{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,5,16]],"date-time":"2026-05-16T14:02:05Z","timestamp":1778940125906,"version":"3.51.4"},"reference-count":10,"publisher":"Wiley","issue":"1","license":[{"start":{"date-parts":[[2022,9,12]],"date-time":"2022-09-12T00:00:00Z","timestamp":1662940800000},"content-version":"vor","delay-in-days":0,"URL":"http:\/\/creativecommons.org\/licenses\/by-nc-nd\/4.0\/"},{"start":{"date-parts":[[2022,9,12]],"date-time":"2022-09-12T00:00:00Z","timestamp":1662940800000},"content-version":"tdm","delay-in-days":0,"URL":"http:\/\/doi.wiley.com\/10.1002\/tdm_license_1.1"}],"funder":[{"DOI":"10.13039\/100005564","name":"Gilead Sciences","doi-asserted-by":"publisher","id":[{"id":"10.13039\/100005564","id-type":"DOI","asserted-by":"publisher"}]}],"content-domain":{"domain":["onlinelibrary.wiley.com"],"crossmark-restriction":true},"short-container-title":["Journal of Medical Virology"],"published-print":{"date-parts":[[2023,1]]},"abstract":"<jats:title>Abstract<\/jats:title>\n                  <jats:p>\n                    Retrospective data showed that when we administered ledipasvir\/sofosbuvir (LDV\/SOF) to patients with hepatitis B and C coinfection, there was a modest reduction in hepatitis B surface antigen (HBsAg). Therefore, we hypothesize that similar HBsAg reduction can be seen in hepatitis B virus\u00a0(HBV) monoinfected subjects. Primary and secondary efficacy endpoints are the decline in HBsAg and HBV DNA at Week 12 from baseline, respectively. We conducted an open\u2010label Phase 2 pilot study to evaluate the safety, tolerability, and antiviral activity of LDV\u00a0and\/or SOF\u00a0for HBV. Eligible subjects were either suppressed on antivirals (Group B) or inactive chronic HBV (Group A, C, D). Group A and B received LDV\/SOF. Group C and D received SOF\u00a0400\u2009mg and LDV 90\u2009mg, respectively. All subjects completed the study, and all related adverse events (AEs) were mild. No discontinuations due to AEs\u00a0or hepatitis flare occurred. At Week 12, HBsAg decline (log\n                    <jats:sub>10<\/jats:sub>\n                    IU\/ml) was similar between Group A (0.399) and B (0.400), less in Group C (0.207), and none in Group D, and there was HBV DNA decline in the inactive chronic HBV groups. LDV\u00a0and SOF\u00a0are safe and well tolerated when given to chronic hepatitis B subjects and have modest antiviral activity, particularly when given in combination.\n                  <\/jats:p>","DOI":"10.1002\/jmv.28105","type":"journal-article","created":{"date-parts":[[2022,9,1]],"date-time":"2022-09-01T00:09:50Z","timestamp":1661990990000},"update-policy":"https:\/\/doi.org\/10.1002\/crossmark_policy","source":"Crossref","is-referenced-by-count":3,"title":["A Phase 2 open label study of ledipasvir\/sofosbuvir for 12 weeks in subjects with hepatitis B virus infection"],"prefix":"10.1002","volume":"95","author":[{"given":"Angie S.","family":"Price","sequence":"first","affiliation":[{"name":"Institute of Human Virology University of Maryland School of Medicine Baltimore Maryland USA"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Amy K.","family":"Nelson","sequence":"additional","affiliation":[{"name":"Institute of Human Virology University of Maryland School of Medicine Baltimore Maryland USA"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Alip","family":"Ghosh","sequence":"additional","affiliation":[{"name":"Institute of Human Virology University of Maryland School of Medicine Baltimore Maryland