TY  - JOUR
A1  - Graf, Christiana
A1  - Mondorf, Antonia
A1  - Knop, Viola
A1  - Peiffer, Kai-Henrik
A1  - Dietz, Julia
A1  - Friess, Julia
A1  - Wedemeyer, Heiner
A1  - Buggisch, Peter
A1  - Mauss, Stefan
A1  - Berg, Thomas
A1  - Rausch, Michael
A1  - Sprinzl, Martin
A1  - Klinker, Hartwig
A1  - Hinrichsen, Holger
A1  - Bronowicki, Jean-Pierre
A1  - Haag, Sebastian
A1  - Hüppe, Dietrich
A1  - Lutz, Thomas
A1  - Poynard, Thierry
A1  - Zeuzem, Stefan
A1  - Friedrich-Rust, Mireen
A1  - Sarrazin, Christoph
A1  - Vermehren, Johannes
T1  - Evaluation of point shear wave elastography using acoustic radiation force impulse imaging for longitudinal fibrosis assessment in patients with HBeAg-Negative HBV infection
JF  - Journal of Clinical Medicine
N2  - Background: Accurate assessment of hepatic fibrosis in patients with chronic HBeAg-negative Hepatitis B is of crucial importance not only to predict the long-term clinical course, but also to evaluate antiviral therapy indication. The aim of this study was to prospectively assess the utility of point shear wave elastography (pSWE) for longitudinal non-invasive fibrosis assessment in a large cohort of untreated patients with chronic HBeAg-negative hepatitis B virus (HBV) infection. Methods: 407 consecutive patients with HBeAg-negative HBV infection who underwent pSWE, transient elastography (TE) as well as laboratory fibrosis markers, including fibrosis index based on four factors (FIB-4), aspartate to platelet ratio index (APRI) and FibroTest, on the same day were prospectively followed up for six years. Patients were classified into one of the three groups: inactive carriers (IC; HBV-DNA <2000 IU/mL and ALT <40 U/L); grey zone group 1 (GZ-1; HBV DNA <2000 IU/mL and ALT >40 U/L); grey zone group 2 (GZ-2; HBV-DNA >2000 IU/mL and ALT <40 U/L). Results: pSWE results were significantly correlated with TE (r = 0.29, p < 0.001) and APRI (r = 0.17; p = 0.005). Median pSWE values did not differ between IC, GZ-1 and GZ-2 patients (p = 0.82, p = 0.17, p = 0.34). During six years of follow-up, median pSWE and TE values did not differ significantly over time (TE: p = 0.27; pSWE: p = 0.05). Conclusion: Our data indicate that pSWE could be useful for non-invasive fibrosis assessment and follow-up in patients with HBeAg-negative chronic HBV infection.
KW  - HBV
KW  - non-invasive fibrosis assessment
KW  - point shear wave elastography
KW  - acoustic radiation force impulse imaging
KW  - transient elastography
KW  - fibrotest
KW  - APRI
KW  - FIB-4
Y1  - 2019
U6  - http://nbn-resolving.de/urn/resolver.pl?urn:nbn:de:bvb:20-opus-193916
SN  - 2077-0383
VL  - 8
IS  - 12
ER  - 
TY  - JOUR
A1  - Cornberg, Markus
A1  - Stoehr, Albrecht
A1  - Naumann, Uwe
A1  - Teuber, Gerlinde
A1  - Klinker, Hartwig
A1  - Lutz, Thomas
A1  - Möller, Hjördis
A1  - Hidde, Dennis
A1  - Lohmann, Kristina
A1  - Simon, Karl-Georg
T1  - 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)
JF  - Viruses
N2  - 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.
KW  - direct-acting antiviral
KW  - glecaprevir/pibrentasvir
KW  - hepatitis C virus
KW  - real world evidence
KW  - German Hepatitis C-Registry
Y1  - 2022
U6  - http://nbn-resolving.de/urn/resolver.pl?urn:nbn:de:bvb:20-opus-281939
SN  - 1999-4915
VL  - 14
IS  - 7
ER  -