{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,5,27]],"date-time":"2026-05-27T23:10:45Z","timestamp":1779923445903,"version":"3.53.1"},"reference-count":58,"publisher":"Ovid Technologies (Wolters Kluwer Health)","issue":"6","license":[{"start":{"date-parts":[[2018,5,21]],"date-time":"2018-05-21T00:00:00Z","timestamp":1526860800000},"content-version":"tdm","delay-in-days":0,"URL":"http:\/\/doi.wiley.com\/10.1002\/tdm_license_1.1"},{"start":{"date-parts":[[2018,5,21]],"date-time":"2018-05-21T00:00:00Z","timestamp":1526860800000},"content-version":"vor","delay-in-days":0,"URL":"http:\/\/onlinelibrary.wiley.com\/termsAndConditions#vor"}],"content-domain":{"domain":["lww.com","ovid.com"],"crossmark-restriction":true},"short-container-title":["Hepatology"],"published-print":{"date-parts":[[2018,6]]},"abstract":"<jats:p>Several highly effective, interferon\u2010free, direct\u2010acting antiviral (DAA)\u2010based regimens are available for the treatment of chronic hepatitis C virus (HCV) infection. Despite impressive efficacy overall, a small proportion of patients in registrational trials experienced treatment failure, which in some cases was associated with the detection of HCV resistance\u2010associated substitutions (RASs) at baseline. In this article, we describe methods and key findings from independent regulatory analyses investigating the impact of baseline nonstructural (NS) 3 Q80K and NS5A RASs on the efficacy of current United States Food and Drug Administration (FDA)\u2010approved regimens for patients with HCV genotype (GT) 1 or GT3 infection. These analyses focused on clinical trials that included patients who were previously na\u00efve to the DAA class(es) in their investigational regimen and characterized the impact of baseline RASs that were enriched in the viral population as natural or transmitted polymorphisms (i.e., not drug\u2010selected RASs). We used a consistent approach to optimize comparability of results across different DAA regimens and patient populations, including the use of a 15% sensitivity cutoff for next\u2010generation sequencing results and standardized lists of NS5A RASs. These analyses confirmed that detection of NS3 Q80K or NS5A baseline RASs was associated with reduced treatment efficacy for multiple DAA regimens, but their impact was often minimized with the use of an intensified treatment regimen, such as a longer treatment duration and\/or addition of ribavirin. We discuss the drug resistance\u2010related considerations that contributed to pretreatment resistance testing and treatment recommendations in drug labeling for FDA\u2010approved DAA regimens. <jats:italic toggle=\"yes\">Conclusion:<\/jats:italic> Independent regulatory analyses confirmed that baseline HCV RASs can reduce the efficacy of certain DAA\u2010based regimens in selected patient groups. However, highly effective treatment options are available for patients with or without baseline RASs. (H<jats:sc>epatology<\/jats:sc> 2018;67:2430\u20102448).<\/jats:p>","DOI":"10.1002\/hep.29693","type":"journal-article","created":{"date-parts":[[2017,12,1]],"date-time":"2017-12-01T20:00:46Z","timestamp":1512158446000},"page":"2430-2448","update-policy":"https:\/\/doi.org\/10.1097\/lww.0000000000001000","source":"Crossref","is-referenced-by-count":40,"title":["Impact of hepatitis C virus polymorphisms on direct\u2010acting antiviral treatment efficacy: Regulatory analyses and perspectives"],"prefix":"10.1097","volume":"67","author":[{"given":"Patrick R.","family":"Harrington","sequence":"first","affiliation":[{"name":"Division of Antiviral Products, Office of Antimicrobial Products, Center for Drug Evaluation and Research,U.S. Food and Drug Administration,Silver Spring,MD"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Takashi E.","family":"Komatsu","sequence":"additional","affiliation":[{"name":"Division of Antiviral Products, Office of Antimicrobial Products, Center for Drug Evaluation and Research,U.S. Food and Drug Administration,Silver Spring,MD"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Damon J.","family":"Deming","sequence":"additional","affiliation":[{"name":"Division of Antiviral Products, Office of Antimicrobial Products, Center for Drug Evaluation and Research,U.S. Food and Drug Administration,Silver Spring,MD"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Eric F.","family":"Donaldson","sequence":"additional","affiliation":[{"name":"Division of Antiviral Products, Office of Antimicrobial Products, Center for Drug Evaluation and Research,U.S. Food and Drug Administration,Silver Spring,MD"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Julian J.","family":"O'Rear","sequence":"additional","affiliation":[{"name":"Division of Antiviral Products, Office of Antimicrobial Products, Center for Drug Evaluation and Research,U.S. Food and Drug Administration,Silver 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