{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,9,30]],"date-time":"2026-09-30T01:03:00Z","timestamp":1790730180638,"version":"4.1.0"},"reference-count":26,"publisher":"MDPI AG","issue":"9","license":[{"start":{"date-parts":[[2024,9,23]],"date-time":"2024-09-23T00:00:00Z","timestamp":1727049600000},"content-version":"vor","delay-in-days":0,"URL":"https:\/\/creativecommons.org\/licenses\/by\/4.0\/"}],"funder":[{"name":"Gilead Sciences"}],"content-domain":{"domain":[],"crossmark-restriction":false},"short-container-title":["Pathogens"],"abstract":"<jats:p>Background: Tenofovir alafenamide (TAF) is a novel prodrug of tenofovir for the treatment of chronic hepatitis B (CHB) that has shown a favourable renal safety profile while offering suppression of HBV DNA similar to tenofovir disoproxil fumarate (TDF). We aimed to study changes in markers of HBV replication and renal function in a real-world setting in European patients. Methods: In our prospective single-arm, non-interventional observational study, HBeAg-positive and HBeAg-negative patients with chronic HBV mono-infection receiving TAF as their first or following line treatment were enrolled. HBV DNA, HBsAg, markers of bone metabolism, and renal function were determined at baseline and every consecutive 3 months. Results: A total of 50 patients (70% male) were included. The mean duration of TAF treatment was 18 (3\u201336) months. In 20 patients with detectable HBV DNA at baseline, median serum levels of HBV DNA log10 changed from 2.33 (0.766\u20136.47) to 1.04 IU\/mL at the end of observation and became undetectable in 11 patients. Median HBsAg log10 decreased from 3.37 (0.88\u20135.10) to 2.39 (1.52\u20134.19) IU\/mL. During the entire observation period, the renal function parameters remained stable in patients with normal renal function and even in those with renal dysfunction. Mild adverse events were reported by 14 patients (28%). Conclusions: TAF was a safe and effective treatment, also in patients with decreased renal function.<\/jats:p>","DOI":"10.3390\/pathogens13090820","type":"journal-article","created":{"date-parts":[[2024,9,24]],"date-time":"2024-09-24T10:41:47Z","timestamp":1727174507000},"page":"820","update-policy":"https:\/\/doi.org\/10.3390\/mdpi_crossmark_policy","source":"Crossref","is-referenced-by-count":2,"title":["Prospective Analysis of Safety and Efficacy of Tenofovir Alafenamide Fumarate (TAF) in European Real-World Patients with Chronic Hepatitis B: A Single-Centre Real-Word Cohort Study"],"prefix":"10.3390","volume":"13","author":[{"given":"Balazs","family":"F\u00fcl\u00f6p","sequence":"first","affiliation":[{"name":"Division of Hepatology, Department of Medicine II, Leipzig University Medical Center, 04103 Leipzig, Germany"},{"name":"Klinik Gastroenterologie und Hepatology, Kantonsspital Baselland, 4410 Liestal, Switzerland"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0002-8710-101X","authenticated-orcid":false,"given":"Janett","family":"Fischer","sequence":"additional","affiliation":[{"name":"Division of Hepatology, Department of Medicine II, Leipzig University Medical Center, 04103 Leipzig, Germany"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0002-3195-6123","authenticated-orcid":false,"given":"Magdalena","family":"Hahn","sequence":"additional","affiliation":[{"name":"Division of Hepatology, Department of Medicine II, Leipzig University Medical Center, 04103 Leipzig, Germany"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Albrecht","family":"B\u00f6hlig","sequence":"additional","affiliation":[{"name":"Department of Internal Medicine, Community Hospital Delitzsch, 34208 Delitzsch, Germany"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Madlen","family":"Matz-Soja","sequence":"additional","affiliation":[{"name":"Division of Hepatology, Department of Medicine II, Leipzig University Medical Center, 04103 Leipzig, Germany"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0003-0003-6241","authenticated-orcid":false,"given":"Thomas","family":"Berg","sequence":"additional","affiliation":[{"name":"Division of Hepatology, Department of Medicine II, Leipzig University Medical Center, 04103 Leipzig, Germany"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0003-2679-0672","authenticated-orcid":false,"given":"Florian","family":"van B\u00f6mmel","sequence":"additional","affiliation":[{"name":"Division of Hepatology, Department of Medicine II, Leipzig University Medical Center, 04103 