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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)open access

Authors
Jun, Dae WonAhn, Sang BongKim, Tae YeobSohn, Joo HyunKim, Sang GyuneLee, Se WhanKim, Byung HoKim, Dong JoonKim, Ja KyungKim, Hyoung SuHwang, Seong GyuChoi, Won ChoongTak, Won YoungLee, Heon JuYoon, Ki TaeYun, Byung CheolLee, Sung WookBaik, Soon KooPark, Seung HaPark, Ji WonPark, Sol JiLee, Ji Sung
Issue Date
20-Jul-2018
Publisher
Zhonghua Yixeuehui Zazhishe/Chinese Medical Association Publishing House
Keywords
Entecavir; Hepatitis B; Peginterferon Alfa-2a
Citation
Chinese Medical Journal, v.131, no.14, pp 1645 - 1651
Pages
7
Journal Title
Chinese Medical Journal
Volume
131
Number
14
Start Page
1645
End Page
1651
URI
https://scholarworks.bwise.kr/sch/handle/2021.sw.sch/5797
DOI
10.4103/0366-6999.235880
ISSN
0366-6999
2542-5641
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.
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