MCC registrar Dr Precious Matsoso confirmed this
week that nevirapine would remain the drug of choice for PMTCT in
Withdrawn in the US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
It was because of the absence of these documents
that Boehringer-Ingelheim withdrew their application for registration of the
drug in the
The MCC registered nevirapine for PMTCT use in
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
The stringent rules and requirements of the FDA,
however, forced the NIH to go back to
The study in
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.Rather it is about confirming the findings of the study that revealed that nevirapine can prevent HIV infection from mother to child by over 50 percent. – (Health-e News)