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Mavyret

Generic Name: glecaprevir and pibrentasvir (glec A pre vir and pi BRENT as vir)
Brand Names: Mavyret
Mavyret (glecaprevir/pibrentasvir) is used to treat chronic hepatitis C. Mavyret information includes news, clinical trial results and side effects.
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Drug Information:
Mavyret contains a combination of glecaprevir and pibrentasvir. Glecaprevir and pibrentasvir are antiviral medications that prevent hepatitis C virus (HCV) from multiplying in your body. Mavyret is used to treat chronic hepatitis C in adults and children over 12 years with HCV genotype 1, 2, 3, 4, 5, or 6. Mavyret is usually given after other medicines have been tried without success. You should not use Mavyret if you have severe liver disease, or if you also take atazanavir or rifampin. You should not use Mavyret if you are allergic to glecaprevir or pibrentasvir, or if: Learn more

Mavyret Side Effects

Mavyret Side Effects

Note: This document contains side effect information about glecaprevir / pibrentasvir. Some of the dosage forms listed on this page may not apply to the brand name Mavyret.

For the Consumer

Applies to glecaprevir / pibrentasvir: oral tablet

Warning

Oral route (Tablet)

Test all patients for evidence of current or prior hepatitis B virus (HBV) infection before initiating treatment with glecaprevir / pibrentasvir. HBV reactivation has been reported in HCV/HBV coinfected patients who were undergoing or had completed treatment with HCV direct-acting antivirals and were not receiving HBV antiviral therapy. Some cases have resulted in fulminant hepatitis, hepatic failure, and death. Monitor HCV/HBV coinfected patients for hepatitis flare or HBV reactivation during HCV treatment and post-treatment follow-up. Initiate appropriate patient management for HBV infection as clinically indicated.

Along with its needed effects, glecaprevir / pibrentasvir may cause some unwanted effects. Although not all of these side effects may occur, if they do occur they may need medical attention.

Some side effects of glecaprevir / pibrentasvir may occur that usually do not need medical attention. These side effects may go away during treatment as your body adjusts to the medicine. Also, your health care professional may be able to tell you about ways to prevent or reduce some of these side effects. Check with your health care professional if any of the following side effects continue or are bothersome or if you have any questions about them:

More common

  • Diarrhea
  • headache
  • itching skin
  • lack or loss of strength
  • nausea
  • unusual tiredness or weakness

For Healthcare Professionals

Applies to glecaprevir / pibrentasvir: oral tablet

General

The most common side effects reported with this drug in hepatitis C virus (HCV)-infected patients without cirrhosis were headache, fatigue, and nausea. The most common side effects reported in HCV-infected patients with compensated cirrhosis (Child-Pugh A) were fatigue, headache, nausea, diarrhea, and pruritus. The most common side effects reported in HCV-infected patients with severe renal dysfunction were pruritus, fatigue, nausea, asthenia, and headache. The most common side effects reported in HCV/HIV-1-coinfected patients were fatigue, nausea, and headache. The most common side effects reported in patients with liver or kidney transplant were headache, fatigue, nausea, and pruritus.

Nervous system

Very common (10% or more): Headache (up to 17%)

Rare (less than 0.1%): Transient ischemic attack

Dermatologic

Very common (10% or more): Pruritus (up to 17.3%)

Postmarketing reports: Angioedema

Hepatic

Very common (10% or more): Elevated bilirubin (up to 17%)

Common (1% to 10%): Elevated total bilirubin

Uncommon (0.1% to 1%): Direct hyperbilirubinemia

Frequency not reported: Jaundice

Postmarketing reports: Hepatic decompensation, hepatic failure

Elevated total bilirubin (at least 2 times the upper limit of normal [2 x ULN]) was reported in 3.5% of patients; such elevations were seen in 1.2% of patients across phase 2 and 3 trials and were related to glecaprevir-mediated inhibition of bilirubin transporters and metabolism. Bilirubin elevations were asymptomatic, transient, and generally occurred early during therapy; these elevations were mainly indirect and not associated with ALT elevations.

In patients with compensated cirrhosis (Child-Pugh A), 17% reported early, transient postbaseline bilirubin elevations above the ULN; these elevations were normally less than 2 x ULN, usually occurred with the first 2 weeks of therapy, and resolved with continued therapy. Patient with compensated cirrhosis and elevated bilirubin did not have concomitant increases in ALT/AST or signs of liver decompensation/failure; these laboratory events did not result in discontinuation of therapy. Few patients reported jaundice or ocular icterus and total bilirubin levels decreased after completion of therapy.

Other

Very common (10% or more): Fatigue (up to 16%)

Common (1% to 10%): Asthenia

Gastrointestinal

Very common (10% or more): Nausea (up to 12%)

Common (1% to 10%): Diarrhea

Ocular

Frequency not reported: Ocular icterus

Editorial References and Review

Medically reviewed by BestRx Medical Team Last updated on 1/1/2020.

Source: Drugs.com Mavyret