South African clinicians are fearful that the country’s Medicine’s Control Council will ban the use of nevirapine for the prevention of mother-to-baby transmission of HIV next month. Such a move would, in effect, override a decision of the country’s Constitutional Court in July that the government must start providing the drug.
The Council is reported to have “serious concerns” about the safety and efficacy of the drug, focused in particular on alleged deaths amongst pregnant women taking the drug in Uganda and the withdrawal of the application for a US license to use the drug to prevent vertical transmission earlier this year by manufacturer Boehringer Ingleheim. The US Food and Drug Administration had raised concerns about record keeping in the Uganda trial.
South African clinicians have reacted to suggestions that nevirapine may have its license withdrawn with dismay. Professor Jerry Coovadia, head of HIV research at the University of Natal said such a move would be “quite disastrous” to South Africa’s HIV programme. A study recently reported on aidsmap.com found that HIV prevalence rates amongst pregnant women in South Africa varied between 29% and 40%.
Dr Glenda Gray of the child health research unit at Chris Hani Baragwanath Hospital in Soweto, who prescribes an average of 22 nevirapine doses a day to pregnant women, expressed bewilderment that the safety and efficacy of nevirapine was being questioned particularly as these issues had been addressed during a South African study into the drug in 2000.
AIDS activists have pledged to take the Medicines Control Council to court if it withdraws approval for the drug. Mark Heywood of the AIDS Law Project at the University of Witwatersrand said: "I can say this without a shadow of a doubt...we'll take them to court...And we'll do it with the best scientific authorities in the world."
For more information from aidsmap.com on research into the use of
nevirapine in preventing mother-to-child transmission href="http://www.aidsmap.com/treatments/ixdata/english/969A6B2B-595F-4F05-
BD07-534F8FAF9CFE.htm">click here