The Food and Drug Administration will approve a new, antiretroviral formula of HIV and AIDS treatment for children, declared UNAIDS and UNICEF on June 5, 2015.
Within the first few weeks of approval, the first batches of the new drug will be shipped to Kenya. Organizations such as Drugs for Neglected Diseases initiative will begin to introduce the formula to local communities to improve the health of children right away, said Dr. Marc Lallermant, head of DNDi’s Pediatric HIV Program.
The pioneer formula can be mixed with food, which makes it easier for children to consume. It is also heat-stable, meaning it does not require refrigeration, and it is more palatable than the drug that is currently available.
The current drug comes in the form of a pungent, unappetizing syrup that is 40 percent alcohol. This harsh formula is difficult for young children to consume. The circulating formula also requires refrigeration, which inhibits treatment in poor areas that do not have electricity or access to refrigeration.
Though the number of children receiving AIDS and HIV treatment has increased from 70,000 in 2006 to 760,000 today, thousands of children remain without treatment. In fact, only one in four infected children are being treated. Today, 3.2 million children live with HIV, and fewer than 800,000 of them are receiving treatment.
“This new formulation is a step in the right direction towards saving more lives of children living with HIV. We expect it to greatly improve treatment access for many more children and support UNICEF’s equity-focused programming aimed at reaching the most disadvantaged children throughout the world,” said Craig McClure, UNICEF’s chief of HIV and AIDS Programs.
If antiretroviral treatment begins early in infected children, according to the World Health Organization’s recommendations, the risk of death is greatly reduced. HIV progresses rapidly in young children.
In many impoverished countries with a greater amount of infected children, HIV is a major contributor to child morbidity and mortality. UNAIDS said, “Without treatment, one in three children who become infected with HIV will die before their first birthday. Half will die before their second birthday.”
The FDA’s approval is to come soon, as an intellectual property issue surrounding who is able to access the new formulation has been resolved. The Medicine Patent Pool signed with AbbVie, the patent holder for the new formula, in December of 2014. “This is a crucial license for pediatric programs as it benefits low- and middle-income countries where 99 percent of children with HIV in the developing world live,” said Greg Perry, executive director of the MPP.
In the future, the organizations UNITAID, DNDi and Cipla aim “to develop two ‘4-in-1’ fixed-dose combinations of Lopinavir/ritonavir with other key antiretroviral components (zidovudine/lamivudine and abacavir/lamivudine) that are recommended by the World Health Organization,” said Medical News’ website. The completely taste-masked version beyond the new pellet will allow for even more access for children with HIV.
– Margaret Anderson