Generic name: SOFOSBUVIR 400mg, VELPATASVIR 100mg, VOXILAPREVIR 100mg
Dosage form: tablet, film coated
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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)].
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
|1, 2, 3, 4, 5, or 6||An NS5A inhibitor*||12 weeks|
|1a or 3||Sofosbuvir without an NS5A inhibitor†||12 weeks|
No Dosage Recommendations in Severe Renal Impairment and End Stage Renal Disease
No dosage recommendation can be given for patients with severe renal impairment (estimated Glomerular Filtration Rate [eGFR] less than 30 mL/min/1.73 m2) or with end stage renal disease (ESRD), due to higher exposures (up to 20-fold) of the predominant sofosbuvir metabolite [see Use in Specific Populations (8.6) and Clinical Pharmacology (12.3)].
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- Drug class: antiviral combinations