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1. Monitoring of endoscope reprocessing with an adenosine triphosphate (ATP) bioluminescence method

Author

Parohl, Nina, Stiefenhöfer, Doris, Heiligtag, Sabine, Reuter, Henning, Dopadlik, Dana, Mosel, Frank, Gerken, Guido, Dechêne, Alexander, Heintschel von Heinegg, Evelyn, Jochum, Christoph, Buer, Jan, and Popp, Walter

Subjects
endoscope reprocessing, contamination, process control, surveillance, ATP, adenosine triphosphate, microbial cultures, Medicine, Public aspects of medicine, RA1-1270, Microbiology, QR1-502
Abstract

Background: The arising challenges over endoscope reprocessing quality proposes to look for possibilities to measure and control the process of endoscope reprocessing.Aim: The goal of this study was to evaluate the feasibility of monitoring endoscope reprocessing with an adenosine triphosphate (ATP) based bioluminescence system.Methods: 60 samples of eight gastroscopes have been assessed from routine clinical use in a major university hospital in Germany. Endoscopes have been assessed with an ATP system and microbial cultures at different timepoints during the reprocessing. Findings: After the bedside flush the mean ATP level in relative light units (RLU) was 19,437 RLU, after the manual cleaning 667 RLU and after the automated endoscope reprocessor (AER) 227 RLU. After the manual cleaning the mean total viable count (TVC) per endoscope was 15.3 CFU/10 ml, and after the AER 5.7 CFU/10 ml. Our results show that there are reprocessing cycles which are not able to clean a patient used endoscope.Conclusion: Our data suggest that monitoring of flexible endoscope with ATP can identify a number of different influence factors, like the endoscope condition and the endoscopic procedure, or especially the quality of the bedside flush and manual cleaning before the AER. More process control is one option to identify and improve influence factors to finally increase the overall reprocessing quality, best of all by different methods. ATP measurement seems to be a valid technique that allows an immediate repeat of the manual cleaning if the ATP results after manual cleaning exceed the established cutoff of 200 RLU.

Published
2017
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3. Prevention in Hepatology

Author

Muñoz-Restrepo, Ana-Maria, primary, Navas, Maria-Cristina, additional, Daza, Jimmy, additional, Girala, Marcos, additional, Ridruejo, Ezequiel, additional, Gerken, Guido, additional, and Teufel, Andreas, additional

Published
2024
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4. Serum alpha-fetoprotein and clinical outcomes in patients with advanced hepatocellular carcinoma treated with ramucirumab

Author

Zhu, Andrew X., Finn, Richard S., Kang, Yoon-Koo, Yen, Chia-Jui, Galle, Peter R., Llovet, Josep M., Assenat, Eric, Brandi, Giovanni, Motomura, Kenta, Ohno, Izumi, Daniele, Bruno, Vogel, Arndt, Yamashita, Tatsuya, Hsu, Chih-Hung, Gerken, Guido, Bilbruck, John, Hsu, Yanzhi, Liang, Kun, Widau, Ryan C., Wang, Chunxiao, Abada, Paolo, and Kudo, Masatoshi

Published
2021
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5. Factors Positively Correlated with Hepatitis B Surface Antigen Seroconversion in Chronic Hepatitis B.

Author

Buechter, Matthias, Günther, Arne Maria, Manka, Paul, Gerken, Guido, and Kahraman, Alisan

Subjects
HEPATITIS associated antigen, HIV seroconversion, CHRONIC hepatitis B, SEROCONVERSION, HEPATITIS B virus, HEPATITIS B
Abstract

Background and Aims: Chronic hepatitis B virus (HBV) infection is a global public health challenge since more than 250 million individuals are affected worldwide. Since different treatment modalities are available and not all patients are candidates for antiviral treatment, biomarkers that potentially predict the possibility of HBsAg clearance and seroconversion may be useful in clinical practice. Patients and methods: In this retrospective study, we aimed to identify factors positively correlated with HBsAg seroconversion in a large cohort of 371 chronic hepatitis B patients treated at a German tertial center between 2005 and 2020. Results: Seroconversion occurred in 25/371 (6.7%) and HBsAg loss in 29/371 patients (7.8%) with chronic HBV infection. Antiviral therapy was associated with a lower chance of seroconversion (seroconversion antiviral therapy 14/260 (5.4%) vs. therapy-naïve patients 11/111 (9.9%), p = 0.027). Seroconversion rates were higher in patients with (very) low titers of HBV DNA (best cut-off value 357 IU/mL) and quantitative HBsAg. The best cut-off value with regard to seroconversion was 357 IU/mL for HBV DNA (AUC 0.693 (95%-CI 0.063–0.422), sensitivity 0.714, specificity 0.729; p < 0.0005) and 33,55 IU/mL for HBsAg (AUC 0.794 (95%-CI 0.651–0.937), sensitivity 0.714, specificity 0.949; p < 0.0005). However, male gender was positively associated with seroconversion (seroconversion: males 7.6% vs. females 2.7%, p = 0.036). Conclusions: Treatment-naïve male chronic HBV patients with low viral load and inflammatory activity have the best chance to achieve seroconversion. In the absence of cirrhosis, antiviral therapy should therefore not be performed in this patient collective. [ABSTRACT FROM AUTHOR]

