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Health-related quality of life improves after entecavir treatment in patients with compensated HBV cirrhosis

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Abstract

Background and aim

Antiviral therapy is effective in decreasing disease progression in HBV cirrhosis. However, the long-term effect of antiviral therapy on health-related quality of life (HRQoL) in patients with compensated HBV cirrhosis is unknown.

Methods

The patients with compensated HBV cirrhosis enrolled in a randomized controlled trial of entecavir-based therapy were recruited in the present study, if they had HRQoL score at 5-year follow-up or who developed liver-related events (LRE) during follow-up were included. HRQoL was measured with 36-Item Short-Form Health Survey (SF-36) and EuroQol-5D (EQ-5D) at baseline and yearly during follow-up. LRE was defined as the development of decompensation, HCC, or death.

Results

A total of 161 patients were included in the present study, with a median age of 48.0 (41.0, 53.0) years, 77.6% being male and 37.2% being HBeAg-positive. During 5 years, 45 patients developed LRE. All eight dimensions of SF-36 were significantly improved after 5 years of antiviral therapy (all p < 0.001), with all dimensions improved more than five points except for physical functioning. Proportion of patients reporting no problems in all five dimensions in EQ-5D increased from 57.8 to 72.0%; visual analogue scale (VAS) and utility index (UI) increased significantly (VAS 79.8 ± 16.4 to 84.4 ± 13.2, UI 0.91 ± 0.13 to 0.95 ± 0.10, both p < 0.001). HRQoL improved or kept stable in the majority of patients who had LRE during follow-up, even stratified by Baveno VI criteria for clinically significant portal hypertension.

Conclusion

After 5 years of ETV treatment, HRQoL significantly improved in patients with compensated HBV cirrhosis. (NCT01943617, NCT02849132)

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Abbreviations

AD:

Anxiety/depression

AFP:

Alpha-fetoprotein

ALB:

Albumin

ALT:

Alanine transaminase

AST:

Aspartate aminotransferase

BP:

Bodily pain

CTP:

Child–Turcotte–Pugh

EQ-5D:

EuroQol-5D

ETV:

Entecavir

GH:

General health

RQoL:

Health-related quality of life

IQR:

Interquartile range

INR:

International normalized ratio

LRE:

Liver-related event

LSM:

Liver stiffness measurement

MCS:

Mental component summary

MELD:

Model for end-stage liver disease

MH:

Mental health

PCS:

Physical component summary

MO:

Mobility

PD:

Pain/discomfort

PF:

Physical functioning

PLT:

Platelet

PROs:

Patient-reported outcomes

RE:

Role emotional

RP:

Role physical

SC:

Self-care

SF:

Social functioning

SF-36:

36-Item Short-Form Health Survey

TB:

Total bilirubin

TDF:

Tenofovir disoproxil fumarate

Thy-α1:

Thymosin-alpha1

UA:

Usual activities

VAS:

Visual analogue scale

VT:

Vitality

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Acknowledgements

The authors would like to express their great appreciation to Dr. Anna Lok for her guidance in data analyses and editing of the manuscript.

Funding

This study was funded by the National Science and Technology Major Project (2018ZX10302204-004, 2018ZX09201016, 2017ZX10203202-003,), the Project of Beijing Municipal Science and Technology Commission (D161100002716003), and the Project of the Digestive Medical Coordinated Development Center of Beijing Hospitals Authority (XXZ0405).

Author information

Author notes

  1. Xiaoning Wu and Jia Hong (co-first authors) contributed equally to this paper.

Authors and Affiliations

  1. Liver Research Center, Beijing Friendship Hospital, Capital Medical University, 95 Yong-an Road, Xi-Cheng District, Beijing, 100050, China

    Xiaoning Wu, Jia Hong, Jialing Zhou, Yameng Sun, Tongtong Meng, Bingqiong Wang, Shuyan Chen, Xiaojuan Ou, Hong You & Jidong Jia

  2. Beijing Key Laboratory of Translational Medicine on Liver Cirrhosis, Beijing, China

    Xiaoning Wu, Hong You & Jidong Jia

  3. National Clinical Research Center for Digestive Diseases, Beijing, China

    Xiaoning Wu, Yuanyuan Kong, Hong You & Jidong Jia

  4. Department of Gastroenterology, Beijing You-an Hospital, Capital Medical University, Beijing, China

    Lei Li

  5. Liver Research Center, Beijing Ditan Hospital, Capital Medical University, Beijing, China

    Wen Xie

  6. Office of Clinical Trials, Affiliated Hospital of Yanbian University, Yanji, Jilin, China

    Hongxin Piao

  7. Division of Infectious Diseases, Peking University First Hospital, Beijing, China

    Xiaoyuan Xu

  8. Department of Gastroenterology, Zhongshan Hospital, Fudan University, Shanghai, China

    Wei Jiang

  9. Liver Research Center, Peking University People’s Hospital, Beijing, China

    Bo Feng

  10. Department of Infectious Diseases, Nan-Fang Hospital, Southern Medical University, Guangzhou, Guangdong, China

    Yongpeng Chen

  11. Department of Gastroenterology and Hepatology, Shanghai General Hospital, Shanghai Jiao-Tong University School of Medicine, Shanghai, China

    Mingyi Xu

  12. Department of Gastroenterology, Shanghai Public Health Clinical Center, Shanghai, China

    Jilin Cheng

Authors
  1. Xiaoning Wu
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Contributions

Guarantor of the article: JDJ and HY take responsibility for the integrity of the work, from inception to published article. Specific author contributions: XNW performed the research; XNW and JH collected and analyzed the data, and wrote the manuscript; JLZ, YMS, LL, WX, HXP, XYX, WJ, BF, YPC, MYX, JLC, TTM, BQW, SYC collected data, YYK contributed to the design of the study and data analysis; JDJ and HY designed the research study and revised the manuscript. All authors approved the final version of the manuscript.

Corresponding authors

Correspondence to Hong You or Jidong Jia.

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Conflict of interest

Jidong Jia has provided consulting to BMS, Gilead, GSK, J&J and Roche, has received research support from Gilead, and is currently principle investigator of Brii Biosciences and Huahui Health Ltd. Hong You has provided consulting to and participated in clinical trials of J&J, Aligos, Brii Biosciences, Huahui Health Ltd, and Suzhou Ribo Life Science Co., Ltd.

Ethical approval

The clinical trial and long-term follow-up study were conducted following the ethical principles enshrined in the Declaration of Helsinki and complied with Good Clinical Practice guidelines and the applicable local regulatory requirements. Each patient provided written informed consent before participation. The studies were registered with the ClinicalTrials.gov identifier NCT01943617 and NCT02849132.

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Supplementary Tables (DOC 22 KB)

12072_2021_10240_MOESM2_ESM.tif

Supplementary Figure 1. Delta of SF-36 scores on-treatment; PCS, physical component summary; MCS, mental component summary (TIF 48 KB)

Supplementary Figure 2. Sensitivity analysis showed similar results in patients without LRE (TIF 81 KB)

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Wu, X., Hong, J., Zhou, J. et al. Health-related quality of life improves after entecavir treatment in patients with compensated HBV cirrhosis. Hepatol Int 15, 1318–1327 (2021). https://doi.org/10.1007/s12072-021-10240-4

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