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).

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

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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).

Author: Dae Won JUN ¹ ; Sang Bong AHN ² ; Tae Yeob KIM ³ ; Joo Hyun SOHN ³ ; Sang Gyune KIM ⁴ ; Se Whan LEE ⁵ ; Byung Ho KIM ⁶ ; Dong Joon KIM ⁷ ; Ja Kyung KIM ⁸ ; Hyoung Su KIM ⁹ ; Seong Gyu HWANG ¹⁰ ; Won Choong CHOI ¹¹ ; Won Young TAK ¹² ; Heon Ju LEE ¹³ ; Ki Tae YOON ¹⁴ ; Byung Cheol YUN ¹⁵ ; Sung Wook LEE ¹⁶ ; Soon Koo BAIK ¹⁷ ; Seung Ha PARK ¹⁸ ; Ji Won PARK ¹⁹ ; Sol Ji PARK ²⁰ ; Ji Sung LEE ²¹
Author Information

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.
Publication Type:Journal Article
Keywords: Entecavir; Hepatitis B; Peginterferon Alfa-2a
From: Chinese Medical Journal 2018;131(14):1645-1651
CountryChina
Language:English
Abstract:
BackgroundUntil 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.
MethodsBetween 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.
ResultsHBeAg 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 logU/ml vs. 7.5 logU/ml, t = 1.70, P = 0.019) and hepatitis B surface antigen titer (3.6 logU/ml vs. 4.0 logU/ml, t = 2.19, P = 0.020) were lower and predictors of responder in mono-treatment and sequential treatment groups, respectively.
ConclusionsThe current study shows no differences in HBeAg seroconversion rate, ALT normalization, and HBV-DNA levels between mono-therapy and sequential therapy regimens.
Trial RegistrationClinicalTrials.gov, NCT01220596; https://clinicaltrials.gov/ct2/show/NCT01220596?term=NCT01220596&rank=1.