Responses are durable for up to 5 years after completion of peginterferon alfa-2a treatment in hepatitis B e antigen-positive patients

W. L. Chuang, J. Jia, H. L.Y. Chan, K. H. Han, T. Tanwandee, D. Tan, X. Chen, E. Gane, T. Piratvisuth, L. Chen, Q. Xie, J. J.Y. Sung, D. Messinger, C. Wat, G. Bakalos, Y. F. Liaw

Research output: Contribution to journalArticlepeer-review

4 Citations (Scopus)

Abstract

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.

Original languageEnglish
Pages (from-to)1306-1316
Number of pages11
JournalAlimentary Pharmacology and Therapeutics
Volume47
Issue number9
DOIs
Publication statusPublished - 2018 May

Bibliographical note

Funding Information:
Declaration of personal interests: Consultancy, speakers? bureau and stock ownership-Roche, BMS, Gilead, AbbVie. Consultancy-Janssen. Speakers? bureau-MSD: Henry Lik-Yuen Chan. Advisory arrangements and speakers? bureau-Gilead and AbbVie. Advisory arrangements-Janssen/Alios: Edward Gane. Research Grants-Roche, Gilead, Novartis, MSD, Covance, GSK, Bayer, BMS, Fibrogen. Speakers? bureau-Roche, Gilead, Novartis, MSD, GSK, Bayer, BMS; Advisory arrangements-Roche, MSD: Teerha Piratvisuth. Employment-PROMETRIS GmbH, which has a contract with Roche to provide statistical support: Diethelm Messinger. Employment and stock ownership-Roche: Cynthia Wat. Employment-Roche: Georgios Bakalos. Wan-Long Chuang, Jidong Jia, Kwang-Hyub Han, Tawesak Tanwandee, Deming Tan, Xinyue Chen, Liang Chen, Qing Xie, Joseph Jao-Yiu Sung and Yun-Fan Liaw have no relationships to disclose. Declaration of funding interests: This research was funded by F. Hoffmann-La Roche Ltd., Basel, Switzerland. Support for third-party writing assistance furnished by Blair Jarvis, Health Interactions, was provided by F. Hoffmann-La Roche Ltd., Basel, Switzerland.

Funding Information:
Declaration of funding interests: This research was funded by F. Hoffmann-La Roche Ltd., Basel, Switzerland. Support for third-party writing assistance furnished by Blair Jarvis, Health Interactions, was provided by F. Hoffmann-La Roche Ltd., Basel, Switzerland.

Publisher Copyright:
© 2018 John Wiley & Sons Ltd

All Science Journal Classification (ASJC) codes

  • Hepatology
  • Gastroenterology
  • Pharmacology (medical)

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