Drug Concerns Threaten AIDS Program

Charmaine and her husband tried for over a year to have a child. The day she found out she was pregnant, a doctor told her she was HIV-positive (search).

Devastated, Charmaine considered abortion, but opted instead to try an AIDS drug called nevirapine (search) to protect her newborn girl — now a healthy 1-year-old "miracle," she says.

Researchers now warn that taking a single dose of nevirapine during pregnancy can make mothers resistant to later treatment with the drug. The finding is threatening a program that's saved thousands of infants in South Africa from HIV transmission in the world's most HIV infected country, where 600 people die each day from AIDS-related complications.

In July, South Africa's Medicines Control Council (search) recommended hospitals give up the single-dose nevirapine regimen in light of resistance concerns, saying mothers should take more effective — and expensive — "cocktails" of anti-retroviral drugs (search) available in the United States and other wealthy countries.

But that would put protection out of reach for mothers like Charmaine, who gave only one name because of the stigma still associated with AIDS. South African doctors say until better options become available here they'll continue giving nevirapine to AIDS-sickened mothers.

"You can't apply a standard here in Africa that says until we can get the Rolls-Royce of treatment, let's not do anything," said Dr. Ashraf Coovadia, head of the pediatric HIV clinic at Johannesburg's Coronation Mother and Child Hospital. "If we just pull the plug on nevirapine ... many, many more babies would die."

South African regulators started asking questions about nevirapine when manufacturer Boehringer-Ingelheim withdrew its 2002 application with the U.S. Food and Drug Administration to market the drug in America to protect babies during birth.

The company noted serious irregularities in a key study conducted in Uganda. Top U.S. officials were warned of the problems weeks before President Bush announced a $500 million initiative in June 2002 to spread nevirapine in Africa, The Associated Press revealed this week.

Subsequent studies, however, confirmed the safety and efficacy of nevirapine, including one at Coronation hospital that found a single dose cut HIV transmission to 8.9 percent.

Nevirapine can cause severe rashes, liver toxicity and even death in some patients who use the drug on a daily basis to treat HIV, the virus that causes AIDS. But no serious reactions have been reported after a single dose, researchers say.

The main concern is that taking nevirapine during pregnancy can cause resistance to the drug, compromising the mother's future treatment. One study conducted here found that 39 percent of HIV-infected women who get a single dose go on to harbor virus that is resistant to the drug.

World Health Organization officials have been aware of the risk since 2000, but said that until recently few infected African mothers could afford life-prolonging anti-retrovirals. WHO says concerns about resistance must be balanced against the practicality of delivering a single dose of nevirapine and recommends it remain an option in impoverished African countries.

More than 5 million of South Africa's 45 million people are infected with HIV, more than any other country. Of the 1 million women who give birth every year, close to 28 percent are HIV-positive, and more than a quarter pass on the virus to their children, researchers say.

Studies have shown that a single dose of nevirapine to an infected woman during labor and another dose to her newborn baby can reduce the chances of HIV transmission by up to 50 percent.

Nevirapine taken with other drugs — as recommended by the South African regulatory body — and other combinations have cut transmission to less than 1 percent in the United States, Europe and Thailand.

But in South Africa, prenatal care is not widely available, and many pregnant women turn up at the hospital for the first time in labor — too late to start more complicated regimens.

The South African Health Department is reviewing its guidelines on mother-to-child transmission. But it says it will continue to provide single-dose nevirapine until an alternative is decided.

Doctors agree state hospitals should expand to more potent regimens, but not at the expense of hard-won programs.

President Thabo Mbeki's government long refused to provide anti-retrovirals through the public health system, citing cost and safety concerns.

In August 2001, a coalition of health workers and AIDS activists won a Constitutional Court ruling ordering the government to provide nevirapine to all HIV-infected pregnant women. But it wasn't until the government launched a comprehensive AIDS treatment program last April that the drug became widely available.

The South African government has promised to provide free treatment to all who need it within five years. Meantime, Boehringer-Ingelheim provides nevirapine free to protect newborns in many developing countries and, under international pressure, other drug manufacturers have slashed their prices in poor countries as well.

Activists from the Treatment Action Campaign say the nevirapine program remains patchy in South Africa, but thousands of HIV infections are being prevented at more than 1,500 sites where the drug is administered.

Charmaine was lucky. The hospital she delivered in had raised its own funds for nevirapine.

The woman lying next to her in the ward never got the drug. Her baby was born HIV-positive and died within two weeks. The mother also died of AIDS-related complications.

Despite the risks to her own treatment, Charmaine didn't hesitate to take nevirapine. Her doctor says it's too early to tell if she's become resistant to the drug.

"If it can help my baby, it is worth taking the risks," Charmaine said as her little girl played with a stethoscope on a recent medical visit. "She is the best thing that ever happened to me."