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1. 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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5. 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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6. 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

7. 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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9. 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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10. 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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11. 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

12. Vitamin D Levels Vary during Antiviral Treatment but Are Unable to Predict Treatment Outcome in HCV Genotype 1 Infected Patients

Author

Grammatikos, Georgios, Lange, Christian, Susser, Simone, Schwendy, Susanne, Dikopoulos, Nektarios, Buggisch, Peter, Encke, Jens, Teuber, Gerlinde, Goeser, Tobias, Thimme, Robert, Klinker, Hartwig, Boecher, Wulf O., Schulte-Frohlinde, Ewert, Penna-Martinez, Marissa, Badenhoop, Klaus, Zeuzem, Stefan, Berg, Thomas, Sarrazin, Christoph, Grammatikos, Georgios, Lange, Christian, Susser, Simone, Schwendy, Susanne, Dikopoulos, Nektarios, Buggisch, Peter, Encke, Jens, Teuber, Gerlinde, Goeser, Tobias, Thimme, Robert, Klinker, Hartwig, Boecher, Wulf O., Schulte-Frohlinde, Ewert, Penna-Martinez, Marissa, Badenhoop, Klaus, Zeuzem, Stefan, Berg, Thomas, and Sarrazin, Christoph

Abstract

Background: Different parameters have been determined for prediction of treatment outcome in hepatitis c virus genotype 1 infected patients undergoing pegylated interferon, ribavirin combination therapy. Results on the importance of vitamin D levels are conflicting. In the present study, a comprehensive analysis of vitamin D levels before and during therapy together with single nucleotide polymorphisms involved in vitamin D metabolism in the context of other known treatment predictors has been performed. Methods: In a well characterized prospective cohort of 398 genotype 1 infected patients treated with pegylated interferon-alpha and ribavirin for 24-72 weeks (INDIV-2 study) 25-OH-vitamin D levels and different single nucleotide polymorphisms were analyzed together with known biochemical parameters for a correlation with virologic treatment outcome. Results: Fluctuations of more than 5 (10) ng/ml in 25-OH-vitamin D-levels have been observed in 66 (39) % of patients during the course of antiviral therapy and neither pretreatment nor under treatment 25-OH-vitamin D-levels were associated with treatment outcome. The DHCR7-TT-polymorphism within the 7-dehydrocholesterol-reductase showed a significant association (P = 0.031) to sustained viral response in univariate analysis. Among numerous further parameters analyzed we found that age (OR = 1.028, CI = 1.002-1.056, P = 0.035), cholesterol (OR = 0.983, CI = 0.975-0.991, P<0.001), ferritin (OR = 1.002, CI = 1.000-1.004, P = 0.033), gGT (OR = 1.467, CI = 1.073-2.006, P = 0.016) and IL28B-genotype (OR = 2.442, CI = 1.271-4.695, P = 0.007) constituted the strongest predictors of treatment response. Conclusions: While 25-OH-vitamin D-levels levels show considerable variations during the long-lasting course of antiviral therapy they do not show any significant association to treatment outcome in genotype 1 infected patients.

Published
2014

13. Cost of treating hepatitis C in Germany: a retrospective multicenter analysis

Author

Stahmeyer, Jona T., Rossol, Siegbert, Bert, Florian, Antoni, Christoph, Demir, Muenevver, Hinrichsen, Holger, Hueppe, Dietrich, Teuber, Gerlinde, Wiebner, Bianka, Wedemeyer, Heiner, Krauth, Christian, Stahmeyer, Jona T., Rossol, Siegbert, Bert, Florian, Antoni, Christoph, Demir, Muenevver, Hinrichsen, Holger, Hueppe, Dietrich, Teuber, Gerlinde, Wiebner, Bianka, Wedemeyer, Heiner, and Krauth, Christian

