October 6-7, 2022

Milan, Italy - Cloisters of San Barnaba

Chairs:
Pietro Lampertico and Heiner Wedemeyer

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Poster Exhibition

Diagnosis and Biomarkers

P 1
Virological diagnosis of Hepatitis Delta Virus infection in France: results of ten years of experience in organizing national quality controls

A. Gerber1, S. Brichler1,2, S. Dziri1, C. Alloui1, E. Gordien1,2, F. Le Gal1,2

1Centre National de Référence pour les virus des hépatites B, C et Delta, Laboratoire de microbiologie clinique, Hôpital Avicenne Assistance Publique - Hôpitaux de Paris, Bobigny, France, 2INSERM U955, Équipe 18, Créteil, France

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P 2
Divergent patterns of HBV-RNA AND HBcrAg levels in untreated chronic hepatitis Delta: a large European cross-sectional study

E. Degasperi1, A. Loglio1, C. Scholtes2,3,4, S. Colonia Uceda Renteria5, C. Charre2,3,4, F. Facchetti1, M.L. Plissonnier2, D. Sambarino1, F. Ceriotti5, A. De Silvestri6, B. Testoni2, M. Levrero2,4,7, F. Zoulim2,4,7, P. Lampertico1,8

1Foundation IRCCS Ca’ Granda Ospedale Maggiore Policlinico, Division of Gastroenterology and Hepatology, Milan, Italy, 2INSERM U1052 - Cancer Research Center of Lyon (CRCL), Lyon, France, 3University Claude Bernard Lyon 1 (UCBL1), University of Lyon, Lyon, France, 4Department of Virology, Hospices Civils de Lyon, Lyon, France, 5Foundation IRCCS Ca’ Granda Ospedale Maggiore Policlinico, Virology Unit, Milan, Italy, 6Servizio di Epidemiologia Clinica e Biometria, Direzione Scientifica - Fondazione IRCCS Policlinico san Matteo, Pavia, Italy, 7Department of Hepatology, Hospices Civils de Lyon, Lyon, 8CRC “A. M. and A. Migliavacca” Center for Liver Disease, Department of Pathophysiology and Transplantation, University of Milan, Milan, Italy

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P 3
Hepatitis delta virus reflex testing in patients with hepatitis B dramatically improves the HDV screening cascade: 10 years of real world experience from Avicenne University Hospital, France

S. Brichler1,3,4, D. Roulot2,3,4, S. Dziri1, A. Gerber1, F. Le Gal1,4, H. Delagrèverie1,3, C. Alloui1,4, E. Gordien1,3,4

1Virology Unit, Avicenne Hospital, Bobigny, France, 2Hepatology Unit, Avicenne Hospital, Bobigny, France, 3Sorbonne Paris Nord University, Bobigny, France, 4INSERM U955, Team 18, Créteil, France

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P 4
HBcrAg to quantitative anti-HBc IgG ratio predicts long-term outcomes in chronic hepatitis D patients

G.P. Caviglia1, A. Olivero1, G. Troshina1, A. Nicolosi1, A. Risso1, M. Rizzetto1, G.M. Saracco1,2, A. Ciancio1,2

1Department of Medical Sciences, University of Turin, Turin, Italy, 2Gastroenterology Unit, Città della Salute e della Scienza - Molinette Hospital, Turin, Italy

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P 5
HBcrAg tightly correlates with elevated HDV replicative activity and with enhanced liver inflammation and damage: role of HBcrAg as a biomarker of liver disease progression in the setting of HDV co-infection

R. Salpini1, L. Piermatteo1, S. D’Anna1, U.S. Gill2, A. Battisti1,2, M. Alkhatib1, R. Scutarisup>1, E. Andreassi1, K.M.A. Ho2, F. Ceccherini-Silberstein1, C. Usai2, P.T.F. Kennedy2, V. Svicher1

1University of Rome Tor Vergata, Department of Experimental Medicine, Rome, Italy, 2Barts Liver Centre, Immunobiology, Blizard Institute, Barts and The London SMD, QMUL, London, United Kingdom

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P 6
Clinical long-term outcome of hepatitis delta compared to HBV monoinfection

1A. Wranke1, B. Calle Serrano1, B. Heidrich1, K. Deterding1, J. Kirschner1, B. Bremer1, M. Cornberg1, M. P. Manns1, H. Wedemeyer1

1Department of Gastroenterology, Hepatology and Endocrinology, Hannover Medical School, Hannover, Germany

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Epidemiology

P 7
Hepatitis D virus infection in a large cohort of immigrants in southern Italy: a multicenter, prospective study

E. Cordua5, M. Pisaturo1,2, L. Alessio1,3, A. Di Fraia1, M. Macera1,4, C. Minichini1, L. Onorato1,6, G. Scotto7,8, G. Di Caprio2,5, F. Calò1,4, C. Sagnelli1,6, N. Coppola

1Department of Mental Health and Public Medicine, Section of Infectious Diseases, Second University of Naples, Italy, 2Medical Center, Centro Sociale ex Canapificio, Caserta, Italy, 3Medical Center, Centro di Accoglienza “La tenda di Abramo”, Caserta, Italy, 4Medical Center, Centro per la Tutela della Salute degli Immigrati, Naples, Italy, 5Infectious Diseases Unit, AORN Sant’Anna e San Sebastiano, Caserta, Italy, 6Medical center, Centro Suore Missionarie della Carità, Naples, Italy, 7Medical center, Centro Borgoroma, Foggia, Italy, 8Infectious Diseases Unit, Foggia, Italy

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P 8
Evaluating screening rates for hepatitis D in hepatitis B patients

J. Strzepka1, M. Bhagwat1, C. Aloman1, N. Reau1

1Rush University Medical Center, Chicago, USA

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P 9
Molecular clock analysis reveals an ancient origin but a recent radiation of hepatitis Delta virus in humans

