{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2025,10,28]],"date-time":"2025-10-28T05:55:06Z","timestamp":1761630906977,"version":"3.40.5"},"reference-count":37,"publisher":"Wiley","issue":"8","license":[{"start":{"date-parts":[[2020,6,1]],"date-time":"2020-06-01T00:00:00Z","timestamp":1590969600000},"content-version":"vor","delay-in-days":0,"URL":"http:\/\/onlinelibrary.wiley.com\/termsAndConditions#vor"}],"funder":[{"DOI":"10.13039\/100009947","name":"Merck Sharp and Dohme","doi-asserted-by":"publisher","id":[{"id":"10.13039\/100009947","id-type":"DOI","asserted-by":"publisher"}]}],"content-domain":{"domain":["onlinelibrary.wiley.com"],"crossmark-restriction":true},"short-container-title":["Liver International"],"published-print":{"date-parts":[[2020,8]]},"abstract":"<jats:title>Abstract<\/jats:title><jats:sec><jats:title>Background<\/jats:title><jats:p>Genotype 1b is the most common HCV genotype worldwide, accounting for the largest proportion of infections in Europe, Russia, Latin America and Asia. Reducing treatment duration can improve adherence, reduce drug exposure and cost. Accordingly, we evaluated the efficacy of 8\u00a0weeks fixed\u2010dose combination of grazoprevir\u2010elbasvir in treatment\u2010na\u00efve patients, with non\u2010severe fibrosis.<\/jats:p><\/jats:sec><jats:sec><jats:title>Methods<\/jats:title><jats:p>HCV mono\u2010infected and treatment na\u00efve patients with non\u2010severe fibrosis (Fibroscan<jats:sup>\u00ae<\/jats:sup>&lt;9.5\u00a0kPa and Fibrotest<jats:sup>\u00ae<\/jats:sup>\u00a0&lt;\u00a00.59) were enrolled in a study which included 117 patients. Genotyping by sequencing identified five patients with non\u20101b genotype (two GT1a, one GT1h, one GT1e and one GT1l). Thus, we included in the final analysis 112 GT1b patients. The primary end point was the proportion of patients with HCVRNA below the lower limit of quantification 12\u00a0weeks after treatment (SVR12).<\/jats:p><\/jats:sec><jats:sec><jats:title>Findings<\/jats:title><jats:p>Mean age was 54\u00a0\u00b1\u00a013\u00a0years, 31% were men and viral load was higher than 800.000\u00a0IU\/mL in 70 of 112 patients (63%). Using Fibroscan<jats:sup>\u00ae<\/jats:sup>, 100 had F0\u20101 fibrosis score. FIB\u20104 lower than 1.45 and APRI less than 1 was found in 74\/112 (66%) and 107\/112 (95%) patients respectively. Relapse occurred in three patients by week 12. These three patients had a viral load higher than 6 million IU\/mL and NS5A Y93H RAS (resistance\u2010associated substitution). Then, modified intention\u2010to\u2010treat SVR12 for patients with genotype 1b was 109\/112 (97%). By week 24; five relapses were observed and all had the Y93H RAS at relapse. SVR12 was achieved in 100% of patients with a baseline viral load below 6 million and decreased to 98% (98\/100) by follow\u2010up week 24.<\/jats:p><\/jats:sec><jats:sec><jats:title>Interpretation<\/jats:title><jats:p>Na\u00efve patients with genotype 1b and non\u2010severe fibrosis can achieve an SVR12 of 97% and an SVR24 of 95%. Then, these patients can be treated with grazoprevir\u2010elbasvir for 8\u00a0weeks.<\/jats:p><\/jats:sec>","DOI":"10.1111\/liv.14502","type":"journal-article","created":{"date-parts":[[2020,5,8]],"date-time":"2020-05-08T07:01:26Z","timestamp":1588921286000},"page":"1853-1859","update-policy":"https:\/\/doi.org\/10.1002\/crossmark_policy","source":"Crossref","is-referenced-by-count":9,"title":["Phase 3, Multicenter Open\u2010Label study to investigate the efficacy of elbasvir and grazoprevir fixed\u2010dose combination for 8 weeks in treatment\u2010na\u00efve, HCV GT1b\u2010infected patients, with non\u2010severe fibrosis"],"prefix":"10.1111","volume":"40","author":[{"ORCID":"https:\/\/orcid.org\/0000-0001-7480-1052","authenticated-orcid":false,"given":"Armand","family":"Abergel","sequence":"first","affiliation":[{"name":"Service de m\u00e9decine digestive et h\u00e9pato\u2010biliaire CHU Estaing Clermont\u2010Ferrand France"},{"name":"UMR 6602 CNRS\u2010Sigma\u2010Universit\u00e9 Clermont Auvergne Clermont\u2010Ferrand France"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"ORCID":"https:\/\/orcid.org\/0000-0002-0024-0595","authenticated-orcid":false,"given":"Tarik","family":"Asselah","sequence":"additional","affiliation":[{"name":"Department of Hepatology Universit\u00e9 Paris