Description
Indications
Pharmacology
NS5A is a phosphoprotein that plays an essential role in the replication, assembly and maturation of infectious viral proteins. The basal phosphorylated form of NS5A, which is maintained by C-terminal serine cluster, is key in ensuring its interaction with the viral capsid protein, or the core protein. By blocking this interaction, pibrentasvir inhibits the assembly of proteins and the production of mature HCV particles. NS5A also interacts with viral and cellular proteins to form the HCV replicase complex, and supports the RNA replication of HCV
Dosage & Administration
Recommended dosage: Three tablets (total daily dose: glecaprevir 300 mg and pibrentasvir 120 mg) taken orally once daily with food.
See recommended treatment duration in tables below-
Treatment-Naïve Patients: HCV Genotype 1, 2, 3, 4, 5, or 6
- No Cirrhosis: 8 weeks
- Compensated Cirrhosis (Child-Pugh A): 12 weeks
Treatment-Experienced Patients: HCV Genotype 1
- Patients Previously Treated With a Regimen Containing: An NS5A inhibitor without prior treatment with an NS3/4A protease inhibitor
- No Cirrhosis: 16 weeks
- Compensated Cirrhosis (Child-Pugh A): 16 weeks
Treatment-Experienced Patients: HCV Genotype 1
- Patients Previously Treated With a Regimen Containing: An NS3/4A PI without prior treatment with an NS5A inhibitor
- No Cirrhosis: 12 weeks
- Compensated Cirrhosis (Child-Pugh A): 12 weeks
Treatment-Experienced Patients: HCV Genotype 1, 2, 4, 5 or 6
- Patients Previously Treated With a Regimen Containing: PRS
- No Cirrhosis: 8 weeks
- Compensated Cirrhosis (Child-Pugh A): 12 weeks
Treatment-Experienced Patients: HCV Genotype 3
- Patients Previously Treated With a Regimen Containing: PRS
- No Cirrhosis: 16 weeks
- Compensated Cirrhosis (Child-Pugh A): 16 weeks
Interaction
Contraindications
Side Effects
Pregnancy & Lactation
Precautions & Warnings
Use in Special Populations
Hepatic Impairment: No dosage adjustment is required in patients with mild hepatic impairment (Child-Pugh A). This is not recommended in patients with moderate hepatic impairment (Child-Pugh B). Safety and efficacy have not been established in HCV-infected patients with moderate hepatic impairment. This is contraindicated in patients with sev.
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