{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2025,2,21]],"date-time":"2025-02-21T08:22:27Z","timestamp":1740126147762,"version":"3.37.3"},"reference-count":49,"publisher":"Wiley","issue":"8","license":[{"start":{"date-parts":[[2018,5,8]],"date-time":"2018-05-08T00:00:00Z","timestamp":1525737600000},"content-version":"vor","delay-in-days":0,"URL":"http:\/\/onlinelibrary.wiley.com\/termsAndConditions#vor"}],"content-domain":{"domain":["onlinelibrary.wiley.com"],"crossmark-restriction":true},"short-container-title":["Journal of Viral Hepatitis"],"published-print":{"date-parts":[[2018,8]]},"abstract":"<jats:title>Summary<\/jats:title><jats:p>Multiple direct\u2010acting antiviral (<jats:styled-content style=\"fixed-case\">DAA<\/jats:styled-content>)\u2010based regimens are now available for all hepatitis C virus (<jats:styled-content style=\"fixed-case\">HCV<\/jats:styled-content>) genotypes (<jats:styled-content style=\"fixed-case\">GT<\/jats:styled-content>s). Because <jats:styled-content style=\"fixed-case\">HCV GT<\/jats:styled-content> 4, 5 and 6 are less common in the United States (<jats:styled-content style=\"fixed-case\">US<\/jats:styled-content>) and worldwide, relatively small numbers of participants with these <jats:styled-content style=\"fixed-case\">GT<\/jats:styled-content>s were evaluated in individual clinical trials. To provide a comprehensive description of subtype diversity and treatment outcomes in clinical trials for these less common <jats:styled-content style=\"fixed-case\">GT<\/jats:styled-content>s, we analysed data from 744 participants with <jats:styled-content style=\"fixed-case\">HCV GT<\/jats:styled-content>4 (n\u00a0=\u00a0573), <jats:styled-content style=\"fixed-case\">GT<\/jats:styled-content>5 (n\u00a0=\u00a081), or <jats:styled-content style=\"fixed-case\">GT<\/jats:styled-content>6 (n\u00a0=\u00a090) across 18 clinical trials of <jats:styled-content style=\"fixed-case\">DAA<\/jats:styled-content> regimens.\u00a0These data are from <jats:styled-content style=\"fixed-case\">US<\/jats:styled-content> New Drug Applications submitted between 2014 and 2017, and our analyses included only approved regimens. Excluding unresolved or mixed subtypes, the distribution of reported <jats:styled-content style=\"fixed-case\">GT<\/jats:styled-content>4 subtypes was 49% 4a, 31% 4d and 16% for one of 14 other subtypes. The distribution of <jats:styled-content style=\"fixed-case\">GT<\/jats:styled-content>6 subtypes was 39% 6a, 27% 6e, 8% 6\u00a0L and 23% for one of 11 other subtypes. Across approved regimens, sustained virologic response rates 12\u00a0weeks post\u2010treatment (<jats:styled-content style=\"fixed-case\">SVR<\/jats:styled-content>12) for <jats:styled-content style=\"fixed-case\">GT<\/jats:styled-content> 4, 5 and 6 ranged from 91% to 100%, 93% to 97% and 96% to 100%, respectively. <jats:styled-content style=\"fixed-case\">SVR<\/jats:styled-content>12 by <jats:styled-content style=\"fixed-case\">GT<\/jats:styled-content>4 subtype ranged from 96% to 100% for 4a and 81% to 100% for 4d. Virologic failures occurred in <jats:styled-content style=\"fixed-case\">GT<\/jats:styled-content> 4a, 4b, 4d and 4r. For <jats:styled-content style=\"fixed-case\">GT<\/jats:styled-content>6, <jats:styled-content style=\"fixed-case\">SVR<\/jats:styled-content>12 was 100% for all subtypes except 6\u00a0L, for which 1 of 7 participants experienced virologic failure. To our knowledge, this is the largest compilation of <jats:styled-content style=\"fixed-case\">HCV GT<\/jats:styled-content> 4, 5 or 6 clinical trial data. These analyses may be useful for clinicians treating <jats:styled-content style=\"fixed-case\">HCV GT<\/jats:styled-content> 4, 5 or 6.