South Africa: HIV/AIDS Drug Could Be Banned

South Africa's Medicines Control Council is set to make a final decision next month on whether HIV-positive pregnant women should continue taking nevirapine. The council has confirmed it is reviewing its approval of the drug because it has "serious concerns" about its effectiveness and toxicity.

The Sunday Times has established that the council questioned drug maker Boehringer Ingelheim in a heated meeting two weeks ago. The company was asked to explain alleged deaths from nevirapine in Uganda and why it had withdrawn an application for approval in the United States. Last week, the council established a watchdog body to monitor "adverse events" related to antiretroviral therapy. Council Registrar Precious Matsoso said the council would release a final report in September on the review of its findings on the drug's future use.

If registration is withdrawn, thousands of mothers with HIV will stop receiving nevirapine treatment. The move comes just months after the cabinet approved the use of nevirapine by pregnant women, and weeks after the Constitutional Court ordered the government to expedite provision of the drug.

Nevirapine's possible de-registration has elicited widespread comment. Professor Jerry Coovadia, head of HIV/AIDS research at the Nelson R. Mandela School of Medicine at the University of Natal, said he believed such a decision would be "quite disastrous" for the government's HIV/AIDS program. He said the World Health Organization and the 14th International AIDS Conference in Barcelona had reaffirmed the essential need for antiretrovirals, including nevirapine, for global programs to prevent mother-to-child HIV transmission.

Dr. Glenda Gray, head of the child health research unit at the Chris Hani Baragwanath Hospital in Soweto, said the facility uses nevirapine to treat an average of 22 new HIV cases every day. She said she could not understand why the efficacy and safety of the drug were being questioned when this had been addressed during a study on nevirapine in South Africa in 2000.

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