Scientist questions MCC on nevirapine
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Transcript
It’s final. The Medicines Control Council has rejected the United States’ National Institutes of Health’s review report into the conduct of the Uganda HIVNET 012 clinical study on the use of Nevirapine as a single agent to prevent HIV transmission from mother to child. Now the challenge is for Boehringer-Ingelheim, manufacturers of the drug, to find new evidence on the efficacy of Nevirapine to present to the MCC within 90 days, seven of which have already been lost. However, the evidence that the regulatory authority is asking for has reportedly been presented to it already. This is a 66-page document detailing a number of clinical studies that have been conducted internationally on the safety and efficacy of Nevirapine when used alone or in combination with other drugs, such as AZT, in reducing the risk of transmission of HIV from mother to child. Dr Glenda Gray is Director of the Peri-natal HIV Research Unit and co-author of the document in question.
‘There are other studies that have been published that show that when a single dose of Nevirapine is added to AZT, this reduces transmission more than AZT alone. So, with or without any other agent Nevirapine has been shown in peer-reviewed journals to reduce transmission from mother to child. We can also see this when looking at various programmes throughout Africa, there’s data from Rakai, there’s data from Zambia that show that mother-to-child transmission using Nevirapine is down to 12 percent. And we know that that is a reduction from historical controls, which represents a significant reduction.’
However, it appears the Medicines Control Council has not given consideration to the alternative report. Seemingly, its decision was made only on the basis of the United States’ National Institutes of Health’s review report into the conduct of the Uganda HIVNET 012 clinical study, which showed several inconsistencies in the gathering and recording of data during the trial. The following is an excerpt from what the registrar of the Medicines Control Council, Precious Matsoso, said on Monday, the 28th of July when she made the announcement that shocked the nation.
‘Council’s concerns regarding documentation are real in that in any clinical trial that is conducted there has to be some source documentation verification. The reasons being that we have to verify that all patients who participated in a trial exist; we also have to ensure that they were available during the course of the trial and that documentation must point to that.
And, I think we can therefore, not just reduce this to administrative problems and as a result, Council is convinced and of the view that they cannot accept the validity of the study.”
I asked Dr Glenda Gray to respond to the charge. She referred to a Nevirapine study conducted here, in South Africa in 2000 ‘ the SAINT trial.
‘The South African Intra-partum Nevirapine trial confirms that HIVNET 012 works. The data we’ve got from the roll-out programmes ‘ from Coronation Hospital, Baragwanath Hospital, King Edward ‘ confirms that there’s a reduction in transmission rates’¦ There’s enough circumstantial evidence’¦ The body of knowledge would point in favour of Nevirapine, not against it.’
But the MCC says the SAINT study cannot be considered in the review of the drug’s continued registration for the prevention of mother-to-child HIV.
‘It was not conclusive. That was the first problem that we had with SAINT. But secondly, the resistance profile of the SAINT study because two doses of Nevirapine were used was quite significant. And it is for that reason that it is not recommended.’
So, that leaves two studies out of the equation ‘ the SAINT study and the Uganda HIVNET 012 trial. The Medicines Control Council seems to have concentrated on one report ‘ the United States’ National Institutes of Health’s review report into the conduct of the Uganda HIVNET 012 study. This, mainly because this is a clinical trial upon which the MCC registered Nevirapine in 2001 as a one-off treatment given to the mother at labour as well as to the baby within 72 hours of being born. Now what happens with the remaining studies submitted as alternative evidence to the MCC by the manufacturers of Nevirapine?
‘I think people should understand that we are rejecting one study because it does not meet regulatory requirements. It cannot be used as a pivotal study for approval of this indication.’
Perhaps the answer lies within that statement by Mrs Matsoso. The MCC might need to go back to the drawing board to re-consider its decision on Nevirapine and read thoroughly the report presented to it by Boehringer-Ingelheim before it makes a rash decision to de-register the drug.
E-mail Khopotso Bodibe
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