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3. Effectiveness of Simeprevir Plus Sofosbuvir, With or Without Ribavirin, in Real-World Patients With HCV Genotype 1 Infection

Author

Afdhal, N., Alam, I., Ben-Ari, Z., Bredfeldt, J., Brown, R.S., Chung, R.T., Darling, J., Harlan, W., Di Bisceglie, A.M., Dickson, R.C., Elbeshbeshy, H.A., Everson, G., Feld, J., Fenkel, J.M., Fried, M.W., Galati, J., Gordon, S.C., Hassan, M., Hawkins, T.N., Hinestrosa, F., Jacobson, I.M., Kerr, C.A., Kuo, A., Kwo, P.Y., Levitsky, J., Lim, J., Lok, A.S., Mailliard, M., Manns, M.P., Morelli, G., Muir, A.J., Nelson, D., O’Leary, J.G., Pearlman, B.L., Pockros, P., Ramani, A., Reau, N., Reddy, K.R., Schiff, E.R., Sherman, K.E., Shiffman, M.L., Smith, C., Spivey, J.R., Sterling, R.K., Sulkowski, M.S., Szabo, G., Terrault, N.A., Trautwein, C., Vargas, H.E., Watts, K., Williams, A., Zeuzem, S., Sulkowski, Mark S., Vargas, Hugo E., Di Bisceglie, Adrian M., Kuo, Alexander, Reddy, K. Rajender, Lim, Joseph K., Morelli, Giuseppe, Darling, Jama M., Feld, Jordan J., Brown, Robert S., Frazier, Lynn M., Stewart, Thomas G., Fried, Michael W., Nelson, David R., and Jacobson, Ira M.

Published
2016
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5. Risk factors and outcomes associated with recurrent autoimmune hepatitis following liver transplantation

Author

Montano-Loza, A.J., Ronca, V., Ebadi, M., Hansen, B.E., Hirschfield, G., Elwir, S., Alsaed, M., Milkiewicz, P., Janik, M.K., Marschall, H.U., Burza, M.A., Efe, C., Caliskan, A.R., Harputluoglu, M., Kabacam, G., Terrabuio, D., Onofrio, F.D., Selzner, N., Bonder, A., Pares, A., Llovet, L., Akyildiz, M., Arikan, C., Manns, M.P., Taubert, R., Weber, A.L., Schiano, T.D., Haydel, B., Czubkowski, P., Socha, P., Oldak, N., Akamatsu, N., Tanaka, A., Levy, C., Martin, E.F., Goel, A., Sedki, M., Jankowska, I., Ikegami, T., Rodriguez, M., Sterneck, M., Weiler-Normann, C., Schramm, C., Donato, M.F., Lohse, A., Andrade, R.J., Patwardhan, V.R., Hoek, B. van, Biewenga, M., Kremer, A.E., Ueda, Y., Deneau, M., Pedersen, M., Mayo, M.J., Floreani, A., Burra, P., Secchi, M.F., Beretta-Piccoli, B.T., Sciveres, M., Maggiore, G., Jafri, S.M., Debray, D., Girard, M., Lacaille, F., Lytvyak, E., Mason, A.L., Heneghan, M., Oo, Y.H., and Int Autoimmune Hepatitis Grp IAIHG

Subjects
Adult, Male, Hepatology, liver transplantation, recurrent disease, autoimmune liver disease, graft survival, Mycophenolic Acid, survival, Hepatitis, Autoimmune, Recurrence, Risk Factors, Immunoglobulin G, Humans, Female, Immunosuppressive Agents
Abstract

Background & Aims: Autoimmune hepatitis can recur after liver transplantation (LT), though the impact of recurrence on patient and graft survival has not been well characterized. We evaluated a large, international, multicenter cohort to identify the probability and risk factors associated with recurrent AIH and the association between recurrent disease and patient and graft survival.Methods: We included 736 patients (77% female, mean age 42 +/- 1 years) with AIH who underwent LT from January 1987 through June 2020, among 33 centers in North America, South America, Europe and Asia. Clinical data before and after LT, biochemical data within the first 12 months after LT, and immunosuppression after LT were analyzed to identify patients at higher risk of AIH recurrence based on histological diagnosis.Results: AIH recurred in 20% of patients after 5 years and 31% after 10 years. Age at LT

