Monday, July 11, 2016

sofosbuvir/velpatasvir (Rx)Epclusa

Dosage Forms & Strengths

sofosbuvir/velpatasvir
tablet
  • 400mg/100mg

Chronic Hepatitis C

Indicated for adults with chronic hepatitis C virus (HCV) infection genotypes 1, 2, 3, 4, 5, and 6
1 tablet (400 mg sofosbuvir/ 100 mg velpatasvir) PO qDay
Treatment duration
  • Patients without cirrhosis or with compensated cirrhosis (Child-Pugh A): Sofosbuvir/velpatasvir for 12 weeks
  • Patients with decompensated cirrhosis (Child-Pugh B or C): Sofosbuvir/velpatasvir plus weight-based ribavirin with food for 12 weeks
  • Weight-based ribavirin dose
    • <75 kg: 1000 mg/day PO divided BID
    • ≥75 kg: 1200 mg/day PO divided BID
    • Ribavirin starting dose and on-treatment dosage should be modified based on hemoglobin and creatinine clearance

Dosage Modifications

Renal impairment
  • Severe renal impairment (eGFR <30mL/min/1.73 m²) or ESRD: No dosage recommendation can be give owing to higher exposures (up to 20-fold) of the predominant sofosbuvir metabolite
Hepatic impairment
  • Mild, moderate, or severe (Child-Pugh A, B, or C): No dosage adjustment required

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