Abstract
ObjectiveTenofovir (TDF) and entecavir (ETV) are both potent antiviral agents for the treatment of chronic hepatitis B virus (HBV) infection. Multiple studies have compared efficacy and safety of these two agents, but yielded inconsistent results. Hence, we conducted a meta-analysis to discern comparative efficacy and safety.MethodsPublished data relevant to a comparison of TDF and ETV used in HBV were included. HBV DNA suppression rate, ALT normalization rate, and HBeAg seroconversion rate at 24 weeks and 48 weeks were reviewed. Drug safety profiles and resistance were also discussed.ResultsSeven articles met entry criteria. Four and six articles included data for 24 and 48-week HBV DNA suppression rates, respectively, and no significant differences for the rates between the two drugs were found in chronic HBV patients (TDF vs. ETV: relative risk [RR] = 1.10, 95% CI = 0.91–1.33 and RR = 1.07, 95% CI = 0.99–1.17 for 24 weeks and 48 weeks, respectively). For the ALT normalization rate (three studies for 24 weeks, four articles for 48 weeks) and HBeAg seroconversion rate (two and four studies for 24 weeks and 48 weeks, respectively), no difference was observed between TDF and ETV. Additionally, no significant distinction in short term safety was found for CHB patients.ConclusionsTDF and ETV are similarly effective and safe in chronic HBV patients after 24 weeks and 48 weeks of anti-viral therapy. Nevertheless, the long-term efficacy and safety of TDF and ETV should be monitored in prolonged therapy.
Highlights
Chronic hepatitis B virus (HBV) infection remains a serious global health concern
The search strategy was based on a combination of the key words ‘‘chronic hepatitis B virus or HBV or CHB’’, ‘‘entecavir or ETV’’, ‘‘tenofovir or TDF’’
Inclusion and exclusion criteria The following inclusion criteria were used for this meta-analysis: (1) randomized and non-randomized control trials, (2) study population consisting of patients with chronic HBV infection, and (3) intervention therapies of entecavir versus tenofovir monotherapy
Summary
Chronic hepatitis B virus (HBV) infection remains a serious global health concern. Currently, approximately 2 billion people have been infected with HBV, and over 350 million are suffering from chronic hepatitis B (CHB) worldwide [1]. Effective antiviral therapy via sustained HBV DNA suppression has become a priority research focus for chronic infection [4,5,6]. ETV is a potent antiviral that effectively suppresses HBV DNA replication. It has a high genetic barrier for resistance in HBeAg-positive and HBeAg-negative patients [8,9] with a cumulative resistance probability of 1.2% after 5 years of treatment [10]. Due to the small sample sizes of past studies and subsequent limited data for comparing the two drugs, a more definitive conclusion is lacking We conducted this metaanalysis by integrating published drug-based data to compare efficacy and safety of TDF and ETV and provide evidence for clinical decisions
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