Prezista Linked to Liver Problems, New Warnings AddedMar 13, 2008 | Parker Waichman LLP
Prezista, a drug used to treat HIV, has been associated with serious liver injuries, the Food & Drug Administration (FDA) has warned. Johnson & Johnson's Tibotec Therapeutics, the maker of Prezista, has modified the drug's prescribing information to include a warning on hepatotoxicity.
Prezista, a protease inhibitor, was granted accelerated approval by the FDA in 2006 to treat people with HIV. Prezista is co-administered with 100 mg ritonavir (PREZISTA/rtv) and with other antiretroviral agents, and is indicated for antiretroviral treatment-experienced adult patients, such as those with HIV-1 strains resistant to more than one protease inhibitor.
According to a Tibotec spokesperson, fifteen cases of liver problems were reported during clinical trials. The spokesperson also told Reuters that the company did not provide information on post-marketing cases reported after the drug's U.S. approval in 2006.
According to a "Dear Healthcare Provider" letter recently sent out by Tibotec, in clinical trials and postmarketing experience, drug induced hepatitis (e.g., acute hepatitis, cytolytic hepatitis) has been reported in patients receiving combination therapy with Prezista. The new Prezista warning says drug induced hepatitis (e.g., acute hepatitis, cytolytic hepatitis) has been reported with Prezista. During the clinical development program for Prezista hepatitis has been reported in 0.5% of patients receiving combination therapy with Prezista. Patients with preexisting liver dysfunction, including chronic active hepatitis B or C, have an increased risk for liver function abnormalities including severe hepatic adverse events.
The company also said that postmarketing cases of liver injury, including some fatalities, have been reported. These have generally occurred in patients with advanced HIV1 disease taking multiple concomitant medications, having comorbidities including hepatitis B or C coinfection, and/or developing immune reconstitution syndrome.
The letter said doctors should test patients before starting treatment with Prezista and continuing monitoring liver enzymes to look for signs of possible liver injury. The letter also advised interrupting or stopping treatment in patients if there's evidence of new or worsening liver dysfunction.