Classes
DEA Class; Rx
Common Brand Names; Vosevi
- HCV NS5A Inhibitors;
- HCV Polymerase Inhibitors;
- HCV Protease Inhibitors
Description
Combination oral antiviral
Used for the treatment of chronic hepatitis C infection in treatment-experienced adults without cirrhosis or with compensated cirrhosis (Child-Pugh A)
Risk of hepatitis B virus (HBV) reactivation has been reported in some cases resulting in fulminant hepatitis, hepatic failure, and death
Indications
Indicated for genotype 1, 2, 3, 4, 5, or 6 previously treated with NS5A inhibitor-containing regimen
Indicated for genotype 1a or 3 previously treated with a sofosbuvir-containing regimen without NS5A inhibitor
Contraindications
Rifampin; significantly decreases sofosbuvir, velpatasvir, and voxilaprevir serum concentrations
Adverse Effects
- Headache (21-23%)
- Fatigue (17-19%)
- Diarrhea (13-14%)
- Nausea (10-13%)
- Asthenia (4-6%)
- Insomnia (3-6%)
Warnings
HBV reactivation reported
Pregnancy and Lactation
No adequate human data are available to establish whether or not sofosbuvir/velpatasvir/voxilaprevir poses a risk to pregnancy outcomes
Unknown if distributed in human breast milk
Maximum Dosage
400 mg/day PO for sofosbuvir; 100 mg/day PO for velpatasvir; 100 mg/day PO for voxilaprevir.
400 mg/day PO for sofosbuvir; 100 mg/day PO for velpatasvir; 100 mg/day PO for voxilaprevir.
Safety and efficacy not established.
Safety and efficacy not established.
Safety and efficacy not established.
Safety and efficacy not established.
How supplied
Sofosbuvir/velpatasvir/voxilaprevir
tablet
- 400mg/100mg/100mg