Abstract

Background Viral hepatitis is major a public health problem affecting millions of people worldwide. Estimates assume 400 000-500 000 people chronically infected with hepatitis C virus (HCV) in Germany. Long-term consequences are the development of liver cirrhosis and hepatocellular carcinoma. The aim of the study was to assess the costs for treating patients with chronic HCV in Germany. Methods We conducted a retrospective multicenter observational study. The design was approved by an ethics committee, and patients were asked for their informed consent. Patients were grouped in four different health states. Healthcare utilization data were extracted from doctor files of six medical centers in Germany. Results Data of 315 patients with chronic HCV were analyzed. The mean age was 49.4 years, 57.5% were male and 67.9% had a genotype 1 infection. The most common routes of transmission were injection drug use (39.0%) and infection through blood products (15.9%). The average total cost was (sic)19 147 including ambulatory care and diagnostics ((sic)1686), pharmaceuticals ((sic)14 875), inpatient care ((sic)1293), and sick leave ((sic)1293). For patients in stable health states (mild and moderate HCV, compensated cirrhosis), costs did not differ significantly and were mainly influenced by antiviral treatment. For patients with decompensated cirrhosis, inpatient care accounted for the largest part of the costs. Conclusion Treatment of HCV patients involves high costs, mainly associated with the length of antiviral therapy. Viral eradication can prevent severe disease stages, which are associated with high costs. It is necessary to follow current guidelines and monitor patients closely to avoid unnecessary costs. (C) 2014 Wolters Kluwer Health vertical bar Lippincott Williams & Wilkins.

Published
2014

14. Treatment of naïve patients with chronic hepatitis C genotypes 2 and 3 with pegylated interferon alpha and ribavirin in a real world setting : relevance for the new era of DAA

Author

Heidrich, Benjamin, Wiegand, Steffen B., Buggisch, Peter, Hinrichsen, Holger, Link, Ralph, Möller, Bernd, Böker, Klaus H. W., Teuber, Gerlinde, Klinker, Hartwig, Zehnter, Elmar, Naumann, Uwe, Busch, Heiner W., Maasoumy, Benjamin, Baum, Undine, Hardtke, Svenja, Manns, Michael P., Wedemeyer, Heiner, Petersen, Jörg, Cornberg, Markus, Heidrich, Benjamin, Wiegand, Steffen B., Buggisch, Peter, Hinrichsen, Holger, Link, Ralph, Möller, Bernd, Böker, Klaus H. W., Teuber, Gerlinde, Klinker, Hartwig, Zehnter, Elmar, Naumann, Uwe, Busch, Heiner W., Maasoumy, Benjamin, Baum, Undine, Hardtke, Svenja, Manns, Michael P., Wedemeyer, Heiner, Petersen, Jörg, and Cornberg, Markus

Abstract

Evidence based clinical guidelines are implemented to treat patients efficiently that include efficacy, tolerability but also health economic considerations. This is of particular relevance to the new direct acting antiviral agents that have revolutionized treatment of chronic hepatitis C. For hepatitis C genotypes 2/3 interferon free treatment is already available with sofosbuvir plus ribavirin. However, treatment with sofosbuvir-based regimens is 10–20 times more expensive compared to pegylated interferon alfa and ribavirin (PegIFN/RBV). It has to be discussed if PegIFN/RBV is still an option for easy to treat patients. We assessed the treatment of patients with chronic hepatitis C genotypes 2/3 with PegIFN/RBV in a real world setting according to the latest German guidelines. Overall, 1006 patients were recruited into a prospective patient registry with 959 having started treatment. The intention-to-treat analysis showed poor SVR (GT2 61%, GT3 47%) while patients with adherence had excellent SVR in the per protocol analysis (GT2 96%, GT3 90%). According to guidelines, 283 patients were candidates for shorter treatment duration, namely a treatment of 16 weeks (baseline HCV-RNA <800.000 IU/mL, no cirrhosis and RVR). However, 65% of these easy to treat patients have been treated longer than recommended that resulted in higher costs but not higher SVR rates. In conclusion, treatment with PegIFN/RBV in a real world setting can be highly effective yet similar effective than PegIFN± sofosbuvir/RBV in well-selected naïve G2/3 patients. Full adherence to guidelines could be further improved, because it would be important in the new era with DAA, especially to safe resources.

