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2. 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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5. Most vulnerable HCV patient groups treated with direct acting antivirals achieve high response rates and gain quality of life-data from the German hepatitis C-registry (DHC-R)

Author

Christensen, Stefan, primary, Stoehr, Albrecht, additional, Teuber, Gerlinde, additional, Petersen, Jörg, additional, Link, Ralph, additional, Naumann, Uwe, additional, John, Christine, additional, Serfert, Yvonne, additional, Simon, Karl-Georg, additional, Zeuzem, Stefan, additional, and Wedemeyer, Heiner, additional

Published
2023
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8. 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)

Author

Cornberg, Markus, primary, Stoehr, Albrecht, additional, Naumann, Uwe, additional, Teuber, Gerlinde, additional, Klinker, Hartwig, additional, Lutz, Thomas, additional, Möller, Hjördis, additional, Hidde, Dennis, additional, Lohmann, Kristina, additional, and Simon, Karl-Georg, additional

Published
2022
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13. The changing characteristics of patients infected with chronic hepatitis C virus from 2014 to 2019: Real‐world data from the German Hepatitis C‐Registry (DHC‐R)

Author

Hüppe, Dietrich, primary, Stoehr, Albrecht, additional, Buggisch, Peter, additional, Mauss, Stefan, additional, Klinker, Hartwig, additional, Teuber, Gerlinde, additional, Hidde, Dennis, additional, Lohmann, Kristina, additional, Bondin, Mark, additional, and Wedemeyer, Heiner, additional

Published
2021
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16. Elevated liver enzymes predict morbidity and mortality despite antiviral cure in patients with chronic hepatitis C: Data from the German Hepatitis C‐Registry.

Author

Tacke, Frank, Klinker, Hartwig, Boeker, Klaus H. W., Merle, Uta, Link, Ralph, Buggisch, Peter, Hüppe, Dietrich, Cornberg, Markus, Sarrazin, Christoph, Wedemeyer, Heiner, Berg, Thomas, Mauss, Stefan, Simon, Karl‐Georg, John, Christine, Stoehr, Albrecht, Teuber, Gerlinde, Ullrich, Rainer, Naumann, Uwe, Günther, Rainer, and Christensen, Stefan

Subjects
HEPATITIS C, GAMMA-glutamyltransferase, CHRONIC hepatitis C, ALANINE aminotransferase, LIVER enzymes, NON-alcoholic fatty liver disease, HEPATITIS, HEPATITIS C virus
Abstract

While direct‐acting antivirals (DAAs) cure chronic hepatitis C virus (HCV) infection in almost all patients, some patients remain at risk of liver disease despite HCV cure. In order to identify risk factors indicating liver‐related morbidity and death after viral cure, we included 6982 patients from the national multicenter real‐world German Hepatitis C Registry with regular follow‐up visits for up to 7 years after DAA therapy. Definitions for normal liver function tests (in women/men) were alanine aminotransferase (ALT; ≤35/≤50 U/L), ALT according to American Association for the Study of Liver Diseases (AASLD; ≤19/≤30 U/L), and gamma‐glutamyltransferase (GGT; ≤40/≤60 U/L). In our cohort, 97.4% of patients achieved sustained virologic response (SVR). At 24 weeks after SVR (SVR24), elevated ALT occurred in 657/6982 (9.4%), elevated ALT (AASLD) in 2609/6982 (37.4%), and elevated GGT in 1777/6982 (25.5%) patients. Risk factors for increased ALT at SVR24 were obesity, alcohol, cirrhosis, elevated baseline ALT, and non‐SVR. Increased GGT at SVR24 was significantly (p < 0.05) and independently associated with male sex (odds ratio [OR], 2.12), higher body mass index (OR, 1.04), age >50 years (OR, 1.60), liver cirrhosis (OR, 3.97), alcohol consumption (OR, 2.99), diabetes (OR, 1.63), non‐SVR (OR, 8.00), and elevated GGT at baseline (OR, 17.12). In multivariate regression analysis, elevated GGT at SVR24, particularly in combination with cirrhosis, was the best predictor for hepatic decompensation, hepatocellular carcinoma development, and death, followed by elevated ALT (AASLD) and standard ALT, which predicted hepatic decompensation. Despite successful HCV therapy, elevated GGT at SVR24 and to a lesser extent ALT are predictive of the future clinical outcome and linked with liver‐associated comorbidities. This may highlight the relevance of nonalcoholic fatty liver disease, diabetes mellitus, alcohol, and cirrhosis for the clinical outcome in a vulnerable population, even after HCV cure. [ABSTRACT FROM AUTHOR]

