Glecaprevir
Pronunciation: Unresolved from the reviewed source..
- Generic name
- glecaprevir
- Brand names
- Mavyret
- Drug class
- Direct-acting antiviral for hepatitis C
- Form
- Film-coated tablet and oral pellet, co-formulated with pibrentasvir
- Route
- Oral
- Legal status
- Unresolved from the reviewed source.
Availability and supply rules vary by country
Trade names by country:
Australia: · Full directory
What glecaprevir is and how it works
Glecaprevir is a direct-acting antiviral that is co-formulated with pibrentasvir as Mavyret. Mavyret is used to treat acute or chronic hepatitis C virus infection. (1)
The reviewed US label covers adults and children 3 years and older with hepatitis C virus genotypes 1, 2, 3, 4, 5, or 6, without cirrhosis or with compensated cirrhosis (Child-Pugh A). Treatment duration depends on genotype, previous treatment, cirrhosis status, and transplant status.
Mechanism of action: how glecaprevir works
Glecaprevir is a direct-acting antiviral for hepatitis C and is co-formulated with pibrentasvir as Mavyret. Further pharmacology details were not established from the reviewed notes. (1)
What glecaprevir is used for
Acute or chronic hepatitis C
Mavyret (glecaprevir/pibrentasvir) is indicated in the reviewed US label for adults and pediatric patients 3 years and older with acute or chronic hepatitis C virus genotype 1, 2, 3, 4, 5, or 6 infection without cirrhosis or with compensated cirrhosis (Child-Pugh A). (1)
Before taking glecaprevir
Do not take / not appropriate for
- Do not use Mavyret in moderate or severe hepatic impairment (Child-Pugh B or C), or with any history of prior hepatic decompensation. (US reviewed label) (1)
- Do not use Mavyret with atazanavir. (US reviewed label) (1)
- Do not use Mavyret with rifampin. (US reviewed label) (1)
Tell your clinician about
- Any current or previous hepatitis B infection. Hepatitis B surface antigen (HBsAg) and hepatitis B core antibody (anti-HBc) testing is required before treatment.
- Any cirrhosis, advanced liver disease, previous hepatic decompensation, jaundice, ascites, encephalopathy, or variceal hemorrhage.
- Every prescription medicine, non-prescription medicine, supplement, and herbal product, particularly atazanavir, rifampin, carbamazepine, efavirenz, St. John's wort, ethinyl estradiol-containing products, statins, digoxin, dabigatran, or warfarin.
- Diabetes, because blood-glucose monitoring may be needed as hepatitis C clears.
- Pregnancy, plans for pregnancy, or breastfeeding.
How to take glecaprevir
- Mavyret contains glecaprevir and pibrentasvir and is taken orally with food.
- For adults, the reviewed US label specifies three tablets taken together once daily with food, providing glecaprevir 300 mg and pibrentasvir 120 mg daily.
- Each tablet contains glecaprevir 100 mg and pibrentasvir 40 mg.
- Treatment duration and the pediatric dose depend on individual clinical factors. Follow the prescription and instructions from the treating clinician.
- Do not change the prescribed number of tablets or packets, treatment duration, or administration plan without advice from the prescriber.
Procedures and treatment changes
Tell the treating team before surgery, procedures, or any medicine change. Do not alter treatment without the responsible clinician. (1)
Missed dose
Missed-dose instructions were not identified in the reviewed source. Contact the prescribing clinician or pharmacist for instructions rather than altering the dosing schedule yourself.
Overdose
A specific overdose-management protocol was not identified in the reviewed source. If more than the prescribed amount may have been taken, contact a poison-information service or seek urgent medical advice.
Side effects
In the reviewed clinical data, the most common adverse reactions overall were headache, fatigue, and nausea. Serious adverse reactions and treatment discontinuation occurred in less than 1% overall.
Headache
What to notice: Headache occurred in 13% overall. In a genotype 3 trial with 8 weeks of treatment, headache occurred in 16%.
What to do: Discuss persistent or troublesome symptoms with the prescribing team. (1)
Fatigue
What to notice: Fatigue occurred in 11% overall. In the severe renal impairment population, fatigue occurred in 12%.
What to do: Discuss persistent or troublesome symptoms with the prescribing team. (1)
Nausea or diarrhea
What to notice: Nausea occurred in 8% overall. Diarrhea was reported in specific trials, including 5% in a genotype 2 trial and 7% in a genotype 3 trial.
What to do: Discuss persistent or troublesome symptoms with the prescribing team. (1)
Pruritus
What to notice: In the severe renal impairment population, pruritus occurred in 17%.
