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1. Incidence and prevalence of primary biliary cholangitis in the Netherlands – A nationwide cohort study

Author

Abraham, Sunje, Adang, Rob P.R., Aktas, Huseyin, Alderlieste, Yasser A., Aparicio-Pages, Maria N., Baak, L. (Bert) C., Baven-Pronk, Martine A.M.C., van der Beek, A. (Sander), Bekkering, Frank C., van Bergeijk, Jeroen D., Beuers, Ulrich, Beukema, Menno, de Boer, Wink, Boersma, Femke, Boonstra, Kirsten, ter Borg, Frank, ter Borg, Martijn J., ter Borg, Pieter C.J., de Bruin, Gijs J., Bus, Paul J., Cahen, Djuna L., Cazemier, Marcel, Cuperus, Frans J.C., van Dam, Lisette J.H., Denters, Maaike J., Drenth, Joost P.H., Epping, Ludger S.M., Erler, Nicole S., Flink, Hajo J., Friederich, Philip W., van Gerven, Nicole F.M., Gevers, Tom J.G., Hansen, Bettina E., van den Hazel, Sven J., van Hoek, Bart, van Hooff, Maria C., Hotho, Daphne M., Janssen, Harry L.A., de Jonge, Hendrik J.M., Jurgens, Matthias C., Kemenade, J.(Netty) van, Kerbert-Dreteler, Marjo J., Klemt-Kropp, Michael, Konings, Ingrid C.A.W., de Kort, Sander, Kuiper, Edith M.M., Kuyvenhoven, Johan P.H., van der Meer, Adriaan J., van Meer, Suzanne, Onderwater, Susanne L., Oterdoom, Leendert H., Ponsioen, Cyriel Y., van Putten, Paul G., van Rooij, Janne E., Roomer, Robert, Schmidt-Böhmer, Johannes, Schmittgens, Stephan, Schreuder, Tim C.M.A., Nicolaas, Jerome Sint, van Soest, Hanneke, Soufidi, Khalida, van Stiphout, Stephan H.C., Thio, Hans H.K., Tielemans, Merel M., Vandebosch, Sigrid, de Veer, Rozanne C., Veldt, Bart J., Verdonk, Robert C., Marleen de Vree, J., de Vries, Elsemieke, Vrieze, Anne, Vrolijk, Jan Maarten, van der Waaij, Laurens A., Werner, Ellen, de Wit, Ulrike, Wolfhagen, Frank H.J., van Hooff, Maria C.B., Baak, L.C., and Borg, Frank ter

Published
2024
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2. Diagnostic accuracy of endoscopic ultrasonography-guided tissue acquisition prior to resection of pancreatic carcinoma: a nationwide analysis

Author

Quispel, Rutger, Schutz, Hannah M., Keultjes, Augustinus W.P., Erler, Nicole S., Janssen, Quisette P., van Hooft, Jeanin E., Venneman, Niels G., Honkoop, Pieter, Hol, Lieke, Scheffer, Robert C., Bisseling, Tanya M., Voermans, Rogier P., Vleggaar, Frank P., Schwartz, Matthijs P., Verdonk, Robert C., Hoge, Chantal V., Kuiken, Sjoerd D., Curvers, Wouter L., van Vilsteren, Frederike G.I., Poen, Alexander C., Spanier, Marcel B., Bruggink, Annette H., Smedts, Frank M., van Velthuysen, Marie-Louise F., van Eijck, Casper H., Besselink, Marc G., Veldt, Bart J., Koerkamp, Bas G., van Driel, Lydi M.J.W., and Bruno, Marco J.

Published
2023
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3. THU-138 The male-to-female ratio among patients with primary biliary cholangitis depends on age

Author

Werner, Ellen, primary, de Veer, Rozanne C., additional, van Hooff, Maria C., additional, Beuers, Ulrich, additional, Drenth, Joost P.H., additional, Cuperus, Frans J.C., additional, van Hoek, Bart, additional, Veldt, Bart J., additional, Kempt-Kropp, Michael, additional, van Meer, Suzanne, additional, Verdonk, Robert C., additional, Flink, Hajo J., additional, Vrolijk, Jan Maarten, additional, Gevers, Tom J.G., additional, Ponsioen, Cyriel Y., additional, Borg, Martijn J. ter, additional, Soufidi, Khalida, additional, Boersma, Femke, additional, de Jonge, Hendrik J.M., additional, Wolfhagen, Frank H.J., additional, Baak, L.C., additional, Onderwater, Susanne L., additional, van Bergeijk, Jeroen D., additional, van Putten, Paul G., additional, de Bruin, Gijs J., additional, Adang, Rob P.R., additional, Pages, Nieves Aparicio, additional, de Boer, Wink, additional, Borg, Frank ter, additional, van Soest, Hanneke, additional, Janssen, Harry L.A., additional, Hansen, Bettina E., additional, Erler, Nicole S., additional, and van der Meer, Adriaan J., additional

