ELBASVIR AND GRAZOPREVIR

Other

Brand names: ZEPATIER

Oral

Mechanism of Action

12.1 Mechanism of Action ZEPATIER is a fixed-dose combination of elbasvir and grazoprevir which are direct-acting antiviral agents against the hepatitis C virus [see Microbiology (12.4) ].

Indications

a hepatitis C virus (HCV) NS5A inhibitor

and grazoprevir

an HCV NS3/4A protease inhibitor

Contraindications

• Use in Specific Populations (8.9)
• strong inducers of cytochrome P450 3A (CYP3A)
• and efavirenz [see Warnings and Precautions (5.5)
• Drug Interactions (7)
• and Clinical Pharmacology (12.3) ] . If ZEPATIER is administered with ribavirin

FDA Warnings

5 WARNINGS AND PRECAUTIONS Risk of Hepatitis B Virus Reactivation: Test all patients for evidence of current or prior HBV infection before initiation of HCV treatment
2 ) Risk of Hepatic Decompensation/Failure in Patients with Evidence of Advanced Liver Disease: Hepatic decompensation/failure, including fatal outcomes, have been reported mostly in patients with cirrhosis and baseline moderate or severe liver impairment (Child-Pugh B or C) treated with HCV NS3/4A protease inhibitor-containing regimens
3 ) Risk Associated with Ribavirin Combination Treatment: If ZEPATIER is administered with ribavirin, the warnings and precautions for ribavirin also apply
1 Risk of Hepatitis B Virus Reactivation in Patients Coinfected with HCV and HBV Hepatitis B virus (HBV) reactivation has been reported in HCV/HBV coinfected patients who were undergoing or had completed treatment with HCV direct acting antivirals, and who were not receiving HBV antiviral therapy

Known Side Effects

10 documented side effects by frequency

Fatigue

>10%

Headache

>10%

Nausea

>10%

Insomnia

1-10%

Diarrhea

1-10%

Vomiting

0.1-1%

Joint Pain

0.1-1%

Itching

0.1-1%

Dizziness

0.1-1%

Abdominal Pain

0.1-1%

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Formulations

Dosage Forms

Tablet

Route

Oral