Can ZEPATIER cause hepatitis B to come back?

Yes, there is a serious risk of Hepatitis B virus reactivation in patients coinfected with HBV.

How should I take ZEPATIER?

Take one tablet orally once every day, with or without food.

What are the most common side effects of ZEPATIER?

The most common side effects include fatigue, headache, and nausea.

Is ZEPATIER safe for children?

It is approved for children 12 years and older who weigh at least 30 kg.

Can I take ZEPATIER if I have liver disease?

ZEPATIER should not be used by people with moderate or severe liver impairment.

Do I need blood tests while taking ZEPATIER?

Yes, you will need liver enzyme (ALT) testing and testing for Hepatitis B before and during treatment.

What should I do if I miss a dose of ZEPATIER?

The provided text does not specify instructions for missed doses.

elbasvir | CAS 1370468-36-2 | BVAZQCUMNICBAQ

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Direct-acting antiviral (combination therapy)

ZEPATIER is a prescription medicine used to treat chronic hepatitis C virus (HCV) infections caused by genotype 1 or 4. It is a combination tablet containing two active ingredients, elbasvir and grazoprevir, which work together to fight the virus.

How it worksZEPATIER contains two drugs that act as direct-acting antivirals. One component (elbasvir) blocks a specific protein called NS5A, while the other (grazoprevir) blocks a protein called NS3/4A, both of which the hepatitis C virus needs to multiply.

Brand names:ZEPATIER

Used for

Chronic hepatitis C virus (HCV) genotype 1 infectionChronic hepatitis C virus (HCV) genotype 4 infection

Conditions

Chronic hepatitis C virus (HCV) genotype 1Chronic hepatitis C virus (HCV) genotype 4

Class

NS5A inhibitorNS3/4A protease inhibitorDirect-acting antiviralDirect-acting antiviral (combination therapy)Hepatic

How to take

FormsOral tablet

RoutesOral

For adults and children 12 years or older (weighing at least 30 kg), the usual dose is one tablet taken once daily, either with or without food.

Specific treatment duration depends on your hepatitis C genotype and previous treatments. Some people may also need to take ribaavirin along with ZEPATIER.

Key warnings

ZEPATIER carries a boxed warning regarding the risk of Hepatitis B virus (HBV) reactivation. People with both hepatitis C and hepatitis B should be tested for HBV before starting treatment, as the drug can cause HBV to flare up, potentially leading to liver failure or death.

·ZEPATIER carries a boxed warning regarding the risk of Hepatitis B virus (HBV) reactivation. People with both hepatitis C and hepatitis B should be tested for HBV before starting treatment, as the drug can cause HBV to flare up, potentially leading to liver failure or death.
·Risk of Hepatitis B virus reactivation in people coinfected with HBV.
·Increased risk of liver enzyme (ALT) elevations.
·Risk of liver failure or decompensation, especially in people with advanced liver disease.
·Potential risks associated with using ribaavirin at the same time.

Do not use if

·People with moderate or severe liver impairment (Child-Pugh B or C).
·People with a history of liver decompensation.
·People taking certain medicines that inhibit OAATP1B1/3 transporters.

Side effects

Common

FatigueHeadacheNausea

Serious

·Hepatitis B virus (HBV) reactivation
·Increased liver enzyme (ALT) levels
·Liver failure or severe liver problems
·Anemia (when taken with ribaavirin)

Seek help if

·Signs of liver failure
·Hepatitis B reactivation symptoms

Interactions

·Avoid using ZEPATIER with certain medicines that block OAATP1B1/3 transporters.
·Moderate CYP3A inducers may make ZEPATIER less effective.
·Strong CYP3A inhibitors may increase the amount of ZEPATIER in your blood.
·Using ZEPATIER with ribaavirin requires extra caution due to ribaavirin's own side effects.
·Other interacting medications include HARVONI, TECHNIVIE, PIFELTRO, REYATAZ, TYBOST, CRESTOR, PREZISTA, PAXLOVID, EMTRIVA, and EXTINA.

FoodZEPATIER can be taken with or without food.

Special populations

PregnancyThere is no adequate human data to confirm if ZEPATIER is safe during pregnancy. Animal studies showed no developmental issues at doses similar to human doses, but caution is advised.

PediatricZEPATIER is for adults and pediatric patients 12 years of age and older who weigh at least 30 kg. Safety and effectiveness in children younger than 12 have not been established.

GeriatricHigher levels of the medicine were seen in people aged 65 and older, and they may experience higher rates of liver enzyme elevations. However, no dose change is specifically recommended for older adults.

Talk to your doctor

Monitor

·Hepatitis B virus reactivation
·ALT (liver enzyme) levels
·Signs of liver failure/decompensation

Questions to ask

·Should I be tested for Hepatitis B before starting ZEPATIER?
·How often will I need liver function blood tests?
·Are my current medications safe to take with ZEPATIER?
·Do I need to take this with ribaavirin?

Pharmacokinetics

BioavailabilityGrazoprevir oral exposures are approximately 2-fold greater in HCV-infected subjects compared to healthy subjects.

Protein bindingElbasvir and grazoprevir are highly bound to plasma protein.

MetabolismElbasvir and grazoprevir are substrates of CYP3A and P-gp.

Practical

OverdoseThere is no specific antidote for an overdose. If an overdose occurs, a person should be monitored for side effects and receive treatment for any symptoms that appear. Hemodialysis will not remove the drug from the system.

StorageStore in the original blister package at room temperature between 68°F and 77°F.

Ingredients

Allergens

lactose

Inactive

colloidal silicon dioxidecopovidonecroscarmellose sodiumhypromelloselactose monohydratemagnesium stearatemannitolmicrocrystalline cellulosesodium chloridesodium lauryl sulfatevitamin E polyethylene glycol succinatecarnauba waxferrosoferric oxideiron oxide rediron oxide yellowtitanium dioxidetriacetin

Educational summary derived from FDA labeling, AI-assisted. Not medical advice — consult a healthcare professional. Updated 2026-04-25.