Important note: Information in this article was accurate in 2003. The state of the art may have changed since the publication date.
Mail & Guardian (Johannesburg) - September 14, 2003
PSSA spokesperson Anita Heyl said in a statement the PSSA appreciated the decision taken by the Medicines Control Council (MCC) to fast track the registration of nevirapine for this purpose.
"It must be understood, however, that further information is essential to monitor the development of drug resistance. There is a possibility that development of resistance could affect the efficacy of future HIV/Aids treatment options," she said.
Heyl said another possibility to limit development of resistance was to use a combination of two or more antiretroviral drugs together.
"It is anticipated that future research results will indicate what regimen would the most beneficial to curb mother-to-child transmission. It is also important to monitor serious side effects and report these to the appropriate health authorities," she said.
In a released report, the MCC said nevirapine had shown to be effective in reducing the risk of intrapartum transmission of HIV-1 infection from mother-to-child. The MCC had scientific evidence to support this.
In 2001, nevirapine was registered for this indication, subject to a number of conditions, including the provision of any new information.
In July this year the MCC decided that, in the interests of public safety, additional information concerning the way in which nevirapine should be used for this indication should be presented within 90 days.
Following this decision, it was brought to the attention of the MCC that additional data from South African researchers was available which may support the continued use of nevirapine for preventing mother-to-child transmission.
Additional information regarding the original study has also now been published.
Recognising the importance of the new information, the MCC, on September 5, adopted a new resolution, which extends the time period for Boehringer Ingelheim (the supplier of nevirapine) to review existing evidence, and to submit additional data for expert assessment by the MCC.
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