Published
2024
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4. Incidence and prevalence of primary biliary cholangitis in the Netherlands – a nationwide cohort study

Author

de Veer, Rozanne C., primary, van Hooff, Maria C.B., additional, Werner, Ellen, additional, Beuers, Ulrich, additional, Drenth, Joost P.H., additional, Cuperus, Frans J.C., additional, van Hoek, Bart, additional, Veldt, Bart J., additional, Klemt-Kropp, Michael, additional, van Meer, Suzanne, additional, Verdonk, Robert C., additional, Flink, Hajo J., additional, Vrolijk, Jan Maarten, additional, Gevers, Tom J.G., additional, Ponsioen, Cyriel Y., additional, ter Borg, Martijn J., additional, Soufidi, Khalida, additional, Boersma, Femke, additional, de Jonge, Hendrik J.M., additional, Wolfhagen, Frank H.J., additional, Baak, L.C., additional, Onderwater, Susanne L., additional, van Bergeijk, Jeroen D., additional, van Putten, Paul G., additional, de Bruin, Gijs J., additional, Adang, Rob P.R., additional, Aparicio-Pages, Maria N., additional, de Boer, Wink, additional, Borg, Frank ter, additional, van Soest, Hanneke, additional, Janssen, Harry L.A., additional, Hansen, Bettina E., additional, Erler, Nicole S., additional, van der Meer, Adriaan J., additional, Abraham, Sunje, additional, Aktas, Huseyin, additional, Alderlieste, Yasser A., additional, Baak, L. (Bert) C., additional, Baven-Pronk, Martine A.M.C., additional, van der Beek, A.Sander, additional, Bekkering, Frank C., additional, Beukema, Menno, additional, Boonstra, Kirsten, additional, ter Borg, Frank, additional, ter Borg, Pieter C.J., additional, Bus, Paul J., additional, Cahen, Djuna L., additional, Cazemier, Marcel, additional, van Dam, Lisette J.H., additional, Denters, Maaike J., additional, Epping, Ludger S.M., additional, Friederich, Philip W., additional, van Gerven, Nicole F.M., additional, van den Hazel, Sven J., additional, van Hooff, Maria C., additional, Hotho, Daphne M., additional, Jurgens, Matthias C., additional, van Kemenade, J.Netty, additional, Kerbert-Dreteler, Marjo J., additional, Konings, Ingrid C.A.W., additional, de Kort, Sander, additional, Kuiper, Edith M.M., additional, Kuyvenhoven, Johan P.H., additional, Oterdoom, Leendert H., additional, van Rooij, Janne E., additional, Roomer, Robert, additional, Schmidt-Böhmer, Johannes, additional, Schmittgens, Stephan, additional, Schreuder, Tim C.M.A., additional, Nicolaas, Jerome Sint, additional, van Stiphout, Stephan H.C., additional, Thio, Hans H.K., additional, Tielemans, Merel M., additional, Vandebosch, Sigrid, additional, de Veer, Rozanne C., additional, Vree, J. Marleen de, additional, de Vries, Elsemieke, additional, Vrieze, Anne, additional, van der Waaij, Laurens A., additional, and de Wit, Ulrike, additional

Published
2024
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5. THU-100 Factors associated with the real-world biochemical response to fibrate therapy in primary biliary cholangitis

Author

van Hooff, Maria C., primary, de Veer, Rozanne C., additional, Werner, Ellen, additional, Beuers, Ulrich, additional, Drenth, Joost P.H., additional, Cuperus, Frans J.C., additional, van Hoek, Bart, additional, Veldt, Bart J., additional, Klemt-Kropp, Michael, additional, van Meer, Suzanne, additional, Verdonk, Robert C., additional, Flink, Hajo J., additional, Vrolijk, Jan Maarten, additional, Gevers, Tom J.G., additional, Ponsioen, Cyriel Y., additional, van Rooij, Janne, additional, Kerbert-Dreteler, Marjo J., additional, Nicolaas, Jerome Sint, additional, De Vree, Marleen, additional, de Vries, Elsemieke S., additional, Friederich, Philip W., additional, Tielemans, Merel M., additional, Aktas, Huseyin, additional, Hotho, Daphne M., additional, de Wit, Ulrike, additional, Kuyvenhoven, Johan P.H., additional, Abraham, Sunje, additional, Kuiper, Edith M.M., additional, Schmittgens, Stephan, additional, Alderslieste, Yasser A., additional, Janssen, Harry L.A., additional, Hansen, Bettina E., additional, Erler, Nicole S., additional, and van der Meer, Adriaan J., additional

Published
2024
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6. THU-120-YI The impact of ursodeoxycholic acid on biochemistry of patients with primary biliary cholangitis in a nationwide cohort

