The fact that one dose may lead to the creation of an HI-virus resistant to Nevirapine is no reason in itself not to register the anti-AIDS drug, but there should be strict monitoring by the drug companies of this, according to Professor Helen Rees chairperson of the Medicines Control Council (MCC).
Addressing parliament’s portfolio health committee on Tuesday (March 27), Rees said the MCC was initially surprised by the high amount of resistance generated by a single dose of Nevirapine to the mother and newborn.
Nevirapine, is currently awaiting MCC registration for use to prevent mother to child transmission of HIV during birth.
“Resistance in itself is not a reason not to register, but how do you monitor that?” Rees asked.She said South Africa would be the first country in the world to register Nevirapine for preventing mother to child transmission.
Rees confirmed that Nevirapine had been approved for use at Government’s 18 pilot sites. She pointed out that one pilot site could be a hospital with several referral clinics.
The pilot sites in all the provinces are supposed to start administering Nevirapine from next week.
In terms of registering the drug for wider use, Rees said the package insert had been approved, but that the MCC was discussing with the company how to tackle the resistance issue.
“In terms of the package insert we were grappling with issues of breastfeeding, having to point out that if women had to breastfeed there could be subsequent HIV transmission.
“In other cases you may have a woman who does not have access to clean water, but is bottle feeding. The baby may develop fatal diarrhoea. What do you say and how do you capture all that in a package insert?”
Rees confirmed that the current MCC’s term of office ended at the end of March and that it was up to the minister to make new appointments or re-appoint current people, including herself.