More from Mavixen
Other strengths and forms by Everest Pharmaceuticals Ltd.
Indications & Uses
Glecaprevir + Pibrentasvir is a fixed-dose combination of two medicines. Glecaprevir is a hepatitis C virus (HCV) NS3/4A protease inhibitor, and pibrentasvir is an HCV NS5A inhibitor. The combination is used to treat patients with chronic HCV genotype (GT) 1, 2, 3, 4, 5 or 6 infection, whether they have no cirrhosis or have compensated cirrhosis (Child-Pugh A). It is also used in adult patients with HCV genotype 1 infection who have been treated before with a regimen containing an HCV NS5A inhibitor or an NS3/4A protease inhibitor, but not both.
Pharmacology
Glecaprevir blocks the HCV NS3/4A protease. This viral enzyme is needed to cut the polyprotein made by HCV into its mature forms, which are the NS3, NS4A, NS4B, NS5A and NS5B proteins. These multifunctional proteins, NS3 included, are essential for the virus to replicate. The N-terminal part of NS3 gives it serine protease activity. The C-terminus of NS3 encodes a DExH/D-box RNA helicase, which hydrolyzes NTP as an energy source to unwind double-stranded RNA in a 3′ to 5′ direction while the viral genomic RNA is being copied. NS4A works as a cofactor for NS3. It directs where NS3 sits in the cell and modulates its enzyme activities. By inhibiting the NS3/4A protease from cleaving the downstream junctions of the HCV polypeptide and from processing the mature structural protein, glecaprevir disrupts the intracellular steps of the viral life cycle.
NS5A is a phosphoprotein that is essential for replication, assembly and maturation of infectious viral proteins. Its basal phosphorylated form is maintained by the C-terminal serine cluster, and this form is needed for NS5A to interact with the viral capsid protein, also called the core protein. Pibrentasvir blocks this interaction, so the proteins can't assemble and mature HCV particles are not produced. NS5A also interacts with viral and cellular proteins to form the HCV replicase complex, and it supports the RNA replication of HCV.
Dosage Reference
Reference Information Only
Dosages shown are general references from official sources. Always consult your doctor or pharmacist for personalized dosing.
Adults:
Testing prior to the initiation of therapy: test all patients for HBV infection by measuring HBsAg and anti-HBc.
The recommended dosage is three tablets taken by mouth once daily with food. That makes a total daily dose of glecaprevir 300 mg and pibrentasvir 120 mg. The treatment duration for each group is given below.
Treatment-naïve patients with HCV genotype 1, 2, 3, 4, 5, or 6 take it for 8 weeks if they have no cirrhosis, and for 12 weeks if they have compensated cirrhosis (Child-Pugh A).
Among treatment-experienced patients, those with HCV genotype 1 who were previously treated with a regimen containing an NS5A inhibitor, without prior treatment with an NS3/4A protease inhibitor, need 16 weeks. This applies with no cirrhosis and with compensated cirrhosis (Child-Pugh A).
Patients with HCV genotype 1 who were previously treated with a regimen containing an NS3/4A PI, without prior treatment with an NS5A inhibitor, need 12 weeks. Again, this is the same with no cirrhosis and with compensated cirrhosis (Child-Pugh A).
For treatment-experienced patients with HCV genotype 1, 2, 4, 5 or 6 who were previously treated with a regimen containing PRS, the duration is 8 weeks with no cirrhosis and 12 weeks with compensated cirrhosis (Child-Pugh A).
Treatment-experienced patients with HCV genotype 3 who were previously treated with a regimen containing PRS need 16 weeks, whether they have no cirrhosis or compensated cirrhosis (Child-Pugh A).
Side Effects
The most common side effects reported in people taking Glecaprevir + Pibrentasvir (more than 10%) are headache and fatigue.
Cautions & Contraindications
Warnings & Precautions
Risk of Hepatitis B Virus Reactivation: Before starting treatment for hepatitis C (HCV), test every patient for current or past hepatitis B virus (HBV) infection. Patients who have both HCV and HBV need to be monitored for HBV reactivation and hepatitis flare, both during HCV treatment and in the follow-up period after it. If HBV infection is found, manage it appropriately as the clinical situation requires.
Pregnancy & Breastfeeding
There isn't enough human data to say whether Glecaprevir + Pibrentasvir carries a risk for pregnancy outcomes. It's also not known if the components pass into human breast milk, change how much milk is made, or affect a breastfed baby. In lactating rodents, the components were found in the milk, and the nursing pups showed no effect on growth and development.
The benefits of breastfeeding for the baby's development and health should be weighed together with the mother's clinical need for Glecaprevir + Pibrentasvir. The weighing should also include any possible adverse effects on the breastfed child, whether they come from the medicine or from the mother's underlying condition.
⚠️ Talk to your doctor before taking any medicine during pregnancy or while breastfeeding.
Use in Special Populations
Renal impairment: No dose change is needed with Glecaprevir + Pibrentasvir in patients with mild, moderate or severe renal impairment, including those on dialysis.
Hepatic impairment: No dose change is needed in patients with mild hepatic impairment (Child-Pugh A). Glecaprevir + Pibrentasvir is not recommended in patients with moderate hepatic impairment (Child-Pugh B), because safety and efficacy have not been established in HCV-infected patients with moderate hepatic impairment. It is contraindicated in patients with sev.
Overdose
If someone takes too much Glecaprevir + Pibrentasvir, watch them closely for any signs and symptoms of toxicity. Start treatment for those symptoms straight away. Haemodialysis doesn't remove glecaprevir and pibrentasvir to any significant degree.
⚠️ In an emergency call 999 or go to the nearest hospital emergency department.
Drug Interactions
Common questions about Mavixen 100 mg
What is Mavixen 100 mg Tablet?
Mavixen 100 mg Tablet is a medicine that contains Glecaprevir + Pibrentasvir. It is made by Everest Pharmaceuticals Ltd. It belongs to the Hepatic viral infections (Hepatitis C) group of medicines.
What is Mavixen used for?
Glecaprevir + Pibrentasvir is a fixed-dose combination of two medicines. Glecaprevir is a hepatitis C virus (HCV) NS3/4A protease inhibitor, and pibrentasvir is an HCV NS5A inhibitor.
What are the side effects of Mavixen?
The most common side effects reported in people taking Glecaprevir + Pibrentasvir (more than 10%) are headache and fatigue.
Can I take Mavixen during pregnancy or while breastfeeding?
There isn't enough human data to say whether Glecaprevir + Pibrentasvir carries a risk for pregnancy outcomes. It's also not known if the components pass into human breast milk, change how much milk is made, or affect a breastfed baby. Talk to your doctor before taking any medicine during pregnancy or while breastfeeding.
What happens if I take too much Mavixen?
If someone takes too much Glecaprevir + Pibrentasvir, watch them closely for any signs and symptoms of toxicity. Start treatment for those symptoms straight away. In an emergency call 999 or go to the nearest hospital emergency department.
Can I take other medicines with Mavixen?
Some medicines can interact with Glecaprevir + Pibrentasvir, for example: Carbamazepine, Efavirenz. Tell your doctor or pharmacist about every medicine you take.
Do I need a prescription for Mavixen?
Mavixen is a prescription (Rx) medicine. Take it as your doctor advises.