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It received European Medicines Agency and Taiwan marketing authorization in 2019 and 2020, for treatment of polycythemia vera. This phase I\/II study aimed to have preliminary evaluation of safety and efficacy in chronic hepatitis B.<\/jats:p>\n              <\/jats:sec><jats:sec>\n                <jats:title>Methods<\/jats:title>\n                <jats:p>Thirty-one HBeAg-positive and 31 HBeAg-negative were stratified by HBeAg status and randomized at 1:1:1 ratio to q2w ropeginterferon alfa-2b 350\u00a0\u03bcg (group 1), q2w 450\u00a0\u03bcg (group 2) or q1w PEG-IFN alfa-2a 180\u00a0\u03bcg (group 3). Each patient received 48-week treatment (TW48) and 24-week post-treatment follow-up (FW24).<\/jats:p>\n              <\/jats:sec><jats:sec>\n                <jats:title>Results<\/jats:title>\n                <jats:p>The baseline demographics were comparable among the three groups, except for mean HBeAg in HBeAg-positive patients (2.90, 2.23, 2.99 log<jats:sub>10<\/jats:sub> S\/CO, respectively). Cumulative HBeAg seroconversion rate at follow-up period was 27.3% (3\/11), 36.4% (4\/11), and 11.1% (1\/9) with time to HBeAg seroconversion starting from TW24, TW16, and TW48 in group 1, 2, and 3, respectively. The rate of HBV DNA\u2009&lt;\u20092000\u00a0IU\/mL and HBsAg levels\u2009&lt;\u20091500\u00a0IU\/mL at FW24 were comparable in all groups. Ropeginterferon alfa-2b (group 1 &amp; 2) had numerically lower incidence of rash (9.5% and 4.5%) as compared to PEG-IFN alfa-2a (36.8%). Ropeginterferon alfa-2b 350\u00a0\u03bcg (group 1) had more ALT elevation (38.1%), however the rate was comparable in group 2 (9.1%) and group 3 (10.5%).<\/jats:p>\n              <\/jats:sec><jats:sec>\n                <jats:title>Conclusion<\/jats:title>\n                <jats:p>In this preliminary study, ropeginterferon alfa-2b, although in only half the number of injections, is as safe and effective as pegylated interferon alfa-2a for chronic hepatitis B.<\/jats:p>\n              <\/jats:sec><jats:sec>\n                <jats:title>Graphic abstract<\/jats:title>\n                \n              <\/jats:sec>","DOI":"10.1007\/s12072-020-10098-y","type":"journal-article","created":{"date-parts":[[2020,10,24]],"date-time":"2020-10-24T13:02:21Z","timestamp":1603544541000},"page":"997-1008","update-policy":"https:\/\/doi.org\/10.1007\/springer_crossmark_policy","source":"Crossref","is-referenced-by-count":28,"title":["Ropeginterferon alfa-2b every 2\u00a0weeks as a novel pegylated interferon for patients with chronic hepatitis B"],"prefix":"10.1007","volume":"14","author":[{"given":"Yi-Wen","family":"Huang","sequence":"first","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Chao-Wei","family":"Hsu","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Sheng-Nan","family":"Lu","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Ming-Lung","family":"Yu","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Chien-Wei","family":"Su","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Wei-Wen","family":"Su","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Rong-Nan","family":"Chien","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Ching-Sheng","family":"Hsu","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Shih-Jer","family":"Hsu","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Hsueh-Chou","family":"Lai","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Albert","family":"Qin","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Kuan-Chiao","family":"Tseng","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0001-8316-3785","authenticated-orcid":false,"given":"Pei-Jer","family":"Chen","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]}],"member":"297","published-online":{"date-parts":[[2020,10,24]]},"reference":[{"key":"10098_CR1","unstructured":"World Health Organization. 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Chao-Wei Hsu, Sheng-Nan Lu, Ming-Lung Yu, Chien-Wei Su, Wei-Wen Su, Rong-Nan Chien, Ching-Sheng Hsu, Shih-Jer Hsu, Hsueh-Chou Lai, declare no conflicts of interest. Yi-Wen Huang joins PharmaEssentia Corp. after completion of the study. Albert Qin and Kuan-Chiao Tseng are employee of PharmaEssentia Corp.","order":2,"name":"Ethics","group":{"name":"EthicsHeading","label":"Conflict of interest"}},{"value":"All procedures followed were in accordance with the ethical standards of the responsible committee on human experimentation (institutional and national) and with the Helsinki Declaration of 1975, as revised in 2008.","order":3,"name":"Ethics","group":{"name":"EthicsHeading","label":"Ethical statement"}},{"value":"Informed consent was obtained from all patients for being included in the study. This study was registered in Taiwan CDE (No. 1015025937).","order":4,"name":"Ethics","group":{"name":"EthicsHeading","label":"Informed consent"}}]}}