{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,4,25]],"date-time":"2026-04-25T07:03:17Z","timestamp":1777100597539,"version":"3.51.4"},"reference-count":32,"publisher":"MDPI AG","issue":"5","license":[{"start":{"date-parts":[[2022,4,27]],"date-time":"2022-04-27T00:00:00Z","timestamp":1651017600000},"content-version":"vor","delay-in-days":0,"URL":"https:\/\/creativecommons.org\/licenses\/by\/4.0\/"}],"funder":[{"name":"Leipzig University"},{"name":"German Research Foundation"}],"content-domain":{"domain":[],"crossmark-restriction":false},"short-container-title":["Pathogens"],"abstract":"<jats:p>Background: The hepatitis B and D virus (HBV\/HDV) hepatocyte entry inhibitor bulevirtide (BLV) has been available in Europe since July 2020, after the registrational trial MYR202. Real-life data on the efficacy and safety of BLV are sparse. Methods: We have analysed the course of treatment with BLV (2 mg\/day) plus tenofovir disoproxil fumarate (TDF) (245 mg\/day) in patients with chronic hepatitis delta (CHD). Virologic (\u22652 log reduction in HDV RNA or suppression of HDV RNA below the lower limit of detection) and biochemical (normalisation of serum ALT) treatment responses after 24 weeks were defined according to the MYR202 trial. Results: Seven patients were recruited (four with liver cirrhosis Child\u2013Pugh A). After 24 weeks, a virologic response was observed in five of seven and a biochemical response was seen in three of six patients with elevated serum ALT at baseline. Extended treatment data &gt; 48 weeks were available in three cases: two presented with continuous virologic and biochemical responses and in one individual an HDV-RNA breakthrough was observed. Adverse effects were not recorded. Conclusions: The first real-life data of the approved dosage of 2 mg of BLV in combination with TDF confirm the safety, tolerability, and efficacy of the registrational trial MYR202 for a treatment period of 24 weeks and beyond.<\/jats:p>","DOI":"10.3390\/pathogens11050517","type":"journal-article","created":{"date-parts":[[2022,4,27]],"date-time":"2022-04-27T22:20:20Z","timestamp":1651098020000},"page":"517","update-policy":"https:\/\/doi.org\/10.3390\/mdpi_crossmark_policy","source":"Crossref","is-referenced-by-count":32,"title":["Efficacy and Safety of Bulevirtide plus Tenofovir Disoproxil Fumarate in Real-World Patients with Chronic Hepatitis B and D Co-Infection"],"prefix":"10.3390","volume":"11","author":[{"ORCID":"https:\/\/orcid.org\/0000-0002-0401-1140","authenticated-orcid":false,"given":"Toni","family":"Herta","sequence":"first","affiliation":[{"name":"Division of Hepatology, Department of Medicine II, Leipzig University Medical Center, 04103 Leipzig, Germany"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Magdalena","family":"Hahn","sequence":"additional","affiliation":[{"name":"Division of Hepatology, Department of Medicine II, Leipzig University Medical Center, 04103 Leipzig, Germany"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"ORCID":"https:\/\/orcid.org\/0000-0003-4158-1473","authenticated-orcid":false,"given":"Melanie","family":"Maier","sequence":"additional","affiliation":[{"name":"Institute of Medical Microbiology and Virology, Leipzig University Medical Center, 04103 Leipzig, Germany"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"ORCID":"https:\/\/orcid.org\/0000-0002-8710-101X","authenticated-orcid":false,"given":"Janett","family":"Fischer","sequence":"additional","affiliation":[{"name":"Division of Hepatology, Department of Medicine II, Leipzig University Medical Center, 04103 