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J Gastroenterol Hepatol. 2012 Dec 27. doi: 10.1111/jgh.12108. [Epub ahead
of print]
Low Incidence of Hepatitis B e Antigen Seroconversion in Patients Treated
with Oral Nucleos(t)ides in Routine Practice.
B型肝炎e抗原血清学转换治疗的患者的低发病率
口服核苷(T)集成开发环境在日常实践中。
Lin B, Ha NB, Liu A, Trinh HN, Nguyen HA, Nguyen KK, Ahmed A, Keeffe EB,
Garcia RT, Garcia G, Nguyen MH.
Source
Pacific Health Foundation, San Jose, CA, USA.
Abstract
BACKGROUND/AIM:
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.
METHODS:
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.
RESULTS:
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
<7.5 log(10) IU/mL (HR=2.59 [1.04-6.44]), p=0.041) and ALT > 1.5 × upper
normal limit (HR=2.86 [1.05-7.81], p=0.040), but not the choice of
nucleos(t)ides.
CONCLUSIONS:
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
endpoints.
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