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Wednesday, March 27, 2002 - Web posted at 11:00:45 am GMT

Nevirapine is safe: US Institute

PRETORIA - The anti-retroviral drug nevirapine was safe and effective in curbing the mother-to-child-transmission of HIV, the United States National Institute of Allergy and Infectious Diseases (NIAID) said on Tuesday.

"There is absolutely no evidence that I know of that the effectiveness of nevirapine... has been compromised," John la Montagne, the institute's deputy director, said in a video-conference from Washington DC.

"I think it is a drug that needs to be used much more." The US Food and Drug Administration (FDA) is probing irregularities in record-keeping in human trials of nevirapine in Uganda.

The FDA's South African counterpart, the Medicines Control Council (MCC), has said it was considering reviewing the registration of the drug pending the outcome of the investigation.

La Montagne said the alleged irregularities amounted to a mere logistical and regulatory matter.

It related to documentation collected during the trials having to be "reconstructed" for filing with the FDA.

This had to be done as part of a bid by pharmaceutical company Boehringer Ingelheim to supplement its licence to enable it to market the drug.

La Montagne said the Ugandan trials, completed in 1999, were done to very high standards and the results were not in doubt.

The trials, funded by NIAID, found that nevirapine significantly reduced the risk of HIV transmission from mother to child during the first weeks of life.

This been confirmed by other studies.

Nevirapine was commonly used in the United States, La Montagne added.

It was approved by the FDA for the treatment of HIV infection in adults and children. Boehringer Ingelheim said in a statement it had offered to support NIAID in a comprehensive review of all the data collected in the course of the study.

"(We are) confident that the results of this review will confirm the positive conclusions," the company said.

"Boehringer Ingelheim continues to support the use of nevirapine and will continue to offer the drug to developing countries for the prevention of mother-to-child transmission of HIV."

At the briefing, NIAID was urged to point out to the MCC that there was no reason to suspend the registration of nevirapine.

The South African government was dispensing the drug at 18 pilot sites country-wide. In the Western Cape and KwaZulu-Natal, not governed by the African National Congress, the drug was freely available.

Aids drug proponents, including the Treatment Action Campaign, recently won a court battle compelling the government to make the drug available at all public hospitals country-wide -- a ruling the State intends appealing in the Constitutional Court. Nampa-Sapa




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