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Chen CH, Hu TH, Hung CH, et al. A comparison of 4-year entecavir efficacy in nucleos(t)ide analog-naïve and -experienced adult Taiwanese chronic hepatitis B patients. Hepatol Int. 2013;7(3):832-43doi: 10.1007/s12072-013-9440-5.
Chen, C. H., Hu, T. H., Hung, C. H., Lu, S. N., Wang, J. H., Chang, M. H., Changchien, C. S., & Lee, C. M. (2013). A comparison of 4-year entecavir efficacy in nucleos(t)ide analog-naïve and -experienced adult Taiwanese chronic hepatitis B patients. Hepatology international, 7(3), 832-43. https://doi.org/10.1007/s12072-013-9440-5
Chen, Chien-Hung, et al. "A comparison of 4-year entecavir efficacy in nucleos(t)ide analog-naïve and -experienced adult Taiwanese chronic hepatitis B patients." Hepatology international vol. 7,3 (2013): 832-43. doi: https://doi.org/10.1007/s12072-013-9440-5
Chen CH, Hu TH, Hung CH, Lu SN, Wang JH, Chang MH, Changchien CS, Lee CM. A comparison of 4-year entecavir efficacy in nucleos(t)ide analog-naïve and -experienced adult Taiwanese chronic hepatitis B patients. Hepatol Int. 2013 Jul;7(3):832-43. doi: 10.1007/s12072-013-9440-5. Epub 2013 Jul 31. PMID: 26201920.
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Hepatol Int. 2013 Jul;7(3):832-43. doi: 10.1007/s12072-013-9440-5. Epub 2013 Jul 31.

A comparison of 4-year entecavir efficacy in nucleos(t)ide analog-naïve and -experienced adult Taiwanese chronic hepatitis B patients.

Hepatology international

Chien-Hung Chen, Tsung-Hui Hu, Chao-Hung Hung, Sheng-Nan Lu, Jing-Houng Wang, Min-Hui Chang, Chi-Sin Changchien, Chuan-Mo Lee

Affiliations

  1. Division of Hepatogastroenterology, Department of Internal Medicine, Kaohsiung Chang Gung Memorial Hospital and Chang Gung University College of Medicine, 123 Ta Pei Road, Kaohsiung, Taiwan.
  2. Division of Hepatogastroenterology, Department of Internal Medicine, Kaohsiung Chang Gung Memorial Hospital and Chang Gung University College of Medicine, 123 Ta Pei Road, Kaohsiung, Taiwan. [email protected].

PMID: 26201920 DOI: 10.1007/s12072-013-9440-5

Abstract

PURPOSE: To compare the efficacy of entecavir (ETV) monotherapy up to 4 years in nucleos(t)ide analog (NA)-experienced and -naïve subjects.

METHODS: One hundred sixty NA-experienced and 282 naïve chronic hepatitis B patients who were treated with ETV were enrolled. Of the 160 NA-experienced patients, 49 had prior lamivudine (LAM)-resistant mutants, 18 had resistant mutants to LAM followed by adefovir (ADV) after switching to ADV sequential therapy (LAM/ADV resistance), and 9 had prior ADV-resistant mutants. NA-resistant mutants were detected by line probe assay.

RESULTS: Four years of ETV therapy resulted in virological response (VR, HBV DNA < 300 copies/ml), HBeAg seroconversion, and ETV-resistant mutants development in 98.2, 45.2, and <1 % of naïve patients, respectively. LAM- and ADV-experienced patients who never developed LAM-resistant mutants had similar VR and ETV-resistant mutant rates to NA-naïve patients. In contrast, prior LAM-resistant mutants were significantly associated with higher ETV-resistant mutants development and reduced VR rates. Patients with prior LAM-resistant mutants but not at baseline had a lower rate of ETV-resistant mutants compared to those with baseline LAM-resistant mutants [hazard ratio (HR): 0.58, 95 % confidence interval (CI): 0.35-0.95] and those who had LAM/ADV resistance (HR:0.16, 95 % CI:1.0.03-0.76). Early add-on ADV achieved VR in eight of nine patients with ETV-resistant mutants when HBV DNA was <2 × 10(5) copies/ml.

CONCLUSIONS: Entecavir was highly efficacious and low resistance in NA-naïve, LAM-, or ADV-experienced patients without LAM-resistant mutants. Patients with prior LAM-resistant mutants but not at baseline had lower ETV-resistant mutant rates compared to those with baseline LAM-resistant mutants or LAM/ADV resistance.

Keywords: Adefovir; Entecavir; Hepatitis B virus; Lamivudine; Resistance

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