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AASLD 2011 abstract 1417. Stopping long-term nucleos(t)ide analogue therapy
before HBsAg loss or seroconversion in HBeAg negative CHB patients:
experience from five referral centers in Germany
J. Petersen1; P. Buggisch1; A. Stoehr1; H. Hinrichsen2; S. Mauss3; T.
Berg4; K. Port5; M. P. Manns 5; H. Wedemeyer 5
1. Asklepiosklinik St. Georg, Liver Center Hamburg IFI Institute, Hamburg,
Germany.
2. Gastroenterology, Gastroenterologische Schwerpunkt Praxis, Kiel,
Germany.
3. Hepatology Center, Gastroenterologische Schwerpunktpraxis, Dusseldorf,
Germany.
4. Gastroenterology and Hepatology, University of Leipzig, Leipzig,
Germany.
5. Gastroenterology and Hepatology, Hanover Medical School, Hanover,
Germany.
Background and aim: Long-term treatment with nucleos(t)ide analogues (NUCs)
is highly effective but associated with increasing rates of side effects
and nonadherence. HBsAg loss or seroconversion is a rare event in HBeAg
negative patients. Small pilot trials have challenged the question of a
sustained biochemical and virological remission after discontinuation of
long-term NUC therapy in some HBeAg negative patients. Here we report on
relapse rates of HBV DNA, ALT flares, re-therapy rates and HBsAg loss in
CHB patients without advanced liver disease after stopping NUC therapy
after long-term viral suppression (3-7 yrs).
Methods: Retrospective data base search. 32 patients were identified in
which NUC therapy was stopped, 14 pts during lamivudin, 7 adefovir, 6
telbivudine, 5 entecavir. All patients were HBeAg negative, 66 % male,
median age 47 years. All patients showed durable suppression of HBV DNA for
NUC therapy in between 3-7yrs (< 300 copies/ml).
Results: 23 out of 32 patients relapsed with virological (HBV DNA >2000
IU/ml) and biochemical hepatitis flares (ALT levels 2.2-7 x ULN) and were
restarted on antiviral therapy in between one month and 12 months after
stopping therapy. 9 patients remained without antiviral therapy (3 after
Lam-, two after ADV-, one after LdT therapy, 3 after entecavir). Of those
nine patients, the majority showed HBsAg levels of less than 1000IU/ml at
stopping point, four lost HBsAg off therapy (6, 9, 12, 14 months), two of
those developed anti-HBs (16,18 months after termination of therapy). All
nine patients demonstrated normal or close to normal ALT levels with
HBV-DNA ranging from undetectable levels to 4.6x106 log copies/ml. All nine
patients showed no apparent progress of liver disease.
Conclusion: Stopping long-term NUC therapy in HBeAg negative CHB patients
with non-advanced liver disease might be an option for some patients,
especially in those with low HBsAg titers. Immunological characterization
of these patients and prospective studies investigating termination of NUC
therapy are urgently needed |
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