First year real life experience with tenofovir alafenamide  fumarate: The pythagorean cohort

Background and Aim: In chronic hepatitis B infection, antiviral therapy significantly reduces the incidence of complications. This study aimed to present real-life 12-month effectiveness and safety data for TAF. Materials and Methods: This Pythagoras Retrospective Cohort Study in cluded patients from 14 centers in Turkiye. The study presents 12-month results of 480 patients treated with TAF as initial therapy or after switching from another antiviral drug. Results: The study shows treatment of about 78.1% patients with at least one antiviral agent (90.6% tenofovir disoproxil [TDF]). The rate of unde tectable HBV DNA increased in both treatment-experienced and naive pa tients. In TDF-experienced patients, the rate of alanine transaminase (ALT) normalization increased slightly (1.6%) within 12 months, but the change was not statistically significant (p=0.766). Younger age, low albumin, and high body mass index and cholesterol were identified as risk factors for abnormal ALT after 12 months, but no linear relationship was detected. In TDF-experienced patients, renal and bone function indicators showed sig nificant improvement three months after the transition to TAF and remained stable for 12 months. Conclusion: Real-life data demonstrated effective virological and bio chemical responses with TAF therapy. After switching to TAF treat ment, gains in kidney and bone functions were achieved in the early period.

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1. Roade L, Riveiro-Barciela M, Esteban R, Buti M. Long-term efficacy and safety of nucleos(t)ides analogues in patients with chronic hepatitis B. Ther Adv Infect Dis 2021;8:2049936120985954.
2. Tang LS, Covert E, Wilson E, Kottilil S. Chronic Hepatitis B infection: a review. JAMA 2018;319(17):1802-1813.
3. Papatheodoridis GV, Manolakopoulos S, Dusheiko G, Archimandritis AJ. Therapeutic strategies in the management of patients with chronic Hepatitis B virus infection. Lancet Infect Dis 2008;8(3):167-178.
4. Buti M, Riveiro-Barciela M, Esteban R. Tenofovir alafenamide fumarate: a new tenofovir prodrug for the treatment of chronic Hepatitis B infection. J Infect Dis 2017;216(8): S792-S796.
5. Charlton MR, Alam A, Shukla A, Dashtseren B, Lesmana CRA, Duger D, et al. An expert review on the use of tenofovir alafenamide for the treatment of chronic hepatitis B virus infection in Asia. J Gastroenterol 2020;55(9):811- 823.
6. Chen YC, Su YC, Li CY, Hung SK. 13-year nationwide cohort study of chronic kidney disease risk among treatment-naïve patients with chronic hepatitis B in Taiwan. BMC Nephrol 2015;16:110.
7. European Association for the Study of the Liver. Electronic address: easlof fice@easloffice.eu; European Association for the Study of the Liver. EASL 2017 Clinical Practice Guidelines on the management of hepatitis B virus infection. J Hepatol 2017;67(2):370-398.
8. Terrault NA, Lok ASF, McMahon BJ, Chang KM, Hwang JP, Jonas MM, et al. Update on prevention, diagnosis, and treatment of chronic hepatitis B: AASLD 2018 hepatitis B guidance. Hepatology 2018;67(4):1560-1599.
9. Karasahin O, Akdemir Kalkan I, Dal T, Altunisik Toplu S, Harputoglu M, Mete AO, et al. Real-life data for tenofovir alafenamide fumarate treatment of hepatitis B: The pythagoras cohort. Hepat Mon 2021;21(2):e104943.
10. Kau A, Vermehren J, Sarrazin C. Treatment predictors of a sustained viro logic response in Hepatitis B and C. J Hepatol 2008;49(4):634-651.
11. Buti M, Gane E, Seto WK, Chan HL, Chuang WL, Stepanova T, et al; GS US-320-0108 Investigators. Tenofovir alafenamide versus tenofovir diso proxil fumarate for the treatment of patients with HBeAg-negative chronic hepatitis B virus infection: a randomised, double-blind, phase 3, non-inferi ority trial. Lancet Gastroenterol Hepatol 2016;1(3):196-206.
12. Chan HL, Fung S, Seto WK, Chuang WL, Chen CY, Kim HJ, et al; GS US-320-0110 Investigators. Tenofovir alafenamide versus tenofovir diso proxil fumarate for the treatment of HBeAg-positive chronic hepatitis B virus infection: a randomised, double-blind, phase 3, non-inferiority trial. Lancet Gastroenterol Hepatol 2016;1(3):185-195.
