{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,10,17]],"date-time":"2026-10-17T21:09:50Z","timestamp":1792271390496,"version":"4.4.0"},"reference-count":20,"publisher":"Wiley","issue":"10","license":[{"start":{"date-parts":[[2023,6,7]],"date-time":"2023-06-07T00:00:00Z","timestamp":1686096000000},"content-version":"vor","delay-in-days":0,"URL":"http:\/\/creativecommons.org\/licenses\/by-nc\/4.0\/"}],"content-domain":{"domain":["onlinelibrary.wiley.com"],"crossmark-restriction":true},"short-container-title":["HIV Medicine"],"published-print":{"date-parts":[[2023,10]]},"abstract":"<jats:title>Abstract<\/jats:title><jats:sec><jats:title>Objectives<\/jats:title><jats:p>We describe the preliminary results of bulevirtide compassionate use in patients with hepatitis B and delta virus (HBV\/HDV)\u2010related cirrhosis and clinically significant portal hypertension, including those living with HIV.<\/jats:p><\/jats:sec><jats:sec><jats:title>Methods<\/jats:title><jats:p>We conducted a prospective observational study of consecutive patients. Clinical evaluation, liver function tests, bile acid levels, HDV\u2010RNA, HBV\u2010DNA, hepatitis B surface antigen, and liver and spleen stiffness were assessed at baseline and after treatment months 1, 2, 3, 4, 6, 9, and 12. HIV\u2010RNA and CD4+\/CD8+ count were assessed in people living with HIV. The first drug injection was administered under nurse supervision, and counselling was provided and adherence reviewed at each visit.<\/jats:p><\/jats:sec><jats:sec><jats:title>Results<\/jats:title><jats:p>In total, 13 patients (61.5% migrants) were enrolled. The median treatment duration was 11\u2009months. At month 6, mean alanine aminotransferase (ALT) levels fell by 64.5% and mean liver and spleen stiffness decreased by 8.6 and 0.9\u2009kPa, respectively. The mean baseline HDV\u2010RNA was 3.34 log IU\/mL and 5.10 log IU\/mL in people without and with HIV (<jats:italic>n<\/jats:italic> =\u20095) (<jats:italic>p<\/jats:italic>\u2009=\u20090.28), respectively. A similar mean decline was observed in both groups: \u22122.06 log IU\/mL and\u2009\u22121.93 log IU\/mL, respectively (<jats:italic>p<\/jats:italic>\u2009=\u20090.87). A combined response (undetectable HDV RNA or\u2009\u2265\u2009\u22122 log IU\/mL decline vs. baseline, with ALT normalization) was achieved in 66% of subjects without and in 60% of patients with HIV. Patients with HIV showed persistently undetectable HIV\u2010RNA and a progressive increase in CD4+\/CD8+ cells during treatment. No patient discontinued bulevirtide because of adverse effects.<\/jats:p><\/jats:sec><jats:sec><jats:title>Conclusions<\/jats:title><jats:p>Preliminary results suggest that bulevirtide is feasible and well\u2010tolerated in populations with difficult\u2010to\u2010treat conditions, such as those with HIV\/HBV\/HDV co\u2010infection and migrants, when special attention is given to patient education. HDV\u2010RNA decline during treatment was similar in people living with and without HIV.<\/jats:p><\/jats:sec>","DOI":"10.1111\/hiv.13518","type":"journal-article","created":{"date-parts":[[2023,6,8]],"date-time":"2023-06-08T06:28:11Z","timestamp":1686205691000},"page":"1075-1082","update-policy":"https:\/\/doi.org\/10.1002\/crossmark_policy","source":"Crossref","is-referenced-by-count":16,"title":["\u201cReal world\u201d efficacy of bulevirtide in <scp>HBV<\/scp>\/<scp>HDV<\/scp>\u2010related cirrhosis including people living with <scp>HIV<\/scp>: Results from the compassionate use programme at <scp>INMI<\/scp> Spallanzani in Rome, Italy"],"prefix":"10.1111","volume":"24","author":[{"ORCID":"https:\/\/orcid.org\/0000-0003-0460-8024","authenticated-orcid":false,"given":"Ubaldo","family":"Visco Comandini","sequence":"first","affiliation":[{"name":"Infectious Diseases and Hepatology Unit, National Institute for Infectious Diseases Lazzaro Spallanzani IRCCS  Rome