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Nevirapine gets the all-clear
Lynne Altenroxel. 23 April 2003. The Mercury. Republished courtesy of Independent Newspapers (Pty) Ltd.
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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 and is to be discussed by South Africa's Medicines Control Council on Friday 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 HIV/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."
Concerns about the Ugandan study were first raised early last year, when the drug's manufacturer, Boehringer-Ingelheim, applied for an extension on its licence for Nevirapine in the US.
In keeping with US law, this meant that officials would have to re-examine the Ugandan trial data - and when they started setting up site visits to Kampala to do so they learned that some of the trial records were in disarray.
The problems with the data were largely administrative. For example, the report explains, investigators found that dating methods were not consistent and written errors had been crossed out in the incorrect way.
Differences in medical norms between the US and Uganda meant that ailments which would have been classified as "serious adverse events" in the US were viewed somewhat differently in Kampala, so they went unreported by staff.
But, despite the data problems, investigators conclude that "these shortcomings did not affect the scientific results of the study nor did they compromise the standard of care given to the mothers or infants in Uganda".
In fact, the report notes, the death rate among mothers and babies involved in the trial was "well below" Uganda's infant and maternal mortality rates.
Only three "serious adverse events" among the trial's 645 mothers were believed to be drug related - two were in mothers who received AZT and one who received a placebo.
On Tuesday, council registrar Precious Matsoso confirmed that the council had received the NIH report.
It would be discussed, Matsoso said, on Friday. |
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