SAFETY AND EFFICACY OF TENOFOVIR DISOPROXIL FUMARATE VERSUS TENOFOVIR ALAFENAMIDE IN THE TREATMENT OF CHRONIC HEPATITIS B: A HOSPITAL-BASED OBSERVATIONAL STUDY
Main Article Content
Keywords
ALT, bone mineral density, HBV-DNA, HBeAg, India
Abstract
While vaccination has lowered the rate of new infections, HBV still results in large number of new cases annually, particularly in the low and middle income countries. Both tenofovir disoproxil fumarate (TDF) and tenofovir alafenamide (TAF) are prodrugs of tenofovir approved for the treatment of chronic hepatitis B. The primary and secondary objective of the study was to compare the efficacy of TAF versus TDF and safety of the study drugs with respect to their impact on kidneys and bones, respectively.
Method:
A total of 104 patients with CHB were divided equally into two groups; group A received Tab. TDF 300mg once daily for 48wks and group B received Tab. TAF 25mg once daily for 48 weeks. All the cases were monitored 12-weekly up till 48 weeks. Efficacy was assessed in terms of virological, serological and biochemical responses. Safety was evaluated by assessing serum creatinine, serum urea and bone mineral density and any adverse drug reactions.
Results:
HBV-DNA levels and HBeAg status were comparable between the two groups at each follow-up. At 48 weeks, the average ALT levels and serum creatinine levels were significantly lower with TAF than TDF (p < 0.05). Bone mineral density tests performed on the hip and spine at 48 weeks revealed that the average BMD with TAF was significantly higher than TDF.
Conclusion: TAF is equally efficacious to the conventionally used TDF while additionally being significantly safer for kidneys and bones.
References
2. Premkumar M, Kumar Chawla Y. Chronic Hepatitis B: Challenges and Successes in India. Clin Liver Dis. 2021;18(3):111–6.
3. Venkatesh SRKD. Diagnosis & Management of Viral Hepatitis. National Health Mission. 2018;1(1):1–80.
4. Lee BT, Chang M, Lim C, Bae HS, Fong TL. Bone and renal safety profile at 72 weeks after switching to tenofovir alafenamide in chronic hepatitis B patients. JGH Open. 2021;5(2):258–63.
5. Lim YS, Chan HLY, Ahn SH, Seto WK, Ning Q, Agarwal K, et al. Tenofovir alafenamide and tenofovir disoproxil fumarate reduce incidence of hepatocellular carcinoma in patients with chronic hepatitis B. JHEP Reports [Internet]. 2023;5(10):100847. Available from: https://doi.org/10.1016/j.jhepr.2023.100847
6. Nguyen MH, Wong G, Gane E, Kao JH, Dusheiko G. Hepatitis B virus: Advances in prevention, diagnosis, and therapy. Clin Microbiol Rev. 2020;33(2).
7. Chevaliez S, Roudot-Thoraval F, Brouard C, Gordien E, Zoulim F, Brichler S, et al. Clinical and virological features of chronic hepatitis B in the French national surveillance program, 2008–2012: A cross-sectional study. JHEP Rep. 2022;4(12):100550. doi:10.1016/j.jhepr.2022.100550.
8. Barbosa JV, Sahli R, Aubert V, Chaouch A, Moradpour D, Fraga M. Demographics and outcomes of hepatitis B and D: A 10-year retrospective analysis in a Swiss tertiary referral center. PLoS One [Internet]. 2021;16(27 April 2021):1–14. Available from: http://dx.doi.org/10.1371/journal.pone.0250347
9. Lahariya C, Subramanya BP, Sosler S. An assessment of hepatitis B vaccine introduction in India: Lessons for roll out and scale up of new vaccines in immunization programs. Indian J Public Health. 2013;57(1):8–14.
10. Liu M, Li L, Zhao J, Ungvari GS, Ng CH, Duan Z, et al. Gender differences in demographic and clinical characteristics in patients with HBV-related liver diseases in China. PeerJ. 2022;10.
11. Hamidu RB, Chalikonda DM, Hann HW. Gender disparity in host responses to hepatitis b-related hepatocellular carcinoma: A case series. Vaccines. 2021;9(8):1–9.
12. Matthews PC, Brown R, Goulder P. Sexual Dimorphism in Chronic Hepatitis B Virus (HBV) Infection: Evidence to Inform Elimination Efforts. Wellcome Open Res. 2022;7(May):1–22.