Published
2014

15. Su1072 Treatment of Chronic Hepatitis C Genotype 1 (G1) Infection With Boceprevir (Victrelis®) in German Real-Life: Impact of Hemoglobin Decline on Virologic Response

Author

Teuber, Gerlinde, primary, Buggisch, Peter, additional, Löhr, Hanns, additional, Steffens, Hermann, additional, Kraus, Michael, additional, John, Christine, additional, Geyer, Peter, additional, Weber, Bernd, additional, Witthoeft, Thomas, additional, Herrmann, Andreas, additional, Hoesl, Mark, additional, Naumann, Uwe, additional, Dahhan, Tarek, additional, Hartmann, Dagmar, additional, Dreher, Bernd, additional, and Bilzer, Manfred, additional

Published
2014
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16. Su1068 Treatment of Previously Untreated Patients With Chronic HCV Genotype 1 Infection With Boceprevir in German Real-Life: High Efficacy in Patients With Early Virologic Response

Author

Buggisch, Peter, primary, Löhr, Hanns, additional, Teuber, Gerlinde, additional, Steffens, Hermann, additional, Kraus, Michael, additional, John, Christine, additional, Geyer, Peter, additional, Weber, Bernd, additional, Witthoeft, Thomas, additional, Herrmann, Andreas, additional, Hoesl, Mark, additional, Naumann, Uwe, additional, Dahhan, Tarek, additional, Hartmann, Dagmar, additional, Dreher, Bernd, additional, and Bilzer, Manfred, additional

Published
2014
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17. Vitamin D Levels Vary during Antiviral Treatment but Are Unable to Predict Treatment Outcome in HCV Genotype 1 Infected Patients

Author

Grammatikos, Georgios, primary, Lange, Christian, additional, Susser, Simone, additional, Schwendy, Susanne, additional, Dikopoulos, Nektarios, additional, Buggisch, Peter, additional, Encke, Jens, additional, Teuber, Gerlinde, additional, Goeser, Tobias, additional, Thimme, Robert, additional, Klinker, Hartwig, additional, Boecher, Wulf O., additional, Schulte-Frohlinde, Ewert, additional, Penna-Martinez, Marissa, additional, Badenhoop, Klaus, additional, Zeuzem, Stefan, additional, Berg, Thomas, additional, and Sarrazin, Christoph, additional

Published
2014
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18. Baseline MELD score predicts hepatic decompensation during antiviral therapy in patients with chronic hepatitis C and advanced cirrhosis

Author

Dultz, Georg, Seelhof, Martin, Herrmann, Eva, Welker, Martin-Walter, Friedrich-Rust, Mireen, Teuber, Gerlinde, Kronenberger, Bernd, Wagner, Michael von, Vermehren, Johannes, Sarrazin, Christoph, Zeuzem, Stefan, Hofmann, Wolf-Peter, Dultz, Georg, Seelhof, Martin, Herrmann, Eva, Welker, Martin-Walter, Friedrich-Rust, Mireen, Teuber, Gerlinde, Kronenberger, Bernd, Wagner, Michael von, Vermehren, Johannes, Sarrazin, Christoph, Zeuzem, Stefan, and Hofmann, Wolf-Peter

Abstract

Background and Aims: In patients with advanced liver cirrhosis due to chronic hepatitis C virus (HCV) infection antiviral therapy with peginterferon and ribavirin is feasible in selected cases only due to potentially life-threatening side effects. However, predictive factors associated with hepatic decompensation during antiviral therapy are poorly defined. Methods: In a retrospective cohort study, 68 patients with HCV-associated liver cirrhosis (mean MELD score 9.18±2.72) were treated with peginterferon and ribavirin. Clinical events indicating hepatic decompensation (onset of ascites, hepatic encephalopathy, upper gastrointestinal bleeding, hospitalization) as well as laboratory data were recorded at baseline and during a follow up period of 72 weeks after initiation of antiviral therapy. To monitor long term sequelae of end stage liver disease an extended follow up for HCC development, transplantation and death was applied (240weeks, ±SD 136weeks). Results: Eighteen patients (26.5%) achieved a sustained virologic response. During the observational period a hepatic decompensation was observed in 36.8%. Patients with hepatic decompensation had higher MELD scores (10.84 vs. 8.23, p<0.001) and higher mean bilirubin levels (26.74 vs. 14.63 µmol/l, p<0.001), as well as lower serum albumin levels (38.2 vs. 41.1 g/l, p = 0.015), mean platelets (102.64 vs. 138.95/nl, p = 0.014) and mean leukocytes (4.02 vs. 5.68/nl, p = 0.002) at baseline as compared to those without decompensation. In the multivariate analysis the MELD score remained independently associated with hepatic decompensation (OR 1.56, 1.18–2.07; p = 0.002). When the patients were grouped according to their baseline MELD scores, hepatic decompensation occurred in 22%, 59%, and 83% of patients with MELD scores of 6–9, 10–13, and >14, respectively. Baseline MELD score was significantly associated with the risk for transplantation/death (p<0.001). Conclusions: Our data suggest that the baseline MELD score predicts

