South African Health Products Regulatory Authority (SAHPRA) has approved the sweet-tasting, heat-stable and '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, Cipla said in a regulatory filing. Homegrown pharma major Cipla Ltd and its partner Drugs for Neglected Diseases initiative (DNDi) on Tuesday announced the launch of a 4-in-1 antiretroviral treatment for children living with HIV in South Africa. South African Health Products Regulatory Authority (SAHPRA) has approved the sweet-tasting, heatstable and '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, Cipla said in a regulatory filing. This combination treatment has been developed by Cipla and not-for-profit DNDi, it added The new formulation does not require refrigeration. It 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 company said. "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," Cipla Managing Director and Global CEO Umang Vohra said. DNDi Head of HIV Irene Mukui said it is highly 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. "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," Mukui added. Until recently, Cipla said 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, it added. South Africa has 2.38 lakh children under the age of 15 living with HIV - the highest in the world, the company said. PTI RKL BAL BAL
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