Published
2024
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6. Longterm Outcome of Therapeutic Vaccination with a Third Generation Pre-S/S HBV Vaccine (PreHevbrio R) of Chronically HBV Infected Patients.

Author

Roggendorf, Hedwig, Shouval, Daniel, Roggendorf, Michael, and Gerken, Guido

Subjects
CHRONIC hepatitis B, HEPATITIS B virus, VACCINATION, VIRUS diseases, CELL surface antigens
Abstract

Several antiviral treatment regimens for chronic hepatitis B (CHB) virus infection have been shown to be effective in suppressing viral load and reducing the risk of hepatocellular injury and its complications. It has been hypothesized that high levels of circulating HBV surface antigen(s) may lead to immune tolerance against HBV and contribute to chronic carriership. Conversely, low-level HBsAg may create a window for the reconstitution of an HBV-specific immune response through vaccination and control of infection. Previous studies in non-responders to yeast-derived HBV vaccines, using a third-generation pre-S/S vaccine, have led to up to 95% anti-HBs seroconversion. This report evaluates the long-term outcome after experimental vaccination with a pre-S/S HBV vaccine intended as a therapeutic intervention in chronic HBV carriers. Four low-level HBsAg carriers (<500 IU/mL) were vaccinated three to seven times with 20 μg PreHevbrioR. Three out of four carriers eliminated HBsAg completely and seroconverted to anti-HBs. One patient seroconverted to anti-HBs but remained with a borderline HBsAg titer (10 IU/mL). Serum anti-HBs levels following repeated vaccination varied between 27 and >1000 IU/L, respectively. Long-term observation (>6 years) showed that after discontinuing NUC treatment for at least two years, HBsAg and HBV DNA remained negative with anti-HBs positive titers ranging between 80 and >1000 IU/L. Based on our preliminary observations, there is a rationale to further evaluate the role of this vaccine as a therapeutic agent. [ABSTRACT FROM AUTHOR]

Published
2024
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8. GALAD Score Detects Early Hepatocellular Carcinoma in an International Cohort of Patients With Nonalcoholic Steatohepatitis

Author

Best, Jan, Bechmann, Lars P., Sowa, Jan-Peter, Sydor, Svenja, Dechêne, Alexander, Pflanz, Kristina, Bedreli, Sotiria, Schotten, Clemens, Geier, Andreas, Berg, Thomas, Fischer, Janett, Vogel, Arndt, Bantel, Heike, Weinmann, Arndt, Schattenberg, Jörn M., Huber, Yvonne, Wege, Henning, von Felden, Johann, Schulze, Kornelius, Bettinger, Dominik, Thimme, Robert, Sinner, Friedrich, Schütte, Kerstin, Weiss, Karl Heinz, Toyoda, Hidenori, Yasuda, Satoshi, Kumada, Takashi, Berhane, Sarah, Wichert, Marc, Heider, Dominik, Gerken, Guido, Johnson, Philip, and Canbay, Ali

Published
2020
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10. Norursodeoxycholic acid versus placebo in the treatment of non-alcoholic fatty liver disease: a double-blind, randomised, placebo-controlled, phase 2 dose-finding trial

Author

Vogel, Wolfgang, Aigner, Elmar, Datz, Christian, Tilg, Herbert, Gerken, Guido, Rust, Christian, Cordes, Hans-Jörg, Steib, Christian, Pathil-Warth, Anita, Prinz, MD, Christian, Lammert, Frank, Antoni, Christoph, Klausmann, Gerhard, Häussinger, Dieter, Zipprich, Alexander, Traussnigg, Stefan, Schattenberg, Jörn M, Demir, Münevver, Wiegand, Johannes, Geier, Andreas, Teuber, Gerlinde, Hofmann, Wolf Peter, Kremer, Andreas E, Spreda, Frank, Kluwe, Johannes, Petersen, Jörg, Boettler, Tobias, Rainer, Florian, Halilbasic, Emina, Greinwald, Roland, Pröls, Markus, Manns, Michael P, Fickert, Peter, and Trauner, Michael

