Figure 2AB shows the changes in the distributions of the Knodell

Figure 2AB shows the changes in the distributions of the Knodell necroinflammatory and Ishak fibrosis scores at the baseline, at week 48, and over the long term. One of the 57 patients had an increase in the Ishak fibrosis score, which rose from 1 at the baseline to 2 at the time of long-term biopsy. This patient had an undetectable HBV DNA level and a normal serum ALT level at the time of long-term biopsy as well as an improvement in the necroinflammatory score (from 3 at the baseline to 1 at the time of long-term biopsy). Ten of the 57 patients had advanced fibrosis or cirrhosis (Ishak score ≥4) at the baseline. With long-term entecavir therapy, all

10 patients demonstrated at least a 1-point reduction Selleckchem HIF inhibitor in the Ishak fibrosis score with a median reduction from the baseline of 1.5 points. Four of the 10 patients had cirrhosis at the baseline (Ishak fibrosis score ≥5), and all demonstrated an improvement in the Ishak fibrosis score with a median drop of 3 points (range = 1-4). Figure 3 shows photomicrographs of biopsy samples taken from a 60-year-old, HBeAg-negative, Caucasian male. The baseline biopsy sample showed an Ishak fibrosis score Cobimetinib order of 6, which indicated cirrhosis; it was unchanged at

week 48. After long-term treatment with entecavir, the week 268 biopsy sample showed an Ishak fibrosis score of 2, which indicated minimal fibrosis. At the time of long-term biopsy, 100% of patients (57/57) had an HBV DNA level <300 copies/mL (Table 2). This represents an increase from 70% of patients (40/57) with an HBV DNA level <300 copies/mL after 48 weeks of entecavir treatment. Similarly, the proportion of patients with an ALT level ≤1 times the upper limit of normal increased from

67% (38/57) after 48 weeks of therapy to 86% (49/57) after long-term treatment. Genotypic testing for resistance was not performed because all the patients achieved a serum HBV DNA level <300 copies/mL. According to the medchemexpress study design of ETV-022, patients who lost HBeAg (with or without seroconversion) during the first or second year of therapy and achieved undetectable serum HBV DNA by branched DNA assay were to discontinue entecavir treatment and be followed off-treatment to determine the sustained response. During the long-term rollover study, 55% of the HBeAg-positive patients (22/40) lost HBeAg, and 33% (13/40) achieved hepatitis B e (HBe) seroconversion. No patient in this cohort lost HBsAg. The majority of patients (96%) experienced at least one adverse event at some time during entecavir treatment, and serious adverse events (the majority of which were grade 1 or 2) occurred in 25% of patients. However, no patient discontinued entecavir treatment because of an adverse event. Two patients experienced on-treatment ALT flares; both cases were resolved with continued treatment.

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