Mavixen100 mg+40 mg

Mavixen is a fixed-dose combination of two direct-acting antivirals (DAAs) used for the treatment of chronic hepatitis C virus (HCV) infection.

Established (FDA-approved) uses

• Treatment of chronic HCV genotype 1, 2, 3, 4, 5, or 6 infection in adults and pediatric patients 3 years of age and older, without cirrhosis or with compensated cirrhosis (Child-Pugh A).
• Treatment of HCV genotype 1 infection in patients who were previously treated with a regimen containing an NS5A inhibitor or an NS3/4A protease inhibitor (but not both).
• Treatment of HCV infection in patients with chronic kidney disease, including those on dialysis (no dose adjustment required).
• Treatment of HCV infection in liver or kidney transplant recipients.

Regimen selection depends on genotype, treatment history, and cirrhosis status

Mavixen is prescribed as part of a defined-duration regimen (8, 12, or 16 weeks); see "Duration of Treatment" for details. There are no recognized off-label uses of Mavixen.

Glecaprevir + Pibrentasvir film-coated tablets: each tablet contains glecaprevir 100 mg and pibrentasvir 40 mg.

Glecaprevir + Pibrentasvir oral pellets (for pediatric use): each packet contains glecaprevir 50 mg and pibrentasvir 20 mg.

Mavixen is an oral, pangenotypic, fixed-dose combination antiviral medicine used to treat chronic hepatitis C virus (HCV) infection. It combines glecaprevir, an HCV NS3/4A protease inhibitor, with pibrentasvir, an HCV NS5A inhibitor, allowing interferon-free and ribavirin-free treatment with a short, defined course.

Mavixen is available as film-coated tablets for adults and adolescents/children weighing 45 kg or more, and as oral pellets for younger children based on body weight.

Direct-Acting Antiviral (DAA) combination for hepatitis C — Mavixen combines an NS3/4A protease inhibitor with an NS5A inhibitor.

Mechanism

Glecaprevir + Pibrentasvir combines two antivirals that act at different steps of the HCV replication cycle: glecaprevir inhibits the HCV NS3/4A protease enzyme required for cleavage of the HCV-encoded polyprotein, and pibrentasvir inhibits the HCV NS5A protein, which is required for viral RNA replication and virion assembly. This dual mechanism gives Glecaprevir + Pibrentasvir activity against HCV genotypes 1 through 6.

Pharmacokinetics

• Absorption: Peak plasma concentrations of both components occur around 5 hours after an oral dose; taking Glecaprevir + Pibrentasvir with food increases absorption of both components and is required.
• Protein binding: Glecaprevir is approximately 97.5% protein bound; pibrentasvir is greater than 99.9% protein bound.
• Metabolism/Excretion: Glecaprevir undergoes minor oxidative metabolism via CYP3A; pibrentasvir is not appreciably metabolized. Both are eliminated predominantly in feces, with minimal renal excretion.
• Half-life: Approximately 6 hours for glecaprevir and 13 hours for pibrentasvir.
• Hepatic impairment: Exposure to both components is markedly increased in patients with moderate-to-severe hepatic impairment (see Contraindications).

Take Mavixen tablets whole, swallowed with a glass of water, together with food (a meal or snack); do not split, crush, or chew the tablets. The oral pellet formulation should be administered by mixing the full packet contents with one tablespoon of soft food (e.g., pudding, chocolate syrup, or ice cream) and swallowed without chewing, within 20 minutes of mixing, taken with food. Do not miss doses; complete the full prescribed course even if symptoms improve, since stopping early can allow the virus to develop resistance and the infection to persist.

Contraindicated combinations

• Atazanavir: significantly increases glecaprevir concentrations, raising the risk of ALT elevation — concurrent use with Mavixen is contraindicated.
• Rifampin: significantly decreases concentrations of both components, reducing efficacy of Mavixen — concurrent use is contraindicated.

Combinations generally not recommended

• Strong CYP3A/P-gp inducers (e.g., carbamazepine, efavirenz-containing antiretroviral regimens, St. John's wort): may substantially lower Mavixen concentrations and reduce antiviral effect.
• Certain statins (atorvastatin, lovastatin, simvastatin): markedly increased statin levels with Mavixen, raising myopathy/rhabdomyolysis risk — avoid; if a statin is needed, use the lowest effective dose of rosuvastatin (max 10 mg/day) or pravastatin with dose reduction, under medical supervision.
• Ethinyl estradiol-containing contraceptives (>20 mcg): increased risk of ALT elevation when combined with Mavixen — alternative contraception should be used during treatment.
• Cyclosporine (doses greater than 100 mg/day): significantly increases exposure to Mavixen's components — avoid.

Requires dose adjustment/monitoring

Digoxin levels can rise with concurrent Mavixen; a dose reduction and monitoring of digoxin levels is generally advised. Always inform your physician and pharmacist of all medicines, supplements, and herbal products being taken before starting Mavixen.