Published
2013

19. Baseline MELD Score Predicts Hepatic Decompensation during Antiviral Therapy in Patients with Chronic Hepatitis C and Advanced Cirrhosis

Author

Dultz, Georg, primary, Seelhof, Martin, additional, Herrmann, Eva, additional, Welker, Martin-Walter, additional, Friedrich-Rust, Mireen, additional, Teuber, Gerlinde, additional, Kronenberger, Bernd, additional, von Wagner, Michael, additional, Vermehren, Johannes, additional, Sarrazin, Christoph, additional, Zeuzem, Stefan, additional, and Hofmann, Wolf Peter, additional

Published
2013
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20. Deep Sequencing Reveals Mutagenic Effects of Ribavirin during Monotherapy of Hepatitis C Virus Genotype 1-Infected Patients

Author

Dietz, Julia, primary, Schelhorn, Sven-Eric, additional, Fitting, Daniel, additional, Mihm, Ulrike, additional, Susser, Simone, additional, Welker, Martin-Walter, additional, Füller, Caterina, additional, Däumer, Martin, additional, Teuber, Gerlinde, additional, Wedemeyer, Heiner, additional, Berg, Thomas, additional, Lengauer, Thomas, additional, Zeuzem, Stefan, additional, Herrmann, Eva, additional, and Sarrazin, Christoph, additional

Published
2013
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21. Sa1050 Efficacy of Boceprevir Based Triple Therapy in Combination With Peginterferon-Alfa-2A Plus Ribavirin (P/R) Under Real Life Conditions in Treatment Experienced Patients Infected With Chronic Hepatitis C, Genotype 1: The PAN Study

Author

Moog, Gero, primary, Mauss, Stefan, additional, Hueppe, Dietrich, additional, Spengler, Ulrich, additional, Schott, Eckart, additional, Eisenbach, Christoph, additional, Schober, Andreas, additional, Heyne, Renate, additional, Jung, Maria-Christina, additional, Teuber, Gerlinde, additional, Doss, Margareta Frank, additional, Rössle, Martin, additional, Pape, Stefan, additional, Schuchmann, Marcus, additional, Alshuth, Ulrich, additional, and Buggisch, Peter, additional

Published
2013
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22. Sa1051 Boceprevir Based Triple Therapy in Combination With Peginterferon-Alfa-2A Plus Ribavirin (P/R) Under Real Life Conditions in Treatment NaïVE Patients Infected With Chronic Hepatitis C, Genotype 1: An Interim Analysis At Week 12 After Start of Treatment

Author

Moog, Gero, primary, Mauss, Stefan, additional, Hueppe, Dietrich, additional, Spengler, Ulrich, additional, Schott, Eckart, additional, Eisenbach, Christoph, additional, Schober, Andreas, additional, Heyne, Renate, additional, Jung, Maria-Christina, additional, Teuber, Gerlinde, additional, Doss, Margareta Frank, additional, Rössle, Martin, additional, Pape, Stefan, additional, Schuchmann, Marcus, additional, Alshuth, Ulrich, additional, and Buggisch, Peter, additional

