Efficacy of Pegylated Interferon Monotherapy versus Sequential Therapy of Entecavir and Pegylated Interferon in Hepatits B e Antigen-Positive Hepatitis B Patients: A Randomized, Multicenter, Phase IIIb Open-Label Study (POTENT Study)
DC Field | Value | Language |
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dc.contributor.author | Jun, Dae Won | - |
dc.contributor.author | Ahn, Sang Bong | - |
dc.contributor.author | Kim, Tae Yeob | - |
dc.contributor.author | Sohn, Joo Hyun | - |
dc.contributor.author | Kim, Sang Gyune | - |
dc.contributor.author | Lee, Se Whan | - |
dc.contributor.author | Kim, Byung Ho | - |
dc.contributor.author | Kim, Dong Joon | - |
dc.contributor.author | Kim, Ja Kyung | - |
dc.contributor.author | Kim, Hyoung Su | - |
dc.contributor.author | Hwang, Seong Gyu | - |
dc.contributor.author | Choi, Won Choong | - |
dc.contributor.author | Tak, Won Young | - |
dc.contributor.author | Lee, Heon Ju | - |
dc.contributor.author | Yoon, Ki Tae | - |
dc.contributor.author | Yun, Byung Cheol | - |
dc.contributor.author | Lee, Sung Wook | - |
dc.contributor.author | Baik, Soon Koo | - |
dc.contributor.author | Park, Seung Ha | - |
dc.contributor.author | Park, Ji Won | - |
dc.contributor.author | Park, Sol Ji | - |
dc.contributor.author | Lee, Ji Sung | - |
dc.date.accessioned | 2021-08-11T11:44:16Z | - |
dc.date.available | 2021-08-11T11:44:16Z | - |
dc.date.issued | 2018-07-20 | - |
dc.identifier.issn | 0366-6999 | - |
dc.identifier.issn | 2542-5641 | - |
dc.identifier.uri | https://scholarworks.bwise.kr/sch/handle/2021.sw.sch/5797 | - |
dc.description.abstract | Background: Until now, various types of combined therapy with nucleotide analogs and pegylated interferon (Peg-INF) in patients with hepatitis B patients have been tried. However, studies regarding the benefits of de novo combination, late-add on, and sequential treatment are very limited. The objective of the current study was to identify the efficacy of sequential treatment of Peg-INF after short-term antiviral treatment. Methods: Between June 2010 and June 2015, hepatitis B e antigen (HBeAg)-positive patients (n = 162) received Peg-IFN for 48 weeks (mono-treatment group, n = 81) and entecavir (ETV) for 12 weeks with a 48-week course of Peg-IFN starting at week 5 of ETV therapy (sequential treatment group, n = 81). The primary endpoint was HBeAg seroconversion at the end of follow-up period after the 24-week treatment. The primary endpoint was analyzed using Chi-square test, Fisher's exact test, and regression analysis. Results: HBeAg seroconversion rate (18.2% vs. 18.2%, t = 0.03, P = 1.000) and seroclearance rate (19.7% vs. 19.7%, t = 0.03, P = 1.000) were same in both mono-treatment and sequential treatment groups. The rate of alanine aminotransferase (ALT) normalization (45.5% vs. 54.5%, t = 1.12, P = 0.296) and serum hepatitis B virus (HBV)-DNA <2000 U/L (28.8% vs. 28.8%, t = 0.10, P = 1.000) was not different in sequential and mono-treatment groups at 24 weeks of Peg-INF. Viral response rate (HBeAg seroconversion and serum HBV-DNA <2000 U/L) was not different in the two groups (12.1% vs. 16.7%, t = 1.83, P = 0.457). Baseline HBV-DNA level (7 log(10)U/ml vs. 7.5 log(10)U/ml, t = 1.70, P = 0.019) and hepatitis B surface antigen titer (3.6 log(10)U/ml vs. 4.0 log(10)U/ml, t = 2.19, P = 0.020) were lower and predictors of responder in mono-treatment and sequential treatment groups, respectively. Conclusions: The current study shows no differences in HBeAg seroconversion rate, ALT normalization, and HBV-DNA levels between mono-therapy and sequential therapy regimens. | - |
dc.format.extent | 7 | - |
dc.language | 영어 | - |
dc.language.iso | ENG | - |
dc.publisher | Zhonghua Yixeuehui Zazhishe/Chinese Medical Association Publishing House | - |
dc.title | Efficacy of Pegylated Interferon Monotherapy versus Sequential Therapy of Entecavir and Pegylated Interferon in Hepatits B e Antigen-Positive Hepatitis B Patients: A Randomized, Multicenter, Phase IIIb Open-Label Study (POTENT Study) | - |
dc.type | Article | - |
dc.publisher.location | 미국 | - |
dc.identifier.doi | 10.4103/0366-6999.235880 | - |
dc.identifier.wosid | 000438436100002 | - |
dc.identifier.bibliographicCitation | Chinese Medical Journal, v.131, no.14, pp 1645 - 1651 | - |
dc.citation.title | Chinese Medical Journal | - |
dc.citation.volume | 131 | - |
dc.citation.number | 14 | - |
dc.citation.startPage | 1645 | - |
dc.citation.endPage | 1651 | - |
dc.type.docType | Article | - |
dc.description.isOpenAccess | Y | - |
dc.description.journalRegisteredClass | sci | - |
dc.description.journalRegisteredClass | scie | - |
dc.description.journalRegisteredClass | scopus | - |
dc.relation.journalResearchArea | General & Internal Medicine | - |
dc.relation.journalWebOfScienceCategory | Medicine, General & Internal | - |
dc.subject.keywordPlus | PEGINTERFERON ALPHA-2A | - |
dc.subject.keywordPlus | COMBINATION THERAPY | - |
dc.subject.keywordPlus | LAMIVUDINE | - |
dc.subject.keywordPlus | TRIAL | - |
dc.subject.keywordAuthor | Entecavir | - |
dc.subject.keywordAuthor | Hepatitis B | - |
dc.subject.keywordAuthor | Peginterferon Alfa-2a | - |
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