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Ledipasvir / Sofosbuvir Dosage

Medically reviewed by Drugs.com. Last updated on Jul 8, 2020.

Applies to the following strengths: 90 mg-400 mg; 45 mg-200 mg; 33.75 mg-150 mg

Usual Adult Dose for:

Usual Pediatric Dose for:

Additional dosage information:

Usual Adult Dose for Chronic Hepatitis C

Ledipasvir 90 mg-sofosbuvir 400 mg orally once a day

Recommended Regimen and Duration of Therapy:
GENOTYPE 1:
-Therapy-naive patients without cirrhosis or with compensated cirrhosis (Child-Pugh A): Ledipasvir-sofosbuvir for 12 weeks
-Therapy-experienced patients without cirrhosis: Ledipasvir-sofosbuvir for 12 weeks
-Therapy-experienced patients with compensated cirrhosis (Child-Pugh A): Ledipasvir-sofosbuvir for 24 weeks
-Therapy-naive and therapy-experienced patients with decompensated cirrhosis (Child-Pugh B or C): Ledipasvir-sofosbuvir plus ribavirin for 12 weeks

GENOTYPE 1 OR 4:
-Therapy-naive and therapy-experienced liver transplant recipients without cirrhosis or with compensated cirrhosis (Child-Pugh A): Ledipasvir-sofosbuvir plus ribavirin for 12 weeks

GENOTYPE 4, 5, OR 6:
-Therapy-naive and therapy-experienced patients without cirrhosis or with compensated cirrhosis (Child-Pugh A): Ledipasvir-sofosbuvir for 12 weeks

Comments:
-Relapse rates are affected by baseline host and viral factors and differ between durations of therapy for some subgroups.
-Dose recommendations also apply to HCV/HIV-1-coinfected patients.
-Therapy-naive genotype 1 patients without cirrhosis: Ledipasvir-sofosbuvir for 8 weeks can be considered in those who have pretreatment HCV RNA less than 6 million international units/mL.
-Therapy-experienced patients have failed a peginterferon alfa (with or without ribavirin)-based regimen with or without an HCV protease inhibitor.
-Therapy-experienced genotype 1 patients with cirrhosis: Ledipasvir-sofosbuvir plus ribavirin for 12 weeks can be considered in those eligible for ribavirin.
-If applicable, the manufacturer product information should be consulted for ribavirin dose recommendations; the manufacturer product information for ribavirin should be consulted for further information regarding dosing and dose adjustments.

Use: For the treatment of chronic HCV
-For genotype 1, 4, 5, or 6 infection without cirrhosis or with compensated cirrhosis
-In combination with ribavirin: For genotype 1 infection with decompensated cirrhosis
-In combination with ribavirin: For genotype 1 or 4 infection in liver transplant recipients without cirrhosis or with compensated cirrhosis

Usual Pediatric Dose for Chronic Hepatitis C

3 years or older:
-Weight less than 17 kg: Ledipasvir 33.75 mg-sofosbuvir 150 mg orally once a day
-Weight 17 to less than 35 kg: Ledipasvir 45 mg-sofosbuvir 200 mg orally once a day
-Weight at least 35 kg: Ledipasvir 90 mg-sofosbuvir 400 mg orally once a day

Recommended Regimen and Duration of Therapy:
GENOTYPE 1:
-Therapy-naive patients without cirrhosis or with compensated cirrhosis (Child-Pugh A): Ledipasvir-sofosbuvir for 12 weeks
-Therapy-experienced patients without cirrhosis: Ledipasvir-sofosbuvir for 12 weeks
-Therapy-experienced patients with compensated cirrhosis (Child-Pugh A): Ledipasvir-sofosbuvir for 24 weeks
-Therapy-naive and therapy-experienced patients with decompensated cirrhosis (Child-Pugh B or C): Ledipasvir-sofosbuvir plus ribavirin for 12 weeks

GENOTYPE 1 OR 4:
-Therapy-naive and therapy-experienced liver transplant recipients without cirrhosis or with compensated cirrhosis (Child-Pugh A): Ledipasvir-sofosbuvir plus ribavirin for 12 weeks

GENOTYPE 4, 5, OR 6:
-Therapy-naive and therapy-experienced patients without cirrhosis or with compensated cirrhosis (Child-Pugh A): Ledipasvir-sofosbuvir for 12 weeks

