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BOXED WARNING: RISK OF HEPATITIS B VIRUS REACTIVATION IN HCVHBV COINFECTED PATIENTS. Test all patients for evidence of current or prior hepatitis B virus (HBV) infection before initiating treatment with HARVONI. HBV reactivation has been reported in HCVHBV coinfected patients who were undergoing or had completed treatment with HCV direct acting antivirals (DAAs) and were not receiving HBV antiviral therapy.

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