MCC extends Nevirapine deadline

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This decision follows a meeting at which the company and medical researchers presented evidence from local and international on studies on the use of Nevirapine as a single agent and also in combination therapy to prevent HIV infection from mother to child. The six-month extension is effective from September 8. As Khopotso Bodibe reports, the MCC says it is favours the use of Nevirapine in combination therapy for PMTCT as opposed to being used alone.

KHOPOTSO BODIBE: The new resolution made by the Medicines Control Council effectively scraps away the initial 90-day deadline it had given to Boehringer-Ingelheim, which was due to expire at the end of next month. But this does not mean that the medicines regulatory authority has changed its mind on questioning the integrity of Nevirapine as a single agent in the prevention of mother to child HIV transmission. Precious Matsoso is the registrar of medicines at the MCC.  

PRECIOUS MATSOSO:   The decision is based on the presentations that were made by the researchers. And I always say that you can’€™t base a decision on power-point presentations. We are saying that based on that we had to understand how long it would take Boehringer to go and collect that data and re-package it in accordance with our requirements. And I think they have conceded it would take them quite a while. But they have said up to six months. And we thought that it was not an unreasonable demand.  

KB: The studies the researchers presented to the MCC include a study conducted in South Africa on resistance to Nevirapine. Matsoso refers to other studies presented as operational research, which does not point to the efficacy of the drug as a single agent in PMTCT use. These were from countries such as Thailand, the Ivory Coast as well as South Africa.

PM: I need to underscore the fact that those studies are not in an instance where Nevirapine was used alone. It’€™s where Nevirapine was used in combination. And we have gone back to Boehringer to say that: re-submit even data where Nevirapine is used in combination because I think there is some indication that Nevirapine ‘€“ when used in combination with other anti-retrovirals – can be of value for both the mother and the baby.’€

KB: Mrs Matsoso carried on with this line of thought on combination therapy. Even though she did not say it in many words, she gave away an impression that the MCC would rather approve Nevirapine in combination with some other drug, as opposed to having the drug registered as a single agent in the prevention of mother-to-child transmission of HIV.

PM: If there are studies where Nevirapine is used in combination and it shows a significant decrease in the risk of transmission, I think we have to look at best practice and whether it’€™s ethical. Is it ethical to continue to save fewer babies, or is it ethical to go the long way to save as many babies as possible? I mean if we have an opportunity to save a significant number of babies in this country, I think that should be the case. And I think MCC is committed to ensuring that if there’€™s an intervention that can save as many babies as possible, or if at all possible, all babies, I think we’€™ll approve that indication. I think that is, sort of, the commitment. We’€™d like to see as many babies as possible saved and their mothers also.

KB: That could mean a combination of Nevirapine and some other drug?

PM: Of course, which is evidence that is available, actually. And I think it’€™s opportune because there is already an intention by government to roll out ARV therapy. And if at all possible, if it presents an opportunity to save both the mother and baby using that – whatever combinations, and if the evidence can be put before the MCC we’€™d really consider it.’€

KB: So, great work is actually on putting that kind of evidence together on combination therapy rather than Nevirapine alone?

PM: I still think that where Nevirapine alone has its own use and if there’€™s supportive evidence it should still be considered. As an example in the US, the mothers who present late in facilities are given one dose. But of course, following that they are put on combination therapy. It might be the route. But I cannot predict and pre-empt the decision of MCC at this stage. I think we can only make those decisions once we have data before us.

E-mail Khopotso Bodibe

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