Drug Summary
Adverse Effects
Class and Mechanism
Indications
Genotype 1
- Treatment-naïve patients without cirrhosis or with compensated cirrhosis (Child-Pugh A) : ledipasvir-sofosbuvir x 12 weeks*
- Treatment-experienced** patients without cirrhosis: ledipasvir-sofosbuvir x 12 weeks
- Treatment-experienced** patients with compensated cirrhosis (Child-Pugh A): ledipasvir-sofosbuvir x 24 weeks†
- Treatment-naïve and treatment-experienced** patients with decompensated cirrhosis (Child-Pugh B or C): ledipasvir-sofosbuvir plus ribavirin‡ x 12 weeks
Genotype 1 or 4
- Treatment-naïve and treatment-experienced ** liver transplant recipients without cirrhosis, or with compensated cirrhosis (Child-Pugh A): ledipasvir-sofosbuvir plus ribavirin§ x 12 weeks
Genotype 4, 5, or 6
- Treatment-naïve and treatment-experienced ** patients without cirrhosis or with compensated cirrhosis (Child-Pugh A): ledipasvir-sofosbuvir plus ribavirin x 12 weeks
Footnotes
*Based on a subset analysis from the ION-3 trial, ledipasvir-sofosbuvir for 8 weeks can be considered in treatment-naïve genotype 1 patients without cirrhosis who have pre‑treatment HCV RNA less than 6 million IU/mL.
**Treatment-experienced patients include those who have failed a peginterferon alfa plus ribavirin based regimen, with or without an HCV protease inhibitor.
†Ledipasvir-sofosbuvir for 12 weeks can be considered in treatment-experienced genotype 1 patients with cirrhosis who are eligible for ribavirin (see footnote§ for ribavirin dosage recommendations).
‡In patients with decompensated cirrhosis, the starting dosage of ribavirin is 600 mg and can be titrated up to 1000 mg for patients <75 kg and 1200 mg for those ≥75 kg in two divided doses with food. If the starting dosage of ribavirin is not well tolerated, the dosage should be reduced as clinically indicated based on hemoglobin levels.
§For patients without cirrhosis or with compensated cirrhosis (Child-Pugh A), the daily dosage of ribavirin is weight-based (1000 mg for patients <75 kg and 1200 mg for those ≥75 kg) administered orally in two divided doses with food.
Dosing
- For patients with any degree of renal impairment including end-stage renal disease requiring dialysis, no dosage adjustment is necessary.
- For patients with mild, moderate, or severe hepatic impairment (Child-Pugh Class A, B, or C), no dosage adjustment is recommended, but the safety and efficacy of ledipasvir-sofosbuvir in patients with decompensated cirrhosis has not been established.
Cost and Medication Access
Key Drug Interactions
Full Prescribing Information
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