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. 2021 Aug 10:2021:3259833.
doi: 10.1155/2021/3259833. eCollection 2021.

Clinical Features and Resistance to Entecavir Monotherapy of Patients with Hepatitis B

Hideo Takayama  1 , Takuya Komura  1 , Takashi Kagaya  1 , Saiho Sugimoto  2 , Noriaki Orita  2 , Yoshiro Asahina  2 , Masashi Nishikawa  1 , Hajime Ohta  3 , Shuichi Kaneko  2 , Masashi Unoura  1
Affiliations

Clinical Features and Resistance to Entecavir Monotherapy of Patients with Hepatitis B

Hideo Takayama et al. Can J Gastroenterol Hepatol. .

Abstract

Aim: Hepatitis B virus (HBV) infection is a major public health concern worldwide. Entecavir (ETV), a first-line nucleos(t)ide analogue (NA) for HBV, has a low risk of resistance. We evaluated the efficacy of ETV monotherapy, ratio of ETV-resistant, and the clinical features of patients with ETV resistance.

Methods: A total of 130 patients (72 males, 58 females; mean age, 61 ± 15 years) were divided into a NA-naïve group (n = 108) and NA-experienced group (n = 22). We examined the clinical outcomes of ETV monotherapy and associated factors. We also assessed the clinical features of 15 patients with resistance to ETV (mean, 51.0 ± 27.4 weeks).

Results: Among the 130 patients, 94.1% achieved ALT normalization and 63.6% achieved serum HBV DNA negativity after ETV monotherapy for 96 weeks. Of the patients in the NA-naïve group, 93.1% and 60.4% achieved ALT normalization and HBV DNA negativity, respectively. Of the patients in the NA-experienced group, 100% and 74.9% achieved ALT normalization and HBV DNA negativity, respectively. Compared to patients on ETV continuously, 15 ETV-resistant patients had a higher baseline HBV viral load. There was a significant difference in the time to HBV DNA negativity, but not ALT normalization after ETV monotherapy in these groups. Rescue treatment with other NAs led to ALT normalization in all of these patients, but not HBV DNA negativity.

Conclusions: ETV monotherapy has a long-term clinical efficacy. While some patients especially with HBV DNA high viral load developed ETV resistance, rescue treatment led to ALT normalization in these patients.

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Conflict of interest statement

The authors declare that they have no conflicts of interest.

Figures

Figure 1
Figure 1
Outcome of ETV monotherapy. Of the 130 patients, ETV monotherapy led to ALT normalization in 89.7% and 94.1% after 48 and 96 weeks, respectively (a). ETV monotherapy led to serum HBV DNA negativity in 49.2% and 63.6% of the patients at 48 and 96 weeks, respectively (b). There was no significant difference between the NA-naïve group (n = 108) and NA-experienced group (n = 22) in the rate of ALT normalization (c) or serum HBV DNA negativity (d).
Figure 2
Figure 2
Correlation between time to ETV monotherapy resistance and pretreatment clinical features. In the ETV-resistant group, the proportion of young patients and the ALT (a), HBV DNA (b), and HBcrAg (c) levels at baseline were significantly higher than those in the ETV-responsive group. Baseline ALT levels were significantly correlated with the baseline HBV DNA (d) and HBcrAg (e) levels, irrespective of ETV resistance. There was no significant group difference in the time to ALT normalization (f), but there was a significant group difference in the time to HBV DNA negativity (p=0.008) (g).
Figure 3
Figure 3
Factors associated with the time taken to switch to NA therapy from ETV monotherapy. The baseline ALT (a), HBV DNA (b), and HBcrAg (c) levels were not significantly correlated with the time taken to switch to NA therapy.
See this image and copyright information in PMC

References

    1. Chemin I., Zoulim F. Hepatitis B virus induced hepatocellular carcinoma. Cancer Letters. 2009;286(1):52–59. doi: 10.1016/j.canlet.2008.12.003. - DOI - PubMed
    1. Trépo C., Chan H. L. Y., Lok A. Hepatitis B virus infection. The Lancet. 2014;384(9959):2053–2063. doi: 10.1016/s0140-6736(14)60220-8. - DOI - PubMed
    1. Bucci L., Garuti F., Lenzi B., et al. The evolutionary scenario of hepatocellular carcinoma in Italy: an update. Liver International. 2017;37(2):259–270. doi: 10.1111/liv.13204. - DOI - PubMed
    1. Bedogni G., Miglioli L., Masutti F., et al. Natural course of chronic HCV and HBV infection and role of alcohol in the general population: the dionysos study. The American Journal of Gastroenterology. 2008;103(9):2248–2253. doi: 10.1111/j.1572-0241.2008.01948.x. - DOI - PubMed
    1. Terrault N. A., Lok A. S. F., McMahon B. J., et al. Update on prevention, diagnosis, and treatment of chronic hepatitis B: AASLD 2018 hepatitis B guidance. Hepatology. 2018;67(4):1560–1599. doi: 10.1002/hep.29800. - DOI - PMC - PubMed

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