<\/jats:p>","DOI":"10.1111\/jvh.12896","type":"journal-article","created":{"date-parts":[[2018,3,26]],"date-time":"2018-03-26T01:21:09Z","timestamp":1522027269000},"page":"969-975","update-policy":"https:\/\/doi.org\/10.1002\/crossmark_policy","source":"Crossref","is-referenced-by-count":10,"title":["<scp>HCV<\/scp> genotype 4, 5 and 6: Distribution of viral subtypes and sustained virologic response rates in clinical trials of approved direct\u2010acting antiviral regimens"],"prefix":"10.1111","volume":"25","author":[{"ORCID":"https:\/\/orcid.org\/0000-0002-5859-7722","authenticated-orcid":false,"given":"S. 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K.","family":"Naeger","sequence":"additional","affiliation":[{"name":"Center for Drug Evaluation and Research Office of Antimicrobial Products Division of Antiviral Products, Food and Drug Administration  Silver Spring MD USA"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"K.","family":"Chan\u2010Tack","sequence":"additional","affiliation":[{"name":"Center for Drug Evaluation and Research Office of Antimicrobial Products Division of Antiviral Products, Food and Drug Administration  Silver Spring MD USA"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"J.","family":"Murray","sequence":"additional","affiliation":[{"name":"Center for Drug Evaluation and Research Office of Antimicrobial Products Division of Antiviral Products, Food and Drug Administration  Silver Spring MD USA"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"D.","family":"Birnkrant","sequence":"additional","affiliation":[{"name":"Center for Drug Evaluation and Research Office of Antimicrobial Products Division of Antiviral Products, Food and Drug Administration  Silver Spring MD USA"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"K.","family":"Struble","sequence":"additional","affiliation":[{"name":"Center for Drug Evaluation and Research Office of Antimicrobial Products Division of Antiviral Products, Food and Drug Administration  Silver Spring MD USA"}],"role":[{"role":"author","vocabulary":"crossref"}]}],"member":"311","published-online":{"date-parts":[[2018,5,8]]},"reference":[{"key":"e_1_2_8_2_1","doi-asserted-by":"publisher","DOI":"10.1371\/journal.pone.0086070"},{"key":"e_1_2_8_3_1","doi-asserted-by":"publisher","DOI":"10.1053\/gast.1997.v112.pm9024300"},{"key":"e_1_2_8_4_1","doi-asserted-by":"publisher","DOI":"10.1016\/j.jhep.2004.01.005"},{"key":"e_1_2_8_5_1","doi-asserted-by":"publisher","DOI":"10.1016\/j.jhep.2014.07.027"},{"key":"e_1_2_8_6_1","doi-asserted-by":"publisher","DOI":"10.1016\/j.cgh.2011.03.004"},{"key":"e_1_2_8_7_1","doi-asserted-by":"publisher","DOI":"10.1001\/jama.2012.144878"},{"key":"e_1_2_8_8_1","doi-asserted-by":"publisher","DOI":"10.1002\/hep.27259"},{"key":"e_1_2_8_9_1","doi-asserted-by":"publisher","DOI":"10.1002\/hep.26744"},{"key":"e_1_2_8_10_1","unstructured":"International Committee on Taxonomy of Viruses.Confirmed HCV genotypes\/subtypes(June 2017).https:\/\/talk.ictvonline.org\/ictv_wikis\/flaviviridae\/w\/sg_flavi\/634\/table-1_confirmed-hcv-genotypes-subtypesAccessed September 20 2017."},{"key":"e_1_2_8_11_1","doi-asserted-by":"publisher","DOI":"10.1128\/AAC.00363-17"},{"key":"e_1_2_8_12_1","unstructured":"KomatsuT HarringtonP O'RearJ.FDA Clinical Virology Review and Evaluation. 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