WHO announces approval of generic antiretrovirals

The World Health Organisation (WHO) on Monday officially approved and recommended the use of three generic versions of an antiretroviral (ARV) drug for people living with HIV/AIDS. The move will immediately help to increase availability of ARVs, by giving a seal of approval to drugs currently available for US $270 per person per year, as opposed to about US $700 for patented ARVs. The announcement in Nairobi that the generic versions, known as Fixed-Dose Combinations (FDCs), had been approved on quality, safety and efficacy grounds was made at the launch of a UN plan - known as "3 by 5" - to treat three million people with ARVs by 2005. The newly approved FDCs, produced by Indian companies Cipla and Ranbaxy, combine three essential drug components in each pill - lamivudine, stavudine and nevirapine. This means only two tablets need to be taken per day. Current patented drugs are produced by separate international pharmaceutical companies, which have not cooperated to combine their medicines into a single pill, resulting in patients having to take several pills a day at different times. "The 3 by 5 strategy recommends simplified AIDS treatment regimens so that countries can quickly expand access to antiretroviral medicines," said Dr Vladimir Lepakhin, WHO Assistant Director-General for Health Technology and Pharmaceuticals, in a statement. "These new products will help the countries which are hardest-hit by the AIDS epidemic get easy-to-take AIDS medicines to the people who need them most urgently." The single-pill combinations are "a major breakthrough" for AIDS treatment in poor countries, said WHO. They reduce the number of pills, improve reliability and security of supplies, are easier to take, and ensure that the right dosage is being taken by each patient. WHO is now recommending four different ARV regimens - down from 35 - one of which is the FDC pill. For patients who did not respond to the FDCs first time around, more expensive patented "blister packs" produced by international pharmaceutical companies were still recommended, said Dr Peter Graaff, technical officer with WHO. "Triple therapy combinations [FDCs] are not suitable for people coinfected with TB," he said. He added that it was important to keep the international companies on board in the struggle against HIV/AIDS. "Yes there is a price difference at the moment, but we also want to ensure that as much as possible the [pharmaceutical] industry stays in the game. We need innovation, we need new products," he said. "For every product on the market we need competition." Dr Morten Restrup, President of the International Council of Medecins sans Frontieres (MSF), welcomed the WHO move but said the target price for treatment still remained too high at US $400 per person per month. "WHO's drug price targets lack ambition and do not reflect prices that are currently available," he said. "Today drug prices have fallen by another 50 percent. WHO should encourage this trend in order that universal access to AIDS treatment becomes a reality." Indian-based Cipla has just offered ARVs to MSF and other organsiations at a cut-price of only US $140 per person per year.