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Sovaldi
sofosbuvir
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, incl. 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, 400 mg; PELLET: 200 mg per pkt
hepatitis C infection, chronic
- [treatment failure, all genotypes (off-label)]
- Dose: 400 mg PO qd x16wk; Info: for glecaprevir/pibrentasvir tx failure; give with glecaprevir/pibrentasvir and ribavirin; 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
- [see below]
- hepatic impairment: no adjustment; decompensated hepatic disease: not defined
Peds Dosing .
- Dosage forms: TAB: 200 mg, 400 mg; PELLET: 150 mg per pkt, 200 mg per pkt
chronic hepatitis C infection, genotype 2
- [3 yo and older, <17 kg]
- Dose: 150 mg PO qd w/ ribavirin x12wk; Info: for patients w/o cirrhosis or w/ compensated cirrhosis; not recommended per AASLD/IDSA hepatitis C guidelines; do not chew pellets
- [3 yo and older, 17-34 kg]
- Dose: 200 mg PO qd w/ ribavirin x12wk; Info: for patient w/o cirrhosis or w/ compensated cirrhosis; not recommended per AASLD/IDSA hepatitis C guidelines; do not chew pellets
- [3 yo and older, >35 kg]
- Dose: 400 mg PO qd w/ ribavirin x12wk; Info: for patients w/o cirrhosis or w/ compensated cirrhosis; not recommended per AASLD/IDSA hepatitis C guidelines; do not chew pellets
chronic hepatitis C infection, genotype 3
- [3 yo and older, <17 kg]
- Dose: 150 mg PO qd w/ ribavirin x24wk; Info: for patients w/o cirrhosis or w/ compensated cirrhosis; not recommended per AASLD/IDSA hepatitis C guidelines; do not chew pellets
- [3 yo and older, 17-34 kg]
- Dose: 200 mg PO qd w/ ribavirin x24wk; Info: for patients w/o cirrhosis or w/ compensated cirrhosis; not recommended per AASLD/IDSA hepatitis C guidelines; do not chew pellets
- [3 yo and older, >35 kg]
- Dose: 400 mg PO qd w/ ribavirin x24wk; Info: for patients w/o cirrhosis or w/ compensated cirrhosis; not recommended per 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
- [not defined]
- hepatic impairment: consider adult hepatic dosing for guidance