Hepatotoxicity with Prezista

Posted on April 29, 2008

FDA and Tibotec Therapeutics are alerting healthcare professionals about the risk of hepatotoxicity associated with the antiretroviral drug Prezista (darunavir). Prezista, co-administered with ritonavir and other antiretroviral agents, is used to treat certain patients with HIV-1.

Some patients receiving the Prezista/ritonavir combination have experienced drug-induced hepatitis and liver injuries, a small number of them fatal. Most of these patients were taking multiple medications that can affect the liver or had other co-morbid conditions. Patients with underlying liver disease, such as chronic hepatitis B or C may be at increased risk for developing liver function abnormalities.

It is not clear that the Prezista/ritonavir combination caused the adverse reactions. Still, clinicians should be alert to the signs and symptoms of liver toxicity in patients taking this drug combination.

Appropriate hepatic lab tests should be done before starting the drug, and patients should be monitored during treatment according to HIV treatment guidelines. Elevated levels of ALT, AST and GGT may indicate liver injury. Patients with underlying chronic hepatitis or cirrhosis, or patients who have elevated transaminase levels before treatment, should be monitored more frequently.

Consider interrupting or stopping the treatment if there is evidence of new or worsening liver dysfunction, including clinically significant elevation of liver enzymes, or symptoms such as fatigue, anorexia, nausea, jaundice, dark urine, liver tenderness, or hepatomegaly. Patients should be told to promptly seek medical attention if they experience these symptoms.

Additional Information:

FDA MedWatch Safety Alert. Prezista (darunavir). March 12, 2008.
http://www.fda.gov/medwatch/safety/2008/safety08.htm#Prezista