13. Byun KS, Choi J, Kim JH, Lee YS, Lee HC, Kim YJ, et al. Tenofovir Alafenamide for Drug-Resistant Hepatitis B: A Randomized Trial for Switching From Tenofovir Disoproxil Fumarate. Clin Gastroenterol Hepatol [Internet]. 2022;20(2):427-437.e5. Available from: https://doi.org/10.1016/j.cgh.2021.04.045
14. Hou J, Ning Q, Duan Z, Chen Y, Xie Q, Wang FS, et al. 3-year treatment of tenofovir alafenamide vs. Tenofovir disoproxil fumarate for chronic hbv infection in China. J Clin Transl Hepatol. 2021;9(3):324–34.
15. Byrne R, Carey I, Agarwal K. Tenofovir alafenamide in the treatment of chronic hepatitis B virus infection: rationale and clinical trial evidence. Therap Adv Gastroenterol. 2018;11:1–12.
16. Chan HLY, Buti M, Lim YS, Agarwal K, Marcellin P, Brunetto M, et al. Long-Term Treatment With Tenofovir Alafenamide for Chronic Hepatitis B Results in High Rates of Viral Suppression and Favorable Renal and Bone Safety. Am J Gastroenterol. 2024;119(3):486–96.
17. Gupta SK, Post FA, Arribas JR, Eron JJ, Wohl DA, Clarke AE, et al. Renal safety of tenofovir alafenamide vs. tenofovir disoproxil fumarate: A pooled analysis of 26 clinical trials. Aids. 2019;33(9):1455–65.
18. Sano T, Kawaguchi T, Ide T, Amano K, Kuwahara R, Arinaga-Hino T, et al. Tenofovir alafenamide rescues renal tubules in patients with chronic hepatitis b. Life. 2021;11(3).
19. Johnson KA, Niu X, Glidden D V., Castillo-Mancilla JR, Yager J, Mawhinney S, et al. Lower Urine Tenofovir Concentrations among Individuals Taking Tenofovir Alafenamide Versus Tenofovir Disoproxil Fumarate: Implications for Point-of-Care Testing. Open Forum Infect Dis. 2021;8(7):1–4.
20. Ueaphongsukkit T, Gatechompol S, Avihingsanon A, Surintrspanont J, Iampenkhae K, Avihingsanon Y, et al. Tenofovir alafenamide nephrotoxicity: a case report and literature review. AIDS Res Ther [Internet]. 2021;18(1):1–8. Available from: https://doi.org/10.1186/s12981-021-00380-w
21. Hashwin Singh TS, Jashwin Singh TS, Chin KY. Effects of tenofovir disoproxil fumarate on bone quality beyond bone density—a scoping review of the literature. Pharmaceuticals. 2024;17(2). doi:10.3390/ph17020162.
22. Hill A, Hughes SL, Gotham D, Pozniak AL. Tenofovir alafenamide versus tenofovir disoproxil fumarate: is there a true difference in efficacy and safety? J Virus Erad [Internet]. 2018;4(2):72–9. Available from: https://doi.org/10.1016/S2055-6640(20)30248-X
23. Soldado-Folgado J, Rins-Lozano O, Arrieta-Aldea I, Gonzále-Mena A, Cañas-Ruano E, Knobel H, et al. Changes in bone quality after switching from a TDF to a TAF based ART: A pilot randomized study. Front Endocrinol (Lausanne). 2023;14(March):1–7.
24. Moore AEB, Burns JE, Sally D, Milinkovic A, Krokos G, John J, et al. Bone turnover change after randomized switch from tenofovir disoproxil to tenofovir alafenamide fumarate in men with HIV. Aids. 2024;38(4):521–9.
25. Tseng TN, Chen CH. Editorial: changes in renal function and bone mineral density after switching from tenofovir disoproxil fumarate to tenofovir alafenamide in patients with chronic hepatitis B. Aliment Pharmacol Ther. 2022;56(5):916–7.
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Dr. Bikash Nayak
Assistant professor, Department of Pharmacology, SLN Medical College and Hospital, Koraput, Odisha-764020
Dr. Lorika Sahu
Assistant professor, Department of Pharmacology, IMS & SUM Hospital-II, Phulanakhara, Bhubaneswar, Odisha-754001
Prof. Dr. Rajendra Kumar Panda
Professor, Department of Pharmacology, Dharanidhar Medical College and Hospital, Keonjhar, Odisha-758002
Dr. Sourya Mohapatra
Assistant professor, Department of Pharmacology, Hi-tech Medical College and Hospital, Rourkela, Odisha-769004
Prof. Dr. Umesh Chandra Patra
Head of Department, Department of Hepatology, SCB Medical College and Hospital, Cuttack, Odisha- 753001