Elbasvir

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) ].

• ZEPATIER ® is indicated for the treatment of chronic hepatitis C virus (HCV) genotype 1 or 4 infection in adult and pediatric patients 12 years of age and older or weighing at least 30 kg. ZEPATIER is indicated for use with ribavirin in certain patient populations [see Dosage and Administration (2.2) ] .ICD-10: B18.2

• ZEPATIER is contraindicated in patients with moderate or severe hepatic impairment (Child-Pugh B or C) due to the expected significantly increased grazoprevir plasma concentration and the increased risk of alanine aminotransferase (ALT) elevations [see Warnings and Precautions (5.2) , Use in Specific Populations (8.9) , and Clinical Pharmacology (12.3) ] . ZEPATIER is contraindicated in patients with moderate or severe hepatic impairment (Child-Pugh B or C) or those with any history of hepatic decompensation due to the risk of hepatic decompensation [see Warnings and Precautions (5.3) , Use in Specific Populations (8.9) ] .contraindicated

Testing Prior to Initiation of Therapy: Test all patients for HBV infection by measuring HBsAg and anti-HBc. ( 2.1 ) Genotype 1a: Testing for the presence of virus with NS5A resistance-associated polymorphisms is recommended. ( 2.1 ) Obtain hepatic laboratory testing. ( 2.1 ) Recommended dosage in adult and pediatric patients 12 years of age and older or weighing at least 30 kg: One tablet taken orally once daily with or without food. ( 2.2 ) Dosage Regimens and Durations for ZEPATIER in Patients with Genotype 1 or 4 HCV with or without Cirrhosis Patient Population Treatment Duration Genotype 1a: Treatment-naïve or PegIFN/RBV-experienced Peginterferon alfa + ribavirin. without baseline NS5A polymorphisms Polymorphisms at amino acid positions 28, 30, 31, or 93. ZEPATIER 12 weeks Genotype 1a: Treatment-naïve or PegIFN/RBV-experienced with baseline NS5A polymorphisms ZEPATIER + ribavirin 16 weeks Genotype 1b: Treatment-naïve or PegIFN/RBV-experienced ZEPATIER 12 weeks Genotype 1a or 1b: PegIFN/RBV/PI-experienced Peginterferon alfa + ribavirin + HCV NS3/4A protease inhibitor. ZEPATIER + ribavirin 12 weeks Genotype 4: Treatment-naïve ZEPATIER 12 weeks Genotype 4: PegIFN/RBV-experienced ZEPATIER + ribavirin 16 weeks HCV/HIV-1 co-infection: Follow the dosage recommendations in the table above. ( 2.2 ) Renal Impairment, including hemodialysis: No dosage adjustment of ZEPATIER is recommended. Refer to ribavirin prescribing information for ribavirin dosing and dosage modifications.

Risk of Hepatitis B Virus Reactivation: Test all patients for evidence of current or prior HBV infection before initiation of HCV treatment. Monitor HCV/HBV coinfected patients for HBV reactivation and hepatitis flare during HCV treatment and post-treatment follow-up. Initiate appropriate patient management for HBV infection as clinically indicated. ( 5.1 ) ALT Elevations: Perform hepatic laboratory testing prior to therapy, at treatment week 8, and as clinically indicated. For patients receiving 16 weeks of therapy, perform additional hepatic laboratory testing at treatment week 12. For ALT elevations on ZEPATIER, follow recommendations in full prescribing information. ( 5.2 ) 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. Monitor for clinical and laboratory evidence of hepatic decompensation. Discontinue ZEPATIER in patients who develop evidence of hepatic decompensation/failure. ( 5.3 ) Risk Associated with Ribavirin Combination Treatment: If ZEPATIER is administered with ribavirin, the warnings and precautions for ribavirin also apply.

