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) medications for newborns and young children with HIV. Cipla Limited and the non-profit Drugs for Neglected Diseases initiative collaborated to create this combo medication (DNDi).
This new formulation outperforms protease inhibitor-containing paediatric ARV formulations that have been used in South Africa for decades. It does not need to be refrigerated, has a sweet flavour, and is simple to administer to infants and children of various weights and ages, which is a significant improvement over previously available formulations for both children and their carers. The country has the greatest number of HIV-positive children under the age of 15 in the world, with 238,000.
“It is extremely noteworthy that the first regulatory approval of the 4-in-1 formulation comes from a country with a high HIV load among children,” said Dr. Irene Mukui, DNDi’s Head of HIV. “SAHPRA’s rapid evaluation is significant and encouraging for other high-burden countries, and we applaud the South African authorities for their dedication. Now, we hope that all essential efforts will be done, first in South Africa and later in other countries, to ensure that as many young children as possible get access to this ideal formulation.”
In the form of granule-filled capsules, the “4-in-1” combination contains an antiretroviral combination suggested by the World Health Organization (WHO) as an alternate first-line treatment for newborns and young children with HIV. Children can be given the drug by sprinkling the granules over soft foods like porridge or dissolving it in water or milk.
Umang Vohra, Managing Director and Global CEO of Cipla, commented on the development, saying, “We are motivated by a great sense of duty to solve unmet patient needs, and we are dedicated to developing unique solutions to better people’s lives. This approval comes at a critical time, when so many children are infected with HIV at such an early age. We will continue to work to ensure that everyone has access to life-saving remedies.”
Until recently, the only WHO-recommended lopinavir-based medication accessible in South Africa for newborns and very young children was a syrup that included 40% alcohol and required refrigeration. Caregivers have difficulty giving this bitter-tasting formulation to small children, resulting in low adherence. Caregivers without freezers had a tough time keeping the formulas cool, often burying them in the ground.
Several new child-friendly formulations of WHO-recommended regimens are now being released, including paediatric formulations of dolutegravir-containing regimens, signifying a long-awaited and long-overdue “treatment revolution” for children with HIV.
“South Africa has achieved significant advances in the treatment of people living with HIV,” said Professor Moherndran Archery, who represents Child and Adolescent Interests at the Southern African HIV Clinicians Society (SAHCS). “Although 72 percent of South African adults are receiving life-saving HIV medication, only half of the country’s HIV-positive youngsters are receiving treatment. The approval of the 4-in-1, together with other optimal ARV formulations being released in South Africa, is a step toward eliminating this gap and ending the neglect of HIV-positive children.”
Without treatment, half of HIV-positive children will die before the age of two. According to UNICEF, 2.78 million children and adolescents worldwide are living with HIV, with 88 percent of them in Sub-Saharan Africa, while only 54 percent have access to treatment.
“For more than 20 years, Cipla has ensured equitable access to affordable, life-saving ARVs, and we are pleased to be continuing this commitment by providing optimal child-friendly antiretroviral formulations, especially for infants and young children who are at highest risk of dying without access to treatment,” says Paul Miller, CEO of Cipla South Africa.