Generic drugs hold the key to AIDS treatment in the developing world, although a target of getting 3 million people on therapy by the end of 2005 may now be out of reach, according to the World Health Organization.
Hans Hogerzeil, its director of medicines policy and standards, said around half of those on AIDS drugs in poor countries were taking generic tablets, most of them made in India.
Speaking at a pharmaceuticals conference in Malta, he urged the United States to work with the world health body to include more generics in its AIDS treatment programs, which currently mainly use more expensive branded medicines.
Worldwide, the number of patients on generic antiretroviral drugs was increasing, he said, despite a problem last year when the WHO delisted some Indian generics which had not been proved to be equivalent to their patented counterparts.
Hogerzeil said the suspensions from the WHO’s pre-qualification list was regrettable but had not been a major setback.
The first batch of delisted antiretroviral medicines from India’s Cipla Ltd. was reinstated in November, after fresh tests, and others from Ranbaxy Laboratories Ltd. should return in the coming months, he added.
“It’s been a difficult message for people to understand, but there were always sufficient pre-qualified products available,” Hogerzeil told Reuters on the fringes the meeting.
The number of people in developing countries receiving treatment at the end of 2004 was 700,000 - an increase of 75 percent from the year before but still only a fraction of those in need.
“Reaching the 3 million (target) by the end of 2005 may not be possible. It will also depend on developments in a few key countries, like India, South Africa, Nigeria and China,” Hogerzeil said.
There is currently a gulf between the WHO approach to selecting medicines for the developing world and that of the United States, which requires all drugs supplied through its AIDS program to be approved by the Food and Drug Administration.
Hogerzeil said this led to duplication and hampered the U.S. effort, since the FDA has approved only a handful of products, despite giving tentative approval to two more generics from India on Monday. The WHO, meanwhile, has around 80 on its list.
“We would very much recommend that the American programs would recognize the WHO pre-qualification. It would save them a lot of time and it would give them access to many more generics,” he said.
The arrival of Indian-made products that combine two or three medicines in one pill has brought the cost of first-line AIDS therapy in Africa down to around $140-$400 per patient a year, he estimates.
Most brand-name drugs, by contrast, still cost $400-$600, although some are as cheap as generics in certain markets.
The next big challenge is to cut the cost of pediatric formulations and second-line treatments, which patients need to receive once they develop resistance to initial therapy.
Treating children with AIDS in poor countries currently costs $1,000-$1,500, reflecting an acute shortage of medication specially designed for children.
“Some of the Indian manufacturers are working on pediatric generics but there are very few available at the moment,” Hogerzeil said.
Revision date: July 4, 2011
Last revised: by Sebastian Scheller, MD, ScD