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:3
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.
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页数:15
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