Generic name: VELPATASVIR 100mg, SOFOSBUVIR 400mg
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 EPCLUSA [see Warnings and Precautions (5.1)].
The recommended dosage of EPCLUSA is one tablet taken orally once daily with or without food [see Clinical Pharmacology (12.3)]. One tablet of EPCLUSA contains 400 mg of sofosbuvir and 100 mg of velpatasvir. Table 1 shows the recommended treatment regimen and duration based on patient population.
For patients with HCV/HIV-1 coinfection, follow the dosage recommendations in Table 1 [see Clinical Studies (14.3)]. Refer to Drug Interactions (7) for dosage recommendations for concomitant HIV-1 antiviral drugs.
|Patient Population||Treatment Regimen and Duration|
|Treatment-naïve and treatment-experienced*, without cirrhosis and with compensated cirrhosis (Child-Pugh A)||EPCLUSA 12 weeks|
|Treatment-naïve and treatment-experienced*, with decompensated cirrhosis (Child-Pugh B or C)||EPCLUSA + ribavirin† 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