Cipla Limited’s ‘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 has been approved by the South African Health Products Regulatory Authority (SAHPRA). The sweet-tasting, heat-stable treatments have been developed by Cipla Limited and the not-for-profit Drugs for Neglected Diseases initiative (DNDi).
“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,” said Dr. Irene Mukui, Head of HIV, DNDi.
According to the company’s press statement, 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 affected children need to given the combination by sprinkling the granules over soft food like porridge or dissolving it in water or milk.
“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,” Umang Vohra, Managing Director, and Global CEO, Cipla said in a statement.
Till now, the only WHO-recommended lopinavir-based treatment available for babies and very young children in South Africa consisted of a syrup that contained 40 percent alcohol and required refrigeration.