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.
Highlights
Hepatitis B virus (HBV) infection is a leading cause of chronic hepatitis, liver cirrhosis, and hepatocellular carcinoma (HCC), all of which result in death [1]
Of the patients in the NAexperienced group, 90.9% and 100%, and 49.9% and 74.9%, achieved ALT normalization and serum HBV DNA negativity after ETV monotherapy for 48 and 96 weeks, respectively. ere was no significant difference between the nucleos(t)ide analogue (NA)-naıve and NA-experienced groups in the rate of ALT normalization (Figure 1(c)) or serum HBV DNA negativity (Figure 1(d))
ETV, the first approved oral NA, develops resistance at a very low rate in treatment-naıve patients, the rate of ETV resistance increases to 51% in patients with resistance to LAM [9]. us, detecting resistant variants is critical for appropriate patient treatment, and some substitutions have been characterized in an ETV-refractory patient, which mediated ETV resistance by significantly reducing viral replication
Summary
Hepatitis B virus (HBV) infection is a leading cause of chronic hepatitis, liver cirrhosis, and hepatocellular carcinoma (HCC), all of which result in death [1]. We examined the probability of and time to normalization of the ALT level and HBV DNA negativity after 48 or 96 weeks of ETV monotherapy.
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