Published
2022

8. Systematic review of response criteria and endpoints in autoimmune hepatitis by the International Autoimmune Hepatitis Group

Author

Pape, S., Snijders, R.J.A.L.M., Gevers, T.J.G., Chazouilleres, O., Dalekos, G.N., Hirschfield, G.M., Lenzi, M., Trauner, M., Manns, M.P., Vierling, J.M., Montano-Loza, A.J., Lohse, A.W., Schramm, C., Drenth, J.P.H., Heneghan, M.A., Pape, S., Snijders, R.J.A.L.M., Gevers, T.J.G., Chazouilleres, O., Dalekos, G.N., Hirschfield, G.M., Lenzi, M., Trauner, M., Manns, M.P., Vierling, J.M., Montano-Loza, A.J., Lohse, A.W., Schramm, C., Drenth, J.P.H., and Heneghan, M.A.

Abstract

Item does not contain fulltext, BACKGROUND & AIMS: Autoimmune hepatitis (AIH) has been well characterised and codified through the development of diagnostic criteria. These criteria have been adapted and simplified and are widely used in clinical practice. However, there is a need to update and precisely define the criteria for both treatment response and treatment. METHODS: A systematic review was performed and a modified Delphi consensus process was used to identify and redefine the response criteria in autoimmune hepatitis. RESULTS: The consensus process initiated by the International Autoimmune Hepatitis Group proposes that the term 'complete biochemical response' defined as 'normalization of serum transaminases and IgG below the upper limit of normal' be adopted to include a time point at 6 months after initiation of treatment. An insufficient response by 6 months was a failure to meet the above definition. Non-response was defined as '<50% decrease of serum transaminases within 4 weeks after initiation of treatment'. Remission is defined as liver histology with a Hepatitis Activity Index <4/18. Intolerance to treatment was agreed to stand for 'any adverse event possibly related to treatment leading to potential drug discontinuation'. CONCLUSIONS: These definitions provide a simple and reproducible framework to define treatment response and non-response, irrespective of the therapeutic intervention. A consensus on endpoints is urgently required to set a global standard for the reporting of study results and to enable inter-study comparisons. Future prospective database studies are needed to validate these endpoints. LAY SUMMARY: Consensus among international experts on response criteria and endpoints in autoimmune hepatitis is lacking. A consensus on endpoints is urgently required to set a global standard for the reporting of study results and to enable the comparison of results between clinical trials. Therefore, the International Autoimmune Hepatitis Group (IAIHG) herein presents a statemen

Published
2022

9. Quantification of polyreactive immunoglobulin G facilitates the diagnosis of autoimmune hepatitis

Author

Taubert, R., Engel, B., Diestelhorst, J., Hupa-Breier, K.L., Behrendt, P., Baerlecken, N.T., Sühs, K.W., Janik, M.K., Zachou, K., Sebode, M., Schramm, C., Londoño, M.C., Habes, S., Oo, Y.H., Lalanne, C., Pape, S., Schubert, M, Hust, M., Dübel, S., Thevis, M., Jonigk, D., Beimdiek, J., Buettner, F.F., Drenth, J.P.H., Muratori, L., Adams, D.H., Dyson, J.K., Renand, A., Graupera, I., Lohse, A.W., Dalekos, G.N., Milkiewicz, P., Stangel, M., Maasoumy, B., Witte, T. de, Wedemeyer, H., Manns, M.P., Jaeckel, E., Taubert, R., Engel, B., Diestelhorst, J., Hupa-Breier, K.L., Behrendt, P., Baerlecken, N.T., Sühs, K.W., Janik, M.K., Zachou, K., Sebode, M., Schramm, C., Londoño, M.C., Habes, S., Oo, Y.H., Lalanne, C., Pape, S., Schubert, M, Hust, M., Dübel, S., Thevis, M., Jonigk, D., Beimdiek, J., Buettner, F.F., Drenth, J.P.H., Muratori, L., Adams, D.H., Dyson, J.K., Renand, A., Graupera, I., Lohse, A.W., Dalekos, G.N., Milkiewicz, P., Stangel, M., Maasoumy, B., Witte, T. de, Wedemeyer, H., Manns, M.P., and Jaeckel, E.

