{"id":15820,"date":"2020-08-20T16:06:34","date_gmt":"2020-08-20T14:06:34","guid":{"rendered":"https:\/\/cri1149.mlcom-dev.net\/?post_type=publications&p=15820"},"modified":"2025-09-11T16:48:01","modified_gmt":"2025-09-11T14:48:01","slug":"efficacy-and-safety-of-glecaprevir-pibrentasvir-in-patients-with-chronic-hepatitis-c-virus-genotype-5-or-6-infection-endurance-56-an-open-label-multicentre-phase-3b-trial","status":"publish","type":"publication","link":"https:\/\/cri1149.mlcom-dev.net\/en\/publication\/efficacy-and-safety-of-glecaprevir-pibrentasvir-in-patients-with-chronic-hepatitis-c-virus-genotype-5-or-6-infection-endurance-56-an-open-label-multicentre-phase-3b-trial\/","title":{"rendered":"Efficacy and safety of glecaprevir\/pibrentasvir in patients with chronic hepatitis C virus genotype 5 or 6 infection (ENDURANCE-5,6): an open-label, multicentre, phase 3b trial"},"content":{"rendered":"","protected":false},"featured_media":0,"template":"","meta":{"_acf_changed":false},"class_list":["post-15820","publication","type-publication","status-publish","hentry"],"acf":{"numero_de_publication":"Lancet Gastroenterol Hepatol","date_de_publication":"20190101","numero_doi":"","equipe":[130],"auteurs-liste":[{"texte_libre":false,"auteur-lien":13023,"auteur-text":""},{"texte_libre":true,"auteur-lien":null,"auteur-text":"[:en]Samuel S Lee[:]"},{"texte_libre":true,"auteur-lien":null,"auteur-text":"[:en]Betty B Yao[:]"},{"texte_libre":true,"auteur-lien":null,"auteur-text":"[:en]Tuan Nguyen[:]"},{"texte_libre":true,"auteur-lien":null,"auteur-text":"[:en]Florence Wong[:]"},{"texte_libre":true,"auteur-lien":null,"auteur-text":"[:en]Adam Mahomed[:]"},{"texte_libre":true,"auteur-lien":null,"auteur-text":"[:en]Seng Gee Lim[:]"},{"texte_libre":true,"auteur-lien":null,"auteur-text":"[:en] Armand Abergel[:]"},{"texte_libre":true,"auteur-lien":null,"auteur-text":"[:en]Joe Sasadeusz[:]"},{"texte_libre":true,"auteur-lien":null,"auteur-text":"[:en]Edward Gane[:]"},{"texte_libre":true,"auteur-lien":null,"auteur-text":"[:en]Neddie Zadeikis[:]"},{"texte_libre":true,"auteur-lien":null,"auteur-text":"[:en]Gretja Schnell[:]"},{"texte_libre":true,"auteur-lien":null,"auteur-text":"[:en]Zhenzhen Zhang[:]"},{"texte_libre":true,"auteur-lien":null,"auteur-text":"[:en]Ariel Porcalla[:]"},{"texte_libre":true,"auteur-lien":null,"auteur-text":"[:en]Federico J Mensa[:]"},{"texte_libre":true,"auteur-lien":null,"auteur-text":"[:en]Kinh Nguyen[:]"}],"auteurs-manuel":"","liens_externes":null,"liens":[{"lien":"https:\/\/www.sciencedirect.com\/science\/article\/abs\/pii\/S2468125318303418"}],"paragraphe":"[:fr]

Summary<\/h2>\r\n
\r\n

Background<\/h3>\r\n

The pangenotypic direct-acting antiviral regimen of glecaprevir coformulated with pibrentasvir is approved to treat chronic\u00a0hepatitis C virus<\/a>\u00a0(HCV) genotype 1\u20136 infection in adults. In registrational studies, 84 (99%) of 85 patients with HCV genotype 5 or 6 infection achieved a sustained virological response (SVR) with glecaprevir\/pibrentasvir, with no virological failures. To increase the body of data for these less prevalent genotypes, ENDURANCE-5,6 evaluated the efficacy and safety of glecaprevir\/pibrentasvir exclusively in patients infected with HCV genotype 5 or 6.<\/p>\r\n<\/div>\r\n

