The New York Times - July 14, 2004
Sharon LaFraniere

South African officials said Tuesday that the Medicines Control Council, which regulates drugs in South Africa, recommended against giving pregnant, H.I.V.-positive women a single dose of the drug nevirapine just before childbirth, even though the practice has become increasingly common in clinics across Africa. A South African health official defended the decision on Wednesday.

The council ruled that mothers who took the drug would be too likely to develop drug resistance to antiretroviral therapy, and that nevirapine is more effective when used in combination with other drugs.

Instead, the council recommended a 28-week regimen that combines nevirapine and another antiretroviral drug, zidovudine, better known as AZT.

Health experts at the international AIDS conference here condemned the decision as another example of South Africa's reluctance to confront the AIDS epidemic head-on, despite the fact that more than five million of its citizens are infected with H.I.V., more people than in any other country.

"It sends out a totally wrong message," said Joep Lange, co-chairman of the conference and president of the International Aids Society, an organization of clinicians and AIDS workers. While the regimen recommended by South Africa's regulators is theoretically better, he said the risk of creating a generation of infected children outweighs the risk of creating drug resistance.

"We know that in many settings the single dose of nevirapine is the only option," he said. "It is better than nothing."

South Africa has a reputation for taking unpopular -- and many experts would say unwise -- stands on AIDS. While specialists say some African nations like Botswana and Uganda have tackled AIDS vigorously, South Africa, the continent's richest country, has moved slowly to fight a disease that researchers estimate kills at least 600 South Africans a day.

Mr. Lange faulted South Africa's president, Thabo Mbeki, for "not showing leadership."

Precious Matsoso, South Africa's register of medicines, defended the decision on nevirapine in an interview on Wednesday, saying that treating pregnant women with single doses of the drug during childbirth increases the likelihood that antiretroviral therapy will not work for them when they become sick later in life.

The World Health Organization issued a pointed statement on Tuesday supporting treatment of pregnant women with nevirapine alone. The organization said such treatment should not be limited while health systems gear up to provide more complex therapies.

"Progress in implementing programs to prevent mother to child transmission based on single-dose maternal and infant nevirapine or other short course regimens should not be undermined," the statement said.

Isabelle de Zoysa, a senior W.H.O. adviser, said that in many African nations, pregnant women wait too long to begin a 28-week course of antiretroviral therapy. In most cases, she said, a shorter course of antiretrovirals or a single dose of nevirapine for the mother and baby are the only options.

Although it increases drug resistance in as many as half of the cases, she said, a single dose of nevirapine for the mother and baby has been shown to cut the risk of transmission from 30 percent to nearly 15 percent. Health experts estimated that tens of thousands of women have been treated under this regimen.

But Ms. Matsoso said that while a riskier treatment might be necessary elsewhere in Africa, women in South Africa typically seek medical attention earlier in pregnancy and can be treated with a longer, more complex therapy. "I don't see why there is a controversy," she said.

Zachie Achmat, who leads the Treatment Action Campaign, which lobbies for antiretroviral therapy in South Africa, said at a conference session here on Wednesday morning that limiting the use of nevirapine was another sign of how the South African government had sowed confusion over AIDS.
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