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Glecaprevir/pibrentasvir
Combination drug From Wikipedia, the free encyclopedia
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Glecaprevir/pibrentasvir (G/P), sold under the brand names Mavyret and Maviret, is a fixed-dose combination medication used to treat hepatitis C.[4][5] It contains glecaprevir and pibrentasvir.[5][6] It works against all six types of hepatitis C.[4] At twelve weeks following treatment between 81% and 100% of people have no evidence of hepatitis C.[7] It is taken once a day by mouth with food.[4][5]
The most common side effects are headache, diarrhea, and tiredness.[7][8] In those with a history of hepatitis B, reactivation may occur.[8] It is not recommended in people with moderate to severe liver disease.[7] Glecaprevir works by blocking the protein NS3/4A protease, while pibrentasvir works by blocking NS5A.[4]
The combination was approved for medical use in the United States and Europe in 2017.[6][4] It is on the World Health Organization's List of Essential Medicines.[9]
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Medical uses
In the United States, G/P is used to treat adults and children aged 12 years and older or weighing at least 99 pounds with chronic hepatitis C virus (HCV) genotypes 1–6 and both without cirrhosis and with compensated cirrhosis who have not been previously treated for HCV (treatment-naïve).[7][5] It is also used to treat adults and children aged 12 years and older or weighing at least 99 pounds with chronic HCV genotype 1 infection who have previously been treated with a NS5A inhibitor or a NS3/4A inhibitor but not both.[5] The duration of treatment was shortened from 12 weeks to eight weeks for many people in 2019.[7]
In the European Union, it is used to treat adults and adolescents aged 12 years and older with chronic (long-term) hepatitis C.[4]
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Side effects
The only known side effects of G/P are hepatitis B reactivation, and more commonly headache, nausea, tiredness, and diarrhea.[10]
Mechanism of action
Glecaprevir inhibits NS3/4A, a serine protease, and pibrentasvir inhibits NS5A, a zinc-binding hydrophilic phosphoprotein. Both of these proteins are essential in hepatitis C viral RNA replication, which can no longer take place upon inhibition of these proteins.[10]
History
The development of G/P as a combination treatment was done by AbbVie and is in accordance with good manufacturing practice (GMP) standards, per the FDA.[10]
Initial identification of glecaprevir was done in a joint effort by AbbVie and Enanta Pharmaceuticals.[11] Enanta had a Collaborative Development and License Agreement with AbbVie for the identification and development of paritaprevir and glecaprevir, two HCV NS3 and NS3/4A protease inhibitors, that lasted from October 2016 to June 2017. In this agreement, Enanta received a total of US$427,000 in the form of license payments, proceeds from a sale of preferred stock, research funding payments, milestone payments, and royalties.[12]
The identification and development of pibrentasvir was done by AbbVie.[13]
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Research
During clinical trials, G/P was shown to be effective at clearing all six genotypes of HCV from the blood. Over the course of eight studies involving greater than 2,300 patients with hepatitis C, 99% of non-cirrhotic patients with genotype 1 were negative for HCV after the eight-week treatment regimen. Of cirrhotic patients from the same group, 97% tested negative for HCV on a 12-week treatment regimen and the results were reportedly similar for the treatment of genotypes 2 and 4–6, whereas 95% of patients with genotype 3 HCV tested negative for the virus after treatment.[10]
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References
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