Efficacy and safety of BLV monotherapy for chronic hepatitis delta: posttreatment results through 48 weeks after the end of treatment from an interim analysis of a randomised Phase 3 study MYR301

被引：0

作者：

Aleman, S. ^{[1
]}

Brunetto, M. ^{[2
,3
]}

Blank, A. ^{[4
]}

Andreone, P. ^{[5
]}

Bogomolov, P. ^{[6
]}

Chulanov, V. ^{[7
]}

Mamonova, N. ^{[8
]}

Geyvandova, N. ^{[9
]}

Morozov, V. ^{[10
]}

Sagalova, O. ^{[11
]}

Stepanova, T. ^{[12
]}

Chee, G. M. ^{[13
]}

Mercier, R. C. ^{[13
]}

Lichtman, A. ^{[13
]}

Manuilov, D. ^{[13
]}

Arterburn, S. ^{[13
]}

Lau, A. H. ^{[13
]}

Osinusi, A. ^{[13
]}

Christian-Cox, Flo. ^{[13
]}

Duff, F. ^{[13
]}

zur Wiesch, J. Schulze ^{[14
]}

Cornberg, M. ^{[15
]}

Zeuzem, S. ^{[16
]}

Wedemeyer, H. ^{[15
]}

Lampertico, P. ^{[17
,18
]}

机构：

[1] Karolinska Inst, Karolinska Univ Hosp, Dept Infect Dis, Stockholm, Sweden

[2] Univ Hosp Pisa, Reference Ctr Tuscany Reg Chron Liver Dis & Canc, Hepatol Unit, Pisa, Italy

[3] Univ Pisa, Dept Clin & Expt Med, Pisa, Italy

[4] Heidelberg Univ, Heidelberg Univ Hosp, Med Fac Heidelberg, Internal Med Dept Clin Pharmacol & Pharmacoepidemi, Heidelberg, Germany

[5] Univ Modena & Reggio Emilia, Baggiovara Hosp, Internal Med, Modena, Italy

[6] MF Vladimirsky Moscow Reg Res & Clin Inst, Moscow, Russia

[7] Sechenov Univ, Moscow, Russia

[8] Minist Hlth Russian Federat, FSBI Natl Res Med Ctr Phthisiopulmonol & Infect Di, Moscow, Russia

[9] Stavropol Reg Hosp, Stavropol, Russia

[10] LLC Med Co Hepatolog, Samara, Russia

[11] South Ural State Med Univ, Chelyabinsk, Russia

[12] LLC Clin Modern Med, Moscow, Russia

[13] Gilead Sci Inc, Foster City, CA USA

[14] Univ Hosp Hamburg Eppendorf, Med Microbiol, Hamburg, Germany

[15] Hannover Med Sch, Clin Gastroenterol Hepatol Infect Dis & Endocrinol, Hannover, Germany

[16] Goethe Univ, Univ Hosp, Dept Nucl Med, Frankfurt, Germany

[17] Fdn IRCCS Ca Granda Osped Maggiore Policlin, Div Gastroenterol & Hepatol, Milan, Italy

[18] Univ Milan, CRC A M&A Migliavacca Ctr Liver Dis, Dept Pathophysiol & Transplantat, Milan, Italy

来源：

DIGESTIVE AND LIVER DISEASE | 2025年 / 57卷

关键词：

D O I：

10.1016/j.dld.2025.01.109

中图分类号：

R57 [消化系及腹部疾病];

