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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 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 plus 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 plus ribavirin for 12 weeks
-Genotype 4, therapy-naive: Elbasvir-grazoprevir for 12 weeks
-Genotype 4, peginterferon alfa/ribavirin-experienced: Elbasvir-grazoprevir plus ribavirin for 16 weeks

Comments:
-This drug should be used with ribavirin in certain patient populations.
-Hepatic laboratory testing recommended prior to and during therapy.
-Peginterferon alfa/ribavirin-experienced: Patients who have failed therapy with peginterferon alfa plus ribavirin
-Baseline NS5A polymorphisms: NS5A resistance-associated polymorphisms at amino acid positions 28, 30, 31, or 93.
-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 for ribavirin should be consulted regarding dosing and dose adjustments (if applicable).

Use: For the treatment of chronic HCV genotype 1 or 4 infection

Renal Dose Adjustments

Any degree of renal dysfunction: No adjustment recommended.

Comments:
-The manufacturer product information for ribavirin tablets should be consulted regarding use in patients with CrCl up to 50 mL/min (if applicable).

Liver Dose Adjustments

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

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 18 years.

Consult WARNINGS section for additional precautions.

Dialysis

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

Comments:
-The manufacturer product information for ribavirin tablets should be consulted regarding use in patients receiving hemodialysis (if applicable).

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).
-Before starting this drug, test patients with HCV genotype 1a infection for virus with NS5A resistance-associated polymorphisms to determine dose regimen and duration.
-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 until use 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.
-Avoid missing doses and complete the entire course of therapy.

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