Published online Oct 28, 2018. doi: 10.3748/wjg.v24.i40.4606
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
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
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.
The primary objective was mortality rate and the secondary objectives were the incidence of decompensated cirrhosis-associated complications and HCC.
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.
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%.
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.
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.