Published
2013
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23. Sa1041 Triple Therapy Under Real Life Conditions: Telaprevir (TVR) and Boceprevir (BOC) in Combination With Peginterferon-Alfa-2A Plus Ribavirin (P/R) in Treatment Experienced Patients Infected With Chronic Hepatitis C, Genotype 1. the PAN Study

Author

Moog, Gero, primary, Mauss, Stefan, additional, Hueppe, Dietrich, additional, Spengler, Ulrich, additional, Schott, Eckart, additional, Eisenbach, Christoph, additional, Schober, Andreas, additional, Heyne, Renate, additional, Jung, Maria-Christina, additional, Teuber, Gerlinde, additional, Doss, Margareta Frank, additional, Rössle, Martin, additional, Pape, Stefan, additional, Schuchmann, Marcus, additional, Alshuth, Ulrich, additional, and Buggisch, Peter, additional

Published
2013
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24. Sa1052 Triple Therapy Under Real Life Conditions: Telaprevir (TVR) in Combination With Peginterferon-Alfa-2A Plus Ribavirin (P/R) in NaïVE Patients Infected With Chronic Hepatitis C, Genotype 1. The PAN Study

Author

Moog, Gero, primary, Mauss, Stefan, additional, Hueppe, Dietrich, additional, Spengler, Ulrich, additional, Schott, Eckart, additional, Eisenbach, Christoph, additional, Schober, Andreas, additional, Heyne, Renate, additional, Jung, Maria-Christina, additional, Teuber, Gerlinde, additional, Doss, Margareta Frank, additional, Rössle, Martin, additional, Pape, Stefan, additional, Schuchmann, Marcus, additional, Alshuth, Ulrich, additional, and Buggisch, Peter, additional

Published
2013
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25. Prediction of minimal residual viremia in HCV type 1 infected patients receiving interferon-based therapy

Author

Knop, Viola, primary, Teuber, Gerlinde, additional, Klinker, Hartwig, additional, Möller, Bernd, additional, Rasenack, Jens, additional, Hinrichsen, Holger, additional, Gerlach, Tilman, additional, Spengler, Ulrich, additional, Buggisch, Peter, additional, Neumann, Konrad, additional, Sarrazin, Christoph, additional, Zeuzem, Stefan, additional, and Berg, Thomas, additional

Published
2013
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26. Sa1052 Thyroid Dysfunction Triggered by Peginterferon Alfa-2B / Ribavirin Treatment of Chronic HCV Genotype 1 Infection Favors Sustained Virologic Response (SVR) by Reducing

Author

Mauss, Stefan, primary, Hueppe, Dietrich, additional, Zehnter, Elmar, additional, Manns, Michael P., additional, Teuber, Gerlinde, additional, Dahhan, Tarek, additional, Meyer, Ulrike, additional, Witthöft, Thomas, additional, Moeller, Bernd, additional, Dikopoulos, Nektarios, additional, Brack, Jochen, additional, Dach, Kristina, additional, Stade, Barbara, additional, and Bilzer, Manfred, additional

Published
2012
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27. Sa1059 Viral Response at Week 2 as a Predicitive Factor for Rvr in Chronic Hepatitis C Genotype 1 Infection Treated With Peginterferon Alfa-2A (PEG) and Ribavirin (RBV)

Author

Mauss, Stefan, primary, Lutz, Thomas, additional, Boeker, Klaus H., additional, Link, Ralph, additional, Moog, Gero, additional, Stoehr, Albrecht D., additional, Baumgarten, Axel, additional, Heyne, Renate, additional, Eisenbach, Christoph, additional, Teuber, Gerlinde, additional, Weber, Bernd, additional, Schott, Eckart, additional, Hillenbrand, Heribert, additional, Alshuth, Ulrich, additional, Hüppe, Dietrich, additional, and Buggisch, Peter, additional

Published
2012
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28. Sa1072 Early Markers of Metabolic Syndrome are Associated With Distinct HCV Genotypes, While Abnormal Glucose Tolerance Substantially Decreases the Likelihood of SVR