Author

Werner, Ellen, primary, van Hooff, Maria C., additional, van der Maas, Gerjan J., additional, de Veer, Rozanne C., additional, Beuers, Ulrich, additional, Drenth, Joost P.H., additional, Cuperus, Frans J.C., additional, van Hoek, Bart, additional, Veldt, Bart J., additional, Klemt-Kropp, Michael, additional, van Meer, Suzanne, additional, Verdonk, Robert C., additional, Flink, Hajo J., additional, Vrolijk, Jan Maarten, additional, Gevers, Tom J.G., additional, Ponsioen, Cyriel Y., additional, de Kort, Sander, additional, van Putten, Paul G., additional, Cahen, Djuna L., additional, van der Waaij, Lauren A., additional, Thio, Hans H.K., additional, Schreuder, Tim C.M.A., additional, van Dam, Lisette J.H., additional, Epping, Ludger S.M., additional, Jurgens, Matthias C., additional, Cazemier, Marcel, additional, van Kemenade, J., additional, Kuiper, Edith M.M., additional, Beukema, Menno, additional, Borg, Martijn J. ter, additional, Soufidi, Khalida, additional, Janssen, Harry L.A., additional, Hansen, Bettina E., additional, Erler, Nicole S., additional, and van der Meer, Adriaan J., additional

Published
2024
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7. Incidence and prevalence of primary biliary cholangitis in the Netherlands – A nationwide cohort study

Author

de Veer, Rozanne C., van Hooff, Maria C., Werner, Ellen, Beuers, Ulrich, Drenth, Joost P.H., Cuperus, Frans J.C., van Hoek, Bart, Veldt, Bart J., Klemt-Kropp, Michael, van Meer, Suzanne, Verdonk, Robert C., Flink, Hajo J., Vrolijk, Jan Maarten, Gevers, Tom J.G., Ponsioen, Cyriel Y., ter Borg, Martijn J., Soufidi, Khalida, Boersma, Femke, de Jonge, Hendrik J.M., Wolfhagen, Frank H.J., Baak, L. C., Onderwater, Susanne L., van Bergeijk, Jeroen D., van Putten, Paul G., Adang, Rob P.R., Aparicio-Pages, Maria N., de Boer, Wink, ter Borg, Frank, van Soest, Hanneke, Janssen, Harry L.A., Hansen, Bettina E., Erler, Nicole S., van der Meer, Adriaan J., de Veer, Rozanne C., van Hooff, Maria C., Werner, Ellen, Beuers, Ulrich, Drenth, Joost P.H., Cuperus, Frans J.C., van Hoek, Bart, Veldt, Bart J., Klemt-Kropp, Michael, van Meer, Suzanne, Verdonk, Robert C., Flink, Hajo J., Vrolijk, Jan Maarten, Gevers, Tom J.G., Ponsioen, Cyriel Y., ter Borg, Martijn J., Soufidi, Khalida, Boersma, Femke, de Jonge, Hendrik J.M., Wolfhagen, Frank H.J., Baak, L. C., Onderwater, Susanne L., van Bergeijk, Jeroen D., van Putten, Paul G., Adang, Rob P.R., Aparicio-Pages, Maria N., de Boer, Wink, ter Borg, Frank, van Soest, Hanneke, Janssen, Harry L.A., Hansen, Bettina E., Erler, Nicole S., and van der Meer, Adriaan J.

Abstract

Background & Aims: Although primary biliary cholangitis (PBC) is considered a rare disorder, accurate determination of its incidence and prevalence remains challenging due to limited comprehensive population-based registries. We aimed to assess the incidence and prevalence of PBC in the Netherlands over time through the nationwide Dutch PBC Cohort Study (DPCS). Methods: DPCS retrospectively included every identifiable patient with PBC in the Netherlands from 1990 onwards in all 71 Dutch hospitals. Incidence and prevalence were assessed between 2008-2018 by Poisson regression between sex and age groups over time. Results: On the 1st of January 2008, there were 1,458 patients with PBC in the Netherlands. Between 2008-2018, 2,187 individuals were newly diagnosed, 46 were transplanted and 468 died. The yearly incidence of PBC in 2008 was 1.38, increasing to 1.74 per 100,000 persons in 2018. When compared to those aged <45 years, females aged 45-64 years (adjusted incidence rate ratio 4.21, 95% CI 3.76-4.71, p <0.001) and males ≥65 years (adjusted incidence rate ratio 14.41, 95% CI 9.62-21.60, p <0.001) were at the highest risk of being diagnosed with PBC. The male-to-female ratio of patients newly diagnosed with PBC during the study period was 1:14 in those <45 years, 1:10 in patients aged 45-64 years, and 1:4 in those ≥65 years. Point prevalence increased from 11.9 in 2008 to 21.5 per 100,000 persons in 2018. Average annual percent change in this time period was 5.94% (95% CI 5.77-6.15, p <0.05), and was the highest among the population aged ≥65 years (5.69%, 95% CI 5.32-6.36, p <0.001). Conclusions: In this nationwide cohort study, we observed an increase in both the incidence and prevalence of PBC in the Netherlands over the past decade, with marked age and sex differences. Impact and implications: This nationwide Dutch primary biliary

Published
2024

8. Diagnostic accuracy of endoscopic ultrasonography-guided tissue acquisition prior to resection of pancreatic carcinoma:a nationwide analysis

