Elbasvir / Grazoprevir Dosage

Medically reviewed by Drugs.com. Last updated on Jun 27, 2023.

Applies to the following strengths: 50 mg-100 mg

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 tablets should be consulted regarding dosing and dose adjustments (if applicable).

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

Usual Pediatric Dose for Chronic Hepatitis C

12 years and older OR weighing at least 30 kg: 1 tablet orally once a day

Recommended Regimen and Duration of Therapy:

Genotype 1a, therapy-naive or peginterferon alfa/ribavirin-experienced without baseline 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 tablets 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) or any history of hepatic decompensation: 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.

CONTRAINDICATIONS:

Moderate or severe liver dysfunction (Child-Pugh B or C) or any history of hepatic decompensation
Coadministration with inhibitors of OATP1B1/3 known/expected to significantly increase grazoprevir plasma levels, strong CYP450 3A inducers, efavirenz, phenytoin, carbamazepine, rifampin, St. John's wort, atazanavir, darunavir, lopinavir, saquinavir, tipranavir, cyclosporine; this is not a complete list of all strong CYP450 3A inducers and may not include all OATP1B1/3 inhibitors that significantly increase grazoprevir plasma levels
Combination Therapy: Contraindications to ribavirin

Safety and efficacy have not been established in patients younger than 12 years who weigh less than 30 kg.

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.
Administer with or without 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:

General: For clinical and laboratory signs of hepatitis flare or HBV reactivation in patients with serological evidence of HBV infection (during HCV therapy with this drug and during posttreatment follow-up)
Hepatic: Hepatic laboratory tests in all patients (before therapy, at treatment week 8, at treatment week 12 [if 16-week regimen], and as clinically indicated; more often in those with compensated cirrhosis [Child-Pugh A] or evidence of advanced liver disease); for signs/symptoms of hepatic decompensation

Patient advice:

Read the US FDA-approved patient information (Patient Information) for this drug and review the Medication Guide for ribavirin, if applicable.
Seek medical evaluation at once for symptoms of worsening liver problems (e.g., nausea, tiredness, yellowing of the skin/white part of the eyes, bleeding/bruising more easily than normal, confusion, loss of appetite, diarrhea, dark/brown urine, dark/bloody stool, swelling of the stomach area [abdomen]/pain in the upper right side of the stomach area, sleepiness, vomiting of blood).
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.