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Entecavir therapy for up to 96 weeks in patients with HBeAg-positive chronic hepatitis B.

Abstract：

BACKGROUND & AIMS:Entecavir demonstrated superior benefit to lamivudine at 48 weeks in nucleoside-naive patients with hepatitis B e antigen (HBeAg)-positive chronic hepatitis B (CHB). We evaluated continued entecavir and lamivudine treatment through 96 weeks. METHODS:709 HBeAg-positive CHB patients were randomized to entecavir 0.5 mg (n = 354) or lamivudine 100 mg (n = 355) once daily. At week 52, protocol-defined virologic responders could continue blinded treatment for up to 96 weeks. Patients continuing in year 2 (entecavir, n = 243; lamivudine, n = 164) were assessed for serum hepatitis B virus (HBV) DNA, alanine aminotransferase (ALT) normalization, HBeAg seroconversion, and safety. Cumulative confirmed proportions of all treated patients who achieved these responses were also analyzed. RESULTS:Among patients treated in year 2, 74% of entecavir-treated versus 37% of lamivudine-treated patients achieved HBV DNA <300 copies/mL by polymerase chain reaction (PCR), and 79% of entecavir-treated versus 68% of lamivudine-treated patients normalized ALT levels. Similar proportions of entecavir-treated and lamivudine-treated patients achieved HBeAg seroconversion (11% vs 12%, respectively). Higher proportions of entecavir-treated than lamivudine-treated patients achieved cumulative confirmed HBV DNA <300 copies/mL by PCR (80% vs 39%; P < .0001) and ALT normalization (87% vs 79%; P = .0056) through 96 weeks. Cumulative confirmed HBeAg seroconversion occurred in 31% of entecavir-treated versus 25% of lamivudine-treated patients (P = NS). Through 96 weeks, no patient experienced virologic breakthrough due to entecavir resistance. The safety profile was comparable in both groups. CONCLUSIONS:Entecavir treatment through 96 weeks results in continued benefit for patients with HBeAg-positive CHB.

journal_name

Gastroenterology

journal_title

Gastroenterology

authors

Gish RG,Lok AS,Chang TT,de Man RA,Gadano A,Sollano J,Han KH,Chao YC,Lee SD,Harris M,Yang J,Colonno R,Brett-Smith H

doi

10.1053/j.gastro.2007.08.025

subject

Has Abstract

pub_date

2007-11-01 00:00:00

pages

1437-44

issue

eissn

0016-5085

issn

1528-0012

pii

S0016-5085(07)01482-5

journal_volume

133

pub_type

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Entecavir therapy for up to 96 weeks in patients with HBeAg-positive chronic hepatitis B.