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 Cipla and the not-for-profit Drugs for Neglected Diseases initiative (DNDi).
As per a company statement, this 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 country has 238,000 children under the age of 15 living with HIV – the highest in the world.
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. Caretakers will be able to give the medicine to children by sprinkling the granules over soft food like 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 South Africa consisted of a syrup that contained 40 per cent alcohol and required refrigeration. Caregivers struggled to give this bitter-tasting formulation to young children, leading to poor adherence. Caregivers without refrigeration had a very difficult time storing the formulations – sometimes burying them in the ground to keep them cold.
Now, there are multiple new child-friendly formulations of WHO-recommended regimens being introduced – including paediatric formulations of dolutegravir-containing regimens – representing a long-awaited and long overdue ‘treatment revolution’ for children with HIV.
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.