Observational Study
Copyright ©The Author(s) 2018. Published by Baishideng Publishing Group Inc. All rights reserved.
World J Gastroenterol. Oct 28, 2018; 24(40): 4606-4614
Published online Oct 28, 2018. doi: 10.3748/wjg.v24.i40.4606
Long term outcome of antiviral therapy in patients with hepatitis B associated decompensated cirrhosis
Young-Cheol Ju, Dae-Won Jun, Jun Choi, Waqar Khalid Saeed, Hyo-Young Lee, Hyun-Woo Oh
Young-Cheol Ju, Dae-Won Jun, Department of Translational Medicine, Graduate school of Biomedical Science and Engineering, Hanyang University, Seoul 04763, South Korea
Dae-Won Jun, Waqar Khalid Saeed, Hyo-Young Lee, Hyun-Woo Oh, Department of Internal Medicine, School of Medicine, Hanyang University, Seoul 04763, South Korea
Jun Choi, Department of Industrial Management Engineering, Korea University, Seoul 02841, South Korea
Author contributions: Jun DW designed and supervised the study; Lee HY, Oh HW independently validated the operational definitions; Choi J collected the HIRA data and analyzed the data; Ju YC wrote the manuscript.
Supported by The Research Supporting Program of The Korean Association for the Study of the Liver and The Korean Liver Foundation.
Institutional review board statement: This study was reviewed and approved by the Institutional Review Board of Hanyang University Hospital (Seoul).
Informed consent statement: This study used insurance reimbursement claims data provided by the Health Insurance Review and Assessment (HIRA). It did not need to make sure of informed written consent prior to study enrollment because the data was already encrypted personal identifiable information.
Conflict-of-interest statement: There are no conflicts of interest to report
Data sharing statement: No additional data are available.
STROBE Statement: The items that should be included in reports of observational studies were checked and the file of STROBE statement was uploaded.
Open-Access: This article is an open-access article which was selected by an in-house editor and fully peer-reviewed by external reviewers. It is distributed in accordance with the Creative Commons Attribution Non Commercial (CC BY-NC 4.0) license, which permits others to distribute, remix, adapt, build upon this work non-commercially, and license their derivative works on different terms, provided the original work is properly cited and the use is non-commercial. See: http://creativecommons.org/licenses/by-nc/4.0/
Correspondence to: Dae-Won Jun, MD, PhD, Professor, Department of Internal Medicine, School of Medicine, Hanyang University, 222 Wangsimni-ro, Seongdong-gu, Seoul 04763, South Korea. noshin@hanyang.ac.kr
Telephone: +82-2-22908338 Fax: +82-2-9720068
Received: July 23, 2018
Peer-review started: July 23, 2018
First decision: August 25, 2018
Revised: September 6, 2018
Accepted: October 5, 2018
Article in press: October 5, 2018
Published online: October 28, 2018
Processing time: 99 Days and 15.2 Hours
ARTICLE HIGHLIGHTS
Research background

According to a population-based cohort study, the annual incidence of decompensated complications was 11% in patients with compensated chronic liver disease. It is clear that antiviral therapy reduces liver disease progression and mortality in decompensated chronic hepatitis B (CHB) patients. However, clinical data for long-term survival rate, the incidence of hepatocellular carcinoma (HCC), and the recurrence of decompensated events in patients with decompensated cirrhosis treated with antiviral agents are still lacking in the antiviral era

Research motivation

Several studies have examined the natural course of CHB in patients without antiviral therapy. Data of the clinical course of CHB-associated decompensated cirrhosis with antiviral agent use are sparse. In this study, we tried to investigate the survival rate and incidence of HCC in patients with decompensated cirrhosis in the antiviral era.

Research objectives

The primary objective was mortality rate and the secondary objectives were the incidence of decompensated cirrhosis-associated complications and HCC.

Research methods

The data source of this study was the insurance reimbursement claims data provided by the Korean Health Insurance Review and Assessment (HIRA). Overall, 48365 antiviral treatment-naïve patients treated between 2008 and 2009 were included, and each had a follow-up period ≥ 5 years. Naïve nucleos(t)ide analog treatment and the decompensated complications were defined with the operational definitions. The appropriateness of the data extracted from the HIRA was assessed and the validation the operational definitions was conducted in two different sized hospitals.

Research results

The 45683 patients included showed compensated liver disease, while 2682 patients had accompanying decompensated complications at initiation of nucleos(t)ide analog treatment. Mean patient age was 43.5 years. In compensated CHB treatment-naïve patients, the 5-year cumulative incidence of various complications was 7.4%, while the annual incidence of the first onset of decompensated complications after using an antiviral agent was 1.2%-2.0%. The 5-year cumulative incidence of HCC in compensated CHB treatment-naïve patients was 11.5%, which was higher than that of decompensated complications (7.4%). In decompensated CHB treatment-naïve patients, the annual incidence of a second decompensation event in decompensated CHB treatment patients was 2.1%-46.9%: It was highest within the first year (46.9%). The 5-year cumulative incidence of HCC in decompensated CHB treatment patients was 24.1%. The 5-year cumulative mortality rate was 32.6% and the cumulative survival rate was 67.4%.

Research conclusions

This study used national database that was compiled from physician reimbursement claims for medical services. There would be several limitations, but we proposed the new methodology when using a long term and large scale clinical database such as HIRA. According to the present study, we suggested that clinicians should be more alert to HCC than to newly developing decompensated complications. Interestingly, antiviral therapy after the onset of decompensated complications reduced the incidence of HCC from 14.26% in the first year to 3.73%, 2.61%, 1.75%, and 1.79% in the following years. However, additional studies are needed to determine. In conclusion, long term outcome of treating hepatitis B-associated decompensated cirrhosis using antiviral agents improved much compare to previous reports. Incidence of cumulative mortality rate and hepatocellular carcinoma was sharply decreased after one year antiviral treatment.

Research perspectives

We investigated the mortality rate and the incidence of decompensated cirrhosis-associated complications and HCC in the antiviral era. We hope the data suggested in this study would be helpful for the future study of comparing antiviral agents.