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Year : 2018  |  Volume : 131  |  Issue : 14  |  Page : 1645-1651

Efficacy of Pegylated Interferon Monotherapy versus Sequential Therapy of Entecavir and Pegylated Interferon in Hepatitis B e Antigen-Positive Hepatitis B Patients: A Randomized, Multicenter, Phase IIIb Open-Label Study (POTENT Study)

1 Department of Internal Medicine, Hanyang University Seoul Hospital, Hanyang University, Seoul 04763, Korea
2 Department of Internal Medicine, Nowon Eulji Hospital, Eulji University, Seoul 01830, Korea
3 Department of Internal Medicine, Hanyang University Guri Hospital, Hanyang University, Guri 11923, Korea
4 Department of Internal Medicine, SoonChunHyang University Bucheon Hospital, SoonChunHyang University, Bucheon 14584, Korea
5 Department of Internal Medicine, SoonChunHyang University Cheonan Hospital, SoonChunHyang University, Cheonan 31151, Korea
6 Department of Internal Medicine, Kyung Hee University Hospital, Kyung Hee University, Seoul 02453, Korea
7 Department of Internal Medicine, Chuncheon Sacred Heart Hospital, Hallym University, Chuncheon 24252, Korea
8 Department of Internal Medicine, Kangdong Sacred Heart Hospital, Hallym University, Seoul 05355, Korea
9 Department of Internal Medicine, Gangnam Severance Hospital, Yonsei University, Seoul 06273, Korea
10 Department of Internal Medicine, CHA Bundang Medical Center, CHA University, Seongnam 13496, Korea
11 Department of Internal Medicine, Sanggye Paik Hospital, Inje University, Seoul 01757, Korea
12 Department of Internal Medicine, Kyungpook National University Hospital, Kyungpook National University, Daegu 41944, Korea
13 Department of Internal Medicine, Yeungnam University Medical Center, Yeungnam University, Daegu 42415, Korea
14 Department of Internal Medicine, Pusan National University Yangsan Hospital, Pusan National University, Yangsan 50612, Korea
15 Department of Internal Medicine, Kosin University Gospel Hospital, Kosin University, Pusan 49267, Korea
16 Department of Internal Medicine, Dong A University Medical Center, Dong A University, Pusan 49201, Korea
17 Department of Internal Medicine, Wonju Severance Christian Hospital, Yonsei University, Wonju 26426, Korea
18 Department of Internal Medicine, Haeundae Paik Hospital, Inje University, Pusan 48108, Korea
19 Department of Internal Medicine, Hallym University Sacred Heart Hospital, Hallym University, Anyang 14068, Korea
20 Department of Clinical Pharmacy, Graduate School of Clinical Pharmacy, Sungkyunkwan University, Suwon 16419, Korea
21 Clinical Research Center, Asan Medical Center, Seoul 05505, Korea

Correspondence Address:
Dr. Joo Hyun Sohn
Department of Internal Medicine, Hanyang University Guri Hospital, 153 Gyeongchun-ro, Guri 11923
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Source of Support: None, Conflict of Interest: None

DOI: 10.4103/0366-6999.235880

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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 log10U/ml vs. 7.5 log10U/ml, t = 1.70, P = 0.019) and hepatitis B surface antigen titer (3.6 log10U/ml vs. 4.0 log10U/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. Trial Registration: ClinicalTrials.gov, NCT01220596; https://clinicaltrials.gov/ct2/show/NCT01220596?term=NCT01220596&rank=1.

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