E-DRUG: Nevirapine /MTCT indication withdrawn in USA
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[Boehringer Ingelheim last wednesday asked the FDA in USA to withdraw the
NDA status for the MTCT indication of nevirapine. This was immediately
picked up by the South African government, which asked the Medicines
Control Council to review the indication for MTCT in South Africa as well.
Please note that the SA government is involved in a court case with the
Treatment Action Campaign which has successfully asked the courts to
instruct the Dept of Health to provide nevirapine to HIV+ pregnant mothers
which have been appropriately counselled and tested. The SA government
position is at odds with WHO's advice of October 2000, in which it was
clearly stated that nevirapine was safe and effective, and that countries
could roll out nationwide.
Below the statements of WHO/UNAIDS and NIH about the USA nevirapine
developments. It appears there is no reason to change the position on
nevirapine for MTCT.
It would however be helpful to know what the administrative irregularities
were in the Uganda trial.
Finally a write-up from the Washington Post. Copied as fair use. WB]
WHO AND UNAIDS CONTINUE TO SUPPORT USE OF NEVIRAPINE FOR PREVENTION OF
MOTHER-TO-CHILD HIV TRANSMISSION
Geneva, 22 March 2002 - The statement released today by the United States
National Institutes of Health (NIH), concerning some reporting and
documentation irregularities in clinical trial HIVNET012, does not warrant
any change in the recommendations issued following a WHO technical
consultation on mother-to-child HIV transmission in October 2000.
This expert group, convened by WHO on behalf of UNICEF, UNFPA, and the
UNAIDS Secretariat, concluded that the safety and effectiveness of
antiretroviral regimens, including nevirapine, in preventing
mother-to-child HIV transmission has been clearly documented and that the
use of these regimens is thus warranted for preventing mother-to-child HIV
transmission. The simplest regimen requires a single dose of nevirapine to
the mother at delivery and a single dose to the newborn within 72 hours of
birth.
The NIH statement emphasized that, according to available information,
there has been no evidence the scientific data from the HIVNET012 study
demonstrating the safety and effectiveness of nevirapine is invalid.
Each year, more than 600 000 infants become infected with HIV, mainly
through mother-to-child transmission. WHO and the UNAIDS Secretariat
recommend that the prevention of mother-to-child transmission of HIV,
including antiretroviral regimens such as nevirapine, should be included in
the minimum standard package of care for HIV-positive women and their
children. We are aware of no information that would cause the WHO and
UNAIDS to change its recommendations.