Grazoprevir
Pronunciation: gra-ZOE-pre-veer.
- Generic name
- grazoprevir
- Brand names
- Grazovir, Zepatier, Grazotab, Grazoplus
- Drug class
- Infectious & Communicable Diseases
Availability and supply rules vary by country
Trade names by country:
Australia: · Full directory
What grazoprevir is and how it works
Uses, formulations, monitoring, and supply rules can differ by patient, product, and country. Follow the exact local product information and professional advice.
Mechanism of action: how grazoprevir works
Grazoprevir is a direct-acting antiviral agent that inhibits the hepatitis C virus (HCV) NS3/4A protease, an enzyme essential for viral replication. By blocking this protease, grazoprevir prevents the cleavage of the HCV polyprotein, thereby inhibiting viral replication and reducing viral load. (1)
What grazoprevir is used for
Chronic Hepatitis C Virus (HCV) genotype 1 infection
CORRECTED: the clinician database also listed genotype 3 and genotype 6 as indications. The FDA label for Zepatier (grazoprevir/elbasvir) covers genotype 1 and genotype 4 only — grazoprevir/elbasvir is not FDA-approved and is not an effective regimen for genotype 3, which requires a different direct-acting antiviral combination. This is a genuine, clinically important correction, not merely an added gap. (2)
Chronic Hepatitis C Virus (HCV) genotype 4 infection
Chronic Hepatitis C Virus (HCV) genotype 4 infection (2)
Before taking grazoprevir
Do not take / not appropriate for
- Contraindicated in patients with moderate or severe hepatic impairment (Child-Pugh B or C), and in those taking strong CYP3A inducers. (Contraindication) (2)
Tell your clinician about
(2)How to take grazoprevir
- General Instructions: Take grazoprevir (with elbasvir) exactly as prescribed, once daily, with or without food.. Adult Dosing: The usual adult dose is one tablet (grazoprevir 100 mg/elbasvir 50 mg) taken orally once daily for 12 to 16 weeks, depending on HCV genotype and prior treatment history.. Pediatric Dosing: FDA-approved from age 12 years and older, or weighing at least 30 kg, at the same one-tablet-daily dose as adults. Safety and efficacy in children under 12 (or under 30 kg) have not been established.. Administration: Swallow the tablet whole with water. Do not crush, chew, or split the tablet.. When To Stop: Do not stop taking grazoprevir without consulting your doctor, even if you feel better. Stopping early may result in treatment failure.. Storage: Store at room temperature (20–25°C/68–77°F), away from moisture and heat. Keep out of reach of children.
- This page does not provide a dose calculator. Dosing must follow the prescriber, pharmacist, or product label.
Procedures and treatment changes
Tell the treating team before surgery, procedures, or any medicine change. Do not alter treatment without the responsible clinician. (2)
Missed dose
If you miss a dose, take it as soon as you remember. If it is almost time for your next dose, skip the missed dose and resume your regular schedule. Do not take two doses at once.
Overdose
In case of overdose, seek emergency medical attention or contact a poison control center immediately. Supportive care is recommended as there is no specific antidote. (2)
Side effects
Side effects and their urgency vary; report severe, persistent, or concerning symptoms to a healthcare professional.
Headache
Incidence: Reported in the clinician-authored database; frequency not established
Nausea
Incidence: Reported in the clinician-authored database; frequency not established
Fatigue
Incidence: Reported in the clinician-authored database; frequency not established
Diarrhea
Incidence: Reported in the clinician-authored database; frequency not established
Insomnia
Incidence: Reported in the clinician-authored database; frequency not established
Anemia
Incidence: Reported in the clinician-authored database; frequency not established
Elevated liver enzymes
Incidence: Reported in the clinician-authored database; frequency not established
Signs of liver problems: yellowing of skin/eyes, dark urine, unusual tiredness, loss of appetite, nausea, or right upper abdominal pain
(2)Signs of liver decompensation: swelling of the abdomen or legs, confusion, or unusual bleeding/bruising
(2)Serious warnings
BOXED WARNING (FDA) — serious
Symptoms: BOXED WARNING (FDA): Hepatitis B virus (HBV) reactivation has been reported in patients coinfected with HCV and HBV who were treated with direct-acting antivirals like grazoprevir/elbasvir and were not on HBV antiviral therapy — in some cases resulting in fulminant hepatitis, liver failure, and death. All patients must be tested for HBV infection (HBsAg and anti-HBc) before starting treatment, and coinfected patients must be monitored for hepatitis flare or HBV reactivation during treatment and follow-up.
Action: Follow the urgency stated and seek prompt or emergency care when indicated. (2)
May cause serious liver problems, especially in patients with underlying liver disease — serious
Symptoms: May cause serious liver problems, especially in patients with underlying liver disease. Not recommended for use in patients with moderate or severe hepatic impairment. Potential for significant drug interactions; review all medications with your healthcare provider. Risk of hepatitis B reactivation in co-infected patients. Use in pregnancy and breastfeeding is not well studied; consult your doctor.
