{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,9,26]],"date-time":"2026-09-26T04:59:23Z","timestamp":1790398763469,"version":"4.1.0"},"reference-count":18,"publisher":"Ovid Technologies (Wolters Kluwer Health)","issue":"4","license":[{"start":{"date-parts":[[2021,9,14]],"date-time":"2021-09-14T00:00:00Z","timestamp":1631577600000},"content-version":"vor","delay-in-days":0,"URL":"http:\/\/onlinelibrary.wiley.com\/termsAndConditions#vor"},{"start":{"date-parts":[[2021,9,14]],"date-time":"2021-09-14T00:00:00Z","timestamp":1631577600000},"content-version":"tdm","delay-in-days":0,"URL":"http:\/\/doi.wiley.com\/10.1002\/tdm_license_1.1"}],"content-domain":{"domain":["lww.com","ovid.com"],"crossmark-restriction":true},"short-container-title":["Hepatology"],"published-print":{"date-parts":[[2021,10]]},"abstract":"<jats:sec>\n            <jats:title>Background and Aims<\/jats:title>\n            <jats:p>In patients with chronic hepatitis B (CHB) infection, activation of toll\u2010like receptor 8 may induce antiviral immunity and drive functional cure. Selgantolimod, a toll\u2010like receptor 8 agonist, was evaluated in patients with CHB who were virally suppressed on oral antiviral treatment or viremic and not on oral antiviral treatment.<\/jats:p>\n          <\/jats:sec>\n          <jats:sec>\n            <jats:title>Approach and Results<\/jats:title>\n            <jats:p>In this phase\u00a01b study, patients were randomized 4:1 to receive either selgantolimod or placebo once weekly. Virally suppressed patients received either 1.5\u00a0mg (for 2\u00a0weeks) or 3\u00a0mg (for 2\u00a0weeks or 4\u00a0weeks). Viremic patients received 3\u00a0mg for 2\u00a0weeks. The primary endpoint was safety, as assessed by adverse events (AEs), laboratory abnormalities, and vital sign examination. Pharmacokinetic and pharmacodynamic parameters were assessed by plasma analysis. A total of 38 patients (28 virally suppressed, 10 viremic) were enrolled from six sites in Australia, New Zealand, and South Korea. Twenty patients (53%) experienced an AE and 32 (84%) had laboratory abnormalities, all of which were mild or moderate in severity. The most common AEs were headache (32%), nausea (24%), and dizziness (13%). With a half\u2010life of 5\u00a0hours, no accumulation of selgantolimod was observed with multiple dosing. Selgantolimod induced transient dose\u2010dependent increases in serum cytokines, including IL\u201012p40 and IL\u20101RA, which are important for the expansion and activity of multiple T\u2010 cell subsets and innate immunity.<\/jats:p>\n          <\/jats:sec>\n          <jats:sec>\n            <jats:title>Conclusion<\/jats:title>\n            <jats:p>Selgantolimod was safe and well\u2010tolerated in virally suppressed and viremic patients with CHB and elicited cytokine responses consistent with target engagement. Further studies with longer durations of selgantolimod treatment are required to evaluate efficacy.<\/jats:p>\n          <\/jats:sec>","DOI":"10.1002\/hep.31795","type":"journal-article","created":{"date-parts":[[2021,3,11]],"date-time":"2021-03-11T07:15:56Z","timestamp":1615446956000},"page":"1737-1749","update-policy":"https:\/\/doi.org\/10.1097\/lww.0000000000001000","source":"Crossref","is-referenced-by-count":38,"title":["Safety, Pharmacokinetics, and Pharmacodynamics of the Oral TLR8 Agonist Selgantolimod in Chronic Hepatitis B"],"prefix":"10.1097","volume":"74","author":[{"given":"Edward J.","family":"Gane","sequence":"first","affiliation":[{"name":"New Zealand Liver Transplant Unit,Auckland City Hospital,Auckland,New Zealand"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Hyung Joon","family":"Kim","sequence":"additional","affiliation":[{"name":"Chung\u2010Ang University Hospital,Seoul,South 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