Hepatitis C, chronic, Genotype 1a, 1b, or 4.
Black Box Warning: Test all patients for current or previous hepatitis B infection. HBV reactivation has been reported in patients coinfected who were undergoing or had completed treatment with HCV direct acting antivirals and were not receiving HBV antiviral therapy. Some cases have resulted in fulminant hepatitis, hepatic failure, and death. 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.
Perform hepatitis C genotype prior to initiation of therapy.
Test for presence of virus with NS5A resistance-associated polymorphisms in patients with genotype 1a infection prior to initiation.
Screen all patients of HBV infection prior to use.
Perform hepatic function testing prior to therapy at treatment week 8, 12, and as clinically indicated.
Monitor clinical and laboratory signs of hepatitis flare or HBV reactivation in patients with evidence of current or prior HBV infection during treatment and post-treatment follow-up.
Common
Severe
Contraindications:
Multiple drug-drug interactions
Antimicrobial class: Antiviral agent, HCV NS5A inhibitor, Protease inhibitor
Average serum half life: 24 hours (Elbasvir), 31 hours (Grazoprevir)
Precautions: Cases of hepatic decompensation/failure have been reported in patients treated with HCV NS3/4A protease inhibitor-containing regimens with baseline cirrhosis with or without moderate or severe liver impairment as well as some patients without cirrhosis; monitoring recommended and discontinuation may be necessary. Increases in ALT have been reported; increased risk in women, patients of Asian race, and patients over the age of 65; monitoring recommended, and discontinuation may be necessary if persistent ALT elevations or signs of liver inflammation occur.