Responses are durable for up to 5 years after completion of peginterferon alfa-2a treatment in hepatitis B e antigen-positive patients
© 2018 John Wiley & Sons Ltd..
BACKGROUND: In the large randomised NEPTUNE study, peginterferon alfa-2a 180 μg/wk for 48 weeks produced higher hepatitis B e antigen (HBeAg) seroconversion rates 24 weeks post-treatment (36%) than a lower dose (90 μg/wk) and/or shorter duration (24 weeks) (range 14%-26%).
AIM: To determine seroconversion rates 5 years after completion of treatment in NEPTUNE.
METHODS: HBeAg-positive patients who completed 24 weeks' follow-up in NEPTUNE (with peginterferon alfa-2a 90 μg/wk × 24 weeks [group 1]; 180 μg/wk × 24 weeks [2]; 90 μg/wk × 48 weeks [3] or 180 μg/wk × 48 weeks [4]) were followed up.
RESULTS: Three hundred and eighty three of the 544 patients in the original study were enrolled in the long-term follow-up study. Many patients (196 overall; more in groups 1-3 than 4) received nucleos(t)ide analogues or immunomodulators during follow-up, and more patients had missing data at year 5 in groups 2 and 4 (48 weeks, 50/112) than in groups 1 and 3 (24 weeks, 23/103), which confounds the planned per-protocol analysis. HBeAg seroconversion rates in groups 1, 2, 3 and 4 at year 5 were 47.5%, 50.7%, 52.2% and 67.1%, respectively, (odds ratio for group 4 versus 1-3: 2.02; 95% CI 1.21, 3.38), using multiple imputation methods for missing measurements.
CONCLUSION: Seroconversion rates are durable for up to 5 years after completion of peginterferon alfa-2a therapy and, consistent with NEPTUNE, the results suggest that the licensed regimen (180 μg × 48 weeks) is more efficacious for HBeAg-positive patients than a lower dose and/or shorter treatment duration.
| Errataetall: |
CommentIn: Aliment Pharmacol Ther. 2018 Jun;47(11):1556-1557. - PMID 29878418 |
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| Medienart: |
E-Artikel |
| Erscheinungsjahr: |
2018 |
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| Erschienen: |
2018 |
| Enthalten in: |
Zur Gesamtaufnahme - volume:47 |
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| Enthalten in: |
Alimentary pharmacology & therapeutics - 47(2018), 9 vom: 23. Mai, Seite 1306-1316 |
| Sprache: |
Englisch |
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| Beteiligte Personen: |
Chuang, W-L [VerfasserIn] |
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| Links: |
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| Anmerkungen: |
Date Completed 31.05.2019 Date Revised 31.05.2019 published: Print-Electronic CommentIn: Aliment Pharmacol Ther. 2018 Jun;47(11):1556-1557. - PMID 29878418 Citation Status MEDLINE |
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| doi: |
10.1111/apt.14595 |
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| funding: |
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| Förderinstitution / Projekttitel: |
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| PPN (Katalog-ID): |
NLM281775001 |
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| 245 | 1 | 0 | |a Responses are durable for up to 5 years after completion of peginterferon alfa-2a treatment in hepatitis B e antigen-positive patients |
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| 500 | |a Date Completed 31.05.2019 | ||
| 500 | |a Date Revised 31.05.2019 | ||
| 500 | |a published: Print-Electronic | ||
| 500 | |a CommentIn: Aliment Pharmacol Ther. 2018 Jun;47(11):1556-1557. - PMID 29878418 | ||
| 500 | |a Citation Status MEDLINE | ||
| 520 | |a © 2018 John Wiley & Sons Ltd. | ||
| 520 | |a BACKGROUND: In the large randomised NEPTUNE study, peginterferon alfa-2a 180 μg/wk for 48 weeks produced higher hepatitis B e antigen (HBeAg) seroconversion rates 24 weeks post-treatment (36%) than a lower dose (90 μg/wk) and/or shorter duration (24 weeks) (range 14%-26%) | ||
| 520 | |a AIM: To determine seroconversion rates 5 years after completion of treatment in NEPTUNE | ||
| 520 | |a METHODS: HBeAg-positive patients who completed 24 weeks' follow-up in NEPTUNE (with peginterferon alfa-2a 90 μg/wk × 24 weeks [group 1]; 180 μg/wk × 24 weeks [2]; 90 μg/wk × 48 weeks [3] or 180 μg/wk × 48 weeks [4]) were followed up | ||
| 520 | |a RESULTS: Three hundred and eighty three of the 544 patients in the original study were enrolled in the long-term follow-up study. Many patients (196 overall; more in groups 1-3 than 4) received nucleos(t)ide analogues or immunomodulators during follow-up, and more patients had missing data at year 5 in groups 2 and 4 (48 weeks, 50/112) than in groups 1 and 3 (24 weeks, 23/103), which confounds the planned per-protocol analysis. HBeAg seroconversion rates in groups 1, 2, 3 and 4 at year 5 were 47.5%, 50.7%, 52.2% and 67.1%, respectively, (odds ratio for group 4 versus 1-3: 2.02; 95% CI 1.21, 3.38), using multiple imputation methods for missing measurements | ||
| 520 | |a CONCLUSION: Seroconversion rates are durable for up to 5 years after completion of peginterferon alfa-2a therapy and, consistent with NEPTUNE, the results suggest that the licensed regimen (180 μg × 48 weeks) is more efficacious for HBeAg-positive patients than a lower dose and/or shorter treatment duration | ||
| 650 | 4 | |a Journal Article | |
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| 650 | 4 | |a Observational Study | |
| 650 | 4 | |a Randomized Controlled Trial | |
| 650 | 7 | |a Antiviral Agents |2 NLM | |
| 650 | 7 | |a DNA, Viral |2 NLM | |
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| 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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| 650 | 7 | |a peginterferon alfa-2a |2 NLM | |
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