S. Tomba1,2, C. Rodriguez3,4,5, S. Brichler1,2,3, S. Fourati3,4,5A. Gerber1,2, J.M. Pawlotsky3,4,5, E. Gordien1,2,3, S. Hué6, F. Le Gal1,2,3

1Laboratoire de microbiologie médicale, hôpital Avicenne (AP-HP), Bobigny, France, 2Laboratoire associé au Centre national de référence des virus des hépatites B, C et Delta, pour le virus de l’hépatite Delta, Bobigny, France, 3Unité INSERM U955, équipe n° 18, Université Paris Est, Créteil, France, 4Laboratoire de virologie, hôpital Henri Mondor (AP-HP), Créteil, France, 5Centre national de référence des virus des hépatites B, C et Delta, Créteil, France, 6Department of Infectious Disease Epidemiology Faculty of Epidemiology & Population Health London School of Hygiene & Tropical Medicine (LSHTM), London, UK

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P 10
Demographic features of HDV-infected patients from Republic of Moldova

A. Turcanu 1, E. Cebanu 1, L. Andries 1, P. Pineau 2

1State University of Medicine and Pharmacy “Nicolae Testemitanu”, Chisinau, Republic of Moldova, 2Unité “Organisation nucléaire et Oncogenèse”, INSERM U993, Institut Pasteur, 28, rue du Docteur Roux, 75015 Paris, France 2

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P 11
High molecular diversity and remarkable geographical distribution of hepatitis Delta virus strains that are spreading in Cameroon

A. Gerber1, J. Delors Mfonkou2, S. Brichler1,3, F. Le Gal1,3, R. Njouom2, E. Gordien 1,3

1Centre National de Référence pour les virus des hépatites B, C et Delta, Laboratoire de microbiologie clinique, Hôpital Avicenne Assistance Publique - Hôpitaux de Paris, Bobigny, France, 2Unité de virologie, Centre Pasteur, Yaoundé, Cameroun, 3INSERM U955, Équipe 18, Créteil, France

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P 12
Evaluating Hepatitis Delta virus disease prevalence, incidence and patient characteristics among adults in Italy in the outpatient setting

P. Lampertico1,2, V. Perrone 3, D. Sangiorgi 3, M. Dovizio 3, L. Degli Esposti 3, C. Kim 4, A. Kaushik 4

1Foundation IRCCS Ca’ Granda Ospedale Maggiore Policlinico, Division of Gastroenterology and Hepatology, Milan, Italy, 2CRC “A. M. and A. Migliavacca” Center for Liver Disease, Department of Pathophysiology and Transplantation, University of Milan, Milan, Italy, 3CliCon S.r.l. Società Benefit, Health, Economics & Outcomes Research, Bologna, Italy, 4HEOR - Global Value & Access, Gilead Sciences, California, USA

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P 13
Real-world analysis of healthcare resource utilization and costs among diagnosed Hepatitis D patients within the outpatient setting in Italy

P. Lampertico1,2, V. Perrone 3, D. Sangiorgi 3, M. Dovizio 3, L. Esposti 3, C. Kim 4, A. Kaushik 4

1Foundation IRCCS Ca’ Granda Ospedale Maggiore Policlinico, Division of Gastroenterology and Hepatology, Milan, Italy, 2CRC “A. M. and A. Migliavacca” Center for Liver Disease, Department of Pathophysiology and Transplantation, University of Milan, Milan, Italy, 3CliCon S.r.l. Società Benefit, Health, Economics & Outcomes Research, Bologna, Italy, 4HEOR - Global Value & Access, Gilead Sciences, California, USA

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P 14
Evaluation of HDV prevalence in outpatient clinic for infectious disease: from low to high endemic countries

A. Di Lorenzo1, S. Tedde1, P.G. Pace1, A. Lodi1, M. Zordan1, F. Barreca1, L. Ansaldo1, D. Checchi1, A. Crea1, F. Caldara1, T. Mulas1, L. Ferrari1, M. Compagno1, G. De Simone1, E. Teti1, M. Iannetta1, M. Andreoni1, A.M. Geretti1, L. Sarmati1

1Clinic of Infectious Diseases, Tor Vergata University Hospital, Rome, Italy

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P 15
The burden of HDV infection: a ten-years’ experience of a Sicilian tertiary centre of liver disease

G.E.M. Rizzo1,2,3, D. Ferraro 4, G. Rancatore1, P. Graceffa1, G. Falco1, C. La Mantia1, V. Calvaruso1, V. Di Marco1

1Section of Gastroenterology & Hepatology, Department of Health Promotion Sciences Maternal and Infant Care, Internal Medicine and Medical Specialties, PROMISE, University of Palermo, Palermo, Italy, 2Ph.D. program, Department of Surgical, Oncological and Oral Sciences (Di.Chir.On.S.), University of Palermo, Palermo, Italy, 3Endoscopy Service, Department of Diagnostic and Therapeutic Services, IRCCS - ISMETT Palermo, Italy, 4Section of Virology, Department of Health Promotion Sciences Maternal and Infant Care, Internal Medicine and Medical Specialties, PROMISE, University of Palermo, Palermo, Italy

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P 16
Significantly higher clinical and economic burden following diagnosis of Hepatitis D virus infection among U.S. adults with chronic Hepatitis B

R. Gish1, R. Wong2,3, C. Kim 4, G. Leung5, I. Jacobson6, J. Lim7, A. Kaushik 4

1Hepatitis B Foundation, Doylestown PA USA, 2Stanford University School of Medicine, Stanford CA USA, 3VA Palo Alto Healthcare System, Palo Alto CA USA, 4HEOR - Global Value & Access, Gilead Sciences, CA, USA, 5RWE - Patient Safety, Gilead Sciences, CA, USA, 6NYU Grossman School of Medicine, New York NY USA, 7Yale University School of Medicine, New Haven CT USA

