New Vision (Kampala) - September 15, 2003

Surpassing a short and expensive course of AZT, the current therapy of choice, the strategy cuts transmission nearly in half by using only $4 worth of nevirapine, a non-nucleoside reverse transcriptase inhibitor. "We were hoping that nevirapine would be at least as good as the AZT," said Anthony Fauci, director of the National Institute of Allergy and Infectious Diseases. The surprise, he said, came when researchers found it was "significantly better than AZT" (CBS, "Evening News," 7/14). Preliminary results of a study comparing nevirapine with a short course of AZT were announced yesterday in Kampala, Uganda and at the National Institutes of Health, which sponsored the study.

Approximately 600 HIV-positive Ugandan women in their ninth month of pregnancy who had not taken anti- HIV therapy received either a short course of AZT treatment -- every three hours during labor, followed by twice-daily doses to newborns for one week -- or a single nevirapine pill, with newborns also taking a single dose, in liquid form, after birth. Nevirapine cut the risk of transmission by nearly 50%, researchers found. Four months after birth, 13% of the infants receiving nevirapine tested positive for HIV, compared with 25% of infants receiving AZT.

The Secret Ingredient

Johns Hopkins University's Dr. Brooks Jackson, who helped run the study in Uganda, said that the secret to nevirapine may be that it "lasts an astonishingly long time." In the mother, the single dose inhibits HIV in the colostrum, which is secreted in breast milk during the first few days of nursing. Infants who received the single dose of nevirapine had bloodstream concentrations 38 times the amount needed to block the virus seven days after birth. "In terms of its ability to save lives, this single-dose regimen will potentially save more lives than any other HIV intervention to date in developing countries," he said, noting that the cost of the drug, especially if manufacturer Boehringer Ingelheim offers a deep discount, will be negligible (Brown, Washington Post, 7/15). Wide-scale use of the drug could "potentially prevent 300,000 to 400,000 newborns each year from beginning life infected with HIV," Fauci said. The nevirapine treatment costs $4, while the short course of AZT carries a $268 price tag and the longer course used in the U.S. costs $815 (Altman, New York Times, 7/15). In addition to its low cost, Fauci said that the strategy can easily fold into the health care system in developing countries in which many women do not receive prenatal care. "The women come in later, when they are about to go into labor," he said, which is exactly when the first dose of nevirapine is administered. Jackson suggested that in high-risk regions, the drug could even be administered to all women giving birth (Los Angeles Times, 7/15).

Applause

Touting the findings as "the most significant medical breakthrough in AIDS since the protease drugs," AIDS Action Executive Director Daniel Zingale said that the effort takes a step toward "alleviat[ing] the global AIDS holocaust" (AIDS Action release, 7/14). HHS Secretary Donna Shalala applauded the findings, saying, "American scientists along with our international partners are committed to developing treatments that not only work, but that are also feasible in other health care settings. These results achieve both those goals" (HHS release, 7/14). Vice President Al Gore said that while "drugs alone are not the solution for countries that lack the systems to adequately provide them, all of us who have been searching for hope in this terrible epidemic should be encouraged by this promising news" (Gore release, 7/14). While noting that the study "approaches ideal prevention therapy" for developing counties, UNAIDS' Dr. Peter Piot said that it was "unrealistic to introduce it on a large scale in developing counties without first using pilot programs" -- which are slated to begin soon (New York Times, 7/15).

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