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 Won; Ahn, Sang Bong; Kim, Tae Yeob; Sohn, Joo Hyun; Kim, Sang Gyune; Lee, Se Whan; Kim, Byung Ho; Kim, Dong Joon; Kim, Ja Kyung; Kim, Hyoung Su; Hwang, Seong Gyu; Choi, Won Choong; Tak, Won Young; Lee, Heon Ju; Yoon, Ki Tae; Yun, Byung Cheol; Lee, Sung Wook; Baik, Soon Koo; Park, Seung Ha; Park, Ji Won; Park, Sol Ji; Lee, 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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