S. Africa won't urge AIDS drug in labor

BANGKOK -- South Africa said yesterday it will no longer recommend that women with HIV receive a single dose of the drug nevirapine during labor to stop transmission of the virus to their babies, igniting criticism at the 15th International AIDS Conference and raising fears that women around Africa would now shun the potentially life-saving medicine.

Nevirapine has significantly reduced the chances of infections being passed to infants during childbirth. But several studies have suggested that at least 40 percent of HIV-positive mothers develop a resistance to the drug when it is used as the sole treatment, and they may remain resistant months or years later when they use it as part of their own antiretroviral therapy.

South Africa's Medicines Control Council, which announced the decision made July 2 in a closed meeting, said in a statement from Johannesburg that a recent study revealed resistance in up to 50 percent of the mothers in that country who had used it. Although the government did not ban the use of the drug, Precious Matsoso, the council's registrar, said in Bangkok that it is recommending that the treatment ''must be used in combination with other drugs."

Doctors overseeing programs that use the drug said that South Africa's decision could create confusion around the continent, including in areas where nevirapine is the only drug available that can prevent HIV transmission in childbirth. Several also said that the decision was not based on proper science and that more studies were needed.

''When medical scientists haven't decided the right path on nevirapine, that's a bad process" to recommend against using it, said Richard G. Marlink, executive director of Harvard AIDS Institute and scientific director of the Elizabeth Glaser Pediatric AIDS Foundation, which helps distribute nevirapine to thousands of mothers in poor countries.

Marlink said in an interview at the conference that the decision could create doubt throughout Africa, given South Africa's strong influence on the rest of the continent.

''In those rural places, women coming into labor probably will not use it now," he said. ''We're saving a whole lot of lives with a simple dose. Yes, you should add AZT or other drugs -- if you have it. But how many places have it?"

An HIV-positive mother in a developing country has a 25 percent chance of passing on the virus to her baby if no drugs are used. With a single dose of nevirapine, the odds are roughly cut in half. If nevirapine is used in combination with other drugs, the percentage can drop to about 5 percent.

Leaders in the AIDS fight were stunned by South Africa's decision, the latest controversy surrounding the country's response to the disease under President Thabo Mbeki.

Four years ago, Mbeki questioned whether HIV led to AIDS and long resisted activists' calls to begin a countrywide program for antiretroviral drugs. Health Minister Manto Tshabalala-Msimang also has repeatedly angered those with HIV by questioning why so much emphasis was put on the virus and so little on other diseases; earlier this year, as activists clamored for a rollout of antiretroviral drugs, she suggested that those infected should focus on eating properly.

Tshabalala-Msimang appeared at the conference during the first two days, but had left Bangkok by yesterday, South African officials said. She could not be reached for comment.

For South African AIDS activists at the conference, the news prompted an outcry.

''We didn't come to Bangkok to fight," said Zackie Achmat, head of the Treatment Action Campaign. ''But now we will. The minister has caused deep pain."

At a session on leadership in the AIDS fight chaired by Graca Machel, a revered women's leader in South Africa and wife of former president Nelson Mandela, Sipho Mthathi of South Africa pleaded with Machel to use her influence to overturn the nevirapine decision.

Mthathi said she spoke with a health worker in South Africa earlier yesterday who ''had to deal with 20 hysterical women who continue to take nevirapine. I beg you to speak to the minister and get her to act responsibly." Machel declined to respond publicly and instead spoke later with Mthathi in private.

Dr. Glenda Gray, codirector of the HIV Perinatal Research Unit at the Chris Hani Baragwanath Hospital in Soweto, the sprawling township near Johannesburg, said in an interview that she is in the midst of a promising trial combining nevirapine with a drug called combivir. Patients used a single dose of nevirapine and then followed it with either four days or seven days of combivir.

She presented the data to state officials two weeks ago. The timing of South Africa's announcement seemed to take her by surprise, even though she agreed that a combination of drugs would be better than nevirapine alone. But Gray said the single dose of nevirapine was ''the backbone" of many mother-to-child prevention programs around Africa.

''We mustn't jeopardize children's lives by not using nevirapine when we have no other option," she said. ''I don't think women should be without any intervention while we're looking for that magic bullet."

The World Health Organization agreed. ''A single dose of nevirapine is very practical and very easy to deliver," said Timothy M. M. Farley, coordinator of sexually transmitted and reproductive-tract infections.

Farley said that, ''when feasible," doctors and health workers should use combination therapy. But he said there was no data yet on whether those women who develop a resistance to nevirapine after receiving a dose will still be resistant months or years later.

Of greater concern now, he said, is whether South Africa and other countries will stop using the single dose of nevirapine. ''We're worried about the ripple effect," he said.

John Donnelly can be reached at donnelly@globe.com