Diderot Sorbonne Paris Cit\u00e9 CRI UMR 1149 Inserm Paris France"},{"name":"Department of Hepatology AP\u2010HP H\u00f4pital Beaujon Clichy France"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Arianne","family":"Mallat","sequence":"additional","affiliation":[{"name":"Department of Hepatology and Gastroenterology H\u00f4pital Henri Mondor AP\u2010HP INSERM Cr\u00e9teil France"},{"name":"Facult\u00e9 de M\u00e9decine Universit\u00e9 Paris\u2010Est Cr\u00e9teil France"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"ORCID":"https:\/\/orcid.org\/0000-0003-4940-2169","authenticated-orcid":false,"given":"Brigitte","family":"Chanteranne","sequence":"additional","affiliation":[{"name":"Service de m\u00e9decine digestive et h\u00e9pato\u2010biliaire CHU Estaing Clermont\u2010Ferrand France"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Frederic","family":"Faure","sequence":"additional","affiliation":[{"name":"Service de m\u00e9decine digestive et h\u00e9pato\u2010biliaire CHU Estaing Clermont\u2010Ferrand France"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Dominique","family":"Larrey","sequence":"additional","affiliation":[{"name":"Department of Hepatology H\u00f4pital Saint Eloi INSERM1183 Montpellier University Montpellier France"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Jerome","family":"Gournay","sequence":"additional","affiliation":[{"name":"Gastroenterology and Hepatology Department Institut des Maladies de l'Appareil Digestif University Hospital Nantes Nantes France"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Veronique","family":"Loustaud\u2010Ratti","sequence":"additional","affiliation":[{"name":"Department of Hepatology and Gastroenterology CHU Limoges INSERM U1248 Universit\u00e9 de Limoges Limoges France"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"ORCID":"https:\/\/orcid.org\/0000-0002-2022-690X","authenticated-orcid":false,"given":"Vincent","family":"Di Martino","sequence":"additional","affiliation":[{"name":"Service d'H\u00e9patologie CHRU Jean Minjoz and Universit\u00e9 de Franche\u2010Comt\u00e9 Besan\u00e7on France"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Isabelle","family":"Fouchard\u2010Hubert","sequence":"additional","affiliation":[{"name":"Hepato\u2010Gastroenterology Department Angers University Hospital Angers France"},{"name":"HIFIH Laboratory, UPRES 3859, SFR 4208 Angers University Angers France"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Stanislas","family":"Pol","sequence":"additional","affiliation":[{"name":"Department of Hepatology APHP H\u00f4pital Cochin Universit\u00e9 Paris Descartes\/INSERM U1223 Institut Pasteur Paris France"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Francois","family":"Bailly","sequence":"additional","affiliation":[{"name":"Service d'H\u00e9patologie et Gastroent\u00e9rologie H\u00f4pital de la Croix\u2010Rousse Lyon France"},{"name":"INSERM U1052 Centre de Recherche en Canc\u00e9rologie de Lyon Lyon France"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"ORCID":"https:\/\/orcid.org\/0000-0001-9481-3616","authenticated-orcid":false,"given":"Didier","family":"Samuel","sequence":"additional","affiliation":[{"name":"AP\u2010HP H\u00f4pital Paul\u2010Brousse Centre H\u00e9pato\u2010Biliaire Universit\u00e9 Paris\u2010Sud UMR\u2010S1193 Universit\u00e9 Paris\u2010Saclay, and Hepatinov Villejuif France"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Albert","family":"Tran","sequence":"additional","affiliation":[{"name":"Department of Gastroenterology Universit\u00e9 C\u00f4te d'Azur CHU de Nice INSERM, Centre Digestif Nice France"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Marie","family":"Dodel","sequence":"additional","affiliation":[{"name":"Service de m\u00e9decine digestive et h\u00e9pato\u2010biliaire CHU Estaing Clermont\u2010Ferrand France"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Nicolas","family":"Andant","sequence":"additional","affiliation":[{"name":"Biostatistics Unit D\u00e9l\u00e9gation Recherche Clinique &amp; Innovation (DRCI) CHU Clermont\u2010Ferrand Clermont\u2010Ferrand France"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Geraldine","family":"Lamblin","sequence":"additional","affiliation":[{"name":"Service de m\u00e9decine digestive et 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