Abstract
Objectives. To compare entecavir (ETV) and tenofovir disoproxil fumarate (TDF) effects in chronic hepatitis B (CHB) patients with high HBV DNA. Method. 96 patients treated initially with tenofovir (TDF group) or entecavir (ETV group) were included in this retrospective study. The following parameters were assessed: HBeAg and hepatitis B e antibody (anti-HBe) status, serum alanine aminotransferase (ALT), and HBV-DNA levels at weeks 4, 12, 24, 36, 48, 60, 72, and 96; time to ALT normalization, undetectable HBV-DNA levels, and HBeAg seroconversion; total duration of follow-up and adverse reactions. Results. The patients included 66 (69%) and 30 (31%) individuals administered ETV and TDF, respectively, comprising 75% males. They were 35.1 ± 4.5 and 33.7 ± 4.6 years old in ETV and TDF groups, respectively. At 36 weeks, the response rate was significantly higher in the TDF group than in ETV treated patients (90% versus 69.7%, p = 0.03). At 48 weeks, less patients administered ETV showed undetectable HBV-DNA levels compared with the TDF group (86.4% versus 96.7%), a non-statistically significant difference (p = 0.13). Only 1 ETV treated patient developed virological breakthrough at 48–96 w. No adverse reactions were found. Conclusion. ETV and TDF are comparable in efficacy and safety to suppress HBV-DNA replication in HBeAg-positive CHB patients with high HBV DNA.
Highlights
Chronic hepatitis B virus (HBV) infection is a significant health problem worldwide; it may cause serious complications such as cirrhosis, liver failure, and hepatocellular carcinoma (HCC) [1]
Two different treatment strategies are commonly used for patients with chronic hepatitis B (CHB) infection: therapy of fixed duration with immunomodulators such as standard or PEGylated interferon-α, long-term treatment with the nucleos(t)ide analogues lamivudine (LAM), adefovir dipivoxil (ADV), entecavir (ETV), telbivudine (LdT), or tenofovir (TDF)
A total of 96 patients were included in this study, comprising 66 and 30 cases treated with entecavir (ETV group) and tenofovir (TDF group), respectively
Summary
Chronic hepatitis B virus (HBV) infection is a significant health problem worldwide; it may cause serious complications such as cirrhosis, liver failure, and hepatocellular carcinoma (HCC) [1]. The primary goal of CHB treatment is to reduce the risk of developing chronic liver disease and associated complications. Two different treatment strategies are commonly used for patients with CHB infection: therapy of fixed duration with immunomodulators such as standard or PEGylated interferon-α, long-term treatment with the nucleos(t)ide analogues lamivudine (LAM), adefovir dipivoxil (ADV), entecavir (ETV), telbivudine (LdT), or tenofovir (TDF). Rates of resistance to LAM and ADV have been reported to be 65–70% and 18–29%, respectively, after 4-5 years of treatment [3, 4]. ETV and TDF are recommended firstline therapeutics for CHB in current guidelines thanks to their high potency in viral suppression, providing genetic barriers against resistance [6,7,8]
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