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Plotting the Nevirapine debate
Health-e
2003-07-31

South Africa is once again at the centre of an AIDS drug controversy. Emotions are running high and the challenge is to determine what the issues are and the likely consequences for the thousands of women and children who may need the drug.  According to South African Medicines Control Council (MCC), the latest findings indicate that the original Uganda HIVNET 012 study no longer meets its regulatory requirements. The MCC says that the findings are no longer valid to approve the use of nevirapine in reducing the risk of HIV transmission from mother to child. It has ordered the manufacturers to provide further evidence of nevirapine for reducing the risk of mother to child transmission of HIV, within 90 days. In summary, the re-monitoring of the Uganda study has determined that nevirapine is safe and effective. However, the conduct of the study lacked the necessary documentation to support a request to the United States Food and Drug Administration to consider this study as a stand alone pivotal trial. This is what set the MCC's alarm bells ringing. Health-e took a look at the different reports and distilled their findings.Summary of findingsPlotting the Nevirapine debate http://www.health-e.org.za/Nevirapine%20dispute%20summary%20july30.doc (Source: Health-e news 30 July, 2003). Fully reports: http://www.health-e.org.za/HIVNET012%20Remonitoring%20Report.pdf http://www.who.int/reproductive-health/rtis/nevirapine.htm http://www.health-e.org.za/NVP%20review%201106.doc

South Africa is once again at the centre of an AIDS drug controversy. Emotions are running high and the challenge is to determine what the issues are and the likely consequences for the thousands of women and children who may need the drug. 

According to South African Medicines Control Council (MCC), the latest findings indicate that the original Uganda HIVNET 012 study no longer meets its regulatory requirements. The MCC says that the findings are no longer valid to approve the use of nevirapine in reducing the risk of HIV transmission from mother to child. It has ordered the manufacturers to provide further evidence of nevirapine for reducing the risk of mother to child transmission of HIV, within 90 days. 

In summary, the re-monitoring of the Uganda study has determined that nevirapine is safe and effective. However, the conduct of the study lacked the necessary documentation to support a  request to the United States Food and Drug Administration to consider this study as a stand  alone pivotal trial. This is what set the MCC's alarm bells ringing. 

Health-e took a look at the different reports and distilled their findings. Summary of findings Plotting the Nevirapine debate http://www.health-e.org.za/nevsummary300703.doc (Source: Health-e news 
30 July, 2003). 
Fully reports: 
http://www.health-e.org.za/hivnet012_report.pdf 
http://www.who.int/reproductive-health/rtis/nevirapine.htm  
http://www.health-e.org.za/nvpreview1106.doc

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