WHO approves combination pills

Fiona Fleck, BMJ

The World Health Organisation will soon formally approve three new combinations of three antiretroviral drugs in fixed doses for use in patients with HIV in sub-Saharan Africa. The approval could have a major impact on antiretroviral treatment for patients all over the world.

Fixed dose drugs have proved successful in treating malaria and tuberculosis. Whether in the form of a single pill or a “blister” pack containing three pills, the triple combinations are expected to be easier and cheaper than other drugs to deliver and simpler for patients to take and could be prescribed by nurses and paramedics. WHO plans a massive training programme to boost the number of non-doctor medical staff who can prescribe the drugs.

“We’re trying to come up with a shortlist of three preferred drug combinations based on published evidence and clinical experience,” said Jonathan Quick, WHO’s head of essential medicines. He added: “By 1 December we will know which are clinically preferred combinations, then it’s a matter for the companies to develop the product.”

Dr Quick said Ranbaxy and Cipla, two Indian companies that make generic drugs, were already producing triple fixed dose combinations that needed to be fully evaluated, while another possibility was for GlaxoSmithKline, Ranbaxy, or Cipla, to convert their current combinations of two fixed dose drugs that are already on WHO’s list of recommended drugs to triple combinations.

The International Federation of Pharmaceutical Manufacturers Associations said it was not opposed to the triple fixed dose combinations but argued that some drugs under consideration had not been properly clinically tested in Africa.

“The developing world is awash today in substandard and fake medicines, and as we all work to expand the treatment of people with HIV/AIDS we should use tested affordable treatments and not encourage use of alternatives of unproven safety, efficacy, and quality,” said Eric Noehrenberg of the Geneva based association.

Mr Noehrenberg said that the triple fixed dose combinations were unlikely to violate patents – for several reasons. Under a World Trade Organisation agreement India is not due to abide by patent law until 2005, and the patents that will then come into force are not retrospective.

Many countries in Africa do not have patents – because drug companies do not bother to file patents in countries that do not have their own drugs industry, as there is no danger of infringement. There are no international patents, only national patents, and very few patents are in force in sub-Saharan Africa.

Mr Noehrenberg said that it had not yet been announced where the triple combinations will be manufactured.

Generic drug manufacturers in countries such as India are already ahead in the race to produce triple fixed dose antiretrovirals – because they can copy patented drugs produced by different companies and combine them. Drug companies in the United States would need special agreement among themselves to combine their products in this way.

For a list of proposed simplified treatment for public consultation:

Source: BMJ 2003;327:1067 (8 November)

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