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Ledipasvir / Sofosbuvir Dosage

Applies to the following strength(s): 90 mg-400 mg

The information at Drugs.com is not a substitute for medical advice. Always consult your doctor or pharmacist.

Usual Adult Dose for:

Additional dosage information:

Usual Adult Dose for Chronic Hepatitis C

1 tablet orally once a day

Duration of Therapy:
-Therapy-naive patients without cirrhosis: 12 weeks; 8 weeks can be considered if pretreatment HCV RNA less than 6 million international units/mL
-Therapy-naive patients with cirrhosis: 12 weeks
-Therapy-experienced patients without cirrhosis: 12 weeks
-Therapy-experienced patients with cirrhosis: 24 weeks

Comments:
-Relapse rates are affected by baseline host and viral factors and differ between durations of therapy for some subgroups.
-Therapy-experienced patients are those patients who have failed treatment with either peginterferon alfa/ribavirin or peginterferon alfa/ribavirin/HCV protease inhibitor.

Use: For the treatment of chronic hepatitis C genotype 1 infection

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.

Liver Dose Adjustments

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

Comments: Safety and efficacy not established in patients with decompensated cirrhosis.

Precautions

Safety and efficacy have not been established in patients younger than 18 years.

Consult WARNINGS section for additional precautions.

Dialysis

End-stage renal disease (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:
-May take 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)

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