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Single dose Nevirapine to stay
16 July 2004. Cape Argus. Republished courtesy of Independent Newspapers (Pty) Ltd.
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Nevirapine will stay - and in a dramatic new development, preliminary tests presented in Bangkok on Thursday by a South African HIV/AIDS research unit indicate that a low-cost, week-long triple regime may reduce resistance to the drug from 50 percent to 10 percent.
"We could probably treat each woman for under R100," said Professor James McIntyre, head researcher at the Perinatal HIV Research Unit at the University of Witwatersrand, speaking from the 15th International AIDS Conference in Bangkok, Thailand.
He had just emerged from the presentation, done together with the SA government and Medicines Control Council delegates. "But first, it's important to clarify that activists, the government, the MCC and researchers are actually all in agreement. Nevirapine monotherapy should not be stopped before there are better alternatives in place."
Health Minister Manto Tshabalala-Msimang confirmed this in a statement on Thursday. It said the Department of Health will continue providing Nevirapine as monotherapy to mothers and babies at public health facilities until new treatment regimens are available. "It must be emphasised that the MCC did not recommend that the use of Nevirapine be stopped altogether, but that it should be used in combination with other drugs, because it is showing a significant resistance ... Also, the drug has not been deregistered as indicated in media reports," Tshabalala-Msimang said.
McIntyre said his unit, with pharmaceutical company Boehringer-Ingelheim and other South African collaborators, had conducted a preliminary test with three arms. In the first, a group of women were given a single dose of nevirapine during labour. Half of these women developed resistance to the antibiotic in six weeks. The second group were given single-dose nevirapine, but were also given a four-day course of AZT and 3TC, combined into a drug known as Combivir. The third group was given the nevirapine and Combivir for seven days.
Resistance to the antibiotics dropped to 10 percent of the women in both the second and third groups, with no significant difference between the groups.
"Generics are available, but even the brand name is not so expensive," said McIntyre. "The preliminary results announced (at the conference) today suggest that these short-course regimens could be a feasible and inexpensive way to protect against resistance and prevent mother-to-child transmission."
In a statement released from Bangkok yesterday, the unit said Nevirapine dramatically reduced HIV transmission from mother to child, and was the mainstay of preventing mother-to-child transmission in resource-poor settings such as South Africa.
"One dose of Nevirapine given to the mother once during labour and once to the baby within 72 hours of birth decreases the risk of transmission by approximately 50 percent.
This single-dose Nevirapine regimen to mother and infant has been shown to be both safe and effective in the field. The choice of an appropriate regimen for mother-to-child transmission prevention programmes must be made considering the efficacy and safety of the regimen as well as resistance issues and the feasibility of administration," said the statement.
"Recent studies showed that starting a course of AZT at 28 weeks of pregnancy as well as having the single dose of nevirapine during labour dramatically reduces the transmission rate to less than 4%, so low that it has been seen only with complex and costly interventions.
"Up to 50 percent of women have detectable HIV-resistance strains within six weeks of taking nevirapine alone or in combination with AZT ... This resistance has been shown to decrease over time.
"The implications of resistance on future maternal ARV therapy or future pregnancy interventions are unclear.
"The public controversy and confusion which has surrounded these issues during the Bangkok conference underscores the need for better dialogue between researchers, policymakers and activists."
Note: The Perinatal HIV Research Unit is a research unit of the University of the Witwatersrand and a division of the Wits Health Consortium. The unit is recognised nationally and internationally in the field of research in mother-to-child transmission of HIV. |
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