Lactic acidosis and severe hepatomegaly with steatosis (including some fatalities) reported rarely in patients receiving nucleoside reverse transcriptase inhibitors (NRTIs) alone or in conjunction with other antiretrovirals. (See Hepatic Effects and Lactic Acidosis under Cautions.)
Single entity or fixed-combination preparations containing emtricitabine not indicated for treatment of chronic hepatitis B virus (HBV) infection; safety and efficacy not established for treatment of HIV infection in patients coinfected with HBV.
Severe, acute exacerbations of HBV reported following discontinuance of emtricitabine. Monitor hepatic function closely with both clinical and laboratory follow-up for at least several months after emtricitabine is discontinued in patients coinfected with HBV and HIV. If appropriate, initiation of treatment for HBV infection may be warranted.
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