The goals of this retrospective study were to determine whether there is a threshold hepatitis B virus (HBV) DNA value associated with spontaneous or antiviral therapy-related hepatitis B e antigen (HBeAg) clearance. We also investigated whether there is an HBV DNA value that can be used for differentiating inactive carriers from patients with HBeAg-negative chronic hepatitis B. HBV DNA levels in sequential serum samples of 165 Chinese patients with different stages of chronic HBV infection were quantified by a polymerase chain reaction (PCR)-based assay. Our results showed that almost all of the patients (83%) who remained HBeAg-positive had HBV DNA levels that were persistently above lo5 copies/mL.
Serum HBV DNA levels decreased by a mean of 3 loglo in patients with HBeAg loss, but 5 1% had levels above lo5 copies/mL at the time HBeAg first became undetectable. Mean serum HBV DNA levels were significantly lower in HBeAg-negative patients. HBV DNA value above lo5 copies/mL would exclude all inactive carriers, but 45% of patients with HBeAgnegative chronic hepatitis would also be excluded if testing were only performed at presentation and 30% would be excluded if testing were performed on 3 occasions. In conclusion, serum HBV DNA levels decreased significantly in patients with HBeAg loss, but there was no threshold HBV DNA level associated with HBeAg clearance. Given the fluctuating course of HBeAg-negative chronic hepatitis, it is not possible to define a single cutoff HBV DNA value for differentiating inactive carriers from patients with HBeAg-negative chronic hepatitis. (HEPATOLOGY 2002;36: 1408-1415.) he evaluation of patients with hepatitis B virus (HBV) infection has evolved from serologic to T molecular diagnostic assays. Using polymerase chain reaction (PCR) assays, the vast majority of patients with chronic HBV infection, including those who are hepatitis B e antigen (HBeAg) negative and hepatitis B e antibody (anti-HBe) positive have detectable HBV DNA in ~erum.~-7 The improvement in sensitivity of HBV