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 Limited and the not-for-profit Drugs for Neglected Diseases initiative (DNDi).
According to Cipla, this new formulation 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 country has 238,000 children under the age of 15 living with HIV – the highest in the world.
Irene Mukui, Head of HIV, DNDi said, "SAHPRA’s accelerated review is notable and encouraging for other high-burden countries, and we acknowledge this show of commitment by the South African authorities. Now, it is our hope that all the necessary steps will be taken – first in South Africa and then in other countries – to ensure the broadest possible access to this optimal formulation for young children who need it."
Umang Vohra, Managing Director and Global CEO, Cipla said, "We are guided by our strong sense of responsibility to address unmet patient needs and we are committed to bringing novel solutions to improve lives. This approval has come at an important time when so many children are suffering from HIV at such a young age. We will continue in our endeavour to enable access to life saving solutions for all."
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