{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,4,18]],"date-time":"2026-04-18T06:54:06Z","timestamp":1776495246011,"version":"3.51.2"},"reference-count":54,"publisher":"MDPI AG","issue":"2","license":[{"start":{"date-parts":[[2026,2,10]],"date-time":"2026-02-10T00:00:00Z","timestamp":1770681600000},"content-version":"vor","delay-in-days":0,"URL":"https:\/\/creativecommons.org\/licenses\/by\/4.0\/"}],"funder":[{"DOI":"10.13039\/501100003196","name":"Ministero della Salute","doi-asserted-by":"crossref","id":[{"id":"10.13039\/501100003196","id-type":"DOI","asserted-by":"crossref"}]}],"content-domain":{"domain":[],"crossmark-restriction":false},"short-container-title":["Pathogens"],"abstract":"<jats:p>Chronic hepatitis delta is the most severe form of viral hepatitis and is associated with rapid progression to cirrhosis and hepatocellular carcinoma. Although bulevirtide (BLV) effectively inhibits hepatitis D virus (HDV) entry, immunological biomarkers reflecting treatment response and residual viral activity remain poorly defined. This study investigated the serum profiles of interleukin-37 (IL-37) and IL-36 isoforms (IL-36\u03b1, IL-36\u03b2, and IL-36\u03b3) in 22 HBV\/HDV-coinfected patients receiving BLV monotherapy (2 mg\/day). Serum cytokine levels were measured by ELISA at baseline (BL) and after 48 weeks of BLV treatment (TW48) and compared with HBV-monoinfected patients under nucleos(t)ide-analogue therapy and healthy donors. Patients were stratified according to virological, biochemical, and combined responses. At both BL and TW48, serum IL-37, IL-36\u03b1, and IL-36\u03b2 levels were significantly higher in HBV\/HDV-coinfected patients than in comparison groups (all p &lt; 0.05), independent of treatment response, indicating a persistent cytokine signature during BLV therapy. IL-36\u03b2 levels significantly decreased over time, particularly in biochemical non-responders (p = 0.0469), whereas IL-36\u03b1 remained elevated and differed at TW48 between combined responders and non-responders (p = 0.0400). IL-36\u03b3 was detectable only in a small subset of patients. Notably, in a subgroup of patients evaluated at week 96, baseline IL-37 levels were significantly lower in those achieving virological response compared with non-responders (p = 0.0275). Moreover, IL-37 was the only cytokine showing a significant positive correlation with HDV RNA levels at TW48 when quantified by the AltoStar\u00ae assay (p = 0.033; R2 = 0.7563). Overall, HBV\/HDV-coinfected patients display a distinct IL-37\/IL-36 cytokine profile during BLV therapy. The association between IL-37 and residual viremia supports further investigation of this cytokine as a complementary biomarker for monitoring low-level viral activity during treatment.<\/jats:p>","DOI":"10.3390\/pathogens15020198","type":"journal-article","created":{"date-parts":[[2026,2,10]],"date-time":"2026-02-10T15:23:14Z","timestamp":1770736994000},"page":"198","update-policy":"https:\/\/doi.org\/10.3390\/mdpi_crossmark_policy","source":"Crossref","is-referenced-by-count":1,"title":["IL-37 and IL-36 Cytokine Profiles in Chronic Hepatitis Delta During Bulevirtide Therapy"],"prefix":"10.3390","volume":"15","author":[{"ORCID":"https:\/\/orcid.org\/0009-0005-8996-4803","authenticated-orcid":false,"given":"Verdiana","family":"Zulian","sequence":"first","affiliation":[{"name":"Virology Laboratory, National Institute for Infectious Diseases Lazzaro Spallanzani IRCCS, 00149 Rome, Italy"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"ORCID":"https:\/\/orcid.org\/0009-0009-2628-6880","authenticated-orcid":false,"given":"Martina","family":"De Sanctis","sequence":"additional","affiliation":[{"name":"Virology Laboratory, National Institute for Infectious Diseases Lazzaro Spallanzani IRCCS, 00149 Rome, Italy"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"ORCID":"https:\/\/orcid.org\/0009-0009-7188-7132","authenticated-orcid":false,"given":"Silvia","family":"Pauciullo","sequence":"additional","affiliation":[{"name":"Virology Laboratory, National Institute for Infectious Diseases Lazzaro Spallanzani IRCCS, 00149 Rome, Italy"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Roberta","family":"Sciamanna","sequence":"additional","affiliation":[{"name":"Virology Laboratory, National Institute for Infectious Diseases Lazzaro Spallanzani IRCCS, 00149 Rome, Italy"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"ORCID":"https:\/\/orcid.org\/0000-0002-2659-0868","authenticated-orcid":false,"given":"Eleonora","family":"Cimini","sequence":"additional","affiliation":[{"name":"Laboratory of Cellular Immunology and Pharmacology, National Institute for Infectious Diseases Lazzaro Spallanzani IRCCS, 00149 Rome, Italy"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Paola","family":"Del Porto","sequence":"additional","affiliation":[{"name":"Department of Biology and Biotechnology \u201cCharles Darwin\u201d, Sapienza University of Rome, 00100 Rome, Italy"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"ORCID":"https:\/\/orcid.org\/0000-0002-2687-8642","authenticated-orcid":false,"given":"Anna Rosa","family":"Garbuglia","sequence":"additional","affiliation":[{"name":"Virology Laboratory, National Institute for Infectious Diseases Lazzaro Spallanzani IRCCS, 00149 Rome, Italy"}],"role":[{"role":"author","vocabulary":"crossref"}]}],"member":"1968","published-online":{"date-parts":[[2026,2,10]]},"reference":[{"key":"ref_1","doi-asserted-by":"crossref","first-page":"100818","DOI":"10.1016\/j.jhepr.2023.100818","article-title":"Delta Cure 2022 Working Group Hepatitis D Virus Infection: Pathophysiology, Epidemiology and Treatment. 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