Health24, November 11 2002, Nevirapine results delay

South Africa's Medicines Control Council will have to wait until the end of the year for a report from the United States which will guide its decision on whether to review the registration of nevirapine for the prevention of mother to child transmission (PMTCT) of HIV.

MCC registrar Dr Precious Matsoso confirmed this week that nevirapine would remain the drug of choice for PMTCT in South Africa until at least the end of December when the long-awaited report from the National Institutes of Health (NIH) is expected.

Withdrawn in the US
Questions around the use of nevirapine for PMTCT arose when the manufacturer Boehringer-Ingelheim brought to the attention of the MCC a decision in March this year, to withdraw its application to the Food and Drug Administration (FDA) in the United States to register nevirapine for PMTCT.

This was done when Boehringer-Ingelheim realised it did not have sufficient documentation to provide to the FDA on the HIVNET 012 trials it had conducted in Uganda between 1997 and 1999.

It was because of the absence of these documents that Boehringer-Ingelheim withdrew their application for registration of the drug in the US.

The MCC registered nevirapine for PMTCT use in South Africa in April last year, based on the results of the HIVNET 012 clinical study.

Draft report of investigation
Matsoso confirmed that the MCC had received a draft report of stage one of the two-stage investigation from the NIH and that is would be discussed at a council meeting on November 15.

"It must however be noted that the interim report is subject to a confidentiality agreement between the MCC and the NIAID, on the latter's insistence," Matsoso said.

She said that as soon as the MCC had received the full report it would evaluate its position on the conditions of the nevirapine registration.

Application after positive results
Dr Edmund Tramont, Director of the NIH's HIV/AIDS division, has said that the lack of regard for record-keeping in the Uganda HIVNET 012 study occurred because the original study had no intention of registering nevirapine for the reduction of risk of HIV transmission from mother-to-child for use in the US.

He said after seeing the positive results of the drug with regard to mother-to-child HIV transmission during the Uganda study, Boehringer-Ingelheim decided to apply for registration of nevirapine for this purpose with the FDA.

The stringent rules and requirements of the FDA, however, forced the NIH to go back to Uganda to search for the missing information, Tramont said.

The study in Uganda involved over 600 pairs of mother and infant, which totalled to more than 1 200 people.

The NIH says the review programme - which includes recollecting paperwork on whether subjects gave sufficient informed consent to participate in the study, the blood tests that were done to determine the participants' HIV status, how long they stayed on the programme, and so on - is not about questioning the safety and efficacy of nevirapine in blocking the transmission of HIV from mother to child.