SAHPRA approves breakthrough granule treatment for children with HIV

SAHPRA has registered a new ‘sweet-tasting’ combination antiretroviral treatment in granule format for infants and young children with HIV.

The ‘4-in-1’ formulation with the trade name Quadrimune has been developed by the non-profit entity, Drugs for Neglected Diseases initiative (DNDi) and Cipla. The treatment is supplied in a granule format, which can be sprinkled on soft food or dissolved in milk or water. The treatment does not require refrigeration. 

Unlike the traditional protease inhibitor-containing paediatric ARV formulations, this new treatment combines the antiretrovirals abacavir, lamivudine, lopinavir and ritonavir in a novel manner, to ease administering it to children and infants. 

Paving the way for generic medicines

SAHPRA has also registered dolutegravir dispersible tablets for children with HIV by Macleods (trade names: Syromak 10 ODT and Kovasyp 10 ODT) and Mylan (trade names: Odinstri and Ristegra dispersible tablets). This comes after the recent registration of dolutegravir dispersible tablets for this cohort by the innovator company GSK (trade name: Tivicay), which paved the way for the registration of generic medicines. 

“These new treatment regimens for infants and children with HIV herald a huge breakthrough. The formulations are also recommended by the World Health Organization. SAHPRA is committed to enabling access to innovative health products that work well and that adhere to the tenets of safety, quality and efficacy,” indicates SAHPRA CEO, Dr Boitumelo Semete-Makokotlela. 

SAHPRA is committed to enabling access to innovative health products that work well and that adhere to the tenets of safety, quality and efficacy