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PRECIOUS MATSOSO: The Medicines Control Council met on the 2nd of July to assess the documentation that was submitted regarding the status of nevirapine for use in the reduction of risk in the transmission of HIV from mother to child. We have lately received data on resistance and the Medicines Control Council is of the view that mono-therapy is no longer allowed, particularly for this intervention of reducing the risk of mother-to-child transmission, where Nevirapine is used alone or where Zidovudine (AZT) is used alone.

The Medicines Control Council, therefore, recommends that combination therapy be used. And this is particularly because the risk benefit profile of nevirapine has changed and there is emerging resistance. The resistance issue has been documented over a period. But, what we are beginning to see is resistance against the back-drop of access to treatment as part of the Comprehensive Plan (on HIV and AIDS Care and Treatment). And that on its own is a significant move that, in the opinion of the MCC, should be considered. In particular, the treatment of women to prevent transmission should take into account some of the studies that have been conducted elsewhere that have been shown to be more efficacious than nevirapine used alone.

In February, the WHO made a statement of fact – that Nevirapine used alone is less efficacious. I think this is consistent with some of the concerns that have been raised.

KHOPOTSO: Your issues as far as resistance is concerned, if you can just clarify that, what are your concerns?

PRECIOUS MATSOSO:There are studies that have been conducted in South Africa that show that resistance can be up to 50%, where nevirapine is used alone. There are studies that show resistance of 40%. I think the concerns are that we need to understand the clinical implications of this, precisely because we are going to start treating women (and) we are going to start treating babies.

And we do not know whether there are implications for women and babies. It has been shown in some of the studies where women were given (a) single dose (of) nevirapine, if they have to be treated six months thereafter, they are unlikely to respond. There is some therapeutic failure. And that is a concern to us. Where women have an opportunity to be treated with good treatment options, they should be considered.

KHOPOTSO: Finally, the Health Ministry is releasing a statement today (Mon, 12/04) in South Africa. What does this mean for the prevention of mother-to-child HIV transmission programme in the country – does it automatically stop?

PRECIOUS MATSOSO: No, it doesn’t stop. Remember, there are quite a number of regimens that exist. And we’ve seen in these studies (that) there are regimens where nevirapine is used in combination to prevent resistance, and I think those should be considered. But it’s not up to the MCC to direct the programme (as to) what treatment to consider.

The Department of Health is aware of these developments. There is going to be a meeting to discuss this. They have already put ther thoughts together. One of the provinces (Western Cape) has already started using combination therapy. There are experiences in the country that people can learn from.   It’s not like people are going to learn anew. But, it’s not up to the MCC to decide as to what is it the programme should do.

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