学科分类号：

摘要：

P-69

引用

页数：2

共 47 条

[11] Efficacy and Safety of Bulevirtide Monotherapy for Chronic Hepatitis Delta in Patients With and Without Cirrhosis: Results From the Week 96 Interim Analysis of a Phase 3 Randomized Study
Aleman, Soo
Wedemeyer, Heiner
Brunetto, Maurizia
Blank, Antje
Andreone, Pietro
Bogomolov, Pavel
Chulanov, Vladimir
Mamonova, Nina
Geyvandova, Natalia
Morozov, Viacheslav
Sagalova, Olga
Stepanova, Tatyana
Manuilov, Dmitry
Mercier, Renee-Claude
An, Qi
Da, Ben
Flaherty, John F.
Buensuceso, Paul
Osinusi, Anu
Lau, Audrey H.
Christian-Cox, Florence
Tseng, Steve
zur Wiesch, Julian Schulze
Cornberg, Markus
Zeuzem, Stefan
Lampertico, Pietro
AMERICAN JOURNAL OF GASTROENTEROLOGY, 2024, 119 (10S): : S1384 - S1385
[12] Efficacy and safety at 96 weeks of bulevirtide 2 mg or 10 mg monotherapy for chronic hepatitis D: results from an interim analysis of a phase 3 randomized study
Wedemeyer, Heiner
Aleman, Soo
Brunetto, Maurizia
Blank, Antje
Andreone, Pietro
Bogomolov, Pavel
Chulanov, Vladimir
Mamonova, Nina
Geyvandova, Natalia
Viacheslav, Morozov
Sagalova, Olga
Stepanova, Tatyana
Manuilov, Dmitry
Mercier, Renee-Claude
An, Qi
Flaherty, John F.
Osinusi, Anu
Lau, Audrey
Wiesch, Julian Schulze Zur
Cornberg, Markus
Zeuzem, Stefan
Lampertico, Pietro
JOURNAL OF HEPATOLOGY, 2023, 78 : S57 - S58
[13] STRONG INTRAHEPATIC DECLINE OF HEPATITIS D VIRUS RNA AND ANTIGEN AFTER 48 WEEKS OF TREATMENT WITH BULEVIRTIDE IN CHRONIC HBV/HDV CO-INFECTED PATIENTS: INTERIM RESULTS FROM A MULTICENTER, OPEN-LABEL, RANDOMIZED PHASE 3 CLINICAL TRIAL (MYR301)
Allweiss, Lena
Volmari, Annika
Ladiges, Yvonne
Eggers, Corinna
Giersch, Katja
Schoneweis, Katrin
Suri, Vithika
Wallin, Jeffrey
Wedemeyer, Heiner
Urban, Stephan
Lutgehetmann, Marc
Bockmann, Jan-Hendrick
Dandri, Maura
HEPATOLOGY, 2021, 74 : 148A - 148A
[14] Safety and efficacy of bulevirtide monotherapy and in combination with Peginterferon alfa-2a in patients with chronic hepatitis delta: 24 weeks interim data of MYR204 Phase 2b study
Asselah, Tarik
Arama, Sorin Stefan
Bogomolov, Pavel
Bourliere, Marc
Fontaine, Helene
Gherlan, George Sebastian
Gorodin, Vladimir
Hilleret, Marie-Noelle
Lazar, Stefan
Mamonova, Nina
Viacheslav, Morozov
Pantea, Victor
Placinta, Gheorghe
Gournay, Jerome
Raffi, Francois
Ratziu, Vlad
Stern, Christiane
Sagalova, Olga
Samuel, Didier
Stepanova, Tatyana
Syutkin, Vladimir
Streinu-Cercel, Adrian
Zoulim, Fabien
Roulot, Dominique
JOURNAL OF HEPATOLOGY, 2021, 75 : S291 - S291
[15] PATIENT- REPORTED OUTCOMES AMONG PATIENTS WITH CHRONIC HEPATITIS DELTA TREATED WITH BULEVIRTIDE 2 MG: A LONG-TERM ANALYSIS OF THE PHASE 3 MYR301 TRIAL AT 144 WEEKS
Buti, Maria
Wedemeyer, Heiner
Aleman, Soo
Chulanov, Vladimir
Morozov, Viacheslav
Sagalova, Olga
