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Systematic Review: Incidence of Liver-Related Events in People Living With Hepatitis Delta Virus
Laura E Telep1, Dominique M Roulot2,3, Amanda W Singer1
1Gilead Sciences, Inc., Foster City, California, USA.
Background:
Hepatitis delta virus (HDV) requires hepatitis B virus (HBV) surface antigen to enter hepatocytes. Although HBV/HDV coinfection is the most severe form of viral hepatitis, disease progression and liver-related data are limited.
Aims:
To evaluate the characteristics of studies reporting HDV outcomes and the incidence of liver-related events among individuals with HDV.
Methods:
We searched online databases from 1 January 2000 to 14 December 2022 and congress proceedings from 2021 to 2022. Randomised controlled trials (RCTs), non-randomised interventional studies and observational studies reporting incidence of cirrhosis, hepatic decompensation, hepatocellular carcinoma (HCC), liver transplant (LT) and liver-related death in ≥ 20 adults with active HDV infection were included. Study/participant characteristics, cumulative incidence and incidence rates were extracted.
Results:
Data were extracted from 32 unique studies in 47 publications. While most (n = 19; 59%) studies included < 100 individuals, five included ≥ 200. Most were retrospective cohort (n = 19; 59%), and the remainder were prospective cohort (n = 5), non-randomised interventional (n = 3), RCT (n = 3) or registry/database studies (n = 2). Outcomes reported by the largest numbers of studies were hepatic decompensation (n = 21) and HCC (n = 20); the least reported was cirrhosis (n = 9). Heterogeneity existed in participant populations, with variability in baseline markers of liver disease severity. Consequently, a wide range of cumulative incidence values was observed (cirrhosis, 0%-63%; hepatic decompensation, 0%-52%; HCC, 0%-19%; LT, 2%-43%; liver-related death, 0%-19%; composite endpoint, 3%-74%).
Conclusions:
The number of studies describing the incidence of liver-related outcomes among people with HDV remains limited. Quantifying incidence of liver-related events can improve our understanding of disease progression and inform potential treatment strategies.
Trial Registration:
PROSPERO registration ID: CRD42023386845.
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