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Stopping long-term NUC therapy in HBeAg negative

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

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 (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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It is rather unusual that
"All nine patients demonstrated normal or close to normal ALT levels with HBV-DNA ranging from undetectable levels to 4.6x106 log copies/ml. "

4.6 x 106 log copies/ml is 4.6 x 1,000,000 copies/ml - which is very high, considering all of them have < 300 copies/ml during treatment!
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Avatar universal
I see you point and it I agree that looks unusual.
I think that they stop the therapy base on qHBsAg. "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 ... " - i think they are teh same 9 that you mentioned and I suppose that they were chose to remain off therapy based on qHBsAg.

I will look for the entire presentation, maybe we will found something interesting
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http://www.multiwebcast.com/aasld/2011/thelivermeeting/13769/

posters are available if you have a AASLD id, I still wait to confirm my ID :)
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Yes, it is the same nine that stopped taking antivirals and maintained normal ALT.  They stopped because they all had < 300 copies/ml hbvdna and normal ALT for several years whilst on treatment. These 9 are the only ones who remained off-treatment.

I don't think there is necessary a full paper. REP9AC never had a full paper published.
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Avatar universal

it maybe important to see genotypes, genotype d has immune control with hbsag<1000iu/ml but the other genotypes need much lower hbsag for immune control according to another study posted at san francisco 2011.so this looks a little contradictory
if we see single patients genotype, hbsag, hbvdna, alt/ast we can have a better idea

i think many posters/studies are so poor of data and done very badly, these conferences look like a circus where you try to sell your ideas/products filtering data....
i hope cientific publications with more data will be available on many of interesting studies presented

i am going to try getting id, please the first to get ID post complete presentations
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Avatar universal
Hey Stef,

since I have genotype D. Can you please post that study that proved the immune control with hbsag<1000iu/ml. Could not find it anywhere. Thank you!
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Avatar universal

there are tons of studies on this since 2008, the first to discover this is my doctor brunetto pisa

so just google inactive carrier brunetto or search on this community
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http://www.natap.org/2010/APASL/APASL_05.htm
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another link related to qHbsAg
http://www.natap.org/2011/AASLD/AASLD_83.htm
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Avatar universal
I also still wait to confirm my ID :)
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Avatar universal
go to MULTIWEBCAST (AASLD) and clik on lost password and put you name and email and they will send you the credentials (i think that some how the credentials was not send via email)  ... if not let me know and I will email my credentials
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