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654
CLINICAL OUTCOMES IN UNTREATED EUROPEAN PATIENTS
WITH CHRONIC HEPATITIS B VIRUS INFECTION AFTER SEVEN
YEARS: A PROSPECTIVE LONGITUDINAL STUDY (ALBATROS
STUDY)
Christiana Graf1, Viola Knop1, Kai-Henrik Peiffer1, Julia Dietz1,
Thomas Berg2, Heiner Wedemeyer3, Markus Cornberg4,
Jörg Petersen5, Dietrich Hueppe6, Martin Sprinzl7, Stefan
Mauss8, Michael Rausch9, Peter Buggisch5, Markus Bickel10,
Hartwig Klinker11, Stefan Zeuzem1, Johannes Vermehren1
and Christoph Sarrazin12, (1)Department of Internal Medicine
I, University Hospital Frankfurt, Germany, (2)Department of
Gastroenterology and Rheumatology, Section of Hepatology,
University Hospital Leipzig, Germany, (3)Department of
Gastroenterology and Hepatology, Essen University Hospital,
Essen, Germany, (4)Department of Gastroenterology,
Hepatology and Endocrinology, Hannover Medical School,
Hannover,Germany, (5)IFI Institute for Interdisciplinary
Medicine, Asklepios Klinik St. George, University of Hamburg,
(6)Practice for Gastroenterology, Herne, Germany, (7)
Department of Medicine I, University Medical Center Mainz,
Germany, (8)Center for HIV and Hepatogastroenterology,
Düsseldorf, Germany, (9)Center for Infectiology, Berlin,
Germany, (10)Center for Infectiology, Frankfurt, Germany, (11)
Internal Medicine, University Hospital Wuerzburg, Germany,
(12)Medical Clinic 2, St. Josefs Hospital Wiesbaden, Germany
Background: Chronic infection with the hepatitis B virus
(HBV) is associated with chronic hepatitis, liver cirrhosis
and hepatocellular carcinoma The clinical course and
outcome of HBV infection varies among different individuals.
The aim of the present analysis was to assess predictive
factors associated with clinical outcomes during long-term
follow-up in a prospective observational cohort of patients
with low replicative HBV and absence of significant liver
inflammation or fibrosis at the time of study inclusion.
Methods: 1192 consecutive patients with chronic HBeAgnegative
HBV-infection (43% men, mean age 42 ±12 years)
were prospectively followed for up to seven years All study
participants were considered not to be candidates for antiviral
treatment at study inclusion based on international guideline
recommendations Patients were also included if they had
HBV DNA levels >2000 IU/ml and normal ALT or low HBV DNA
≤2000 IU/ml and elevated ALT during follow-up. Virological,
biochemical and non-invasive fibrosis parameters (transient
elastography (TE) and point shearwave elastography (pSWE))
were performed at baseline and during annual follow-up
Treatment decisions were made based on the development
of active carrier state (HBV DNA >2000 IU/ml plus repeated
elevated ALT and/or advanced fibrosis/cirrhosis). Results:
Mean HBV DNA and alanine serum transferase (AST) serum
concentrations at baseline were 3 65 log10IU/mL (SD=4 5) and
28 76 U/mL (SD=14 11), respectively A total of 47 individuals
cleared HBsAg during follow-up (6 6 per 100 person years)
Low HBsAg (p<0.001), low HBV-DNA (p<0.001) and low ALT
values (p=0 027) were predictive of HBsAg seroclearance
Antiviral treatment was started in 46 patients (6 4 per 100
person years). High HBsAg (p=0.006), HBV-DNA >2000 IU/ml
(p=0 005), high ALT (p<0 001) and high TE values (p<0 001)
at baseline were significantly associated with development of
re-activation of HBV infection. Patients with HBsAg ≤1000 IU/
ml, HBV DNA ≤2000 IU/ml and normal ALT at baseline had a
minimal risk of disease progression after seven years (n=305,
26% of patients; NPV >98%). In the seven years of followup,
median TE did not differ significantly from baseline values
(median intra-patient changes at the end of follow-up relative
to baseline, TE: 0.30, p=0.43) and none of the patients
developed HCC Conclusion: Baseline levels of HBsAg and
HBV DNA were strong predictors of both re-activation of HBV
infection and HBsAg seroclearance in this predominantly
Caucasian cohort Follow-up of the cohort for 10 years is
planned to determine long-term prognosis and to evaluate
dynamics of HBV infection leading to disease progression. |
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