Introduction to the instructions and marketing status of Glecaprevir/pibrentasvir tablets

1. Name: glecaprevir/pibrentasvir tablets, glecaprevir/pibrentasvir

Product name:Maviret, Ainoquan, Mavyret

2. Indications:

Glecaprevir/pibrentasvir tablets (Glecaprevir/pibrentasvir) are suitable for the treatment of the following conditions:

1. Patients with acute or chronic hepatitis C virus（HCV)genotype1, 2, 3, 4, 5 or 6 infection without cirrhosis or compensated cirrhosis (Child-Pugh A)Adult and pediatric patients 3 years old and above;

2. Adult and pediatric patients aged 3 years and older with HCV genotype 1 infection who have previously received a treatment regimen containing an HCV NS5A inhibitor or an NS3/4A protease inhibitor (PI), but not both.

3. Usage and dosage:

1. Testing before starting treatment: Before starting MAVYRET to treat hepatitis C virus, test all patients for signs of current or previous HBV infection by measuring hepatitis B surface antigen (HBsAg) and hepatitis B core antibody (anti-HBc).

2. Recommended treatment duration for patients 3 years of age and older

For untreated patients with HCV genotypes 1, 2, 3, 4, 5, or 6 who do not have cirrhosis or compensated cirrhosis (Child Pugh A), the usual duration of treatment is 8 weeks. Untreated means they have not received any previous treatment for their current infection. For treatment-experienced patients, the recommended treatment duration is 8, 12, or 16 weeks based on prior treatment, HCV genotype, or presence of compensated cirrhosis (Child-Pugh A).

3. Recommended dosage:

(1) Gcaprevir and pibrentasvir tablets are a fixed combination drug product, each tablet contains glecaprevir 100 mg and pibrentasvir 40 mg. The recommended oral dose for adults is 3 tablets once daily, taken with food (total daily dose: glecaprevir 300 mg and pibrentasvir 120 mg).

(2) Recommended dosage for pediatric patients 3 years of age and older: Recommended dosage for patients is based on body weight.

It is recommendedChildren aged 3 to 12 years old and weighing less than 45kg should take glecaprevir and pibrentasvir oral granules, each containing glecaprevir 50mg and pibrentasvir 20mg. For pediatric patients 12 years of age and older or those weighing at least 45 kg, the recommended dose of glecaprevir and pibrentasvir tablets is three tablets once daily, taken with food (total daily dose: glecaprevir 300 mg and pibrentasvir 120 mg).

4. Liver or kidney transplant recipients: For liver or kidney transplant recipients 3 years old and above, MAVYRET is recommended for 12 weeks of treatment. For genotype 1-infected patients who have not previously received NS3/4A protease inhibitors and are experienced with NS5A inhibitors, or for genotype 3-infected patients who are experienced with PRS, the recommended treatment duration is 16 weeks.

4. Adverse reactions:

In clinical studies of glecaprevir and pibrentasvir combination preparations, common adverse reactions included headache, fatigue and nausea.

5. Supply and storage:

Gcaprevir and pibrentasvir tablets are a fixed combination drug product, each tablet contains glecaprevir 100 mg and pibrentasvir 40 mg; glecaprevir and pibrentasvir oral granules, each tablet contains glecaprevir 50 mg and pibrentasvir 20 mg; need to be stored at 30°C (86°F) or below.

6. Taboo:

1. Gcaprevir and pibrentasvir combination preparations are contraindicated in patients with moderate or severe liver damage (Child-Pugh B or C) or patients with any previous history of liver decompensation.

2. It is contraindicated to use glecaprevir-pirentasvir compound preparation with atazanavir or rifampicin.

7. Mechanism of action:

Glecaprevir and pibrentasvir tablets are a fixed-dose combination of glecaprevir and pibrentasvir. They are direct-acting antiviral agents against hepatitis C virus. The main active substances glecaprevir and pibrentasvir block two proteins necessary for the reproduction of hepatitis C virus. Gcaprevir blocks the action of a protein called NS3/4A protease, while pibrentasvir blocks a protein called NS5A. By blocking these proteins, the combination prevents the hepatitis C virus from multiplying and infecting new cells.

8. Listing situation:

United States: 2017-08, approved for marketing (trade name: Maviret)

EU: 2017-07, approved for marketing (trade name: Maviret)

China: 2019-05, approved for listing (trade name: Ainoquan)

Reference materials:https://www.mavyret.com/