South Africa 'may ban' nevirapine for prevention of vertical transmission

Michael Carter
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This article is more than 22 years old.

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South African clinicians have reacted to suggestions that nevirapine may have its license withdrawn with dismay.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%.

Glossary

efficacy

How well something works (in a research study). See also ‘effectiveness’.

vertical transmission

Transmission of an infection from mother-to-baby, during pregnancy, childbirth, or breastfeeding.

 

Food and Drug Administration (FDA)

Regulatory agency that evaluates and approves medicines and medical devices for safety and efficacy in the United States. The FDA regulates over-the-counter and prescription drugs, including generic drugs. The European Medicines Agency performs a similar role in the European Union.

mother-to-child transmission (MTCT)

Transmission of HIV from a mother to her unborn child in the womb or during birth, or to infants via breast milk. Also known as vertical transmission.

withdrawal

In the context of drugs or alcohol, withdrawal is when a person cuts out, or cuts back, on using the substance, also known as detoxification or detox. In a context of sexual risk reduction, it refers to the insertive partner in penetrative sex withdrawing before ejaculation. It is not a particularly effective way to lower the risk of HIV transmission or pregnancy.

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

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