Important note: Information in this article was accurate in 2003. The state of the art may have changed since the publication date.
Newsday - February 13, 2003
Laurie Garrett, Staff Correspondent
The research presented yesterday at the 10th Conference on Retroviruses raised questions about plans to escalate use of the cheap, German-made drug to save babies in poor countries.
A single dose of nevirapine - trade name Viramune made by Boehringer Ingelheim - can dramatically reduce the chances that an HIV-positive mother will pass her infection to her baby. When another fairly inexpensive drug, AZT, is added, the risk of spreading HIV from mother to child is cut to 5 percent, research has shown. The added bonus: Nevirapine is the cheapest of all the anti-HIV drugs, costing pennies per dose.
But the Zimbabwe study, led by Dr. David Katzenstein of Stanford University, raises the specter of drug resistance that itself could limit the mothers' future use of the drug. And the fact that mutant viruses concentrate in breast milk is problematic in countries where women breast-feed their babies for as long as 33 months.
"I have significant concerns about that," the conference leader, Dr. Constance Benson, told the media. "I think we need to study it in a very careful way."
However, Benson said it seemed premature to recommend a change in treatment policy until further studies validate the Zimbabwe findings.
The possibility that, for pennies per pregnancy, thousands of babies could be spared prompted Sen. Jesse Helms (R-N.C.) and President George W. Bush last year to advocate spending $500 million in 14 poor nations to implement mother-to-child transmission prevention programs. The potential of single dose treatment of mothers in poor nations was also a key element in Bush's recently proposed $15-billion AIDS program.
The Zimbabwe study of 33 pregnant women who received a single dose of nevirapine during labor found that within eight weeks after delivery, 40 percent of the mothers had drug-resistant, mutant HIV in their bloodstreams. Sixty-five percent of the new mothers had nevirapine-resistant mutant viruses in their breast milk.
One possible explanation for the levels in breast milk is that the drug is fat-soluble, concentrating in the fatty tissue of the breast, Katzenstein said in an interview.
"I think it's important to understand this," Katzenstein said. "But I would not want to see this interpreted as 'You should stop giving single dose nevirapine to pregnant women.'"
Katzenstein noted that no transmission of drug-resistant viruses to the babies occurred in the Zimbabwe study. Eight weeks after their births, four of the babies tested HIV-positive. All but one of them appear to have acquired their infections in utero or during labor, he said.
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