Abstract

Hepatocellular carcinoma (HCC) incidence is high in The Gambia and hepatitis B virus (HBV) infection is the main cause. People co-infected with HBV and hepatitis D virus (HDV) have an even greater risk of HCC and cirrhosis. Using a new HDV quantitative microarray antibody capture (Q-MAC) assay, we evaluated the association between HDV infection and HCC or cirrhosis among participants in The Gambia Liver Cancer Study. In this case-control study, cases had HCC (n=312) or cirrhosis (n=119). Controls (n=470) had no clinical evidence of liver disease and normal serum alfa-fetoprotein. Participants were previously tested for hepatitis B surface antigen (HBsAg); we tested HBsAg+ specimens by HDV Q-MAC, western blot, and RNA assays. We evaluated separate cutoffs of the Q-MAC assay for predicting anti-HDV and RNA positivity. Q-MAC correctly identified 29/29 subjects who were western blot positive (sensitivity=100%, specificity=99.4%) and 16/17 who were RNA positive (sensitivity=94.1%, specificity=100%). Compared to controls, cases more often had HBV monoinfection (HBsAg+/HDV RNA-; 54.1% vs. 17.0%; odds ratio [OR]= 6.28; p<0.001) or HBV-HDV coinfection (HBsAg+/HDV RNA+; 3.9% vs 0%; OR=; p<0.001). Risk estimates (for HCC or cirrhosis) based on HDV antibody status and adjusted for covariates (demographics, alcohol, smoking, body mass index, anti-HCV, and aflatoxin B1 exposure) yielded consistent results for both HBV monoinfection (adjusted OR=8.29; 95% confidence interval=5.74-11.98) and HBV-HDV coinfection (adjusted OR=30.66; 95% confidence interval=6.97-134.95). In this Gambian population, HDV Q-MAC had high sensitivity and specificity for both anti-HDV and HDV RNA. HDV infection contributed to the high risk of HCC in The Gambia. This article is protected by copyright. All rights reserved.

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