Mavixen

• Chronic Hepatitis C: Genotype 1, 2, 3, 4, 5 or 6 infection - without cirrhosis or with compensated cirrhosis
• HCV genotype 1 treatment-experienced patients: who have been previously treated with a regimen containing either an NS5A inhibitor or an NS3/4A protease inhibitor, but not both

Glecaprevir is an inhibitor of the HCV NS3/4A protease, which is a viral enzyme necessary for the proteolytic cleavage of the HCV encoded polyprotein into mature forms of the NS3, NS4A, NS4B, NS5A, and NS5B proteins. NS5A is a phosphoprotein that plays an essential role in replication, assembly and maturation of infectious viral proteins. Pibrentasvir blocks this interaction to inhibit the assembly of proteins and production of mature HCV particles.

Recommended Dosage:

• 3 tablets (glecaprevir 300 mg + pibrentasvir 120 mg) once daily with food

Treatment-Naïve Patients:

• Genotypes 1-6, no cirrhosis: 8 weeks
• Genotypes 1-6, compensated cirrhosis: 12 weeks

Treatment-Experienced (HCV Genotype 1):

• NS5A inhibitor prior, no cirrhosis: 16 weeks
• NS3/4A PI prior, no cirrhosis: 12 weeks

Mild Hepatic Impairment (Child-Pugh A): No dosage adjustment required

Renal Impairment: No dosage adjustment required

* Use as directed by the registered physician

Common Side Effects (>10%):

• Headache (9-17%)
• Fatigue (11-14%)
• Nausea (6-12%)

Other (1-10%):

• Diarrhea (3-7%)
• Increased bilirubin (3.5%)
• Pruritus (7%)

Use in Pregnancy: No adequate human data are available to establish whether or not this poses a risk to pregnancy outcomes.

Precautions:

• Hepatitis B virus reactivation may occur in HCV/HBV coinfected patients.
• Test all patients for HBV infection before initiation of HCV treatment.

Overdose: Monitor patient for any signs and symptoms of toxicities. Appropriate symptomatic treatment should be instituted immediately. Glecaprevir and pibrentasvir are not significantly removed by hemodialysis.

Storage: Store at or below 30°C.