Tenofovir disoproxil fumarate versus tenofovir alafenamide on risk of osteoporotic fracture in patients with chronic hepatitis B: A nationwide claims study in South Korea

Author:

Kim Eunju1ORCID,Lee Hyun Woong2ORCID,Kim Soon Sun3ORCID,Yoon Eileen4,Jang Eun Sun5,Chang Jong‐In1,Cho Young Youn6,Seo Gi Hyeon7,Kim Hyung Joon6

Affiliation:

1. Department of Gastroenterology Chung‐Ang University Gwangmyeong Hospital Gwangmyeong Korea

2. Department of Internal Medicine Yonsei University College of Medicine Seoul Korea

3. Department of Gastroenterology Ajou University School of Medicine Suwon Korea

4. Department of Internal Medicine Hanyang University Hospital, Hanyang University College of Medicine Seoul Korea

5. Department of Internal Medicine Seoul National University College of Medicine, Seoul National University Bundang Hospital Seongnam Korea

6. Department of Internal Medicine Chung‐Ang University Hospital Seoul Korea

7. Health Insurance Review and Assessment Service Seoul South Korea

Abstract

SummaryBackgroundAs tenofovir disoproxil fumarate (TDF) requires long‐term use, a reduction in bone density should be considered a possibility when treating patients with chronic hepatitis B (CHB) with aging and systemic diseases. Patients treated with tenofovir alafenamide (TAF) have improved bone mineral density loss compared to patients treated with TDF. Although improvements in bone density caused by TAF have been reported, studies on the actual reduction of fractures are insufficient.AimTo evaluate the impact of TAF on the risk of osteoporotic fractures in comparison with that of TDF.MethodsUsing the national claims data of the Health Insurance Review and Assessment Service, we conducted a retrospective cohort study of 32,582 patients with CHB who had been initially treated with TDF or TAF between November 2017 and December 2020. The numbers of patients treated with TDF and TAF were 20,877 and 11,705, respectively. The annual fracture rate per 100 patients in each group was calculated, and the Cox proportional hazard ratio (HR) was analysed after applying inverse probability treatment weights (IPTW) for both groups.ResultsAmong 32,582 patients, the average age was 47.8 ± 11.2 years, 64.5% were men, and the follow‐up period was 24.4 ± 11.6 months. The incidence of osteoporotic fractures was 0.78 and 0.49 per 100 person‐years in the TDF and TAF groups, respectively. After application of IPTW, the HR was 0.68 (95% confidence interval 0.55–0.85, p = 0.001).ConclusionTAF‐treated patients with CHB had a significantly lower risk of osteoporotic fracture than TDF‐treated patients.

Funder

Korean Association for the Study of the Liver

Publisher

Wiley

Subject

Pharmacology (medical),Gastroenterology,Hepatology

Reference35 articles.

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4. MarcellinP GaneE FlisiakR PetersenJ TsaiN Aguilar SchallR et al.Long term treatment with tenofovir disoproxil fumarate for chronic hepatitis B infection is safe and well tolerated and associated with durable virologic response with no detectable resistance: 8 year results from two phase 3 trials.2014.

5. Randomized Comparison of Tenofovir Disoproxil Fumarate vs Emtricitabine and Tenofovir Disoproxil Fumarate in Patients With Lamivudine-Resistant Chronic Hepatitis B

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