Serum TNF-α and biomarkers Levels after Tenofovir in Patients with serum HBeAg-Positive Chronic Hepatitis B
Serum TNF-α and biomarkers and Chronic Hepatitis B
Keywords:
Serum, TNF-α, serum HBeAg-positive; chronic hepatitis B; Tenofovir Amibufenamide; liver function; renal function
Abstract
Introduction: chronic hepatitis B (CHB) is a serious and common infectious disease, the pathogenesis of which has not been fully elucidated. Tenofovir Amibufenamide belongs to the nucleoside reverse transcriptase inhibitor class and was allowed for CHB treatment. This work investigated the effectiveness and safety of Tenofovir Amibufenamide in treating HBeAg-positive CHB. Materials and Methods: 60 patients with HBeAg-positive CHB were grouped: an entecavir (ETV) group (entecavir, 0.5 mg) and a TMF group (Tenofovir Amibufenamide, 0.25 mg) at a 1:1 ratio. Changes in renal function, liver function, and tumor necrosis factor α (TNF-α) levels after 2 years of treatment were analyzed to assess the antiviral efficacy and safety. Results: patients in TMF group showed smaller changes in serum creatinine (Scr) and glomerular filtration rate (GFR) after treatment, and decreased alanine aminotransferase (ALT) and total bilirubin (TBIL), demonstrating obvious differences with those in ETV group (P<0.05). Postoperative TNF-α was elevated greatly in ETV group, showing obvious difference with that in TMF group (P<0.05). Meanwhile, in contrast to the ETV group, patients in the TMF group presented lower hepatitis B surface antigen (HBsAg), hepatitis B e antigen (HBeAg), and hepatitis B DNA load after treatment (P<0.05). Furthermore, the post-treatment incidence of adverse reactions (IoAR) was 13.3% in the ETV group and 3.3% in the TMF group (P>0.05). Conclusion: Tenofovir Amibufenamide in treating HBeAg-positive CHB exhibited better efficacy, remarkable improvement in liver function, no impact on renal function, and high safety.
References
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31. El Jamaly H, Eslick GD, Weltman M. Meta-analysis: hepatitis B reactivation in patients receiving biological therapy. Alimentary Pharmacology & Therapeutics, 2022;56(7):1104-1118.
32. Talaat RM, Abdelkhalek MS, El-Maadawy EA, Abdel-Mageed WS, El-Shenawy SZ, Osman MA. Association of TNF-Alpha gene polymorphisms and susceptibility to hepatitis B virus infection in egyptians. Human Immunology, 2017;78(11-12):739-746.
33. Shiue SJ, Cheng CL, Shiue HS, Chen CN, Cheng SW, Wu LW, Jargalsaikhan G, Chan TS, Lin HY, Wu MS. Arthrospira enhances seroclearance in patients with chronic hepatitis B receiving nucleos(t)ide analogue through modulation of TNF-α/IFN-γ profile. Nutrients, 2022;14(14):2790(1-16).
34. Park YK, Park ES, Kim DH, Ahn SH, Park SH, Lee AR, Park S, Kang HS, Lee JH, Kim JM, Lee SK, Lim KH, Isorce N, Tong S, Zoulim F, Kim KH. Cleaved c-FLIP mediates the antiviral effect of TNF-α against hepatitis B virus by dysregulating hepatocyte nuclear factors. Journal of Hepatology, 2016;64(2):268-277.
35. Suhail M, Abdel-Hafiz H, Ali A, Fatima K, Damanhouri GA, Azhar E, Chaudhary AG, Qadri I. Potential mechanisms of hepatitis B virus induced liver injury. World Journal of Gastroenterology, 2014;20(35):12462-72.
36. Bacaksız F, Gökcan H, Akdoğan M, Gökçe DT, Arı D, Gökbulut V, Ergün Y, Öztürk Ö, Kacar S. Role of hepatosteatosis in HBsAg seroconversion in HBeAg-negative chronic hepatitis B patients. International Journal of Clinical Practice, 2021;75(12):e14899(1-6).
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2. Nguyen MH, Wong G, Gane E, Kao JH, Dusheiko G. Hepatitis B virus: advances in prevention, diagnosis, and therapy. Clinical Microbiology Reviews, 2020;33(2):e00046-19.
3. Wilkins T, Sams R, Carpenter M. Hepatitis B: screening, prevention, diagnosis, and treatment. American Family Physician, 2019;99(5):314-323.