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P 17
Impact of HBV-HDV infection in a small town in central Italy

M. Maracci1, B. Canovari1, C. Temperoni1, M. Balbucci1, F. Barchiesi1

1UO Malattie Infettive-Ospedali Marche Nord-Pesaro, Italy

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P 18
Rising clinical and economic burden among chronic Hepatitis D patients who attended Spanish hospitals

M. Buti1, A. Kaushik2, M. Ascanio3, J. Darba4, N. Kachru2

1Liver Unit. Hospital Universitario Valle Hebron, Barcelona, Spain, 2HEOR - Global Value & Access, Gilead Sciences, California, USA, 3BCN Health Economics & Outcomes Research SL, Barcelona, Spain, 4Department of Economics, University of Barcelona, Barcelona, Spain

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Hepatitis D antiviral treatment

P 19
Bulevirtide monotherapy in HDV patients with compensated cirrhosis and clinically significant portal hypertension

E. Degasperi1, M.P. Anolli1, S. Colonia Uceda Renteria2, D. Sambarino1, M. Borghi1, R. Perbellini1, C. Scholtes3,4, F. Facchetti1, A. Loglio1, S. Monico1, M. Fraquelli5, A. Costantino5, F. Ceriotti2, F. Zoulim3,4, P. Lampertico1,6

1Foundation IRCCS Ca’ Granda Ospedale Maggiore Policlinico, Division of Gastroenterology and Hepatology, Milan, Italy, 2Foundation IRCCS Ca’ Granda Ospedale Maggiore Policlinico, Virology Unit, Milan, Italy, 3Hepatology Department, Hospices Civils de Lyon (HCL) and Université Claude Bernard Lyon 1 (UCBL1), Lyon, France, 4INSERM U1052, Centre de Recherche sur le Cancer de Lyon (CRCL), 5Foundation IRCCS Ca’ Granda Ospedale Maggiore Policlinico, Division of Gastroenterology and Endoscopy, Milan, Italy, 6CRC “A. M. and A. Migliavacca” Center for Liver Disease, Department of Pathophysiology and Transplantation, University of Milan, Milan, Italy

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P 20
Cure of Hepatitis Delta infection following 3 years of Bulevirtide monotherapy in a patient with compensated advanced cirrhosis

M.P. Anolli1, E. Degasperi1, L. Allweiss2,3, S. Colonia Uceda Renteria 4, D. Sambarino1, M. Borghi1, R. Perbellini1, A. Loglio1, A. Sangiovanni1, M. Maggioni5, C. Scholtes6,7, F. Facchetti1, F. Ceriotti2, C. Neumann-Haefelin8, M. Dandri2,3, F. Zoulim6,7, P. Lampertico1,9

1Foundation IRCCS Ca’ Granda Ospedale Maggiore Policlinico, Division of Gastroenterology and Hepatology, Milan, Italy, 2I. Department of Internal Medicine, University Medical Center Hamburg-Eppendorf, Hamburg, Germany, 3German Center for Infection Research (DZIF), Hamburg-Lübeck-Borstel-Riems site, Germany, 4Foundation IRCCS Ca’ Granda Ospedale Maggiore Policlinico, Virology Unit, Milan, Italy, 5Foundation IRCCS Ca’ Granda Ospedale Maggiore Policlinico, Pathology Unit, Milan, Italy 6Hepatology Department, Hospices Civils de Lyon (HCL) and Université Claude Bernard Lyon 1 (UCBL1), Lyon, France, 7INSERM U1052, Centre de Recherche sur le Cancer de Lyon (CRCL), 8Department of Medicine II, Freiburg University Medical Center, Faculty of Medicine, University of Freiburg, Freiburg, Germany, 9CRC “A. M. and A. Migliavacca” Center for Liver Disease, Department of Pathophysiology and Transplantation, University of Milan, Milan, Italy

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P 21
Functional cure with lonafarnib-based therapy in chronic hepatitis delta

C. Yurdaydin1,2,3, E. Yurdcu2, M. Gümüşsoy1, O. Keskin1, G. Gençdal 3, M. Akyildiz 3, M. Zeybel 3, R. Idilman1,2 A. Mithat Bozdayi2, I. Choong 4, S.G. Jeffrey5

1Department of Gastroenterology, University of Ankara Medical School, 2Hepatology Institute, University of Ankara, Turkey, 3Department of Gastroenterology and Hepatology, Koç University Medical School, Istanbul, Turkey

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P 22
Bulevirtide treatment of hepatitis D in Germany: multicentre real-world experience

C. Dietz-Fricke1, F. Tacke2, C. Zöllner2, M. Demir2, H. Schmidt 3, C. Schramm 3, K. Willuweit 3, C.M. Lange 4, S. Weber 4, G. Denk 4, C. Berg5, J. Grottenthaler5, Merle6, A. Olkus6, S. Zeuzem7, K. Sprinzl7, T. Berg8, F. van Bömmel8, J. Wiegand8, T. Herta8, T. Seufferlein9, E. Zizer9, N. Dipopoulos9, R. Thimme10, C. Neumann-Haefelin10, P. R. Galle11, M. Sprinzl11, A. Lohse12, J. Schulze-zur-Wiesch12, J. Kempski12, A. Geier13, F.P. Reiter13, W.P. Hofmann14, P. Buggisch15, J. Goedicker16, B. Schlevogt16, J. Kahlhöfer1, K. Port1, B. Maasoumy1, M. Cornberg1, H. Wedemeyer1, K. Deterding1

