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Pegylated-interferon consolidation treatment versus nucleos(t)ide analogue consolidation treatment in non-cirrhotic hepatitis B patients with hepatitis B e antigen seroconversion: an open-label pilot trial

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Abstract

Background

The safety of nucleos(t)ide analogue (NA) treatment cessation remains one of the most controversial topics in the management of chronic hepatitis B (CHB) patients. This study investigated the efficiency of 48-week pegylated-interferon (peg-IFN) alfa-2a consolidation therapy on viral relapse after discontinued NA treatment in CHB patients who achieved hepatitis B e antigen (HBeAg) seroconversion for > 1 year.

Methods

NA-treated HBeAg-positive patients who achieved the standard of discontinued NA treatment (i.e. time of HBeAg seroconversion > 1 year) were randomly assigned to receive peg-IFN consolidation (n = 24) treatment or continue original NA therapy (n = 24) for 48 weeks. The treatments were then discontinued, and the patients were observed up to 144 weeks. The primary endpoint was the proportion of patients with viral relapse at week 144 among those who received at least one dose of study drug or had at least one study visit [modified intention-to-treat population (mITT)].

Results

Of the 24 patients who received peg-IFN treatment, 6 (25%) experienced viral relapse and 8 (36.3%) showed HBsAg loss during 96 weeks of treatment-free follow-up. Of the patients who underwent NA consolidation treatment, only 1 (4.3%) of 23 patients showed HBsAg loss and 14 (58.3%) of 24 patients experienced viral relapse during follow-up. HBsAg level decline < 0.25 log10 IU/mL at week 96 was significantly associated with viral relapse.

Conclusion

A 48-week peg-IFN alfa-2a consolidation therapy increased the rate of HBsAg loss and sustained viral replication suppression in HBeAg-positive patients who achieved HBeAg seroconversion for > 1 year after NA treatment discontinuation.

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Acknowledgements

The authors would like to thank the patients and their families for their contribution to this study.

Funding

The study was supported by a grant from The Science and Technology department of Zhejiang province. NO 2014C33128 and by a grant from Zhejiang provincial health and Family Planning Commission. No C2015W162.

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Authors and Affiliations

  1. Department of Infectious Diseases, Zhejiang Provincial People’s Hospital, People’s Hospital Hang Zhou Medical College, Zhejiang, China

    Ying Zhou, Rong Yan & Hong Wang

  2. Department of Pathology, Zhejiang Provincial People’s Hospital, People’s Hospital Hang Zhou Medical College, Zhejiang, China

    Guo Qing Ru & Li Li Yu

  3. Department of Medical Record Statistic Information, Zhejiang Provincial People’s Hospital, People’s Hospital Hang Zhou Medical College, Zhejiang, China

    Jiong Yao

Authors
  1. Ying Zhou
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  2. Rong Yan
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  4. Li Li Yu
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  6. Hong Wang
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Contributions

Hong Wang designed the research. Ying Zhou and Rong Yan collected the data and established the database. Jiong Yao presided over the enrolment and exclusion of the research subjects. Hong Wang analysed the data statistically and drafted the manuscript. Guo Qing Ru and Li Li Yu collected the pathologic data

Corresponding author

Correspondence to Hong Wang.

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Conflict of interest

Ying Zhou, Rong Yan, Guo Qing Ru, Li Li Yu, Jiong Yao and Hong Wang declare that they have no conflict of interesting.

Ethical approval

All procedures performed in studies involving human participants were in accordance with the ethical standards of the institutional and/or national research committee and with the 1964 Helsinki declaration and its later amendments or comparable ethical standards. The study protocol was reviewed and approved by the ethics committee of the hospital.

Informed consent

All patients signed an informed consent form before screening in accordance with regulatory and local ethics committee requirements.

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Zhou, Y., Yan, R., Ru, G.Q. et al. Pegylated-interferon consolidation treatment versus nucleos(t)ide analogue consolidation treatment in non-cirrhotic hepatitis B patients with hepatitis B e antigen seroconversion: an open-label pilot trial. Hepatol Int 13, 422–430 (2019). https://doi.org/10.1007/s12072-019-09957-0

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  • DOI: https://doi.org/10.1007/s12072-019-09957-0

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