13. US Food and Drug Administration. Prescribing information for vemlidy (tenofovir alafenamide) 2020 [Available from: https://www.accessdata.fda. gov/drugsatfda_docs/label/2020/208464s008lbl.pdf.] (assessed date: 20 April 2021)
14. Babusis D, Phan TK, Lee WA, Watkins WJ, Ray AS. Mechanism for ef fective lymphoid cell and tissue loading following oral administration of nucleotide prodrug GS-7340. Mol Pharm 2013;10(2):459-466.
15. Kaneko S, Kurosaki M, Tamaki N, Itakura J, Hayashi T, Kirino S, et al. Tenofovir alafenamide for hepatitis B virus infection including switch ing therapy from tenofovir disoproxil fumarate. J Gastroenterol Hepatol 2019;34(11):2004-2010.
16. Ogawa E, Nomura H, Nakamuta M, Furusyo N, Koyanagi T, Dohmen K, et al; Kyushu University Liver Disease Study (KULDS) Group. Tenofovir alafenamide after switching from entecavir or nucleos(t)ide combination therapy for patients with chronic hepatitis B. Liver Int 2020;40(7):1578- 1589.
17. Scherzer R, Estrella M, Li Y, Choi AI, Deeks SG, Grunfeld C, Shlipak MG. Association of tenofovir exposure with kidney disease risk in HIV infection. AIDS 2012;26(7):867-875.
18. Marcellin P, Wong DK, Sievert W, Buggisch P, Petersen J, Flisiak R, et al. Ten-year efficacy and safety of tenofovir disoproxil fumarate treatment for chronic hepatitis B virus infection. Liver Int 2019;39(10):1868-1875.
19. Lampertico P, Buti M, Fung S, Ahn SH, Chuang WL, Tak WY, et al. Switch ing from tenofovir disoproxil fumarate to tenofovir alafenamide in viro logically suppressed patients with chronic hepatitis B: a randomised, dou ble-blind, phase 3, multicentre non-inferiority study. Lancet Gastroenterol Hepatol 2020;5(5):441-453.
20. Farag MS, Fung S, Tam E, Doucette K, Wong A, Ramji A, et al. Effec tiveness and renal safety of tenofovir alafenamide fumarate among chronic hepatitis B patients: real-world study. J Viral Hepat 2021;28(6):942-950.
21. Farag MS, Fung S, Tam E, Doucette K, Wong A, Ramji A, et al. Effective ness and Renal Safety of Tenofovir Alafenamide Fumarate among Chronic Hepatitis B Patients: Real-World Study. J Viral Hepat 2021;28(6):942-950.
22. Casado JL. Renal and bone toxicity with the use of tenofovir: Understand ing at the end. AIDS Rev 2016;18(2):59-68.
23. Gill US, Zissimopoulos A, Al-Shamma S, Burke K, McPhail MJ, Barr DA, et al. Assessment of bone mineral density in tenofovir-treated patients with chronic hepatitis B: can the fracture risk assessment tool identify those at greatest risk? J Infect Dis 2015;211(3):374-382.
24. Santos JR, Saumoy M, Curran A, et al. The lipid-lowering effect of teno fovir/emtricitabine: a randomized, crossover, double-blind, placebo-con trolled trial. Clin Infect Dis 2015;61(3):403-408.
25. Randell PA, Jackson AG, Zhong L, Yale K, Moyle GJ. The effect of teno fovir disoproxil fumarate on whole-body insulin sensitivity, lipids and adipokines in healthy volunteers. Antivir Ther 2010;15(2):227-233.
26. Sarı ND, Köksal I, Erdem H, Yıldız D, İnce N, Yamazhan T, et al. Changes in lipid profile among HBV patients treated with tenofovir alafenamide: Turkey’s experience of real life setting. AASLD-TASL; Digital Hepatology Connect, January 15-16, 2021.