1Dept. of Gastroenterology, Hepatology and Endocrinology at Hannover Medical School, Hannover, Germany, 2Dept. of Hepatology and Gastroenterology, Charité Universitätsmedizin Berlin, Campus Virchow-Klinikum (CVK) and Campus Charité Mitte (CCM), Berlin, Germany, 3Dept. of Gastroenterology, Hepatology and Transplantational Medicine, University Hospital Essen, Essen, Germany, 4Department of Medicine II, University Hospital, Ludwig Maximilian University Munich, Munich, Germany, 5Department of Gastroenterology, Hepatology, and Infectiology, Medical Clinic, University of Tübingen, Tübingen, Germany, 6Department of Internal Medicine IV, University of Heidelberg, Heidelberg, Germany, 7Internal Medicine Department, Goethe University Hospital, Frankfurt, Germany, 8Division of Hepatology, Clinic and Polyclinic for Gastroenterology, Hepatology, Infectiology, and Pneumology, University Clinic Leipzig, Leipzig, Germany, 9Department of Internal Medicine I, University of Ulm, Ulm, Germany, 10Department of Medicine II, University Medical Centre Freiburg, Faculty of Medicine, University of Freiburg, Freiburg, Germany, 11Department of Medicine I, University Medical Center of the Johannes-Gutenberg University Mainz, Mainz, Germany, 12Department of Medicine, University Medical Center Hamburg-Eppendorf, Hamburg, Germany, 13University Hospital Würzburg, Dept. of medicine II, Würzburg, Germany, 14MVZ for Gastroenterology at Bayerischer Platz, Berlin, Germany, 15IFI - Institute for interdisciplinary medicine, Hamburg, Germany, 16Department of Medicine B, University Hospital Münster, Münster, Germany

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P 23
Once daily dosing of Lonafarnib and Ritonavir in patients with chronic Hepatitis Delta

O. Etzion1, A. Nevo-Shor1, C. Yurdaydin2, D. Munteanu1, Z. Lerner1, E. Gane 3, I. Lipnitzky1, A. Mushkalo1, E. Brav1, H. Abu-Kaf1, S. Hameed4

1Department of Gastroenterology and Liver Diseases, Soroka University Medical Center, Beersheva, Israel, 2Department of Gastroenterology and Hepatology, Koç University Medical School, Istanbul, Turkey, 3Department of Gastroenterology and Hepatology, Auckland City Hospital, New Zealand, 4Aga Khan University and Hospital, Karachi, Pakistan

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P 24
Case report: liver cirrhosis HBV-HDV in a young woman on bulevirtide therapy

M. Maracci1, P. Castelli2, B. Canovari1, C. Temperoni1, L. Santilli1, F. Barchiesi1

1Ospedali Riuniti Marche Nord, Pesaro, Italy, 2Anlaids, Macerata, Italy

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P 25
Strong decline of intrahepatic HDV markers and signs of liver inflammation after 48 weeks of treatment with Bulevirtide in chronic hepatitis D patients: combined intrahepatic results from the clinical trials MYR203 and MYR301

L. Allweiss1,2, A. Volmari1,2, Y. Ladiges1, C. Eggers1, V. Suri 3, J. Wallin 3, J. Flaherty 3, D. Manuilov 3, H. Wedemeyer4,2, S. Urban5,2, M. Lütgehetmann1,2, J. Bockmann1,2, M. Dandri1,2

1University Medical Center Hamburg-Eppendorf, Hamburg, Germany, 2German Center for Infection Research (DZIF), Hamburg-Lübeck-Borstel-Riems, Hannover and Hei- delberg Partner Sites, 3Gilead Sciences, Inc, Foster City, CA, USA, 4Hannover Medical School, Hannover, Germany, 5University Hospital Heidelberg, Heidelberg, Germany

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P 26
Virological breakthrough after more than 48 weeks of complete HDV-RNA suppression on Bulevirtide therapy: a case report of 2 patients

C. Stern12, J. Moussalli1, M. Rudler1, D. Thabut1, V. Ratziu1

1Hôpital Pitié Salpêtrière, Paris, France, 2Hôpital Beaujon, Clichy, France

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P 27
Rescue of cirrhotic HBV/HDV infection from bulevirtide failure by subcutaneous REP 2139-Mg

M. Bourlière1, V. Loustaud-Ratti2, C. Stern3, M. Bazinet4, S. Ben Ali1, L. Lecomte1, S. Francois2, C. de Freitas3, A. Gerber5, S. Brichler5, E. Gordien5, A. Vaillant 4

1Service Hépato-Gastro-Entérologie, Hôpital Saint-Joseph, Marseille, France, 2Service d’Hépato-Gastroentérologie, Centre hospitalier universitaire à Limoges, Limoges, France, 3Department de Hépatologie, AP-HP Hôpital Beaujon, Clichy, France, 4Replicor Inc. Montreal, Canada, 5Centre national de référence des hépatite B, C et Delta - Laboratoire associé, Hôpital Avicenne, Bobigny, France

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P 28
A biochemical basis for the hepatoprotective effects of REP 2139 during host mediated transaminase flares

A. Vaillant

Replicor Inc. Montreal, Canada

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P 29
Sustained off therapy control of HBV and HDV infection following removal of NAP-based therapy in cirrhotic HBV/HDV coinfection

A. Streinu-Cercel1,2, A. Streinu-Cercel1, M. Bazinet 3, C. Elsner 4, U. Dittmer 4, A.Vaillant3

1National Institute of Infectious Diseases “Prof. Dr. Matei Bals” Bucharest, Romania, 2Carola Davila University of Medicine and Pharmacy, Bucharest, Romania, 3Replicor Inc. Montreal, Canada, 4University Hospital Essen, Institute for Virology, Essen, Germany

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P 30
Antiviral treatment for Hepatitis delta virus (HDV): over 1000 unsolicited medical information requests from 39 countries over 18 months