Published
2022
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17. Real-Life Experiences with Telaprevir in the Treatment of Chronic Genotype 1 Hepatitis C — The TEPS Study

Author

Berg, Thomas, Buggisch, Peter, Hüppe, Dietrich, Mauss, Stefan, Wedemeyer, Heiner, Teuber, Gerlinde, Lutz, Thomas, Stein, Kerstin, Wegner, Sven, and Hinrichsen, Holger

Subjects
medicine.medical_specialty, shortening of treatment, RC799-869, Telaprevir, Virological response, Therapy naive, Internal medicine, Medicine, media_common.cataloged_instance, Protease inhibitor (pharmacology), In patient, ddc:610, European union, hepatitis c, General Environmental Science, media_common, business.industry, stopping rule, Stopping rule, Hepatitis C, Diseases of the digestive system. Gastroenterology, medicine.disease, sustained virological response (svr), General Earth and Planetary Sciences, business, direct acting antivirals (daa), medicine.drug
Abstract

As one of the first Direct Acting Antivirals (DAA), the protease inhibitor Telaprevir (TVR) was available in the European Union from 9/2011 until 9/2016 as a new treatment option for chronic Hepatitis C.Aim. To assess the implementation of therapy stopping rules or shortening of the treatment and their impact on sustained virological response (SVR), as well as the safety and efficacy of the TVR-based therapy during routine daily treatment of patients in Germany.Materials and Methods. 802 patients were assessed (272 treatment naïve, 520 pre-treated) in the noninterventional, multi-center study.Results. 56.6 % of the patients achieved SVR. SVR rate was higher in patients with relapse after previous treatment (68.0 %) than in patients with a previous null-response (31.1 %) and in previously untreated patients (58.1 %). Stopping rule conditions were fulfilled by 3.2 % of patients and it was implemented in 65.4 % of these. 34.3 % of the patients fulfilled the conditions for a therapy shortening. This rule was adhered to in 48.4 % of these, in 34.5 % it was not adhered to. Thus recommendations were not always being followed. Therapy shortening was considered more frequently in previously untreated (54.8 %) than for previously treated patients (24.2 %). Stopping rule application but not shortened treatment reduced therapy costs.Conclusion. The TVR-based therapy represented a breakthrough at that time. Further DAAs have been added as therapeutic options since, increasing the complexity of treatment choice and correct implementation. They represent both an opportunity and a challenge for all those involved.As one of the first Direct Acting Antivirals (DAA), the protease inhibitor Telaprevir (TVR) was available in the European Union from 9/2011 until 9/2016 as a new treatment option for chronic Hepatitis C.Aim. To assess the implementation of therapy stopping rules or shortening of the treatment and their impact on sustained virological response (SVR), as well as the safety and efficacy of the TVR-based therapy during routine daily treatment of patients in Germany.Materials and Methods. 802 patients were assessed (272 treatment naïve, 520 pre-treated) in the noninterventional, multi-center study.Results. 56.6 % of the patients achieved SVR. SVR rate was higher in patients with relapse after previous treatment (68.0 %) than in patients with a previous null-response (31.1 %) and in previously untreated patients (58.1 %). Stopping rule conditions were fulfilled by 3.2 % of patients and it was implemented in 65.4 % of these. 34.3 % of the patients fulfilled the conditions for a therapy shortening. This rule was adhered to in 48.4 % of these, in 34.5 % it was not adhered to. Thus recommendations were not always being followed. Therapy shortening was considered more frequently in previously untreated (54.8 %) than for previously treated patients (24.2 %). Stopping rule application but not shortened treatment reduced therapy costs.Conclusion. The TVR-based therapy represented a breakthrough at that time. Further DAAs have been added as therapeutic options since, increasing the complexity of treatment choice and correct implementation. They represent both an opportunity and a challenge for all those involved. Ингибитор протеазы Телапревир (ТПВ) является одним из первых противовирусных препаратов прямого действия (ПППД) и применялся в странах Евросоюза при лечении хронического гепатита С в качестве нового метода с сентября 2011 года по сентябрь 2016 года. Цель: Оценить применение правил остановки (прекращения) или сокращения периода терапии и их влияние на устойчивый вирусологический ответ (УВО), а также безопасность и эффективность противовирусной терапии на основе ТПВ при рутинном применении в Германии. Материалы и методы. В неинтервенционном мультицентровом исследовании участвовали 802 пациента (272 пациента, ранее не получавшие, и 520 пациентов, ранее получавшие противовирусные препараты). Результаты. Устойчивый вирусологический ответ (УВО) был достигнут у 56,6 % пациентов. Доля пациентов с УВО среди пациентов с рецидивом после предыдущего лечения была выше (68,0 %), чем у пациентов с предыдущим нулевым ответом (31,1 %) и у пациентов, ранее не получавших противовирусные препараты (58,1 %). Критериям прекращения терапии соответствовали 3,2 % пациентов, из них у 65,4 % лечение было остановлено. Критериям сокращения терапии соответствовали 34,3 % пациентов. Это правило было применено в отношении 48,4 % из них, у 34,5 % оно не соблюдалось. Таким образом, не всегда соблюдались рекомендации по прекращению или сокращению терапии. Чаще терапию сокращали в группе пациентов, ранее не получавших лечения (54,8%), чем в группе пациентов, получавших противовирусную терапию в анамнезе (24,2%). Именно применение правил прекращения терапии, а не сокращение ее продолжительности, позволило снизить затраты на лечение. Заключение. Терапия на основе ТПВ в свое время стала прорывом в лечении гепатита С. Позже были предложены новые варианты ПППД для терапии, что усложнило выбор и точность применения препаратов. ПППД привнесли одновременно как новые возможности, так и новые сложности.

