Chronic hepatitis B virus (HBV) infection in adults with evidence of active viral replication and either evidence of persistent elevations in serum aminotransferases (ALT or AST) or histologically active disease.
≥16yrs: Take on empty stomach. Compensated liver disease: nucleoside-naive: 0.5mg once daily; lamivudine-refractory or known lamivudine or telbivudine resistance mutations: 1mg once daily. Decompensated liver disease: 1mg once daily. Renal impairment (nucleoside-naive): CrCl 30–49mL/min: 0.25mg once daily or 0.5mg every 48 hours; CrCl 10–29mL/min: 0.15mg once daily or 0.5mg every 72 hours; CrCl <10mL/min or on hemodialysis: 0.05mg once daily or 0.5mg every 7 days; (lamivudine-refractory or decompensated liver disease): CrCl 30–49mL/min: 0.5mg once daily or 1mg every 48 hours; CrCl 10–29mL/min: 0.3mg once daily or 1mg every 72 hours; CrCl <10mL/min or on hemodialysis: 0.1mg once daily or 1mg every 7 days. For doses <0.5mg: use oral soln. If on hemodialysis day, give after session.
<16yrs: not recommended.
HIV/HBV co-infected patients not receiving highly active antiretroviral therapy (HAART): not recommended. HIV antibody testing recommended before starting therapy. Monitor hepatic function during and for several months after ending therapy (risk of hepatitis B reactivation). Renal impairment (see Dose). Liver transplant. Reevaulate periodically. Labor & delivery. Pregnancy (Cat.C). Nursing mothers: not recommended.