S. Sandhu1, L. Chen1, G. Chee1, C. Frenette1, C. Hezode2, B. Collins1, A. Reiter1, M. Mertens3

1Gilead Sciences, Foster City, CA USA, 2Gilead Sciences, Paris, France, 3Gilead Sciences, Stockley Park, UK

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P 31
Efficacy and safety of bulevirtide monotherapy given at 2 mg or 10 mg dose level once daily for treatment of chronic hepatitis delta: week 48 primary endpoint results from a phase 3 randomized, multicenter, parallel-design study

H. Wedemeyer1, S. Aleman2, M. Brunetto 3, A. Blank 4, P. Andreone5, P. Bogomolov6, V. Chulanov7, N. Mamonova7, N. Geyvandova8, V. Morozov9, O. Sagalova10, T. Stepanova11, D. Manuilov12, V. Suri12, Q. An12, J.F. Flaherty12, A. Osinusi12, J. Schulze zur Wiesch13, M. Cornberg1, S. Zeuzem14, P. Lampertico15,16

1Clinic for Gastroenterology, Hepatology, and Endocrinology, Hannover Medical School, Hannover, Germany, 2Department of Infectious Diseases, Karolinska University Hospital/Karolinska Institute, Stockholm, Sweden, 3Hepatology Unit, Reference Center of the Tuscany Region for Chronic Liver Disease and Cancer, University Hospital of Pisa and Department of Clinical and Experimental Medicine, University of Pisa, Pisa, Italy, 4Clinical Pharmacology and Pharmacoepidemiology, Heidelberg University Hospital, Heidelberg, Germany, 5Internal Medicine, University of Modena and Reggio Emilia, Modena, Italy, 6State Budgetary Institution of Health Care of Moscow region “Moscow Regional Research Clinical Institute after M.F. Vladimirsky,” Moscow, Russia, 7FSBI National Research Medical Center for Phthisiopulmonology and Infectious Diseases of the Ministry of Health of the Russian Federation, Moscow, Russia, 8Stavropol Regional Hospital, Stavropol, Russia, 9LLC Medical Company “Hepatolog”, Samara Russia, 10Federal State-Funded Institution of Higher Education “Southern Ural State Medical University of Ministry of Health of the Russian Federation,” Chelyabinsk, Russia, 11LLC “Clinic of Modern Medicine,” Moscow, Russia, 12Gilead Sciences, Inc., Foster City, CA USA, 13Hepatology Outpatient Medical Clinic, University Hospital Hamburg-Eppendorf, Hamburg, Germany, 14Department of Medicine, University Hospital Frankfurt, Frankfurt am Main, Germany, 15Foundation IRCCS Ca’ Granda Ospedale Maggiore Policlinico, Division of Gastroenterology and Hepatology, Milan, Italy, 16CRC “A. M. and A. Migliavacca” Center for Liver Disease, Department of Pathophysiology and Transplantation, University of Milan, Milan, Italy

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P 32
Integrated safety analysis of 24-week data from three Phase 2 and one Phase 3 clinical trials of bulevirtide monotherapy given at 2 mg and 10 mg dose level for treatment of chronic hepatitis delta

P. Lampertico1,2, S. Aleman 3, T. Asselah 4, M. Bourliere5, A. Streinu-Cercel6, P. Bogomolov7, M. Viacheslav8, T. Stepanova9, S. Lazar10, V. Suri11, D. Manuilov11, L. Ye11, J.F. Flaherty11, A. Osinusi11, M. Brunetto12,13, H. Wedemeyer14

1Foundation IRCCS Ca’ Granda Ospedale Maggiore Policlinico, Division of Gastroenterology and Hepatology, Milan, Italy, 2CRC “A. M. and A. Migliavacca” Center for Liver Disease, University of Milan, Department of Pathophysiology and Transplantation, Milan, Italy, 3Karolinska University Hospital/Karolinska Institutet, Department of Infectious Diseases, Stockholm, Sweden, 4Hôpital Beaujon APHP, Université de Paris, INSERM, Clichy, France, 5Hôpital Saint Joseph Marseille, Marseille, France, 6Matei Bals National Institute of Infectious Diseases, Bucharest, Romania, 7State budgetary institution of health care of Moscow region “Moscow regional research clinical institute named after 11M.F. Vladimirsky,” Moscow, Russia, 8LLC Medical Company “Hepatolog,” Samara, Russia, 9Limited liability company “Clinic of Modern Medicine,” Moscow, Russia, 10Dr. Victor Babes Foundation-Infectious and Tropical Diseases Hospital, Bucharest, Romania, 11Gilead Sciences, Foster City, CA USA, 12University Hospital of Pisa, Hepatology Unit, Reference Center of the Tuscany Region for Chronic Liver Disease and Cancer, Pisa, Italy, 13University of Pisa, Department of Clinical and Experimental Medicine, Pisa, Italy, 14Medizinische Hochschule Hannover, Klinik für Gastroenterologie, Hepatologie und Endokrinologie, Hannover, Germany

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P 33
Integrated efficacy analysis of 24-week data from two Phase 2 and one Phase 3 clinical trials of bulevirtide monotherapy given at 2 mg or 10 mg dose levels for treatment of chronic hepatitis delta

P. Lampertico1,2, S. Aleman 3, A. Blank 4, P. Bogomolov5, V. Chulanov6, N. Mamonova6, M. Viacheslav7, O. Sagalova8, T. Stepanova9, V. Suri10, D. Manuilov10, L. Ye10, J.F. Flaherty10, A. Osinusi10, M. Cornberg11, M. Brunetto12,13, H. Wedemeyer12