Leipzig, Germany"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Johannes","family":"Niemeyer","sequence":"additional","affiliation":[{"name":"Division of Hepatology, Department of Medicine II, Leipzig University Medical Center, 04103 Leipzig, Germany"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"ORCID":"https:\/\/orcid.org\/0000-0001-7517-402X","authenticated-orcid":false,"given":"Mario","family":"H\u00f6nemann","sequence":"additional","affiliation":[{"name":"Institute of Medical Microbiology and Virology, Leipzig University Medical Center, 04103 Leipzig, Germany"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Albrecht","family":"B\u00f6hlig","sequence":"additional","affiliation":[{"name":"Division of Hepatology, Department of Medicine II, Leipzig University Medical Center, 04103 Leipzig, Germany"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Florian","family":"Gerhardt","sequence":"additional","affiliation":[{"name":"Division of Hepatology, Department of Medicine II, Leipzig University Medical Center, 04103 Leipzig, Germany"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Aaron","family":"Schindler","sequence":"additional","affiliation":[{"name":"Division of Hepatology, Department of Medicine II, Leipzig University Medical Center, 04103 Leipzig, Germany"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Jonas","family":"Schumacher","sequence":"additional","affiliation":[{"name":"Division of Hepatology, Department of Medicine II, Leipzig University Medical Center, 04103 Leipzig, Germany"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"ORCID":"https:\/\/orcid.org\/0000-0003-0003-6241","authenticated-orcid":false,"given":"Thomas","family":"Berg","sequence":"additional","affiliation":[{"name":"Division of Hepatology, Department of Medicine II, Leipzig University Medical Center, 04103 Leipzig, Germany"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"ORCID":"https:\/\/orcid.org\/0000-0001-9233-4064","authenticated-orcid":false,"given":"Johannes","family":"Wiegand","sequence":"additional","affiliation":[{"name":"Division of Hepatology, Department of Medicine II, Leipzig University Medical Center, 04103 Leipzig, Germany"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"ORCID":"https:\/\/orcid.org\/0000-0003-2679-0672","authenticated-orcid":false,"given":"Florian","family":"van B\u00f6mmel","sequence":"additional","affiliation":[{"name":"Division of Hepatology, Department of Medicine II, Leipzig University Medical Center, 04103 Leipzig, Germany"}],"role":[{"role":"author","vocabulary":"crossref"}]}],"member":"1968","published-online":{"date-parts":[[2022,4,27]]},"reference":[{"key":"ref_1","doi-asserted-by":"crossref","first-page":"31","DOI":"10.1038\/nrgastro.2009.205","article-title":"Epidemiology, pathogenesis and management of hepatitis D: Update and challenges ahead","volume":"7","author":"Wedemeyer","year":"2010","journal-title":"Nat. Rev. Gastroenterol. Hepatol."},{"key":"ref_2","doi-asserted-by":"crossref","first-page":"1629","DOI":"10.1053\/j.gastro.2009.01.052","article-title":"A 28-year study of the course of hepatitis Delta infection: A risk factor for cirrhosis and hepatocellular carcinoma","volume":"136","author":"Romeo","year":"2009","journal-title":"Gastroenterology"},{"key":"ref_3","doi-asserted-by":"crossref","first-page":"54","DOI":"10.1111\/liv.14356","article-title":"Future treatments for hepatitis delta virus infection","volume":"40","author":"Asselah","year":"2020","journal-title":"Liver Int."},{"key":"ref_4","doi-asserted-by":"crossref","first-page":"512","DOI":"10.1136\/gutjnl-2018-316601","article-title":"Prevalence and burden of hepatitis D virus infection in the global population: A systematic review and meta-analysis","volume":"68","author":"Chen","year":"2018","journal-title":"Gut"},{"key":"ref_5","doi-asserted-by":"crossref","first-page":"523","DOI":"10.1016\/j.jhep.2020.04.008","article-title":"The global prevalence of hepatitis D virus infection: Systematic review and meta-analysis","volume":"73","author":"Stockdale","year":"2020","journal-title":"J. Hepatol."},{"key":"ref_6","doi-asserted-by":"crossref","first-page":"e00049","DOI":"10.7554\/eLife.00049","article-title":"Sodium taurocholate cotransporting polypeptide is a functional receptor for human hepatitis B and D virus","volume":"1","author":"Yan","year":"2012","journal-title":"Elife"},{"key":"ref_7","doi-asserted-by":"crossref","first-page":"1070","DOI":"10.1053\/j.gastro.2013.12.024","article-title":"Hepatitis B and D viruses exploit sodium taurocholate co-transporting polypeptide for species-specific entry into hepatocytes","volume":"146","author":"Ni","year":"2014","journal-title":"Gastroenterology"},{"key":"ref_8","doi-asserted-by":"crossref","first-page":"1514","DOI":"10.1136\/gutjnl-2015-310686","article-title":"The rs2296651 (S267F) variant on NTCP (SLC10A1) is inversely associated with chronic hepatitis B and progression to cirrhosis and hepatocellular carcinoma in patients with chronic hepatitis B","volume":"65","author":"Hu","year":"2016","journal-title":"Gut"},{"key":"ref_9","doi-asserted-by":"crossref","first-page":"364","DOI":"10.1111\/hepr.13007","article-title":"Genetic variants in NTCP exon gene are associated with HBV infection status in a Chinese Han population","volume":"48","author":"Wu","year":"2018","journal-title":"Hepatol. Res."},{"key":"ref_10","doi-asserted-by":"crossref","first-page":"147","DOI":"10.1016\/j.ijid.2019.01.038","article-title":"NTCP S267F variant associates with decreased susceptibility to HBV and HDV infection and decelerated progression of related liver diseases","volume":"80","author":"Binh","year":"2019","journal-title":"Int. J. Infect. Dis."},{"key":"ref_11","doi-asserted-by":"crossref","unstructured":"Wedemeyer, H., Bogomolov, P., Blank, A., Allweiss, L., Dandri-Petersen, M., Bremer, B., Voronkova, N., Sch\u00f6neweis, K., Pathil, A., and Burhenne, J. (2018, January 11\u201315). Final results of a multicenter, open-label phase 2b clinical trial to assess safety and efficacy of Myrcludex B in combination with Tenofovir in patients with chronic HBV\/HDV co-infection. Proceedings of the EASL International Liver Congress, Paris, France.","DOI":"10.1016\/S0168-8278(18)30224-1"},{"key":"ref_12","doi-asserted-by":"crossref","first-page":"304","DOI":"10.1038\/nrgastro.2011.85","article-title":"PEG-IFN for the treatment of hepatitis D","volume":"8","author":"Ciancio","year":"2011","journal-title":"Nat. Rev. Gastroenterol. Hepatol."},{"key":"ref_13","doi-asserted-by":"crossref","first-page":"463","DOI":"10.3851\/IMP2728","article-title":"Treatment of chronic hepatitis D patients with pegylated interferon: A real-world experience","volume":"19","author":"Abbas","year":"2014","journal-title":"Antivir. Ther."},{"key":"ref_14","doi-asserted-by":"crossref","first-page":"322","DOI":"10.1056\/NEJMoa0912696","article-title":"Peginterferon plus Adefovir versus Either Drug Alone for Hepatitis Delta","volume":"364","author":"Wedemeyer","year":"2011","journal-title":"N. Engl. J. Med."