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This once-daily, fixed-dose combination regimen demonstrated high sustained virologic response 12 weeks postdosing (SVR\n            <jats:sub>12<\/jats:sub>\n            ) rates in CERTAIN-1 and CERTAIN-2 studies in Japanese HCV-infected patients, with a low virologic failure rate (1.2%). There were no virologic failures among direct-acting antiviral (DAA)-treatment-naive genotype 1a (GT1a) (\n            <jats:italic>n<\/jats:italic>\n            = 4)-, GT1b (\n            <jats:italic>n<\/jats:italic>\n            = 128)-, and GT2 (\n            <jats:italic>n<\/jats:italic>\n            = 97)-infected noncirrhotic patients treated for 8 weeks or among GT1b (\n            <jats:italic>n<\/jats:italic>\n            = 38)- or GT2 (\n            <jats:italic>n<\/jats:italic>\n            = 20)-infected patients with compensated cirrhosis treated for 12 weeks. Two of 33 DAA-experienced and 2 of 12 GT3-infected patients treated for 12 weeks experienced virologic failure. Pooled resistance analysis, grouped by HCV subtype, treatment duration, prior treatment experience, and cirrhosis status, was conducted. Among DAA-naive GT1b-infected patients, the baseline prevalence of NS3-D168E was 1.2%, that of NS5A-L31M was 3.6%, and that of NS5A-Y93H was 17.6%. Baseline polymorphisms in NS3 or NS5A were less prevalent in GT2, with the exception of the common L\/M31 polymorphism in NS5A. Among DAA-experienced GT1b-infected patients (30\/32 daclatasvir plus asunaprevir-experienced patients), the baseline prevalence of NS3-D168E\/T\/V was 48.4%, that of NS5A-L31F\/I\/M\/V was 81.3%, that of the NS5A P32deletion was 6.3%, and that of NS5A-Y93H was 59.4%. Common baseline polymorphisms in NS3 and\/or NS5A had no impact on treatment outcomes in GT1- and GT2-infected patients; the impact on GT3-infected patients could not be assessed due to the enrollment of patients infected with diverse subtypes and the limited number of patients. The glecaprevir-pibrentasvir combination regimen allows a simplified treatment option without the need for HCV subtyping or baseline resistance testing for DAA-naive GT1- or GT2-infected patients. (The CERTAIN-1 and CERTAIN-2 studies have been registered at ClinicalTrials.gov under identifiers NCT02707952 and NCT02723084, respectively.)\n          <\/jats:p>","DOI":"10.1128\/aac.02217-17","type":"journal-article","created":{"date-parts":[[2017,11,27]],"date-time":"2017-11-27T16:30:14Z","timestamp":1511800214000},"update-policy":"https:\/\/doi.org\/10.1128\/asmj-crossmark-policy-page","source":"Crossref","is-referenced-by-count":27,"title":["Integrated Resistance Analysis of CERTAIN-1 and CERTAIN-2 Studies in Hepatitis C Virus-Infected Patients Receiving Glecaprevir and Pibrentasvir in Japan"],"prefix":"10.1128","volume":"62","author":[{"given":"Preethi","family":"Krishnan","sequence":"first","affiliation":[{"name":"Research and Development, AbbVie Inc., North Chicago, Illinois, USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Gretja","family":"Schnell","sequence":"additional","affiliation":[{"name":"Research and Development, AbbVie Inc., North Chicago, Illinois, USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Rakesh","family":"Tripathi","sequence":"additional","affiliation":[{"name":"Research and Development, AbbVie Inc., North Chicago, Illinois, USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Jill","family":"Beyer","sequence":"additional","affiliation":[{"name":"Research and Development, AbbVie Inc., North Chicago, Illinois, USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Thomas","family":"Reisch","sequence":"additional","affiliation":[{"name":"Research and Development, AbbVie Inc., North Chicago, Illinois, USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Tatyana","family":"Dekhtyar","sequence":"additional","affiliation":[{"name":"Research and Development, AbbVie Inc., North Chicago, Illinois, USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Michelle","family":"Irvin","sequence":"additional","affiliation":[{"name":"Research and Development, AbbVie Inc., North Chicago, Illinois, USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Wangang","family":"Xie","sequence":"additional","affiliation":[{"name":"Research and Development, AbbVie Inc., North Chicago, Illinois, USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Bo","family":"Fu","sequence":"additional","affiliation":[{"name":"Research and Development, AbbVie Inc., North Chicago, Illinois, USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Margaret","family":"Burroughs","sequence":"additional","affiliation":[{"name":"Research and Development, AbbVie Inc., North Chicago, Illinois, USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Rebecca","family":"Redman","sequence":"additional","affiliation":[{"name":"Research and Development, AbbVie Inc., North Chicago, Illinois, USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Hiromitsu","family":"Kumada","sequence":"additional","affiliation":[{"name":"Department of Hepatology, Toranomon Hospital, Tokyo, Japan"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Kazuaki","family":"Chayama","sequence":"additional","affiliation":[{"name":"Department of Gastroenterology and Metabolism, Hiroshima University, Hiroshima, Japan"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Christine","family":"Collins","sequence":"additional","affiliation":[{"name":"Research and Development, AbbVie Inc., North Chicago, Illinois, USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Tami","family":"Pilot-Matias","sequence":"additional","affiliation":[{"name":"Research and Development, AbbVie Inc., North Chicago, Illinois, USA"}],"role":[{"vocabulary":"crossref","role":"author"}]}],"member":"235","reference":[{"key":"e_1_3_3_2_2","volume-title":"Global hepatitis report 2017","author":"World Health Organization","year":"2017","unstructured":"World Health Organization. 2017. 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