4. Marrone A, Ciotti M, Rinaldi L, Adinolfi LE, Ghany M. Hepatitis B and C virus infection and risk of haematological malignancies. Journal of Viral Hepatitis, 2020;27(1):4-12.
5. Loggi E, Gitto S, Gabrielli F, Franchi E, Seferi H, Cursaro C, Andreone P. Virological treatment monitoring for chronic hepatitis B. Viruses, 2022;14(7):1376(1-14).
6. Tong J, Ye T, Yang XF, Peng H, Xiao X, Xie BJ, Wan ZQ, Li W, Zhou L, Chen J, Guo JJ. HBeAg precursor proteins interact with APOBEC3A and inhibit HBV replication. Journal of Biological Regulators and Homeostatic Agents, 2023;37(3):1361-1370
7. Liu SH, Seto WK, Lai CL, Yuen MF. Hepatitis B: treatment choice and monitoring for response and resistance. Expert Review of Gastroenterology & Hepatology, 2016;10(6):697-707.
8. Li L, Zhou J, Li Y, Wang F, Zhang D, Wang M, Tao Y, Chen E. Effectiveness and safety of tenofovir amibufenamide and its comparison with tenofovir alafenamide in patients with chronic hepatitis B: results from a retrospective real-world study. Frontiers in Pharmacology, 2023;14:1165990(1-12).
9. Liu Z, Jin Q, Zhang Y, Gong G, Wu G, Yao L, Wen X, Gao Z, Huang Y, Yang D, Chen E, Mao Q, Lin S, Shang J, Gong H, Zhong L, Yin H, Wang F, Hu P, Wu Q, Pan C, Jia W, Li C, Sun C, Niu J, Hou J; TMF Study Group. 96-Week treatment of tenofovir amibufenamide and tenofovir disoproxil fumarate in chronic hepatitis B patients. Journal of Clinical and Translational Hepatology, 2023;11(3):649-660.
10. Hong X, Cai Z, Zhou F, Jin X, Wang G, Ouyang B, Zhang J. Improved pharmacokinetics of tenofovir ester prodrugs strengthened the inhibition of HBV replication and the rebalance of hepatocellular metabolism in preclinical models. Frontiers in Pharmacology, 2022;13:932934(1-17).
11. Liu Z, Jin Q, Zhang Y, Gong G, Wu G, Yao L, Wen X, Gao Z, Huang Y, Yang D, Chen E, Mao Q, Lin S, Shang J, Gong H, Zhong L, Yin H, Wang F, Hu P, Xiao L, Li C, Wu Q, Sun C, Niu J, Hou J; TMF Study Group. Randomised clinical trial: 48 weeks of treatment with tenofovir amibufenamide versus tenofovir disoproxil fumarate for patients with chronic hepatitis B. Alimentary Pharmacology & Therapeutics, 2021;54(9):1134-1149.
12. Chang ML, Liaw YF. Hepatitis B flare in hepatitis B e antigen-negative patients: a complicated cascade of innate and adaptive immune responses. International Journal of Molecular Sciences, 2022;23(3):1552(1-23).
13. Xing T, Xu H, Cao L, Ye M. HBeAg seroconversion in HBeAg-positive chronic hepatitis B patients receiving long-term nucleos(t)ide analog treatment: a systematic review and network meta-analysis. PLoS One, 2017;12(1):e0169444(1-18).
14. Chu YJ, Jeng WJ, Pan MH, Hu HH, Luo WS, Su CY, Chiang CT, Jen CL, Chen CJ, Yang HI. Serum soluble programmed death-1 levels predict the spontaneous HBeAg seroclearance in chronic hepatitis B. Journal of Gastroenterology, 2022;57(6):423-432.
15. Agarwal K, Brunetto M, Seto WK, Lim YS, Fung S, Marcellin P, Ahn SH, Izumi N, Chuang WL, Bae H, Sharma M, Janssen HLA, Pan CQ, Çelen MK, Furusyo N, Shalimar D, Yoon KT, Trinh H, Flaherty JF, Gaggar A, Lau AH, Cathcart AL, Lin L, Bhardwaj N, Suri V, Mani Subramanian G, Gane EJ, Buti M, Chan HLY; GS-US-320-0110; GS-US-320-0108 Investigators. 96 weeks treatment of tenofovir alafenamide vs. tenofovir disoproxil fumarate for hepatitis B virus infection. Journal of Hepatology, 2018;68(4):672-681.
16. Van Bömmel F, Berg T. Risks and Benefits of discontinuation of nucleos(t)ide analogue treatment: a treatment concept for patients with HBeAg-negative chronic hepatitis B. Hepatology Communications, 2021;5(10):1632-1648.
