Abstract
Aims: Chronic hepatitis B virus (CHB) infection causes chronic liver disease, cirrhosis, and hepatocellular carcinoma. Our study aimed to evaluate the effects of newly initiated tenofovir alafenamide fumarate (TAF) on clinical parameters in naïve and treatment-experienced patients with CHB.
Methods: This retrospective, single-center observational study was performed in the Department of Infectious Diseases and Clinical Microbiology, Kayseri City Hospital. Demographic and clinical characteristics of the cases were obtained from the outpatient clinic follow-up files. The change over time in the clinical data of all patients at the beginning, 3rd, 6th, and 12th months of TAF treatment was evaluated using One-Way Analysis of Variance in Repeated Measures (ANOVA) and Friedman Analysis of Variance in Repeated Measures, according to their compliance with normal distribution.
Results: The mean age of the patients was 56.5±12.2 years, and 59 (57.8%) were male. 70.6% of the patients had at least one additional disease, and the most common additional diseases were hypertension (29.4%) and Diabetes mellitus (23.5%). Of the 102 patients who started TAF treatment, 81 (79.4%) were treatment-experienced, and 21 (20.6%) were treatment-naïve patients. The reasons for switching to TAF treatment were osteoporosis (44.1%), the need for a more potent agent (34.3%), and low GFR (13.7). While the detectable HBV DNA rate was 38.2% at the beginning of treatment, this rate was 2.9% at the 12th month (p<0.001). While there was a statistically significant change in ALT, abnormal ALT, and detectable HBV DNA rates from all four follow-up periods within 12 months after the start of TAF treatment (p values <0.001), there was no significant change in AST (p=0.081). While the GFR level did not change statistically significantly during the follow-up period (p=0.381), the phosphorus level changed statistically significantly (p-value<0.001).
Conclusion: In our study, a significant improvement in detectable HBV DNA, ALT level, and phosphorus level was observed in both naive and treatment-experienced patients with the initiation of TAF.
References
- Hepatitis B. World Health Organization (WHO): 2023. Accessed January 4, 2024. World Health Organization (WHO)
- Pan CQ, Zhang JX. Natural history and clinical consequences of hepatitis B virus infection. Int J Med Sci. 2005;2(1):36-40. doi: 10.7150/ijms.2.36
- Lo AOS, Wong GLH. Current developments in nucleoside/nucleotide analogues for hepatitis B. Expert Rev Gastroenterol Hepatol. 2014;8(6):607-622. doi: 10.1586/17474124.2014.909724
- Locarnini S, Hatzakis A, Chen DS, Lok A. Strategies to control hepatitis B: public policy, epidemiology, vaccine and drugs. J Hepatol. 2015;62(1):S76-S86. doi: 10.1016/j.jhep.2015.01.018
- Lok ASF, McMahon BJ, Brown RS, et al. Antiviral therapy for chronic hepatitis B viral infection in adults: a systematic review and meta-analysis. Hepatol Baltim Md. 2016;63(1):284-306. doi: 10.1002/hep.28280
- Chen CH, Lin CL, Kao CH. Association Between Chronic Hepatitis B Virus Infection and Risk of Osteoporosis: A Nationwide Population-Based Study. Medicine (Baltimore). 2015;94(50):e2276. doi: 10.1097/MD.0000000000002276
- Min IS, Lee CH, Shin IS, et al. Treatment outcome and renal safety of 3-year tenofovir disoproxil fumarate therapy in chronic hepatitis B patients with preserved glomerular filtration rate. Gut Liver. 2019;13(1):93-103. doi: 10.5009/gnl18183
- Pilkington V, Hughes SL, Pepperrell T, et al. Tenofovir alafenamide vs. tenofovir disoproxil fumarate: an updated meta-analysis of 14 894 patients across 14 trials. Aids. 2020;34(15):2259-2268. doi: 10.1097/QAD.0000000000002699
- Sosyal güvenlik kurumu sağlık uygulama tebliğinde değişiklik yapılmasına dair tebliğ. Resmi Gazete. June 16, 2020:1-203.
