21:40 09.11.2008 | All news from "AIDS/HIV"
South Africa: Study Warns On HIV Drug in Childbirth
This is according to interim results from an international study funded by the US National Institutes of Health.
Nevirapine is widely used in SA and other developing countries to reduce the risk of an HIV-positive pregnant woman passing the virus on to her baby, and to treat the disease. Each year in SA, about 100000 HIV-positive pregnant women are given a single dose of nevirapine during labour.
Researchers involved in the study have called for an urgent review of SA's guidelines for preventing mother-to-child transmission of HIV, saying the problem of nevirapine resistance can be easily fixed by giving mothers a cheap, seven-day course of combivir after their babies are born.
"I'm not saying nevirapine should not have been given to these women - it was the best we had at the time. What we can do now is protect nevirapine (to ensure it can be safely used in their subsequent treatment)," said study investigator Dr Francesca Conradie of the University of the Witwatersrand's Clinical HIV Research Unit.
Women who received nevirapine during childbirth and were now being treated with a nevirapine-based cocktail should be closely monitored to make sure the drugs were effectively suppressing HIV, and switched to a drug called kaletra if they showed signs of drug resistance, she said.
"The longer you leave them on a failing regimen, the greater the risk that they will become resistant to all the drugs they are taking," she said.
The optimal combination therapy after nevirapine exposure (Octane) study included 745 women in seven African countries. It compared two AIDS-drug cocktails - nevirapine, emtricitabine (FTC) and tenofovir (TDF) or lopinavir-boosted ritonavir, FTC and TDF - in two groups of women: those who got nevirapine during labour, and those who did not.
A routine interim review of the trial by an independent data safety monitoring board on October 6 found women who had nevirapine-resistant strains of HIV fared better if they were treated with a regimen that did not contain the drug. Five of the 13 women (38%) who had nevirapine-resistant strains of HIV and were treated with a nevirapine-based cocktail either died or failed to suppress the virus, while all 12 women who had nevirapine-resistant strains of HIV but were treated with a cocktail containing lopinavir-boosted ritonavir were alive and holding the virus at bay.
The board recommended that this part of the trial stop, and researchers have begun informing trial participants of their findings. Research is continuing to compare the efficacy of nevirapine and lopinavir-boosted ritonavir in women with no prior exposure to nevirapine.
Health department spokesman Fidel Hadebe said officials were studying the review of the Octane study, and were consulting experts about its implications. "After this consultative process, a policy decision will be taken for the prevention of mother to child transmission programme."
Dr Francois Venter, president of the Southern African HIV Clinicians' Society, said the study had important implications and needed to be studied carefully.
Dr Ashraf Coovadia of the National AIDS Council said, "This is important news."http://allafrica.com/