{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,10,23]],"date-time":"2026-10-23T12:00:42Z","timestamp":1792756842176,"version":"4.5.0"},"reference-count":33,"publisher":"Wiley","issue":"11","license":[{"start":{"date-parts":[[2022,7,19]],"date-time":"2022-07-19T00:00:00Z","timestamp":1658188800000},"content-version":"vor","delay-in-days":0,"URL":"http:\/\/onlinelibrary.wiley.com\/termsAndConditions#vor"}],"content-domain":{"domain":["onlinelibrary.wiley.com"],"crossmark-restriction":true},"short-container-title":["Journal of Medical Virology"],"published-print":{"date-parts":[[2022,11]]},"abstract":"<jats:title>Abstract<\/jats:title><jats:sec><jats:label\/><jats:p>Hepatitis B surface antigen (HBsAg) loss or seroconversion is an ideal treatment endpoint for patients with chronic hepatitis B but is rarely achievable in\u00a0\u00a0hepatitis B e\u2010antigen\u00a0(HBeAg)\u2010positive patients using existing treatment strategies. In this study, the effect of pegylated interferon (peg\u2010IFN) alfa\u20102b plus tenofovir disoproxil fumarate (TDF), granulocyte\u2010macrophage colony\u2010stimulating factor (GM\u2010CSF), and hepatitis B vaccine was evaluated.\u00a0This randomized controlled trial was conducted at nine liver centers in Chinese university hospitals from May 2018 to July 2020. Patients (<jats:italic>n\u2009<\/jats:italic>=\u2009303) enrolled were randomly administered peg\u2010IFN\u2010\u03b1\u20102b combined with TDF, GM\u2010CSF, and hepatitis B vaccine (experimental group); peg\u2010IFN\u2010\u03b1\u20102b plus TDF (control group 2); or interferon\u2010\u03b1\u20102b alone (control group 1). The primary efficacy endpoint was HBsAg seroconversion at 48 weeks and the secondary endpoint included safety.\u00a0No differences in baseline HBsAg levels were observed among the groups. The primary endpoint was achieved in three (3.0%), one (1.03%), and one (1.19%) patient in the experimental group, control group 2, and control group 1, respectively. The incidence of HBsAg seroconversion at week 48 was not significantly different among the three groups (<jats:italic>p\u2009<\/jats:italic>=\u20090.629). However, the decrease in serum levels of HBsAg at week 48 was significantly higher in the experimental and control group 2 compared with that in control group 1 (<jats:italic>p\u2009<\/jats:italic>=\u20090.008 and 0.006, respectively). No significant difference between the experimental and control group 2 was observed (<jats:italic>p\u2009<\/jats:italic>=\u20090.619). Adverse events were not significantly different among the groups except for the lower incidence of neutropenia in the experimental group.\u00a0Peg\u2010IFN\u2010\u03b1\u20102b combined with TDF, GM\u2010CSF, and hepatitis B vaccine is not superior to peg\u2010IFN\u2010\u03b1\u20102b combined with TDF in HBeAg\u2010positive na\u00efve patients. Clinical Trials Registration:\u00a0ChiCTR1800016173.<\/jats:p><\/jats:sec>","DOI":"10.1002\/jmv.28003","type":"journal-article","created":{"date-parts":[[2022,7,15]],"date-time":"2022-07-15T03:13:58Z","timestamp":1657854838000},"page":"5475-5483","update-policy":"https:\/\/doi.org\/10.1002\/crossmark_policy","source":"Crossref","is-referenced-by-count":13,"title":["Pegylated interferon\u2010\u03b1\u20102b combined with tenofovir disoproxil fumarate, granulocyte\u2010macrophage colony\u2010stimulating factor, and hepatitis B vaccine treatment for na\u00efve HBeAg\u2010positive chronic hepatitis B patients: A prospective, multicenter, randomized controlled study"],"prefix":"10.1002","volume":"94","author":[{"given":"Jiangshan","family":"Lian","sequence":"first","affiliation":[{"name":"Department of Infectious Diseases State Key Laboratory for Diagnosis and Treatment of Infectious Diseases, National Clinical Research Center for Infectious Diseases, Collaborative Innovation Center for 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Collaborative Innovation Center for Diagnosis and Treatment of Infectious Diseases,\u00a0The First Affiliated Hospital, Zhejiang University School of Medicine  Hangzhou China"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Yingfeng","family":"Lu","sequence":"additional","affiliation":[{"name":"Department of Infectious Diseases State Key Laboratory for Diagnosis and Treatment of Infectious Diseases, National Clinical Research Center for Infectious Diseases, Collaborative Innovation Center for Diagnosis and Treatment of Infectious Diseases,\u00a0The First Affiliated Hospital, Zhejiang University School of Medicine  Hangzhou China"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Xiaoli","family":"Zhang","sequence":"additional","affiliation":[{"name":"Department of Infectious Diseases State Key Laboratory for Diagnosis and Treatment of Infectious Diseases, National Clinical Research Center for Infectious Diseases, Collaborative Innovation Center for 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