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In February 2008, the label for darunavir was revised to reflect the drug’s potential for hepatotoxicity. In clinical trials involving 3063 patients receiving ritonavir-boosted darunavir as part of combination regimens, 15 (0.5%) developed acute hepatitis. In addition, postmarketing cases of liver injury have been reported, including some fatalities. Although no specific numbers are available, the cases generally occurred in patients with advanced HIV disease who were taking multiple concomitant medications, were developing immune reconstitution syndrome, or had comorbidities including coinfection with hepatitis B or C virus.
The new labeling calls for appropriate laboratory testing before initiation of ritonavir-boosted darunavir and for mo…