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Durability of HBeAg Seroconversion Following Adefovir Dipivoxil Treatment for Chronic Hepatitis B
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TT Chang,1 ML Shiffman,2 M Tong,3 YF Liaw,4 P Komolmit,5 J Sorbel,6
S Arterburn,6 E Mondou,6 S Chuck,6 and P Marcellin7
1National Cheng Kung University Hospital, Tainan, Taiwan; 2Virginia Commonwealth University Medical Center,
Richmond, Virginia, USA; 3Huntington Medical Research Institute, Pasadena, California, USA;
4Chang-Gung Memorial Hospital, Taipei, Taiwan; 5Chulalongkom University Hospital, Bangkok, Thailand;
6Gilead Sciences Inc., Foster City, California, USA; 7Hopital Beaujon, Clichy, France
Poster Number 503
41st Annual Meeting of the European Association for the Study of The Liver (EASL 2006)
April 26-30, 2006, Vienna, Austria
AUTHOR CONCLUSIONS
Among patients who seroconverted to anti-HBe on ADV 10 mg QD, seroconversion was maintained in 91% over a median off-treatment
follow-up of 3 years.
Four patients (9%) seroreverted to HBeAg+ within 16 weeks off drug.
Patients who seroreverted had a shorter duration of ADV treatment after seroconversion than those with durable seroconversion (median 41 weeks vs 20-32 weeks) see table below.
BACKGROUND
HBeAg seroconversion (HBeAg loss with development of anti-HBe) has been
considered an important therapeutic marker in the treatment of chronic hepatitis
B (CHB) in HBeAg+ patients.
Study 481 evaluated the durability of seroconversion following adefovir dipivoxil
(ADV) treatment.
Primary Study Purpose
To investigate the durability of HBeAg seroconversion in patients with CHB who
have seroconverted while participating in a previous Gilead-sponsored study of ADV.
METHODS
This presentation is of data from patients (n=45) who had confirmed
seroconversion to anti-HBe during treatment with ADV 10 mg QD, the approved
dose for the treatment of CHB.
-- Patients seroconverting on placeboa or ADV 30 mg QD also participated
in Study 481 but are not included in this presentation
-- The study of origin was 437 for all seroconverters on ADV 10 mg QD
Study 481 enrolled CHB patients with compensated liver function.
Entry criteria required HBV DNA < 105 copies/mL by Roche Amplicor PCR assay
in conjunction with confirmed seroconversion on ADV.
Patients were followed off treatment with serologic assessments at least every 24 weeks.
Data cutoff for this presentation was 29 September 2005 (Study 481 is ongoing).
a. All maintained seroconversion at last follow-up in Study 481.
RESULTS
Durable Seroconversion in Majority Off Drug
The majority of patients 41/45 (91%) maintained durable seroconversion at the
last 2 assessments.
Median follow-up off drug was 144 weeks.
Interquartile range (IQR) 122-194 weeks; range 13-245 weeks.
Four patients (9%) lost seroconversion and reverted to HBeAg+
-- n=3 at follow-up week 12
-- n=1 at follow-up week 16
-- Median follow-up off drug 18 weeks
-- At the time of seroreversion patients had ALT 84-222 IU/L and all had HBV DNA
> 105 copies/mL
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