Author

Jaeckel, Elmar, primary, Zehnter, Elmar, additional, Lutz, Thomas, additional, Carlebach, Amina, additional, Link, Ralph, additional, Teuber, Gerlinde, additional, Schmidt, Wolfgang, additional, Bruch, Harald-Robert, additional, Heyne, Renate, additional, Weber, Bernd, additional, Stern, Marek, additional, Naumann, Uwe, additional, Spengler, Ulrich, additional, Herold, Christoph, additional, Stoehr, Albrecht D., additional, Sandow, Petra, additional, Stoll, Sabine, additional, and Manns, Michael P., additional

Published
2012
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29. Sa1053 Age-Dependent Rise in Early Hemoglobin (HB) Decline Contributes to a Higher Frequency of Anemia in Elder Patients Treated With Peginterferon Alfa-2B (Peg2b)/Ribavirin (RBV) for Chronic HCV Genotype 1 (G1) Infection

Author

Teuber, Gerlinde, primary, Mauss, Stefan, additional, Hüppe, Dietrich, additional, Zehnter, Elmar, additional, Manns, Michael P., additional, Dahhan, Tarek, additional, Meyer, Ulrike, additional, Witthöft, Thomas, additional, Moeller, Bernd, additional, Dikopoulos, Nektarios, additional, Brack, Jochen, additional, Dach, Kristina, additional, Stade, Barbara, additional, and Bilzer, Manfred, additional

Published
2012
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30. Predictive Factors of Thrombocytopenia in Treatment of Chronic Hepatitis C (CHC) Patients With Peginterferon Alfa-2a (40KD) and Ribavirin

Author

Mauss, Stefan, primary, Schober, Andreas, additional, Lutz, Thomas, additional, Moog, Gero, additional, Schuchmann, Marcus, additional, Heyne, Renate, additional, John, Christine, additional, Schiffelholz, Willibold, additional, Baumgarten, Axel, additional, Hey, Karl-Heinz, additional, Eisenbach, Christoph, additional, Teuber, Gerlinde, additional, Schmidt, Wolfgang, additional, Bruch, Harald-Robert, additional, Geyer, Peter, additional, Alshuth, Ulrich, additional, and Hueppe, Dietrich, additional

Published
2011
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31. High SVR-Rates in Patients With HCV Genotype 1-Infection, Who Are Dually Infected With Either Genotype 2 or 3 and Treated With PEG-IFNα-2B and Ribavirin

Author

Mauss, Stefan, primary, Teuber, Gerlinde, additional, Zehnter, Elmar, additional, Manns, Michael P., additional, Dahhan, Tarek, additional, Meyer, Ulrike, additional, Moeller, Bernd, additional, Dikopoulos, Nektarios, additional, Witthoeft, Thomas, additional, Bilzer, Manfred, additional, Tossing, Gudrun, additional, and Hueppe, Dietrich, additional

Published
2011
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32. Pathological Glucose Levels and Presence of Hypertension Identifies HCV Patients With Minor Treatment Responses

Author

Jaeckel, Elmar, primary, Zehnter, Elmar, additional, Lutz, Thomas, additional, Hey, Karl-Heinz, additional, John, Christine, additional, Teuber, Gerlinde, additional, Schmidt, Wolfgang, additional, Bruch, Harald-Robert, additional, Geyer, Peter, additional, Heyne, Renate, additional, Stern, Marek, additional, Weber, Bernd, additional, Herold, Christoph, additional, Hinrichsen, Holger M., additional, Stoll, Sabine, additional, and Manns, Michael P., additional

Published
2011
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34. T1993 Comparison of the Efficacy of Peginterferon Alfa-2a and -2B Plus Ribavirin in the Treatment of Chronic Hepatitis C Patients in Daily Routine: Results From Practice

Author

Witthoeft, Thomas, primary, Mauss, Stefan, additional, Hueppe, Dietrich, additional, John, Christine, additional, Heyne, Renate, additional, Moeller, Bernd, additional, Dikopoulos, Nektarios, additional, Baumgarten, Axel, additional, Teuber, Gerlinde, additional, Link, Ralph, additional, and Herrmann, Andreas, additional

Published
2010
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35. S1937 Type of Response to Prior Pegylated Interferon Alfa-2b (12KD)/RBV Predicts Subsequent Response to Retreatment with Peginterferon Alfa-2a (40KD)/RBV

