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Data were summarised for patients who received simeprevir 150\u00a0mg once daily (<jats:italic>n<\/jats:italic>\u00a0=\u00a0924) or placebo (<jats:italic>n<\/jats:italic>\u00a0=\u00a0540) plus pegylated interferon\u2010<jats:italic>\u03b1<\/jats:italic>\/ribavirin for 12\u00a0weeks. During the first 12\u00a0weeks of treatment, few patients discontinued simeprevir or placebo due to adverse events (<jats:styled-content style=\"fixed-case\">AE<\/jats:styled-content>s) (both 2.2%). Pruritus (23.8% <jats:italic>vs<\/jats:italic> 17.4%), rash (any; 22.9% <jats:italic>vs<\/jats:italic> 16.7%) and photosensitivity (3.2% <jats:italic>vs<\/jats:italic> 0.6%) <jats:italic>[Correction added on 16 January 2015, after first online publication: In the above sentence, the values in \u2018Photosensitivity\u2019 were previously incorrect and have now been changed to 3.2% vs 0.6%.]<\/jats:italic> were more prevalent in the simeprevir <jats:italic>vs<\/jats:italic> the placebo groups. Most <jats:styled-content style=\"fixed-case\">AE<\/jats:styled-content>s were grade 1\/2 (72.4% for simeprevir <jats:italic>vs<\/jats:italic> 71.3% for placebo). All grade 3\/4 <jats:styled-content style=\"fixed-case\">AE<\/jats:styled-content>s occurred in &lt;5.0% of patients, except neutropenia (9.8% <jats:italic>vs<\/jats:italic> 7.6%). Overall incidence of neutropenia was similar (17.3% <jats:italic>vs<\/jats:italic> 15.7%). Incidence of anaemia was 13.2% for simeprevir <jats:italic>vs<\/jats:italic> 10.9% for placebo, and incidence of increased bilirubin was 8.4% <jats:italic>vs<\/jats:italic> 2.8%. Bilirubin increases were mild\u2010to\u2010moderate and transient without concurrent transaminase increases or association with hepatic injury. Safety and tolerability did not vary with <jats:styled-content style=\"fixed-case\">METAVIR<\/jats:styled-content> score, although increased bilirubin and anaemia were more frequent in simeprevir\u2010treated patients with <jats:styled-content style=\"fixed-case\">METAVIR<\/jats:styled-content> F4 (increased bilirubin, 13.0% <jats:italic>vs<\/jats:italic> 3.3%; anaemia, 19.0% <jats:italic>vs<\/jats:italic> 14.8%). Serious <jats:styled-content style=\"fixed-case\">AE<\/jats:styled-content>s were infrequent (2.1% for simeprevir <jats:italic>vs<\/jats:italic> 3.0% for placebo). No deaths were reported during the first 12\u00a0weeks of treatment. Patient\u2010reported fatigue and other outcomes were comparable for both groups, but were of shorter duration for simeprevir due to the use of response\u2010guided therapy. Simeprevir is well tolerated in <jats:styled-content style=\"fixed-case\">HCV<\/jats:styled-content> genotype 1\u2010infected patients.<\/jats:p>","DOI":"10.1111\/jvh.12346","type":"journal-article","created":{"date-parts":[[2014,11,3]],"date-time":"2014-11-03T05:48:07Z","timestamp":1414993687000},"page":"366-375","source":"Crossref","is-referenced-by-count":15,"title":["Simeprevir with peginterferon\/ribavirin for treatment of chronic hepatitis C virus genotype 1 infection: pooled safety analysis from Phase <scp>II<\/scp>b and <scp>III<\/scp> studies"],"prefix":"10.1111","volume":"22","author":[{"given":"M. P.","family":"Manns","sequence":"first","affiliation":[{"name":"Department of Gastroenterology, Hepatology and Endocrinology Medizinische Hochschule Hannover Hannover Germany"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"M. 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