News
HST collects relevant news from a variety of sources, for your convenience and thus has no control over the content of these news articles. Select a story from below, or use our search feature to find stories of interest.

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 The MCC says that the findings are no longer valid to approve the use of nevirapine in reducing the risk of HIV transmission from mother to child.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 The MCC says that the findings are no longer valid to approve the use of nevirapine in reducing the risk of HIV transmission from mother to child.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

Keywords	This Item is associated with the Following Keywords: .
You Can Comment on this Item, or View other people's Comments
Easy Print  Email to a friend

	Related News
	Nevirapine given a (tentative) nod (2000-07-13) Nevirapine Trials to Proceed in South Africa Despite Drug Warning (2001-01-12) Combination Therapy Might Be Better Choice Than Nevirapine Alone To Prevent Vertical HIV Transmission, Researchers Say (2005-02-28) Anti-AIDS drug result expected soon (2000-03-17) South Africa: MCC softens stance on Nevirapine (2003-09-18)

	Related Publications
	South African Health Review 2007 (2007-12-05) Missed opportunities for participation in prevention of mother to child transmission programmes: Simplicity of nevirapine does not necessarily lead to optimal uptake, a qualitative study (2007-11-22) South African Health Review 2008 (2008-12-11) Interim Findings of the National PMTCT Pilot Sites: Summary of Lessons and Recommendations (2002-07-17) Reducing Mother-to-Child Transmission in Hlabisa District: Incremental Program Costs (2001-08-16)

	Related Health Statistics
	Percentage of facilities that are PMTCT sites (2004-05-14) Diarrhoea incidence under 5 years (per 1 000) (0000-00-00) HIV prevalence (%) (antenatal) (2004-10-04) Health systems performance rank (2002-02-09) Reported deaths from cholera (2004-05-12)

	Related Events
	Women's Health - Cervical Cancer Awareness Month (2007-09-01) Human Rights Training for Health Professional Educators (2010-01-25) HISA 2006 Conference (2006-05-03) 2nd South African Gender Based Violence and Health Conference (2003-05-07) Private Health. Public Value (2005-02-06)

	Related links
	Women, Children and HIV Medicines Control Council United States Pharmacopeia Drug Quality and Information Center for Health and Gender Equity [CHANGE] Pharmaceutical Management Information System (PharMIS)

	Related Content
	Treatment Monitor: Useful Links (2008-10-02) Prevention of Mother-to-Child Transmission of HIV/AIDS (PMTCT) (2004-04-07) Treatment Monitor: Sexual and Reproductive Intentions (2008-02-14) Treatment Monitor:Contraception (2008-02-14) Treatment Monitor: Abortion (2008-02-14)