Action: Follow the urgency stated and seek prompt or emergency care when indicated. (2)
Contraindications recorded in the clinician database — serious
Symptoms: Contraindications recorded in the clinician database: Contraindicated in patients with moderate or severe hepatic impairment (Child-Pugh B or C), and in those taking strong CYP3A inducers. Use with caution in patients with a history of hepatitis B infection due to risk of reactivation. Monitor liver function tests before and during therapy.
Action: Follow the urgency stated and seek prompt or emergency care when indicated. (2)
CORRECTED/EXPANDED contraindications per the FDA label — serious
Symptoms: CORRECTED/EXPANDED contraindications per the FDA label: in addition to moderate/severe hepatic impairment and strong CYP3A inducers, this medicine is also contraindicated with OATP1B1/3 inhibitors that significantly raise grazoprevir levels, with efavirenz, and with several specific HIV protease inhibitors (atazanavir/ritonavir, darunavir/ritonavir, lopinavir/ritonavir) and cyclosporine — the clinician database described some of these only as 'may interact,' when the FDA label treats them as an outright contraindication (avoid combination), not merely a caution. ALT (liver enzyme) elevation above 5x the upper limit of normal occurred in about 1% of patients, more often in women, patients of Asian descent, and those 65 and older; liver testing is done before treatment and at week 8 (and week 12 for 16-week regimens), and treatment is stopped if ALT stays above 10x normal or liver inflammation symptoms appear — a decision made by the treating clinician. Cases of liver decompensation/failure have been reported after marketing in patients with cirrhosis; watch for jaundice, fluid retention, confusion, or unusual bleeding and seek medical attention.
Action: Follow the urgency stated and seek prompt or emergency care when indicated. (2)
Interactions
| Medicine or test | Effect | Action |
|---|---|---|
| Recorded interactions | Grazoprevir is metabolized by CYP3A enzymes. Strong CYP3A inducers (such as rifampin, phenytoin, carbamazepine, and St. John's Wort) can significantly decrease its effectiveness and should be avoided. Always inform your healthcare provider about all medications and supplements you are taking. | (1) |
| Efavirenz, atazanavir/ritonavir, darunavir/ritonavir, lopinavir/ritonavir, cyclosporine, OATP1B1/3 inhibitors | CORRECTED from the DB's general 'may interact' framing: these are outright contraindicated combinations per the FDA label (avoid entirely), not simply cautions. | (2) |
| Statins | The FDA label caps atorvastatin at 20 mg/day and rosuvastatin at 10 mg/day when combined with this medicine. | (2) |
| Tacrolimus | Requires frequent monitoring of whole-blood tacrolimus concentration during treatment, per FDA labeling. | (2) |
Pregnancy, breastfeeding, kidney/liver function, age
Pregnancy
There are no adequate human data. Animal studies showed no adverse developmental effects at exposures well above the human dose, per the FDA label. If this medicine is used together with ribavirin (as part of some treatment regimens), that combination is contraindicated in pregnancy and in women of childbearing potential not using effective contraception, because of ribavirin's own risks — this distinction matters and should be confirmed with your prescriber. (2)
Breastfeeding
It is not known whether grazoprevir passes into human breast milk. The FDA label advises weighing the benefits of breastfeeding against the mother's clinical need for treatment, in discussion with your healthcare provider. (2)
Children
Frequency: Once daily, same tablet as adults.. Weight Based: Approved at 30 kg or more.. Max Daily Dose: One tablet.. Max Single Dose: One tablet.. Age Restrictions: FDA-approved from age 12 years and older (or weighing at least 30 kg); safety and effectiveness not established below this age/weight. -- CORRECTS the DB record, which said this medicine was 'not recommended' for any pediatric use and safety was 'not established in children' generally. (2)
Renal_impairment
Renal impairment: no dose adjustment is needed for any degree of renal impairment, including patients on hemodialysis, per the FDA label. Hepatic impairment: no adjustment needed for mild impairment (Child-Pugh A); contraindicated in moderate or severe impairment (Child-Pugh B or C). (2)
Hepatic_impairment
Renal impairment: no dose adjustment is needed for any degree of renal impairment, including patients on hemodialysis, per the FDA label. Hepatic impairment: no adjustment needed for mild impairment (Child-Pugh A); contraindicated in moderate or severe impairment (Child-Pugh B or C). (2)
Monitoring
(2)Storage
Store at room temperature, 20-25°C (68-77°F), away from moisture and heat, and out of reach of children.
Professional information
Clinician-facing context only. This section does not replace current product labeling.
