Sustained serological and complete responses in HBeAg-positive patients treated with Peginterferon alfa-2b : a 6-year long-term follow-up of a multicenter, randomized, controlled trial in China
BACKGROUND: Pegylated interferon (PEG-IFN) alfa-2b is recommended for chronic hepatitis B (CHB). We aimed to investigate the sustainability of off-treatment responses among Chinese HBeAg-positive CHB patients treated with PEG-IFN alfa-2b from a randomized trial.
METHODS: Eligible Chinese patients (n = 322) were followed up by one visit after a median of 6 years (LTFU) following their participation in a randomized trial evaluating the efficacy of three PEG-IFN alfa-2b dosing regimens (1.0 or 1.5 μg/kg/wk. 24 weeks or 1.5 μg/kg/wk. 48 weeks). Primary endpoints at the LTFU were sustained SR and CR (SR/CR at the end of original study [EOS] and at the LTFU). SR was defined as HBeAg loss and seroconversion to anti-HBe and CR as HBeAg loss and seroconversion to anti-HBe and HBV-DNA < 2000 IU/mL.
RESULTS: The proportions of patients achieving sustained SR among patients who had SR at EOS were high in three treatment groups (61.9, 65.5, 76.5%, respectively, p = 0.46); treatment with PEG-IFN alfa-2b 1.5 μg/kg/wk. 48 weeks had the highest proportion of a sustained CR among patients who had CR at EOS (75.0%, p = 0.05). A considerable number of patients achieved sustained SR (18.2-29.9%) and sustained CR (14.8-18.3%) after EOS despite no further NA treatment. At the LTFU, rates of SR and CR were less than 70.0 and 50.0%, respectively, among all enrolled patients regardless of additional nucleos(t)ide analogs before the LTFU.
CONCLUSIONS: PEG IFN alfa-2b therapy had considerable off-treatment sustainability in Chinese HBeAg positive chronic hepatitis B patients with serological and complete responses.
| Medienart: |
E-Artikel |
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| Erscheinungsjahr: |
2019 |
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| Erschienen: |
2019 |
| Enthalten in: |
Zur Gesamtaufnahme - volume:19 |
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| Enthalten in: |
BMC gastroenterology - 19(2019), 1 vom: 02. Mai, Seite 65 |
| Sprache: |
Englisch |
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| Beteiligte Personen: |
Sun, Jian [VerfasserIn] |
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| Links: |
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| Anmerkungen: |
Date Completed 16.05.2019 Date Revised 25.02.2020 published: Electronic Citation Status MEDLINE |
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| doi: |
10.1186/s12876-019-0981-5 |
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| funding: |
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| Förderinstitution / Projekttitel: |
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NLM296663115 |
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| 100 | 1 | |a Sun, Jian |e verfasserin |4 aut | |
| 245 | 1 | 0 | |a Sustained serological and complete responses in HBeAg-positive patients treated with Peginterferon alfa-2b |b a 6-year long-term follow-up of a multicenter, randomized, controlled trial in China |
| 264 | 1 | |c 2019 | |
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| 500 | |a Date Completed 16.05.2019 | ||
| 500 | |a Date Revised 25.02.2020 | ||
| 500 | |a published: Electronic | ||
| 500 | |a Citation Status MEDLINE | ||