Author

Quispel, Rutger, Schutz, Hannah M., Keultjes, Augustinus W.P., Erler, Nicole S., Janssen, Quisette P., van Hooft, Jeanin E., Venneman, Niels G., Honkoop, Pieter, Hol, Lieke, Scheffer, Robert C., Bisseling, Tanya M., Voermans, Rogier P., Vleggaar, Frank P., Schwartz, Matthijs P., Verdonk, Robert C., Hoge, Chantal V., Kuiken, Sjoerd D., Curvers, Wouter L., van Vilsteren, Frederike G.I., Poen, Alexander C., Spanier, Marcel B., Bruggink, Annette H., Smedts, Frank M., van Velthuysen, Marie Louise F., van Eijck, Casper H., Besselink, Marc G., Veldt, Bart J., Koerkamp, Bas G., van Driel, Lydi M.J.W., Bruno, Marco J., Quispel, Rutger, Schutz, Hannah M., Keultjes, Augustinus W.P., Erler, Nicole S., Janssen, Quisette P., van Hooft, Jeanin E., Venneman, Niels G., Honkoop, Pieter, Hol, Lieke, Scheffer, Robert C., Bisseling, Tanya M., Voermans, Rogier P., Vleggaar, Frank P., Schwartz, Matthijs P., Verdonk, Robert C., Hoge, Chantal V., Kuiken, Sjoerd D., Curvers, Wouter L., van Vilsteren, Frederike G.I., Poen, Alexander C., Spanier, Marcel B., Bruggink, Annette H., Smedts, Frank M., van Velthuysen, Marie Louise F., van Eijck, Casper H., Besselink, Marc G., Veldt, Bart J., Koerkamp, Bas G., van Driel, Lydi M.J.W., and Bruno, Marco J.

Abstract

Introduction: Endoscopic ultrasonography guided tissue acquisition (EUS + TA) is used to provide a tissue diagnosis in patients with suspected pancreatic cancer. Key performance indicators (KPI) for these procedures are rate of adequate sample (RAS) and sensitivity for malignancy (SFM). Aim: assess practice variation regarding KPI of EUS + TA prior to resection of pancreatic carcinoma in the Netherlands. Patients and methods: Results of all EUS + TA prior to resection of pancreatic carcinoma from 2014–2018, were extracted from the national Dutch Pathology Registry (PALGA). Pathology reports were classified as: insufficient for analysis (b1), benign (b2), atypia (b3), neoplastic other (b4), suspected malignant (b5), and malignant (b6). RAS was defined as the proportion of EUS procedures yielding specimen sufficient for analysis. SFM was calculated using a strict definition (malignant only, SFM-b6), and a broader definition (SFM-b5+6). Results: 691 out of 1638 resected patients (42%) underwent preoperative EUS + TA. RAS was 95% (range 89–100%), SFM-b6 was 44% (20–77%), and SFM-b5+6 was 65% (53–90%). All centers met the performance target RAS>85%. Only 9 out of 17 met the performance target SFM-b5+6 > 85%. Conclusion: This nationwide study detected significant practice variation regarding KPI of EUS + TA procedures prior to surgical resection of pancreatic carcinoma. Therefore, quality improvement of EUS + TA is indicated.

Published
2023

10. THU-109 Increasing prevalence of primary biliary cholangitis in The Netherlands

Author

de Veer, Rozanne C., van Hooff, Maria C., Werner, Ellen, Beuers, Ulrich, Drenth, Joost P.H., Cuperus, Frans J.C., van Hoek, Bart, Veldt, Bart J., Kempt-Kropp, Michael, van Meer, Suzanne, Verdonk, Robert C., Flink, Hajo J., Vrolijk, Jan Maarten, Gevers, Tom J.G., Ponsioen, Cyriel Y., Borg, Martijn J. ter, Soufidi, Khalida, Boersma, Femke, de Jonge, Hendrik J.M., Wolfhagen, Frank H.J., Baak, L.C., Onderwater, Susanne L., van Bergeijk, Jeroen D., van Putten, Paul G., de Bruin, Gijs J., Adang, Rob P.R., Pages, Nieves Aparicio, de Boer, Wink, Borg, Frank ter, van Soest, Hanneke, Janssen, Harry L.A., Hansen, Bettina E., Erler, Nicole S., and van der Meer, Adriaan J.

