Select a medication above to begin.
Harvoni
ledipasvir/ sofosbuvir
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: 45 mg/200 mg, 90 mg/400 mg; PELLET: 45 mg/200 mg per pkt
hepatitis C infection, chronic
- [genotype 1, tx-naive pts]
- Dose: 90 mg/400 mg PO qd x12wk; Info: may consider 8wk tx duration in non-HIV infected pts w/o cirrhosis and w/ pre-tx HCV RNA levels <6 million units/mL; give w/ ribavirin in pts w/ decompensated cirrhosis or liver transplant hx; refer to AASLD/IDSA hepatitis C guidelines; do not chew pellets
- [genotype 1, tx-experienced pts]
- Dose: 90 mg/400 mg PO qd x12wk; Info: may give w/ ribavirin; may give x24wk in pts w/ decompensated cirrhosis; refer to AASLD/IDSA hepatitis C guidelines; do not chew pellets
- [genotype 4]
- Dose: 90 mg/400 mg PO qd x12wk; Info: may give w/ ribavirin x12wk or x24wk; may give x24wk in pts w/ decompensated cirrhosis; refer to AASLD/IDSA hepatitis C guidelines; do not chew pellets
- [genotypes 5 or 6]
- Dose: 90 mg/400 mg PO qd x12wk; Info: for pts w/ or w/o compensated cirrhosis; give w/ ribavirin in pts w/ liver transplant hx; may give x24wk in pts w/ decompensated cirrhosis; refer to AASLD/IDSA hepatitis C guidelines; do not chew pellets
renal dosing
- [pts w/ decompensated cirrhosis]
- mild-moderate impairment: no adjustment; severe impairment: not defined
- HD/PD: not defined
- [all other pts]
- renal impairment: no adjustment
- HD/PD: no adjustment; no supplement
hepatic dosing
- [no adjustment]
Peds Dosing .
- Dosage forms: TAB: 45 mg/200 mg, 90 mg/400 mg; PELLET: 33.75 mg/150 mg per pkt, 45 mg/200 mg per pkt
chronic hepatitis C infection, genotype 1
- [tx-naive pts, 3 yo and older, <17 kg]
- Dose: 33.75 mg/150 mg PO qd x12wk; Info: for pts w/o cirrhosis or w/ compensated cirrhosis; refer to AASLD/IDSA hepatitis C guidelines; do not chew pellets
- [tx-naive pts, 3 yo and older, 17-34 kg]
- Dose: 45 mg/200 mg PO qd x12wk; Info: for pts w/o cirrhosis or w/ compensated cirrhosis; refer to AASLD/IDSA hepatitis C guidelines; do not chew pellets
- [tx-naive pts, 3 yo and older, >35 kg]
- Dose: 90 mg/400 mg PO qd x12wk; Info: for pts w/o cirrhosis or w/ compensated cirrhosis; refer to AASLD/IDSA hepatitis C guidelines; do not chew pellets
- [tx-experienced pts, 3 yo and older, <17 kg]
- Dose: 33.75 mg/150 mg PO qd x12wk; Info: give x24 wk in pts w/ compensated cirrhosis; refer to AASLD/IDSA hepatitis C guidelines; do not chew pellets
- [tx-experienced pts, 3 yo and older, 17-34 kg]
- Dose: 45 mg/200 mg PO qd x12wk; Info: give x24 wk in pts w/ compensated cirrhosis; refer to AASLD/IDSA hepatitis C guidelines; do not chew pellets
- [tx-experienced pts, 3 yo and older, >35 kg]
- Dose: 90 mg/400 mg PO qd x12wk; Info: give x24 wk in pts w/ compensated cirrhosis; refer to AASLD/IDSA hepatitis C guidelines; do not chew pellets
chronic hepatitis C infection, genotypes 4, 5, or 6
- [3 yo and older, <17 kg]
- Dose: 33.75 mg/150 mg PO qd x12wk; Info: for pts w/o cirrhosis or w/ compensated cirrhosis; refer to AASLD/IDSA hepatitis C guidelines; do not chew pellets
- [3 yo and older, 17-34 kg]
- Dose: 45 mg/200 mg PO qd x12wk; Info: for pts w/o cirrhosis or w/ compensated cirrhosis; refer to AASLD/IDSA hepatitis C guidelines; do not chew pellets
- [3 yo and older, >35 kg]
- Dose: 90 mg/400 mg PO qd x12wk; Info: for pts w/o cirrhosis or w/ compensated 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]