Comments:
-Relapse rates are affected by baseline host and viral factors and differ between durations of therapy for some subgroups.
-Dose recommendations also apply to HCV/HIV-1-coinfected patients.
-Therapy-naive genotype 1 patients without cirrhosis: Ledipasvir-sofosbuvir for 8 weeks can be considered in those who have pretreatment HCV RNA less than 6 million international units/mL.
-Therapy-experienced patients have failed a peginterferon alfa (with or without ribavirin)-based regimen with or without an HCV protease inhibitor.
-Therapy-experienced genotype 1 patients with cirrhosis: Ledipasvir-sofosbuvir plus ribavirin for 12 weeks can be considered in those eligible for ribavirin.
-If applicable, the manufacturer product information should be consulted for ribavirin dose recommendations; the manufacturer product information for ribavirin should be consulted for further information regarding dosing and dose adjustments.

Use: For the treatment of chronic HCV
-For genotype 1, 4, 5, or 6 infection without cirrhosis or with compensated cirrhosis
-In combination with ribavirin: For genotype 1 infection with decompensated cirrhosis
-In combination with ribavirin: For genotype 1 or 4 infection in liver transplant recipients without cirrhosis or with compensated cirrhosis

Renal Dose Adjustments

Mild, moderate, or severe renal dysfunction: No adjustment recommended.

Comments:
-No safety data available in patients with both decompensated cirrhosis and severe renal dysfunction.
-No safety data available in pediatric patients with renal dysfunction.
-The manufacturer product information for ribavirin tablets should be consulted for ribavirin dose adjustment in patients with CrCl up to 50 mL/min (if applicable).

Liver Dose Adjustments

Mild, moderate, or severe liver dysfunction (Child-Pugh A, B, or C): No adjustment recommended.

Comments:
-Clinical and hepatic monitoring (as clinically indicated) recommended for patients with decompensated cirrhosis using this drug plus ribavirin.

Precautions

US BOXED WARNING:
-RISK OF HBV REACTIVATION IN PATIENTS COINFECTED WITH HCV AND HBV: All patients should be tested for evidence of current/prior HBV infection before starting this drug. HBV reactivation has been reported during or after completion of HCV direct-acting antiviral therapy in HCV/HBV-coinfected patients who were not receiving HBV antiviral therapy; some cases resulted in fulminant hepatitis, hepatic failure, and death. HCV/HBV-coinfected patients should be monitored for hepatitis flare or HBV reactivation during HCV therapy and posttherapy follow-up; appropriate patient management for HBV infection should be started as clinically indicated.

CONTRAINDICATIONS:
Combination Therapy: Contraindications to ribavirin

Safety and efficacy have not been established in patients younger than 3 years.

Consult WARNINGS section for additional precautions.

Dialysis

ESRD requiring dialysis: No adjustment recommended.

Comments:
-No safety data available in dialysis patients with decompensated cirrhosis.

Other Comments

Administration advice:
-Before starting this drug, test all patients for evidence of current/prior HBV infection; measure hepatitis B surface antigen (HBsAg) and hepatitis B core antibody (anti-HBc).
-Administer with or without food.
-Use the oral pellets in pediatric patients who cannot swallow the tablet formulation; consult the manufacturer product information (Instructions for Use) for details regarding administration.
-Do not chew the oral pellets.
-If administered with food, sprinkle the oral pellets on at least 1 spoonful of nonacidic soft food (e.g., pudding, chocolate syrup, mashed potato, ice cream) at or below room temperature; administer oral pellets within 30 minutes of gently mixing with food and swallow the entire contents without chewing (to avoid bitter aftertaste).
-Consult the manufacturer product information regarding missed doses.

Storage requirements:
-Store below 30C (86F).
-Tablets: Dispense only in original container.

Reconstitution/preparation techniques:
-Oral pellets: The manufacturer product information should be consulted.

General:
-The manufacturer product information for ribavirin should be consulted for additional information (if applicable).

Patient advice:
-Read the US FDA-approved patient labeling (Patient Information and Instructions for Use).
-Avoid missing doses and complete the entire course of therapy.

Frequently asked questions

Further information

Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances.