{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,8,9]],"date-time":"2026-08-09T19:26:26Z","timestamp":1786303586936,"version":"build-2736575974"},"reference-count":35,"publisher":"Wiley","issue":"4","license":[{"start":{"date-parts":[[2024,12,8]],"date-time":"2024-12-08T00:00:00Z","timestamp":1733616000000},"content-version":"vor","delay-in-days":0,"URL":"http:\/\/creativecommons.org\/licenses\/by\/4.0\/"},{"start":{"date-parts":[[2024,12,8]],"date-time":"2024-12-08T00:00:00Z","timestamp":1733616000000},"content-version":"tdm","delay-in-days":0,"URL":"http:\/\/doi.wiley.com\/10.1002\/tdm_license_1.1"}],"funder":[{"DOI":"10.13039\/100005564","name":"Gilead Sciences","doi-asserted-by":"publisher","id":[{"id":"10.13039\/100005564","id-type":"DOI","asserted-by":"publisher"}]}],"content-domain":{"domain":["onlinelibrary.wiley.com"],"crossmark-restriction":true},"short-container-title":["Liver International"],"published-print":{"date-parts":[[2025,4]]},"abstract":"<jats:title>ABSTRACT<\/jats:title>\n                  <jats:sec>\n                    <jats:title>Background and Aims<\/jats:title>\n                    <jats:p>The safety and tolerability of bulevirtide (BLV), a novel entry inhibitor of hepatitis delta virus, were evaluated in an integrated analysis of clinical trial results from patients with chronic hepatitis delta (CHD).<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Methods<\/jats:title>\n                    <jats:p>\n                      Week 48 on\u2010treatment clinical and laboratory results from two Phase 2 trials (MYR203 [NCT02888106] and MYR204 [NCT03852433]) and one Phase 3 trial (MYR301 [NCT03852719]) were pooled (\n                      <jats:italic>N<\/jats:italic>\n                      \u2009=\u2009269). Patients were grouped as follows: BLV 2\u2009mg (\n                      <jats:italic>n<\/jats:italic>\n                      \u2009=\u200964), BLV 10\u2009mg (\n                      <jats:italic>n<\/jats:italic>\n                      \u2009=\u2009115), pegylated interferon\u2010alfa (\n                      <jats:italic>n<\/jats:italic>\n                      \u2009=\u200939) and control (\n                      <jats:italic>n<\/jats:italic>\n                      \u2009=\u200951). The control group consisted of patients assigned to the delayed treatment group in Study MYR301.\n                    <\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Results<\/jats:title>\n                    <jats:p>Adverse events (AEs) that occurred more frequently with BLV 2\u2009mg and BLV 10\u2009mg versus control included increased total bile acid levels (20% and 17% vs. 0%), injection\u2010site reactions (16% and 20% vs. 0%), headache (16% and 17% vs. 0%), pruritus (11% and 10% vs. 0%) and eosinophilia (9% and 4% vs. 0%). Increases in total bile acid levels were observed with BLV without clear correlation with AEs, such as pruritus, eosinophilia or vitamin D deficiency. Grade 3 or 4 study drug\u2013related AEs occurred in a higher proportion of patients receiving pegylated interferon\u2010alfa (51%) than with BLV 2 or 10\u2009mg (3% and 4%, respectively). There were no serious AEs related to BLV, and no patients discontinued BLV due to an AE. Neither hepatic decompensation nor death occurred.<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Conclusions<\/jats:title>\n                    <jats:p>BLV monotherapy was safe and well tolerated through 48\u2009weeks of treatment in patients with CHD.<\/jats:p>\n                    <jats:p>\n                      <jats:bold>Trial Registration:<\/jats:bold>\n                      NCT02888106, NCT03852433 and NCT03852719\n                    <\/jats:p>\n                  <\/jats:sec>","DOI":"10.1111\/liv.16174","type":"journal-article","created":{"date-parts":[[2024,12,9]],"date-time":"2024-12-09T01:55:06Z","timestamp":1733709306000},"update-policy":"https:\/\/doi.org\/10.1002\/crossmark_policy","source":"Crossref","is-referenced-by-count":12,"title":["Bulevirtide Monotherapy Is Safe and Well Tolerated in Chronic Hepatitis Delta: An Integrated Safety Analysis of Bulevirtide Clinical Trials at Week 48"],"prefix":"10.1111","volume":"45","author":[{"ORCID":"https:\/\/orcid.org\/0000-0002-0024-0595","authenticated-orcid":false,"given":"Tarik","family":"Asselah","sequence":"first","affiliation":[{"name":"Department of Hepatology, H\u00f4pital Beaujon, Universit\u00e9 de Paris\u2010Cit\u00e9, INSERM UMR1149  Clichy France"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0002-1026-7476","authenticated-orcid":false,"given":"Pietro","family":"Lampertico","sequence":"additional","affiliation":[{"name":"Division of Gastroenterology and Hepatology Foundation IRCCS Ca' Granda Ospedale Maggiore Policlinico  Milan Italy"},{"name":"CRC \u2018A. M. And A. Migliavacca\u2019 Center for Liver Disease, Department of Pathophysiology and Transplantation University of Milan  Milan Italy"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Soo","family":"Aleman","sequence":"additional","affiliation":[{"name":"Department of Infectious Diseases Karolinska University Hospital\/Karolinska Institutet  Stockholm Sweden"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Marc","family":"Bourli\u00e8re","sequence":"additional","affiliation":[{"name":"H\u00f4pital Saint Joseph  Marseille France"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Adrian","family":"Streinu\u2010Cercel","sequence":"additional","affiliation":[{"name":"National Institute for Infectious Diseases \u2018Prof. Dr. Matei Bals\u2019  Bucharest Romania"},{"name":"Carol Davila Medicine and Pharmacy University  Bucharest Romania"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Pavel","family":"Bogomolov","sequence":"additional","affiliation":[{"name":"M.F. Vladimirsky Moscow Regional Research and Clinical Institute  Moscow Russian Federation"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Viacheslav","family":"Morozov","sequence":"additional","affiliation":[{"name":"LLC Medical Company \u2018Hepatolog\u2019  Samara Russian Federation"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Tatiana","family":"Stepanova","sequence":"additional","affiliation":[{"name":"Limited Liability Company \u2018Clinic of Modern Medicine\u2019  Moscow Russian Federation"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Stefan","family":"Lazar","sequence":"additional","affiliation":[{"name":"Dr. Victor Babes Foundation  Bucharest Romania"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0009-0005-3873-096X","authenticated-orcid":false,"given":"Dmitry","family":"Manuilov","sequence":"additional","affiliation":[{"name":"Gilead Sciences Inc.  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