| 520 | |a BACKGROUND: Pegylated interferon (PEG-IFN) alfa-2b is recommended for chronic hepatitis B (CHB). We aimed to investigate the sustainability of off-treatment responses among Chinese HBeAg-positive CHB patients treated with PEG-IFN alfa-2b from a randomized trial | ||
| 520 | |a METHODS: Eligible Chinese patients (n = 322) were followed up by one visit after a median of 6 years (LTFU) following their participation in a randomized trial evaluating the efficacy of three PEG-IFN alfa-2b dosing regimens (1.0 or 1.5 μg/kg/wk. 24 weeks or 1.5 μg/kg/wk. 48 weeks). Primary endpoints at the LTFU were sustained SR and CR (SR/CR at the end of original study [EOS] and at the LTFU). SR was defined as HBeAg loss and seroconversion to anti-HBe and CR as HBeAg loss and seroconversion to anti-HBe and HBV-DNA < 2000 IU/mL | ||
| 520 | |a RESULTS: The proportions of patients achieving sustained SR among patients who had SR at EOS were high in three treatment groups (61.9, 65.5, 76.5%, respectively, p = 0.46); treatment with PEG-IFN alfa-2b 1.5 μg/kg/wk. 48 weeks had the highest proportion of a sustained CR among patients who had CR at EOS (75.0%, p = 0.05). A considerable number of patients achieved sustained SR (18.2-29.9%) and sustained CR (14.8-18.3%) after EOS despite no further NA treatment. At the LTFU, rates of SR and CR were less than 70.0 and 50.0%, respectively, among all enrolled patients regardless of additional nucleos(t)ide analogs before the LTFU | ||
| 520 | |a CONCLUSIONS: PEG IFN alfa-2b therapy had considerable off-treatment sustainability in Chinese HBeAg positive chronic hepatitis B patients with serological and complete responses | ||
| 650 | 4 | |a Journal Article | |
| 650 | 4 | |a Multicenter Study | |
| 650 | 4 | |a Randomized Controlled Trial | |
| 650 | 4 | |a Chronic hepatitis B | |
| 650 | 4 | |a Long-term follow-up | |
| 650 | 4 | |a Peg-interferon | |
| 650 | 4 | |a Sustained combined clinical response | |
| 650 | 4 | |a Sustained serological response | |
| 650 | 7 | |a Antiviral Agents |2 NLM | |
| 650 | 7 | |a Hepatitis B e Antigens |2 NLM | |
| 650 | 7 | |a Interferon alpha-2 |2 NLM | |
| 650 | 7 | |a Interferon-alpha |2 NLM | |
| 650 | 7 | |a Recombinant Proteins |2 NLM | |
| 650 | 7 | |a Polyethylene Glycols |2 NLM | |
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| 700 | 1 | |a Ding, Huiguo |e verfasserin |4 aut | |
| 700 | 1 | |a Chen, Guofeng |e verfasserin |4 aut | |
| 700 | 1 | |a Wang, Guiqiang |e verfasserin |4 aut | |
| 700 | 1 | |a Wei, Lai |e verfasserin |4 aut | |
| 700 | 1 | |a Zhang, Jiming |e verfasserin |4 aut | |
| 700 | 1 | |a Xie, Qing |e verfasserin |4 aut | |
| 700 | 1 | |a Wan, Mobin |e verfasserin |4 aut | |
| 700 | 1 | |a Tang, Hong |e verfasserin |4 aut | |
| 700 | 1 | |a Chen, Shijun |e verfasserin |4 aut | |
| 700 | 1 | |a Gao, Zhiliang |e verfasserin |4 aut | |
| 700 | 1 | |a Wang, Yuming |e verfasserin |4 aut | |
| 700 | 1 | |a Zhang, Dazhi |e verfasserin |4 aut | |
| 700 | 1 | |a Huang, Wenxiang |e verfasserin |4 aut | |
| 700 | 1 | |a Sheng, Jifang |e verfasserin |4 aut | |
| 700 | 1 | |a Ning, Qin |e verfasserin |4 aut | |
| 700 | 1 | |a Yang, Dongliang |e verfasserin |4 aut | |
| 700 | 1 | |a Lu, Jian |e verfasserin |4 aut | |
| 700 | 1 | |a Pan, Chen |e verfasserin |4 aut | |
| 700 | 1 | |a Yang, Yuxiu |e verfasserin |4 aut | |
| 700 | 1 | |a Wang, Jue |e verfasserin |4 aut | |
| 700 | 1 | |a Sun, Chuanzhen |e verfasserin |4 aut | |
| 700 | 1 | |a Wang, Qixin |e verfasserin |4 aut | |
| 700 | 1 | |a Hou, Jinlin |e verfasserin |4 aut | |
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