Hepatitis C, chronic, Genotype 1, 2, 4, 5, and 6.
Black Box Warning: Test all patients for evidence of current or prior hepatitis B virus (HBV) infection before initiating treatment. HBV reactivation has been reported in HCV/HBV coinfected patients who were undergoing or had completed treatment with HCV direct acting antivirals and were not receiving HBV antiviral therapy. Monitor HCV/HBV coinfected patients for hepatitis flare or HBV reactivation during HCV treatment and post-treatment follow-up. Initiate appropriate patient management for HBV infection as clinically indicated.
Test for HCV genotype prior to initiation of therapy.
Test for hepatitis B surface antigen and hepatitis B core antibody prior to initiation.
Monitor signs and symptoms of hepatitis flare or HBV reactivation during treatment and post-treatment follow-up in patients with evidence of current or prior HBV infection.
Monitor hepatic function in patients with decompensated cirrhosis who are co-administered ribavirin.
Common
Severe
Contraindicated
Concomitant use not recommended:
Antimicrobial class: Antiviral agent, HCV NS5A Inhibitor
Average serum half life: 47 hours (Ledipasvir), 0.5 (Sofosbuvir) 27 hours (Primary sofosbuvir metabolite)
Precautions: Bradycardia and fatal cardiac arrest have been reported during concurrent use of amiodarone, with some cases requiring pacemaker intervention; monitoring recommended and discontinuation may be necessary. Increased risk of bradycardia during concurrent amiodarone among patients with concomitant beta blocker use, underlying cardiac comorbidities, and advanced liver disease; monitoring recommended.
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