Glecaprevir/Pibrentasvir: First Global Approval
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A fixed-dose combination tablet of the hepatitis C virus (HCV) NS3/4A protease inhibitor (PI) glecaprevir and the HCV NS5A inhibitor pibrentasvir [glecaprevir/pibrentasvir; MAVIRET™ (EU); MAVYRET™ (USA)] has been developed by AbbVie. Oral glecaprevir/pibrentasvir 300 mg/120 mg (three 100 mg/40 mg tablets) taken once daily has been approved by the EMA for the treatment of all major genotypes (genotypes 1–6) of chronic HCV infection in adults. It has also been approved by the US FDA for the treatment of adult patients with chronic HCV genotype 1–6 infection without cirrhosis and with compensated cirrhosis, and for the treatment of adult patients with HCV genotype 1 infection who previously have been treated with a regimen containing either an HCV NS5A inhibitor or an NS3/4A PI, but not both. This article summarizes the milestones in the development of glecaprevir/pibrentasvir leading to its first global approval in the EU and subsequent approval in the USA for chronic HCV infection.
Compliance with Ethical Standards
The preparation of this review was not supported by any external funding.
Conflict of interest
During the peer review process the manufacturer of the agent under review was offered an opportunity to comment on the article. Changes resulting from any comments received were made by the author on the basis of scientific completeness and accuracy. Yvette Lamb is a salaried employee of Adis/Springer, is responsible for the article content and declares no relevant conflicts of interest.
Additional information about this Adis Drug Review can be found at http://www.medengine.com/Redeem/357AF0607A3E4BD2.
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