All patients with chronic HBeAg negative hepatitis B treated with nucleos(t)ide analogues, who discontinue treatment based in the criteria outlined in the EASL hepatitis B guidelines shall be included in the present study. The aim is to evaluate the clinical outcome (virological relapse, HBsAg decline) and associated virological and immunological parameters.
Study Type
OBSERVATIONAL
Enrollment
50
Hannover Medical School
Hanover, Lower Saxony, Germany
RECRUITINGHBsAg
HBsAg Change \> 1 log 48 weeks after stopping NA
Time frame: 48 weeks
Virological relapse
HBV DNA \> 2,000 IU/ml
Time frame: at every visit up to 96 weeks
Biochemical relapse
ALT \> 2 x upper limit of normal
Time frame: at every visit up to 96 weeks
Retreatment
Retreatment until week 48 according to current EASL guidelines
Time frame: at every visit up to 48 weeks
Negativity for HBsAg
HBsAg negative until week 96 of follow-up
Time frame: at every visit up to 96 weeks
timepoint of relapse
timepoint of relapse
Time frame: at every visit up to 96 weeks
T cell response
\> 3x change of T cell responses from baseline after in vitro culture with HBV specific peptides
Time frame: at every visit up to 96 weeks
Cytokine response
\> 3x change of cytokines from baseline measured by ELISA and Multiplex assay
Time frame: at every visit up to 96 weeks
Chance in HBcrAg
Chance in HBcrAg (U/mL)
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Time frame: at every visit up to 96 weeks
Change in HBV RNA
Chance in HBV RNA (U/mL)
Time frame: at every visit up to 96 weeks