Drug Detail:Vosevi (Sofosbuvir, velpatasvir, and voxilaprevir [ soe-fos-bue-vir, vel-pat-as-vir, and-vox-i-la-pre-vir ])
Generic Name: SOFOSBUVIR 400mg, VELPATASVIR 100mg, VOXILAPREVIR 100mg
Dosage Form: tablet, film coated
Drug Class: Antiviral combinations
Testing Prior to the Initiation of Therapy
Test all patients for evidence of current or prior HBV infection by measuring hepatitis B surface antigen (HBsAg) and hepatitis B core antibody (anti-HBc) before initiating HCV treatment with VOSEVI [see Warnings and Precautions (5.1)].
Recommended Dosage
The recommended dosage of VOSEVI is one tablet, taken orally, once daily with food [see Clinical Pharmacology (12.3)]. One tablet of VOSEVI contains 400 mg of sofosbuvir, 100 mg of velpatasvir, and 100 mg of voxilaprevir. Table 1 shows the recommended treatment regimen and duration based on patient population.
Genotype | Patients Previously Treated with an HCV Regimen Containing: | VOSEVI Duration |
---|---|---|
|
||
1, 2, 3, 4, 5, or 6 | An NS5A inhibitor* | 12 weeks |
1a or 3 | Sofosbuvir without an NS5A inhibitor† | 12 weeks |
Renal Impairment
No dosage adjustment of VOSEVI is recommended in patients with any degree of renal impairment including patients on dialysis [see Use in Specific Populations (8.6) and Clinical Pharmacology (12.3)].
Moderate or Severe Hepatic Impairment
VOSEVI is not recommended in patients with moderate or severe hepatic impairment (Child-Pugh B or C) due to higher exposures of voxilaprevir in these patients [see Warnings and Precautions (5.2), Use in Specific Populations (8.7), and Clinical Pharmacology (12.3)].