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Anti-AIDS Drug for Newborns gets BoostBy Steve Sternberg, USA TODAY, April 10, 2005 |
Volume 4 Issue 41April 2005 |
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Despite a fevered controversy over the reliability of the study that led to worldwide use of the AIDS drug nevirapine to protect newborns, doctors have begun testing a strategy for boosting the drug's proven benefits. New research suggests that nevirapine works best when given with a drug called Combivir. Combivir dramatically reduces the likelihood that single-dose nevirapine treatment will breed resistance to an entire class of AIDS drugs, robbing them of their effectiveness when AIDS patients need therapy most. During a scientific meeting in Boston in February, World Health Organization officials said they would consider recommending Combivir and nevirapine for the prevention of HIV transmission to newborns. |
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More than 39 million people worldwide are infected with HIV. Most new infections occur among women of childbearing age. Without treatment, a pregnant woman has a 25% chance of infecting her infant. A 1997 study by researchers at Johns Hopkins University and Uganda's Makerere University, called HIVNET 012, compared nevirapine and AZT. It found that a single dose of nevirapine given to pregnant mothers and newborns cut the risk in half. But the study has been dogged by allegations of flawed science and ethical irregularities. A panel from the National Academy of Sciences' Institute of Medicine concluded last week that the study was sound, despite some procedural irregularities and record-keeping errors. "The concerns that have been raised about HIVNET 012 have had a chilling effect on the use of this drug. We are happy to report that the study is valid," said IOM committee member and University of Wisconsin bioethicist Alta Charo. The most serious charges were brought by a National Institutes of Health administrator named Jonathan Fishbein. His allegations that the study was poorly carried out and did not properly warn volunteers of the risks they faced by participating in the study appeared to cast doubt on the study's results. Fishbein's accusations generated worldwide concern because poor nations with epidemics of HIV have virtually no other affordable options for protecting newborns. But Fishbein said in an interview Sunday that he is not challenging nevirapine's effectiveness. "The effectiveness of the drug is an issue I can't comment on," he told USA TODAY. "My issue is the conduct of this one study. ... It's a scientific-integrity question for me, not a nevirapine safety and effectiveness issue." Mark Isaac of the Elizabeth Glaser Pediatric AIDS Foundation said doctors have "already moved beyond this controversy" by trying to expand the prevention and treatment options open to pregnant women and newborns. The best option, he said, is lifelong combination therapy for the mother, now becoming more available through government and foundation programs. |
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