1Foundation IRCCS Ca’ Granda Ospedale Maggiore Policlinico, Division of Gastroenterology and Hepatology, Milan, Italy, 2CRC “A. M. and A. Migliavacca” Center for Liver Disease, University of Milan, Department of Pathophysiology and Transplantation, Milan, Italy, 3Karolinska University Hospital/Karolinska Institutet, Department of Infectious Diseases, Stockholm, Sweden, 4Heidelberg University Hospital, Clinical Pharmacology and Pharmacoepidemiology, Heidelberg, Germany, 5State budgetary institution of health care of Moscow region “Moscow regional research clinical institute named after M.F. Vladimirsky,” Moscow, Russia, 6FSBI National Research Medical Center for Phthisiopulmonology and Infectious Diseases of the Ministry of Health of the Russian Federation, Moscow, Russia, 7LLC Medical Company “Hepatolog,” Samara, Russia, 8Federal state-funded institution of higher education “Southern Ural State Medical University of Ministry of Health of the Russian Federation,” Chelyabinsk, Russia, 95,6Limited liability company “Clinic of Modern Medicine,” Moscow, Russia, 10Gilead Sciences, Foster City, CA USA, 11Medizinische Hochschule Hannover, Klinik für Gastroenterologie, Hepatologie und Endokrinologie, Hannover, Germany, 12University Hospital of Pisa, Hepatology Unit, Reference Center of the Tuscany Region for Chronic Liver Disease and Cancer, Pisa, Italy, 135,6University of Pisa, Department of Clinical and Experimental Medicine, Pisa, Italy

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P 34
No detectable resistance to bulevirtide in participants with chronic hepatitis D through 24 weeks of treatment

J. Hollnberger1,2, Y. Liu 3, R. Martin 3, S. Manhas 3, T. Aeschbacher 3, S. Chang 3, S. Xu 3, B. Han 3, T. Yazdi 3, L. May 3, D. Han 3, K. Schöneweis 3, J.F. Flaherty 3, V. Suri 3,D. Manuilov 3, T. Asselah 4, P. Lampertico5,6, H. Wedemeyer7, S. Aleman8, R. Mateo 3, E.S. Svarovskaia 3, H. Mo 3, S. Urban1,2

1University Hospital Heidelberg, Department of Molecular Virology, Heidelberg, Germany, 2German Center for Infection Research (DZIF), Heidelberg, Germany, 3Gilead Sciences, Inc., Foster City, CA USA, 4Hôpital Beaujon, Université de Paris, Clichy, France, 5Fondazione IRCCS Ca’ Granda Ospedale Maggiore Policlinico, Milano, Italy, 6”A.M. e A. Migliavacca” Center for the Study of Liver Disease, Università degli Studi di Milano, Milano, Italy, 7Medizinische Hochschule Hannover, Hannover, Germany, 8Karolinska Universitetssjukhuset, Karolinska Institutet, Stockholm, Sweden

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P 35
Improvement of portal hypertension during viral suppression in patients with hepatitis delta - The ImPHrove-D study

L. Sandmann1, T. L. Tergast1, K. Deterding1, H. Wedemeyer1,2, B. Maasoumy1,2

1Department of Gastroenterology, Hepatology and Endocrinology, Hannover Medical School, Germany, 2German Center for Infection Research (DZIF), Hannover/ Braunschweig, Germany

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P 36
Real life study of bulevirtide in chronic hepatitis Delta: preliminary results of the ANRS I MIE HD EP01 HDV prospective cohort

F. Zoulim1, C. Fougerou-Leurent2, D. Roulot 3, S. Metivier 4, V. De Ledinghen5, V. Ratziu6, C. Stern6, P. Mathurin7, V. Loustaud-Ratti8, V. Leroy9, J. Dumortier10, C. Jezequel11, D. Samuel12, N. Ganne13, L. Alric14, A. Minello15, A. Abergel16, GP. Pageaux17, D. Alfaiate18, C. Lascoux-combe19, K. Lacombe20, I. Rosa21, O. Chazouilleres22, G. Riachi23, X. Causse24, J. Chas25, L. d’Alteroche26, M. Bourliere27, P. Carrieri28, E. Gordien29, J. Guedj30, M. Levrero31, A. Renault2, C. Scholtès32, L. Serfaty33, C. Sureau34, C. Birklé35, E. Le Pabic2, C. Tual2, V. Petrov-Sanchez35, H. Fontaine36

