SA rejects nevirapine study

2003-07-29 09:16

Antoinette Pienaar

Johannesburg - The hopes of thousands of pregnant women with HIV/Aids that the antiretroviral drug nevirapine will prevent mother-to-child transmission may be in tatters.

The Medicines Control Council confirmed on Monday evening that it "rejected" Uganda's HIVNET012 study published earlier that the drug halved a baby's chances of contracting the virus from its mother.

If the manufacturing company, Boehringer Ingelheim, doesn't provide evidence within 90 days to show nevirapine's efficacy in this regard, the temporary registration will be withdrawn.

Registration for general use is not being questioned.

Precious Matsoso, head of the council, says it's been established that the study didn't meet its criteria for the registration of a substance to prevent the spread from mother-to-child.

There was an outcry in South Africa earlier after a registration application was withdrawn in the United States, following the Food and Drug Administration's complaint about the "reporting and documenting" of the Ugandan study.

Matsoso says the National Institutes of Health in the US has established that the patient records didn't support the published results. The records also didn't indicate how the drug was handled, distributed or stored.

She says a document was also missing indicating which drugs were administered to patients.

"The council's decision has grave implications if the manufacturer doesn't provide information within the next 90 days. Luckily there are other treatments, such as a short course of AZT, which can prevent the spread of the disease," says Matsoso.

The constitutional court ruled last year that the government should provide nevirapine where necessary to help prevent the spread of the virus from mother to child.

The Uganda study found that nevirapine lowered a baby's chances of getting the virus in the first 14 to 16 weeks after being born by about 50%.

Kenna Mckenna, a Boehringer Ingelheim director, says they haven't officially been informed of the board's decision.

- Beeld