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
In parts of
Africa, AIDS kills about half of HIV-infected children
before they reach the age of 2, said Peter Havens,
chairman of an academy AIDS committee. By contrast,
about 98% 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,
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.
also is designed to raise awareness among policy makers, he
said, noting that two federal measures encouraging research
and development of medicines for children are up for
reauthorization this year.
for lawmakers to know this issue is important,'' Havens
The statement was
prepared for release Monday in April's
Pediatrics, the academy's monthly medical journal.
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 Carlo Giaquinto of the Pediatric
European Network for Treatment of AIDS, whose group is
among those that have endorsed the academy's statement.
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% of
people in those regions who needed treatment were
receiving virus-fighting drugs last year, the UN/WHO
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 Food and
Drug Administration 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.
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 drugmaker. The pills,
called Pedimune, combine three key virus-fighting
medicines--evirapine, stavudine, and
lamivudine--in doses for infants and older children.
They are being studied in African children.
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.
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...in particular, [with] fast-track
licensing of new formulations of new and older drugs
for children.'' (AP)