Authors: Mark Sanford
Publish Date: 2015/01/06
Volume: 75, Issue: 2, Pages: 183-196
Abstract
Simeprevir Olysio™ Galexos™ Sovriad® is an orallyadministered NS3/4A protease inhibitor for use in combined drug regimens against chronic hepatitis C virus HCV infection This article reviews studies relevant to the EU simeprevir label In proofofconcept studies simeprevir had potent antiviral activity against all HCV genotypes except genotype 3 In trials in patients with chronic HCV genotype 1 infection week12 sustained virological response SVR12 rates in treatmentnaïve patients and prior relapsers were significantly higher with simeprevir plus peginterferonα/ribavirin PR 79–89 than with placebo plus PR 36–62 In prior partial/null responders the SVR12 rate with simeprevir plus PR 54 was noninferior to that with telaprevir plus PR 55 Simeprevir plus PR was also efficacious in patients with HCV genotype 1/HIV1 coinfection In prior null responders without severe liver fibrosis cohort 1 and treatmentnaïve patients with severe liver fibrosis cohort 2 treated with simeprevir plus sofosbuvir the SVR12 rate for the two cohorts combined was 92 In patients with chronic HCV genotype 4 infection the SVR12 rates with simeprevir plus PR were 83 87 and 40 in treatmentnaïve patients prior relapsers and prior null responders respectively Grade 3–4 adverse event serious adverse event and treatment withdrawal rates with simeprevir plus PR were similar to those with placebo plus PR Skin rashes with simeprevir were mostly mild or moderate serious photosensitivity reactions occur but are rare Simeprevir is efficacious and generally well tolerated in patients with chronic HCV genotypes 1 and 4 infection Studies of simeprevir in interferonfree regimens and in other subpopulations with HCV infections will be of interestThe manuscript was reviewed by A Ascione Department of Internal Medicine Centre for Liver Disease Fatebenefratelli Hospital Naples Italy H Hofer Division of Gastroenterology and Hepatology Department of Internal Medicine III Medical University of Vienna Vienna Austria N Izumi Division of Gastroenterology and Hepatology Musashino Red Cross Hospital Tokyo Japan S K Roberts Department of Gastroenterology The Alfred Hospital Melbourne AustraliaThe preparation of this review was not supported by any external funding Mark Sanford is a salaried employee of Adis/Springer During the peer review process the manufacturer of the agent under review was offered an opportunity to comment on this article Changes resulting from comments received were made by the author on the basis of scientific and editorial merit
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