Published
2019

18. Effectiveness and Safety of Direct-Acting Antiviral Combination Therapies for Treatment of Hepatitis C Virus in Elderly Patients: Results from the German Hepatitis C Registry

Author

Dultz, Georg, Müller, Tobias, Petersen, Jörg, Mauss, Stefan, Zimmermann, Tim, Muche, Marion, Simon, Karl-Georg, Berg, Thomas, Zeuzem, Stefan, Hüppe, Dietrich, Böker, Klaus, Wedemeyer, Heiner, Welzel, Tania M., Günther, Rainer, Hinrichsen, Holger, Heyne, Renate, Roth, Johannes, Goeser, Tobias, Ullrich, Rainer, John, Christine, Hofmann, Wolf Peter, Teuber, Gerlinde, Möller, Hjördis, Baumgarten, Axel, Schwenzer, Jeannette, Pathil, Anita, Kraus, Michael R., Weber, Andreas, Jung, Maria-Christina, Gerken, Guido, Antoni, Christoph, Doss, Margareta Frank, Schober, Andreas, Hoffstadt, Martin, Lucadou, Armand v., Steffens, Hermann, Klinker, Hartwig, Geier, Andreas, Klausen, Gerd, Buggisch, Peter, Cornberg, Markus, Sarrazin, Christoph, Manns, Michael P., Niederau, Claus, Protzer, Ulla, and Schirmacher, Peter

Subjects
Adult, Male, medicine.medical_specialty, Hepatitis C virus, Medizin, Hepacivirus, medicine.disease_cause, Antiviral Agents, Immunotherapy, Adoptive, 03 medical and health sciences, 0302 clinical medicine, Pharmacotherapy, Germany, Internal medicine, Diabetes mellitus, Humans, Medicine, Pharmacology (medical), Registries, Adverse effect, Aged, business.industry, Hepatitis C, Hepatitis C, Chronic, Middle Aged, medicine.disease, Clinical trial, Treatment Outcome, 030220 oncology & carcinogenesis, Cohort, Drug Therapy, Combination, Female, 030211 gastroenterology & hepatology, Safety, Geriatrics and Gerontology, business, Cohort study
Abstract

With the aging of the hepatitis C virus (HCV)-infected patient cohort and the availability of highly effective and tolerable treatment regimens, an increasing number of elderly patients are now eligible for HCV therapy. This study investigated clinical and epidemiologic characteristics of elderly HCV-infected patients as well as the effectiveness and safety of available therapies. Patients were enrolled into the German Hepatitis C Registry (DHC-R), a prospective, multicenter, real-world cohort study. Patients were treated at the discretion of the physician, and data were collected by a web-based system. Of 7133 patients who initiated treatment, 686 (9.6%) were > 70 years of age. In patients > 70 years, intent-to-treat (ITT) SVR12 was 92.6% (514/555) compared to 90.7% (4521/4985) in patients ≤ 70 years of age. Overall, adverse events (AEs) were reported in 374 (54.5%) and 3435 patients (53.3%) > 70 or ≤ 70 years of age; 7.6% (52) and 3.6% (235) in the respective age groups had a serious AE. Twenty-two (3.2%) and 62 (1.0%) of the patients > 70 or ≤ 70 years discontinued treatment due to AEs. Death was reported in 34 patients, of whom eight were > 70 years of age. Frequent comorbidities in patients > 70 years of age were cardiac disease, renal disease and diabetes. Psychiatric disorders, substance abuse and viral co-infection were more frequent in younger patients. Direct-acting antiviral therapies were well tolerated in patients older than 70 years. SVR12 rates in the elderly patient group were similar to those observed in younger patients. Differences in the prevalence of comorbidities between age groups warrant individualized attention with respect to drug–drug interactions and therapy adherence. The study was registered in the German Clinical Trials Register, DRKS-ID: DRKS00009717.

