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

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 [10 4 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 HBeAgnegative CHB patients, but further studies are needed to obtain long-term results.

Real-World Evidence for Nucleoside/Nucleotide Analogues in a 5-Year Multicentre Study of Antiviral-Naive Chronic Hepatitis B Patients in China: 52-Week Results

“…Nearly 60.0% of patients with HBV DNA ≥10 8 copies/ml in the ETV group had a virological response by week 52, and >80% of patients in the ETV group who had cirrhosis at baseline achieved a virological response. The efficacy and safety data for ETV in this study are consistent with results from global and Chinese clinical trials with ETV [7,8,13]. A large observational study conducted in China in 2013 reported similar virological responses with ETV in NUC-naive patients (69%) and in those with cirrhosis (64-68%) after a 48-week treatment period [14].…”

Combination lamivudine and adefovir versus entecavir for the treatment of naïve chronic hepatitis B patients: A pilot study

“…Based on the paradigm that a drug combination is more effective than monotherapy for the treatment of human immunodeficiency virus (HIV), the same approach may be appropriate for chronic hepatitis B. Few studies have assessed combination therapy in chronic hepatitis B [12,15,16]. From those studies, it was shown that de novo combination therapy with LAM and ADV was better than add-on combination therapy in terms of changes in Child-Pugh score, viral inhibition, and renal function [15].…”

“…Both LAM +ADV combination therapy and ETV monotherapy are effective in naïve HBeAg-negative CHB patients [12]. However, it is unclear whether the combination of LAM and ADV is effective in HBeAg positive patients.…”

Update on rescue therapies in patients with lamivudine-resistant chronic hepatitis B

“…In certain clinical settings, including LAM failure and post-liver transplant status, combination therapy has been found to improve long-term efficacy of viral suppression 41. Although no large trials have been completed yet, the combination of ADV and LAM, given de novo, has compared favorably to LAM monotherapy and even been shown to be as good as ETV in achieving virological and biochemical response 41,42. Given that the largest study involved only 71 patients (31 LAM plus ADV, 40 ETV) and treatment duration was only 48 weeks, larger studies over longer periods of time are needed.…”