What to do: Discuss persistent or troublesome symptoms with the prescribing team. (1)
Vomiting, fatigue, or headache in children under 12 years
What to notice: In the DORA-Part 2 pediatric study, vomiting, fatigue, and headache each occurred in 8%.
What to do: Tell the prescribing team about persistent, severe, or concerning symptoms. (1)
Possible hepatic decompensation
What to notice: Jaundice, ascites, encephalopathy, or variceal hemorrhage.
What to do: Seek prompt medical assessment. (1)
Rash
What to notice: A new or worsening rash, particularly if severe. One pediatric-trial participant had Grade 3 rash that required treatment discontinuation.
What to do: Contact the prescribing team promptly for assessment. (1)
Serious warnings
Hepatitis B virus reactivation — serious
Symptoms: The reviewed source requires monitoring for hepatitis B virus reactivation during and after treatment. Report new or concerning symptoms to the treatment team.
Action: Testing for current or prior hepatitis B infection with HBsAg and anti-HBc is required before treatment. The clinician should monitor for hepatitis B virus reactivation during and after treatment. (1)
Hepatic decompensation or hepatic failure — emergency
Symptoms: Jaundice, ascites, encephalopathy, or variceal hemorrhage can be signs of hepatic decompensation.
Action: Seek urgent medical assessment for these symptoms. Hepatic decompensation and hepatic failure, including fatal outcomes, have been reported, primarily in people with Child-Pugh B or C impairment or a history of hepatic decompensation. (1)
Interactions
| Medicine or test | Effect | Action |
|---|---|---|
| Atazanavir | Atazanavir significantly increases glecaprevir/pibrentasvir exposure, with approximately 4- to 6.5-fold increases in area under the curve. | This combination is contraindicated. The prescriber must select an appropriate regimen. (1) |
| Rifampin | Rifampin significantly decreases glecaprevir exposure, with an approximately 88% decrease in area under the curve. | This combination is contraindicated. The prescriber must select an appropriate regimen. (1) |
| Carbamazepine, efavirenz, and St. John's wort | These enzyme inducers can decrease glecaprevir/pibrentasvir concentrations and may reduce therapeutic effect. Carbamazepine decreases exposure by approximately 66%. | Concomitant use is not recommended. Ask the prescriber or pharmacist to review alternatives. (1) |
| Ethinyl estradiol-containing products | Glecaprevir/pibrentasvir increases ethinyl estradiol exposure by approximately 1.28- to 1.40-fold. Available data support ethinyl estradiol doses of 20 mcg or less; doses above 20 mcg increase the risk of ALT elevation. | Provide the exact product and ethinyl estradiol dose to the prescriber or pharmacist for review. (1) |
| Statins | Glecaprevir/pibrentasvir can substantially increase statin exposure, including approximately 8.28-fold for atorvastatin and 2.15-fold for rosuvastatin. | Statin dose reduction or restriction is required during co-administration; this must be managed by the prescribing clinician. (1) |
| Digoxin | Digoxin exposure is increased by approximately 1.48-fold. | The reviewed label recommends an approximately 50% digoxin dose reduction; the clinician managing digoxin must determine the individual plan. (1) |
| Dabigatran | Dabigatran exposure is increased by approximately 2.38-fold. | The clinician and pharmacist should use dabigatran product labeling for P-glycoprotein-inhibitor dosing guidance. (1) |
Pregnancy, breastfeeding, kidney/liver function, age
Children and adolescents
The reviewed US label covers children 3 years and older. Dosing is weight-based for children weighing less than 45 kg, using oral pellets. Patients weighing 45 kg or more, or aged 12 years or older, receive standard adult dosing under the reviewed label. (1)
Pregnancy and breastfeeding
There are no adequate human pregnancy data in the reviewed source. It is not known whether glecaprevir or pibrentasvir are excreted in human breast milk. Discuss pregnancy and breastfeeding with the treating clinician. (1)
Renal impairment and dialysis
No Mavyret dosage adjustment is required in mild, moderate, or severe renal impairment, including in people receiving dialysis, according to the reviewed US label. (1)
Hepatic impairment
No dosage adjustment is required for mild hepatic impairment (Child-Pugh A). Mavyret is contraindicated in moderate or severe hepatic impairment (Child-Pugh B or C) and in people with any prior hepatic decompensation. (1)
Monitoring
Before starting
- Test for current or prior hepatitis B virus infection using HBsAg and anti-HBc.
- Assess hepatic impairment, cirrhosis status, and any history of hepatic decompensation.
