Abstract

Recent studies have suggested a potential increase in the incidence of osteoporosis for patients receiving tenofovir disoproxil fumarate (TDF), but this issue remains controversial.Retrospective cohort study of 1,224 Asian chronic hepatitis B (CHB) patients >18 years without baseline osteopenia/osteoporosis seen at four U.S. centers from 2008-2016. Patients were categorized into three groups-treatment naive patients who initiated therapy with TDF (1) or entecavir (ETV) (2), or untreated patients (3). Patients were followed until development of osteopenia/osteoporosis or end of study.Of the 1,224 study patients, 276 were treated with TDF, 335 with ETV, and 613 were untreated. The prevalence of cirrhosis was lower for untreated patients (2.6% vs. 16.3% for TDF and 17.6% for ETV, p<0.001). The 8-year cumulative incidence rate of osteopenia/osteoporosis was 13.17% for TDF, 15.09% for ETV and 10.17% for untreated patients, with no statistically significant difference among the three groups (p=0.218). On multivariate Cox regression controlling for demographics, osteoporosis risk factors, albumin, and hepatitis B virus (HBV) DNA levels, neither TDF (adjusted HR 0.74, 95% CI: 0.34, 1.59) nor ETV (adjusted HR 0.98, 95% CI: 0.51, 1.90) were associated with increased osteopenia/osteoporosis risk compared to untreated patients.Our retrospective study suggests there is no significant increase in incidence of osteopenia/osteoporosis for CHB patients treated with TDF or ETV during median follow-up of about 4-5 years. However, further study with longer follow-up is needed as anti-HBV therapy is often lifelong or long-term and the development of osteopenia/osteoporosis can be a slow process. This article is protected by copyright. All rights reserved.

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