Published
2024
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11. Cumulative sum learning curves guiding multicenter multidisciplinary quality improvement of EUS-guided tissue acquisition of solid pancreatic lesions

Author

Schutz, Hannah M, Quispel, Rutger, Veldt, Bart J, Smedts, Frank M M, Anten, Marie-Paule G F, Hoogduin, Klaas J, Honkoop, Pieter, van Nederveen, Francien H, Hol, Lieke, Kliffen, Mike, Fitzpatrick, Claire E, Erler, Nicole S, Bruno, Marco J, van Driel, Lydi M J W, Schutz, Hannah M, Quispel, Rutger, Veldt, Bart J, Smedts, Frank M M, Anten, Marie-Paule G F, Hoogduin, Klaas J, Honkoop, Pieter, van Nederveen, Francien H, Hol, Lieke, Kliffen, Mike, Fitzpatrick, Claire E, Erler, Nicole S, Bruno, Marco J, and van Driel, Lydi M J W

Abstract

Background and study aims In this study, we evaluated the performance of community hospitals involved in the Dutch quality in endosonography team regarding yield of endoscopic ultrasound (EUS)-guided tissue acquisition (TA) of solid pancreatic lesions using cumulative sum (CUSUM) learning curves. The aims were to assess trends in quality over time and explore potential benefits of CUSUM as a feedback-tool. Patients and methods All consecutive EUS-guided TA procedures for solid pancreatic lesions were registered in five community hospitals between 2015 and 2018. CUSUM learning curves were plotted for overall performance and for performance per center. The American Society of Gastrointestinal Endoscopy-defined key performance indicators, rate of adequate sample (RAS), and diagnostic yield of malignancy (DYM) were used for this purpose. Feedback regarding performance was provided on multiple occasions at regional interest group meetings during the study period. Results A total of 431 EUS-guided TA procedures in 403 patients were included in this study. The overall and per center CUSUM curves for RAS improved over time. CUSUM curves for DYM revealed gradual improvement, reaching the predefined performance target (70 %) overall, and in three of five contributing centers in 2018. Analysis of a sudden downslope development in the CUSUM curve of DYM in one center revealed temporary absence of a senior cytopathologist to have had a temporary negative impact on performance. Conclusions CUSUM-derived learning curves allow for assessment of best practices by comparison among peers in a multidisciplinary multicenter quality improvement initiative and proved to be a valuable and easy-to-interpret means to evaluate EUS performance over time.

Published
2022

16. Reliable prediction of clinical outcome in patients with chronic HCV infection and compensated advanced hepatic fibrosis: a validated model using objective and readily available clinical parameters

Author

van der Meer, Adriaan J, Hansen, Bettina E, Fattovich, Giovanna, Feld, Jordan J, Wedemeyer, Heiner, Dufour, Jean-François, Lammert, Frank, Duarte-Rojo, Andres, Manns, Michael P, Ieluzzi, Donatella, Zeuzem, Stefan, Hofmann, Peter W, de Knegt, Robert J, Veldt, Bart J, and Janssen, Harry L A

Published
2015
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24. Optimizing cytological specimens of EUS‐FNA of solid pancreatic lesions: A pilot study to the effect of a smear preparation training for endoscopy personnel on sample quality and accuracy

Author

Riet, Priscilla A., primary, Quispel, Rutger, additional, Cahen, Djuna L., additional, Erler, Nicole S., additional, Snijders‐Kruisbergen, Mieke C., additional, Van Loenen, Petri, additional, Poley, Jan‐Werner, additional, Driel, Lydi M.J.W., additional, Mulder, Sanna A., additional, Veldt, Bart J., additional, Leeuwenburgh, Ivonne, additional, Anten, Marie‐Paule G.F., additional, Honkoop, Pieter, additional, Thijssen, Annemieke Y., additional, Hol, Lieke, additional, Hadithi, Mohammed, additional, Fitzpatrick, Claire E., additional, Schot, Ingrid, additional, Bergmann, Jilling F., additional, Bhalla, Abha, additional, Bruno, Marco J., additional, and Biermann, Katharina, additional

Published
2020
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25. Diagnostic yield and agreement on fine-needle specimens from solid pancreatic lesions: comparing the smear technique to liquid-based cytology

Author

van Riet, Priscilla A., additional, Quispel, Rutger, additional, Cahen, Djuna L., additional, Snijders-Kruisbergen, Mieke C., additional, van Loenen, Petri, additional, Erler, Nicole S., additional, Poley, Jan-Werner, additional, van Driel, Lydi M. J. W., additional, Mulder, Sanna A., additional, Veldt, Bart J., additional, Leeuwenburgh, Ivonne, additional, Anten, Marie-Paule G. F., additional, Honkoop, Pieter, additional, Thijssen, Annemieke Y., additional, Hol, Lieke, additional, Hadithi, Mohammed, additional, Fitzpatrick, Claire E., additional, Schot, Ingrid, additional, Bergmann, Jilling F., additional, Bhalla, Abha, additional, Bruno, Marco J., additional, and Biermann, Katharina, additional

Published
2020
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29. Optimizing cytological specimens of EUS‐FNA of solid pancreatic lesions: A pilot study to the effect of a smear preparation training for endoscopy personnel on sample quality and accuracy.

