Abstract
BackgroundCurrently, there is no consensus on the efficacy and resistance of de novo combination therapy versus monotherapy for treatment naive patients of chronic hepatitis B (CHB).ObjectivesThe aim of this study was to evaluate the effectiveness and resistance of de novo combination of lamivudine (LAM) and adefovir dipivoxil (ADV) compared with entecavir (ETV) monotherapy for nucleos(t)ide–naive patients with CHB.Study designPublications on the effectiveness and resistance of LAM plus ADV versus ETV monotherapy for nucleos(t)ide-naive patients with CHB were identified by a search of PubMed, Embase, the Cochrane Library, Web of science, OVID, and CBM (Chinese Biological Medical Literature) until May 1, 2013. Biochemical response, hepatitis B e antigen seroconversion, and viroligic response were extracted and combined to obtain an integrated result. Viral resistance and safety were reviewed.ResultsFive eligible studies (328 patients in total) were included in the analysis. LAM plus ADV combination therapy produced more rapid HBV DNA reduction rate at 12 weeks than that of ETV monotherapy. At 48 weeks, the combination group had superior viroligic response rates compared with ETV group (90.0% vs. 78.9%, P=0.01). The difference in the ALT normalization and HBeAg seroconversion rates was not found. At week 96, LAM + ADV was more effective than ETV in ALT normalization [RR = 1. 11, 95% CI (1.02, 1.21), P =0.01] and HBeAg seroconversion [RR = 2.00, 95% CI (1.26, 3.18, P=0.003)], and no significant difference was found in the virologic response (P =0.23). No viral resistance occurred in combination therapy and six patients in ETV group were experienced with viral breakthrough. Both groups were well tolerated.ConclusionThe de novo LAM plus ADV combination therapy for treatment-naïve patients with CHB was greater than ETV monotherapy in both biochemical response and HBeAg seroconversion rate up to 96 weeks. The rate of emergence of viral resistance in the combination group was less than that in the ETV monotherapy.
Highlights
Nucleos(t)ide analogs(NAS)have become the mainstay of chronic hepatitis B (CHB) treatment mainly due to their profound viral suppressive effects, the convenience of single daily dosing and relative lack of significant side effects
At week 96, LAM + adefovir dipivoxil (ADV) was more effective than ETV in Alanine aminotransferase (ALT) normalization [relative risk (RR) = 1. 11, 95% confidence intervals (CI) (1.02, 1.21), P =0.01] and hepatitis B e antigen (HBeAg) seroconversion [RR = 2.00, 95% CI (1.26, 3.18, P=0.003)], and no significant difference was found in the virologic response (P =0.23)
No viral resistance occurred in combination therapy and six patients in ETV group were experienced with viral breakthrough
Summary
Nucleos(t)ide analogs(NAS)have become the mainstay of CHB treatment mainly due to their profound viral suppressive effects, the convenience of single daily dosing and relative lack of significant side effects. Prolonged therapy is associated with the development of drug resistance [2]. Available clinical data has shown that the emergence of drug-resistant can compromise the initial clinical benefits, and lead to hepatitis flares, hepatic decompensation and even death [3,4]. The prudent selection of appropriate agents for the initial treatment of CHB patients to achieve an efficacy, while simultaneously avoiding the emergence of resistance, is a vital clinical concern. There is no consensus on the efficacy and resistance of de novo combination therapy versus monotherapy for treatment naive patients of chronic hepatitis B (CHB)
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