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Clin Microbiol Infect. 2017 Feb 9. pii: S1198-743X(17)30089-7. doi: 10.1016/j.cmi.2017.02.001. [Epub ahead of print]
Comparison of the efficacy and safety of entecavir and tenofovir in nucleos(t)ide analogue-naïve chronic hepatitis B patients with high viremia: a retrospective cohort study.Wu IT1, Hu TH1, Hung CH1, Lu SN1, Wang JH1, Lee CM1, Chen CH2.
Author information
- 1Division of Hepato-Gastroenterology, Department of Internal Medicine, Kaohsiung Chang Gung Memorial Hospital and Chang Gung University College of Medicine, Taiwan.
- 2Division of Hepato-Gastroenterology, Department of Internal Medicine, Kaohsiung Chang Gung Memorial Hospital and Chang Gung University College of Medicine, Taiwan. Electronic address: [email protected].
AbstractOBJECTIVES: The aims of this study are to compare the long-term efficacy and safety of entecavir (ETV) and tenofovir (TDF) in nucleos(t)ide analogue (NA)-naïve chronic hepatitis B (CHB) patients with high HBV DNA (>6 log10 IU/mL).
METHODS: We recruited 419 NA-naïve patients for analysis (313 ETV, 106 TDF). We used propensity score matching to match 106 patients in TDF group with 212 patients in ETV group by age, baseline HBV DNA levels and cirrhosis after subgrouping by HBeAg status.
RESULTS: There was no significant difference in 3-year cumulative rates of virological response (VR) (96.4% vs. 92.1%, P=0.26 in HBeAg-positive or 98.2% vs. 98.6%, P=0.64 in HBeAg-negative patients), HBeAg loss (53.8% vs. 47.4%, P=0.89) or seroconversion (40.2% vs. 41.3%, P=0.77), and hepatocellular carcinoma (HCC) development (4% vs. 2.7%, P=0.55) between the TDF and ETV groups in either cohort or propensity-score matching patients. In subgroup analysis of patients with HBV DNA>108 IU/mL, ETV and TDF showed similar effectiveness in achieving VR (90.9% vs. 87.7% at 3 year; P=0.13). TDF and diabetes mellitus were independent factors for acute kidney injury (AKI) during treatment. Multivariate analysis showed that HBeAg-negative status, and lower baseline HBV DNA and HBsAg levels were independent factors for achieving VR. Older age, lower baseline HBV DNA levels, cirrhosis and α-fetoprotein ≥8 ng/mL at 12 months of treatment were independently associated with HCC development.
CONCLUSIONS: TDF and ETV have similar effectiveness in NA-naïve CHB patients with high viremia. TDF might have a higher incidence of AKI compared with ETV during treatment.
Copyright © 2017 European Society of Clinical Microbiology and Infectious Diseases. Published by Elsevier Ltd. All rights reserved.
KEYWORDS: Chronic hepatitis B; Entecavir; Tenofovir; acute kidney injury; hepatocellular carcinoma
PMID:28189857DOI:10.1016/j.cmi.2017.02.001
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