Efficacy of Glecaprevir/Pibrentasvir for 8 or 12 Weeks in Patients With Hepatitis C Virus Genotype 2, 4, 5, or 6 Infection Without Cirrhosis

Clinical Gastroenterology and Hepatology - Tập 16 - Trang 417-426 - 2018
Tarik Asselah1, Kris V. Kowdley2, Neddie Zadeikis3, Stanley Wang3, Tarek Hassanein4, Yves Horsmans5, Massimo Colombo6, Filipe Calinas7, Humberto Aguilar8, Victor de Ledinghen9, Parvez S. Mantry10, Christophe Hezode11, Rui Tato Marinho12, Kosh Agarwal13, Frederik Nevens14, Magdy Elkhashab15, Jens Kort3, Ran Liu3, Teresa I. Ng3, Preethi Krishnan3
1Centre de Recherche sur l'Inflammation, INSERM UMR 1149, Université Paris Diderot, Department of Hepatology, AP-HP Hôpital Beaujon, Clichy, France
2Swedish Medical Center, Seattle, Washington
3AbbVie Inc, North Chicago, Illinois
4Southern California GI and Liver Centers and Southern California Research Center, Coronado, California
5Cliniques Universitaires Saint-Luc, Université Catholique de Louvain, Brussels, Belgium
6Humanitas Clinical and Research Center, Rozzano, Italy
7Central Lisbon Hospital Centre, Lisbon, Portugal
8Louisiana Research Center, Shreveport, Louisiana
9Centre d'Investigation de la Fibrose Hépatique, Hôpital Haut-Lévêque, Centre Hospitalier Universitaire de Bordeaux, Pessac, France, and INSERM U1053, Université Bordeaux, Bordeaux, France
10The Liver Institute at Methodist Dallas, Dallas, Texas
11Hôpital Henri Mondor, AP-HP, Université Paris-Est, INSERM U955, Créteil, France
12Hospital S. Maria, Medical School of Lisbon, University of Lisbon, Portugal
13Institute of Liver Studies, Kings College Hospital, London, United Kingdom
14University Hospitals KU, Leuven, Belgium
15Toronto Liver Centre, Toronto, Ontario, Canada

Tài liệu tham khảo

Hatzakis, 2015, The present and future disease burden of hepatitis C virus (HCV) infections with today's treatment paradigm: volume 2, J Viral Hepat, 22, 26, 10.1111/jvh.12351 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, 2016, Direct-acting antivirals for the treatment of hepatitis C virus infection: optimizing current IFN-free treatment and future perspectives, Liver Int, 36, 47, 10.1111/liv.13027 2016 2016 HARVONI (ledipasvir and sofosbuvir) tablets. Prescribing information. Foster City, CA: Gilead Sciences, 2015. 2016 2017 2017, EASL. Recommendations on treatment of hepatitis C 2016, J Hepatol, 66, 153, 10.1016/j.jhep.2016.09.001 Ng, 2017, In vitro antiviral activity and resistance profile of the next generation hepatitis C virus NS5A inhibitor pibrentasvir, Antimicrob Agents Chemother, 61, 10.1128/AAC.02558-16 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 Westfall, 2001, Optimally weighted, fixed sequence and gatekeeper multiple testing procedures, J Stat Plan Inference, 99, 25, 10.1016/S0378-3758(01)00077-5 Schinazi, 2017, From HCV to HBV cure, Liver Int, 37, 73, 10.1111/liv.13324 Kwo, 2011, The therapeutic approaches for hepatitis C virus: protease inhibitors and polymerase inhibitors, Gut Liver, 5, 406, 10.5009/gnl.2011.5.4.406 Chae, 2013, Direct-acting antivirals for the treatment of chronic hepatitis C: open issues and future perspectives, Scientific World Journal, 2013, 704912, 10.1155/2013/704912 Banerjee, 2016, Review article: safety and tolerability of direct-acting anti-viral agents in the new era of hepatitis C therapy, Aliment Pharmacol Ther, 43, 674, 10.1111/apt.13514 2015, Hepatitis C guidance: AASLD-IDSA recommendations for testing, managing, and treating adults infected with hepatitis C virus, Hepatology, 62, 932, 10.1002/hep.27950 Foster, 2015, Sofosbuvir and velpatasvir for HCV genotype 2 and 3 infection, N Engl J Med, 373, 2608, 10.1056/NEJMoa1512612 Feld, 2015, Sofosbuvir and velpatasvir for HCV genotype 1, 2, 4, 5, and 6 infection, N Engl J Med, 373, 2599, 10.1056/NEJMoa1512610 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 2017 2017 Cheng, 2016, In vitro antiviral activity and resistance profile characterization of the hepatitis C virus NS5A inhibitor ledipasvir, Antimicrob Agents Chemother, 60, 1847, 10.1128/AAC.02524-15 Wang, 2014, Comparison of daclatasvir resistance barriers on NS5A from hepatitis C virus genotypes 1 to 6: implications for cross-genotype activity, Antimicrob Agents Chemother, 58, 5155, 10.1128/AAC.02788-14 Kwo, 2017, High SVR rates upon 8- or 12-week treatment with glecaprevir and pibrentasvir in patients with chronic HCV genotype 1-6 infection without cirrhosis, J Hepatol, 67, 263, 10.1016/j.jhep.2017.03.039 Zeuzem S, Feld J, Wang S, et al. ENDURANCE-1: efficacy and safety of 8- versus 12-week treatment with ABT-493/ABT-530 in patients with chronic HCV genotype 1 infection. The Liver Meeting, Boston, MA, 2016. Ng, 2016, Analysis of HCV variants in the MAGELLAN-I study (part 1): ABT-493 and ABT-530 combination therapy of genotype 1-infected patients who had failed prior direct acting antiviral-containing regimens, Hepatology, 64, 417A Muir, 2016, High SVR rates with ABT-493 + ABT-530 co-administered for 8 weeks in non-cirrhotic patients with HCV genotype 3 infection, Hepatology, 64, 183 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 Infectious Diseases, 17, 1062, 10.1016/S1473-3099(17)30496-6 Puoti M, Foster G, Wang S, et al. High SVR rates with eight and twelve weeks of pangenotypic glecaprevir/pibrentasvir: integrated efficacy analysis of genotype 1–6 patients without cirrhosis. International Liver Congress, Amsterdam, Netherlands, 2017.