MAVYRET 100 mg/40 mg (Glecaprevir / Pibrentasvir)

Direct-Acting Antiviral — Film-Coated Tablets

Therapeutic Category: Antiviral Agent | Direct-Acting Antiviral (DAA)

Active Ingredients:

• Glecaprevir 100 mg
• Pibrentasvir 40 mg

Dosage Form: Oral film-coated tablets

Pack Size: 21 tablets per weekly carton; the standard 4-week supply contains 84 tablets in four weekly cartons.

Medical Description

Mavyret is a prescription antiviral medicine containing glecaprevir and pibrentasvir, a fixed-dose combination used to treat hepatitis C virus (HCV) infection. Hepatitis C is a viral infection that can cause inflammation of the liver and, if untreated, may lead to chronic liver disease, cirrhosis, or liver cancer.

Mavyret combines two direct-acting antiviral agents that target different proteins essential for HCV replication. This dual mechanism helps stop the virus from multiplying and can achieve a sustained virologic response, which is considered a virological cure when HCV RNA remains undetectable after treatment.

It is approved for eligible adults and children aged 3 years and older with acute or chronic HCV genotypes 1–6, without cirrhosis or with compensated cirrhosis (Child-Pugh A), according to the applicable prescribing information. Treatment selection and duration depend on previous HCV treatment, liver status, and other clinical factors.

Indications and Potential Benefits

Mavyret is indicated for the treatment of eligible patients with hepatitis C virus infection across genotypes 1–6.

Potential clinical benefits include:

• Viral clearance: Can eliminate detectable HCV RNA and achieve sustained virologic response.
• Pan-genotypic activity: Targets all six major HCV genotypes.
• Short-course treatment: Many eligible patients can complete treatment in 8 weeks, although other treatment durations may be required.
• Liver health protection: Successful eradication of HCV can reduce the risk of ongoing liver inflammation and future liver-related complications.
• Oral administration: Provides a convenient tablet-based treatment regimen.

A sustained virologic response does not provide immunity against future hepatitis C infection.

Mechanism of Action

Mavyret works by inhibiting two essential proteins involved in the hepatitis C virus life cycle:

• Glecaprevir: An HCV NS3/4A protease inhibitor that blocks the processing of viral proteins required for viral replication.
• Pibrentasvir: An HCV NS5A inhibitor that interferes with viral RNA replication and the assembly of new virus particles.

By targeting two different viral proteins simultaneously, the combination suppresses HCV replication and helps the body's immune system clear the infection.

Dosage and Administration

Usual adult dosage:

• Dose: Three tablets taken together once daily.
• Total daily dose: Glecaprevir 300 mg + pibrentasvir 120 mg.
• Administration: Take orally with food.
• Swallow tablets according to the product instructions.
• Take the medication for the full duration prescribed by the treating physician.

Important pack-size clarification: Each tablet contains glecaprevir 100 mg and pibrentasvir 40 mg. Therefore, 21 tablets provide a 7-day supply, based on three tablets daily. A standard 4-week supply contains 84 tablets.

Treatment commonly lasts 8 weeks for many eligible patients, but some patients require 12 or 16 weeks depending on their treatment history, liver condition, or transplant status. The treatment duration must be determined by the prescribing specialist.

Possible Side Effects

Common adverse effects include:

• Headache.
• Fatigue.
• Nausea.
• Diarrhea, in some patients.
• Occasionally, itching or other gastrointestinal symptoms.

Serious risks and precautions:

• Hepatitis B virus (HBV) reactivation: May cause severe liver complications in patients with current or previous HBV infection.
• Hepatic decompensation or liver failure: Rare but serious cases have been reported, particularly in patients with advanced liver disease or a history of hepatic decompensation.
• Drug interactions: Some concomitant medicines can significantly alter antiviral concentrations or increase toxicity.

Seek urgent medical care for jaundice, dark urine, unusual confusion, severe abdominal swelling, or other signs of worsening liver function.

Warnings and Precautions

• Hepatitis B screening: Patients should be tested for current or previous HBV infection before treatment.
• Liver disease: Mavyret is contraindicated in patients with moderate or severe hepatic impairment (Child-Pugh B or C) and in patients with any history of prior hepatic decompensation, according to U.S. prescribing information.
• Drug interactions: Concomitant use with rifampin or atazanavir is contraindicated. Review all prescription medicines, supplements, and herbal products before starting treatment.
• Pregnancy and breastfeeding: Discuss treatment suitability with a healthcare professional.
• Treatment adherence: Do not skip doses or stop treatment prematurely without consulting the treating physician.
• Follow-up testing: HCV RNA testing after treatment is used to determine whether a sustained virologic response has been achieved.

Treatment should be prescribed and monitored by a qualified healthcare professional experienced in managing hepatitis C.

Storage

• Store according to the manufacturer's package instructions.
• Keep tablets in their original packaging to protect them from moisture.
• Keep out of the reach and sight of children.
• Do not use after the expiry date printed on the package.

References

1. U.S. Food and Drug Administration (FDA) — .gov: Official prescribing information for Mavyret, including indications, dosing, contraindications, and safety warnings. Read FDA prescribing information.
2. DailyMed — U.S. National Library of Medicine (.gov): Official drug labeling, composition, packaging, administration, and precautions. Read DailyMed drug information.
3. Mavyret Official Healthcare Professional Website: Dosing regimens and treatment-duration information. Read dosing guidance.

Patient Disclaimer

This description is intended for educational purposes only and is not a substitute for professional medical advice, diagnosis, or treatment. Mavyret is a prescription antiviral medication that must be used under the supervision of a qualified healthcare professional. Appropriate assessment of liver function, hepatitis B status, drug interactions, and treatment response is essential. Do not start, discontinue, or modify treatment without consulting your treating physician. Always follow the approved patient leaflet supplied with your medication.