Published
2019
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12. Ramucirumab after sorafenib in patients with advanced hepatocellular carcinoma and increased α-fetoprotein concentrations (REACH-2): a randomised, double-blind, placebo-controlled, phase 3 trial

Author

Zhu, Andrew X, Kang, Yoon-Koo, Yen, Chia-Jui, Finn, Richard S, Galle, Peter R, Llovet, Josep M, Assenat, Eric, Brandi, Giovanni, Pracht, Marc, Lim, Ho Yeong, Rau, Kun-Ming, Motomura, Kenta, Ohno, Izumi, Merle, Philippe, Daniele, Bruno, Shin, Dong Bok, Gerken, Guido, Borg, Christophe, Hiriart, Jean-Baptiste, Okusaka, Takuji, Morimoto, Manabu, Hsu, Yanzhi, Abada, Paolo B, and Kudo, Masatoshi

Published
2019
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15. The tolerability of sofosbuvir/velpatasvir for 12 weeks in patients treated in the ASTRAL 1, 2 and 3 studies: A pooled safety analysis

Author

Jacobson, Ira M., primary, Bourgeois, Stefan, additional, Mathurin, Phillipe, additional, Thuluvath, Paul, additional, Ryder, Stephen D., additional, Gerken, Guido, additional, Hernandez, Candido, additional, Vanstraelen, Kim, additional, Scherbakovsky, Stacey, additional, Osinusi, Anu, additional, Tedesco, Dana, additional, and Foster, Graham R., additional

Published
2023
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17. Ledipasvir plus sofosbuvir fixed-dose combination for 6 weeks in patients with acute hepatitis C virus genotype 1 monoinfection (HepNet Acute HCV IV): an open-label, single-arm, phase 2 study

Author

Deterding, Katja, Spinner, Christoph D, Schott, Eckart, Welzel, Tania M, Gerken, Guido, Klinker, Hartwig, Spengler, Ulrich, Wiegand, Johannes, zur Wiesch, Julian Schulze, Pathil, Anita, Cornberg, Markus, Umgelter, Andreas, Zöllner, Caroline, Zeuzem, Stefan, Papkalla, Armin, Weber, Kristina, Hardtke, Svenja, von der Leyen, Heiko, Koch, Armin, von Witzendorff, Dorothee, Manns, Michael P, and Wedemeyer, Heiner

Published
2017
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21. Altered Microbiota Diversity and Bile Acid Signaling in Cirrhotic and Noncirrhotic NASH-HCC

Author

Sydor, Svenja, Best, Jan, Messerschmidt, Insa, Manka, Paul, Vilchez-Vargas, Ramiro, Brodesser, Susanne, Lucas, Christina, Wegehaupt, Annemarie, Wenning, Chiara, Aßmuth, Sophia, Hohenester, Simon, Link, Alexander, Faber, Klaas Nico, Moshage, Han, Cubero, Francisco Javier, Friedman, Scott L., Gerken, Guido, Trauner, Michael, Canbay, Ali, and Bechmann, Lars P.

Published
2020
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27. Role of the GALAD and BALAD-2 Serologic Models in Diagnosis of Hepatocellular Carcinoma and Prediction of Survival in Patients

Author

Berhane, Sarah, Toyoda, Hidenori, Tada, Toshifumi, Kumada, Takashi, Kagebayashi, Chiaki, Satomura, Shinji, Schweitzer, Nora, Vogel, Arndt, Manns, Michael P., Benckert, Julia, Berg, Thomas, Ebker, Maria, Best, Jan, Dechêne, Alexander, Gerken, Guido, Schlaak, Joerg F., Weinmann, Arndt, Wörns, Marcus A., Galle, Peter, Yeo, Winnie, Mo, Frankie, Chan, Stephen L., Reeves, Helen, Cox, Trevor, and Johnson, Philip

Published
2016
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37. LiMAx Prior to Radioembolization for Hepatocellular Carcinoma as an Additional Tool for Patient Selection in Patients with Liver Cirrhosis

