Abstract
BackgroundThere have been limited studies directly comparing the long-term efficacy between entecavir (ETV) and tenofovir disoproxil fumarate (TDF). This study was aimed to compare the long-term efficacy between them in treatment-naïve chronic hepatitis B (CHB).MethodsOut of 345 CHB patients who received first line therapy with ETV (n = 200) or TDF (n = 145) in a cohort, 210 patients were analyzed using propensity score matching, at a ratio of 1:1.ResultsTwo groups showed no difference in baseline characteristics. During the follow-up of 12 months, HBV DNA levels were similarly suppressed in both groups (ETV vs. TDF; −5.01 vs. -5.242 log10IU/mL, P = 0.559). At month 12, both groups showed no difference in terms of the serologic, biochemical and virologic (VR) response. In multivariate analysis, the initial virologic response at 3 months (IVR-3) was independent factor for VR at 1 year. During the long-term follow-up, HBV DNA levels were more strongly suppressed by TDF than ETV in hepatitis B e antigen (HBeAg) positive patients (P = 0.035), especially with high viral load (P = 0.012), although there was no significant difference in overall VR between two groups. The type of antivirals was not an independent factor for long-term VR.ConclusionsAlthough either ETV or TDF, overall, may show a comparable long-term antiviral efficacy in treatment-naïve CHB, TDF might be better regimen than ETV in the subgroup of HBeAg-positive CHB, especially with a higher HBV DNA levels.
Highlights
There have been limited studies directly comparing the long-term efficacy between entecavir (ETV) and tenofovir disoproxil fumarate (TDF)
Approximately 350 million people are estimated to be chronically infected with hepatitis B virus (HBV), which may result in serious complications, such as hepatic failure, advanced cirrhosis, and/or hepatocellular carcinoma (HCC) in 15–40% of patients [1,2,3]
Patients and study design A total of 345 treatment-naïve chronic hepatitis B (CHB) patients who received a single regimen of either TDF (n = 145) or ETV (n = 200) for at least 12 months were consecutively enrolled from 4 tertiary university hospitals in Korea between January 2011 and December 2014
Summary
There have been limited studies directly comparing the long-term efficacy between entecavir (ETV) and tenofovir disoproxil fumarate (TDF). This study was aimed to compare the long-term efficacy between them in treatment-naïve chronic hepatitis B (CHB). According to several international guidelines, entecavir (ETV) or tenofovir disoproxil fumarate (TDF) are recommended as first line therapy in the treatment of naïve CHB because of their higher antiviral potency and higher genetic. There have been a few reports comparing the short-term efficacy directly between TDF and ETV in treatment-naïve CHB, there is still little available clinical information about the long-term efficacy. We performed this study to compare the long-term efficacy between TDF and ETV in treatment-naïve CHB patients
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