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Epclusa
sofosbuvir/ velpatasvir
Black Box Warnings .
Hepatitis B Reactivation
test all pts for currrent or prior HBV infection before starting tx; reported in HCV/HBV co-infected pts on or those who completed HCV direct-acting antiviral tx who were not on anti-HBV tx, incl. cases resulting in fulminant hepatitis, hepatic failure, and death; screen all pts for HBV infection before initial tx; monitor for hepatitis flare or s/sx HBV reactivation during tx and after D/C; initiate anti-HBV tx if needed
Adult Dosing .
Dosage forms: TAB: 200 mg/50 mg, 400 mg/100 mg; PELLET: 150 mg/37.5 mg per pkt, 200 mg/50 mg per pkt
chronic hepatitis C infection, genotypes 1-6
- [pts w/o cirrhosis or w/ compensated cirrhosis]
- Dose: 400 mg/100 mg PO qd x12wk; Info: may give w/ ribavirin in pts w/ genotype 3; refer to AASLD/IDSA hepatitis C guidelines; do not chew pellets
- [pts w/ decompensated cirrhosis]
- Dose: 400 mg/100 mg PO qd x12wk or x24wk; Info: may give w/ ribavirin; duration depends on ribavirin eligibility, prior tx, liver transplant status; refer to AASLD/IDSA hepatitis C guidelines; do not chew pellets
renal dosing
- [pts w/o cirrhosis or w/ compensated cirrhosis]
- renal impairment: no adjustment
- HD/PD: no adjustment; no supplement
- [pts w/ decompensated cirrhosis]
- mild-moderate impairment: no adjustment; severe impairment: not defined
- HD/PD: not defined
hepatic dosing
- [no adjustment]
Peds Dosing .
- Dosage forms: TAB: 200 mg/50 mg, 400 mg/100 mg; PELLET: 150 mg/37.5 mg per pkt, 200 mg/50 mg per pkt
chronic hepatitis C infection, genotypes 1-6
- [3 yo and older, <17 kg]
- Dose: 150 mg/37.5 mg pellets PO qd x12wk; Info: give w/ ribavirin if decompensated cirrhosis; refer to AASLD/IDSA hepatitis C guidelines; do not chew pellets
- [3 yo and older, 17-29 kg]
- Dose: 200 mg/50 mg PO qd x12wk; Info: give w/ ribavirin if decompensated cirrhosis; refer to AASLD/IDSA hepatitis C guidelines; do not chew pellets
- [3 yo and older, >30 kg]
- Dose: 400 mg/100 mg PO qd x12wk; Info: give w/ ribavirin if decompensated cirrhosis; refer to AASLD/IDSA hepatitis C guidelines; do not chew pellets
renal dosing
- [not defined]
- renal impairment: consider adult renal dosing for guidance
- HD/PD: consider adult renal dosing for guidance
hepatic dosing
- [no adjustment]