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 Lactic Acidosis and Severe Hepatomegaly with Steatosis under Cautions.)
Severe acute exacerbations of hepatitis reported following discontinuance of tenofovir in patients with HBV infection. Monitor hepatic function closely with both clinical and laboratory follow-up for at least several months after tenofovir is discontinued. If appropriate, resumption of treatment for HBV infection may be warranted.
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