Nevirapine-Associated Hepatotoxicity in Virologically Suppressed Patients – Role of Gender and CD4+ Cell Counts

The US Food and Drug Administration (FDA) andthe European Agency for the Evaluation of MedicinalProducts (EMEA) have issued a warning in the nevirapinepackage-insert recommending not initiatingnevirapine in adult women with CD4+ lymphocytecounts > 250 cells/mm3 or in adult men with a count> 400 cells/mm3 because of a higher risk of hepatotoxicity.The data was mainly derived from a retrospectiveanalysis of the Boehringer Ingelheim databases,including almost exclusively antiretroviral-naivepatients. Due to its low price, lack of influence onlipid and glucose metabolism, and safety for pregnantwomen and newborns, nevirapine has beenwidely used in both the developed and developingworld. Nevirapine has also been frequently prescribedin simplification of protease inhibitor-containing therapies,and the risk of major toxicities in this settingseems to be lower than in drug-naive patients.