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Daclatasvir in hepatitis C virus infection: a guide to its use in the EU

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Abstract

Daclatasvir (Daklinza®), an inhibitor of hepatitis C virus (HCV) NS5A protein, is an oral, direct-acting antiviral with potent pangenotypic activity that approved in many countries worldwide. In the EU, it is approved for use in combination with other drugs for the treatment of chronic HCV genotype 1, 3 or 4 infection. Daclatasvir produces high sustained virological response rates in patients chronically infected with HCV genotypes 1–4 when used in combination with peginterferon-α + ribavirin or in combination with sofosbuvir (± ribavirin). Daclatasvir has a moderately high genetic barrier to resistance, is effective during short-term treatment over 12 weeks, has a safety and tolerability profile similar to that of placebo, has a relatively low potential for drug interactions, and is not associated with clinically relevant drug interactions with drugs commonly used in patients with HCV, including other antivirals and transplant medications.

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Acknowledgments

The review was updated from Drugs 2015; 75(5):515–24 [33], and was reviewed by: A. Antonelli, Department of Clinical and Experimental Medicine, University of Pisa, Pisa, Italy; F. Araujo, Faculty of Experimental Sciences, Pablo de Olavide University, Seville, Spain; F. Bessone, Department of Gastroenterology and Hepatology, University of Rosario School of Medicine, Rosario, Argentina; S. Mirkov, Auckland, New Zealand; S. Saluja, Saran Ashram Hospital, Dayalbagh, Agra, India. During the peer review process, the manufacturer of daclatasvir was also offered an opportunity to review this article. Changes resulting from comments received were made on the basis of scientific and editorial merit.

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Correspondence to Paul L. McCormack.

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The preparation of this review was not supported by any external funding.

Conflicts of interest

P. L. McCormack and K. A. Lyseng-Williamson are salaried employees of Adis/Springer, are responsible for the article content and declare no conflicts of interest.

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McCormack, P.L., Lyseng-Williamson, K.A. Daclatasvir in hepatitis C virus infection: a guide to its use in the EU. Drugs Ther Perspect 32, 42–49 (2016). https://doi.org/10.1007/s40267-015-0272-3

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