PARIS, July 2 (AFP) - A single dose of three copycat drugs is as effective in combatting the AIDS virus as the expensive triple cocktail of branded drugs made by pharmaceutical giants, a study says.
The announcement is being hailed as excellent news for the UN's campaign to distribute antiretroviral drugs in poor countries.
It is the first clinical scrutiny into whether the much-trumpeted single-tablet generic tritherapy is safe and effective.
Supporters of generics say they are the key to lowering the cost of providing anti-HIV treatment in Africa and other poor, AIDS-ravaged locations.
In addition, by combining three drugs in a single tablet, that offers a big advantage for patients by simplifying an complex daily regime of drug-taking.
French researchers tested a single dose treatment called Triomune, made by Indian pharmaceutical firm Cipla, among 60 HIV-infected volunteers in the West African state of Cameroon, 92 percent of whom had full-blown AIDS.
They were given one tablet of Triomune -- which combines equivalents of three antiretroviral drugs called lamivudine, stavudine and nevirapine -- in the morning and another tablet at night.
Six months later, HIV levels in 80 percent of the patients had fallen to below detectable levels, and their once-ravaged immune systems began to be restored, as measured by the count of CD4 white blood cells.
Levels of drug concentrations in the blood were "fully satisfactory", and equivalent to patients who took brand-name drugs. Patients closely followed the treatment regime.
"This generic fixed-dose combination gives results comparable to those seen in the developed world using triple drug therapy comprising brand-name drugs," said Eric Delporte, of the France's National Agency for AIDS Research (ANRS).
"Thanks to these findings, it is now no longer possible to raise scientific uncertainty as an objection to the widespread utilisation of (single-dose generics) in the developing countries."
The research, published in the British medical weekly The Lancet, was showcased at a press conference in Paris on Thursday. It will be presented at the July 11-16 International AIDS Conference in Bangkok.
The UN's World Health Organisation (WHO) has set the end of the 2005 as the deadline for giving access to antiretroviral drugs to three million people with HIV.
The WHO is focussing on sub-Saharan Africa, home to two-thirds of the 40 million people in the world with the human immunodeficiency virus (HIV).
But of the many obstacles facing this campaign, the biggest is money -- and the more cash that can be economised by spending less on drugs, the more lives can be saved.
The cost of antiretrovirals has fallen sharply in recent years, thanks to goodwill cuts by big pharmaceutical companies and the emergence of copycat equivalents made in Brazil, India and Thailand.
Big Pharma has fought against generic manufacturers, saying their copying saps the profit motive that drives pharmaceutical innovation, and questioning whether their products meet standards of safety and efficacy.
The Cameroon study will be extended to assess the long-term effects of using single-dose generics.
In Cameroon, where antiretroviral therapy is state-subsidised, the monthly cost of Triomune treatment is 20 dollars, compared with 35 dollars for equivalent brand-name drugs, ANRS said in a press release.
However, this price difference could be as wide as 30 dollars per month in other countries.
Antiretroviral drugs, commonly called the AIDS "cocktail", were introduced in the mid-1990s.
They stop the virus from replicating after it penetrates an immune cell and hijacks the cellular machinery.
In many people, they can make HIV a manageable disease, although they are not a cure and there can be toxic side-effects. If the treatment is stopped, the virus rebounds.
Until now, the beneficiaries of these revolutionary drugs have been in the rich world, simply because of the cost factor.
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