{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,9,16]],"date-time":"2026-09-16T06:48:16Z","timestamp":1789541296839,"version":"build-2803163510"},"reference-count":22,"publisher":"Ovid Technologies (Wolters Kluwer Health)","issue":"3","license":[{"start":{"date-parts":[[2002,3,1]],"date-time":"2002-03-01T00:00:00Z","timestamp":1014940800000},"content-version":"tdm","delay-in-days":0,"URL":"http:\/\/doi.wiley.com\/10.1002\/tdm_license_1.1"},{"start":{"date-parts":[[2003,12,30]],"date-time":"2003-12-30T00:00:00Z","timestamp":1072742400000},"content-version":"vor","delay-in-days":669,"URL":"http:\/\/onlinelibrary.wiley.com\/termsAndConditions#vor"}],"content-domain":{"domain":["lww.com","ovid.com"],"crossmark-restriction":true},"short-container-title":[],"published-print":{"date-parts":[[2002,3]]},"abstract":"<jats:sec>\n            <jats:title\/>\n            <jats:p>Treatment of chronic hepatitis B virus (HBV) infection with interferon alfa and lamivudine is characterized by lack of viral clearance, loss of response, or emergence of drug-resistant mutants. Thus, new and multiple drug approaches are needed. We have developed two fully human monoclonal antibodies, directed against different epitopes of hepatitis B surface antigen (HBsAg) that bind to all major HBV subtypes. A phase I clinical study was conducted to evaluate the safety, tolerability, and efficacy of a mixture of these two monoclonal antibodies, HBV-AB<jats:sup>XTL<\/jats:sup>. A total of 27 chronic HBV patients were enrolled. In part A of the study 15 patients in 5 cohorts received a single intravenous infusion of antibodies with doses ranging from 0.26 mg (260 IU) to 40 mg (40,000 IU). All patients completed 16 weeks of follow-up. In the second part of the study (part B), 12 patients in 4 cohorts received 4 weekly infusions of 10, 20, 40, or 80 mg each of HBV-AB<jats:sup>XTL<\/jats:sup> and were followed for 4 additional weeks. Administration of antibodies was well tolerated. Patients administered doses at an Ab:Ag molar ratio of 1:2 to 1:20 showed a rapid and significant decrease in HBsAg to undetectable levels, with a corresponding reduction of HBV-DNA levels. In part B, HBV-AB<jats:sup>XTL<\/jats:sup> induced a significant reduction in both HBsAg and HBV-DNA levels repeatedly after administration. In conclusion, these data suggest that HBV-AB<jats:sup>XTL<\/jats:sup> binds HBV particles and reduces serum viral titers and HBsAg levels. HBV-AB<jats:sup>XTL<\/jats:sup> could be combined with other monotherapies that are currently used to treat HBV carriers. (Hepatology 2002;35:673-679.)<\/jats:p>\n          <\/jats:sec>","DOI":"10.1053\/jhep.2002.31867","type":"journal-article","created":{"date-parts":[[2002,8,25]],"date-time":"2002-08-25T03:46:10Z","timestamp":1030247170000},"page":"673-679","update-policy":"https:\/\/doi.org\/10.1097\/lww.0000000000001000","source":"Crossref","is-referenced-by-count":73,"title":["Clinical evaluation (phase I) of a combination of two human monoclonal antibodies to HBV: Safety and antiviral properties"],"prefix":"10.1097","volume":"35","author":[{"given":"Eithan","family":"Galun","sequence":"first","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Rachel","family":"Eren","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Rifaat","family":"Safadi","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Yaffa","family":"Ashour","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Norah","family":"Terrault","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Emmet B.","family":"Keeffe","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Edith","family":"Matot","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Sara","family":"Mizrachi","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Dov","family":"Terkieltaub","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Merav","family":"Zohar","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Ido","family":"Lubin","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Judith","family":"Gopher","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Daniel","family":"Shouval","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Shlomo","family":"Dagan","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]}],"member":"276","reference":[{"key":"10.1053\/jhep.2002.31867-BIB1|cit1","doi-asserted-by":"crossref","first-page":"696","DOI":"10.1016\/S0140-6736(05)65598-5","article-title":"Global status of hepatitis B immunisation","volume":"348","author":"Kane","year":"1996","journal-title":"Lancet"},{"key":"10.1053\/jhep.2002.31867-BIB2|cit2","doi-asserted-by":"crossref","first-page":"745","DOI":"10.1056\/NEJM199903113401001","article-title":"Rising incidence of hepatocellular carcinoma in the United States","volume":"340","author":"El-Serag","year":"1999","journal-title":"N Engl J Med"},{"key":"10.1053\/jhep.2002.31867-BIB3|cit3","doi-asserted-by":"crossref","first-page":"312","DOI":"10.7326\/0003-4819-119-4-199308150-00011","article-title":"Effect of alpha-interferon treatment in patients with hepatitis B e antigen-positive chronic hepatitis B. 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