De novo combination of lamivudine and adefovir versus entecavir monotherapy for the treatment of naïve HBeAg-negative chronic hepatitis B patients

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http://www.springerlink.com/content/r12p178743885649/

Hepatology International

DOI: 10.1007/s12072-010-9243-xOnline First™

Original Article

De novo combination of lamivudine and adefovir versus entecavir monotherapy for

the treatment of naïve HBeAg-negative chronic hepatitis B patients

Li-Chun Wang, En-Qiang Chen, Jing Cao, Li Liu, Li Zheng, Da-Jiang Li, Lu Xu,

Xue-Zhong Lei, Cong liu and Hong Tang

Abstract

Purpose

Either combination treatment or monotherapy using agents with a high genetic

barrier are recommended for hepatitis B e antigen (HBeAg)-negative chronic

hepatitis B (CHB). The aim of this study was to compare effect of naïve

HBeAg-negative CHB patients with either de novo combination of lamivudine (LAM)

and adefovir dipivoxil (ADV) or entecavir (ETV) monotherapy.

Methods

HBeAg-negative CHB patients (n = 71) with ALT levels between 2 and 10 times the

upper normal limit and HBV DNA levels >104 copies/mL were enrolled. Patients

were treated with either LAM 100 mg plus ADV 10 mg per day (n = 31) or ETV 0.5

mg per day (n = 40) for 48 weeks.

Results

The average reduction in HBV DNA level compared with baseline were 5.16 ± 1.69

log in the LAM + ADV group and 5.36 ± 1.70 log in the ETV group by week 48 (P =

0.624). The virological response (VR) rates were 80.65 and 77.5%, the

biochemical response (BR) rates were 93.55 and 90.00% at week 48 in the LAM +

ADV and ETV groups, respectively. There was no significant difference in the VR

and BR between the two groups. During the 48-week treatment period, virological

breakthrough and serious side effects were not noted in any patient.

Conclusions

Both LAM + ADV combination therapy and ETV monotherapy are effective in naïve

HBeAg-negative CHB patients, but further studies are needed to obtain long-term

results.