Important note: Information in this article was accurate in 2002. The state of the art may have changed since the publication date.
South African Press Association (Johannesburg) - August 16, 2002
MCC registrar Precious Matsoso was speaking after a presentation on Friday to Parliament's health portfolio committee on the council's decision to review the drug.
The review was initiated after manufacturer Boehringer Ingelheim retracted its application for a similar registration in the United States.
Matsoso told the MPs nevirapine was still approved in South Africa for treatment of HIV/Aids and mother-to-child transmission.
"Nevirapine is not banned in this country," she said.
However, a special MCC committee had been set up to review all documentation around the Ugandan clinical trials on which the original approval was based.
Asked if it was possible that MTCT approval could eventually be withdrawn, she said: "It will be difficult to predict given what we have so far.
"I don't want to pre-empt the outcome of the committee's decision." The portfolio committee meeting followed newspaper headlines that the drug could be "banned", and speculation by the Aids lobby group, Treatment Action Campaign (TAC) that the MCC action was politically motivated.
It was attended by TAC leader Zackie Achmat and a group of TAC supporters wearing "HIV positive" T-shirts.
Matsoso told the committee the MCC approved nevirapine for MTCT prevention in March 2001, a decision based partly on information from the HIVNET012 study in Uganda.
Although the MCC had had only limited data, it gave the go-ahead because of the seriousness of the Aids epidemic.
In March this year, Boehringer told the MCC it had withdrawn its US application for registration because of problems with reporting and documentation in the Ugandan trial, Matsoso said.
The MCC had already received an audit of HIVNET012 carried out by Boehringer and the US National Institutes for Health.
It was now awaiting the institutes' "re-monitoring report" on the trial, which should come in September, and would be used to finalise the matter.
"The conduct of clinical trials is important and we cannot undermine data integrity," she said. "We are reviewing to look if integrity of data was compromised or not."
She emphasised that Boehringer had acted "very responsibly".
"We have not had any problem whatsoever with the company," she said.
Boehringer has said the problems related to the US withdrawal are technical, not clinical, and that it will resubmit its application later.
Clinical statistician and MCC member Dr Jonathan Levin told the committee no major concerns over safety were raised by either the Ugandan trial or the subsequent South African SAINT trial.
He also said there was no basis for the belief that nevirapine halved the rate of HIV transmission during birth.
If 100 women were given the so-called Petra A antiretroviral regimen, which included the antiretroviral AZT, after six weeks six babies would be HIV positive.
Petra B, also including AZT, would result in nine infected babies. Nevirapine would mean 12 or 13 infections, and no treatment at all would result in 16 to 18 infections.
Achmat said after the meeting that if there was any doubt about nevirapine's effectiveness, the government should switch immediately to AZT or triple therapy.
TAC had from the beginning wanted AZT, but the department of health decided on nevirapine as being cheaper and easier to use.
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