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South Africa to Decide on Key Anti-AIDS Drug
Steven Swindells
November 24, 2000
JOHANNESBURG (Reuters) - South Africa's top medical body met on Friday to decide whether to approve a key anti-AIDS drug in what experts believe is a litmus test for the government's commitment to fight the deadly disease.

The regulatory Medicines Control Council was to rule on granting a licence to allow German firm Boehringer-Ingelheim to distribute its nevirapine (viramune) drug as a preventive drug in mother-to-child (MTC) transmission and its wider use in the public health system for HIV-positive adults and minors.

Approval for the drug is seen as a gauge of the government's commitment to fight AIDS, which already infects one in 10, or 4.2 million, South Africans and threatens to kill up to seven million within a decade.

An estimated 5,000 HIV-positive babies are born every month in South Africa, which is at the epicentre of the AIDS epidemic that affects some 35 million people globally.

President Thabo Mbeki has been lashed by scientific and diplomatic criticism after voicing doubts over the link between HIV and AIDS and denying the use of drugs such as AZT in the public health system on cost and safety grounds.

"As far as we are aware it's on the Council's agenda today. They have the latest report by the World Health Organisation in front of them," a Boehringer-Ingelheim spokesman in Johannesburg told Reuters.

The WHO concluded this month that the safety and effectiveness of antiretroviral regimes that prevent MTC transmission of HIV - including nevirapine - meant there was no justification for restricting any of the regimens to pilot projects which are also under way in South Africa.

WHO had earlier expressed concerns over development of a nivirapine-resistant virus in women using treatment, a concern that was shared by the South African government which has denied a licence to nevirapine for MTC and public health system use for more than a year.

Babies are infected with the virus by their mothers either in the womb, during birth or through breast feeding. Up to 600,000 babies are born each year with the virus. Ninety percent of these cases are in the developing world.

South Africa To Approve Aids Drug

Separately, it was reported that the country's Health Ministry - which has said antiretroviral drugs have a highly limited role in public health policy - was set to give a rare green light to another drug in the fight against AIDS.

The Business Day newspaper said the ministry and Pfizer would sign a deal on World AIDS Day, December 1, to provide the antifungal treatment drug fluconazole free of charge to poor AIDS patients suffering from cryptococcal meningitis. "We are pleased with the way the negotiations have gone between the department and Pfizer," Health Minister Manto Tshabalala-Msimang said. "The spirit during the negotiations has been frank and characterised by cooperation."

AIDS activist groups, who protested outside the Council meeting, have imported cheaper generic versions of fluconazole from Thailand to protest against government's refusal to license the drug.