Abstract

Contains fulltext : 252186.pdf (Publisher’s version ) (Open Access), BACKGROUND AND AIMS: Detection of autoantibodies is a mainstay of diagnosing autoimmune hepatitis (AIH). However, conventional autoantibodies for the workup of AIH lack either sensitivity or specificity, leading to substantial diagnostic uncertainty. We aimed to identify more accurate serological markers of AIH with a protein macroarray. APPROACH AND RESULTS: During the search for more-precise autoantibodies to distinguish AIH from non-AIH liver diseases (non-AIH-LD), IgG antibodies with binding capacities to many human and foreign proteins were identified with a protein macroarray and confirmed with solid-phase ELISAs in AIH patients. Subsequently, polyreactive IgG (pIgG) was exemplarily quantified by reactivity against human huntingtin-interacting protein 1-related protein in bovine serum albumin blocked ELISA (HIP1R/BSA). The diagnostic fidelity of HIP1R/BSA binding pIgG to diagnose AIH was assessed in a retrospective training, a retrospective multicenter validation, and a prospective validation cohort in cryoconserved samples from 1,568 adults from 10 centers from eight countries. Reactivity against HIP1R/BSA had a 25% and 14% higher specificity to diagnose AIH than conventional antinuclear and antismooth muscle antibodies, a significantly higher sensitivity than liver kidney microsomal antibodies and antisoluble liver antigen/liver pancreas antigen, and a 12%-20% higher accuracy than conventional autoantibodies. Importantly, HIP1R/BSA reactivity was present in up to 88% of patients with seronegative AIH and in up to 71% of AIH patients with normal IgG levels. Under therapy, pIgG returns to background levels of non-AIH-LD. CONCLUSIONS: pIgG could be used as a promising marker to improve the diagnostic workup of liver diseases with a higher specificity for AIH compared to conventional autoantibodies and a utility in autoantibody-negative AIH. Likewise, pIgG could be a major source of assay interference in untreated AIH.

Published
2022

10. Systematic review of response criteria and endpoints in autoimmune hepatitis by the International Autoimmune Hepatitis Group

Author

Arıkan, Çiğdem (ORCID 0000-0002-0794-2741 & YÖK ID 240198), Pape, S.; Snijders R.J.; Gevers, T.J.; Chazouilleres, O.; Dalekos, G.N.; Hirschfield, G.M.; Lenzi, M.; Trauner, M.; Manns, M.P.; Vierling, J.M.; Montano Loza, A.J.; Lohse, A.W.; Schramm, C.; Drenth, J.P.; Heneghan, M.A.; International Autoimmune Hepatitis Group (IAIHG), School of Medicine, Arıkan, Çiğdem (ORCID 0000-0002-0794-2741 & YÖK ID 240198), Pape, S.; Snijders R.J.; Gevers, T.J.; Chazouilleres, O.; Dalekos, G.N.; Hirschfield, G.M.; Lenzi, M.; Trauner, M.; Manns, M.P.; Vierling, J.M.; Montano Loza, A.J.; Lohse, A.W.; Schramm, C.; Drenth, J.P.; Heneghan, M.A.; International Autoimmune Hepatitis Group (IAIHG), and School of Medicine

