Treatment maintenance was defined as patients who completed 3 years of therapy without any treatment modification. Treatment modification was defined as one of the following types, regardless of the reason for modification: (i) switch to another NA; (ii) addition Epacadostat mw of another NA; (iii) discontinuation of the initial NA; (iv) dose modification of the initial NA; and (v) other issues (e.g. safety concern). Both clinical and non-clinical reasons associated with treatment modification were recorded. Adherence was defined as the percentage of days
per year that a given patient was on NA treatment, as previously described.[16] Virological breakthrough was defined as serum HBV DNA increase > 1 log IU/mL from the nadir on NA treatment. The evaluable population included all enrolled patients without any major protocol deviation. Continuous data were summarized in terms of the mean, SD, median, minimum, maximum, and number of observations. The proportion of patients who modified the initial NA treatment Pexidartinib was calculated by year for the 3 years of visits and by treatment arms, and presented by reasons for treatment modification. This analysis was repeated by stratification of reasons of initial NA treatment modification (i.e. clinical or non-clinical reasons)
and also performed based on (i) all reasons associated with treatment modification and (ii) clinical reasons only. A Kaplan–Meier analysis
was used to describe the time to treatment modification of the initial NA treatment. Median survival time was the time when 50% of the patients had a treatment modification. Log-rank test was used to compare the time to treatment modification among the different NA treatments. Adherence rates were calculated by year. Chi-square was used to compare the number of patients with adherence rate > 90% versus adherence rate ≤ 90%. Statistical analyses were performed Methocarbamol using SAS® version 9.1.3 (SAS Institute Inc., Cary, NC, USA). A P-value < 0.05 was considered statistically significant. A total of 600 treatment-naïve CHB patients were recruited from 33 hospitals in Taiwan (Fig. 1). Five hundred and eighty-three patients who did not have a major protocol deviation comprised the evaluable population (97.2%). Of these patients, 475 (79.2%) completed a 3-year of treatment. ETV was used as the initial treatment in 476 (79.3%), LdT in 68 (11.3%), and LVD in 56 (9.3%) patients. The ETV group had the highest proportion of patients who completed a 3-year treatment (86.6%). Overall, the most common reason for withdrawal was “discontinuation of the initial NA treatment” (26.4%), followed by “switch to another NA” (18.4%). Our patients were predominantly male (71.9%) (Table 1). The mean age (± SD) was 43.8 (± 12.9) years, ranging from 17 to 81 years.