- Terrault N, Lok A, McMahon B, et al. Update on prevention, diagnosis, and treatment and of chronic hepatitis B: AASLD 2018 hepatitis B guidance. Hepatol. 2018;67(4):1560-1599. doi: 10.1002/hep.29800
- Ishak K, Baptista A, Bianchi L, et al. Histological grading and staging of chronic hepatitis. J Hepatol. 1995;22(6):696-699. doi: 10.1016/0168-8278(95)80226-6
- Karasahin O, Kalkan IA, Dal T, et al. First year real life experience with tenofovir alafenamide fumarate: the pythagorean cohort. Hepatol Forum. 2023;4(2):61-68. doi: 10.14744/hf.2022.2022.0043
- Lampertico P, Agarwal K, Berg T, Buti M, Janssen HL, Papatheodoridis G. European Association for the Study of the Liver. Electronic address: easloffice@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. doi: 10.1016/j.jhep.2017.03.021
- Ogawa E, Nomura H, Nakamuta M, et al. 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. doi: 10.1111/liv.14482
- Casado JL. Renal and bone toxicity with the use of tenofovir: understanding at the end. Aids Rev. 2016;18(2):59-68.
- Fischer MG, Newman W, Hammer K, Rohrich M, Lo TS. Comparison of renal function between tenofovir disoproxil fumarate and other nucleos(t)ide reverse transcriptase inhibitors in patients with hepatitis B virus infection. Fed Pract. 2021;38(8):363-367. doi: 10.12788/fp.0169
- Trinh S, Le AK, Chang ET, et al. Changes in renal function in patients with chronic HBV infection treated with tenofovir disoproxil fumarate vs entecavir. Clin Gastroenterol Hepatol. 2019;17(5):948-956. doi: 10.1016/j.cgh.2018.08.037
- Karasahin O, Kalkan IA, Dal T, et al. Real-life data for tenofovir alafenamide fumarate treatment of hepatitis B: the pythagoras cohort. Hepat Mon. 2021;21(2):e104943. doi: 10.5812/hepatmon.104943
- Akar M. Real-life data of tenofovir disoproxil fumarate and tenofovir alafenamide fumarate in the patients with chronic hepatitis B: a single-center experience. Anatol Curr Med J. 2021; 3(3):239-245.
Abstract
Aim: Chronic hepatitis B virus (CHB) infection causes chronic liver disease, cirrhosis, and hepatocellular carcinoma. Our study aimed to evaluate the effects of newly initiated tenofovir alafenamide fumarate (TAF) on clinical parameters in naïve and treatment-experienced patients with CHB.
Material and Method: This retrospective, single-center observational study was performed in the Department of Infectious Diseases and Clinical Microbiology, XXX City Hospital. Demographic and clinical characteristics of the cases were obtained from the outpatient clinic follow-up files. The change over time in the clinical data of all patients at the beginning, 3rd, 6th, and 12th months of TAF treatment was evaluated using One-Way Analysis of Variance in Repeated Measures (ANOVA) and Friedman Analysis of Variance in Repeated Measures, according to their compliance with normal distribution.
Results: The mean age of the patients was 56.5± 12.2 years, and 59 (57.8%) were male. 70.6% of the patients had at least one additional disease, and the most common additional diseases were hypertension (29.4%) and Diabetes mellitus (23.5%). Of the 102 patients who started TAF treatment, 81 (79.4%) were treatment-experienced, and 21 (20.6%) were treatment-naïve patients. The reasons for switching to TAF treatment were osteoporosis (44.1%), the need for a more potent agent (34.3%), and low GFR (13.7). While the detectable HBV DNA rate was 38.2% at the beginning of treatment, this rate was 2.9% at the 12th month (p=<0.001). While there was a statistically significant change in ALT, abnormal ALT, and detectable HBV DNA rates from all four follow-up periods within 12 months after the start of TAF treatment (p values <0.001), there was no significant change in AST (p = 0.081). While the GFR level did not change statistically significantly during the follow-up period (p = 0.381), the phosphorus level changed statistically significantly (p-value = <0.001).
Conclusion: In our study, a significant improvement in detectable HBV DNA, ALT level, and phosphorus level was observed in both naïve and treatment-experienced patients with the initiation of TAF.
