New evidence to avert Nevirapine crisis

New evidence will be presented to the Medicines Control Council (MCC) in a bid to ensure that the anti-AIDS drug Nevirapine is not de-registered for prevention of mother-to-child HIV transmission (PMTCT).

However, in the meantime the drug could be used “off label” (without being registered) for PMTCT, suggested eminent scientist Professor Salim Abdool Karim.

Registrar of Medicines, Dr Precious Matsoso, told the SA AIDS Conference that while the MCC could not register the drug on the basis of the Ugandan HIVNET 012 study, which had a range of irregularities, “researchers say that there is something else they can give us”.

The MCC would meet researchers and the Department of Health before its next council meeting in early September in a bid to avert a potential public health crisis if Nevirapine was to be de-registered.

Matsoso stressed that Nevirapine was safe but that, according to “regulatory requirements”, evidence to support the registration of medicines had to be based on “randomised clinical trials”.

The MCC was unhappy with certain administrative aspects of the Ugandan study, including recording keeping of consent forms from trial participants.

However, she indicated that “a preponderance of evidence” to support the efficacy of Nevirapine, rather than a new trial, “may be an option offered to council” as a way out of the impasse.

“But we would not want to encourage this approach,” she stressed.

Three studies presented at the conference provide new evidence that the drug works. Of 600 HIV positive women at Chris Hani-Baragwanath Hospital given Nevirapine, only 11,9% transmitted HIV to their babies. With 300 HIV positive women at Coronation Hospital, the transmission rate was 8,9%, while a small study of 54 women at St Marys showed a transmission rate of 1,8%.

The crisis was sparked almost two weeks ago when the MCC wrote to Boehringer Ingleheim, the manufacturers of Nevirapine, and said it had rejected the Ugandana study. It has given the company 90 days in which to supply new evidence to support the registration of Nevirapine for PMTCT.

Abdool Karim, who chaired the conference’s scientific committee, suggested yesterday that the MCC could either “extend 90-day period could be extended, or the drug could be used off-label”.

This would ensure that the government’s PMTCT programme, which is serving an estimated 80 000 women and their babies, was not disrupted and more babies were not born with HIV.


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