- Review all medicines and relevant products for interactions, including atazanavir, rifampin, carbamazepine, efavirenz, St. John's wort, ethinyl estradiol-containing products, statins, digoxin, dabigatran, and warfarin.
During treatment
- Monitor for hepatitis B virus reactivation during and after treatment.
- Monitor hepatic function in people with compensated cirrhosis (Child-Pugh A) or advanced liver disease.
- Monitor for jaundice, ascites, encephalopathy, and variceal hemorrhage as possible signs of hepatic decompensation.
- Monitor INR in people taking warfarin and blood glucose in people with diabetes, because hepatic function changes as hepatitis C clears can affect these measures.
Storage
Specific storage instructions were not reviewed and remain unresolved. Use the current dispensing packaging and pharmacist instructions.
Professional information
Clinician-facing context only. Use the current local product information, patient-specific hepatitis C assessment, interaction review, and monitoring plan.
United States
Indication: Acute or chronic hepatitis C virus genotype 1, 2, 3, 4, 5, or 6 infection in adults and pediatric patients 3 years and older without cirrhosis or with compensated cirrhosis (Child-Pugh A)
Dose summary: Adults: three tablets together once daily with food, totaling glecaprevir 300 mg/pibrentasvir 120 mg daily. Treatment-naive or peginterferon/ribavirin/sofosbuvir-experienced patients, all genotypes 1-6, without cirrhosis or with compensated cirrhosis: 8 weeks. Genotype 1 patients previously exposed to an NS5A inhibitor without an NS3/4A protease inhibitor: 16 weeks; previously exposed to an NS3/4A protease inhibitor without an NS5A inhibitor: 12 weeks. Genotype 3 patients previously exposed to peginterferon/ribavirin/sofosbuvir: 16 weeks. Transplant recipients: 12 weeks, except 16 weeks for NS5A-inhibitor-experienced genotype 1 or peginterferon/ribavirin/sofosbuvir-experienced genotype 3. Pediatric patients weighing less than 45 kg use pellets: less than 20 kg, 150 mg/60 mg daily (3 packets); 20 to less than 30 kg, 200 mg/80 mg daily (4 packets); 30 to less than 45 kg, 250 mg/100 mg daily (5 packets). Patients weighing 45 kg or more, or aged 12 years or older, receive standard adult dosing.
Renal context: No dosage adjustment is required for mild, moderate, or severe renal impairment, including dialysis. (1)
Other regions
Dose summary: Not established from the sources reviewed: do not extrapolate US dosing or indications to other regions without the applicable local product information.
Hepatic guidance
No dosage adjustment is required for Child-Pugh A impairment. Mavyret is contraindicated in Child-Pugh B or C impairment and in patients with a history of prior hepatic decompensation.
Overdose note
A specific overdose-management protocol was not identified in the reviewed source. (1)
Frequently asked questions
Is glecaprevir available by itself?
No. The reviewed notes state that glecaprevir is always co-formulated and co-marketed with pibrentasvir as Mavyret. (1)
Why do I need hepatitis B testing before Mavyret?
Hepatitis B virus reactivation has been reported in people coinfected with hepatitis C and hepatitis B who received hepatitis C direct-acting antivirals without hepatitis B antiviral therapy. The reviewed label requires HBsAg and anti-HBc testing before treatment and monitoring during and after treatment. (1)
Can Mavyret be used in kidney impairment or during dialysis?
According to the reviewed US label, no dosage adjustment is required for mild, moderate, or severe renal impairment, including dialysis. (1)
What is the mechanism of action of glecaprevir?
Glecaprevir is a direct-acting antiviral for hepatitis C and is co-formulated with pibrentasvir as Mavyret. Further pharmacology details were not established from the reviewed notes. (1)
What is the generic name of Glecaprevir?
The generic name is glecaprevir. It is sold under brand names including Mavyret. (1)
What class of drug is glecaprevir?
Glecaprevir is classed as: Direct-acting antiviral for hepatitis C. (1)
References
- MAVYRET- glecaprevir and pibrentasvir tablet, film coated / MAVYRET- glecaprevir and pibrentasvir pelletU.S. Food and Drug Administration (DailyMed) · United States · dated 2026 · accessed 2026-08-05 · source 1
- Mavyret — FDA approval record (Drugs@FDA NDA215110)U.S. Food and Drug Administration · US · accessed 2026-08-14 · source 2
- glecaprevir — RxNorm normalized drug concept (RXCUI 1940635)U.S. National Library of Medicine (RxNorm) · US · accessed 2026-08-14 · source 3
Brand names by country
Single-ingredient glecaprevir names are shown separately by country. Product availability, strengths, and supply rules can change; combination products are not included here.