icon-    folder.gif   Conference Reports for NATAP  
 
  EASL
43rd Annual Meeting of the European Association For The Study Of The Liver
Milan, Italy
April 23-27, 2008
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Virological and biochemical response in patients with HBeAg-negative chronic hepatitis B treated with PEGASYS with or without lamivudine: results of 4-year follow-up: 11% HBsAg Clearance
 
 
  Reported by Jules Levin
43rd EASL
April 23-27, 2008
Milan Italy
 
Patrick Marcellin*, Teerha Piratvisuth, Maurizia Brunetto, Ferruccio Bonino, George K.K. Lau, Patrizia Farci, Cihan Yurdaydin, Jian Wu, Matei Popescu
 
*Service d'Hepatologie, Hopital Beaujon, Clichy, France
 
AUTHOR SUMMARY

 
48 weeks' therapy with PEG-IFN_-2a provides continuing benefits up to 4 years after end of treatment in patients with HBeAg-negative disease
 
4 years after end of treatment:
 
--PEG-IFN_-2a continued to maintain HBV DNA suppression and normal ALT levels -- 11% of PEG-IFN_-2a-treated patients had cleared HBsAg. HBsAg clearance is known to be associated with favourable clinical outcome and considered closest endpoint to a 'cure'
 
AUTHOR CONCUSION
 
PEG-IFN_-2a should be considered as first-line therapy in patients with HBeAg-negative CHB because of its:

 
-- Ability to achieve sustained response following a short course of treatment in a substantial proportion of patients
 
-- This avoids the need for long-term maintenance therapy and the associated risks of developing drug resistance in those patients who respond
 
Benefits of HBsAg clearance
 
Spontaneous HBsAg clearance may occur but at a low annual incidence:

 
-- 0.10.8% in high endemic areas1,2
-- 1.02.1% in the low endemic areas3-6
 
Associated with improved long-term outcome7
 
-- Reduced incidence of hepatic complications and HCC
Closest outcome to a 'cure'
 
1. Wu et al. J Hepatol 1987; 2. Liaw et al. Hepatology 1991; 3. Sampliner et al. Am J Med Sci 1979;
4. Feinman et al. Hepato-Gastro 1982; 5. McMahon et al. Ann Intern Med 2001;
6. de Franchis et al. Ann Intern Med 1993; 7. Chen et al. Gastroenterology 2002
 

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Long-term follow-up study in patients with HBeAg-negative CHB
 
Results of the initial part of this large international randomised study1 have documented:
 
-- Superior efficacy 6 months post-treatment (ALT normalisation, HBV DNA suppression) of PEG-IFN_-2a vs LAM
 
-- No benefit of combining PEG-IFN_-2a and LAM
 
All study centres were offered participation in a long-term (LT) observational follow-up study
 
-- Interim analyses were planned a priori for each of the yearly follow-up visits, ie at 1-yearly intervals after treatment in the initial study
 
4-year post-treatment data are presented here
 
1. Marcellin et al. N Engl J Med 2004
 
Methodological considerations
 
Of the 54 centres involved in the initial study, 42 participated in the LT study
 
-- Contributed a total of 315 (59%) of the original 537 patients
 
-- Significantly more patients who received PEG-IFN_-2a +/- LAM (66% and 64%, respectively) than LAM alone (47%) entered LT study (P <0.01)
 
-- A total of 230/356 PEG-IFN_-2a-treated and 85/181 LAM-treated patients entered the study
 
Participants in the LT study were more likely to have a response at the end of the initial study, especially in the LAM monotherapy arm

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