HBV DNA level as an important determinant of E antigen seroconversion of chronic hepatitis B during adefovir dipivoxil therapy.

Author(s): Tseng KC, Cheng PN, Wu IC, Chang CK, Chou AL, Liu WC, Chang TT

Affiliation(s): Department of Internal Medicine, Buddhist Dalin Tzu Chi General Hospital, Chiayi, Taiwan.

Publication date & source: 2009-05, Hepatogastroenterology., 56(91-92):813-8.

Publication type: Clinical Trial, Phase III; Randomized Controlled Trial

BACKGROUND/AIMS: Adefovir dipivoxil treatment leads to higher HBeAg seroconversion rates than placebo. The study was to evaluate which clinical or virological variables correlate with endpoints (e.g. HBeAg seroconversion and HBV DNA <10(5) copies/mL) during Adefovir dipivoxil or placebo therapy. METHODOLOGY: Fifty-two patients were enrolled with 33 in the ADV group and 19 in the placebo group. The correlation between clinical/virological variables and endpoints was evaluated by logistic regression as well as stratified analyses using Fisher's exact test. RESULTS: After one year of treatment, HBeAg seroconversion was associated with low pre-treatment HBV DNA levels. HBeAg seroconversion rates categorized by pre-treatment HBV DNA levels were distinct in the placebo group (<10(7) vs. >10(7) copies/mL, P=0.037) and in the ADV group (<10(8) vs. >10(8) copies/mL, P=0.039). In addition, HBV DNA levels reductions at week 4, week 8 and week 12 were associated with higher rates of HBeAg seroconversion. CONCLUSIONS: Low pre-treatment HBV DNA level is predictive of HBeAg seroconversion in patients treated with Adefovir dipivoxil or placebo. Adefovir dipivoxil may provide additional benefits for HBeAg seroconversion in patients with pre-treatment HBV DNA levels between 10(7) and 10(8) copies/mL. Profound early HBV DNA reduction may contribute to HBeAg seroconversion.