Safety of Long-Term Oral Nucleos(t)ide Analogues Therapy for Chronic Hepatitis B

doi:10.19803/j.1672-8629.20250189

Abstract

Abstract: Objective To explore the safety of long-term oral nucleos(t)ide analogues (NAs) in treating chronic hepatitis B (CHB) and to provide references for clinical practice. Methods By analyzing drug inserts, results of clinical trials, data on post-marketing surveillance and real-world cohort data, the risks of nephrotoxicity, bone toxicity, and dyslipidemia were compared between entecavir (ETV), tenofovir disoproxil fumarate (TDF), tenofovir alafenamide fumarate (TAF) and tenofovir amibufenamide (TMF). Results NAs were generally safe, but chronic use might lead to decreased renal function, hypophosphatemia and dyslipidemia. TAF and TMF caused significantly lower nephrotoxicity and bone toxicity than TDF, but were associated with a higher risk of hyperlipidemia. Conclusion NAs should be selected based on differences between individual patients. TAF/TMF is the first option for patients with renal insufficiency or at high risk of bone metabolism. For patients with cardiovascular risks or dyslipidemia, TAF/TMF should be used with caution.

Key words: Chronic Hepatitis B, Nucleos(t)ide Analogues, Nephrotoxicity, Bone Toxicity, Dyslipidemia

CLC Number:

ZHU Haomin, LI Yue, ZHANG Mengdie, GAO Lihong, WANG Jia, LI Xin, TAO Tiantian. Safety of Long-Term Oral Nucleos(t)ide Analogues Therapy for Chronic Hepatitis B[J]. Chinese Journal of Pharmacovigilance, 2025, 22(11): 1315-1320.

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