References
- Hepatitis B. World Health Organization (WHO): 2023. Accessed January 4, 2024. World Health Organization (WHO)
- Pan CQ, Zhang JX. Natural history and clinical consequences of hepatitis B virus infection. Int J Med Sci. 2005;2(1):36-40. doi: 10.7150/ijms.2.36
- Lo AOS, Wong GLH. Current developments in nucleoside/nucleotide analogues for hepatitis B. Expert Rev Gastroenterol Hepatol. 2014;8(6):607-622. doi: 10.1586/17474124.2014.909724
- Locarnini S, Hatzakis A, Chen DS, Lok A. Strategies to control hepatitis B: public policy, epidemiology, vaccine and drugs. J Hepatol. 2015;62(1):S76-S86. doi: 10.1016/j.jhep.2015.01.018
- Lok ASF, McMahon BJ, Brown RS, et al. Antiviral therapy for chronic hepatitis B viral infection in adults: a systematic review and meta-analysis. Hepatol Baltim Md. 2016;63(1):284-306. doi: 10.1002/hep.28280
- Chen CH, Lin CL, Kao CH. Association Between Chronic Hepatitis B Virus Infection and Risk of Osteoporosis: A Nationwide Population-Based Study. Medicine (Baltimore). 2015;94(50):e2276. doi: 10.1097/MD.0000000000002276
- Min IS, Lee CH, Shin IS, et al. Treatment outcome and renal safety of 3-year tenofovir disoproxil fumarate therapy in chronic hepatitis B patients with preserved glomerular filtration rate. Gut Liver. 2019;13(1):93-103. doi: 10.5009/gnl18183
- Pilkington V, Hughes SL, Pepperrell T, et al. Tenofovir alafenamide vs. tenofovir disoproxil fumarate: an updated meta-analysis of 14 894 patients across 14 trials. Aids. 2020;34(15):2259-2268. doi: 10.1097/QAD.0000000000002699
- Sosyal güvenlik kurumu sağlık uygulama tebliğinde değişiklik yapılmasına dair tebliğ. Resmi Gazete. June 16, 2020:1-203.
- Terrault N, Lok A, McMahon B, et al. Update on prevention, diagnosis, and treatment and of chronic hepatitis B: AASLD 2018 hepatitis B guidance. Hepatol. 2018;67(4):1560-1599. doi: 10.1002/hep.29800
- Ishak K, Baptista A, Bianchi L, et al. Histological grading and staging of chronic hepatitis. J Hepatol. 1995;22(6):696-699. doi: 10.1016/0168-8278(95)80226-6
- Karasahin O, Kalkan IA, Dal T, et al. First year real life experience with tenofovir alafenamide fumarate: the pythagorean cohort. Hepatol Forum. 2023;4(2):61-68. doi: 10.14744/hf.2022.2022.0043
- Lampertico P, Agarwal K, Berg T, Buti M, Janssen HL, Papatheodoridis G. European Association for the Study of the Liver. Electronic address: easloffice@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. doi: 10.1016/j.jhep.2017.03.021
- Ogawa E, Nomura H, Nakamuta M, et al. 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. doi: 10.1111/liv.14482
- Casado JL. Renal and bone toxicity with the use of tenofovir: understanding at the end. Aids Rev. 2016;18(2):59-68.
- Fischer MG, Newman W, Hammer K, Rohrich M, Lo TS. Comparison of renal function between tenofovir disoproxil fumarate and other nucleos(t)ide reverse transcriptase inhibitors in patients with hepatitis B virus infection. Fed Pract. 2021;38(8):363-367. doi: 10.12788/fp.0169
- Trinh S, Le AK, Chang ET, et al. Changes in renal function in patients with chronic HBV infection treated with tenofovir disoproxil fumarate vs entecavir. Clin Gastroenterol Hepatol. 2019;17(5):948-956. doi: 10.1016/j.cgh.2018.08.037
- Karasahin O, Kalkan IA, Dal T, et al. Real-life data for tenofovir alafenamide fumarate treatment of hepatitis B: the pythagoras cohort. Hepat Mon. 2021;21(2):e104943. doi: 10.5812/hepatmon.104943
- Akar M. Real-life data of tenofovir disoproxil fumarate and tenofovir alafenamide fumarate in the patients with chronic hepatitis B: a single-center experience. Anatol Curr Med J. 2021; 3(3):239-245.
Details
| Primary Language | English |
|---|---|
| Subjects | Infectious Diseases |
| Journal Section | Research Articles [en] Araştırma Makaleleri [tr] |
| Authors | |
| Publication Date | February 29, 2024 |
| Submission Date | January 8, 2024 |
| Acceptance Date | February 13, 2024 |
| Published in Issue | Year 2024 Volume: 5 Issue: 1 |
Cite
TR DİZİN ULAKBİM and International Indexes (1d)
Interuniversity Board (UAK) Equivalency: Article published in Ulakbim TR Index journal [10 POINTS], and Article published in other (excuding 1a, b, c) international indexed journal (1d) [5 POINTS]
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