A “4-in-1” treatment for children with HIV, priced at below a dollar a day, currently being reviewed by the US Food and Drug Administration, could be ready for use this year if it receives approval.
The drug which is currently being reviewed for use in children between 3 and 25 kilograms of body weight, has been developed by Indian pharmaceutical company Cipla and the not-for-profit Drugs for Neglected Diseases initiative (DNDi) with financial support from Unitaid and other donors.
The product named Quadrimune is a pleasant tasting, heat-stable fixed-dose combination of four antiretrovirals (ARVs) for infants and young children. If it receives approval by the FDA in 2020, the 4-in-1 will represent a major improvement in the treatment of HIV in very young children and will replace older, bitter-tasting medicines, medicines requiring refrigeration, or regimens that are no longer recommended by the World Health Organization (WHO).
Children living with HIV have long been recommended treatment consisting of a bitter-tasting syrup with 40 per cent alcohol content. Dr Bernard Pécoul, Executive Director of DNDi, said, “Mothers were often forced to bury the syrup in the sand to keep it cool, because it required refrigeration. The new Quadrimune is pleasant-tasting, heat-stable and easy-to-use. We will finally have a treatment designed specifically for infants and young children, who are at the highest risk of dying if they do not receive treatment”.
According to the National Aids Control Report of 2012-13, India has estimated 145,000 children less than 15 years of age who are infected by HIV/AIDS, and about 22,000 new infections occur every year. Children account for 7 per cent of all the new HIV infections. It is estimated that 1.8 million children are living with HIV, almost 90 per cent of whom live in sub-Saharan Africa. Only an estimated 54 per cent of these children have access to HIV treatment and over 300 children still die from the disease every day. Inappropriate, suboptimal treatment options have contributed to low treatment coverage.
Quadrimune contains the WHO-recommended ARVs abacavir, lamivudine, lopinavir, and ritonavir, in the form of granules filled in capsules. If approved, parents and caretakers will be able to administer the drugs to children by sprinkling the granules with soft food, water, or milk. The 4-in-1 does not require refrigeration and is easy to administer to infants and children of different weights and ages.