\r\n

Methods<\/h3>\r\n

ENDURANCE-5,6 was a phase 3b, single-arm, open-label, multicentre trial done in 24 hospitals or clinics in Europe, Oceania, North America, South Africa, and southeast Asia. Adults with chronic HCV genotype 5 or 6 infection who were previously untreated or treatment-experienced were eligible to be enrolled. Glecaprevir\/pibrentasvir (300 mg\/120 mg) was given orally once daily for 8 weeks (for patients without cirrhosis) or 12 weeks (for patients with compensated cirrhosis). The primary efficacy endpoint was SVR12 (ie, HCV RNA <15 IU\/mL at 12 weeks post-treatment), assessed within each HCV genotype, and analysed in the\u00a0intention-to-treat<\/a>\u00a0population. This trial is registered with\u00a0ClinicalTrials.gov<\/a>, number\u00a0NCT02966795<\/a>.<\/p>\r\n<\/div>\r\n

\r\n

Findings<\/h3>\r\n

Between Feb 9, 2017, and Aug 28, 2018, 84 patients were enrolled: 23 with genotype 5 infection and 61 with genotype 6 infection. Overall, 82 (97\u00b76%, 95% CI 94\u00b74\u2013100\u00b70) of the 84 patients achieved SVR12. 22 (95\u00b77%, 95% CI 87\u00b73\u2013100\u00b70) of 23 patients with genotype 5 infection achieved SVR12, as did 60 (98\u00b74%, CI 95\u00b72\u2013100\u00b70) of 61 with genotype 6 infection. One patient with an HCV genotype 6f infection and\u00a0cirrhosis<\/a>\u00a0had on-treatment virological failure at treatment week 12, and one patient with HCV genotype 5a without cirrhosis who had achieved SVR at post-treatment week 4 relapsed at post-treatment week 12. Five (6%) patients had serious adverse events, none of which were deemed related to glecaprevir\/pibrentsavir or led to discontinuation. Fatigue (11 [13%] patients) and headache (11 [13%]) were the only adverse events that occurred in 10% or more of patients. No post-baseline grade 3 or higher increases in\u00a0aminotransferase<\/a>\u00a0concentrations were reported.<\/p>\r\n<\/div>\r\n

\r\n

Interpretation<\/h3>\r\n

Glecaprevir\/pibrentasvir achieved high SVR12 rates, comparable with data reported in registrational studies, and was well tolerated in patients with HCV genotype 5 or 6 infection with compensated liver disease.<\/p>\r\n<\/div>[:]","paragraphe_en":"[:en]

Summary<\/h2>\r\n
\r\n

Background<\/h3>\r\n

The pangenotypic direct-acting antiviral regimen of glecaprevir coformulated with pibrentasvir is approved to treat chronic\u00a0hepatitis C virus<\/a>\u00a0(HCV) genotype 1\u20136 infection in adults. In registrational studies, 84 (99%) of 85 patients with HCV genotype 5 or 6 infection achieved a sustained virological response (SVR) with glecaprevir\/pibrentasvir, with no virological failures. To increase the body of data for these less prevalent genotypes, ENDURANCE-5,6 evaluated the efficacy and safety of glecaprevir\/pibrentasvir exclusively in patients infected with HCV genotype 5 or 6.<\/p>\r\n<\/div>\r\n

\r\n

Methods<\/h3>\r\n

ENDURANCE-5,6 was a phase 3b, single-arm, open-label, multicentre trial done in 24 hospitals or clinics in Europe, Oceania, North America, South Africa, and southeast Asia. Adults with chronic HCV genotype 5 or 6 infection who were previously untreated or treatment-experienced were eligible to be enrolled. Glecaprevir\/pibrentasvir (300 mg\/120 mg) was given orally once daily for 8 weeks (for patients without cirrhosis) or 12 weeks (for patients with compensated cirrhosis). The primary efficacy endpoint was SVR12 (ie, HCV RNA <15 IU\/mL at 12 weeks post-treatment), assessed within each HCV genotype, and analysed in the\u00a0intention-to-treat<\/a>\u00a0population. This trial is registered with\u00a0ClinicalTrials.gov<\/a>, number\u00a0NCT02966795<\/a>.<\/p>\r\n<\/div>\r\n