17. Tovo CV, Ahlert M, Panke C, de Mattos ÂZ, de Mattos AA. Treatment of hepatitis B virus infection in chronic infection with HBeAg-positive adult patients (immunotolerant patients): a systematic review. European Journal of Gastroenterology & Hepatology Publish Ahead of Print, 2021;33(5):605-609.
18. Tan DJH, Ng CH, Tay PWL, Syn N, Muthiah MD, Lim WH, Tang ASP, Lim KE, Lim GEH, Tamaki N, Kim BK, Teng MLP, Fung J, Loomba R, Nguyen MH, Huang DQ. Risk of hepatocellular carcinoma with tenofovir vs entecavir treatment for chronic hepatitis B virus: a reconstructed individual patient data meta-analysis. JAMA Network Open, 2022;5(6):e2219407(1-15).
19. Jourdain G, Ngo-Giang-Huong N, Harrison L, Decker L, Khamduang W, Tierney C, Salvadori N, Cressey TR, Sirirungsi W, Achalapong J, Yuthavisuthi P, Kanjanavikai P, Na Ayudhaya OP, Siriwachirachai T, Prommas S, Sabsanong P, Limtrakul A, Varadisai S, Putiyanun C, Suriyachai P, Liampongsabuddhi P, Sangsawang S, Matanasarawut W, Buranabanjasatean S, Puernngooluerm P, Bowonwatanuwong C, Puthanakit T, Klinbuayaem V, Thongsawat S, Thanprasertsuk S, Siberry GK, Watts DH, Chakhtoura N, Murphy TV, Nelson NP, Chung RT, Pol S, Chotivanich N. Tenofovir versus placebo to prevent perinatal transmission of hepatitis B. The New-England Medical Review and Journal, 2018;378(10):911-923
20. Li LQ, Zhou J, Li YJ, Wang FD, Zhang DM, Wang ML, Tao YC, Chen EQ. Effectiveness and safety of tenofovir amibufenamide and its comparison with tenofovir alafenamide in patients with chronic hepatitis B: results from a retrospective real-world study. Frontiers in Pharmacology, 2023;14:1165990(1-12).
21. Atilla A, Taşkın MH, Kazak Z, Aydın S, Kılıç SS. GP73 level in patients with chronic hepatitis B: Relationship with liver biopsy, levels of ALT, AST and HBV DNA. Indian Journal of Pathology & Microbiology, 2022;65(1):55-58.
22. Makita T, Kanzaki H, Onishi H, Ikeda A, Takaki A, Wada N, Takeuchi Y, Yasunaka T, Ikeda F, Shiraha H, Tanaka Y, Nishihara S, Murakawa K, Kitamura Y, Okada H, Sendo T. [Adefovir dipivoxil-induced fanconi's syndrome and osteomalacia following multiple bone fractures in a patient with chronic hepatitis B]. Yakugaku Zasshi: Journal of the Pharmaceutical Society of Japan, 2019;139(4):641-645.
23. Li J, Hu C, Chen Y, Zhang R, Fu S, Zhou M, Gao Z, Fu M, Yan T, Yang Y, Li J, Liu J, Chen T, Zhao Y, He Y. Short-term and long-term safety and efficacy of tenofovir alafenamide, tenofovir disoproxil fumarate and entecavir treatment of acute-on-chronic liver failure associated with hepatitis B. BMC Infectious Diseases, 2021;21(1):567(1-9).
24. Jung CY, Kim HW, Ahn SH, Kim SU, Kim BS. Higher risk of kidney function decline with entecavir than tenofovir alafenamide in patients with chronic hepatitis B. Liver International: Official Journal of the International Association for the Study of the Liver, 2022;42(5):1017-1026.
25. Yap DY, Yung S, Tang CS, Seto WK, Ma MK, Mok MM, Kwan LP, Chan GC, Choy BY, Yuen MF, Chan TM. Entecavir treatment in kidney transplant recipients infected with hepatitis B. Clinical Transplantation, 2014;28(9):1010-5.
26. Tsai MC, Chang KC, Yen YH, Wu CK, Lin MT, Hu TH. Comparison of tenofovir and entecavir in the development of acute kidney injury in cirrhotic chronic hepatitis B patients with refractory ascites. European Journal of Gastroenterology & Hepatology Publish Ahead of Print, 2021;32(2):208-213.