USA"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Shyamasundaran","family":"Kottilil","sequence":"additional","affiliation":[{"name":"Institute of Human Virology University of Maryland School of Medicine Baltimore Maryland USA"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"ORCID":"https:\/\/orcid.org\/0000-0002-7579-4672","authenticated-orcid":false,"given":"Joel V.","family":"Chua","sequence":"additional","affiliation":[{"name":"Institute of Human Virology University of Maryland School of Medicine Baltimore Maryland USA"}],"role":[{"role":"author","vocabulary":"crossref"}]}],"member":"311","published-online":{"date-parts":[[2022,9,12]]},"reference":[{"key":"e_1_2_10_2_1","unstructured":"World Health Organization. Hepatitis B. Published June 24 2022. Accessed September 6 2022.https:\/\/www.who.int\/news-room\/fact-sheets\/detail\/hepatitis-b"},{"key":"e_1_2_10_3_1","doi-asserted-by":"publisher","DOI":"10.1002\/hep.23190"},{"key":"e_1_2_10_4_1","doi-asserted-by":"publisher","DOI":"10.1016\/j.gcb.2009.03.002"},{"key":"e_1_2_10_5_1","doi-asserted-by":"publisher","DOI":"10.1053\/j.gastro.2008.07.008"},{"key":"e_1_2_10_6_1","doi-asserted-by":"publisher","DOI":"10.1002\/hep.28156"},{"key":"e_1_2_10_7_1","doi-asserted-by":"publisher","DOI":"10.1038\/nrgastro.2011.33"},{"key":"e_1_2_10_8_1","doi-asserted-by":"publisher","DOI":"10.1093\/cid\/ciab971"},{"key":"e_1_2_10_9_1","doi-asserted-by":"publisher","DOI":"10.1016\/j.jcv.2017.05.021"},{"key":"e_1_2_10_10_1","unstructured":"National Institutes of Health National Cancer Institute. Common Terminology Criteria for Adverse Events (CTCAE) version 4.0. Published May 29 2009. Accessed October 10 2017.https:\/\/evs.nci.nih.gov\/ftp1\/CTCAE\/CTCAE_4.03\/Archive\/CTCAE_4.0_2009-05-29_QuickReference_8.5x11.pdf"},{"key":"e_1_2_10_11_1","doi-asserted-by":"publisher","DOI":"10.1371\/journal.ppat.1003030"}],"container-title":["Journal of Medical Virology"],"original-title":[],"language":"en","link":[{"URL":"https:\/\/onlinelibrary.wiley.com\/doi\/pdf\/10.1002\/jmv.28105","content-type":"application\/pdf","content-version":"vor","intended-application":"text-mining"},{"URL":"https:\/\/onlinelibrary.wiley.com\/doi\/full-xml\/10.1002\/jmv.28105","content-type":"application\/xml","content-version":"vor","intended-application":"text-mining"},{"URL":"https:\/\/onlinelibrary.wiley.com\/doi\/pdf\/10.1002\/jmv.28105","content-type":"unspecified","content-version":"vor","intended-application":"similarity-checking"}],"deposited":{"date-parts":[[2026,3,8]],"date-time":"2026-03-08T08:41:56Z","timestamp":1772959316000},"score":1,"resource":{"primary":{"URL":"https:\/\/onlinelibrary.wiley.com\/doi\/10.1002\/jmv.28105"}},"subtitle":[],"short-title":[],"issued":{"date-parts":[[2022,9,12]]},"references-count":10,"journal-issue":{"issue":"1","published-print":{"date-parts":[[2023,1]]}},"alternative-id":["10.1002\/jmv.28105"],"URL":"https:\/\/doi.org\/10.1002\/jmv.28105","archive":["Portico"],"relation":{},"ISSN":["0146-6615","1096-9071"],"issn-type":[{"value":"0146-6615","type":"print"},{"value":"1096-9071","type":"electronic"}],"subject":[],"published":{"date-parts":[[2022,9,12]]},"assertion":[{"value":"2022-06-10","order":0,"name":"received","label":"Received","group":{"name":"publication_history","label":"Publication History"}},{"value":"2022-08-27","order":2,"name":"accepted","label":"Accepted","group":{"name":"publication_history","label":"Publication History"}},{"value":"2022-09-12","order":3,"name":"published","label":"Published","group":{"name":"publication_history","label":"Publication History"}}],"article-number":"e28105"}}