1 Department of Medicine, Division of Gastroenterology and Hepatology, Stanford University, Palo Alto, CA.
2 Department of Gastroenterology, Kaiser Permanente, Northern California, Santa Clara, CA.
3 School of Medicine and Department of Medical Research, Fu-Jen Catholic University, New Taipei, Taiwan.
4 Chinese Hospital, San Francisco, CA.
5 C. Wong Clinic, San Francisco, CA.
6 CL. Wong Clinic, San Francisco, CA.
7 Division of Gastroenterology and Hepatology, Veterans Affairs Palo Alto Health Care System, Palo Alto, California, USA.
BACKGROUND: Recent studies have suggested a potential increase in the incidence of osteoporosis for patients receiving tenofovir disoproxil fumarate (TDF), but this issue remains controversial.
METHODS: 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.
RESULTS: 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.
CONCLUSIONS: 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.