The HIVNET 012 Study and the Safety and Effectiveness of Nevirapine in Preventing Mother-to-Infant Transmission of HIV
Questions and Answers
December 17, 2004
1. Is single-dose nevirapine a safe and effective drug for the prevention of mother-to-infant transmission of HIV?
Single-dose nevirapine is a safe and effective drug for preventing mother-to-infant transmission of HIV. This has been proven by multiple studies, including the HIVNET 012 study conducted in Uganda (see Selected Bibliography).
2. An Associated Press news story issued December 13, 2004, states "... top U.S. health officials [at the National Institutes of Health] were warned that research on the key drug [nevirapine] was flawed and may have underreported thousands of severe reactions including deaths. ..." Is this true?
The statement in the Associated Press article of December 13, 2004, that there may have been thousands of underreported serious adverse events in the HIVNET 012 study implies that those were due to the drug nevirapine. This implication is absolutely false. Remonitoring reports of HIVNET 012 found no additional serious adverse reactions related to nevirapine. The original published study and the multiple subsequent reviews of the HIVNET 012 trial that have carefully scrutinized its data have found only a very small number of serious adverse reactions that potentially might be due to nevirapine.
HIVNET 012 compared the safety and efficacy of preventing mother-to-infant HIV transmission using an AZT regimen versus a nevirapine regimen. In the six weeks following treatment, among the 309 infants in the AZT arm of the trial, 38 infants experienced serious adverse events, seven of which were thought possibly to be due to AZT. In the 320 infants who received nevirapine, 35 infants experienced serious adverse events, only two of which were thought to be possibly due to nevirapine. In the 302 mothers in the AZT arm of the trial, 12 experienced serious adverse reactions, and only one was thought possibly to be due to AZT. Of the 306 mothers who received nevirapine, 16 experienced serious adverse events, and only one was thought possibly to be due to nevirapine.
3. The same December 13th Associated Press news story alleges that NIH officials chose not to inform the White House in the spring of 2002 about safety issues concerning nevirapine. Is this true?
There is no truth to the allegation that NIH officials chose not to inform the White House in the spring of 2002 about safety issues concerning nevirapine. An initial review of the HIVNET 012 data conducted in early 2002 did not identify safety issues associated with the drug nevirapine. The review did, however, identify procedural problems related to record-keeping in the conduct of HIVNET 012. NIH officials did not directly inform the White House of these procedural problems identified in early 2002 because they had no bearing on the safety and efficacy of single-dose nevirapine used to prevent mother-to-infant transmission of HIV.
The conclusions of the HIVNET 012 study, that single-dose nevirapine is a safe and effective treatment for blocking mother-to-infant HIV transmission, were never called into question by any information turned up in the initial and subsequent multiple reviews initiated by NIAID and NIH.
4. Associated Press stories published December 13 and 14, 2004, also report allegations of scientific and administrative misconduct by staff within NIAID's Division of AIDS. Are these allegations true?
An individual has made several allegations regarding the scientific and professional conduct of officials at NIAID's Division of AIDS and of the scientific validity of the findings from the HIVNET 012 study. The allegations of misconduct have been assessed by the NIH Office of the Director using standard NIH protocols for handling this type of allegation and have been found to have no merit. To address the issues of the scientific validity of the study, NIH has contracted with the Institute of Medicine, part of the National Academy of Sciences, to conduct an additional independent review of HIVNET 012. The findings of that review are expected in March 2005.
5. Why is NIAID deeply concerned about the consequences of the distortion of facts that has resulted from the recent publicity about the HIVNET 012 trial conducted in Uganda?
As a result of distortions of facts resulting from the recent press reports concerning nevirapine and the HIVNET 012 trial, 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. NIAID stands by the results of HIVNET 012 and the safety and efficacy of single-dose nevirapine to prevent mother-to-infant transmission of HIV. This lifesaving approach is also endorsed by multiple groups, including the World Health Organization www.who.int/reproductive-health/rtis/nevirapine.htm; the Elizabeth Glaser Pediatric AIDS Foundation www.pedaids.org/press_release_nevirapine_december_14_2004.htm; Global Strategies for HIV Prevention www.niaid.nih.gov/Newsroom/Releases/global_strategies.pdf (PDF); and Project Inform www.thebody.com/content/art5030.html. 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.
NIAID Statements and News Releases
Key HIVNET 012 Publications
Project Inform Statement Regarding the Use of Single-Dose Nevirapine to Prevent Mother-to-Child Transmission of HIV
This article was provided by U.S. National Institute of Allergy and Infectious Diseases.