{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2025,10,12]],"date-time":"2025-10-12T11:08:38Z","timestamp":1760267318167},"reference-count":29,"publisher":"Wiley","issue":"8","license":[{"start":{"date-parts":[[2014,11,21]],"date-time":"2014-11-21T00:00:00Z","timestamp":1416528000000},"content-version":"vor","delay-in-days":0,"URL":"http:\/\/onlinelibrary.wiley.com\/termsAndConditions#vor"}],"funder":[{"name":"NasVax Ltd, Ness-Ziona Israel"},{"name":"Roman-Epstein Liver Research Foundation"}],"content-domain":{"domain":[],"crossmark-restriction":false},"short-container-title":["Journal of Viral Hepatitis"],"published-print":{"date-parts":[[2015,8]]},"abstract":"<jats:title>Summary<\/jats:title><jats:p>Orally administered anti\u2010<jats:styled-content style=\"fixed-case\">CD<\/jats:styled-content>3 antibodies are biologically active in the gut through induction of regulatory T cells, exert an immune\u2010modulatory effect, and alleviate insulin resistance and liver damage in patients with <jats:styled-content style=\"fixed-case\">NASH<\/jats:styled-content>. Aims: To determine the safety of oral anti\u2010<jats:styled-content style=\"fixed-case\">CD<\/jats:styled-content>3 monoclonal antibody (<jats:styled-content style=\"fixed-case\">MA<\/jats:styled-content>b) immunotherapy in chronic <jats:styled-content style=\"fixed-case\">HCV<\/jats:styled-content> patients with associated immune dysfunction. Methods: Four groups (<jats:italic>n<\/jats:italic>\u00a0=\u00a09) of chronic <jats:styled-content style=\"fixed-case\">HCV<\/jats:styled-content> patients who were nonresponders to interferon plus ribavirin therapy received oral placebo (group A) or anti\u2010<jats:styled-content style=\"fixed-case\">CD<\/jats:styled-content>3 <jats:styled-content style=\"fixed-case\">MA<\/jats:styled-content>b at one of three dosage levels for 30\u00a0days. Patients were followed for safety parameters and serum levels of liver enzymes, virus, cytokines and regulatory T cells. Results: Oral anti\u2010<jats:styled-content style=\"fixed-case\">CD<\/jats:styled-content>3 immunotherapy was safe and well tolerated; no treatment\u2010related adverse events were noted. The following improvements were noted relative to pretreatment levels: <jats:styled-content style=\"fixed-case\">HCV<\/jats:styled-content> viral load and <jats:styled-content style=\"fixed-case\">AST<\/jats:styled-content> and <jats:styled-content style=\"fixed-case\">ALT<\/jats:styled-content> levels decreased in the low\u2010 and high\u2010dose groups following 30\u00a0days of therapy. In two of the treated groups, an increase in regulatory T cells (<jats:styled-content style=\"fixed-case\">CD<\/jats:styled-content>4<jats:sup>+<\/jats:sup> <jats:styled-content style=\"fixed-case\">CD<\/jats:styled-content>25<jats:sup>+<\/jats:sup>) was noted. The positive effects were somewhat more apparent in subjects with initially elevated liver enzyme levels. Conclusions: Oral anti\u2010<jats:styled-content style=\"fixed-case\">CD<\/jats:styled-content>3 <jats:styled-content style=\"fixed-case\">MA<\/jats:styled-content>b immunotherapy for nonresponder <jats:styled-content style=\"fixed-case\">HCV<\/jats:styled-content> patients was safe and well tolerated. Trends and statistically significant improvements were observed as reductions in viral load and liver enzyme levels, along with an increase in regulatory T\u2010cell levels. These data support a role for the immune system in the pathogenesis of <jats:styled-content style=\"fixed-case\">HCV<\/jats:styled-content> infection and suggest that this immunotherapy is worthy of evaluation in combination with <jats:styled-content style=\"fixed-case\">HCV<\/jats:styled-content> antiviral drugs.<\/jats:p>","DOI":"10.1111\/jvh.12369","type":"journal-article","created":{"date-parts":[[2014,11,21]],"date-time":"2014-11-21T09:00:10Z","timestamp":1416560410000},"page":"651-657","source":"Crossref","is-referenced-by-count":26,"title":["Oral anti\u2010<scp>CD<\/scp>3 immunotherapy for <scp>HCV<\/scp>\u2010nonresponders is safe, promotes regulatory <scp>T<\/scp> cells and decreases viral load and liver enzyme levels: results of a phase\u20102a placebo\u2010controlled trial"],"prefix":"10.1111","volume":"22","author":[{"given":"W.","family":"Halota","sequence":"first","affiliation":[{"name":"Department of Infectious Diseases and Hepatology Collegium Medicum Nicolaus Copernicus University Bydgoszcz Poland"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"P.","family":"Ferenci","sequence":"additional","affiliation":[{"name":"University Hospital Vienna Austria"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"D.","family":"Kozielewicz","sequence":"additional","affiliation":[{"name":"Department of Infectious Diseases and Hepatology Collegium Medicum Nicolaus Copernicus University Bydgoszcz Poland"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"D.","family":"Dybowska","sequence":"additional","affiliation":[{"name":"Department of Infectious Diseases and Hepatology Collegium Medicum Nicolaus Copernicus University Bydgoszcz Poland"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"N.","family":"Lisovoder","sequence":"additional","affiliation":[{"name":"NasVax Ltd Ness\u2010Ziona Israel"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"S.","family":"Samira","sequence":"additional","affiliation":[{"name":"NasVax Ltd Ness\u2010Ziona Israel"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"I.","family":"Shalit","sequence":"additional","affiliation":[{"name":"NasVax Ltd Ness\u2010Ziona Israel"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"R.","family":"Ellis","sequence":"additional","affiliation":[{"name":"NasVax Ltd Ness\u2010Ziona Israel"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Y.","family":"Ilan","sequence":"additional","affiliation":[{"name":"Liver Unit Department of Medicine Hadassah\u2010Hebrew University Medical Center Jerusalem 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