The following adverse reaction is described below and elsewhere in the labeling: Increased Risk of ALT Elevations [see Warnings and Precautions (5.2) ]. In subjects receiving ZEPATIER for 12 weeks, the most commonly reported adverse reactions of all intensity (greater than or equal to 5% in placebo-controlled trials) were fatigue, headache, and nausea. In subjects receiving ZEPATIER with ribavirin for 16 weeks, the most commonly reported adverse reactions of moderate or severe intensity (greater than or equal to 5%) were anemia and headache. ( 6.1 ) To report SUSPECTED ADVERSE REACTIONS, contact Merck Sharp & Dohme LLC at 1-877-888-4231 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch . 6.1 Clinical Trials Experience Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in practice. If ZEPATIER is administered with ribavirin, refer to the prescribing information for ribavirin for a description of ribavirin-associated adverse reactions. Clinical Trials in Adult Subjects The safety of ZEPATIER in adult subjects was assessed based on 2 placebo-controlled trials and 7 uncontrolled Phase 2 and 3 clinical trials in approximately 1700 subjects with chronic hepatitis C virus infection with compensated liver disease (with or without cirrhosis) [see Clinical Studies (14) ] .

8.1 Pregnancy Risk Summary No adequate human data are available to establish whether or not ZEPATIER poses a risk to pregnancy outcomes. In animal reproduction studies, no evidence of adverse developmental outcomes was observed with the components of ZEPATIER (elbasvir or grazoprevir) at exposures greater than those in humans at the recommended human dose (RHD) (see Data ) . During organogenesis in the rat and rabbit, systemic exposures (AUC) were approximately 10 and 18 times (for elbasvir) and 117 and 41 times (for grazoprevir), respectively, the exposure in humans at the RHD. In rat pre/postnatal developmental studies, maternal systemic exposures (AUC) to elbasvir and grazoprevir were approximately 10 and 78 times, respectively, the exposure in humans at the RHD. The background risk of major birth defects and miscarriage for the indicated population is unknown. In the U.S. general population, the estimated background risk of major birth defects and miscarriage in clinically recognized pregnancies is 2-4% and 15-20%, respectively. If ZEPATIER is administered with ribavirin, the combination regimen is contraindicated in pregnant women and in men whose female partners are pregnant. Refer to the ribavirin prescribing information for more information on use in pregnancy.

Metabolism

The pharmacokinetic properties of elbasvir and grazoprevir have been evaluated in non-HCV-infected adult subjects and in HCV-infected adult subjects. Elbasvir pharmacokinetics were similar in healthy subjects and HCV-infected subjects and were approximately dose-proportional over the range of 5-100 mg once daily.

Human experience of overdose with ZEPATIER is limited. No specific antidote is available for overdose with ZEPATIER. In case of overdose, it is recommended that the patient be monitored for any signs or symptoms of adverse reactions and appropriate symptomatic treatment instituted. Hemodialysis does not remove elbasvir or grazoprevir since elbasvir and grazoprevir are highly bound to plasma protein [see Clinical Pharmacology (12.3) ] .

• Jan 28, 2016NDANDA208261Msd Sub Merck

Reference statistics from the openFDA drug-shortage dataset. For a live view, consult the FDA database directly. Not clinical guidance.

• Zepatier, Tablet, 50 mg; 100 mg (NDC 0006-3074-02)To be discontinued
  Sponsor: Merck Sharp & Dohme LLC
  Updated Oct 17, 2025

1. 1Fatigue95723%
2. 2Headache75518%
3. 3Nausea55313%
4. 4Insomnia3087.3%
5. 5Diarrhoea2556.0%
6. 6Drug Dose Omission2536.0%
7. 7Vomiting1814.3%
8. 8Adverse Event1503.5%
9. 9Pneumonia1433.4%
10. 10Hepatitis C1373.2%
11. 11Arthralgia1333.1%
12. 12Pruritus1232.9%
13. 13Dizziness1212.9%
14. 14Pain1212.9%
15. 15Abdominal Pain1152.7%

The 10 most recently updated of 85 ClinicalTrials.gov registrations naming Elbasvir as an intervention. Registration is not evidence of efficacy or safety — reference crosswalk only.