Author

Leyh, Catherine, primary, Heucke, Niklas, additional, Schotten, Clemens, additional, Büchter, Matthias, additional, Bechmann, Lars P., additional, Wichert, Marc, additional, Dechêne, Alexander, additional, Herrmann, Ken, additional, Heider, Dominik, additional, Sydor, Svenja, additional, Lemmer, Peter, additional, Ludwig, Johannes M., additional, Pospiech, Josef, additional, Theysohn, Jens, additional, Damm, Robert, additional, March, Christine, additional, Powerski, Maciej, additional, Pech, Maciej, additional, Özcürümez, Mustafa, additional, Weigt, Jochen, additional, Keitel, Verena, additional, Lange, Christian M., additional, Schmidt, Hartmut, additional, Canbay, Ali, additional, Best, Jan, additional, Gerken, Guido, additional, and Manka, Paul P., additional

Published
2022
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39. All-oral daclatasvir plus asunaprevir for hepatitis C virus genotype 1b: a multinational, phase 3, multicohort study

Author

Manns, Michael, Pol, Stanislas, Jacobson, Ira M, Marcellin, Patrick, Gordon, Stuart C, Peng, Cheng-Yuan, Chang, Ting-Tsung, Everson, Gregory T, Heo, Jeong, Gerken, Guido, Yoffe, Boris, Towner, William J, Bourliere, Marc, Metivier, Sophie, Chu, Chi-Jen, Sievert, William, Bronowicki, Jean-Pierre, Thabut, Dominique, Lee, Youn-Jae, Kao, Jia-Horng, McPhee, Fiona, Kopit, Justin, Mendez, Patricia, Linaberry, Misti, Hughes, Eric, and Noviello, Stephanie

Published
2014
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45. Performance of the Liver Maximum Function Capacity Test, Fibrinogen, and Transient Elastography in Patients with Acute Liver Injury.

Author

Kreimeyer, Henriette, Buechter, Matthias, Best, Jan, Gieseler, Robert K., Katsounas, Antonios, Sowa, Jan-Peter, Gerken, Guido, Canbay, Ali, Manka, Paul, and Bechmann, Lars P.

Subjects
FIBRINOGEN, LIVER injuries, AUTOIMMUNE hepatitis, BLOOD coagulation factors, LIVER
Abstract

Background: Acute liver failure (ALF) occurs as a rare, sudden, extensive loss of liver function in a previously healthy liver. In advanced cases, ALF may require liver transplantation (LT). Available prognostic parameters have limited accuracy to decide, which patient to consider for LT. The liver maximum function capacity test (LiMAx) can accurately determine liver function and was assessed as predictor of survival, along with coagulation parameters and liver stiffness in nonacetaminophen-induced ALF. Methods: Various liver function tests, including LiMAx measurements, coagulation factors, and transient elastography (TE), were analyzed retrospectively for associations with clinical outcome in 34 patients with ALF or acute hepatitis (AH). Data were compared between patients with spontaneous recovery (SR) and non-SR (3-month mortality/LT; NSR). Results: The analysis included 34 patients (22 ALF, 12 AH; 19 males, 15 females; age 36.7 ± 14.6 years) with drug-induced liver injury (DILI) (n = 12), autoimmune hepatitis (AIH; n = 13), AIH-DILI overlap (n = 1), viral (n = 9), or cryptogenic liver failure (n = 1). Thirty-one patients recovered spontaneously, 2 patients died, and 1 patient underwent LT. The LiMAx was 197.6 (±68.4) for SR versus 92.33 (±65.0) for NSR (p = 0.0157). Fibrinogen was significantly lower in patients with NSR than in SR patients (209.0 vs. 106.3; p = 0.02). Mean liver stiffness measured by TE was 39.3 for NSR and 17.3 for SR (p = 0.26). KCC was fulfilled in only 4 patients (3 SR, 1 NSR). LiMAx results correlated positively with serum fibrinogen and antithrombin III concentrations and correlated negatively with liver stiffness. No other analyzed factor could differentiate between SR and NSR. Conclusion: Decision-making in ALF remains challenging. LiMAx and fibrinogen might predict the prognosis in patients with nonacetaminophen-induced ALF and in combination could be feasible tools to decide if LT is necessary. [ABSTRACT FROM AUTHOR]

Published
2023
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48. Akute und chronische infektiöse Hepatitiden

Author

Gerken, Guido, Jochum, Christoph, Schölmerich, Jürgen, editor, Burdach, S., editor, Drexler, H., editor, Hallek, M., editor, Hiddemann, W., editor, Hörl, W.H., editor, Klein, H., editor, Landthaler, M., editor, Lenz, K., editor, Mann, K., editor, Mössner, J., editor, Müller-Ladner, U., editor, Reichen, J., editor, Schmiegel, W., editor, Schröder, J.O., editor, Seeger, W., editor, Stremmel, W., editor, Suttorp, N., editor, Weilemann, L.S., editor, and Wöhrle, J.C., editor

Published
2005
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