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Epclusa Dosage

Generic name: VELPATASVIR 100mg, SOFOSBUVIR 400mg
Dosage form: tablet, film coated

Medically reviewed on November 15, 2017.

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)].

Recommended Dosage

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.

Table 1 Recommended Treatment Regimen in Patients with Genotype 1, 2, 3, 4, 5, or 6 HCV
Patient Population Treatment Regimen and Duration
In clinical trials, regimens contained peginterferon alfa/ribavirin with or without an HCV NS3/4A protease inhibitor (boceprevir, simeprevir, or telaprevir).
When administered with EPCLUSA, the recommended dosage of ribavirin is based on weight (administered with food): 1000 mg per day for patients less than 75 kg and 1200 mg for those weighing at least 75 kg, divided and administered twice daily. The starting dosage and on-treatment dosage of ribavirin can be decreased based on hemoglobin and creatinine clearance. For ribavirin dosage modifications, refer to the ribavirin prescribing information.
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)].

Further information

Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances.