{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,8,23]],"date-time":"2026-08-23T14:45:25Z","timestamp":1787496325061,"version":"build-2736575974"},"reference-count":28,"publisher":"Wiley","issue":"3","license":[{"start":{"date-parts":[[2023,1,12]],"date-time":"2023-01-12T00:00:00Z","timestamp":1673481600000},"content-version":"vor","delay-in-days":0,"URL":"http:\/\/creativecommons.org\/licenses\/by-nc-nd\/4.0\/"}],"content-domain":{"domain":["onlinelibrary.wiley.com"],"crossmark-restriction":true},"short-container-title":["Journal of Viral Hepatitis"],"published-print":{"date-parts":[[2023,3]]},"abstract":"<jats:title>Abstract<\/jats:title>\n                  <jats:p>\n                    Treatment for chronic hepatitis B virus infection (cHBV) is mostly indefinite, with new finite\u2010duration therapies needed. We report safety, pharmacokinetics and antiviral activity of the investigational HBV core inhibitor ABI\u2010H2158. This Phase 1a\/b study (NCT03714152) had three parts: Part A, participants received a single ascending oral dose of ABI\u2010H2158 (5\u2013500\u2009mg) or placebo; Part B, participants received multiple doses of ABI\u2010H2158 300\u2009mg once (QD) or twice (BID) daily or placebo, for 10\u2009days; Part C, cHBV patients received ABI\u2010H2158 (100, 300, or 500\u2009mg QD or 300\u2009mg BID) or placebo, for 14\u2009days. Ninety\u2010three participants enrolled. In Parts A\/B, there were no serious adverse events (SAEs) or deaths, and all treatment\u2010emergent AEs (TEAEs) were Grade 1. In Part C, two patients had Grade 3 TEAEs unrelated to ABI\u2010H2158; there were no deaths, SAEs or Grade 4 TEAEs. In Part A, median time to maximum ABI\u2010H2158 plasma concentration (\n                    <jats:italic>T<\/jats:italic>\n                    <jats:sub>max<\/jats:sub>\n                    ) and mean terminal elimination half\u2010life (\n                    <jats:italic>t<\/jats:italic>\n                    <jats:sub>\u00bd<\/jats:sub>\n                    ) were 1\u20134 and 9.8\u201320.7\u00a0h, and area under the plasma concentration\u2010time curve increased dose proportionally. In Part B, Day 10\n                    <jats:italic>T<\/jats:italic>\n                    <jats:sub>max<\/jats:sub>\n                    was 2\u00a0h, mean\n                    <jats:italic>t<\/jats:italic>\n                    <jats:sub>\u00bd<\/jats:sub>\n                    was 15.5\u201318.4\u00a0h, and exposure accumulated 1.7\u2010 to 3.1\u2010fold. In Part C, Day 14\n                    <jats:italic>T<\/jats:italic>\n                    <jats:sub>max<\/jats:sub>\n                    was 1\u00a0h, exposure accumulated 1.4\u2010 to 1.8\u2010fold, and ABI\u2010H2158 was associated with &gt;2 log\n                    <jats:sub>10<\/jats:sub>\n                    declines in HBV nucleic acids. In conclusion, ABI\u2010H2158 in cHBV patients following 14\u2009days of dosing was well tolerated and demonstrated potent antiviral activity. Safety and pharmacokinetics supported future QD dosing.\n                  <\/jats:p>","DOI":"10.1111\/jvh.13764","type":"journal-article","created":{"date-parts":[[2022,10,27]],"date-time":"2022-10-27T14:39:15Z","timestamp":1666881555000},"page":"209-222","update-policy":"https:\/\/doi.org\/10.1002\/crossmark_policy","source":"Crossref","is-referenced-by-count":6,"title":["Safety, pharmacokinetics and antiviral activity of\n                    <scp>ABI\u2010H2158<\/scp>\n                    , a hepatitis B virus core inhibitor: A randomized, placebo\u2010controlled phase 1 study"],"prefix":"10.1111","volume":"30","author":[{"ORCID":"https:\/\/orcid.org\/0000-0002-4754-828X","authenticated-orcid":false,"given":"Kosh","family":"Agarwal","sequence":"first","affiliation":[{"name":"Institute of Liver Studies King's College Hospital  London UK"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Jia","family":"Xu","sequence":"additional","affiliation":[{"name":"Phase 1 Clinical Trials Unit The First Hospital of Jilin University  Jilin China"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0003-4086-7955","authenticated-orcid":false,"given":"Edward J.","family":"Gane","sequence":"additional","affiliation":[{"name":"University of Auckland  Auckland New Zealand"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Tuan T.","family":"Nguyen","sequence":"additional","affiliation":[{"name":"T Nguyen Research and Education, Inc.  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