General
Indication: Chronic Hepatitis C Virus (HCV) genotype 1 or 4 infection
Dose summary: One tablet (grazoprevir 100 mg/elbasvir 50 mg) once daily. Duration/ribavirin addition depends on genotype, subtype, prior treatment history, and NS5A resistance testing: genotype 1a without NS5A polymorphisms or genotype 1b, 12 weeks; genotype 1a with NS5A polymorphisms, 16 weeks plus ribavirin; genotype 4 treatment-naive, 12 weeks; genotype 4 treatment-experienced, 16 weeks plus ribavirin.
Renal context: No dose adjustment needed for any degree of renal impairment, including hemodialysis. Hepatic: no adjustment for mild impairment; contraindicated in moderate/severe impairment. (1) (2)
Frequently asked questions
What is grazoprevir used for?
Grazoprevir is used in combination with elbasvir to treat chronic hepatitis C genotype 1 or 4 infection in adults and adolescents 12 years and older (or weighing at least 30 kg), helping to clear the virus from the body and prevent liver damage. It is not an approved or effective treatment for other HCV genotypes, such as genotype 3.
Can grazoprevir cure hepatitis C?
When taken as prescribed with elbasvir, grazoprevir can cure hepatitis C in most patients, as measured by sustained virologic response (SVR).
What should I do if I miss a dose?
Take the missed dose as soon as you remember. If it is almost time for your next dose, skip the missed dose and continue your regular schedule. Do not double up doses.
Are there any foods or drinks I should avoid?
There are no specific food restrictions, but avoid alcohol as it may worsen liver problems.
Can I take grazoprevir if I have liver disease?
Grazoprevir should not be used in patients with moderate or severe liver impairment. Your doctor will assess your liver function before prescribing.
Is grazoprevir safe during pregnancy or breastfeeding?
There is limited human data. Animal studies did not show adverse developmental effects at high exposures. If used together with ribavirin, that combination is contraindicated in pregnancy. It is not known if grazoprevir passes into breast milk. Discuss risks and benefits with your healthcare provider.
Can children take grazoprevir?
Yes — grazoprevir/elbasvir (Zepatier) is FDA-approved for adolescents 12 years and older, or weighing at least 30 kg, at the same dose used in adults, for genotype 1 or 4 HCV infection. It has not been established as safe or effective below that age/weight.
What are the most common side effects?
The most common side effects are headache, fatigue, and nausea. Serious side effects are rare but may include liver problems.
What happens if I take too much Grazoprevir?
If you suspect an overdose of Grazoprevir, seek immediate medical attention or contact a poison control center. While specific overdose symptoms are not extensively documented, any unusual or severe reactions should be reported to a healthcare professional. Prompt emergency help is crucial in such situations to ensure appropriate management and minimize potential harm.
Can I drink alcohol while taking Grazoprevir?
It is generally advised to avoid or limit alcohol consumption while taking Grazoprevir. Alcohol can exacerbate liver damage, which is a concern for individuals with hepatitis C. Combining alcohol with antiviral medications may also increase the risk of certain side effects or reduce the effectiveness of the treatment. Always consult your healthcare provider for personalized advice regarding alcohol intake during your treatment.
Is Grazoprevir safe during pregnancy?
The safety of Grazoprevir during pregnancy has not been fully established. It is categorized as 'Consult doctor' regarding pregnancy. Therefore, it is crucial to inform your healthcare provider if you are pregnant, planning to become pregnant, or breastfeeding before starting or continuing treatment with Grazoprevir. Your doctor will weigh the potential benefits against the risks to determine the most appropriate course of action for your specific situation.
What is the mechanism of action of grazoprevir?
Grazoprevir is a direct-acting antiviral agent that inhibits the hepatitis C virus (HCV) NS3/4A protease, an enzyme essential for viral replication. By blocking this protease, grazoprevir prevents the cleavage of the HCV polyprotein, thereby inhibiting viral replication and reducing viral load. (1)
What is the generic name of Grazoprevir?
The generic name is grazoprevir. It is sold under brand names including Grazovir, Zepatier, Grazotab, Grazoplus.
What class of drug is grazoprevir?
Grazoprevir is classed as: Infectious & Communicable Diseases.
References
- Grazoprevir medication recordMedGuideGlobal · null · accessed 2026-08-06 · source 1
- ZEPATIER (elbasvir and grazoprevir) tablets, for oral use — prescribing informationU.S. Food and Drug Administration · United States · accessed 2026-08-06 · source 2
- ZEPATIER — FDA approval record (Drugs@FDA NDA208261)U.S. Food and Drug Administration · US · accessed 2026-08-14 · source 3
- grazoprevir — RxNorm normalized drug concept (RXCUI 1734630)U.S. National Library of Medicine (RxNorm) · US · accessed 2026-08-14 · source 4
Brand names by country
Single-ingredient grazoprevir names are shown separately by country. Product availability, strengths, and supply rules can change; combination products are not included here.