Abstract 756
SERUM HBSAG DECLINE IS FASTER THAN PREVIOUSLY ESTIMATED IN LONG-TERM NUC RESPONDERS WITH LOW TREATMENT-INDUCED HBSAG LEVELS
G. Mangia1, P. Lampertico1*, F. Invernizzi1, F. Facchetti1, R. Soffredini1, G. Lunghi2, M. Colombo1
11st Division of Gastroenterology, 2Istituto di Medicina Preventiva, Fondazione IRCCS Ca' Granda Ospedale Maggiore Policlinico, Università degli Studi di Milano, Milan, Italy. *pietro.***@****
Serum HBsAg loss is the recommended stopping rule in NUC responders, yet this event occurs rarely. A 50% decline of HBsAg titers every 5 to 6 years has been described among HBeAg-negative NUC responders, leading to an estimated duration of treatment exceeding 30-50 years in most cases. Whether such a sloppy HBsAg kinetics applies also to patients with treatment-induced low HBsAg levels, is unknown.
Methods: 39 consecutive CHB patients displaying HBsAg titers between 100 and 10 IU/ml following long-term exposure to NUC, were recruited in a single center. HBeAg positive patients with a recent HBeAg seroconversion, immunocompromised patients, acute protracted cases and recently IFN treated patients were excluded. At baseline, age was 60 years, 87% males, 82% HBeAg-negative, 65% genotype D, 52% IL28B CC genotype, 59% cirrhotics, 97% with undetectable HBV-DNA, 95% with normal ALT, 67% NUC experienced, 36% on monotherapy (8 LAM, 4 ETV, 2 TDF), 64% on combo (LAM+ADV in 13, LAM+TDF in 12). Liver function tests, HBV-DNA and HBsAg levels (Abbott assay) were assessed every 3-4 months.
Results: During 39 (11-78) months of study, the median HBsAg titers progressively declined from 95 (range 16-270) IU/ml at baseline to 46 (0.02.-139) at year 1, to 23 (0.11-87) at year 2, to 7 (0.07-68) at year 3. The median decline was 50% every year, with more than 1 log decline over 3 years of continuous NUC therapy. The proportion of patients achieving >1 log decline increased over time, from 22% at year 1 and 2, to 37% at year 3 and 54% at last follow-up visit. Serum HBV-DNA remained undetectable in all patients, HBeAg seroconversion occurred in 3 patients between 5 and 10 months. Eleven patients (28%), 9 HBeAg negative, lost HBsAg between 11 and 73 months (median 27) and 10 of them successfully discontinued NUC.
Conclusion: HBsAg kinetics is faster than previously estimated in long-term NUC suppressed CHB patients achieving low HBsAg levels, a finding that might help in the design of cost effective algorithms of immunomodulatory add-on or switch therapies in NUC suppressed patients.
Assigned speakers:
Dr. Pietro Lampertico, Fondazione IRCCS Ca' Granda Ospedale Maggiore Policlinico, Università degli Studi di Milano , Milan , Italy
Assigned in sessions:
26.04.2013, 09:00-18:00, Poster Session, P02-07c, Category 07c: Viral Hepatitis B & D: Clinical (therapy, new compounds, resistance), Poster Area