The South African pilot studies to reduce mother-to-child transmission of HIV through the administration of nevirapine will not be delayed by recent reports of drug toxicity. However the women participating in the program will be closely monitored, according to recent press reports. The CDC in the US recently issued a warning on the toxic side effects of nevirapine when administered over several weeks. These included severe liver damage, when used to treat health care workers accidentally exposed to HIV by needle sticks. However, vertical transmission prevention requires only one dose of the drug. African National Congress National Health Secretary Saadiq Kariem said, In light of the U.S. report, we will exercise caution at the research sites. It would be irresponsible not to monitor the women, even in the context of a single-low dose of nevirapine as opposed to a month-long regimen. After meeting with South African Health Minister Manto Tshabalala-Msimang, Kariem said that Tshabalala-Msimang has always used caution with the countrywide implementation of the mother-to-child transmission program before permitting drug research.
The reports on the toxicity of Nevirapine will have no impact on the Democratic Alliance's
proposal to provide the medicine free to HIV-positive pregnant women in the party's controlled municipalities. Party spokesman Sandy Kalyan said reports of Nevirapine being potentially harmful concerned multiple doses of the drug.
Safety data from three separate efficacy trials in the US, South Africa and Uganda involving more than 1,000 mother-infant pairs have demonstrated no severe adverse reactions associated with a single-dose of Nevirapine, Kaplan said. She added that with regard to cases of sexual assault, where multiple doses of the drug are required, the party will continue to provide AZT until more detailed research has been carried out on the basis of these findings.
The South African Medicines Control Council last year registered nevirapine and approved its use for trials after UNAIDS and WHO endorsed the drug as a safe treatment for one-off use in the recommended dosage, saying the benefits outweighed the potential adverse effects. Drug research is said to begin soon at pilot sites in each province, for a period of one year
Sources: Vial, Cape
Argus/allAfrica, 1/10 and kaisernetwork.org.