27. Law ST, Li KK, Ho YY. Acquired fanconi syndrome associated with prolonged adefovir dipivoxil therapy in a chronic hepatitis B patient. American Journal of Therapeutics, 2013;20(6):e713-6.5.
28. Wong GL, Wen WH, Pan CQ. Hepatitis b-management of acute infection and active inflammation in pregnancy-a hepatologist's perspective. Best Practice & Research. Clinical Obstetrics & Gynaecology, 2020;68:54-65.
29. Saxena R, Kaur J. Th1/Th2 cytokines and their genotypes as predictors of hepatitis B virus related hepatocellular carcinoma. World Journal of Hepatology, 2015;7(11):1572-80.
30. Sominskaya I, Skrastina D, Petrovskis I, Dishlers A, Berza I, Mihailova M, Jansons J, Akopjana I, Stahovska I, Dreilina D, Ose V, Pumpens P. A VLP library of C-terminally truncated Hepatitis B core proteins: correlation of RNA encapsidation with a Th1/Th2 switch in the immune responses of mice. PLoS One, 2013;8(9):e75938(1-13).
31. El Jamaly H, Eslick GD, Weltman M. Meta-analysis: hepatitis B reactivation in patients receiving biological therapy. Alimentary Pharmacology & Therapeutics, 2022;56(7):1104-1118.
32. Talaat RM, Abdelkhalek MS, El-Maadawy EA, Abdel-Mageed WS, El-Shenawy SZ, Osman MA. Association of TNF-Alpha gene polymorphisms and susceptibility to hepatitis B virus infection in egyptians. Human Immunology, 2017;78(11-12):739-746.
33. Shiue SJ, Cheng CL, Shiue HS, Chen CN, Cheng SW, Wu LW, Jargalsaikhan G, Chan TS, Lin HY, Wu MS. Arthrospira enhances seroclearance in patients with chronic hepatitis B receiving nucleos(t)ide analogue through modulation of TNF-α/IFN-γ profile. Nutrients, 2022;14(14):2790(1-16).
34. Park YK, Park ES, Kim DH, Ahn SH, Park SH, Lee AR, Park S, Kang HS, Lee JH, Kim JM, Lee SK, Lim KH, Isorce N, Tong S, Zoulim F, Kim KH. Cleaved c-FLIP mediates the antiviral effect of TNF-α against hepatitis B virus by dysregulating hepatocyte nuclear factors. Journal of Hepatology, 2016;64(2):268-277.
35. Suhail M, Abdel-Hafiz H, Ali A, Fatima K, Damanhouri GA, Azhar E, Chaudhary AG, Qadri I. Potential mechanisms of hepatitis B virus induced liver injury. World Journal of Gastroenterology, 2014;20(35):12462-72.
36. Bacaksız F, Gökcan H, Akdoğan M, Gökçe DT, Arı D, Gökbulut V, Ergün Y, Öztürk Ö, Kacar S. Role of hepatosteatosis in HBsAg seroconversion in HBeAg-negative chronic hepatitis B patients. International Journal of Clinical Practice, 2021;75(12):e14899(1-6).
37. Perrillo R, Lin HS, Schwarz KB, Rosenthal P, Lisker-Melman M, Chung RT, Prokunina-Olsson L, Cloherty G, Feld J; Hepatitis B Research Network (HBRN). Changes in serum hepatitis B surface and e antigen, interferon-inducible protein 10, and aminotransferase levels during combination therapy of immune-tolerant chronic hepatitis B. Hepatology (Baltimore, Md.), 2022;76(3):775-787.
38. Chang X, Wang J, Chen Y, Long Q, Song L, Li Q, Liu H, Shang Q, Yu Z, Jiang L, Xiao G, Li L, Chen L, Wang X, Li Z, Chen D, Dong Z, An L, Tan L, Chen Y, Yang Y. A novel nomogram to predict evident histological liver injury in patients with HBeAg-positive chronic hepatitis B virus infection. EBioMedicine, 2021;67:103389(1-11).
39. Li M, Zhang L, Xie S, Sun F, Zeng Z, Deng W, Jiang T, Bi X, Lin Y, Yang L, Lu Y, Shen G, Liu R, Wu S, Chang M, Hu L, Dong J, Yi W, Xie Y. Dynamic changes of cytokine profiles and virological markers associated with HBsAg loss during peginterferon alpha-2a treatment in HBeAg-positive chronic hepatitis B patients. Frontiers in Immunology, 2022;13:892031(1-11).
Published
2025/03/05
Section
Original paper
Copyright (c) 2025 Xijie Lai
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