Significance of hepatitis B viremia levels determined by a quantitative polymerase chain reaction assay in patients with hepatitis B e antigen-negative chronic hepatitis B virus infection.
OBJECTIVE
In hepatitis B e antigen (HBeAg)-negative chronic hepatitis B virus (HBV) infection, the clinical relevance of low viremia levels remains unclear. We evaluated the clinical significance of a single baseline serum HBV DNA measurement by a quantitative polymerase chain reaction (PCR) assay in this setting.


METHODS
In total, 196 patients with HBeAg-negative chronic HBV infection (62 inactive carriers, 134 with chronic hepatitis B) were studied. ALT activity was normal at baseline in 25/134 HBeAg-negative chronic hepatitis B patients (18.7%), whereas it remained normal throughout follow-up in all inactive carriers.


RESULTS
HBV DNA was <30,000 copies/ml in 14 (10.5%) and <100,000 copies/ml in 17 (12.9%) HBeAg-negative chronic hepatitis B patients, whereas it was <30,000 copies/ml in all inactive carriers (undetectable in 14). In particular, HBV DNA levels were <100,000 copies/ml in eight (32%) and <30,000 copies/ml in five (20%) of the 25 patients with HBeAg-negative chronic hepatitis B and normal baseline ALT values. HBV DNA levels with a cut-off at 30,000 or 100,000 copies/ml could correctly classify 92.9% or 91.3% of patients with HBeAg-negative chronic HBV infection, whereas ALT or IgM anti-HBc (IgM class antibody to HBV core antigen) index > 0.200 could correctly classify only 87.2% and 82.1% of patients, respectively. A combined HBV DNA and IgM anti-HBc index performed better by correctly classifying 94.4% of cases.


CONCLUSIONS
Serum HBV DNA levels evaluated by sensitive quantitative PCR assays can be used for differentiation between HBeAg-negative chronic hepatitis B and inactive hepatitis B surface antigen carrier state, but the cut-off level should be set at approximately 30,000 copies/ml and certainly lower than the recently suggested level of 100,000 copies/ml.
Academic Department of Medicine, Hippokration General Hospital, Athens, Greece.
Emanuel K
EK
Manesis
George V
GV
Papatheodoridis
Vasilios
V
Sevastianos
Evangelos
E
Cholongitas
Christos
C
Papaioannou
Stephanos J
SJ
Hadziyannis
D000293:Adolescent; D000328:Adult; D000368:Aged; D002353:Carrier State / Q000821:virology*; D015331:Cohort Studies; D004279:DNA, Viral / Q000032:analysis; D005260:Female; D006513:Hepatitis B e Antigens / Q000032:analysis / Q000276:immunology*; D006515:Hepatitis B virus / Q000276:immunology; D019694:Hepatitis B, Chronic / Q000175:diagnosis* / Q000276:immunology; D006801:Humans; D008297:Male; D008875:Middle Aged; D016133:Polymerase Chain Reaction; D011336:Probability; D011379:Prognosis; D011446:Prospective Studies; D012680:Sensitivity and Specificity; D012720:Severity of Illness Index; D014766:Viremia / Q000175:diagnosis* / Q000276:immunology
D004279:DNA, Viral; D006513:Hepatitis B e Antigens