Leipzig, Germany"}],"role":[{"vocabulary":"crossref","role":"author"}]}],"member":"1968","published-online":{"date-parts":[[2024,9,23]]},"reference":[{"key":"ref_1","doi-asserted-by":"crossref","first-page":"261","DOI":"10.1002\/hep.28156","article-title":"AASLD guidelines for treatment of chronic hepatitis B","volume":"63","author":"Terrault","year":"2016","journal-title":"Hepatology"},{"key":"ref_2","doi-asserted-by":"crossref","unstructured":"European Association for the Study of the Liver (2017). EASL 2017 Clinical Practice Guidelines on the management of hepatitis B virus infection. J. Hepatol., 67, 370\u2013398.","DOI":"10.1016\/j.jhep.2017.03.021"},{"key":"ref_3","doi-asserted-by":"crossref","first-page":"468","DOI":"10.1016\/S0140-6736(12)61425-1","article-title":"Regression of cirrhosis during treatment with tenofovir disoproxil fumarate for chronic hepatitis B: A 5-year open-label follow-up study","volume":"381","author":"Marcellin","year":"2013","journal-title":"Lancet"},{"key":"ref_4","first-page":"227","article-title":"Long-term effects of tenofovir on renal function in patients with chronic hepatitis B: A real-life observational study","volume":"64","author":"Schmid","year":"2016","journal-title":"J. Hepatol."},{"key":"ref_5","doi-asserted-by":"crossref","first-page":"296","DOI":"10.1016\/S2468-1253(19)30015-9","article-title":"Safety and efficacy of stopping tenofovir disoproxil fumarate in patients with chronic hepatitis B following at least 8 years of therapy: A prespecified follow-up analysis of two randomised trials","volume":"4","author":"Buti","year":"2019","journal-title":"Lancet Gastroenterol. Hepatol."},{"key":"ref_6","doi-asserted-by":"crossref","first-page":"185","DOI":"10.1016\/S2468-1253(16)30024-3","article-title":"Tenofovir alafenamide versus tenofovir disoproxil fumarate for the treatment of HBeAg-positive chronic hepatitis B virus infection: A randomised, double-blind, phase 3, non-inferiority trial","volume":"1","author":"Chan","year":"2016","journal-title":"Lancet Gastroenterol. Hepatol."},{"key":"ref_7","doi-asserted-by":"crossref","first-page":"672","DOI":"10.1016\/j.jhep.2017.11.039","article-title":"96 weeks treatment of tenofovir alafenamide vs tenofovir disoproxil fumarate for hepatitis B virus infection","volume":"68","author":"Agarwal","year":"2018","journal-title":"J. Hepatol."},{"key":"ref_8","doi-asserted-by":"crossref","first-page":"196","DOI":"10.1016\/S2468-1253(16)30107-8","article-title":"The effect of tenofovir alafenamide on bone and renal safety compared with tenofovir disoproxil fumarate in patients with chronic hepatitis B virus infection: A randomised controlled trial","volume":"1","author":"Gane","year":"2016","journal-title":"Lancet Gastroenterol. Hepatol."},{"key":"ref_9","first-page":"197","article-title":"Treatment of chronic hepatitis B: The role of tenofovir alafenamide","volume":"10","author":"Mena","year":"2017","journal-title":"Infect. Drug Resist."},{"key":"ref_10","first-page":"1153","article-title":"Review article: Treatment of chronic hepatitis B virus infection\u2014Perspectives on the current guidelines","volume":"45","author":"Lampertico","year":"2017","journal-title":"Aliment. Pharmacol. Ther."},{"key":"ref_11","doi-asserted-by":"crossref","unstructured":"Sano, T., Amano, K., Ide, T., Kawaguchi, T., Kuwahara, R., Arinaga-Hino, T., Koga, H., Kuromatsu, R., and Torimura, T. (2021). Short-term efficacy after switching from adefovir dipivoxil and tenofovir disoproxil fumarate therapy to tenofovir alaferamide for chronic hepatitis B. Biomed. Rep., 14.","DOI":"10.3892\/br.2020.1388"},{"key":"ref_12","first-page":"67","article-title":"Impact of baseline ALT and viral load on the efficacy of tenofovir disoproxil fumarate in chronic hepatitis B","volume":"75","author":"Kim","year":"2021","journal-title":"J. Hepatol."},{"key":"ref_13","doi-asserted-by":"crossref","first-page":"1254","DOI":"10.1016\/j.jhep.2023.06.002","article-title":"Guidance on treatment endpoints and study design for clinical trials aiming to achieve cure in chronic hepatitis B and D: Report from the 2022 AASLD-EASL HBV-HDV Treatment Endpoints Conference","volume":"79","author":"Ghany","year":"2023","journal-title":"J. Hepatol."},{"key":"ref_14","doi-asserted-by":"crossref","first-page":"1517","DOI":"10.1111\/liv.15261","article-title":"Efficacy and safety of tenofovir alafenamide versus tenofovir disoproxil fumarate in treatment-na\u00efve chronic hepatitis B","volume":"42","author":"Lim","year":"2022","journal-title":"Liver Int."