},{"key":"ref_15","doi-asserted-by":"crossref","first-page":"1782","DOI":"10.1136\/gutjnl-2020-323888","article-title":"Hepatitis D virus in 2021: Virology, immunology and new treatment approaches for a difficult-to-treat disease","volume":"70","author":"Urban","year":"2021","journal-title":"Gut"},{"key":"ref_16","doi-asserted-by":"crossref","first-page":"1601","DOI":"10.1007\/s40265-020-01400-1","article-title":"Bulevirtide: First Approval","volume":"80","author":"Kang","year":"2020","journal-title":"Drugs"},{"key":"ref_17","doi-asserted-by":"crossref","unstructured":"Wedemeyer, H., Sch\u00f6neweis, K., Bogomolov, P., Voronkova, N., Chulanov, V., Stepanova, T., Bremer, B., Allweiss, L., Dandri, M., and Burhenne, J. (2019, January 10\u201314). Final results of a multicenter, open-label phase 2 clinical trial (MYR203) to assess safety and efficacy of myrcludex B in cwith PEG-interferon Alpha 2a in patients with chronic HBV\/HDV co-infection. Proceedings of the EASL International Liver Congress, Vienna, Austria.","DOI":"10.1016\/S0618-8278(19)30141-0"},{"key":"ref_18","doi-asserted-by":"crossref","unstructured":"Wedemeyer, H., Aleman, S., Andreone, P., Blank, A., Brunetto, M., Bogomolov, P., Chulanov, V., Geyvandova, N., Hilgard, G., and Mamonova, N. (2021, January 23\u201326). Bulevirtide monotherapy at low and high dose in patients with chronic hepatitis delta: 24 weeks interim data of the phase 3 MYR301 study. Proceedings of the EASL International Liver Congress, Digital.","DOI":"10.1016\/j.dld.2022.01.047"},{"key":"ref_19","doi-asserted-by":"crossref","first-page":"S52","DOI":"10.1016\/S0168-8278(20)30651-6","article-title":"48 weeks of high dose (10 mg) bulevirtide as monotherapy or with peginterferon alfa-2a in patients with chronic HBV\/HDV co-infection","volume":"73","author":"Wedemeyer","year":"2020","journal-title":"J. Hepatol."},{"key":"ref_20","doi-asserted-by":"crossref","first-page":"464","DOI":"10.1016\/j.jhep.2021.10.012","article-title":"Safety and effectiveness of up to 3 years\u2019 bulevirtide monotherapy in patients with HDV-related cirrhosis","volume":"76","author":"Loglio","year":"2022","journal-title":"J. Hepatol."},{"key":"ref_21","doi-asserted-by":"crossref","first-page":"1509","DOI":"10.1111\/liv.14950","article-title":"Early virological response in six patients with hepatitis D virus infection and compensated cirrhosis treated with Bulevirtide in real-life","volume":"41","author":"Asselah","year":"2021","journal-title":"Liver. Int."},{"key":"ref_22","unstructured":"De Ledinghen, V., Guyader, D., Metivier, S., Hilleret, M.-N., Fontaine, H., Roche, B., Ganne-Carrie, N., D\u2019Alteroche, L., Loustaud-Ratti, V., and Gervais, A. (2020, January 13\u201316). Safety and efficacy of 2 mg bulevirtide in patients with chronic HBD\/HDV co-infection: First real-world results. Proceedings of the AASLD The Liver Meeting, Digital. Available online: https:\/\/www.natap.org\/2021\/AASLD\/AASLD_69.htm."},{"key":"ref_23","unstructured":"Loglio, A., Renteria, S.C.U., Sambarino, D., Borghi, M., Perbellini, R., Scholt\u00e8s, C., Facchetti, F., Fraquelli, M., Costantino, A., and Orsini, C. (2021, January 23\u201326). Early clinical and virological changes in HDV patients with advanced cirrhosis treated with bulevirtide monotherapy in a real-life setting. Proceedings of the AASLD The Liver Meeting, Digital. Available online: https:\/\/www.aasld.org\/sites\/default\/files\/2021-11\/TLM%202021%20Late%20Breaking%20Abstracts%2011.01.21.pdf."},{"key":"ref_24","unstructured":"Binter, T., Jachs, M., Hartl, L., Aberle, S., Zoller, H., Aigner, E., St\u00e4ttermayer, A.F., Kozbial, K., Steindl-Munda, P.E., and Bauer, D. (2020, January 13\u201316). Efficacy of long-term treatment of chronic hepatitis D patients with bulevirtide\u2014Results of a \u201creal world\u201d study. Proceedings of the AALSD The Liver Meeting, Digital. Available online: https:\/\/www.natap.org\/2021\/AASLD\/AASLD_95.htm."