1Service d’Hépatologie et Gastroentérologie Hôpital de la Croix Rousse Lyon France, 2Service de Pharmacologie, CHU Pontchaillou INSERM, CIC 1414 Clinical Investigation Centre Rennes France, 3Unité Fonctionnelle d’Hépatologie, Hôpital Avicenne, Bobigny France, 4Service d’Hépato-gastroentérologie Hôpital Rangueil Toulouse France, 5Service d’Hépato-gastroentérologie Hôpital Haut-Lévêque Bordeaux France, 6Service d’Hépato- gastroentérologie APHP- Hôpital de La Pitié-Salpêtrière Paris France, 7Service des Maladies de l’Appareil Digestif Hôpital Claude Huriez, Lille, France, 8Service d’Hépato-gastroentérologie Hôpital Dupuytren Limoges France, 9Service d’Hépato-gastroentérologie Hôpital Henri Mondor Créteil France, 10Service d’Hépato-gastroentérologie HCL- Hôpital Edouard Herriot Lyon France, 11Service des Maladies du Foie Hôpital Pontchaillou Rennes France, 12Centre Hépato-biliaire Hôpital Paul Brousse, Villejuif, France, 13Service d’Hépatologie Hôpital Avicenne Bobigny France, 14Service de Médecine Interne Hôpital Rangueil Toulouse France, 15Service d’Hépato-gastroentérologie Hôpital du Bocage Dijon France, 16Pôle Digestif et Hépatobiliaire Hôpital Estaing, Clermont-Ferrand, France, 17Service d’Hépato-gastroentérologie Hôpital Saint- Eloi, Montpellier, France, 18Service des Maladies Infectieuses et Tropicales Hôpital de la Croix Rousse, Lyon, France, 19Service des Maladies Infectieuses et Tropicales Hôpital Saint Louis, Paris, France, 20Service des Maladies Infectieuses et Tropicales APHP- Hôpital Saint-Antoine Paris France, 21Médecine Interne et Hépato-gastroentérologie CHIC, Créteil, France, 22Service d’Hépatologie Hôpital Saint Antoine, Paris, France, 23Service d’Hépato-gastroentérologie Hôpital Charles Nicolle, Rouen, France, 24Service d’Hépatogastroentérologie Hôpital de La Source, Orléans, France, 25Service des Maladies Infectieuses et Tropicales APHP- Hôpital Tenon, Paris France, 26Service d’Hépatogastroentérologie Hôpital Trousseau, Tours, France, 27Service d’Hépato-gastroentérologie Hôpital Saint-Joseph Marseille France, 28SESSTIM / U1252 Marseille France, 29CNR des Hépatites B, C et Delta APHP- Hôpital Avicenne Bobigny France, 30Infection. Antimicrobials. Modelling Evolution (IAME) - UMR 1137 Inserm Paris France, 31Cancer Research Center of Lyon (CRCL) - INSERM U1052 Lyon France, 32Laboratoire de Virologie HCL- Hôpital de la Croix Rousse Lyon France, 33Service d’hépatogastroentérologie HUS- Hôpital de Hautepierre Strasbourg France, 34Laboratoire de Virologie Moléculaire Institut National de Transfusion Sanguine (INTS) Paris France, 35ANRS | Maladies Infectieuses Emergentes Paris France, 36Pôle d’Hépato-gastroentérologie, APHP-Hôpital Cochin, Paris, France

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P 37
Treatment with bulevirtide improves patient-reported outcomes in patients with chronic hepatitis delta: an exploratory analysis of a Phase 3 trial at 48 weeks

M. Buti1, H. Wedemeyer2, S. Aleman 3, V. Chulanov 4, V. Morozov5, O. Sagalova6, T. Stepanova7, R. G. Gish8, A. Lloyd9, A. M. Kaushik10, V. Suri10, D. Manuilov10, A. O. Osinusi10, J. Flaherty10, P. Lampertico12

1Hospital Universitario Valle Hebron, Barcelona, Spain, 2Medizinische Hochschule Hannover, Germany, 3Karolinska Universitetssjukhuset, Karolinska lnstitutet, Stockholm, Sweden, 4Central Research Institute of Epidemiology, Moscow, Russia, 5Hepatolog, LLC, Samara, Russian Federation, 6Southern Ural State Medical University, Chelyabinsk, Russian Federation, 7Clinic of Modern Medicine, Moscow, Russia, 8Robert G. Gish Consultants, LLC, San Diego, CA, USA, 9Acaster Lloyd Consulting Ltd, London, UK, 10Gilead Sciences, Inc., Foster City, CA, USA, 11Foundation lRCCS Ca’ Granda Ospedale Maggiore Policlinico, CRC “A.M. and A. Migliavacca” Center for Liver Disease, University of Milan, Italy

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P 38
HBV RNA levels are associated with virological response to treatment with PEG-IFN in patients with chronic HDV infection

L. Sandmann1, B. Bremer1, C. Yurdaydin2,3, K. Deterding1, M. P. Manns1,6, M. Cornberg1,4,5,6, H. Wedemeyer1,4,6, B. Maasoumy1,5,6

1Department of Gastroenterology, Hepatology and Endocrinology, Hannover Medical School, Germany, 2Department of Gastroenterology, University of Ankara Medical School, Ankara, Turkey, 3Department of Gastroenterology and Hepatology, Koç University Medical School, Istanbul, Turkey, 4German Center for Infection Research (DZIF), Partner Site HepNet Study-House, Hannover, Germany, 5Centre for Individualised Infection Medicine (CiiM), Helmholtz Centre for Infection Research, Germany, 6German Center for Infection Research (DZIF), Partner Site Hannover-Braunschweig, Germany

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P 39
Treatment with Bulevirtide (BLV) for 48 weeks reduces necroinflammation: results from a histological subset analysis of patients enrolled in studies MYR203 and MYR301

P. Lampertico1, S. Aleman2, T. Stepanova 3, M. Brunetto 4, Y. Guo5, V. Suri5, D. Manuilov5, C. Frenette5, J. Flaherty5, V. Chulanov6, M. Cornberg7, P. Bogolomov8, H. Wedemeyer7

1Fondazione IRCCS Ca’ Granda Ospedale Maggiore Policlinico, CRC “A.M. and A. Migliavacca” Center for Liver Disease, Università degli Studi di Milano, Milan, Italy, 2Karolinska Universitetssjukhuset, Karolinska Institutet, Stockholm, Sweden, 3Clinic of Modern Medicine, Moscow, Russia, 4UO Epatologia, Azienda Ospedaliero Universitaria Pisana, Pisa, Italy, 5Gilead Sciences, Inc. Foster City, CA USA, 6FSBI National Research Medical Center for Phthisiopulmonology and Infectious Diseases of the Ministry of Health of the Russian Federation, Moscow, Russia, 7Medizinische Hochschule Hannover, Klinik für Gastroenterologie, Hepatologie und Endokrinologie, Hannover, Germany, 8State budgetary institution of health care of Moscow region “Moscow regional research clinical institute named after M.F. Vladimirsky”, Moscow, Russia

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P 40
Elevations in total serum bile acids with bulevirtide treatment are asymptomatic and not associated with adverse events of interest in patients with chronic hepatitis D