Most adverse effects reported with Mavixen are mild. The most common (>10% of patients) are:

• Headache
• Fatigue

Other reported reactions (generally <10%) include nausea, diarrhea, and pruritus (itching), the last being reported more often in patients with severe renal impairment. In pediatric patients under 12 years, vomiting, rash, and abdominal pain were reported somewhat more frequently than in adults.

Serious adverse effects are uncommon but include hepatic decompensation/failure and hepatitis B reactivation in coinfected patients — see Precautions and Warnings for details. Seek prompt medical attention for yellowing of the skin/eyes, severe abdominal pain, dark urine, or unusual bleeding/bruising while taking Mavixen.

Pregnancy

Adequate human data on the use of Mavixen in pregnancy are not available. Animal reproduction studies did not show adverse fetal effects at drug exposures well above human therapeutic exposure, but this does not guarantee safety in humans. Mavixen should be used during pregnancy only if clearly needed and if the potential benefit justifies the potential risk to the fetus; a physician should always be consulted before use in pregnancy.

Lactation

It is not known whether the components of Mavixen pass into human breast milk. A decision to continue or discontinue breastfeeding during treatment with Mavixen should be made in consultation with a physician, weighing the benefits of breastfeeding against any potential risk to the infant.

Hepatitis B virus (HBV) reactivation

All patients should be tested for current or prior HBV infection (HBsAg and anti-HBc) before starting Mavixen. HBV reactivation, in rare cases resulting in fulminant hepatitis, liver failure, or death, has been reported in HCV/HBV coinfected patients treated with direct-acting antivirals. HBV-coinfected patients should be monitored during and after treatment with Mavixen.

Hepatic decompensation/failure

Cases of worsening liver function or liver failure, including fatal cases, have been reported, mainly in patients with evidence of advanced or decompensated liver disease at baseline. Mavixen is contraindicated in patients with moderate-to-severe hepatic impairment or any history of decompensation (see Contraindications). Discontinue Mavixen immediately if clinical signs or symptoms of liver decompensation develop.

Drug interactions

Mavixen has clinically significant interactions with certain medicines, including some statins, hormonal contraceptives, and enzyme-inducing drugs — see Interactions for details, and disclose all current medicines to your physician before starting therapy.

Adherence

Mavixen must be taken exactly as prescribed for the full recommended duration. Skipping doses or stopping treatment early can lead to treatment failure and may allow the virus to develop resistance to antiviral therapy.

There is no specific antidote for Mavixen overdose. In the event of a suspected overdose, seek immediate medical attention or contact a poison control center/emergency services. Management is supportive: the patient should be monitored for signs and symptoms of toxicity, and general symptomatic and supportive care instituted as needed. Because glecaprevir and pibrentasvir are highly protein-bound, they are not expected to be significantly removed by hemodialysis.

Store at room temperature (below 30°C), away from light and moisture. Keep out of reach of children.

• Renal impairment: No dose adjustment of Mavixen is needed in mild, moderate, or severe renal impairment, including patients on dialysis.
• Hepatic impairment: No adjustment needed in mild impairment (Child-Pugh A); contraindicated in moderate-severe impairment (Child-Pugh B/C) — see Contraindications.
• Elderly (65 years and older): No overall differences in safety or effectiveness have been observed compared with younger adults; no dose adjustment is needed.
• Liver or kidney transplant recipients: Mavixen can be used with an appropriate regimen and duration under specialist supervision; monitoring of immunosuppressant levels is advised due to potential interactions.
• Pediatric patients: see Pediatric Uses.

Treatment duration with Mavixen depends on HCV genotype, prior treatment history, and cirrhosis status:

The exact regimen and duration of Mavixen should always be determined and confirmed by the treating physician based on complete clinical and virologic assessment.

Glecaprevir + Pibrentasvir belongs to the direct-acting antiviral (DAA) class for hepatitis C: glecaprevir is an NS3/4A protease inhibitor and pibrentasvir is an NS5A inhibitor.

Glecaprevir + Pibrentasvir works by simultaneously blocking two proteins the hepatitis C virus needs to multiply. Glecaprevir inhibits the HCV NS3/4A protease, an enzyme required to cleave the viral polyprotein into functional pieces, while pibrentasvir inhibits the HCV NS5A protein, which is essential for viral RNA replication and assembly of new virus particles. Together, this dual, complementary mechanism gives Glecaprevir + Pibrentasvir potent activity against HCV genotypes 1 through 6 and a high barrier to resistance.

Mavixen is approved for use in pediatric patients 3 years of age and older, dosed by body weight using oral pellets (for children weighing less than 45 kg) or tablets (for those weighing 45 kg or more, or aged 12 years or older) — see Dosage for the weight-based table. Efficacy and safety in this age group are considered similar to adults, though vomiting, rash, and upper abdominal pain were reported somewhat more frequently in children under 12 years than in adults. Safety and efficacy of Mavixen have not been established in children younger than 3 years of age.