27. Onat A, Hergenç G, Uzunlar B, Ceyhan K, Uyarel H. Türk toplumunda ko roner risk faktörü olarak HDL-kolesterol: öngördürücülüğü, belirleyicileri ve ilişkileri. Türk Kardiyol Dern Arş 2003;31:9-16. [Turkish]
28. Onat A, Can G, Yüksel H, Ademoğlu E, Ünaltuna NE, Kaya A. TEKHARF 2017 Tıp dünyasının kronik hastalıklara yaklaşımına öncülük. İstanbul: Lo gos Yayıncılık, 2017. [Turkish]

APA	Karaşahin Ö, Akdemir Kalkan İ, Dal T, ALTUNIŞIK TOPLU S, Harputluoglu M, mete a, komur s, Sarıgül F, Yildiz Y, ESMER F, Kandemir Ö, NAZİK S, İNAN D, akgul f, Kaya S, TUNÇ N, BAYINDIR Y, özer balın ş, TASOVA Y, aktar f, Ören M, ayhan m, DEMİR Y, CELEN M (2023). First year real life experience with tenofovir alafenamide fumarate: The pythagorean cohort. , 61 - 68. 10.14744/hf.2022.2022.0043
Chicago	Karaşahin Ömer,Akdemir Kalkan İrem,Dal Tuba,ALTUNIŞIK TOPLU SİBEL,Harputluoglu Murat,mete ayşe özlem,komur suheyla,Sarıgül Figen,Yildiz Yesim,ESMER FATİH,Kandemir Özlem,NAZİK SELÇUK,İNAN DİLARA,akgul fethiye,Kaya Safak,TUNÇ NURETTIN,BAYINDIR Yasar,özer balın şafak,TASOVA YESIM,aktar fesih,Ören Merve,ayhan merve,DEMİR YAKUP,CELEN MUSTAFA First year real life experience with tenofovir alafenamide fumarate: The pythagorean cohort. (2023): 61 - 68. 10.14744/hf.2022.2022.0043
MLA	Karaşahin Ömer,Akdemir Kalkan İrem,Dal Tuba,ALTUNIŞIK TOPLU SİBEL,Harputluoglu Murat,mete ayşe özlem,komur suheyla,Sarıgül Figen,Yildiz Yesim,ESMER FATİH,Kandemir Özlem,NAZİK SELÇUK,İNAN DİLARA,akgul fethiye,Kaya Safak,TUNÇ NURETTIN,BAYINDIR Yasar,özer balın şafak,TASOVA YESIM,aktar fesih,Ören Merve,ayhan merve,DEMİR YAKUP,CELEN MUSTAFA First year real life experience with tenofovir alafenamide fumarate: The pythagorean cohort. , 2023, ss.61 - 68. 10.14744/hf.2022.2022.0043
AMA	Karaşahin Ö,Akdemir Kalkan İ,Dal T,ALTUNIŞIK TOPLU S,Harputluoglu M,mete a,komur s,Sarıgül F,Yildiz Y,ESMER F,Kandemir Ö,NAZİK S,İNAN D,akgul f,Kaya S,TUNÇ N,BAYINDIR Y,özer balın ş,TASOVA Y,aktar f,Ören M,ayhan m,DEMİR Y,CELEN M First year real life experience with tenofovir alafenamide fumarate: The pythagorean cohort. . 2023; 61 - 68. 10.14744/hf.2022.2022.0043
Vancouver	Karaşahin Ö,Akdemir Kalkan İ,Dal T,ALTUNIŞIK TOPLU S,Harputluoglu M,mete a,komur s,Sarıgül F,Yildiz Y,ESMER F,Kandemir Ö,NAZİK S,İNAN D,akgul f,Kaya S,TUNÇ N,BAYINDIR Y,özer balın ş,TASOVA Y,aktar f,Ören M,ayhan m,DEMİR Y,CELEN M First year real life experience with tenofovir alafenamide fumarate: The pythagorean cohort. . 2023; 61 - 68. 10.14744/hf.2022.2022.0043
IEEE	Karaşahin Ö,Akdemir Kalkan İ,Dal T,ALTUNIŞIK TOPLU S,Harputluoglu M,mete a,komur s,Sarıgül F,Yildiz Y,ESMER F,Kandemir Ö,NAZİK S,İNAN D,akgul f,Kaya S,TUNÇ N,BAYINDIR Y,özer balın ş,TASOVA Y,aktar f,Ören M,ayhan m,DEMİR Y,CELEN M "First year real life experience with tenofovir alafenamide fumarate: The pythagorean cohort." , ss.61 - 68, 2023. 10.14744/hf.2022.2022.0043
