
Associated Press - December 17, 2004
Alexandra Zavis
JOHANNESBURG - Charmaine and her husband tried for more than year to have a child. The day she found out she was pregnant, a doctor told her she was HIV-positive.
Devastated, Charmaine considered abortion, but to try an AIDS drug called nevirapine to protect her newborn girl -- now a healthy 1-year-old "miracle," she says.
Researchers now warn that 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 here 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 recommended that 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 available in the United States and other wealthy countries.
But that would put protection beyond the reach of mothers like Charmaine, who gave only one name because of the stigma still associated with AIDS. South African doctors say that until better options are available, they'll give nevirapine to mothers with AIDS.
NOT ALL OR NOTHING
"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.
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.
Later 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. The 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.
LEVEL OF INFECTION
More than five million of South Africa's 45 million people are infected with HIV, more than any other country. Of the one million women who give birth every year, close to 28 percent are HIV-positive, and more than a quarter pass 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.
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