerated review is notable and encouraging for other high-burden countries, and we acknowledge this show of commitment by the SA authorities.

“It is our hope that all the necessary steps will be taken —  first in SA and then in other countries — to ensure the broadest possible access to this optimal formulation for young children who need it.”

The fixed-dose formulation combines the antiretrovirals abacavir, lamivudine, lopinavir and ritonavir. Its developers say it is a significant improvement on protease inhibitor-containing paediatric ARV formulations that have been used in SA for decades.

The combination it contains is recommended by the World Health Organisation (WHO) as an alternative first-line regimen for infants and young children with HIV.

Caregivers will administer the medicine to children by sprinkling granules from a capsule  over soft food such as porridge or dissolving it in water or milk.

Until recently, the only WHO-recommended lopinavir-based treatment available for babies and very young children in SA consisted of a syrup that contained 40% alcohol and required refrigeration.

Caregivers struggled to give this bitter-tasting formulation to young children, leading to poor adherence, and those without fridges found storage difficult, with some burying the bottle in the ground to keep it cold.

The 4-in-1 treatment joins other new WHO-approved child-friendly treatment options.

Moherndran Archary, who represents child and adolescent interests at the Southern African HIV Clinicians Society, said children with HIV had been left behind and only half of them were on treatment.

“Along with other optimal ARV formulations being introduced in SA, the approval of the 4-in-1 is a step towards closing this gap and ending the neglect of children with HIV.” 

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