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Entecavir for HBV in Lamivudine Failures
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SUSTAINED VIRAL LOAD AND ALT REDUCTION FOLLOWING 48 WEEKS OF ENTECAVIR
TREATMENT IN HBEAG-NEGATIVE AND -POSITIVE PATIENTS WITH CHRONIC HEPATITIS B
WHO HAVE FAILED PRIOR LAMIVUDINE THERAPY
R. Gish*, 1 T.T. Chang, 2 S. Hadziyannis, 3 J. Cianciara, 4 M. Rizzetto, 5
E. Schiff, 6 G. Pastore, 7 K. Klesczewski, 8 G. Densiky, 8 J. Zhu, 8
D. DeHertogh, 8 R. Hindes, 8 *Presenting Author
1California Pacific Medical Center, San Francisco, CA, USA 2National Cheng
Kung Univ Hosp, Tainan, Taiwan 3Henry Dunant Hosp, Athens, Greece 4Instytutu
Chorob Zakaznych Akademii Medycznej, Warsaw, Poland 5Ospedale Molinette,
Torino, Italy 6Univ Of Miami, Miami, FL, USA 7Univ Di Bari, Bari, Italy
8Bristol-Myers Squibb Pharmaceutical Research Institute, Wallingford, CT, USA
Background: Entecavir (ETV) is a potent and selective antiviral in phase III
clinical trials for chronic hepatitis B (CHB). CHB patients with
HBeAg-negative disease generally experience good response to antivirals, but
often relapse with treatment discontinuation. Aim: analyze impact of HBeAg
status on response, as measured by HBVDNA reduction and ALT normalization.
Methods: 181 patients with serum HBVDNA > 10MEq/mL (Quantiplex assay) after
at least 24 weeks of LVD therapy or YMDD mutation and serum ALT <10x ULN were
randomized to ETV 0.1, 0.5, or 1.0 mg, or LVD 100 mg daily for up to 52
weeks.
Results: Treatment groups were comparable for baseline demographics, HBeAg
status (67% positive), mean HBVDNA (8.1 log10 copies/ml PCR), and median ALT
(71 u/L). Mean decrease from baseline in HBVDNA for all ETV doses was
superior to LVD at 48 weeks. For HBeAg-negative patients in the ETV 0.1, 0.5,
and 1.0 mg groups, mean log10 HBVDNA reductions were 2.9, 4.0 and 5.6,
respectively, versus 0.7 for LVD; whereas ALT normalization occurred in 5/10,
10/12, and 9/10 ETV patients, respectively, versus 0/13 LVD. For
HBeAg-positive patients, mean log10 HBVDNA reductions were 2.8, 4.6 and 4.7
respectively, versus 1.8 for LVD; whereas ALT normalization occurred in 6/11,
7/12, and 9/15 ETV patients, respectively, versus 2/10 LVD. Preliminary
analysis demonstrates durable virologic suppression and ALT normalization
through 6 months off treatment follow-up in a substantial proportion of ETV
patients.
Conclusion: In patients previously failing LVD therapy, HBVDNA reduction and
ALT normalization after 48 weeks of ETV therapy were comparable in
HBeAg-positive and negative patients. HBeAg-negative patients who responded
to ETV treatment frequently demonstrated a durable post-treatment response.
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