ISNAD	Karaşahin, Ömer vd. "First year real life experience with tenofovir alafenamide fumarate: The pythagorean cohort". (2023), 61-68. https://doi.org/10.14744/hf.2022.2022.0043

APA	Karaşahin Ö, Akdemir Kalkan İ, Dal T, ALTUNIŞIK TOPLU S, Harputluoglu M, mete a, komur s, Sarıgül F, Yildiz Y, ESMER F, Kandemir Ö, NAZİK S, İNAN D, akgul f, Kaya S, TUNÇ N, BAYINDIR Y, özer balın ş, TASOVA Y, aktar f, Ören M, ayhan m, DEMİR Y, CELEN M (2023). First year real life experience with tenofovir alafenamide fumarate: The pythagorean cohort. Hepatology forum, 4(2), 61 - 68. 10.14744/hf.2022.2022.0043
Chicago	Karaşahin Ömer,Akdemir Kalkan İrem,Dal Tuba,ALTUNIŞIK TOPLU SİBEL,Harputluoglu Murat,mete ayşe özlem,komur suheyla,Sarıgül Figen,Yildiz Yesim,ESMER FATİH,Kandemir Özlem,NAZİK SELÇUK,İNAN DİLARA,akgul fethiye,Kaya Safak,TUNÇ NURETTIN,BAYINDIR Yasar,özer balın şafak,TASOVA YESIM,aktar fesih,Ören Merve,ayhan merve,DEMİR YAKUP,CELEN MUSTAFA First year real life experience with tenofovir alafenamide fumarate: The pythagorean cohort. Hepatology forum 4, no.2 (2023): 61 - 68. 10.14744/hf.2022.2022.0043
MLA	Karaşahin Ömer,Akdemir Kalkan İrem,Dal Tuba,ALTUNIŞIK TOPLU SİBEL,Harputluoglu Murat,mete ayşe özlem,komur suheyla,Sarıgül Figen,Yildiz Yesim,ESMER FATİH,Kandemir Özlem,NAZİK SELÇUK,İNAN DİLARA,akgul fethiye,Kaya Safak,TUNÇ NURETTIN,BAYINDIR Yasar,özer balın şafak,TASOVA YESIM,aktar fesih,Ören Merve,ayhan merve,DEMİR YAKUP,CELEN MUSTAFA First year real life experience with tenofovir alafenamide fumarate: The pythagorean cohort. Hepatology forum, vol.4, no.2, 2023, ss.61 - 68. 10.14744/hf.2022.2022.0043
AMA	Karaşahin Ö,Akdemir Kalkan İ,Dal T,ALTUNIŞIK TOPLU S,Harputluoglu M,mete a,komur s,Sarıgül F,Yildiz Y,ESMER F,Kandemir Ö,NAZİK S,İNAN D,akgul f,Kaya S,TUNÇ N,BAYINDIR Y,özer balın ş,TASOVA Y,aktar f,Ören M,ayhan m,DEMİR Y,CELEN M First year real life experience with tenofovir alafenamide fumarate: The pythagorean cohort. Hepatology forum. 2023; 4(2): 61 - 68. 10.14744/hf.2022.2022.0043
Vancouver	Karaşahin Ö,Akdemir Kalkan İ,Dal T,ALTUNIŞIK TOPLU S,Harputluoglu M,mete a,komur s,Sarıgül F,Yildiz Y,ESMER F,Kandemir Ö,NAZİK S,İNAN D,akgul f,Kaya S,TUNÇ N,BAYINDIR Y,özer balın ş,TASOVA Y,aktar f,Ören M,ayhan m,DEMİR Y,CELEN M First year real life experience with tenofovir alafenamide fumarate: The pythagorean cohort. Hepatology forum. 2023; 4(2): 61 - 68. 10.14744/hf.2022.2022.0043
IEEE	Karaşahin Ö,Akdemir Kalkan İ,Dal T,ALTUNIŞIK TOPLU S,Harputluoglu M,mete a,komur s,Sarıgül F,Yildiz Y,ESMER F,Kandemir Ö,NAZİK S,İNAN D,akgul f,Kaya S,TUNÇ N,BAYINDIR Y,özer balın ş,TASOVA Y,aktar f,Ören M,ayhan m,DEMİR Y,CELEN M "First year real life experience with tenofovir alafenamide fumarate: The pythagorean cohort." Hepatology forum, 4, ss.61 - 68, 2023. 10.14744/hf.2022.2022.0043
ISNAD	Karaşahin, Ömer vd. "First year real life experience with tenofovir alafenamide fumarate: The pythagorean cohort". Hepatology forum 4/2 (2023), 61-68. https://doi.org/10.14744/hf.2022.2022.0043