Author

Marcellin, Patrick, primary, Freilich, Bradley L., additional, Andreone, Pietro, additional, Di Bisceglie, Adrian M., additional, Brandao-Mello, Carlos E., additional, Reddy, K. Rajender, additional, Craxi, Antonio, additional, Olveira, Antonio, additional, Teuber, Gerlinde, additional, Messinger, Diethelm, additional, Hooper, Greg, additional, Popescu, Matei, additional, and Jensen, Donald M., additional

Published
2008
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36. M1908 Tenofovir Disoproxil Fumarate (TDF) for the Treatment of HBeAg-Negative Chronic Hepatitis B: Week 72 TDF Data and Week 24 Adefovir Dipivoxil Switch Data (Study 102)

Author

Marcellin, Patrick, primary, Jacobson, Ira M., additional, Tsai, Naoky, additional, Bzowej, Natalie, additional, Habersetzer, François, additional, Senturk, Hakan, additional, Moyes, Christopher D., additional, Teuber, Gerlinde, additional, Sorbel, Jeff, additional, Anderson, Jane, additional, Mondou, Elsa, additional, Quinn, Joe, additional, and Rousseau, Franck, additional

Published
2008
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37. S1006 Efficacy and Safety of Peginterferon Alfa-2a or −2b Plus Ribavirin in the Routine Daily Treatment of Chronic Hepatitis C Patients in Germany: the Practice Study

Author

Witthoeft, Thomas, primary, Hueppe, Dietrich, additional, John, Christine, additional, Goelz, Joerg, additional, Meyer, Ulrike, additional, Heyne, Renate, additional, Moeller, Bernd, additional, Link, Ralph, additional, Teuber, Gerlinde, additional, Sworszt, Slawomir, additional, Herrmann, Andreas, additional, Wollschlaeger, Andreas, additional, Baumgarten, Axel, additional, Simon, Karl-Georg, additional, Cordes, Joerg, additional, Moog, Gero, additional, Dikopoulos, Nektarios, additional, and Mauss, Stefan, additional

Published
2008
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38. S1938 HCV-RNA Status At Week 12 of Treatment with Peginterferon Alfa-2a/RBV Predicts SVR in Patients with Prior Non-Response to Pegylated Interferon Alfa-2b/RBV: Results from Repeat Study

Author

Marcellin, Patrick, primary, Freilich, Bradley L., additional, Andreone, Pietro, additional, Di Bisceglie, Adrian M., additional, Brandao-Mello, Carlos E., additional, Reddy, K. Rajender, additional, Craxi, Antonio, additional, Olveira, Antonio, additional, Teuber, Gerlinde, additional, Messinger, Diethelm, additional, Hooper, Greg, additional, Popescu, Matei, additional, and Jensen, Donald M., additional

Published
2008
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39. W1000 Estimating the Likelihood of Sustained Virological Response in Chronic Hepatitis C (cHC) Therapy

Author

Mauss, Stefan, primary, Hueppe, Dietrich, additional, John, Christine, additional, Goelz, Joerg, additional, Meyer, Ulrike, additional, Heyne, Renate, additional, Moeller, Bernd, additional, Link, Ralph, additional, Teuber, Gerlinde, additional, Sworszt, Slawomir, additional, Herrmann, Andreas, additional, Spelter, Maria, additional, Wollschlaeger, Andreas, additional, Steffens, Hermann, additional, Baumgarten, Axel, additional, Simon, Karl-Georg, additional, Dikopoulos, Nektarios, additional, and Witthoeft, Thomas, additional

Published
2008
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40. S1941 Easy to Assess On-Treatment Parameters Correlate with Degree of Virological Response After 12 Weeks of Treatment

Author

Jensen, Donald M., primary, Freilich, Bradley L., additional, Andreone, Pietro, additional, Di Bisceglie, Adrian M., additional, Brandao-Mello, Carlos E., additional, Reddy, K. Rajender, additional, Craxi, Antonio, additional, Olveira, Antonio, additional, Teuber, Gerlinde, additional, Messinger, Diethelm, additional, Hooper, Greg, additional, Popescu, Matei, additional, Tietz, Andreas, additional, and Marcellin, Patrick, additional

