Real-World Safety, Effectiveness, and Patient-Reported Outcomes in Patients with Chronic Hepatitis C Virus Infection Treated with Glecaprevir/Pibrentasvir: Updated Data from the German Hepatitis C-Registry (DHC-R)

被引:5
作者
Cornberg, Markus [1 ]
Stoehr, Albrecht [2 ]
Naumann, Uwe [3 ]
Teuber, Gerlinde [4 ]
Klinker, Hartwig [5 ]
Lutz, Thomas [6 ]
Moller, Hjoerdis [7 ]
Hidde, Dennis [8 ]
Lohmann, Kristina [8 ]
Simon, Karl-Georg [9 ]
机构
[1] Hannover Med Hsch, Klin Gastroenterol Hepatol & Endokrinol, D-30625 Hannover, Germany
[2] IFI Med GmbH, D-20099 Hamburg, Germany
[3] UBN Praxis, D-14059 Berlin, Germany
[4] Practice PD Dr Med G Teuber, D-60594 Frankfurt, Germany
[5] Univ Hosp Wurzburg, Dept Internal Med, D-97080 Wurzburg, Germany
[6] Infektiologikum, D-60596 Frankfurt, Germany
[7] Leberzentrum Checkpoint, D-10961 Berlin, Germany
[8] AbbVie Germany GmbH & Co KG, D-65189 Wiesbaden, Germany
[9] MVZ Dres Eisenbach Simon Schwarz GbR, D-51375 Leverkusen, Germany
来源
VIRUSES-BASEL | 2022年 / 14卷 / 07期
关键词
direct-acting antiviral; glecaprevir; pibrentasvir; hepatitis C virus; real world evidence; German Hepatitis C-Registry; UNITED-STATES; DRUG-USE; SF-36;
D O I
10.3390/v14071541
中图分类号
Q93 [微生物学];
学科分类号
071005 ; 100705 ;
摘要
Using data from the German Hepatitis C-Registry (Deutsche Hepatitis C-Register, DHC-R), we report the real-world safety and effectiveness of glecaprevir/pibrentasvir (GLE/PIB) treatment and its impact on patient-reported outcomes (PROs) in underserved populations who are not typically included in clinical trials, yet who will be crucial for achieving hepatitis C virus (HCV) elimination. The DHC-R is an ongoing, non-interventional, multicenter, prospective, observational cohort study on patients treated for chronic HCV infection in Germany. The data cutoff was 17 January 2021. The primary effectiveness endpoint was sustained virologic response at post-treatment Week 12 (SVR12). Safety outcomes were assessed in all patients receiving GLE/PIB. PROs were assessed using the SF-36 survey. Of 2354 patients, 1964 had valid SVR12 data (intention-to-treat analysis). Of these, 1905 (97.0%) achieved SVR12 with rates similar across the comorbidities analyzed, except for people who actively use drugs (PWUD (active)) (86.4%). Excluding those who discontinued treatment and did not achieve SVR12, or were reinfected with HCV, the rate was 99.3%, with similar results regardless of comorbidity. PWUD (active) and those with psychiatric disorders had the most meaningful improvements in PROs. Adverse events (AEs) occurred in 631/2354 patients (26.8%), and serious AEs in 44 patients (1.9%). GLE/PIB was highly effective and well tolerated in this real-world study of patient groups key to HCV elimination.
引用
收藏
页数:15
相关论文
共 38 条
[1]  
[Anonymous], ABBVIE MAVIRET GLECA
[2]  
[Anonymous], American Association for the Study of Liver Diseases Evaluation for Liver Transplantation in Adults
[3]  
[Anonymous], GUID CAR TREATM PERS
[4]   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 [J].
Asselah, Tarik ;
Lee, Samuel S. ;
Yao, Betty B. ;
Tuan Nguyen ;
Wong, Florence ;
Mahomed, Adam ;
Lim, Seng Gee ;
Abergel, Armand ;
Sasadeusz, Joe ;
Gane, Edward ;
Zadeikis, Neddie ;
Schnell, Gretja ;
Zhang, Zhenzhen ;
Porcalla, Ariel ;
Mensa, Federico J. ;
Kinh Nguyen .
LANCET GASTROENTEROLOGY & HEPATOLOGY, 2019, 4 (01) :45-51
[5]   Efficacy of Glecaprevir/Pibrentasvir for 8 or 12 Weeks in Patients With Hepatitis C Virus Genotype 2, 4, 5, or 6 Infection Without Cirrhosis [J].
