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Report says Nevirapine is no threat
Glynnis Underhill. Cape Times. 07 November 2002. Republished courtesy of Independent Newspapers.
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An interim report on the remonitoring of the Ugandan trial of the anti-retroviral Nevirapine for use in the prevention of mother-to-child transmission of HIV/AIDS has revealed no irregularities in documentation at the trial site.
It may be a flimsy three-and-a-half pages long, but this confidential interim report prepared by the National Institute for Allergy and Infectious Diseases in the United States has great significance for many HIV-positive pregnant women in South Africa.
The findings of the report mean there is no current threat to the continued use of the nevirapine drug in South Africa, where it is being widely and successfully used to prevent mother-to-child transmission of HIV/AIDS.
Fears mounted that Nevirapine could be deregistered in South Africa when it was leaked in August that the documentation of the Ugandan study had not met the American Federal Drug Administration's requirements for use in the prevention of maternal transmission.
The National Institute of Allergy and Infectious Diseases funded the study of Nevirapine for the prevention of mother-to-child transmission in Uganda, in partnership with Ugandan investigators, and has now undertaken to remonitor the trial.
But South Africa's Medicines Control Council (MCC), which maintains it took an unprecedented decision to register Nevirapine for use in South Africa based solely on the findings of the Ugandan trial HIVNET 012, said on Wednesday it would wait for the final report of the remonitoring of the Ugandan trial, expected in December.
MCC chairman Peter Eagles said that once the final report has been released, the MCC will meet to discuss the findings and expected to inform the public of its decision on nevirapine in January.
For reasons unknown to its members, the MCC was asked to sign a confidentiality agreement when recently it received a copy of the interim report, said Eagles.
"This re-assessment is a two-stage process at the Ugandan site. The first stage is to check up on the documentation and that part has been completed. The next stage is to look at the content, which has not been started," he said.
An American delegation from the National Institute of Allergy and Infectious Diseases arrived in Cape Town this week and called a press conference at the United States embassy, where it was widely expected they would discuss the findings of the interim report.
However, Nathan Geffen, national manager and head of finances at the Treatment Action Campaign, said he had arrived at the press conference to find it had been cancelled.
"I have since received an apology from the American consulate. It was explained that it was a double booking, and we are satisfied with the explanation. We are looking forward to the publication of the audited report of the Ugandan trial. We trust that the report will be made available to the public as soon as it is completed," he said.
Eagles said the MCC had told the American delegation it would not be attending the press conference as they had signed a confidentiality agreement and would therefore not be able to speak to the press.
In the United States, nevirapine is widely used in combination with other anti-retroviral drugs to treat HIV/AIDS infected adults, adolescents and children.
The Treatment Action Campaign will begin a campaign of civil disobedience if the government does not agree, by February, to set up anti-retroviral programmes in the public health sector.
The lobby group decided six weeks ago to launch a civil disobedience campaign in December if the government had not agreed to a treatment plan by then.
The campaign could include hunger strikes and occupations and result in the arrest of participants.
TAC still believes it is feasible for government to agree on a treatment plan by December, said Geffen, but it has agreed to wait until February.
"We have engaged properly with government and it must take us seriously," said Geffen. |
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