P. Lampertico1,2, S. Aleman 3, T. Asselah 4, A. Streinu-Cercel5, P. Bogomolov6, V. Morozov7, T. Stepanova8, S. Lazar9, D. Manuilov10, R.C. Mercier10, J.F. Flaherty10, C. Frenette10, V. Suri10, L. Ye10, S. Tseng10, F. Christian-Cox10, M. Brunetto11, H. Wedemeyer12

1Fondazione IRCCS Ca’ Granda Ospedale Maggiore Policlinico, Milan, Italy, 2“A.M. e A. Migliavacca” Center for the Study of Liver Disease, Università degli Studi di Milano, Italy, 3Karolinska Universitetssjukhuset/Karolinska Institutet, Stockholm, Sweden, 4Hôpital Beaujon, Université de Paris, Clichy, France, 5Institutul Național de Boli Infecțioase “Prof. Dr. Matei Balț”, Bucureşti, Romania, 6Moscow Regional Research Clinical Institute Named After M. F. Vladimirsky, Moscow, Russian Federation, 7Hepatolog, Samara, Russian Federation, 8Clinic of Modern Medicine, Moscow, Russian Federation, 9Spitalului Clinic de Boli Infecţioase şi Tropicale, Dr.Victor Babeş, Bucureşti, 10Gilead Sciences, Inc., Foster City, California, USA, 11Hepatology Unit, University Hospital of Pisa, Italy, 12Medizinische Hochschule Hannover, Germany

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P 41
Baseline bile acid levels but not bile acid increases during bulevirtide treatment of hepatitis D are associated with HDV RNA decline

K. Deterding1, C.J. Xu1,2, K. Port1, B. Maasoumy1, M. Cornberg1,2, H. Wedemeyer1

1Department of Gastroenterology, Hepatology and Endocrinology, Hannover Medical School, Germany, 2Center for Individualized Infection Medicine, CiiM, a joint venture between Hannover Medical School and the Helmholtz Center for Infection Research, Hannover, Germany

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Pathogenesis and Immunology

P 42
Outcomes of patients with active hepatitis delta infection after 15 years of follow up

V. Piazzolla1, G. Cocomazzi1, M.M. Squillante1, N. Minerva2, M.C. Cavorsi1, A. Napolitano1, F. Fraticelli1, A. Mangia1

1Liver Unit, IRCCS “Casa Sollievo della Sofferenza San Giovanni Rotondo, Italy, 2Internal Medicine Ospedale Bonomo Andria, Italy

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P 43
Immunology of HDV in untreated and treated patients. A case report.

M. Radu1, C. Timis1, R. Baloi1

1National Institute for Infectious Diseases “Prof. Dr. Matei Bals”, Bucharest, Romania

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P 44
Innate immune responses and liver damage pathways are highly activated in chronic hepatitis delta

E. García-Pras1, T. Leonel1, S. Rodríguez-Tajes1, M. García-López1, S. Lens1, B. Testoni2, Z. Mariño1, A. Díaz 3, A. Rando 4, Y. Fundora5, F. Zoulim2, X. Forns1, S. Pérez-del-Pulgar1

1Liver Unit, Hospital Clínic, University of Barcelona, IDIBAPS, CIBEREHD, Barcelona, Spain, 2INSERM U1052-Cancer Research Center of Lyon (CRCL), University of Lyon, UMR_S1052, Lyon, France, 3Pathology Department, Biomedical Diagnostic Center, Hospital Clínic, CIBEREHD, Barcelona, Spain, 4Liver Pathology Unit, Department of Biochemistry and Microbiology, Hospital Universitari Vall d’Hebron, Universitat Autònoma de Barcelona, CIBERehd, Barcelona, Spain, 5Hepatobilio-pancreatic and Liver Transplant Department, Hospital Clinic, Barcelona, Spain

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Virology

P 45
Quantification of serum HDV RNA by Robogene 2.0 in untreated and bulevirtide-treated HDV patients is significanlty influenced by the extraction methods

E. Degasperi1, S. Colonia Uceda Renteria2, M.P. Anolli1, M. Borghi1, D. Sambarino1, R. Perbellini1, F. Facchetti1, S. Monico1, F. Ceriotti2, P. Lampertico 1,3

1Foundation IRCCS Ca’ Granda Ospedale Maggiore Policlinico, Division of Gastroenterology and Hepatology, Milan, Italy, 2Foundation IRCCS Ca’ Granda Ospedale Maggiore Policlinico, Virology Unit, Milan, Italy, 3CRC “A. M. and A. Migliavacca” Center for Liver Disease, Department of Pathophysiology and Transplantation, University of Milan, Milan, Italy

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P 46
Studying by next-generation sequencing the delta antigen quasispecies: complexity, variability and epitopes binding prediction

B. Pacin-Ruiz1,2,3, M.F. Cortese1,2,3, A. Palom 4, S. Garcia-Garcia1,2,3, D. Tabernero1,2,3, A. Rando-Segura5, A. Najarro1, M. Vila1,2,3, J. Gregori6, J. Quer6, M.Riveiro-Barciela3,4, M. Buti3,4, F. Rodriguez-Frias1,2,3

1Liver Pathology Unit, Departments of Biochemistry and Microbiology, Vall d’Hebron University Hospital, Barcelona, Spain, 2Clinical Biochemestry, Area of Immunomediated Diseases and Innovative Therapies, Vall d’Hebron Research Institute, Barcelona, Spain, 3Centro de Investigación Biomédica en Red de Enfermedades Hepáticas y Digestivas, Instituto de Salud Carlos III, Madrid, Spain, 4Liver Unit, Department of Internal Medicine, Vall d’Hebron University Hospital, Barcelona, Spain, 5Department of Microbiology, Vall d’Hebron University Hospital, Barcelona, Spain, 6Liver Unit, Liver Disease, Laboratory-Viral Hepatitis, Vall d’Hebron Institut Recerca, Barcelona, Spain

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