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Elbasvir / Grazoprevir Dosage

Applies to the following strength(s): 50 mg-100 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

Recommended Regimen and Duration of Therapy:
-Genotype 1a, therapy-naive or peginterferon alfa/ribavirin-experienced without baseline nonstructural protein 5A (NS5A) polymorphisms: Elbasvir-grazoprevir for 12 weeks
-Genotype 1a, therapy-naive or peginterferon alfa/ribavirin-experienced with baseline NS5A polymorphisms: Elbasvir-grazoprevir and ribavirin for 16 weeks
-Genotype 1b, therapy-naive or peginterferon alfa/ribavirin-experienced: Elbasvir-grazoprevir for 12 weeks
-Genotype 1a or 1b, peginterferon alfa/ribavirin/HCV protease inhibitor-experienced: Elbasvir-grazoprevir and ribavirin for 12 weeks
-Genotype 4, therapy-naive: Elbasvir-grazoprevir for 12 weeks
-Genotype 4, peginterferon alfa/ribavirin-experienced: Elbasvir-grazoprevir and ribavirin for 16 weeks

Comments:
-Patients with HCV genotype 1a infection should be tested for virus with NS5A resistance-associated polymorphisms (at amino acid positions 28, 30, 31, or 93) before starting this drug to determine regimen and duration.
-Hepatic laboratory testing recommended prior to and during therapy.
-Peginterferon alfa/ribavirin-experienced: Patients who have failed therapy with peginterferon alfa plus ribavirin
-Peginterferon alfa/ribavirin/HCV protease inhibitor-experienced: Patients who have failed therapy with peginterferon alfa plus ribavirin plus HCV NS3/4A protease inhibitor (e.g., boceprevir, simeprevir, telaprevir)
-Optimal regimen and duration of therapy not established for peginterferon alfa/ribavirin/HCV protease inhibitor-experienced genotype 1a-infected patients with at least 1 baseline NS5A resistance-associated polymorphism at positions 28, 30, 31, and 93.
-The manufacturer product information should be consulted for recommended ribavirin dose in patients with CrCl greater than 50 mL/min; the manufacturer product information for ribavirin should be consulted for further information on ribavirin dosing, including dose adjustments.

Use: With or without ribavirin, for the treatment of chronic HCV genotypes 1 or 4 infection

Renal Dose Adjustments

Any degree of renal dysfunction: No adjustment recommended.

Comments:
-If required, the manufacturer product information for ribavirin tablet should be consulted for recommended ribavirin dose in patients with CrCl up to 50 mL/min.

Liver Dose Adjustments

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

Precautions

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

Consult WARNINGS section for additional precautions.

Dialysis

Hemodialysis: No adjustment recommended.
Peritoneal dialysis: Data not available

Comments:
-If required, the manufacturer product information for ribavirin tablet should be consulted for recommended ribavirin dose in patients receiving hemodialysis.

Other Comments

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

Storage requirements:
-Store at 20C to 25C (68F to 77F); excursions permitted between 15C to 30C (59F to 86F).
-Store in original package to protect from moisture

General:
-Each fixed-dose combination tablet contains elbasvir 50 mg and grazoprevir 100 mg.
-In patients using this drug for 12 weeks, sustained virologic response rates were lower in genotype 1a-infected patients with at least 1 baseline NS5A resistance-associated polymorphism at amino acid positions 28, 30, 31, or 93.
-Relapse rates are affected by baseline host and viral factors and differ between treatment regimens and durations for certain subgroups.
-The manufacturer product information for ribavirin should be consulted for additional information.

Monitoring:
-Hepatic: Hepatic laboratory tests (before therapy, at treatment week 8, at treatment week 12 [if 16-week regimen], and as clinically indicated)

Patient advice:
-Read the US FDA-approved patient information (Patient Information) for this drug and review the Medication Guide for ribavirin, if applicable.
-Watch for signs of liver inflammation (e.g., early signs: fatigue, weakness, lack of appetite, nausea and vomiting; later signs: jaundice, discolored feces); consult healthcare provider immediately if these symptoms develop.

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