South African Nevirapine Trials to Proceed Despite Drug Warning

The South African research program to reduce mother-to-child transmission of HIV through the administration of nevirapine will not be delayed by recent reports of drug toxicity, although the women participating in the program will be closely monitored, the Cape Town Cape Argus/allAfrica reports. Last week the CDC issued a warning on the toxic side effects of nevirapine, including severe liver damage, when used to treat health care workers accidentally exposed to HIV by needle sticks. However, such treatment involves drug administration over many weeks, whereas 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 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 slated to begin soon at sites in each province, and will run for one year (Vial, Cape Argus/allAfrica, 1/10).