Abstract

Background and aims: Autoimmune hepatitis (AIH) has been well characterised and codified through the development of diagnostic criteria. These criteria have been adapted and simplified and are widely used in clinical practice. However, there is a need to update and precisely define the criteria for both treatment response and treatment. Methods: a systematic review was performed and a modified Delphi consensus process was used to identify and redefine the response criteria in autoimmune hepatitis. Results: the consensus process initiated by the International Autoimmune Hepatitis Group proposes that the term 'complete biochemical response' defined as 'normalization of serum transaminases and IgG below the upper limit of normal' be adopted to include a time point at 6 months after initiation of treatment. An insufficient response by 6 months was a failure to meet the above definition. Non-response was defined as '<50% decrease of serum transaminases within 4 weeks after initiation of treatment'. Remission is defined as liver histology with a Hepatitis Activity Index <4/18. Intolerance to treatment was agreed to stand for 'any adverse event possibly related to treatment leading to potential drug discontinuation'. Conclusions: these definitions provide a simple and reproducible framework to define treatment response and non-response, irrespective of the therapeutic intervention. A consensus on endpoints is urgently required to set a global standard for the reporting of study results and to enable inter-study comparisons. Future prospective database studies are needed to validate these endpoints. Lay summary: consensus among international experts on response criteria and endpoints in autoimmune hepatitis is lacking. A consensus on endpoints is urgently required to set a global standard for the reporting of study results and to enable the comparison of results between clinical trials. Therefore, the International Autoimmune Hepatitis Group (IAIHG) herein presents a statem, YAEL Foundation

Published
2022

14. Autoimmune hepatitis cholestatic variant syndromes recurrence following liver transplantation affects graft and patient survival in an international multicentre cohort

Author

Ronca, V., Parente, A., Ebadi, M., Hansen, B.E., Hirschfield, G., Elwir, S., Alsaed, M., Milkiewicz, P., Janik, M.K., Marschall, H.U., Burza, M.A., Efe, C., Kan, Ali Rıza Calıs, Harputluoglu, M., Kabaçam, G., Terrabuio, D., Onofrio, F. de Quadros, Selzner, N., Bonder, A., Parés, A., Llovet, L., Akyıldız, M., Arikan, C., Manns, M.P., Taubert, R., Weber, A.L., Schiano, T.D., Haydel, B., Czubkowski, P., Socha, P., Ołdak, N., Akamatsu, N., Tanaka, A., Levy, C., Martin, E.F., Goel, A., Sedki, M., Jankowska, I., Ikegami, T., Rodriguez, M., Sterneck, M., Weiler-Normann, C., Schramm, C., Donato, M.F., Lohse, A., Andrade, R.J., Patwardhan, V.R., van Hoek, B., Biewenga, M., Kremer, A.E., Ueda, Y., Deneau, M., Pedersen, M., Mayo, M.J., Floreani, A., Burra, P., Secchi, M.F., Beretta-Piccoli, B. Terziroli, Sciveres, M., Maggiore, G., Jafri, S.M., Debray, D., Girard, M., Lacaille, F., Lytvyak, E., Mason, A.L., Heneghan, M., Montano-Loza, A.J., and Oo, Y. Htun

Published
2024
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29. A transient early HBV-DNA increase during PEG-IFNα therapy of hepatitis D indicates loss of infected cells and is associated with HDV-RNA and HBsAg reduction

Author

Anastasiou, O.E. Yurdaydin, C. Maasoumy, B. Hardtke, S. Caruntu, F.A. Curescu, M.G. Yalcin, K. Akarca, U.S. Gürel, S. Zeuzem, S. Erhardt, A. Lüth, S. Papatheodoridis, G.V. Radu, M. Liebig, S. Bantel, H. Bremer, B. Manns, M.P. Cornberg, M. Wedemeyer, H.

Subjects
virus diseases, digestive system diseases
Abstract

HBV-DNA levels are low or even undetectable in the majority HDV-infected patients. The impact of PEG-IFNα on HBV-DNA kinetics in HDV-infected patients has not been studied in detail. We analysed data of a prospective treatment trial where 120 HDV-RNA–positive patients were randomized to receive PEG-IFNα-2a plus tenofovir-disoproxil-fumarate (PEG-IFNα/TDF, n = 59) or placebo (PEG-IFNα/PBO; n = 61) for 96 weeks. At week 96, HBV-DNA was still quantifiable in 71% of PEG-IFNα/PBO-treated patients but also in 76% of PEG-IFNα/TDF-treated patients, despite low HBV-DNA baseline values. Surprisingly, a transient HBV-DNA increase between weeks 12 and 36 was observed in 12 in PEG-IFNα/TDF-treated and 12 PEG-IFNα/PBO-treated patients. This increase was positively associated with HBsAg loss [(P = 0.049, odds ratio (OR) 5.1] and HDV-RNA suppression (P = 0.007, OR 4.1) at week 96. Biochemical markers of cell death (M30 and ALT) were higher during the HBV-DNA peak but no distinct systemic immune pattern could be observed by screening 91 soluble inflammatory markers. In conclusion, an early increase in HBV-DNA during PEG-IFNα-2a therapy occurred in more than 20% of patients, even in TDF-treated patients. This transient HBV-DNA rise may indicate PEG-IFNα–induced cell death and lead to long-term HDV-RNA suppression and HBsAg loss. © 2020 John Wiley & Sons Ltd

