Elbasvir/Grazoprevir — Membership Pricing

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What Elbasvir/Grazoprevir is approved for (FDA label)

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) ] . ZEPATIER is a fixed-dose combination product containing elbasvir, a hepatitis C virus (HCV) NS5A inhibitor, and grazoprevir, an HCV NS3/4A protease inhibitor, and is indicated for treatment of chronic 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. ( 1 )

Source: Read the full FDA label on DailyMed. Label effective date: March 13, 2026.

Excerpt from the FDA-approved prescribing information. This is not medical advice; talk to your doctor or pharmacist.

Boxed warning for Elbasvir/Grazoprevir (FDA label)

WARNING: RISK OF HEPATITIS B VIRUS REACTIVATION IN PATIENTS COINFECTED WITH HCV AND HBV Test all patients for evidence of current or prior hepatitis B virus (HBV) infection before initiating treatment with ZEPATIER. HBV reactivation has been reported in HCV/HBV coinfected patients who were undergoing or had completed treatment with HCV direct acting antivirals and were not receiving HBV antiviral therapy. Some cases have resulted in fulminant hepatitis, hepatic failure, and death. Monitor HCV/HBV coinfected patients for hepatitis flare or HBV reactivation during HCV treatment and post-treatment follow-up. Initiate appropriate patient management for HBV infection as clinically indicated [see Warnings and Precautions (5.1) ]. WARNING: RISK OF HEPATITIS B VIRUS REACTIVATION IN PATIENTS COINFECTED WITH HCV AND HBV See full prescribing information for complete boxed warning. Hepatitis B virus (HBV) reactivation has been reported, in some cases resulting in fulminant hepatitis, hepatic failure, and death. ( 5.1 )

Source: FDA prescribing information (DailyMed). Set ID: 164dc02a-9180-426a-b8b5-04ab39d2bbd4. SPL document ID: 227ae348-5f6f-44d8-a6dc-103e63d28102. Label effective date: March 13, 2026. Read the full label.

Excerpt from the FDA-approved prescribing information. This is not medical advice; talk to your doctor or pharmacist.

Dosage forms and strengths for Elbasvir/Grazoprevir (FDA label)

ZEPATIER is available as a beige-colored, oval-shaped, film-coated tablet debossed with "770" on one side and plain on the other. Each tablet contains 50 mg elbasvir and 100 mg grazoprevir. Tablets: 50 mg elbasvir and 100 mg grazoprevir ( 3 )

Source: FDA prescribing information (DailyMed). Set ID: 164dc02a-9180-426a-b8b5-04ab39d2bbd4. SPL document ID: 227ae348-5f6f-44d8-a6dc-103e63d28102. Label effective date: March 13, 2026. Read the full label.

Excerpt from the FDA-approved prescribing information. This is not medical advice; talk to your doctor or pharmacist.

Adverse reactions for Elbasvir/Grazoprevir (FDA label)

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.

Source: FDA prescribing information (DailyMed). Set ID: 164dc02a-9180-426a-b8b5-04ab39d2bbd4. SPL document ID: 227ae348-5f6f-44d8-a6dc-103e63d28102. Label effective date: March 13, 2026. Read the full label.

Excerpt from the FDA-approved prescribing information. This is not medical advice; talk to your doctor or pharmacist.

Contraindications for Elbasvir/Grazoprevir (FDA label)

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) ] . ZEPATIER is contraindicated with inhibitors of organic anion transporting polypeptides 1B1/3 (OATP1B1/3) that are known or expected to significantly increase grazoprevir plasma concentrations, 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, the contraindications to ribavirin also apply to this combination regimen.

Source: FDA prescribing information (DailyMed). Set ID: 164dc02a-9180-426a-b8b5-04ab39d2bbd4. SPL document ID: 227ae348-5f6f-44d8-a6dc-103e63d28102. Label effective date: March 13, 2026. Read the full label.

Excerpt from the FDA-approved prescribing information. This is not medical advice; talk to your doctor or pharmacist.

Warnings and precautions for Elbasvir/Grazoprevir (FDA label)

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.

Source: FDA prescribing information (DailyMed). Set ID: 164dc02a-9180-426a-b8b5-04ab39d2bbd4. SPL document ID: 227ae348-5f6f-44d8-a6dc-103e63d28102. Label effective date: March 13, 2026. Read the full label.

Excerpt from the FDA-approved prescribing information. This is not medical advice; talk to your doctor or pharmacist.

Drug interactions for Elbasvir/Grazoprevir (FDA label)

Co-administration of ZEPATIER with moderate CYP3A inducers is not recommended as they may decrease the plasma concentration of ZEPATIER. ( 7 ) Co-administration of ZEPATIER with certain strong CYP3A inhibitors is not recommended as they may increase the plasma concentration of ZEPATIER. ( 7 ) Clearance of HCV infection with direct-acting antivirals may lead to changes in hepatic function, which may impact safe and effective use of concomitant medications. Frequent monitoring of relevant laboratory parameters (INR or blood glucose) and dose adjustments of certain concomitant medications may be necessary. ( 7.2 ) Consult the full prescribing information prior to and during treatment for potential drug interactions. ( 4 , 5.5 , 7 , 12.3 ) 7.1 Potential for Drug Interactions Grazoprevir is a substrate of OATP1B1/3 transporters.

Source: FDA prescribing information (DailyMed). Set ID: 164dc02a-9180-426a-b8b5-04ab39d2bbd4. SPL document ID: 227ae348-5f6f-44d8-a6dc-103e63d28102. Label effective date: March 13, 2026. Read the full label.

Excerpt from the FDA-approved prescribing information. This is not medical advice; talk to your doctor or pharmacist.