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Epclusa
sofosbuvir/ velpatasvir
Black Box Warnings .
Hepatitis B Reactivation
test all patients for currrent or prior HBV infection before starting tx; reported in HCV/HBV co-infected patients on or those who completed HCV direct-acting antiviral tx who were not on anti-HBV tx, including cases resulting in fulminant hepatitis, hepatic failure, and death; screen all patients for HBV infection before initial tx; monitor for hepatitis flare or signs/symptoms of 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 packet, 200 mg/50 mg per packet
chronic hepatitis C infection, genotypes 1-6
- [patients without cirrhosis or with compensated cirrhosis]
- Dose: 400 mg/100 mg PO qd x12wk; Info: give with ribavirin in patients with genotype 3 with compensated cirrhosis and NS5A resistance-associated substitution Y93H; refer to AASLD/IDSA hepatitis C guidelines; do not chew pellets
- [patients with decompensated cirrhosis]
- Dose: 400 mg/100 mg PO qd x12wk; Info: give with ribavirin; if ribavirin ineligible, give x24wk; refer to AASLD/IDSA hepatitis C guidelines; do not chew pellets
renal dosing
- [see below]
- renal impairment: no adjustment
- HD: no adjustment; no supplement; 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 packet, 200 mg/50 mg per packet
chronic hepatitis C infection, genotypes 1-6
- [3 yo and older, <17 kg]
- Dose: 150 mg/37.5 mg pellets PO qd x12wk; Info: 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: 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: refer to AASLD/IDSA hepatitis C guidelines; do not chew pellets
renal dosing
- [see below]
- renal impairment: no adjustment
- HD: no adjustment; no supplement; PD: not defined
hepatic dosing
- [no adjustment]