Elbasvir/Grazoprevir

Dosing

1 tab = Elbasvir 50 mg/Grazoprevir 100 mg

국내허가사항Genotype 1a, with or without baseline NS5A polymorphism, treatment-naïve or treatment failure with Peginterferon alfa and RibavirinGenotype 1a, with baseline NS5A polymorphism, treatment-naïve or treatment failure with Peginterferon alfa and RibavirinGenotype 1b, treatment-naïve or treatment failure Peginterferon alfa and RibavirinGenotype 1a/1b, treatment failure with Peginterferon alfa, Ribavirin, and HCV NS3/4A protease inhibitorGenotype 1a, treatment-naïve or Peg IFN/RBV-experienced 1 tab PO once daily x12w1 tab PO once daily x12w- BW <66 kg: 1 tab PO once daily x16w + Ribavirin 800 mg/d

  • BW 66-80 kg: 1 tab PO once daily x16w + Ribavirin 1,000 mg/d

  • BW 81-105 kg: 1 tab PO once daily x16w + Ribavirin 1,200 mg/d

  • BW >105 kg: 1 tab PO once daily x16w + Ribavirin 1,400 mg/d 1 tab PO once daily x12w- BW <66 kg: 1 tab PO once daily x12w + Ribavirin 800 mg/d

  • BW 66-80 kg: 1 tab PO once daily x12w + Ribavirin 1,000 mg/d

  • BW 81-105 kg: 1 tab PO once daily x12w + Ribavirin 1,200 mg/d

  • BW >105 kg: 1 tab PO once daily x12w + Ribavirin 1,400 mg/d

Treatment-naïveTreatment failure with Peginterferon alfa and Ribavirin1 tab PO once daily x12w- BW <66 kg: 1 tab PO once daily x16w + Ribavirin 800 mg/d

  • BW 66-80 kg: 1 tab PO once daily x16w + Ribavirin 1,000 mg/d

  • BW 81-105 kg: 1 tab PO once daily x16w + Ribavirin 1,200 mg/d

  • BW >105 kg: 1 tab PO once daily x16w + Ribavirin 1,400 mg/d

No renal dose adjustment

Safety and efficacy for pediatric patients <18y of age have not been established

Mild hepatic impairmentModerate or severe hepatic impairmentNo dose adjustmentUse is contraindicated

General Information

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

  • Nausea

  • Fatigue

  • Headache

Severe

  • ALT/SGPT level raised

  • Decreased liver function

  • Liver failure

  • Reactivation of hepatitis B viral hepatitis

Contraindications:

  • Inhibitors of organic anion transporting polypeptides 1B1/3 (OATP1B1/3)- may increase grazoprevir plasma concentrations

  • Strong CYP3A inducers

  • Select protease inhibitors (i.e. Atazanavir)

  • Efavirenz

  • Ritonavir

  • Rifampin

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.

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