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Ledipasvir / Sofosbuvir Dosage

Medically reviewed on December 26, 2017.

Applies to the following strengths: 90 mg-400 mg

Usual Adult Dose for:

Usual Pediatric Dose for:

Additional dosage information:

Usual Adult Dose for Chronic Hepatitis C

1 tablet 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/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.
-The manufacturer product information for ribavirin should be consulted regarding dosing and dose adjustments (if applicable).

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

12 years and older or weighing at least 35 kg: 1 tablet 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

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:
-Dose recommendations also apply to HCV/HIV-1-coinfected patients.
-Therapy-experienced patients have failed an interferon-based regimen with or without ribavirin.

Use: For the treatment of HCV genotype 1, 4, 5, or 6 infection without cirrhosis or with compensated cirrhosis

Renal Dose Adjustments

Mild or moderate renal dysfunction: No adjustment recommended.
Severe renal dysfunction (estimated glomerular filtration rate less than 30 mL/min/1.73 m2): Data not available

Comments:
-Safety and efficacy have not been established in patients with severe renal dysfunction; dose not established due to higher exposures of the main sofosbuvir metabolite.
-The manufacturer product information for ribavirin should be consulted regarding use in renal dysfunction patients (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.

Safety and efficacy have not been established in patients younger than 12 years and weighing less than 35 kg, in patients younger than 18 years with decompensated cirrhosis, or in pediatric liver transplant recipients.

Consult WARNINGS section for additional precautions.

Dialysis

ESRD requiring hemodialysis: Data not available

Comments:
-Safety and efficacy have not been established in ESRD patients requiring hemodialysis; dose not established due to higher exposures of the main sofosbuvir metabolite.

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).
-May administer without regard to food
-Consult the manufacturer product information regarding missed doses.

Storage requirements:
-Store in the original container at room temperature below 30C (86F).

General:
-Each fixed-dose combination tablet contains ledipasvir 90 mg and sofosbuvir 400 mg.
-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).

Further information

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

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