Published
2021

30. Residual low HDV viraemia is associated HDV RNA relapse after PEG-IFNa-based antiviral treatment of hepatitis delta: Results from the HIDIT-II study

Author

Bremer, B. Anastasiou, O.E. Hardtke, S. Caruntu, F.A. Curescu, M.G. Yalcin, K. Akarca, U.S. Gürel, S. Zeuzem, S. Erhardt, A. Lüth, S. Papatheodoridis, G.V. Radu, M. Idilman, R. Manns, M.P. Cornberg, M. Yurdaydin, C. Wedemeyer, H.

Subjects
viruses, virus diseases, biochemical phenomena, metabolism, and nutrition
Abstract

The role of low levels of HDV-RNA during and after interferon therapy of hepatitis D is unknown. We re-analysed HDV RNA in 372 samples collected in the HIDIT-2 trial (Wedemeyer et al, Lancet Infectious Diseases 2019) with the Robogene assay (RA; Jena Analytics). Data were compared with the previously reported in-house assay (IA). We detected HDV-RNA in one-third of samples previously classified as undetectable using the highly sensitive RA. Low HDV viraemia detectable at week 48 or week 96 was associated with a high risk for post-treatment relapse, defined as HDV RNA positivity in both assays at week 120. HDV RNA relapses occurred in 10/15 (67%) patients with detectable low HDV RNA at week 48 and in 10/13 (77%) patients with low viraemia samples at week 96. In contrast, the post-treatment relapse rate was lower in patients with undetectable HDV RNA in both assays during treatment. © 2020 The Authors. Liver International published by John Wiley & Sons Ltd

Published
2021

40. Carbachol increases [Na.sup.+]-HC[O.sup.-.sub.3] cotransport activity in murine colonic crypts in a [M.sup.-.sub.3], [Ca.sup.2+]/calmodulin-, and PKC-dependent manner

Author

Bachmann, O., Reichelt, D., Tuo, B., Manns, M.P., and Seidler, U.

Subjects
Carbachol -- Physiological aspects, Cyclic adenylic acid -- Research, Epithelium -- Research, Biological sciences
Abstract

The [Na.sup.+]-HC[O.sup.-.sub.3] cotransporter (NBC) mediates HC[O.sup.-.sub.3] import into the colonocyte via its pNBC1 isoform. Whereas renal kNBC1 is inhibited by increased cAMP levels, pNBC1 is stimulated. Cholinergic stimulation activates renal NBC, but the effect on intestinal NBC is unknown. Therefore, crypts were isolated from the murine proximal colon by [Ca.sup.2+] chelation and loaded with the pH-sensitive dye 2',7'-bis-carboxyethyl-5,6-carboxyfluorescein. [Na.sup.+]-HC[O.sup.-.sub.3] cotransport activity was calculated from the dimethylamiloride-insensitive (500 [micro]M) intracellular pH recovery from an acid load in the presence of C[O.sub.2]-HC[O.sup.-.sub.3] and the intracellular buffering capacity. Carbachol strongly increased [Na.sup.+]-HC[O.sup.-.sub.3] cotransport activity compared with control rates. [Ca.sup.2+] chelation with BAPTA-AM, blockade of the [M.sub.3] subtype of muscarinergic receptors with 4-diphenylacetoxy-N-methylpiperidine methiodide, and inhibition of [Ca.sup.2+]/calmodulin kinase II with KN-62 all caused significant inhibition of the carbachol-induced NBC activity increase. Furthermore, PKC inhibition with Go-6976 and Go-6850 significantly reduced the carbachol effect, which may be related to the unique N[H.sub.2]-terminal consensus site for PKC-dependent phosphorylation of pNBC1. We conclude that NBC in the murine colon is thus activated by carbachol, consistent with its presumed function as an anion uptake pathway during intestinal anion secretion, but that the signal transductions pathways are distinct from those involved in the cholinergic activation of renal NBC1. colon; anion secretion; ion transport; intestinal epithelium

