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The efficacy of an 8-week regimen for treatment-naive HCV-1\u2013infected patients with mild fibrosis has not been determined.<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Methods<\/jats:title>\n                    <jats:p>Treatment-naive HCV-1b\u2013infected patients with mild fibrosis were randomly assigned to receive 8 (n = 41) or 12 (n = 41) weeks of grazoprevir\/elbasvir therapy. The primary end point was a sustained virologic response, defined as an HCV RNA level of &lt; 12 IU\/mL, at posttreatment week 12 (SVR12).<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Results<\/jats:title>\n                    <jats:p>SVR12 was achieved by 87.8% of patients (36 of 41) in the 8-week arm and 100% (41 of 41) in the 8-week arm of the full-analysis population and by 90.0% (36 of 40) and 100% (41 of 41), respectively, in the per-protocol population (all P = .055). In the 8-week arm, a significantly lower SVR12 rate was observed among patients with a high HCV-1b load, defined as \u22651 500 000 IU\/mL (79% vs 100%; P = .042), and among those with a baseline Y93H resistance-associated substitution (RAS) frequency of &gt;15% in HCV nonstructural protein 5A (NS5A; 40.0% vs 97.1%; P = .004). Between-group analysis demonstrated that, among patient with a high HCV-1b load and a baseline Y93H RAS frequency of &gt;15%, those in the 8-week arm had a substantially lower SVR12 rate than those in the 12-week arm (40.0% vs 100.0%). All 4 HCV-1b relapses had a Y93H RAS frequency of &gt;99% at posttreatment week 12.<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Conclusions<\/jats:title>\n                    <jats:p>Twelve weeks of grazoprevir\/elbasvir therapy is highly effective for treatment-naive patients with mild fibrosis. A truncated, 8-week grazoprevir\/elbasvir regimen might be applied for those with low viral loads or without a significant NS5A RAS frequency.<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Clinical trials registration<\/jats:title>\n                    <jats:p>NCT03186365.<\/jats:p>\n                  <\/jats:sec>","DOI":"10.1093\/infdis\/jiz154","type":"journal-article","created":{"date-parts":[[2019,4,1]],"date-time":"2019-04-01T15:10:25Z","timestamp":1554131425000},"page":"557-566","source":"Crossref","is-referenced-by-count":18,"title":["An Open-Label, Randomized, Active-Controlled Trial of 8 Versus 12 Weeks of Elbasvir\/Grazoprevir for Treatment-Naive Patients With Chronic Hepatitis C Genotype 1b Infection and Mild Fibrosis (EGALITE Study): Impact of Baseline Viral Loads and NS5A Resistance-Associated Substitutions"],"prefix":"10.1093","volume":"220","author":[{"given":"Chung-Feng","family":"Huang","sequence":"first","affiliation":[{"name":"Hepatobiliary Division, Department of Internal Medicine, ChiaYi"},{"name":"Hepatitis Center, Kaohsiung Medical University Hospital, ChiaYi"},{"name":"Hepatitis Research Center, Kaohsiung Medical University, ChiaYi"},{"name":"Center for Liquid Biopsy, Kaohsiung Medical University, ChiaYi"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Chao-Hung","family":"Hung","sequence":"additional","affiliation":[{"name":"Division of Hepatogastroenterology, Department of Internal Medicine, ChiaYi Chang Gung Memorial Hospital, ChiaYi"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Pin-Nan","family":"Cheng","sequence":"additional","affiliation":[{"name":"Division of Gastroenterology and Hepatology, Department of Internal Medicine, National Cheng Kung University Hospital"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Ming-Jong","family":"Bair","sequence":"additional","affiliation":[{"name":"Division of Gastroenterology, Department of Internal Medicine, Taitung Mackay Memorial Hospital, Taitung City"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Yi-Hsiang","family":"Huang","sequence":"additional","affiliation":[{"name":"Division of Gastroenterology and Hepatology, Department of Medicine, Taipei Veterans General Hospital, Taipei"},{"name":"Institute of Clinical Medicine, National Yang-Ming University, Taipei"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Jia-Horng","family":"Kao","sequence":"additional","affiliation":[{"name":"Department of Internal Medicine, National Taiwan University Hospital and National Taiwan University College of Medicine, Taipei"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Shih-Jer","family":"Hsu","sequence":"additional","affiliation":[{"name":"Department of Internal Medicine, National Taiwan University Hospital\u2013Yunlin Branch, Yunlin"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Pei-Lun","family":"Lee","sequence":"additional","affiliation":[{"name":"Division of Gastroenterology and Hepatology, Chi-Mei Medical Center, Tainan"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Jyh-Jou","family":"Chen","sequence":"additional","affiliation":[{"name":"Division of Gastroenterology and Hepatology, Chi-Mei Medical Center, Tainan"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Rong-Nan","family":"Chien","sequence":"additional","affiliation":[{"name":"Division of Hepatology, Department of Gastroenterology and Hepatology, Linkou Medical Center, Chang Gung Memorial Hospital, 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