抗病毒藥品 Chronic hepatitis C infection
#仿單變更2020

Glecaprevir: NS3/4A Protease Inhibitor (Anti-HCV)
Glecaprevir is an inhibitor of hepatitis C virus (HCV) NS3/4A protease, necessary for the proteolytic cleavage of the HCV-encoded polyprotein (into mature forms of the NS3, NS4A, NS4B, NS5A, and NS5B proteins) and is essential for viral replication.
Pibrentasvir: NS5A Inhibitor (Anti-HCV)
Pibrentasvir is an inhibitor of HCV NS5A, essential for viral RNA replication and virion assembly.

1. Protein binding: (Glecaprevir) 97.5%; (Pibrentasvir) >99.9%
2. Metabolism: (Glecaprevir) Secondary to CYP3A
3. Half-life elimination: (Glecaprevir) 6 hours; (Pibrentasvir) 13 hours
4. Time to peak: 5 hours
5. Excretion: (Glecaprevir) Feces: 92.1%, urine: 0.7%; (Pibrentasvir) Feces: 96.6%

1. Hypersensitivity to glecaprevir or pibrentasvir
2. Severe liver disease

Treatment of HCV is not currently recommended for women who are already pregnant.

It is not known if glecaprevir or pibrentasvir are present in breast milk.

Headache, Fatigue, Nausea, Diarrhea, Increased serum bilirubin

Genotype 1:
1. Prior treatment with an NS5A inhibitor, without an NS3/4A protease inhibitor: Three tablets once daily for 16 weeks
2. Prior treatment with an NS3/4A protease inhibitor , without an NS5A inhibitor: Three tablets once daily for 12 weeks
Genotype 1, 2, 4, 5, or 6:
Prior treatment with regimens containing interferon (including pegylated formulations), ribavirin, and/or sofosbuvir, but no prior treatment with an NS3/4A protease inhibitor or NS5A inhibitor:
1. Without cirrhosis: Three tablets once daily for 8 weeks
2. With compensated cirrhosis [Child-Pugh class A]:Three tablets once daily for 12 weeks
Genotype 3:
Prior treatment with regimens containing interferon (including pegylated formulations), ribavirin, and/or sofosbuvir, but no prior treatment with an NS3/4A protease inhibitor or NS5A inhibitor: Three tablets once daily for 16 weeks

No dosage adjustment necessary.

1. Mild impairment (Child-Pugh class A): No dosage adjustment necessary
2. Moderate impairment (Child-Pugh class B): Use is contraindicated.<20201209>
3. Severe impairment (Child-Pugh class C): Use is contraindicated.