Tenofovir Alafenamid Fumarat Tedavisine Başlanan Hastalarda Metabolik Değişikliklerin Değerlendirilmesi

Abstract

Amaç: Hepatit B virüsü (HBV) enfeksiyonu milyonlarca kişiyi etkileyen yaygın bir küresel sağlık sorunu olmaya devam ediyor ve ciddi komplikasyonlara yol açabiliyor. Etkili HBV tedavisi için antiviral ilaçların seçimi hasta sonuçlarında kritik bir rol oynar, ancak bu ilaçların yan etkileri de dikkate alınmalıdır. Materyaller ve Yöntemler: Bu retrospektif çalışmaya 1 Şubat 2020 ile 1 Şubat 2023 tarihleri ​​arasında HBV için antiviral tedaviye başlayan veya tenofovir alfenamid fumarat (TAF) tedavisine geçen 57 hasta dahil edildi. Hastaların tıbbi kayıtları retrospektif olarak incelendi. Sonuçlar: Dahil edilen 57 hastadan 34'ü erkekti (%59,6) ve ortalama yaşları 60,8±11,3 yıldı. Yedi hastanın (%12,3) solid organ nakli öyküsü vardı. TAF tedavisi 3 hastada (%5,3) entekavir'den ve 46 hastada (%80,7) tenofovir disproksil fumarat'tan geçişin ardından başlatıldı. Vücut ağırlığında ve açlık kan şekerinde sayısal artışlar olmasına rağmen, bu değişiklikler istatistiksel olarak anlamlı değildi (sırasıyla p=0,44, p=0,28). Ortalama başlangıç ​​trigliserit (TG) seviyesi 128,7±18,69 mg/dL iken, ortalama takip seviyesi 148,8±14,6 mg/dL'ye yükseldi, bu istatistiksel olarak anlamlı bir değişiklikti (p=0,043). Sonuç: TAF tedavisi serum TG seviyelerinde artışla ilişkilendirildi. Ancak, hem tedavi görmemiş hem de daha önce tedavi görmüş hastalarda TAF'ın metabolik etkilerini değerlendirmek için daha büyük kohortlarla daha uzun vadeli prospektif çalışmalara ihtiyaç vardır.

Keywords

• Metabolik disfonksiyon
• hipertrigliseridemi
• hepatit B tedavisi

Evaluation of Metabolic Changes in Patients Initiated on Tenofovir Alafenamide Fumarate Therapy

Abstract

Aim: Hepatitis B virus (HBV) infection remains a common global health issue affecting millions and may lead to severe complications. The choice of antiviral drugs for effective HBV treatment plays a critical role in patient outcomes, although the side effects of these drugs must also be considered. Materials and Methods: This retrospective study included 57 patients who either started antiviral treatment for HBV or switched to tenofovir alfenamid fumarate(TAF) therapy between February 1, 2020, and February 1, 2023. The patients' medical records were retrospectively reviewed. Results: Among the 57 patients included, 34 were male (59.6%) with a mean age of 60.8±11.3 years. Seven patients (12.3%) had a history of solid organ transplantation. TAF therapy was initiated following a switch from entecavir in 3 patients (5.3%) and from tenofovir disproksil fumarat in 46 patients (80.7%). Although there were numerical increases in body weight and fasting blood glucose, these changes were not statistically significant (p=0.44, p=0.28, respectively). The mean baseline triglyceride (TG) level was 128.7±18.69 mg/dL, while the mean follow-up level increased to 148.8±14.6 mg/dL, a statistically significant change (p=0.043). Conclusion: TAF therapy was associated with increased serum TG levels. However, these findings should be interpreted with caution due to the relatively small sample size (n=57), which limits the generalizability of the results. However, further long-term prospective studies with larger cohorts are needed to assess the metabolic effects of TAF, both in treatment-naïve and previously treated patients.

Keywords

• Metabolic dysfunction
• hypertriglyceridemia
• hepatitis B treatment
• chronic liver disease

References

1. Walter SR, Thein HH, Gidding HF, et al. Risk factors for hepatocellular carcinoma in a cohort infected with hepatitis B or C. J Gastroenterol Hepatol. 2011;26(12):1757-1764. doi:10.1111/j.1440-1746.2011.06785.x
2. Agarwal K, Brunetto M, Seto WK, et al. Ninety-six weeks treatment of tenofovir alafenamide vs tenofovir disoproxil fumarate for hepatitis B virus infection. J Hepatol. 2018;68(4):672-681. doi:10.1016/j.jhep.2017.11.039
3. Noordeen F. Hepatitis B virus infection: an insight into infection outcomes and recent treatment options. Virusdisease. 2015;26(1-2):1-8. doi:10.1007/s13337-015-0247-y
4. Suzuki K, Suda G, Yamamoto Y, et al. Effect of switching from tenofovir disoproxil fumarate to tenofovir alafenamide on lipid profiles in patients with hepatitis B. PLoS One. 2022;17(1):e0261760. doi:10.1371/journal.pone.0261760
5. Buti M, Gane E, Seto WK, et al. Tenofovir alafenamide versus tenofovir disoproxil fumarate for the treatment of patients with HBeAg-negative chronic hepatitis B virus infection: a randomised, double-blind, phase 3, non-inferiority trial. Lancet Gastroenterol Hepatol. 2016;1(3):196-206. doi:10.1016/S2468-1253(16)30107-8
6. Kaneko S, Kurosaki M, Tamaki N, et al. Tenofovir alafenamide for hepatitis B virus infection including switching therapy from tenofovir disoproxil fumarate. J Gastroenterol Hepatol. 2019;34(11):2004-2010. doi:10.1111/jgh.14686
7. Ogawa E, Furusyo N, Nguyen MH. Tenofovir alafenamide in the treatment of chronic hepatitis B: design, development, and place in therapy. Drug Des Devel Ther. 2017;11:3197-3204. doi:10.2147/DDDT.S126742
8. Surial B, Mugglin C, Calmy A, et al. Weight and metabolic changes after switching from tenofovir disoproxil fumarate to tenofovir alafenamide in people living with HIV: a cohort study. Ann Intern Med. 2021;174(6):758- 767. doi:10.7326/M20-4853

9. Milinkovic A, Berger F, Arenas-Pinto A, et al. Reversible effect on lipids by switching from tenofovir disoproxil fumarate to tenofovir alafenamide and back. AIDS. 2019;33(15):2387-2391. doi:10.1097/ QAD.0000000000002350
10. Mallon PWG, Brunet L, Fusco JS, et al. Lipid changes after switch from tenofovir disoproxil fumarate to tenofovir alafenamide in the OPERA cohort: LDL cholesterol and triglycerides. Open Forum Infect Dis. 2022;9(1):ofab621. doi:10.1093/ofid/ofab621
11. Cao F, Fan T, Jiang X, et al. Effects of tenofovir alafenamide fumarate on serum lipid profiles in patients with chronic hepatitis B. Virol J. 2024;21:234. doi:10.1186/s12985-024-02515-7
12. Lin S, Huang W, Liao Z, et al. Comparison of lipid profile alterations in chronic hepatitis B patients receiving tenofovir alafenamide or tenofovir disoproxil fumarate. Sci Rep. 2024;14:27369. doi:10.1038/s41598-024-78656-0