Author

Riet, Priscilla A., Quispel, Rutger, Cahen, Djuna L., Erler, Nicole S., Snijders‐Kruisbergen, Mieke C., Van Loenen, Petri, Poley, Jan‐Werner, Driel, Lydi M.J.W., Mulder, Sanna A., Veldt, Bart J., Leeuwenburgh, Ivonne, Anten, Marie‐Paule G.F., Honkoop, Pieter, Thijssen, Annemieke Y., Hol, Lieke, Hadithi, Mohammed, Fitzpatrick, Claire E., Schot, Ingrid, Bergmann, Jilling F., and Bhalla, Abha

Published
2021
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30. Retreatment of hepatitis C non-responsive to Interferon. A placebo controlled randomized trial of Ribavirin monotherapy versus combination therapy with Ribavirin and Interferon in 121 patients in the Benelux [ISRCTN53821378]

Author

Delwaide Jean, Michielsen Peter, Nevens Frederik, Adler Michael, Brouwer Johannes T, Veldt Bart J, Hansen Bettina E, and Schalm Solko W

Subjects
Hepatitis C, Treatment, Randomised controlled trial, Interferon, Ribavirin, Non-responders, Monotherapy, Placebo, Diseases of the digestive system. Gastroenterology, RC799-869
Abstract

Abstract Background Evidence based medicine depends on unbiased selection of completed randomized controlled trials. For completeness it is important to publish all trials. This report describes the first large randomised controlled trial where combination therapy was compared to placebo therapy and to ribavirin monotherapy, which has not been published untill now. Methods One hundred and twenty one patients with chronic hepatitis C and elevated transaminases who did not respond to previous treatment with standard interferon monotherapy, were included from 16 centers in Belgium, the Netherlands and Luxembourg between 1992 and 1996. Patient poor-response characteristics were: genotype 1 (69%), HCV RNA above 2 × 106 copies/ml (55%) and cirrhosis (38%). Patients were randomized to 6 months combination therapy with interferon alpha-2b (3 MU tiw) and ribavirin (1000–1200 mg / day), 6 months ribavirin monotherapy (1000–1200 mg / day) or 6 months ribavirin placebo. The study was double blinded for the ribavirin / placebo component. One patient did not fit the entry criteria, and 3 did not start. All 117 patients who received at least one dose of treatment were included in the intention to treat analysis. Results At the end of treatment, HCV RNA was undetectable in 35% of patients on combination therapy and in none of the patients treated with ribavirin monotherapy or placebo. The sustained virological response rate at 6 months after therapy was 15% for patients treated with interferon and ribavirin. During the 6 months treatment period 13% of patients on interferon ribavirin combination therapy, 13% of patients on ribavirin monotherapy and 11% of patients on placebo withdrew due to side effects or noncompliance. At 24 weeks of treatment the mean Hb level was 85% of the baseline value, which means a mean decrease from 9.1 mmol/l to 7.8 mmol/l. The Hb levels at the end of treatment were not significantly different from patients treated with ribavirin monotherapy (p = 0.76). End of treatment WBC was significantly lower in patients treated with combination therapy, compared to ribavirin (p < 0.01) as well as for patients treated with ribavirin monotherapy compared to placebo (p < 0.01). Discussion This belated report on the only placebo controlled study of interferon ribavirin combination therapy in non responders to standard doses of interferon monotherapy documents the effectiveness, be it limited, of this approach as well as the dynamics of the effects on blood counts.

Published
2003
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32. Association of dietary macronutrient composition and non-alcoholic fatty liver disease in an ageing population: the Rotterdam Study

Author

Alferink, Louise JM, primary, Kiefte-de Jong, Jessica C, additional, Erler, Nicole S, additional, Veldt, Bart J, additional, Schoufour, Josje D, additional, de Knegt, Robert J, additional, Ikram, M Arfan, additional, Metselaar, Herold J, additional, Janssen, Harry LA, additional, Franco, Oscar H, additional, and Darwish Murad, Sarwa, additional

Published
2018
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33. Improvement of platelets after SVR among patients with chronic HCV infection and advanced hepatic fibrosis

Author

Veldt, Bart J, Feld, Jordan J, Van Der Meer, Adriaan J, Zeuzem, Stefan, Dufour, Jean-François, Maan, Raoel, Lammert, Frank, Hansen, Bettina E, Janssen, Harry L A, Wedemeyer, Heiner, De Knegt, Robert J, Manns, Michael P, Peter Hofmann, W, Duarte-Rojo, Andres, and Gastroenterology & Hepatology

Subjects
SDG 3 - Good Health and Well-being, 610 Medicine & health
Abstract

BACKGROUND & AIMS Patients with chronic hepatitis C virus (HCV) infection may develop cirrhosis with portal hypertension, reflected by decreased platelet count and splenomegaly. This retrospective cohort study aimed to assess changes in platelet counts after antiviral therapy among chronic HCV-infected patients with advanced fibrosis. METHODS Platelet counts and spleen sizes were recorded in an international cohort of patients with Ishak 4-6 fibrosis who started antiviral therapy between 1990 and 2003. Last measured platelet counts and spleen sizes were compared to their pre-treatment values (within 6 six months prior to the start of therapy). All registered platelet count measurements from 24 week following cessation of antiviral therapy were included in repeated measurement analyses. RESULTS This study included 464 patients; 353 (76%) had cirrhosis and 187 (40%) attained sustained virological response (SVR). Among patients with SVR, median platelet count, increased by 35 x10(9) /L (IQR 7-62, p

