The South African Health Products Regulatory Authority (SAHPRA) has approved a sweet-tasting, heat-stable, ‘4-in-1’ fixed-dose combination of four antiretroviral (ARV) treatments composed of abacavir, lamivudine, lopinavir, and ritonavir that is specifically designed for infants and young children with HIV. This combination treatment has been developed by pharmaceutical firm Cipla and the not-for-profit Drugs for Neglected Diseases initiative (DNDi). 

The new formulation represents a significant improvement over protease inhibitor-containing paediatric ARV formulations that have been used in South Africa for decades. It does not require refrigeration, has a sweet taste and is easy to administer to infants and children of different weights and ages, a major improvement for both children and their caregivers over previously available formulations. 

The ‘4-in-1’ combination contains an antiretroviral combination that is recommended by the World Health Organization (WHO) as an alternative first-line regimen for infants and young children with HIV – in the form of granule-filled capsules. 

The 4-in-1 was developed and registered with the financial support of Unitaid; the French Development Agency; the Swiss Agency for Development and Cooperation; Médecins Sans Frontières International; the UBS Optimus Foundation; the Monegasque Cooperation for Development; MSF Norway; the Spanish Agency for International Development Cooperation; and other private foundations and individuals.