[The clinical significance of quantitation of HBV DNA in serum-comparison of the branched-DNA assay with the second-generation digene hybrid capture assay and long-term observation].
OBJECTIVE
Serum levels of hepatitis B virus (HBV) DNA are direct measures of viral replication in hepatocytes. We compared branched-DNA assay (Quantiplex(TM), bDNA) and Hybridization Capture II (HCII), and evaluated the clinical significance of HBV DNA quantitation in the natural course of HBV infection.


METHODS
We analyzed results of bDNA in 324 serum samples from 83 untreated male patients with chronic hepatitis B. Mean follow up period was 11.8 years. HCII was also performed in 157 arbitrarily selected samples.


RESULTS
HBV DNA levels measured with two assays were very similar (r(2)=0.893, p<0.0001). HBV DNA detection rate of HCII was 6.4% higher than that of bDNA in HBeAg positive samples. HBV DNA detection rate was higher in cases with higher ALT. Among 73 patients with initial diagnosis of chronic hepatitis, 38 patients (52.1%) experienced progression to cirrhosis, and hepatocellular carcinoma (HCC) was developed in 9 (12.3%). HCC was developed in 5 (50.0%) of 10 patients with initial diagnosis of cirrhosis. While HBeAg positive rates during chronic hepatitis, cirrhosis and HCC were 57.8%, 55.0% and 14.3%, respectively (p=0.006), HBV DNA detection rates were 70.6%, 64.0% and 42.9%, respectively (p=0.08). Especially in HCC, the discrepancy between HBeAg positive rate and HBV DNA detection rate may suggest the appearance of variants which cannot produce HBeAg.


CONCLUSIONS
Both HCII and bDNA were similar HBV DNA quantitation assays for clinical use. HBV DNA level correlated with the severity of liver disease. Screening tests for HCC should be recommended in patients whose HBeAg is negative and have detectable HBV DNA.
Jun
Eun Jung
EJ
Department of Internal Medicine, College of Medicine, The Catholic University of Korea, Seoul, Korea. jkkim@cmc.cuk.ac.kr
Han
Joon Yeol
JY
Choi
Hwang
H
Chang
U Im
UI
Lee
Tae Kyu
TK
Kim
Young Hwan
YH
Kim
Jin Il
JI
Park
Soo Heon
SH
Kim
Jae Kwang
JK
Chung
Kyu Won
KW
Sun
Hee Sik
HS
D021121:Branched DNA Signal Amplification Assay; D006528:Carcinoma, Hepatocellular / Q000821:virology; D004279:DNA, Viral / Q000032:analysis*; D005500:Follow-Up Studies; D006515:Hepatitis B virus / Q000235:genetics*; D019694:Hepatitis B, Chronic / Q000150:complications / Q000821:virology*; D006801:Humans; D008103:Liver Cirrhosis / Q000821:virology; D008113:Liver Neoplasms / Q000821:virology; D008297:Male; D009693:Nucleic Acid Hybridization; D011379:Prognosis
D004279:DNA, Viral