HERACLIS‐TAF: a multi‐centre prospective cohort study on 2‐year safety and efficacy of tenofovir alafenamide in patients with chronic hepatitis B with renal and/or bone disorders or risks

Summary Background Tenofovir alafenamide (TAF) has exhibited a favourable safety profile on estimated glomerular filtration (eGFR) and bone mineral density (BMD), but has not been extensively studied in patients with renal impairment and/or BMD disorders. Aims To assess predictors of eGFR changes an...

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Published in:Alimentary pharmacology & therapeutics 2022-08, Vol.56 (4), p.702-712
Main Authors: Papatheodoridis, George V., Mimidis, Kostas, Manolakopoulos, Spilios, Gatselis, Nikolaos, Goulis, John, Kapatais, Andreas, Manesis, Emanuel, Vasiliadis, Themistoklis, Triantos, Christos, Samonakis, Dimitrios, Sevastianos, Vasilios, Karatapanis, Stelios, Elefsiniotis, Ioannis, Deutsch, Melanie, Mylopoulou, Theodora, Papatheodoridi, Margarita, Kranidioti, Hariklia, Agorastou, Polyxeni, Karaoulani, Theofani, Kyriazidou, Anastasia, Zisimopoulos, Konstantinos, Dalekos, George N.
Format: Article
Language:English
Subjects:
Bisphosphonates
Bone diseases
Bone mineral density
Cohort analysis
Epidermal growth factor receptors
Hepatitis
Hepatitis B
Interferon
Kidneys
Malignancy
Patients
Safety
Tenofovir
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Summary:Summary Background Tenofovir alafenamide (TAF) has exhibited a favourable safety profile on estimated glomerular filtration (eGFR) and bone mineral density (BMD), but has not been extensively studied in patients with renal impairment and/or BMD disorders. Aims To assess predictors of eGFR changes and other safety and efficacy outcomes during 24‐month TAF therapy in patients with chronic hepatitis B with renal and/or BMD disorders/risks. Methods Adult patients who started TAF at 13 clinics throughout Greece were prospectively included. Main exclusion criteria were hepatitis D, active malignancy and bisphosphonates recent use. MDRD formula was used for eGFR estimation. Results TAF was initiated in 176 patients (91% switched from another agent). At 12 and 24 months, HBV DNA was undetectable in 97% and 100%, and ALT was normal in 96% and 95% of patients. Median ALT decreased from baseline to month 12/24 (p 
ISSN:0269-2813
1365-2036
DOI:10.1111/apt.17093