Published
2006

43. Tumour necrosis factor related apoptosis inducing ligand (TRAIL) induces hepatic steatosis in viral hepatitis and after alcohol intake

Author

Mundt, B., Wirth, T., Zender, L., Waltemathe, M., Trautwein, C., Manns, M.P., Kuhnel, F., and Kubicka, S.

Subjects
Fatty liver -- Development and progression, Hepatitis, Viral -- Physiological aspects, Hepatitis, Alcoholic -- Physiological aspects, Tumor necrosis factor -- Genetic aspects, Tumor necrosis factor -- Research, Gene expression -- Analysis, Health
Published
2005

47. The [Na.sup.+]/[H.sup.+] exchanger isoform 2 is the predominant NHE isoform in murine colonic crypts and its lack causes NHE3 upregulation

Author

Bachmann, O.,Riederer, B., Rossmann, H., Groos, S., Schultheis, P.J., Shull, G.E., Gregor, M., Manns, M.P., and Seidler, U.

Subjects
Colon (Anatomy) -- Research, Biological sciences
Abstract

The [Na.sup.+]/[H.sup.+] exchanger isoform NHE2 is highly expressed in the intestinal tract, but its physiological role has remained obscure. The aim of this study was to define its expression, location, and regulatory properties in murine colon and to look for the compensatory changes in NHE2 (-/-) colon that allow normal histology and absorptive function. To this end, we measured murine proximal colonic surface and crypt cell NHE1, NHE2, and NHE3 expression levels, transport rates in response to acid, hyperosmolarity and cAMP in routine proximal colonic crypts, as well as changes in transcript levels and acid-activated NHE activity in NHE2 (-/-) crypts. We found that NHE2 was expressed most abundantly in crypts, NHE1 equally in crypts and surface cells, and NHE3 much stronger in surface cells. NHE2, like NHE1, was activated by low intracellular pH ([pH.sub.i]), hyperosmolarity, and cAMP, whereas NHE3 was activated only by low [pH.sub.i]. Crypts isolated from NHE2 (-/-) mice displayed increased acid-activated NHE1- and NHE3-attributable [Na.sup.+]/[H.sup.+] exchange activity, no change in NHE1 expression, and NHE3 expression levels twice as high as in normal littermates. No change in cellular ultra-structure was found in NHE2 (-/-) colon. Our results demonstrate high NHE2 expression in the crypts and suggest a role for NHE2 in cryptal [pH.sub.i] and volume homeostasis. NHE2 knockout mice; pH regulation; colon; ion transport

Published
2004

48. Cost effectiveness of peginterferon α-2b plus ribavirin versus interferon α-2b plus ribavirin for initial treatment of chronic hepatitis C. (Hepatitis)

Author

Siebert, U., Sroczynski, G., Rossol, S., Wasem, J., Ravens-Sieberer, U., Kurth, B.M., Manns, M.P., McHutchison, J.G., and Wong, J.B.

Subjects
Schering-Plough Corp. -- Product information, Peg-Intron (Medication) -- Evaluation -- Product information -- Product/service Evaluations, Drug therapy, Evaluation, Product information, Cost benefit analysis, Cost benefit analysis -- Product information, Hepatitis C -- Drug therapy -- Product information, Ribavirin -- Evaluation -- Product information -- Product/service Evaluations, Pharmaceutical industry -- Product information
Abstract

German Hepatitis C Model (GEHMO) Group, International Hepatitis Interventional Therapy (IHIT) Group Background: Peginterferon α-2b plus ribavirin therapy in previously untreated patients with chronic hepatitis C yields the highest sustained [...]

Published
2003

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