Published
2015

34. Risk of cirrhosis-related complications in patients with advanced fibrosis following hepatitis C virus eradication

Author

van der Meer, Adriaan J., primary, Feld, Jordan J., additional, Hofer, Harald, additional, Almasio, Piero L., additional, Calvaruso, Vincenza, additional, Fernández-Rodríguez, Conrado M., additional, Aleman, Soo, additional, Ganne-Carrié, Nathalie, additional, D’Ambrosio, Roberta, additional, Pol, Stanislas, additional, Trapero-Marugan, Maria, additional, Maan, Raoel, additional, Moreno-Otero, Ricardo, additional, Mallet, Vincent, additional, Hultcrantz, Rolf, additional, Weiland, Ola, additional, Rutter, Karoline, additional, Di Marco, Vito, additional, Alonso, Sonia, additional, Bruno, Savino, additional, Colombo, Massimo, additional, de Knegt, Robert J., additional, Veldt, Bart J., additional, Hansen, Bettina E., additional, and Janssen, Harry L.A., additional

Published
2017
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36. Risk of infections during interferon-based treatment in patients with chronic HCV infection and advanced hepatic fibrosis

Author

Maan, Raoel, van der Meer, Adriaan J, Hansen, Bettina E, Feld, Jordan J, Wedemeyer, Heiner, Dufour, Jean-François, Lammert, Frank, Manns, Michael P, Zeuzem, Stefan, Janssen, Harry L A, de Knegt, Robert J, and Veldt, Bart J

Subjects
610 Medicine & health
Abstract

BACKGROUND & AIMS Pegylated interferon-based treatment is still the backbone of current hepatitis C therapy and is associated with bone marrow suppression and an increased risk of infections. The aim of this retrospective cohort study was to assess the risk of infections during interferon-based treatment among patients with chronic HCV infection and advanced hepatic fibrosis and its relation to treatment-induced neutropenia. METHODS This cohort study included all consecutive patients with chronic HCV infection and biopsy-proven bridging fibrosis or cirrhosis (Ishak 4-6) who started treatment between 1990 and 2003 in five large hepatology units in Europe and Canada. Neutrophil counts between 500/μL-749/μL and below 500/μL were considered as moderate and severe neutropenia, respectively. RESULTS This study included 723 interferon-based treatments, administered to 490 patients. In total, 113 infections were reported during 88 (12%) treatments, of which 24 (21%) were considered severe. Only one patient was found to have moderate neutropenia and three patients were found to have severe neutropenia at the visit before the infection. Three hundred and twelve (99.7%) visits with moderate neutropenia and 44 (93.6%) visits with severe neutropenia were not followed by an infection. Multivariable analysis showed that cirrhosis (OR 2.85, 95%CI 1.38-5.90, p=0.005) and severe neutropenia at the previous visit (OR 5.42, 95%CI 1.34-22.0, p=0.018) were associated with the occurrence of infection, while moderate neutropenia was not. Among a subgroup of patients treated with PegIFN, severe neutropenia was not significantly associated (OR 1.63, 95%CI 0.19-14.2, p=0.660). CONCLUSIONS In this large cohort of patients with bridging fibrosis and cirrhosis, infections during interferon-based therapy were generally mild. Severe interferon-induced neutropenia rarely occurred, but was associated with on-treatment infection. Moderate neutropenia was not associated with infection, suggesting that current dose reduction guidelines might be too strict.

Published
2015
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37. Association of dietary macronutrient composition and non-alcoholic fatty liver disease in an ageing population: the Rotterdam Study.

Author

Alferink, Louise J. M., Kiefte-de Jong, Jessica C., Erler, Nicole S., Veldt, Bart J., Schoufour, Josje D., de Knegt, Robert J., Ikram, M. Arfan, Metselaar, Herold J., Janssen, Harry L. A., Franco, Oscar H., and Murad, Sarwa Darwish

Subjects
FATTY liver, AGE factors in disease, POPULATION aging, GAMMA-glutamyltransferase, SOMATOTROPIN, HEPATITIS associated antigen
Published
2019
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38. Real‐world medical costs of antiviral therapy among patients with chronic HCV infection and advanced hepatic fibrosis

Author

Maan, Raoel, primary, Zaim, Remziye, additional, van der Meer, Adriaan J, additional, Feld, Jordan J, additional, Wedemeyer, Heiner, additional, Dufour, Jean‐François, additional, Lammert, Frank, additional, Manns, Michael P, additional, Zeuzem, Stefan, additional, Hansen, Bettina E, additional, Janssen, Harry LA, additional, Veldt, Bart J, additional, de Knegt, Robert J, additional, and Uyl‐de Groot, Carin A, additional

