Mavixen Tablet

Introduction

Glecaprevir and Pibrentasvir are used in combination as an antiviral medication for the treatment of chronic hepatitis C virus (HCV) infection. This combination is known as Mavyret.

Uses

This combination is used for:

Treatment of Chronic Hepatitis C: It is effective for treating genotypes 1-6 of chronic HCV infection.
HCV Cure: The goal of treatment is to achieve a sustained virologic response (SVR), indicating that the virus is undetectable in the blood after completion of therapy.

Brand Name	Mavixen
Type	Tablet
Weight	100 mg+40 mg
Generic	Glecaprevir + Pibrentasvir
Manufacturer	Everest Pharmaceuticals Ltd.
Available in	English বাংলা

Mechanism of Action

The mechanism of action involves:

Glecaprevir: A protease inhibitor that blocks the NS3/4A protease enzyme, which is essential for the replication of the HCV virus.
Pibrentasvir: An NS5A inhibitor that interferes with the HCV NS5A protein, which is crucial for viral replication and assembly.

How Long Does It Take to Work?

Improvement in HCV infection markers can be observed:

Sustained Virologic Response (SVR): Typically assessed 12 weeks after the completion of therapy. Most patients achieve SVR by this time.
Early Response: Initial reductions in HCV RNA levels can be observed within the first few weeks of treatment.

Absorption

Absorption details are:

Glecaprevir: Rapidly absorbed, with peak plasma concentrations occurring within 4-6 hours of administration.
Pibrentasvir: Also rapidly absorbed, with peak plasma concentrations occurring within 4-5 hours of administration.

Route of Elimination

The routes of elimination are:

Glecaprevir: Metabolized primarily by the liver, with minimal excretion in the urine.
Pibrentasvir: Metabolized primarily in the liver and excreted in the feces.

Dosage

Testing Prior to the Initiation of Therapy: Test all patients for HBV infection by measuring HBsAg and anti-HBc.

Recommended dosage: Three tablets (total daily dose: glecaprevir 300 mg and pibrentasvir 120 mg) taken orally once daily with food.

See recommended treatment duration in tables below-

Treatment-Naïve Patients: HCV Genotype 1, 2, 3, 4, 5, or 6

No Cirrhosis: 8 weeks
Compensated Cirrhosis (Child-Pugh A): 12 weeks

Treatment-Experienced Patients: HCV Genotype 1

Patients Previously Treated With a Regimen Containing: An NS5A inhibitor without prior treatment with an NS3/4A protease inhibitor
No Cirrhosis: 16 weeks
Compensated Cirrhosis (Child-Pugh A): 16 weeks

Treatment-Experienced Patients: HCV Genotype 1

Patients Previously Treated With a Regimen Containing: An NS3/4A PI without prior treatment with an NS5A inhibitor
No Cirrhosis: 12 weeks
Compensated Cirrhosis (Child-Pugh A): 12 weeks

Treatment-Experienced Patients: HCV Genotype 1, 2, 4, 5 or 6

Patients Previously Treated With a Regimen Containing: PRS
No Cirrhosis: 8 weeks
Compensated Cirrhosis (Child-Pugh A): 12 weeks

Treatment-Experienced Patients: HCV Genotype 3

Patients Previously Treated With a Regimen Containing: PRS
No Cirrhosis: 16 weeks
Compensated Cirrhosis (Child-Pugh A): 16 weeks

The typical dosage regimen is:

Mavixen Tablet 100 mg+40 mg: One tablet (300 mg Glecaprevir/120 mg Pibrentasvir) taken orally once daily with food.

Administration

Administration guidelines include:

Take with Food: To enhance absorption and efficacy.
Regular Dosing: Adhere to the prescribed daily schedule, usually for 8, 12, or 16 weeks depending on the HCV genotype and treatment history.

Side Effects

Possible side effects include:

Common Side Effects: Headache, fatigue, nausea, and diarrhea.
Serious Side Effects: Liver enzyme abnormalities and potential risk of reactivation of hepatitis B in susceptible individuals.

Toxicity

Toxicity risks include:

Hepatotoxicity: Monitoring liver function is important, especially in patients with pre-existing liver conditions.
Drug Interactions: Can be affected by drugs that induce or inhibit CYP3A4 and P-glycoprotein.

Precautions

Precautions include:

Liver Disease: Use with caution in patients with severe liver impairment.
Drug Interactions: Evaluate potential drug interactions with other medications the patient is taking.

Interaction

Drug interactions include:

CYP3A4 Inducers/Inhibitors: Drugs that affect CYP3A4 activity can alter the effectiveness of Glecaprevir and Pibrentasvir.
P-glycoprotein Substrates/Inhibitors: May interact with medications that affect P-glycoprotein.

Disease Interaction

Disease interactions include:

Chronic Liver Disease: Regular monitoring is necessary for patients with pre-existing liver conditions.
Hepatitis B: Screen for hepatitis B virus before starting treatment as reactivation can occur.

Drug Interaction

Drug interactions include:

Antiretrovirals: Can interact with HIV medications and may require dose adjustments.
Antifungals: Azole antifungals may affect the metabolism of this combination.

Food Interactions

Food interactions:

Administration with Food: Enhances absorption; should be taken with a meal.

Pregnancy Use

Pregnancy use recommendations:

Category: Use during pregnancy only if clearly needed and the benefits outweigh the risks.
Consult Healthcare Provider: To evaluate the potential risks and benefits of use during pregnancy.

Lactation Use

Lactation use recommendations:

Excretion in Breast Milk: Minimal data available; use with caution and consult healthcare provider.
Risk to Infant: Assess potential risks versus benefits before use in breastfeeding mothers.

Acute Overdose

Acute overdose management includes:

Seek Medical Attention: Immediate medical evaluation is necessary. Overdose may cause exacerbation of side effects.
Treatment: Supportive care and symptomatic treatment.

Contraindication

Contraindications include:

Hypersensitivity: Contraindicated in patients with known hypersensitivity to Glecaprevir, Pibrentasvir, or any of the excipients.
Severe Liver Impairment: Not recommended for patients with severe hepatic impairment (Child-Pugh C).

Use Direction

Use directions include:

Follow Prescribed Dosage: Take as directed by the healthcare provider.
Consistency: Ensure adherence to the treatment schedule for optimal efficacy.