The American Academy of Pediatrics says more child-friendly HIV drugs are needed, including smaller pills and three-in-one tablets for kids, to help address a crisis affecting more than 2 million youngsters globally.
In a new policy statement endorsed by 19 international groups including the World Health Organization, the academy outlines barriers and solutions to an issue that is critical in developing regions.
In parts of Africa, AIDS kills about half of HIV-infected children before they reach the age of 2, said Dr. Peter Havens, chairman of an academy AIDS committee. By contrast, about 98 percent of HIV-infected U.S. children are expected to live to adulthood and have nearly normal life spans, thanks to readily available virus-fighting drugs, Havens said.
Some HIV drugs come as bottled liquids that require refrigeration. That poses a problem in rural countries, where some families travel for days by foot to get several months’ supply of bottled medicine that weighs as much as the infected child, said Havens, an infectious disease specialist at the Medical College of Wisconsin.
Pills pose a separate problem. Caregivers sometimes break or crush adult-dose tablets to give youngsters smaller amounts, but that results in inexact and inappropriate doses, the policy statement says.
“We hope that this outline ... will give some guidance to the pharmaceutical industry about where it might be best for them to put some of their energies,” Havens said.
The statement also is designed to raise awareness among policymakers, he said, noting that two federal measures encouraging research and development of medicines for children are up for reauthorization this year.
“It’s important for lawmakers to know this issue is important,” Havens said.
The statement was prepared for release Monday in April’s Pediatrics, the academy’s monthly medical journal.
While much attention has been focused on AIDS in Africa, limited access to HIV medicine and treatment is also an issue in Eastern Europe, “where the number of newly infected infants is still high,” said Dr. Carlo Giaquinto of the Pediatric European Network for Treatment of AIDS, whose group is among those that have endorsed the academy’s statement.
Low commitment to infected children
According to a United Nations/WHO report, 1.7 million people were living with AIDS in Eastern Europe and Central Asia in 2006, a 20-fold increase in less than a decade. Only 13 percent of people in those regions who needed treatment were receiving virus-fighting drugs last year, the UN/WHO report said.
By contrast, there were about 438,000 U.S. AIDS patients in 2005, nearly 4,000 of them under age 13, according to the federal Centers for Disease Control and Prevention.
Lack of pediatric drugs and clinical expertise is a problem in some Eastern European countries, as is a “low commitment of health care authorities in implementing treatment of HIV infected children,” Giaquinto said.
There are some HIV drugs designed for children, but not nearly as many as there are for adults, Havens said. As of September, 13 virus-fighting HIV drugs were approved by the FDA for use in children, compared with 22 for adults.
There are no three-in-one HIV drugs approved by the FDA for children, an agency representative said.
Many pediatric HIV drugs are in liquid form or chalky-tasting powders that children reject, Havens said.
Among the newest HIV medicines for children are mini-pills developed by Cipla Pharmaceuticals, an Indian drug maker. The pills, called Pedimune, combine three key virus-fighting medicines — nevirapine, stavudine and lamivudine — in doses for infants and older children. They are being studied in African children.
Also, Illinois-based Abbott Laboratories is seeking FDA approval for a new pill version of its Kaletra liquid medicine for children, which combines the virus-fighting drugs lopinavir and ritonavir.
The new tablet is being developed in part to eliminate the need for refrigeration, said Abbott spokeswoman Laureen Cassidy.
AIDS researcher Diana Gibb of the United Kingdom’s Medical Research Council praised the academy’s report and industry efforts to address the problem, but added: “There is still a way to go and in particular, fast track licensing of new formulations of new and older drugs for children.”