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Elbasvir/Grazoprevir: First Global Approval

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Abstract

A fixed-dose combination tablet of the hepatitis C virus (HCV) NS5A inhibitor elbasvir and the HCV NS3/4A protease inhibitor grazoprevir (elbasvir/grazoprevir; Zepatier™) is under development by Merck. Oral elbasvir/grazoprevir 50/100 mg once daily has been approved in the USA for the treatment of adults with chronic HCV genotype 1 or 4 infection. This article summarizes the milestones in the development of elbasvir/grazoprevir leading to this first global approval for chronic HCV genotype 1 or 4 infection.

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Disclosure

The preparation of this review was not supported by any external funding. During the peer review process the manufacturer of elbasvir/grazoprevir 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. Gillian Keating is a salaried employee of Adis, Springer SBM.

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Correspondence to Gillian M. Keating.

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This profile has been extracted and modified from the AdisInsight database. AdisInsight tracks drug development worldwide through the entire development process, from discovery, through pre-clinical and clinical studies to market launch and beyond.

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Keating, G.M. Elbasvir/Grazoprevir: First Global Approval. Drugs 76, 617–624 (2016). https://doi.org/10.1007/s40265-016-0558-3

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