Article: HIV Prevention Drug Endorsed by Top U.S. Doctors

27 March 2002

Article: HIV Prevention Drug Endorsed by Top U.S. Doctors

U.S. experts dispel misconceptions about nevirapine

By Charlene Porter
Washington File Staff Writer

Washington -- Medical professionals from the United States and South Africa agree that the drug nevirapine is a safe and effective way to prevent transmission of the HIV virus from pregnant mothers to their newborns. Meeting in a videoconference sponsored by the U.S. Department of State March 26, physicians from the two nations discounted a variety of recent reports that have cast doubt on whether the drug is reliable.

"Nevirapine is a very, very safe drug," said Dr. John La Montagne, the deputy director of the U.S. National Institute of Allergy and Infectious Diseases (NIAID). "It is approved for the treatment of HIV in adults and children" in the United States.

Questions arose about the safety of the drug earlier in March when the drug's manufacturer Boehringer Ingelheim (BI) temporarily abandoned its attempt to win U.S. government approval to market the drug for prevention of mother-to-child-transmission (MTCT). The U.S. Food and Drug Administration (FDA) had previously approved the drug as an antiretroviral therapy. Under U.S. law, further FDA review is necessary if BI wants to advise use of the drug for a new purpose.

A drug trial sponsored by NIAID in Uganda from 1997-1999 provided the evidence that nevirapine is effective in the prevention of MTCT. La Montagne called the Uganda work a "very successful trial in that it demonstrated the effectiveness of nevirapine." Results of that study were published in the respected British medical journal The Lancet.

In order to win the expanded FDA approval, however, BI must undergo what La Montagne described as a "rigorous process" of re-analyzing the original patient records kept in the Ugandan drug trial. BI and the NIAID reported in separate statements issued March 22 that the manner of record keeping used in a program begun in 1997 may not be consistent with FDA requirements of today. A more intensive review of the primary data -- now stored in Uganda and two different U.S. cities -- will be necessary to determine whether the data will conform to the FDA methodology. That review is expected to take 6-8 months, the NIAID experts said.

"The only issue here is that the demands for record-keeping ... are quite exhaustive," said La Montagne. Both BI and NIAID emphasize that the withdrawal of the application in no way taints the original findings that Nevirapine is safe and effective.

"Boehringer Ingelheim continues to support the use of nevirapine and will continue to offer the drug to developing countries for the prevention of mother-to-child transmission of HIV," said BI in its March 22 statement. Both UNAIDS and WHO have also recently restated their support for this use of nevirapine.

Dr. David McCoy with South Africa's Health Systems Trust listened to the NIAID presentation in the videoconference and concluded that the status of nevirapine's expanded approval is "a bureaucratic procedural issue between BI and FDA." He said that matter has nothing to do with how the drug can be used in South Africa to prevent MTCT.

Obstetrician Ed Coetzee from Capetown's Groote Schuur Hospital said, "It seems clear cut this is all a bit of a storm in a teacup." He agreed with Dr. McCoy that nevirapine is effective in the South Africa population because it can prevent MTCT in as little as a single dose. That is a great advantage, Coetzee said, for a population with poor access to medical facilities.

Coetzee also asked the NIAID experts to respond to suggestions made in South African newspaper reports that BI and U.S. medical officials view nevirapine as a drug that's good enough for Africans, but not good enough for Americans. The NIAID physicians dismissed that suggestion as false.

La Montagne said nevirapine is "a common component of the standard triple drug therapy" used in the United States. The drug is currently in use, he said, correcting erroneous reports that suggest the drug had been withdrawn from the U.S. market.

As the NIAID experts addressed the concerns about nevirapine and denounced the false reports recently circulated in South Africa, one Johannesburg participant also pointed out that the drug has been used in selected areas to treat an estimated 10,000 South African HIV-positive pregnant women. They have taken the nevirapine to prevent MTCT without adverse effects.