Published
2018
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21. Hepatitis C population in Germany, changing over time: 958

Author

Klass, Dietmar M., Hinrichsen, Holger, Boeker, Klaus H., Teuber, Gerlinde, Naumann, Uwe, von Lucadou, Armand, Antoni, Christoph, Jung, Maria-Christina, Ullrich, Rainer, Herrmann, Andreas, Weber, Andreas, Gösseringer, Roger, Hueppe, Dietrich, and Mauss, Stefan

Published
2012

27. Sofosbuvir, velpatasvir, and voxilaprevir for patients with failure of previous direct-acting antiviral therapy for chronic hepatitis C: Results from the German Hepatitis C-Registry (DHC-R)

Author

Wedemeyer, Heiner, primary, Vermehren, Johannes, additional, Serfert, Yvonne, additional, Cornberg, Markus, additional, Stoehr, Albrecht, additional, Klinker, Hartwig, additional, Simon, Karl-Georg, additional, Teuber, Gerlinde, additional, Deterding, Katja, additional, Schulze zur Wiesch, Julian, additional, Jung, Maria-Christina, additional, Manns, Michael P., additional, Zeuzem, Stefan, additional, and Sarrazin, Christoph, additional

Published
2020
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28. Hepatitis C therapy with grazoprevir/elbasvir and glecaprevir/ pibrentasvir in patients with advanced chronic kidney disease - data from the German hepatitis C-registry (DHC-R)

Author

Stein, Kerstin, primary, Stoehr, Albrecht, additional, Klinker, Hartwig, additional, Teuber, Gerlinde, additional, Naumann, Uwe, additional, John, Christine, additional, Heyne, Renate, additional, Serfert, Yvonne, additional, Niederau, Claus, additional, Zeuzem, Stefan, additional, Berg, Thomas, additional, Wiegand, Johannes, additional, and C-Registry, German Hepatitis, additional

Published
2020
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32. Re-treatment of patients with chronic hepatitis C who do not respond to peginterferon-[alpha]2b: a randomized trial

Author

Jensen, Donald M., Marcellin, Patrick, Freilich, Bradley, Andreone, Pietro, Bisceglie, Adrian Di, Brandao-Mello, Carlos E., Reddy, K. Rajender, Craxi, Antonio, Martin, Antonio Olveira, Teuber, Gerlinde, Messinger, Diethelm, Thommes, James A., and Tietz, Andreas

Subjects
Hepatitis C -- Drug therapy, Hepatitis C -- Development and progression, Chronic diseases -- Drug therapy, Chronic diseases -- Development and progression, Peginterferon alfa-2b -- Dosage and administration, Health
Abstract

Background: Many patients with chronic hepatitis C have not responded to therapy with pegylated interferon plus ribavirin. Objective: To evaluate use of peginterferon-[alpha]2a plus ribavirin to re-treat nonresponders to peginterferon-[alpha]2b plus ribavirin. Design: Randomized, parallel-group trial conducted between September 2003 and February 2007. Patients and researchers were not blinded to intervention assignment. Random assignment was centralized, computer-generated, and stratified by geographic region, hepatitis C virus (HCV) genotype, and histologic diagnosis. Setting: 106 international centers. Patients: 950 nonresponders to 12 of more weeks of therapy with peginterferon-[alpha]2b plus ribavirin. Intervention: Peginterferon-[alpha]2a, 360 [micro]g/wk, for 12 weeks, then 180 [micro]g/wk to complete 72 weeks (group A) of 48 weeks (group B), of peginterferon-[alpha]2a, 180/[micro]g/wk for 72 weeks (group C) or 48 weeks (group D). All patients received ribavirin, 1000 or 1200 mg/d. Measurements: Sustained virologic response (SVR), defined as undetectable ( Results: The SVR rates in groups A (n = 317), B (n = 156), C (n = 156), and D (n = 313) were 16%, 7%, 14%, and 9%, respectively (relative risk [RR] for group A vs. group D [the primary comparison], 1.80 [95% Cl, 1.17 to 2.77]; P = 0.006). Extended treatment duration increased SVR rates (16% for 72 weeks [groups A and C] vs. 8% for 48 weeks [groups B and D]; RR, 2.00 [CI, 1.32 to 3.02]; P< 0.001). Complete viral suppression (HCV RNA level Limitation: Nonresponders to peginterferon-[alpha]2a plus ribavirin were not evaluated. Conclusion: Re-treating nonresponders to therapy with peginterferon-[alpha]2b plus ribavirin for 72 weeks significantly increases SVR rates compared with re-treating them for 48 weeks. The overall SVR rate was low, but patients who ate most likely to respond to re-treatment can be identified at week 12. Primary Funding Source: Roche.