},{"key":"ref_15","doi-asserted-by":"crossref","unstructured":"Nishikawa, T., Matsui, M., Onishi, S., Ushiro, K., Asai, A., Kim, S.K., and Nishikawa, H. (2024). Long-Term Outcomes after Switching to Tenofovir Alafenamide in Patients with Chronic Hepatitis B. Int. J. Mol. Sci., 25.","DOI":"10.3390\/ijms25042245"},{"key":"ref_16","doi-asserted-by":"crossref","first-page":"921","DOI":"10.1111\/apt.16788","article-title":"Review article: Switching patients with chronic hepatitis B to tenofovir alafenamide-a review of current data","volume":"55","author":"Lim","year":"2022","journal-title":"Aliment Pharmacol. Ther."},{"key":"ref_17","doi-asserted-by":"crossref","first-page":"773","DOI":"10.1053\/j.ajkd.2011.01.022","article-title":"Tenofovir-associated kidney toxicity in HIV-infected patients: A review of the evidence","volume":"57","author":"Hall","year":"2011","journal-title":"Am. J. Kidney Dis."},{"key":"ref_18","doi-asserted-by":"crossref","first-page":"2606","DOI":"10.1016\/S0140-6736(15)60616-X","article-title":"Tenofovir alafenamide versus tenofovir disoproxil fumarate, coformulated with elvitegravir, cobicistat, and emtricitabine, for initial treatment of HIV-1 infection: Two randomised, double-blind, phase 3, non-inferiority trials","volume":"385","author":"Sax","year":"2015","journal-title":"Lancet"},{"key":"ref_19","first-page":"354908","article-title":"Tenofovir nephrotoxicity: 2011 update","volume":"2011","author":"Sanz","year":"2011","journal-title":"AIDS Res. Treat."},{"key":"ref_20","doi-asserted-by":"crossref","first-page":"486","DOI":"10.14309\/ajg.0000000000002468","article-title":"Long-Term Treatment With Tenofovir Alafenamide for Chronic Hepatitis B Results in High Rates of Viral Suppression and Favorable Renal and Bone Safety","volume":"119","author":"Chan","year":"2024","journal-title":"Am. J. Gastroenterol."},{"key":"ref_21","doi-asserted-by":"crossref","first-page":"S653","DOI":"10.1016\/S0168-8278(20)32202-9","article-title":"Longer-term experience with tenofovir alafenamide (TAF) in HBVinfected patients; changes in EGFR, FIB4, ALT, and DNA suppression","volume":"73","author":"Reddy","year":"2020","journal-title":"J. Hepatol."},{"key":"ref_22","doi-asserted-by":"crossref","first-page":"1009","DOI":"10.4254\/wjh.v16.i7.1009","article-title":"Improvement of hepatic fibrosis after tenofovir disoproxil fumarate switching to tenofovir alafenamide for three years","volume":"16","author":"Huynh","year":"2024","journal-title":"World J. Hepatol."},{"key":"ref_23","doi-asserted-by":"crossref","first-page":"181","DOI":"10.1007\/s40273-019-00852-y","article-title":"Cost-Effectiveness of Tenofovir Alafenamide for Treatment of Chronic Hepatitis B in Canada","volume":"38","author":"Tian","year":"2020","journal-title":"Pharmacoeconomics"},{"key":"ref_24","doi-asserted-by":"crossref","unstructured":"Lai, C.-H., Shi, H.-Y., Tsai, C.-E., Yang, Y.-C., and Chiu, S.-U.F. (2024). Cost\u2013Utility Analysis of Tenofovir Alafenamide and Entecavir in Chronic Hepatitis B Patients: A Markov Decision Model. Cancers, 16.","DOI":"10.3390\/cancers16040813"},{"key":"ref_25","first-page":"315","article-title":"Cost-effectiveness of Tenofovir alafenamide versus Tenofovir disoproxil fumarate for treatment of chronic hepatitis B","volume":"35","author":"Stauffer","year":"2015","journal-title":"Clin. Drug Investig."},{"key":"ref_26","doi-asserted-by":"crossref","first-page":"811","DOI":"10.1007\/s00535-020-01698-4","article-title":"An expert review on the use of tenofovir alafenamide for the treatment of chronic hepatitis B virus infection in Asia","volume":"55","author":"Charlton","year":"2020","journal-title":"J. Gastroenterol."}],"container-title":["Pathogens"],"original-title":[],"language":"en","link":[{"URL":"https:\/\/www.mdpi.com\/2076-0817\/13\/9\/820\/pdf","content-type":"unspecified","content-version":"vor","intended-application":"similarity-checking"}],"deposited":{"date-parts":[[2025,10,10]],"date-time":"2025-10-10T16:00:57Z","timestamp":1760112057000},"score":1,"resource":{"primary":{"URL":"https:\/\/www.mdpi.com\/2076-0817\/13\/9\/820"}},"subtitle":[],"short-title":[],"issued":{"date-parts":[[2024,9,23]]},"references-count":26,"journal-issue":{"issue":"9","published-online":{"date-parts":[[2024,9]]}},"alternative-id":["pathogens13090820"],"URL":"https:\/\/doi.org\/10.3390\/pathogens13090820","relation":{},"ISSN":["2076-0817"],"issn-type":[{"value":"2076-0817","type":"electronic"}],"subject":[],"published":{"date-parts":[[2024,9,23]]}}}