Harvoni Disease Interactions

HBV reactivation has been reported during or after completion of HCV direct-acting antiviral therapy in HCV/HBV-coinfected patients who were not receiving HBV antiviral therapy; some cases resulted in fulminant hepatitis, hepatic failure, and death. Cases have been reported in hepatitis B surface antigen (HBsAg)-positive patients and patients with serologic evidence of resolved HBV infection (i.e., HBsAg negative and hepatitis B core antibody [anti-HBc] positive). HBV reactivation has also been reported in patients using certain immunosuppressant or chemotherapeutic agents; risk of HBV reactivation associated with HCV direct-acting antiviral therapy may be increased in these patients. All patients should be tested for evidence of current or prior HBV infection by measuring HBsAg and anti-HBc before starting HCV direct-acting antiviral therapy. Patients with serologic evidence of current or prior HBV infection should be monitored for clinical and laboratory signs of hepatitis flare or HBV reactivation during HCV therapy and posttherapy follow-up; appropriate patient management for HBV infection should be started as clinically indicated.

The use of products containing ledipasvir and sofosbuvir in patients with mild or moderate renal impairment does not require dosage adjustment. Exercise care when using in patients with severe renal impairment (eGFR less than 30 mL/min/1.73 m2) or ESRD requiring hemodialysis as the safety and efficacy has not been established, and no dosage recommendation can be given for these patients.

Sofosbuvir is extensively metabolized in the liver. The safety and efficacy of sofosbuvir as a single agent have not been established in patients with decompensated cirrhosis. No dosage adjustment is required for patients with mild, moderate or severe hepatic impairment (Child-Pugh Class A, B or C).

The safety and efficacy of sofosbuvir as a single agent have not been established in patients with severe renal impairment (eGFR less than 30 mL/min/1.73m2) or ESRD requiring hemodialysis. No dosage recommendation can be given for patients with severe renal impairment or ESRD. No dosage adjustment is necessary for patients with mild or moderate renal impairment.