\r\n

Findings<\/h3>\r\n

Between Feb 9, 2017, and Aug 28, 2018, 84 patients were enrolled: 23 with genotype 5 infection and 61 with genotype 6 infection. Overall, 82 (97\u00b76%, 95% CI 94\u00b74\u2013100\u00b70) of the 84 patients achieved SVR12. 22 (95\u00b77%, 95% CI 87\u00b73\u2013100\u00b70) of 23 patients with genotype 5 infection achieved SVR12, as did 60 (98\u00b74%, CI 95\u00b72\u2013100\u00b70) of 61 with genotype 6 infection. One patient with an HCV genotype 6f infection and\u00a0cirrhosis<\/a>\u00a0had on-treatment virological failure at treatment week 12, and one patient with HCV genotype 5a without cirrhosis who had achieved SVR at post-treatment week 4 relapsed at post-treatment week 12. Five (6%) patients had serious adverse events, none of which were deemed related to glecaprevir\/pibrentsavir or led to discontinuation. Fatigue (11 [13%] patients) and headache (11 [13%]) were the only adverse events that occurred in 10% or more of patients. No post-baseline grade 3 or higher increases in\u00a0aminotransferase<\/a>\u00a0concentrations were reported.<\/p>\r\n<\/div>\r\n

\r\n

Interpretation<\/h3>\r\n

Glecaprevir\/pibrentasvir achieved high SVR12 rates, comparable with data reported in registrational studies, and was well tolerated in patients with HCV genotype 5 or 6 infection with compensated liver disease.<\/p>\r\n<\/div>[:]","documents":null},"yoast_head":"\nEfficacy and safety of glecaprevir\/pibrentasvir in patients with chronic hepatitis C virus genotype 5 or 6 infection (ENDURANCE-5,6): an open-label, multicentre, phase 3b trial - CRI<\/title>\n<meta name=\"robots\" content=\"noindex, follow, max-snippet:-1, max-image-preview:large, max-video-preview:-1\" \/>\n<meta property=\"og:locale\" content=\"en_US\" \/>\n<meta property=\"og:type\" content=\"article\" \/>\n<meta property=\"og:title\" content=\"Efficacy and safety of glecaprevir\/pibrentasvir in patients with chronic hepatitis C virus genotype 5 or 6 infection (ENDURANCE-5,6): an open-label, multicentre, phase 3b trial - CRI\" \/>\n<meta property=\"og:url\" content=\"https:\/\/cri1149.mlcom-dev.net\/publication\/efficacy-and-safety-of-glecaprevir-pibrentasvir-in-patients-with-chronic-hepatitis-c-virus-genotype-5-or-6-infection-endurance-56-an-open-label-multicentre-phase-3b-trial\/\" \/>\n<meta property=\"og:site_name\" content=\"CRI\" \/>\n<meta property=\"article:publisher\" content=\"https:\/\/www.facebook.com\/CRI-Centre-de-recherche-sur-linflammation-100116118884153\" \/>\n<meta property=\"article:modified_time\" content=\"2025-09-11T14:48:01+00:00\" \/>\n<meta name=\"twitter:card\" content=\"summary_large_image\" \/>\n<script type=\"application\/ld+json\" class=\"yoast-schema-graph\">{\"@context\":\"https:\/\/schema.org\",\"@graph\":[{\"@type\":\"WebPage\",\"@id\":\"https:\/\/cri1149.mlcom-dev.net\/publication\/efficacy-and-safety-of-glecaprevir-pibrentasvir-in-patients-with-chronic-hepatitis-c-virus-genotype-5-or-6-infection-endurance-56-an-open-label-multicentre-phase-3b-trial\/\",\"url\":\"https:\/\/cri1149.mlcom-dev.net\/publication\/efficacy-and-safety-of-glecaprevir-pibrentasvir-in-patients-with-chronic-hepatitis-c-virus-genotype-5-or-6-infection-endurance-56-an-open-label-multicentre-phase-3b-trial\/\",\"name\":\"Efficacy and safety of glecaprevir\/pibrentasvir in patients with chronic hepatitis C virus genotype 5 or 6 infection (ENDURANCE-5,6): an open-label, multicentre, phase 3b trial - 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