Entecavir monotherapy in 418 NUC-naïve patients with chronic hepatitis B from field practice : high efficacy and favorable safety profile over 3 years of treatment

direct anti-hepatitis B agents; however, prevalence and clinical impact of this adverse event are poorly appreciated. Material and Methods: 124 patients (78% males, 58 yr, 60% cirrhosis, 14% with 2(OH)-vitamin D deficiency, 90% under tenofovir±lamivudine treatment for 15 months) underwent two dual energy X-ray absorptiometry (DXA) of the lumbar spine (LS) and femoral neck (FN) performed at least 12 months a part. A T score of less than -2.5 and a T score between -1 and -2.5 identified osteoporosis and osteopenia, respectively (WHO criteria). All patients lacked concomitant medication affecting bone metabolism or osteoporosi in the first DXA scan. Results: During a median interval of 15 months (12-50) between DXA scan, 13 (26%) of 50 (40%) patients with normal BMD at the first DXA scan progressed to osteopenia (3 at LS, 7 at FN and 3 at both LS and FN) but none to osteoporosis. Among the 74 (60%) patients with osteopenia at the first DXA scan, 5 (7%) progressed to osteoporosis (2 at LS, 2 at FN and 1 at both LS and FN). Overall, 77% of the patients had stable BMD, 8% improved and 15% worsened. Median LS and FN T scores remained stable between DXA scans (-0.70 vs -0.80; -1.10 vs -1.10, p=ns). Age, gender, BMI, cirrhosis, nucleotide treatment, duration of antiviral therapy, immunosuppression and vitamin D status were not associated with worsening of BMD. In conclusion, in patients with chronic hepatitis B under nucleos(t)ide therapy, BMD worsened in a minority of patients only.