Published
2008
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42. Randomized, controlled trial with interferon-α (IFN-α) combined with ribavirin with and without amantadinsulfat in primary IFN-α non-responders with chronic hepatitis C

Author

Teuber, Gerlinde, primary, Berg, Thomas, additional, Lafrenz, Manfred, additional, Weidenbach, Hans, additional, Schoelmerich, Juergen, additional, Wietzke-Braun, Perdita, additional, Pausch, Juergen, additional, Arnold, Rudolf, additional, Lock, Guntram, additional, Udo, Hopf, additional, and Zeuzem, Stefan, additional

Published
2001
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44. S1006 Efficacy and Safety of Peginterferon Alfa-2a or -2b Plus Ribavirin in the Routine Daily Treatment of Chronic Hepatitis C Patients in Germany: the Practice Study.

Author

Witthoeft, Thomas, Hueppe, Dietrich, John, Christine, Goelz, Joerg, Meyer, Ulrike, Heyne, Renate, Moeller, Bernd, Link, Ralph, Teuber, Gerlinde, Sworszt, Slawomir, Herrmann, Andreas, Wollschlaeger, Andreas, Baumgarten, Axel, Simon, Karl-Georg, Cordes, Joerg, Moog, Gero, Dikopoulos, Nektarios, and Mauss, Stefan

Published
2008
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45. Treatment of naïve patients with chronic hepatitis C genotypes 2 and 3 with pegylated interferon alpha and ribavirin in a real world setting: relevance for the new era of DAA.

Author

Heidrich B, Wiegand SB, Buggisch P, Hinrichsen H, Link R, Möller B, Böker KH, Teuber G, Klinker H, Zehnter E, Naumann U, Busch HW, Maasoumy B, Baum U, Hardtke S, Manns MP, Wedemeyer H, Petersen J, and Cornberg M

Subjects
Adult, Aged, Aged, 80 and over, Antiviral Agents chemistry, Female, Hepacivirus drug effects, Hepacivirus genetics, Hepacivirus isolation & purification, Hepatitis C, Chronic diagnosis, Humans, Immunologic Factors chemistry, Interferon-alpha chemistry, Male, Middle Aged, Polyethylene Glycols chemistry, Prospective Studies, Young Adult, Antiviral Agents therapeutic use, Hepatitis C, Chronic drug therapy, Immunologic Factors therapeutic use, Interferon-alpha therapeutic use, Ribavirin therapeutic use
Abstract

Evidence based clinical guidelines are implemented to treat patients efficiently that include efficacy, tolerability but also health economic considerations. This is of particular relevance to the new direct acting antiviral agents that have revolutionized treatment of chronic hepatitis C. For hepatitis C genotypes 2/3 interferon free treatment is already available with sofosbuvir plus ribavirin. However, treatment with sofosbuvir-based regimens is 10-20 times more expensive compared to pegylated interferon alfa and ribavirin (PegIFN/RBV). It has to be discussed if PegIFN/RBV is still an option for easy to treat patients. We assessed the treatment of patients with chronic hepatitis C genotypes 2/3 with PegIFN/RBV in a real world setting according to the latest German guidelines. Overall, 1006 patients were recruited into a prospective patient registry with 959 having started treatment. The intention-to-treat analysis showed poor SVR (GT2 61%, GT3 47%) while patients with adherence had excellent SVR in the per protocol analysis (GT2 96%, GT3 90%). According to guidelines, 283 patients were candidates for shorter treatment duration, namely a treatment of 16 weeks (baseline HCV-RNA <800.000 IU/mL, no cirrhosis and RVR). However, 65% of these easy to treat patients have been treated longer than recommended that resulted in higher costs but not higher SVR rates. In conclusion, treatment with PegIFN/RBV in a real world setting can be highly effective yet similar effective than PegIFN± sofosbuvir/RBV in well-selected naïve G2/3 patients. Full adherence to guidelines could be further improved, because it would be important in the new era with DAA, especially to safe resources.

Published
2014
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