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, Soonkoo Baik, Seung Ha Park, Ji Won Park & 2 others Sol Ji Park, Ji Sung Lee

Research output: Contribution to journalArticle

3 Citations (Scopus)

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 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.

Original languageEnglish
Pages (from-to)1645-1651
Number of pages7
JournalChinese Medical Journal
Volume131
Issue number14
DOIs
Publication statusPublished - 2018 Jul 20

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Hepatitis B e Antigens
Hepatitis B
Interferons
Hepatitis B virus
Therapeutics
DNA
Alanine Transaminase
entecavir
Chi-Square Distribution
Hepatitis B Surface Antigens
Serum
Antiviral Agents
Nucleotides
Regression Analysis

All Science Journal Classification (ASJC) codes

  • Medicine(all)

Cite this

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, Soonkoo ; Park, Seung Ha ; Park, Ji Won ; Park, Sol Ji ; Lee, Ji Sung. / 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). In: Chinese Medical Journal. 2018 ; Vol. 131, No. 14. pp. 1645-1651.
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title = "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)",
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 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.",
author = "Jun, {Dae Won} and Ahn, {Sang Bong} and Kim, {Tae Yeob} and Sohn, {Joo Hyun} and Kim, {Sang Gyune} and Lee, {Se Whan} and Kim, {Byung Ho} and Kim, {Dong Joon} and Kim, {Ja Kyung} and Kim, {Hyoung Su} and Hwang, {Seong Gyu} and Choi, {Won Choong} and Tak, {Won Young} and Lee, {Heon Ju} and Yoon, {Ki Tae} and Yun, {Byung Cheol} and Lee, {Sung Wook} and Soonkoo Baik and Park, {Seung Ha} and Park, {Ji Won} and Park, {Sol Ji} and Lee, {Ji Sung}",
year = "2018",
month = "7",
day = "20",
doi = "10.4103/0366-6999.235880",
language = "English",
volume = "131",
pages = "1645--1651",
journal = "Chinese Medical Journal",
issn = "0366-6999",
publisher = "Chinese Medical Association",
number = "14",

}

Jun, DW, Ahn, SB, Kim, TY, Sohn, JH, Kim, SG, Lee, SW, Kim, BH, Kim, DJ, Kim, JK, Kim, HS, Hwang, SG, Choi, WC, Tak, WY, Lee, HJ, Yoon, KT, Yun, BC, Lee, SW, Baik, S, Park, SH, Park, JW, Park, SJ & Lee, JS 2018, '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)', Chinese Medical Journal, vol. 131, no. 14, pp. 1645-1651. https://doi.org/10.4103/0366-6999.235880

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). / 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, Soonkoo; Park, Seung Ha; Park, Ji Won; Park, Sol Ji; Lee, Ji Sung.

In: Chinese Medical Journal, Vol. 131, No. 14, 20.07.2018, p. 1645-1651.

Research output: Contribution to journalArticle

TY - JOUR

T1 - Efficacy of pegylated interferon monotherapy versus sequential therapy of entecavir and pegylated interferon in Hepatitis B e antigen-Positive Hepatitis B Patients

T2 - A randomized, multicenter, phase IIIb Open-Label Study (POTENT Study)

AU - Jun, Dae Won

AU - Ahn, Sang Bong

AU - Kim, Tae Yeob

AU - Sohn, Joo Hyun

AU - Kim, Sang Gyune

AU - Lee, Se Whan

AU - Kim, Byung Ho

AU - Kim, Dong Joon

AU - Kim, Ja Kyung

AU - Kim, Hyoung Su

AU - Hwang, Seong Gyu

AU - Choi, Won Choong

AU - Tak, Won Young

AU - Lee, Heon Ju

AU - Yoon, Ki Tae

AU - Yun, Byung Cheol

AU - Lee, Sung Wook

AU - Baik, Soonkoo

AU - Park, Seung Ha

AU - Park, Ji Won

AU - Park, Sol Ji

AU - Lee, Ji Sung

PY - 2018/7/20

Y1 - 2018/7/20

N2 - 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.

AB - 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.

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DO - 10.4103/0366-6999.235880

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EP - 1651

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