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Wamkelekile, Welkom
Wamkelekile, Welkom
aidswatch: Nevirapine gets the all-clear
09 February 2006
A year-long investigation into the anti-AIDS drug nevirapine has found beyond doubt that the treatment is safe and effective.
The finding is made in a report by the United States National Institutes of Health (NIH) and was to be discussed by South Africa's Medicines Control Council on Friday (April 25) at a special meeting about Nevirapine's possible deregistration.
In recent months there have been fears that the drug could be banned in South Africa, effectively stopping doctors from giving HIV-positive pregnant women the cheap, single dose they need to halve the risk of passing on the deadly virus to their babies.
Panic over reports about the possible banning, which surfaced during last year's Constitutional Court battle over the drug, were fuelled by the political debacle over AIDS dissidents and the government's insistence that nevirapine was dangerous.
But the 50-page report, which scrutinises the standards of the 1997 Ugandan drug trial where nevirapine was first tested on pregnant women, recommends that the treatment continue to be used.
Its findings are pivotal for the Council, which based its registration of nevirapine for prevention of maternal transmission on the Ugandan study and has been waiting for the report to be completed before deciding whether to withdraw its approval.
The report concludes that: "In summary, the efficacy and safety data from (the Ugandan trial) combined with efficacy and safety data from other trials using single-dose nevirapine, as well as information from other multi-dose studies involving nevirapine, support the continued use of this drug for prevention of mother to child transmission of HIV."
The finding is made in a report by the United States National Institutes of Health (NIH) and was to be discussed by South Africa's Medicines Control Council on Friday (April 25) at a special meeting about Nevirapine's possible deregistration.
In recent months there have been fears that the drug could be banned in South Africa, effectively stopping doctors from giving HIV-positive pregnant women the cheap, single dose they need to halve the risk of passing on the deadly virus to their babies.
Panic over reports about the possible banning, which surfaced during last year's Constitutional Court battle over the drug, were fuelled by the political debacle over AIDS dissidents and the government's insistence that nevirapine was dangerous.
But the 50-page report, which scrutinises the standards of the 1997 Ugandan drug trial where nevirapine was first tested on pregnant women, recommends that the treatment continue to be used.
Its findings are pivotal for the Council, which based its registration of nevirapine for prevention of maternal transmission on the Ugandan study and has been waiting for the report to be completed before deciding whether to withdraw its approval.
The report concludes that: "In summary, the efficacy and safety data from (the Ugandan trial) combined with efficacy and safety data from other trials using single-dose nevirapine, as well as information from other multi-dose studies involving nevirapine, support the continued use of this drug for prevention of mother to child transmission of HIV."
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