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

The Lancet Gastroenterology & Hepatology - Tập 4 - Trang 45-51 - 2019
Tarik Asselah1, Samuel S Lee2, Betty B Yao3, Tuan Nguyen4, Florence Wong5, Adam Mahomed6, Seng Gee Lim7, Armand Abergel8, Joe Sasadeusz9, Edward Gane10, Neddie Zadeikis3, Gretja Schnell3, Zhenzhen Zhang3, Ariel Porcalla3, Federico J Mensa3, Kinh Nguyen11
1Centre de Recherche sur l'Inflammation, INSERM UMR 1149, Université Paris Diderot, Department of Hepatology, AP-HP Hôpital Beaujon, Clichy, France
2University of Calgary, Calgary, AB, Canada
3AbbVie Inc., North Chicago, IL, USA
4Research and Education, Inc, San Diego, CA, USA
5Toronto General Hospital, University of Toronto, Toronto, ON, Canada
6Department of Gastroenterology and Hepatology, Faculty of Health Sciences, University of Witwatersrand, Charlotte Maxeke Johannesburg Academic Hospital, Johannesburg, South Africa
7Division of Gastroenterology and Hepatology, National University Health System, Singapore
8CHU Estaing, Clermont Ferrand, France
9Royal Melbourne Hospital, Melbourne, Vic, Australia
10Auckland Clinical Studies, Auckland, New Zealand
11National Hospital for Tropical Diseases, Hanoi, Vietnam

Tài liệu tham khảo

Smith, 2014, Expanded classification of hepatitis C virus into 7 genotypes and 67 subtypes: updated criteria and genotype assignment web resource, Hepatology, 59, 318, 10.1002/hep.26744 Messina, 2015, Global distribution and prevalence of hepatitis C virus genotypes, Hepatology, 61, 77, 10.1002/hep.27259 Asselah, 2017, Eliminating hepatitis C within low-income countries—the need to cure genotypes 4, 5, 6, J Hepatol Boyd, 2018, HCV genotype 4, 5 and 6: distribution of viral subtypes and sustained virologic response rates in clinical trials of approved direct-acting antiviral regimens, J Viral Hepat, 25, 969, 10.1111/jvh.12896 Thong, 2014, Hepatitis C virus genotype 6: virology, epidemiology, genetic variation and clinical implication, World J Gastroenterol, 20, 2927, 10.3748/wjg.v20.i11.2927 Li, 2014, Nine additional complete genome sequences of HCV genotype 6 from Vietnam including new subtypes 6xb and 6xc, Virology, 468–470, 172, 10.1016/j.virol.2014.08.006 Li, 2015, An expanded taxonomy of hepatitis C virus genotype 6: characterization of 22 new full-length viral genomes, Virology, 476, 355, 10.1016/j.virol.2014.12.025 2017 Ng, 2018, In vitro antiviral activity and resistance profile of the next-generation hepatitis C virus NS3/4A protease inhibitor glecaprevir, Antimicrob Agents Chemother, 62, e01620, 10.1128/AAC.01620-17 Ng, 2017, In vitro antiviral activity and resistance profile of the next generation hepatitis C virus NS5A inhibitor pibrentasvir, Antimicrob Agents Chemother, 61, e02558, 10.1128/AAC.02558-16 Reau, 2018, Glecaprevir/pibrentasvir treatment in liver or kidney transplant patients with hepatitis C virus infection, Hepatology, 68, 1298, 10.1002/hep.30046 Rockstroh, 2018, Efficacy and safety of glecaprevir/pibrentasvir in patients coinfected with hepatitis C virus and human immunodeficiency virus type 1: the EXPEDITION-2 Study, Clin Infect Dis, 67, 1010, 10.1093/cid/ciy220 Forns, 2017, Glecaprevir plus pibrentasvir for chronic hepatitis C virus genotype 1, 2, 4, 5, or 6 infection in adults with compensated cirrhosis (EXPEDITION-1): a single-arm, open-label, multicentre phase 3 trial, Lancet Infect Dis, 17, 1062, 10.1016/S1473-3099(17)30496-6 Asselah, 2018, Efficacy of glecaprevir/pibrentasvir for 8 or 12 weeks in patients with hepatitis C virus genotype 2, 4, 5, or 6 infection without cirrhosis, Clin Gastroenterol Hepatol, 16, 417, 10.1016/j.cgh.2017.09.027 Kwo, 2017, Glecaprevir and pibrentasvir yield high response rates in patients with HCV genotype 1-6 without cirrhosis, J Hepatol, 67, 263, 10.1016/j.jhep.2017.03.039 Gane, 2017, Glecaprevir and pibrentasvir in patients with HCV and severe renal impairment, N Engl J Med, 377, 1448, 10.1056/NEJMoa1704053 Puoti, 2018, High SVR12 with 8-week and 12-week glecaprevir/pibrentasvir therapy: an integrated analysis of HCV genotype 1-6 patients without cirrhosis, J Hepatol, 69, 293, 10.1016/j.jhep.2018.03.007 Chao, 2011, Systematic review: epidemiology of hepatitis C genotype 6 and its management, Aliment Pharmacol Ther, 34, 286, 10.1111/j.1365-2036.2011.04714.x George, 2018, Elbasvir/grazoprevir in Asia-Pacific/Russian participants with chronic hepatitis C virus genotype 1, 4, or 6 infection, Hepatol Commun, 2, 595, 10.1002/hep4.1177 2018, EASL Recommendations on Treatment of Hepatitis C 2018, J Hepatol, 69, 461, 10.1016/j.jhep.2018.03.026 Feld, 2015, Sofosbuvir and velpatasvir for HCV genotype 1, 2, 4, 5, and 6 infection, N Engl J Med, 373, 2599, 10.1056/NEJMoa1512610 Abergel, 2016, Ledipasvir-sofosbuvir in patients with hepatitis C virus genotype 5 infection: an open-label, multicentre, single-arm, phase 2 study, Lancet Infect Dis, 16, 459, 10.1016/S1473-3099(15)00529-0 Gane, 2015, Efficacy of ledipasvir and sofosbuvir, with or without ribavirin, for 12 weeks in patients with HCV genotype 3 or 6 infection, Gastroenterology, 149, 1454, 10.1053/j.gastro.2015.07.063 Bourliere, 2017, Sofosbuvir, velpatasvir, and voxilaprevir for previously treated HCV infection, N Engl J Med, 376, 2134, 10.1056/NEJMoa1613512 Jacobson, 2017, Efficacy of 8 weeks of sofosbuvir, velpatasvir, and voxilaprevir in patients with chronic HCV infection: 2 phase 3 randomized trials, Gastroenterology, 153, 113, 10.1053/j.gastro.2017.03.047 D'Ambrosio, 2018, Real-life effectiveness and safety of glecaprevir/pibrentasvir among 723 Italian patients with chronic hepatitis C: the Navigator-II study, J Hepatol, 68, S65, 10.1016/S0168-8278(18)30351-9 Berg, 2018, First real-world data on safety and effectiveness of glecaprevir/pibrentasvir for the treatment of patients with chronic hepatitis C virus infection: data from the German Hepatitis C-Registry, J Hepatol, 68, S37, 10.1016/S0168-8278(18)30290-3