HARVONI is indicated for the treatment of adults and pediatric patients 3 years of age and older with chronic hepatitis C virus (HCV) genotype (GT) 1, 4, 5, or 6 infection without cirrhosis or with compensated cirrhosis. HARVONI is used with ribavirin in GT 1 patients with decompensated cirrhosis and in GT 1 or 4 liver
transplant recipients without cirrhosis or with compensated cirrhosis.
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IMPORTANT SAFETY INFORMATION
BOXED WARNING: RISK OF HEPATITIS B VIRUS REACTIVATION IN HCV/HBV 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 HCV/HBV coinfected patients who were undergoing or had completed treatment with HCV direct-acting antivirals (DAAs) and were not receiving HBV antiviral therapy. Some cases have resulted in fulminant hepatitis, hepatic failure, and death. Cases have been reported in patients who are HBsAg positive, in patients with serologic evidence of resolved HBV, and also in patients receiving certain immunosuppressant or chemotherapeutic agents; the risk of HBV reactivation associated with treatment with HCV DAAs may be increased in patients taking these other agents. Monitor HCV/HBV coinfected patients for hepatitis flare or HBV reactivation during HCV treatment and posttreatment follow-up. Initiate appropriate patient management for HBV infection as clinically indicated.
Contraindications
Warnings and Precautions
Adverse Reactions
Drug Interactions
Consult the full Prescribing Information for HARVONI for more information on potentially significant drug interactions, including clinical comments.
Please see full Prescribing Information for HARVONI, including BOXED WARNING.
1. Data on file. Data SOF Claims from December 2013 through July 2020.
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IMPORTANT SAFETY INFORMATION
BOXED WARNING: RISK OF HEPATITIS
B VIRUS REACTIVATION IN HCV/HBV COINFECTED PATIENTS: Test all patients for
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 HCV/HBV coinfected patients who were undergoing or had completed treatment