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Benefit–risk assessment of new and emerging treatments for hepatitis C: focus on simeprevir and sofosbuvir

Authors Gaetano J

Received 23 January 2014

Accepted for publication 28 February 2014

Published 31 March 2014 Volume 2014:6 Pages 37—45


Checked for plagiarism Yes

Review by Single-blind

Peer reviewer comments 3

John N Gaetano

Section of Gastroenterology, Hepatology and Nutrition, Department of Medicine, University of Chicago Hospitals, Chicago, IL, USA

Abstract: Greater understanding of the hepatitis C virus (HCV) genome and life cycle of the HCV virion allows for new targets for therapy that directly act on the viral machinery to inhibit replication. Numerous direct-acting antivirals are in development, and four have been brought to market. Simeprevir, a second-generation protease inhibitor, has been approved for HCV genotype 1 patients in combination with pegylated interferon- α and ribavirin. Sofosbuvir, a novel nucleotide analog, has pangenotypic coverage and has been approved for HCV genotype 1 patients with ribavirin and pegylated interferon-α. For HCV genotypes 2 and 3, an all-oral regimen of sofosbuvir with ribavirin has become the new gold standard for treatment. The efficacy and safety for these two novel therapies among various subpopulations of those infected with chronic hepatitis C are discussed in the following review. In addition, off-label and future therapeutic regimens are addressed, as well as the concerns about cost of current and future therapies.

Keywords: liver disease, treatment-naïve and treatment experienced, HCV genotype

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