• Study to Assess Efficacy and Safety of Grazoprevir/Elbasvir Associated With Sofosbuvir and Ribavirin in HCV Genotype 1 or 4-infected Patients Who Failed Direct Acting Antivirals (DAA) Bitherapy With Sofosbuvir
  Completed · Phase 2 · Interventional · 26 enrolled · ANRS, Emerging Infectious Diseases
  NCT02647632updated 2026-06-12
• Pembrolizumab (MK-3475) in Hepatocellular Carcinoma
  Completed · Phase 2 · Interventional · 15 enrolled · M.D. Anderson Cancer Center
  NCT02940496updated 2025-07-15
• Pilot Study Evaluate Efficacy of Grazoprevir + Elbasvir for 12 or 16 Weeks in Liver Transplant Recipients.
  Withdrawn · Phase 3 · Interventional · 0 enrolled · Fundacion Clinic per a la Recerca Biomédica
  NCT02890719updated 2025-06-22
• Zepatier in Patients with Substance Use
  Completed · Observational · 25 enrolled · University of Illinois at Chicago
  NCT04048850updated 2025-01-28
• HCV Treatment Immune Response With Grazoprevir/Elbasvir Before or After Renal Transplant
  Completed · Phase 4 · Interventional · 21 enrolled · University of Maryland, Baltimore
  NCT02902120updated 2024-04-22
• Transplanting Hepatitis C Kidneys Into Negative Kidney Recipients
  Completed · Phase 1 · Phase 2 · Interventional · 62 enrolled · University of Pennsylvania
  NCT02743897updated 2023-06-15
• Elbasvir (EBR)/Grazoprevir (GZR) in Pediatric Participants With Chronic Hepatitis C Infection (MK-5172-079)
  Completed · Phase 2 · Interventional · 57 enrolled · Merck Sharp & Dohme LLC
  NCT03379506updated 2023-05-31
• Cardiovascular Disease in HIV and Hepatitis C: Risk Outcomes After Hepatitis C Eradication
  Completed · Phase 4 · Interventional · 87 enrolled · University of Maryland, Baltimore
  NCT03823911updated 2023-05-22
• ATTIC - Access To Treat in the Community
  Terminated · Phase 4 · Interventional · 13 enrolled · King's College Hospital NHS Trust
  NCT03797066updated 2023-05-06
• Transplanting Hepatitis C Lungs Into Negative Lung Recipients
  Completed · Phase 1 · Phase 2 · Interventional · 10 enrolled · University of Pennsylvania
  NCT03724149updated 2023-04-14

Frequently asked questions

How does Elbasvir work?

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) ].

What is Elbasvir used for?

According to FDA labeling, Elbasvir carries indications including: ZEPATIER ® is indicated for the treatment of chronic hepatitis C virus (HCV) genotype 1 or 4 infection in adult and pediatric patients 12 years of age and older or weighing at least 30 kg. ZEPATIER is indicated for use with ribavirin in certain patient populations [see Dosage and Administration (2.2) ] .. This is a reference summary of labeled uses, not medical advice or a treatment recommendation.

What class of drug is Elbasvir?

Elbasvir is classified as Antivirals for treatment of HCV infections, Hepatitis C Virus NS5A Inhibitor, Breast Cancer Resistance Protein Inhibitors, Cytochrome P450 3A Inducers, Organic Anion Transporting Polypeptide 1B1 Inhibitors, Organic Anion Transporting Polypeptide 1B3 Inhibitors, P-Glycoprotein Inhibitors, Unknown Physiological Effect.

What are the brand names for Elbasvir?

Elbasvir is marketed under brand names including Zepatier.

What are the contraindications for Elbasvir?

Elbasvir labeling lists contraindications including: ZEPATIER is contraindicated in patients with moderate or severe hepatic impairment (Child-Pugh B or C) due to the expected significantly increased grazoprevir plasma concentration and the increased risk of alanine aminotransferase (ALT) elevations [see Warnings and Precautions (5.2) , Use in Specific Populations (8.9) , and Clinical Pharmacology (12.3) ] . ZEPATIER is contraindicated in patients with moderate or severe hepatic impairment (Child-Pugh B or C) or those with any history of hepatic decompensation due to the risk of hepatic decompensation [see Warnings and Precautions (5.3) , Use in Specific Populations (8.9) ] .. Always consult the full prescribing information and a clinician.