Published
2009

38. 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

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

Published
2019
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39. FRI-208-Predictors of treatment response during addition of pegylated Interferon alfa-2a to an onging nucleos (t)id treatment in chronic hepatitis B: Results from the PADD-ON trial

Author

Sprinzl, Martin, primary, Grambihler, Annette, additional, Teuber, Gerlinde, additional, Antoni, Christoph, additional, Zeuzem, Stefan, additional, Discher, Thomas, additional, Cornberg, Markus, additional, Berg, Thomas, additional, Loehr, Hanns, additional, Tacke, Frank, additional, Lammert, Frank, additional, Schott, Eckart, additional, Berg, Christoph, additional, Zizer, Eugen, additional, Heyne, Renate, additional, Spengler, Ulrich, additional, Geisler, Fabian, additional, Thimme, Robert, additional, Pathil, Anita, additional, Klinker, Hartwig, additional, Weigand, Kilian, additional, Riedl, Michaela, additional, Wosniok, Julia, additional, Kittner, Jens, additional, Schuchmann, Marcus, additional, Alshuth, Ulrich, additional, and Galle, Peter Robert, additional

Published
2019
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40. Real-world effectiveness and safety of glecaprevir/pibrentasvir for the treatment of chronic hepatitis C infection: data from the German Hepatitis C-Registry

Author

Berg, Thomas, primary, Naumann, Uwe, additional, Stoehr, Albrecht, additional, Sick, Christoph, additional, John, Christine, additional, Teuber, Gerlinde, additional, Schiffelholz, Willibold, additional, Mauss, Stefan, additional, Lohmann, Kristina, additional, König, Bettina, additional, Pangerl, Andreas, additional, and Niederau, Claus, additional

Published
2019
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47. 1981. Real-World Data on Safety and Effectiveness of Glecaprevir/Pibrentasvir for the Treatment of Patients With Chronic Hepatitis C Virus Infection on Opioid Substitution Therapy: Latest Results from the German Hepatitis C-Registry

Author

Reimer, Jens, primary, Stoehr, Albrecht, additional, Naumann, Uwe, additional, Teuber, Gerlinde, additional, Zamani, Carsten, additional, Mauss, Stefan, additional, Qurishi, Nazifa, additional, Lohmann, Kristina, additional, Kleine, Henning, additional, Pangerl, Andreas, additional, and Christensen, Stefan, additional

Published
2018
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49. norUrsodeoxycholic acid (norUDCA) improves non-alcoholic fatty liver disease (NAFLD): Results from a randomized placebo-controlled, double-blind phase IIa study

Author

Traussnigg, Stefan, Schattenberg, Jorn M., Demir, Muenevver, Wiegand, Johannes, Geier, Andreas, Teuber, Gerlinde, Hofmann, Wolf Peter, Kremer, Andreas E., Spreda, Frank, Kluwe, Johannes, Petersen, Joerg, Boettler, Tobias, Halilbasic, Emina, Greinwald, Roland, Proels, Markus, Manns, Michael P., Fickert, Peter, Trauner, Michael H., Traussnigg, Stefan, Schattenberg, Jorn M., Demir, Muenevver, Wiegand, Johannes, Geier, Andreas, Teuber, Gerlinde, Hofmann, Wolf Peter, Kremer, Andreas E., Spreda, Frank, Kluwe, Johannes, Petersen, Joerg, Boettler, Tobias, Halilbasic, Emina, Greinwald, Roland, Proels, Markus, Manns, Michael P., Fickert, Peter, and Trauner, Michael H.

Published
2017

50. Comparison of new faecal antigen test with [sup.13]C-urea breath test for detecting Helicobacter pylori infection and monitoring eradication treatment: prospective clinical evaluation

Author

Braden, Barbara, Teuber, Gerlinde, Dietrich, Christoph F., Caspary, Wolfgang F., and Lembcke, Bernhard

Subjects
Helicobacter infections -- Diagnosis, Immunoassay -- Evaluation, Health, Diagnosis, Evaluation
Abstract

The [sup.13]C-urea breath test is currently regarded as the best non-invasive diagnostic method for detecting Helicobacter pylori infection, even when monitoring efficacy of treatment.[1-2] Serological methods are not appropriate for [...]

Published
2000

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