Nevirapine at the centre of MTCT controversy

In recent weeks the spotlight has been on the drug nevirapine and its role in the reduction of mother to child transmission (MTCT).

The results of the HIVNet 012 study — in which a single dose of nevirapine given to a mother in labour followed by a single dose to her baby was shown to significantly reduce the incidence of mother to child transmission — and data from other studies supporting these findings, was followed by an application submitted to the US Food and Drug Administration (FDA) by the drug’s manufacturer Boehringer Ingelheim to market the drug for this purpose.

On examination, the HIVNet 012 results were found to have paperwork irregularities and therefore may not conform to the FDA regulatory requirements, and owing to the timeline for the review, Boehringer then withdrew the application. The company will however continue to support the use of nevirapine and to donate the drug to developing countries for the prevention of mother to child transmission.

This news of the FDA’s concerns was greeted with alarm by some, provoking statements from the WHO/UNAIDS, the National Institute of Allergy and Infectious Diseases (NIAID), the Elizabeth Glaser Foundation and several activist groups, defending the drug’s safety and its use within this setting.

None of these statements, however, addressed the ease with which nevirapine resistance can occur — from even a single dose — or the importance of treating the mother’s own disease and risking her future treatment options.

Meanwhile, in her commentary, reproduced below, following the publication of the results from the PETRA trial which used a two-drug combination of AZT and 3TC to reduce mother to child transmission, Dr Karen Beckerman, writing in The Lancet, criticises these interventions which ignore treatment for maternal disease and the inevitable creation of orphans.

She asks: “Is it justifiable to visit the antiretroviral mistakes of the industrialised world on regions that have been devastated by the HIV epidemic but are at least antiretrovirally naïve?”

Beckerman argues for strategies that save the lives of mothers, and continues that the “lack is particularly disturbing in view of the developed world’s experience that treatment of maternal HIV disease results in transmission rates far lower than transmission prophylaxis alone.”