Warning on Hepatotoxicity of Darunavir

The U.S. Food and Drug Administration (FDA)has, in March 2008, released a warning concerningthe risk of hepatotoxicity using darunavir boostedwith ritonavir. Although significant liver enzyme elevationshad already been seen during the clinicaldevelopment of darunavir, in which 3,063 patientsreceived the drug, hepatitis was reported in only0.5% of cases. As expected, subjects with preexistingliver dysfunction, including chronic hepatitis B orC, were at increased risk of liver function abnormalitiesfollowing treatment with darunavir-basedregimens.