Asselah, Tarik ;
Kowdley, Kris V. ;
Zadeikis, Neddie ;
Wang, Stanley ;
Hassanein, Tarek ;
Horsmans, Yves ;
Colombo, Massimo ;
Calinas, Filipe ;
Aguilar, Humberto ;
de Ledinghen, Victor ;
Mantry, Parvez S. ;
Hezode, Christophe ;
Marinho, Rui Tato ;
Agarwal, Kosh ;
Nevens, Frederik ;
Elkhashab, Magdy ;
Kort, Jens ;
Liu, Ran ;
Ng, Teresa I. ;
Krishnan, Preethi ;
Lin, Chih-Wei ;
Mensa, Federico J. .
CLINICAL GASTROENTEROLOGY AND HEPATOLOGY, 2018, 16 (03) :417-426
[6]   Real-world effectiveness and safety of glecaprevir/pibrentasvir for the treatment of chronic hepatitis C infection: data from the German Hepatitis C-Registry [J].
Berg, Thomas ;
Naumann, Uwe ;
Stoehr, Albrecht ;
Sick, Christoph ;
John, Christine ;
Teuber, Gerlinde ;
Schiffelholz, Willibold ;
Mauss, Stefan ;
Lohmann, Kristina ;
Koenig, Bettina ;
Pangerl, Andreas ;
Niederau, Claus .
ALIMENTARY PHARMACOLOGY & THERAPEUTICS, 2019, 49 (08) :1052-1059
[7]   Glecaprevir/pibrentasvir for 8 weeks in treatment-naive patients with chronic HCV genotypes 1-6 and compensated cirrhosis: The EXPEDITION-8 trial [J].
Brown, Robert S., Jr. ;
Buti, Maria ;
Rodrigues, Lino ;
Chulanov, Vladimir ;
Chuang, Wan-Long ;
Aguilar, Humberto ;
Horvath, Gabor ;
Zuckerman, Elimelech ;
Carrion, Barbara Rosado ;
Rodriguez-Perez, Federico ;
Urbanek, Petr ;
Abergel, Armand ;
Cohen, Eric ;
Lovell, Sandra S. ;
Schnell, Gretja ;
Lin, Chih-Wei ;
Zha, Jiuhong ;
Wang, Stanley ;
Trinh, Roger ;
Mensa, Federico J. ;
Burroughs, Margaret ;
Felizarta, Franco .
JOURNAL OF HEPATOLOGY, 2020, 72 (03) :441-449
[8]   Real-world effectiveness of 8-week treatment with ledipasvir/sofosbuvir in chronic hepatitis C [J].
Buggisch, Peter ;
Vermehren, Johannes ;
Mauss, Stefan ;
Guenther, Rainer ;
Schott, Eckart ;
Pathil, Anita ;
Boeker, Klaus ;
Zimmermann, Tim ;
Teuber, Gerlinde ;
Vornkahl, Heike-Pfeiffer ;
Simon, Karl-Georg ;
Niederau, Claus ;
Wedemeyer, Heiner ;
Zeuzem, Stefan .
JOURNAL OF HEPATOLOGY, 2018, 68 (04) :663-671
[9]   Evaluation of the meaningfulness of health-related quality of life improvements as assessed by the SF-36 and the EQ-5D VAS in patients with active Crohn's disease [J].
Coteur, G. ;
Feagan, B. ;
Keininger, D. L. ;
Kosinski, M. .
ALIMENTARY PHARMACOLOGY & THERAPEUTICS, 2009, 29 (09) :1032-1041
[10]   Loss to follow-up: A significant barrier in the treatment cascade with direct-acting therapies [J].
Darvishian, Maryam ;
Wong, Stanley ;
Binka, Mawuena ;
Yu, Amanda ;
Ramji, Alnoor ;
Yoshida, Eric M. ;
Wong, Jason ;
Rossi, Carmine ;
Butt, Zahid A. ;
Bartlett, Sofia ;
Pearce, Margo E. ;
Samji, Hasina ;
Cook, Darrel ;
Alvarez, Maria ;
Chong, Mei ;
Tyndall, Mark ;
Krajden, Mel ;
Janjua, Naveed Z. .
JOURNAL OF VIRAL HEPATITIS, 2020, 27 (03) :243-260