Italy"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Emanuela","family":"De Santis","sequence":"additional","affiliation":[{"name":"Department of Translational and Precision Medicine Sapienza University of Rome  Rome Italy"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Francesco","family":"De Maria","sequence":"additional","affiliation":[{"name":"Infectious Diseases and Hepatology Unit, National Institute for Infectious Diseases Lazzaro Spallanzani IRCCS  Rome Italy"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0003-2827-4591","authenticated-orcid":false,"given":"Raffaella","family":"Lionetti","sequence":"additional","affiliation":[{"name":"Infectious Diseases and Hepatology Unit, National Institute for Infectious Diseases Lazzaro Spallanzani IRCCS  Rome Italy"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Chiara","family":"Taibi","sequence":"additional","affiliation":[{"name":"Infectious Diseases and Hepatology Unit, National Institute for Infectious Diseases Lazzaro Spallanzani IRCCS  Rome Italy"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Marzia","family":"Montalbano","sequence":"additional","affiliation":[{"name":"Infectious Diseases and Hepatology Unit, National Institute for Infectious Diseases Lazzaro Spallanzani IRCCS  Rome Italy"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Alessia","family":"Rianda","sequence":"additional","affiliation":[{"name":"Infectious Diseases and Hepatology Unit, National Institute for Infectious Diseases Lazzaro Spallanzani IRCCS  Rome Italy"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Paola","family":"Piccolo","sequence":"additional","affiliation":[{"name":"Internal Medicine Unit, Fatebenefratelli Isola Tiberina Hospital\u2013Gemelli Isola  Rome Italy"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Chiara","family":"De Ponte","sequence":"additional","affiliation":[{"name":"Pharmacy Unit, National Institute for Infectious Diseases Lazzaro Spallanzani IRCCS  Rome Italy"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Stefania","family":"Mazzotta","sequence":"additional","affiliation":[{"name":"Pharmacy Unit, National Institute for Infectious Diseases Lazzaro Spallanzani IRCCS  Rome Italy"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0003-2097-9116","authenticated-orcid":false,"given":"Alessandro","family":"Caioli","sequence":"additional","affiliation":[{"name":"Infectious Diseases and Hepatology Unit, National Institute for Infectious Diseases Lazzaro Spallanzani IRCCS  Rome Italy"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Anna Rosa","family":"Garbuglia","sequence":"additional","affiliation":[{"name":"Virology Unit, National Institute for Infectious Diseases Lazzaro Spallanzani IRCCS  Rome Italy"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Fabrizio","family":"Maggi","sequence":"additional","affiliation":[{"name":"Virology Unit, National Institute for Infectious Diseases Lazzaro Spallanzani IRCCS  Rome Italy"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Gianpiero","family":"D'Offizi","sequence":"additional","affiliation":[{"name":"Infectious Diseases and Hepatology Unit, National Institute for Infectious Diseases Lazzaro Spallanzani IRCCS  Rome Italy"}],"role":[{"vocabulary":"crossref","role":"author"}]}],"member":"311","published-online":{"date-parts":[[2023,6,7]]},"reference":[{"key":"e_1_2_10_2_1","doi-asserted-by":"publisher","DOI":"10.1016\/j.jhep.2020.04.008"},{"key":"e_1_2_10_3_1","doi-asserted-by":"publisher","DOI":"10.1016\/j.dld.2013.11.006"},{"key":"e_1_2_10_4_1","doi-asserted-by":"publisher","DOI":"10.1007\/s00103\u2010022\u201003486\u20102"},{"key":"e_1_2_10_5_1","doi-asserted-by":"publisher","DOI":"10.1016\/S1473\u20103099(22)00318\u20108"},{"key":"e_1_2_10_6_1","first-page":"13","article-title":"Safety and efficacy of 2mg bulevirtide in patients with chronic hbv\/hdv co\u2010infection. 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