},{"key":"ref_25","unstructured":"Z\u00f6llner, C., Lutz, K., Demir, M., and Tacke, F. (2021, January 23\u201326). First real-life experiences with bulevirtide for the treatment of hepatitis delta\u2014Data from a tertiary reference center in Germany. Proceedings of the EASL International Liver Congress, Digital. Available online: https:\/\/www.postersessiononline.eu\/173580348_eu\/congresos\/ILC2021\/aula\/-PO_1419_ILC2021.pdf."},{"key":"ref_26","doi-asserted-by":"crossref","first-page":"1046","DOI":"10.1016\/j.jhep.2020.06.038","article-title":"Origin, HDV genotype and persistent viremia determine outcome and treatment response in patients with chronic hepatitis delta","volume":"73","author":"Roulot","year":"2020","journal-title":"J. Hepatol."},{"key":"ref_27","doi-asserted-by":"crossref","first-page":"680","DOI":"10.3748\/wjg.v24.i6.680","article-title":"Analysis of hepatitis B virus preS1 variability and prevalence of the rs2296651 polymorphism in a Spanish population","volume":"24","author":"Casillas","year":"2018","journal-title":"World J. Gastroenterol."},{"key":"ref_28","doi-asserted-by":"crossref","first-page":"501","DOI":"10.3109\/00498254.2011.555567","article-title":"Genetic polymorphisms in Na+-taurocholate co-transporting polypeptide (NTCP) and ileal apical sodium-dependent bile acid transporter (ASBT) and ethnic comparisons of functional variants of NTCP among Asian populations","volume":"41","author":"Pan","year":"2011","journal-title":"Xenobiotica"},{"key":"ref_29","doi-asserted-by":"crossref","first-page":"2265","DOI":"10.1038\/s41467-019-10211-2","article-title":"Recapitulation of HDV infection in a fully permissive hepatoma cell line allows efficient drug evaluation","volume":"10","author":"Lempp","year":"2019","journal-title":"Nat. Commun."},{"key":"ref_30","doi-asserted-by":"crossref","first-page":"254","DOI":"10.1007\/s00103-022-03486-2","article-title":"Bulevirtide als erster spezifischer Wirkstoff gegen Hepatitis-D-Virusinfektionen\u2014Mechanismus und klinische Wirkung","volume":"65","author":"Nkongolo","year":"2022","journal-title":"Bundesgesundheitsblatt-Gesundh.-Gesundh."},{"key":"ref_31","doi-asserted-by":"crossref","first-page":"1109","DOI":"10.1002\/hep.27585","article-title":"Pegylated interferon therapy of chronic hepatitis D: In need of revision","volume":"61","author":"Rizzetto","year":"2015","journal-title":"Hepatology"},{"key":"ref_32","doi-asserted-by":"crossref","first-page":"176","DOI":"10.1186\/s12985-017-0844-z","article-title":"Clade homogeneity and low rate of delta virus despite hyperendemicity of hepatitis B virus in Ethiopia","volume":"14","author":"Belyhun","year":"2017","journal-title":"Virol. J."}],"container-title":["Pathogens"],"original-title":[],"language":"en","link":[{"URL":"https:\/\/www.mdpi.com\/2076-0817\/11\/5\/517\/pdf","content-type":"unspecified","content-version":"vor","intended-application":"similarity-checking"}],"deposited":{"date-parts":[[2025,10,10]],"date-time":"2025-10-10T23:01:46Z","timestamp":1760137306000},"score":1,"resource":{"primary":{"URL":"https:\/\/www.mdpi.com\/2076-0817\/11\/5\/517"}},"subtitle":[],"short-title":[],"issued":{"date-parts":[[2022,4,27]]},"references-count":32,"journal-issue":{"issue":"5","published-online":{"date-parts":[[2022,5]]}},"alternative-id":["pathogens11050517"],"URL":"https:\/\/doi.org\/10.3390\/pathogens11050517","relation":{},"ISSN":["2076-0817"],"issn-type":[{"value":"2076-0817","type":"electronic"}],"subject":[],"published":{"date-parts":[[2022,4,27]]}}}