Glecaprevir and Pibrentasvir Medication Information

Get detailed information on Glecaprevir and Pibrentasvir, including pronunciation, uses, dosage guidelines, indications, and instructions on how and when to take it and when to avoid it.

The updated prescription information on Glecaprevir and Pibrentasvir provides an overview of possible side effects, precautions, warnings, and storage tips.

You'll also find brand names used in india and internationally, along with pricing details. For further clarification, consult your healthcare provider.

Generic Name : Glecaprevir and Pibrentasvir

Pronunciation : glek-A-pre-vir / pi-BRENT-as-vir

Therapeutic Classification : Antivirals

Trade Names/Brand Names of Glecaprevir and Pibrentasvir

India :

Mavyret

Overview of Glecaprevir and Pibrentasvir

• Glecaprevir / pibrentasvir is a fixed-dose combination of two antiviral drugs approved by FDA in August 2017 for the treatment of chronic hepatitis C infection.

Why is Glecaprevir and Pibrentasvir Prescribed? (Indications)

Glecaprevir (a HCV NS3/4A protease inhibitor) and pibrentasvir (HCV NS5A phosphoprotein inhibitor) combination is used for the treatment of all genotypes (1-6) of chronic hepatitis C virus infection either without cirrhosis or with compensated early stage cirrhosis in adults.

Hepatitis C is a viral disease that causes swelling of the liver which leads to reduced liver function, cirrhosis, liver failure or in some cases death.

This fixed-dose combination is also used to treat adult patients suffering from HCV genotype infection 1 who have been already treated with either HCV NS3/4A protease inhibitors or HCV NS5A inhibitors but not in combination.

When should Glecaprevir and Pibrentasvir not be taken? (Contraindications)

Glecaprevir and pibrentasvir are contraindicated in:

• Patients with severe hepatic impairment with Child-Pugh score C.
• Concomitant administration with atazanavir (antiretroviral drug) or rifampin (antitubercular drug) because of the potential loss of therapeutic effect.

What is the dosage of Glecaprevir and Pibrentasvir?

• The fixed-dose combination contains glecaprevir 100mg and pibrentasvir 40mg.
• The usual adult oral dose is three tablets (glecaprevir 300mg and pibrentasvir 120mg) to be taken once daily with food.

The recommended treatment duration is as follows:

For treatment-naive patients for HCV genotype (1,2,3,4,5, or 6):
• Patients with no cirrhosis - 8 weeks treatment schedule
• Patients with compensated cirrhosis (Child-Pugh A) -12 weeks of treatment

For treatment-experienced patients:
• Patients treated previously with other antiviral drugs for HCV genotype 1,2,4,5 or 6 but with no treatment with HCV NS3/4A PI or NS5A inhibitor require:
a) 8 weeks in cirrhosis condition
b) 12 weeks in compensated cirrhosis (Child-Pugh A)

• Patients with HCV genotype 3 infection need 16 weeks of treatment duration in both compensated cirrhosis or no cirrhosis conditions.

• Patients with HCV genotype 1 infection treated with NS5A inhibitor but not with NS3/4A PI require 16 weeks of treatment duration in no cirrhosis or compensated cirrhosis states.

• Patients with HCV genotype 1 infection treated with NS3/4A PI but not with NS5A inhibitor need 12 weeks treatment in both cases.

How should Glecaprevir and Pibrentasvir be taken?

• Glecaprevir and pibrentasvir combination comes as a tablet that should be taken by mouth.
• The tablets should be taken with food.

What are the warnings and precautions for Glecaprevir and Pibrentasvir?

• Before starting glecaprevir / pibrentasvir treatment, all patients have to be examined for the prior or current hepatitis B infection history by HBsAg or anti-HBc tests.

• Reactivation of hepatitis B virus occurs in patients with HCV or HBV infected patients who underwent or completed the treatment only with directly acting HCV antiviral drug but not with HBV treatment.

• In some cases hepatic failure, fulminant hepatitis, and death have also been reported.

What are the side effects of Glecaprevir and Pibrentasvir?

The side effects of the fixed-dose combination of glecaprevir and pibrentasvir are as follows:
• Headache
• Fatigue
• Nausea
• Diarrhea
• Increased bilirubin levels
• Intense itching of the skin

What are the other precautions for Glecaprevir and Pibrentasvir?

• In case of overdosage, the patient should be monitored strictly for the signs and symptoms.
• It is necessary to initiate an appropriate symptomatic treatment at the earliest.

What are the Drug Interactions of Glecaprevir and Pibrentasvir?

• Drugs such as carbamazepine, efavirenz and St.John’s Wort may decrease the effectiveness of glecaprevir and pibrentasvir combination.
• Ethinyl estradiol products in oral contraceptives should not be taken together with glecaprevir and pibrentasvir because of the risk of increased liver enzyme (ALT or SGPT) levels.
• Raised serum concentrations of statins (atorvastatin or simvastatin) occur when administered together with glecaprevir/pibrentasvir combination resulting in muscle pain or muscle weakness.
• Antiarrhythmic drugs such as digoxin concentrations are increased; therefore, reduction of the dose of digoxin is required when taken together with glecaprevir and pibrentasvir combination.
• Dose adjustment of anticoagulants such as dabigatran must be considered in concomitant administration with glecaprevir and pibrentasvir combination.