World Health Organisation Statement
Nevirapine for the Prevention of Mother to Child Transmission of HIVWHO
reconfirms its support for the use of nevirapine to prevent mother-to-child
transmission of HIV.
July 2003
The Division of AIDS, National Institute of Allergy and Infectious Diseases,
National Institutes of Health, Bethesda has recently released the final
report (dated March 2003) from the reassessment of the trial procedures
and results in the HIVNET 012 trial conducted in Uganda1. This trial,
the first to demonstrate the safety and efficacy of nevirapine to prevent
mother-to-child transmission (MTCT) of HIV, was started in Uganda in 1997
and the results were published in 19992. A single dose of nevirapine given
at onset of labour plus a single dose to the newborn within 72 h of birth
reduced the risk of HIV transmission down to 13%, almost 2-fold lower
than a short course of zidovudine started during labour. Concerns about
the trial were raised in March 2002 when claims emerged that certain serious
adverse events had not been properly reported. The Division issued a statement
with the final report that concludes: "In summary, the re-monitoring
of the study determined that nevirapine, 200mg orally given to the mother
at delivery and 2mg/kg given to the neonate within 72 hours, is safe and
effective. However, the conduct of the study lacked the necessary documentation
to support a request to the FDA to consider this study as a stand alone
pivotal trial." Nevirapine has been registered in the USA, countries
of the European Union and numerous other countries for the treatment of
AIDS (in combination with other antiretroviral agents), and is also registered
for MTCT prevention in many countries worldwide. Nevirapine is recommended
by the US Public Health Service Task Force for MTCT prevention among women
in labour who have had no prior therapy3 and is included for both treatment
and MTCT prevention purposes in the WHO Model List of Essential Medicines,
which is updated on a regular basis.
In October 2000, WHO in partnership with UNAIDS, UNICEF and UNFPA, convened
a technical consultation to review all available evidence on the safety
and effectiveness of short-course antiretroviral drug-based interventions
to reduce the risk of MTCT4. The consultation concluded that all regimens
which had been shown to be safe and effective in controlled clinical trials
could be used in MTCT-prevention programmes. These regimens included zidovudine
alone or in combination with lamivudine, as well as nevirapine.
Since the consultation, further research conducted in South Africa has
demonstrated the safety and efficacy of nevirapine as well as the zidovudine
and lamivudine combinations.
Scaling-up MTCT-prevention programmes in resource-limited settings to
reach more HIV-positive mothers and prevent any further infants being
infected with HIV is a major challenge, to which many governments, non-governmental
organizations, international aid agencies and WHO are committed. While
nevirapine is only one of several regimens which has been shown to be
safe and effective, the low cost and simplicity of use of the regimen
makes it particularly attractive.
Recommendations
WHO continues to support the use of nevirapine in MTCT-prevention programmes.
WHO agrees with the National Institutes of Health report and the accompanying
statement, which emphasize that there is no evidence that the scientific
data from the HIVNET012 study demonstrating the safety and efficacy of
nevirapine are invalid. Each year, about 800,000 infants become infected
with HIV, mainly through mother-to-child transmission. WHO and its partner
United Nations agencies recommend that MTCT prevention using antiretroviral
regimens such as nevirapine should be included in the minimum standard
package of care for HIV-positive women and their children. WHO is not
aware of any information that should lead to a change in this recommendation.
References
1. www.niaid.nih.gov/daids/Prevention.htm
2. Guay LA, Musoke P, Fleming T, Bagenda D, Allen M, Nakabiito C, Sherman
J, Bakaki P, Ducar C, Deseyve M, Emel L, Mirochnick M, Fowler MG, Mofenson
L, Miotti P, Dransfield K, Bray D, Mmiro F, Jackson JB. Intrapartum and
neonatal single-dose nevirapine compared with zidovudine for prevention
of mother-to-child transmission of HIV-1 in Kampala, Uganda: HIVNET 012
randomised trial. Lancet 1999;354:795-802.
3. Public Health Service Task Force. Recommendations for Use of Antiretroviral
Drugs in Pregnant HIV-1 Infected women for Maternal Health and Interventions
to Reduce Perinatal HIV-1 Transmission in the United States, June 16,
2003. (http://AIDSinfo.nih.gov)
4. www.who.int/reproductive-health/rtis/MTCT_consultation.en.html
5. Moodley D, Moodly J, Coodavia H, Gray G, McIntyre J, Hofmyer J, Nikodem
C, Hall D, Gigliotti M, Robinson P, Boshoff L, Sullivan JL, for the South
African Intrapartum Nevirapine Trial (SAINT) Investigators. A multicenter
randomized controlled trial of nevirapine versus a combination of zidovudine
and lamivudine to reduce intrapartum and early postpartum mother-to-child
transmission of human immunodeficiency virus type 1. Journal of Infectious
Diseases 2003;187:725-735.
Contact
For further information please contact:
Dr Tim Farley
Department of Reproductive Health and Research
E-mail: FarleyT@who.int
or
Dr Isabelle de Zoysa
Department of HIV/AIDS
E-mail: DeZoysaI@who.int
[END OF WHO STATEMENT]
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