Encavir Special Precautions

Exacerbations of Hepatitis: Severe acute exacerbations of hepatitis have occurred following discontinuance of HBV therapy, including entecavir therapy. Exacerbations of hepatitis also have been reported during entecavir treatment of HBV, but generally resolved with continued therapy.
Hepatic function should be monitored during ENCAVIR therapy and should be monitored closely both clinical and laboratory follow-up at repeated intervals for at least several months after ENCAVIR is discontinued. If appropriate, resumption of anti-HBV therapy may be warranted.
Individuals Coinfected with HBV and HIV: Use of entecavir for treatment of chronic HBV infections in patients with unrecognized or untreated HIV infection may result in emergence of HIV isolates with resistance to nucleoside reverse transcriptase inhibitors (NRTIs). Prior to initiation of entecavir therapy, all patients should be offered HIV testing. ENCAVIR should not be used for the treatment of HBV in HIV-infected patients who are not receiving antiretroviral therapy.
Entecavir has not been systematically evaluated for the treatment of HIV infection and such use is not recommended.
Lactic Acidosis and Severe Hepatomegaly with Steatosis: Lactic acidosis and severe hepatomegaly with steatosis, including some fatalities, have been reported in patients receiving nucleoside analogs alone or in conjunction with antiretrovirals. ENCAVIR should be discontinued in any patient with clinical or laboratory findings suggestive of lactic acidosis or pronounced hepatotoxicity.