Misinformation

Exaggerated Concerns About Anti-AIDS Drug Nevirapine

Media allegations that anti-AIDS drug causes severe reactions disproved
Beginning in December 2004, widely reported media articles contained allegations that have led to exaggerated concerns about the anti-AIDS drug Nevirapine. Given as a single dose to both mother and newborn, nevirapine is widely used to prevent mother-to-child transmission of AIDS.

The articles charged:

• Flawed research in a clinical trial of Nevirapine in Uganda (known as HIVNET 012) led to the underreporting of "thousands of severe reactions, including deaths."
• The National Institutes of Health (NIH) "chose not to inform the White House as it scrambled to keep its experts' concerns from scuttling the use of Nevirapine in Africa."
• The chief of NIH's AIDS division "doctored" a key report on this issue.

In addition, some groups and individuals have interpreted the articles as indicating that Nevirapine is unsafe, and that Africans and others taking it are being used as "guinea pigs."

On the safety and efficacy of single-dose Nevirapine in the prevention of mother-to-infant transmission of HIV, the facts are:

• NIH has stated, "Single-dose Nevirapine is a safe and effective drug for preventing mother-to-infant transmission of HIV. This has been proven by multiple studies."
• The World Health Organization (WHO) has stated, "WHO continues to support the use of Nevirapine in MTCT (mother-to-child transmission)-prevention programs." It adds, "While Nevirapine is only one of several regimens which have been shown to be safe and effective, the low cost and simplicity of use
  of the regime makes it particularly attractive."
• The use of single-dose Nevirapine, alone or in combination with other antiretroviral drugs, is recommended by all international health agencies and national governments conducting prevention of mother-to-child transmission (PMTCP) programs.

While Nevirapine is not the first treatment of choice when combination antiretroviral therapy is available, it is clearly better than doing nothing.

On the thousands of alleged "severe reactions" in the HIVNET 012 trial, the facts are:

• Virtually all these "reactions" were a consequence of underlying medical conditions, including HIV/AIDS, and not side effects of Nevirapine.
• 306 mothers in the Uganda trial received Nevirapine. Sixteen had serious adverse events (not reactions), only one of which was thought to be possibly due to Nevirapine. 320 infants received Nevirapine. Thirty five had serious adverse events, only two of which were thought to be possibly due to
  Nevirapine.

On the NIH decision not to inform the White House, the facts are:

• The problems with the Uganda trial were related to procedural, record-keeping issues, not the safety or efficacy of the single-dose Nevirapine regimen. There was no need to inform the White House of these
  issues since they did not impact the decision to use single-dose Nevirapine for the prevention of mother-to-infant transmission of HIV.

On the alleged "doctoring" or "altering" of a report, the facts are:

• The director of NIH's AIDS division, Dr. Edmund Tramont, edited several draft "subreports" submitted to him in the process of issuing the final "remonitoring" report. This report was not "doctored." It was Dr. Tramont's responsibility to provide a comprehensive report that accurately reflected all of the available information on the HIVNET 012 trial.

Health professionals have expressed concern that misinformation about Nevirapine may prevent its use in saving the lives of some of the 1,900 infants born every day infected with HIV. The NIH stated, "There is a real possibility that physicians and health care providers in developing countries will not use the lifesaving single-dose Nevirapine regimen to block mother-to-infant transmission of HIV in situations where there are no other options, such as multiple drug antiviral treatments...It is conceivable that thousands of babies will become infected with HIV and die if single-dose Nevirapine for mother-to-infant HIV prevention is withheld because of misinformation."

An article in the December 21, 2004, issue of The New York Times quoted Dr. Rachel Cohen of Doctors Without Borders, noting that most of the 38 million people infected with HIV worldwide live in very poor countries. More than half are women, most of them of child-bearing age.

• In Africa, Ms. Cohen noted, women often seek medical care only just before giving birth, and they often have advanced AIDS. In such cases, it is too late to do anything but give one dose of Nevirapine to the mother and one to the baby, which cuts the chances of infection by about half. The two doses cost only $5.
• The World Health Organization prefers a six-week course of Nevirapine "when feasible," but it costs about $40, so the single-dose is still used when it is the only chance to save a baby from infection.

Relevant documents:

• December 17, 2004 - NIH Questions and Answers
• December 14, 2004 - NIH Statement
• July 2003 - WHO on "Nevirapine for the Prevention of Mother to Child Transmission of HIV"

Created: 14 Jan 2005 Updated: 14 Jan 2005