Stepanova, Tatyana
Gish, Robert
Lloyd, Andrew
Suri, Vithika
Manuilov, Dmitry
Chee, Grace
Lau, Audrey
Osinusi, Anu
Flaherty, John
Rock, Marvin
Kim, Chong Hoon
Pandey, Shubhram
Singh, Barinder
Lampertico, Pietro
HEPATOLOGY, 2024, 80 : S150 - S151
[16] 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 end point results from a phase 3 randomized, multicenter, parallel design study
Wedemeyer, Heiner
Aleman, Soo
Brunetto, Maurizia
Blank, Antje
Andreone, Pietro
Bogomolov, Pavel
Chulanov, Vladimir
Mamonova, Nina
Geyvandova, Natalia
Viacheslav, Morozov
Sagalova, Olga
Stepanova, Tatyana
Manuilov, Dmitry
Suri, Vithika
An, Qi
Flaherty, John F.
Osinusi, Anu
Zur Wiesch, Julian Schulze
Cornberg, Markus
Zeuzem, Stefan
Lampertico, Pietro
JOURNAL OF HEPATOLOGY, 2022, 77 : S4 - S5
[17] A Phase 2 Randomized Clinical Trial to Evaluate the Safety and Efficacy of Pegylated Interferon Lambda Monotherapy in Patients with Chronic Hepatitis Delta Virus Infection. Interim Results From the LIMT HDV Study
Hamid, Saeed S.
Etzion, Ohad
Lurie, Yoav
Bader, Nimrah
Yardeni, David
Channa, Saleh M.
Mawani, Minaz
Parkash, Om
Martins, Eduardo B.
Gane, Edward J.
HEPATOLOGY, 2017, 66 : 496A - 496A
[18] 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
Wedemeyer, Heiner
Aleman, Soo
Brunetto, Maurizia R.
Blank, Antje
Andreone, Pietro
Bogomolov, Pavel
Chulanov, Vladimir
Mamonova, Nina
Geyvandova, Natalia
Morozov, Viacheslav
Sagalova, Olga
Stepanova, Tatyana V.
Manuilov, Dmitry
Shah, Vicki
Suri, Vithika
An, Qi
Flaherty, John F.
Osinusi, Anu
zur Wiesch, Julian Schulze
Cornberg, Markus
Zeuzem, Stefan
Lampertico, Pietro
GASTROENTEROLOGY, 2023, 164 (06) : S1367 - S1368
[19] EFFICACY AND SAFETY OF A NOVEL NUCLEOSIDE ANALOGUE HEPENOFOVIR FOR THE TREATMENT OF CHRONIC HEPATITIS B VIRUS INFECTION: INTERIM RESULTS FROM THE PHASE IC/IIb STUDY
Zhou, Jing
Zhang, Hong
Chen, Hong
Wang, Wen
Jin, Weili
Han, Lei
Wang, Daidi
Wen, Xiuhong
Zhang, Chi
Wang, Yali
Niu, Junqi
Ding, Yanhua Yan
HEPATOLOGY, 2024, 79 (02) : E71 - E72
[20] 48-week off-therapy efficacy and safety of bulevirtide in combination with pegylated interferon alfa-2a in patients with chronic hepatitis delta: final results from the phase 2b, openlabel, randomised, multicentre study MYR204
Asselah, Tarik
Chulanov, Vladimir
Lampertico, Pietro
Wedemeyer, Heiner
Streinu-Cercel, Adrian
Pantea, Victor
Lazar, Stefan
Gherlan, George Sebastian
Bogomolov, Pavel
Stepanova, Tatyana
Morozov, Viacheslav
Syutkin, Vladimir
Sagalova, Olga
Manuilov, Dmitry
Mercier, Renee-Claude
Ye, Lei
Chee, Grace M.
Da, Ben L.
Lau, Audrey H.
Osinusi, Anu
Bourliere, Marc
Ratziu, Vlad
Pol, Stanislas
Hilleret, Marie-Noelle
Zoulim, Fabien
JOURNAL OF HEPATOLOGY, 2024, 80 : S1 - S2

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