By: Christophe Hitayezu
The Indian pharmaceutical company Cipla has announced their commitment to price the ground-breaking new product Quadrimune, a “4‑in‑1” treatment for young children with HIV, at below a dollar a day. Quadrimune is currently under review by the US Food and Drug Administration (FDA) for use in children between 3 and 25 kg bodyweight.
This pleasant tasting, heat-stable fixed-dose combination of four antiretrovirals (ARVs) for infants and young children with HIV was developed in partnership by Cipla and the not-for-profit Drugs for Neglected Diseases initiative (DNDi) with financial support from Unitaid and other donors. If it receives tentative 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).
‘Cipla is happy that over the past 20 years it has contributed to making adult antiretroviral drugs available at affordable prices for patients throughout the developing world, in particular Africa, and has pioneered the development of paediatric fixed-dose combinations of ARVs for children,’ said Dr Yusuf K Hamied, Chairman of Cipla. ‘Over the years, the treatment of children with HIV has been neglected. In order to ensure faster access, particularly in sub-Saharan Africa, our product Quadrimune, once approved, will be offered for less than one dollar a day for children.’
‘Children living with HIV have been neglected for too long, with the recommended treatment for years consisting of a bitter-tasting syrup with 40% alcohol content,’ said Dr Bernard Pécoul, Executive Director of DNDi. ‘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.’
It is estimated that 1.8 million children are living with HIV, almost 90% of whom live in sub-Saharan Africa. Only an estimated 54% 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.
Cipla will provide Quadrimune at an ex-factory cost of US$ 15 per pack of 120 capsules, giving a price of $1 per day ($360 per year) for children in the medium weight bracket of 10 to 13.9 kg, with prices lower, at 50 US cents per day for younger children and infants.
“This optimal child-adapted all-in-one ARV regimen, that meets WHO recommendations, will be a game-changer for millions of infants and young children,” Unitaid Executive Director Lelio Marmora said. “Unitaid is proud to have supported from day one the development of this new 4-in-1 treatment that is safe and effective, adapted and palatable, easy-to-use and with no requirement for refrigeration. Once adopted, this innovative formulation will enable great advances in the treatment of the youngest kids.”
Since 2013, WHO has recommended regimens that include a class of ARVs called protease inhibitors, which includes lopinavir/ritonavir (LPV/r), for infants and young children. Cipla and DNDi worked closely to develop Quadrimune, testing over 30 formulations of abacavir, lamivudine, and LPV/r, ensuring good taste-masking, and selecting one which met the standards required for enable regulatory submission.
The 4-in-1 could be the first of several new treatment options for young children with HIV that are now on the horizon.
“We hope that Cipla’s commitment to affordable Quadrimune will enable rapid uptake of this medicine,” said Dr Pécoul.