IOM: Nevirapine Study Is Reliable

by John S. James

Summary: The Institute of Medicine re-analyzed the key study that first showed prevention of mother-to-child HIV transmission by single-dose nevirapine. The IOM released a 150-page report concluding that the study was properly conducted and its results are valid.

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Due to questions raised about HIVNET 012, the groundbreaking study that first showed that single-dose nevirapine could reduce transmission of HIV from infected mothers to their babies, the prestigious Institute of Medicine reviewed the study at the request of the U.S. National Institutes of Health, and presented an independent assessment. It concluded that the study was conducted ethically, that the findings that nevirapine is safe and effective for preventing maternal transmission were well supported, and that policy makers and scientists can rely on the resulting data and conclusions. [1, 2]

The IOM report will be published in a document of about 150 pages, including an executive summary of about 7 pages. Meanwhile, an uncorrected proof of the executive summary and complete report are available online. [2] A report of the press briefing of April 8 was published in Science, April 15. [3] AIDS Treatment News published a background report on the recent controversy last December. [4]

References

[1] Press release from the Institute of Medicine, April 7, 2005,
http://www.iom.edu/report.asp?id=26287 (click on "Press Release").

[2] Complete report, Review of the HIVNET 012 Perinatal HIV Prevention Study, http://books.nap.edu/catalog/11264.html

[3] For a report from the public press briefing of April 8, see Jennifer Couzin, "IOM Panel Clears HIV Prevention Study," Science, April 15, 2005, volume 308, issue 5720, page 334.

[4] "Nevirapine Misinformation: Will It Kill?" by John S. James. AIDS Treatment News, December 2004, http://www.aidsnews.org/2004/12/nevirapine-ap.html Reprinted in IAPAC Monthly, December 2004.

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