Published
2016
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39. ITPA Polymorphisms Are Associated with Hematological Side Effects during Antiviral Therapy for Chronic HCV Infection

Author

Maan, Raoel, primary, van der Meer, Adriaan J., additional, Brouwer, Willem Pieter, additional, Plompen, Elisabeth P. C., additional, Sonneveld, Milan J., additional, Roomer, Robert, additional, van der Eijk, Annemiek A., additional, Groothuismink, Zwier M. A., additional, Hansen, Bettina E., additional, Veldt, Bart J., additional, Janssen, Harry L. A., additional, Boonstra, Andre, additional, and de Knegt, Robert J., additional

Published
2015
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41. Effect of thrombocytopenia on treatment tolerability and outcome in patients with chronic HCV infection and advanced hepatic fibrosis

Author

Maan, Raoel, primary, van der Meer, Adriaan J., additional, Hansen, Bettina E., additional, Feld, Jordan J., additional, Wedemeyer, Heiner, additional, Dufour, Jean-François, additional, Zangneh, Hooman F., additional, Lammert, Frank, additional, Manns, Michael P., additional, Zeuzem, Stefan, additional, Janssen, Harry L.A., additional, de Knegt, Robert J., additional, and Veldt, Bart J., additional

Published
2014
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44. Reliable prediction of clinical outcome in patients with chronic HCV infection and compensated advanced hepatic fibrosis: a validated model using objective and readily available clinical parameters

Author

van der Meer, Adriaan J, primary, Hansen, Bettina E, additional, Fattovich, Giovanna, additional, Feld, Jordan J, additional, Wedemeyer, Heiner, additional, Dufour, Jean-François, additional, Lammert, Frank, additional, Duarte-Rojo, Andres, additional, Manns, Michael P, additional, Ieluzzi, Donatella, additional, Zeuzem, Stefan, additional, Hofmann, W Peter, additional, de Knegt, Robert J, additional, Veldt, Bart J, additional, and Janssen, Harry L A, additional

Published
2014
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46. Improvement of platelets after SVR among patients with chronic HCV infection and advanced hepatic fibrosis.

Author

Meer, Adriaan J, Maan, Raoel, Veldt, Bart J, Feld, Jordan J, Wedemeyer, Heiner, Dufour, Jean ‐ François, Lammert, Frank, Duarte ‐ Rojo, Andres, Manns, Michael P, Zeuzem, Stefan, Hofmann, W Peter, Knegt, Robert J, Hansen, Bettina E, and Janssen, Harry LA

Subjects
CHRONIC hepatitis C, HEPATIC fibrosis, CYSTIC fibrosis treatment, PLATELET count, SPLENOMAGALY, THERAPEUTICS
Abstract

Background and Aims: Patients with chronic hepatitis C virus (HCV) infection may develop cirrhosis with portal hypertension, reflected by decreased platelet count and splenomegaly. This retrospective cohort study aimed to assess changes in platelet counts after antiviral therapy among chronic HCV-infected patients with advanced fibrosis. Methods: Platelet counts and spleen sizes were recorded in an international cohort of patients with Ishak 4-6 fibrosis who started antiviral therapy between 1990 and 2003. Last measured platelet counts and spleen sizes were compared with their pre-treatment values (within 6 months prior to the start of therapy). All registered platelet count measurements from 24-week following cessation of antiviral therapy were included in repeated measurement analyses. Results: This study included 464 patients; 353 (76%) had cirrhosis and 187 (40%) attained sustained virological response (SVR). Among patients with SVR, median platelet count, increased by 35 × 109/L (IQR 7-62, P < 0.001). In comparison, patients without SVR showed a median decline of 17 × 109/L (IQR −5-47, P < 0.001). In a subgroup of 209 patients, median decrease in spleen size was 1.0 cm (IQR 0.3-2.0) for patients with SVR, while median spleen size increased with 0.6 cm (IQR −0.1-2.0, P < 0.001) among those without SVR. The changes in spleen size and platelet count were significantly correlated ( R = −0.41, P < 0.001). Conclusions: Among chronic HCV-infected patients with advanced hepatic fibrosis, the platelet counts improved following SVR and the change in platelets correlated with the change in spleen size following antiviral therapy. These results suggest that HCV eradication leads to reduced portal pressure. [ABSTRACT FROM AUTHOR]

Published
2016
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48. Reply

Author

Veldt, Bart J., primary and Janssen, Harry L. A., additional

Published
2008
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49. Randomized placebo controlled phase I/II trial of α-galactosylceramide for the treatment of chronic hepatitis C

Author

Veldt, Bart J., primary, van der Vliet, Hans J.J., additional, von Blomberg, B. Mary E., additional, van Vlierberghe, Hans, additional, Gerken, Guido, additional, Nishi, Nobusuke, additional, Hayashi, Kunihiko, additional, Scheper, Rik J., additional, de Knegt, Robert J., additional, van den Eertwegh, Alfons J.M., additional, Janssen, Harry L.A., additional, and van Nieuwkerk, Carin M.J., additional

Published
2007
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