 |
|
|
| |
Entecavir, new HBV drug, Suppresses Lamivudine Resistance
|
| |
| |
"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"
Robert Gish, California Pacific Medical Center, San Francisco, CA, USA
reported this study at EASL Liver Meeting, July 2003.
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 HBV-DNA (8.1 log10 copies/ml PCR), and median ALT
(71 u/L). Mean decrease from baseline in HBV-DNA 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 HBV-DNA 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, HBV-DNA 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.
|
|
| |
|
|
|
|
|
