Pacific Health Foundation, San Jose, CA, USA.
Treatment endpoint of therapy for patients with hepatitis B e
antigen-positive (HBeAg) chronic hepatitis B (CHB) includes HBeAg
seroconversion, which ranges 15-22% after 1 year of oral nucleos(t)ides
according to clinical trials. Our goal was to determine the incidence
and predictors of HBeAg seroconversion in such patients in routine
clinical practice, since it may differ than reported rates.
We conducted a retrospective cohort study of 333 consecutive
treatment-naïve HBeAg-positive patients who were treated for CHB between
1/2000 and 6/2010 at 3 gastroenterology and liver clinics in the United
States. Primary study endpoint was HBeAg seroconversion - loss of HBeAg
and antibody to HBeAg (anti-HBe) development.
The majority of patients were Asian (96%). Median treatment duration
prior to HBeAg seroconversion was 50 (range, 26-52) weeks. Of the 333
study patients, 25% received lamivudine (LAM), 16% adefovir (ADV), 51%
entecavir (ETV) and 8% tenofovir (TDF). HBeAg seroconversion at month 12
was 8.2%. On multivariate analysis inclusive of age, gender and
antiviral agents, independent predictors for HBeAg seroconversion at
month 12 were HBV DNA 1.5 × upper normal limit (HR=2.86 [1.05-7.81], p=0.040), but
not the choice of nucleos(t)ides.
The HBeAg seroconversion rate seen in clinical settings for oral
nucleos(t)ides appears much lower than those reported in pivotal trials,
especially in those with lower ALT and higher HBV DNA levels.
HBeAg-positive patients should be counseled about the high possibility
of the long treatment duration required to achieve recommended treatment