Harvoni Dosage

Generic name: ledipasvir and sofosbuvir
Drug class: Antiviral combinations

Medically reviewed by  A Ras MD.

Recommended 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]

Recommended 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]

SRC: NLM .