Abstract

Nucleos(t)ide analogues (NAs) are widely used for antiviral therapy in patients with chronic hepatitis B (CHB), but real-world data on treatment patterns and long-term clinical outcomes are not always available. Using data from electronic medical records between January 2011 and December 2016 in Shanghai, China, we evaluated patient characteristics, treatment patterns and clinical outcomes in patients with CHB. There were 6688 patients in the study cohort. The incidences of cirrhosis and hepatocellular carcinoma (HCC) were 41.0‰ and 6.8‰ person-years, respectively. There were more cirrhosis and HCC cases among patients who had shorter NA treatment duration (<365 days), or who were less compliant (<80%). In addition, increased risk of cirrhosis and HCC was observed in patients who did not achieve hepatitis B surface antigen (HBsAg) loss/seroconversion. Moreover, patients with cirrhosis developed after antiviral treatments had a higher incidence of HCC (adjusted hazard ratio 15.86, 95% confidence interval 7.35-34.24). Good compliance with treatment and longer treatment duration significantly decreased the risk of developing cirrhosis and HCC. HBsAg loss seemed to be a protective factor for cirrhosis/HCC in NAs-treated patients with CHB, and cirrhosis was a confirmed risk factor for HCC development as expected.

Highlights

  • Viral hepatitis is a leading cause of death worldwide, and more than half of the viral hepatitis deaths in China are caused by hepatitis B virus (HBV) [1]

  • There were 113 patients who were excluded since they have been diagnosed with hepatocellular carcinoma (HCC) before the date of the first Nucleos(t)ide analogues (NAs) treatment, 1185 had cirrhosis and 56 patients had been diagnosed with co-infections with hepatitis C, hepatitis D, hepatitis G or human immunodeficiency virus (HIV)

  • Associations between biological breakthrough (BBT), virological breakthrough (VBT), hepatitis B e antigen (HBeAg) loss/seroconversion and the occurrence of HCC. This retrospective study comprehensively describes current antiviral treatment duration and compliance of chronic hepatitis B (CHB) patients as well as possible serological factors which may correlate with the development of cirrhosis and HCC

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Summary

Introduction

Viral hepatitis is a leading cause of death worldwide, and more than half of the viral hepatitis deaths in China are caused by hepatitis B virus (HBV) [1]. It is well known that chronic HBV infection results in continuous liver injury and sometimes life-threatening complications, especially cirrhosis and hepatocellular carcinoma (HCC) [2, 3]. With an estimated 257 million people infected with HBV globally, 2–10% of these patients will progress to cirrhosis, and 0.2– 0.6% of them will eventually develop HCC [4, 5]. The wide availability of antiviral drugs has significantly decreased the incidence rate of HBV-related cirrhosis and HCC [6,7,8,9]. Liver disease progression and HCC development in patients with chronic hepatitis B (CHB) cannot be eliminated completely even in patients taking long-term nucleos(t)ide analogue (NA) therapy [9,10,11]. Monitoring of disease progression in CHB patients taking antiviral therapy is still critical

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