[Relationship between serum hepatitis B virus DNA load and hepatocellular carcinoma in Qidong, China: a cohort follow-up study of 14 years].

Objective To explore the relationship between serum HBV DNA load and hepatocellular carcinogenesis in Qidong HBsAg carriers.Methods In 1997,477 HBsAg carriers and 477 age,gender and residence matched HBsAg negative controls were enrolled as a prospective cohort in Qidong city.The entry serum samples were detected for the levels of HBeAg and HBV DNA.The relationship between baseline HBV DNA load and hepatocellular carcinoma (HCC) during the follow-up period from June 1997 to June 2011 were analyzed.Results The total observed person-years (PY) were 12 200.Eightyseven patients developed HCC with an incidence of 1498/100 000 PY in the HBsAg positive group versus 6 with an incidence of 94/100 000 PY ( P =0.000) in the HBsAg negative group.The relative risk (RR) was 15.96.No significant difference existed between the incidences of other tumors in two groups ( P =0.161 ).Compared with the HBsAg negative group,the RR of HCC was 11.38(95％ CI 4.87 -26.62,P ＜0.01 ) in the HBsAg +/HBeAg - group and 29.08 ( 95％ CI 12.37 - 68.37,P ＜ 0.01 ) in the HBsAg + /HBeAg + group; 5.80(95％ CI 2.29 - 14.70,P ＜0.01 ) in the HBsAg +/HBV DNA - group and 27.75 (95％ CI 12.07 -63.81,P ＜0.01 )in the HBsAg +/HBV DNA + group.In HBsAg positive subjects,while the HBV DNA load was classified into 5 levels namely 250-104,104-,105-,106- and ≥107 copies/ml,the relative risks for HCC at each level were 2.84 ( 95％ CI 1.44 - 5.61,P ＜ 0.01 ),5.75 (95％ CI 2.77 -11.95,P＜0.01),9.05(95％ CI 4.71-17.41,P＜0.01),6.39(95％ CI 2.79-14.64,P＜0.01)and 4.35 (95％ CI 2.21 - 8.56,P ＜ 0.01 ) respectively versus the ＜ 250 copies/ml group.Conclusion HBV DNA is an important risk predictor of hepatocellular carcinoma.The HBsAg carriers with the serum loads of HBV DNA between 105 - 106 copies/ml are most likely to present with HCC. Key words: Carcinoma,hepatocellular; Hepatitis B virus; Viral load; Prospective studies