CLINICAL AND VIRUSOLOGICAL OUTCOMES OF TENOFOVIR ALAFENAMIDE TREATMENT IN PATIENTS WITH HEPATITIS B VIRUS INFECTION
Keywords:
HBV-DNA, qHBsAg, HBeAg, tenofovir alafenamid fumarate, tenofovirdisoproxil fumarate
Abstract
The clinical trials have evaluated TAF in НBeAg positive and HBeAg negative HBV patients. The trials have
similar design and randomized,Single-blind, the subjects are unaware of which group they have been assigned to
studies. The primary efficacy endpoint was the proportion of patients with HBV-DNA<29IU/ml at weeks 96.
Other virological result endpoints were the proportion of patients with HBsAg seroconversion at weeks 96.
References
1. World Health Organization. Guidlines for the prevention, care and treatment of persons with chronic hepatitis B infection. [accessed on 14 January 2018].
Available at: https://apps.who.int/iris/bitstream/handle/10665/154590/9789241549059.
2. Dashtseren B, Bungert A, Bat-Ulzii P, Enkhbat M, Lhagva-Ochir O, Jargalsaikhan G, et al. Endemic prevalence of hepatitis, B and C in Mongolia: A nationwide survive amongst Mongolian adults. J Viral Hep 2017; 24(9): 759-67.
3. Hill A, Hughes S, Gotham D, Pozniak A. Tenofovir alafenamide versus tenofovir disoproxil fumarate is there a true difference in efficacy and safety? J Virus Erad 2018; (4): 73-80.
4. Ogawa E, Furusyo N, Mindie HN. Tenofovir alafenamide in the treatment of chronic hepatitis B design, development, and place in therapy. Drug Des Devel Ther 2017; (11): 3197–204.
5. Basit SA, Dawood A, Ryan J, Gish R. Tenofovir alafenamide for the treatment of chronic hepatitis B virus infection. Expert Rev Clin Pharmacol 2017; 10(7): 707–16.
6. Ruth B, Ivana C, Kosh A. Tenofovir alafenamide in the treatment of chronic hepatitis B virus infection: rationale and clinical trial evidence. Ther Adv Gastroenterol 2018; (11):1–12.
7. Buti M, Riveiro M, Esteban R. Tenofovir alafenamide fumarate: a new tenofovir prodrug for the treatment of chronic hepatitis B infection. J Infect Dis 2017; 216(8): S792-96.
8. Agarwal K, Brunetto M, Seto WK, Lim YS, Fung S, Marcellin P, et al. 96 weeks treatment of tenofovir alafenamide vs. tenofovir disoproxil fumarate for hepatitis B virus infection. J Hepatol 2018; 68(4): 672- 81.
9. Agarwal K, Fung SK, Nguyen TT, Cheng W, Sicard E, Ryder SD, et al. Twenty-eight day safety, antiviral activity and pharmacokinetics of tenofovir alafenamide for treatment of chronic hepatitis B infection. J Hepatol 2015; 62(3): 533-40.
10. Schweitzer A, Horn J, Mikolajczyk RT. Estimations of worldwide prevalence of chronic hepatitis B virus infection: a systematic review of data published between 1965 and 2013. Lancet Gastroenterol Hepatol 2015; 386: 1546–55.
11. Nikolaos P, Prodromos H, Lavrentios P, Emmanouil S, Ioannis K, Evangelos A. Antiviral therapy leads to histological improvement of HBeAgnegative chronic hepatitis B patients. Ann Gastroenterol 2015; 28(3): 374-8.
12. Abdul BS, Dawood A, Ryan J, Gish R. Tenofovir alafenamide for the treatment of chronic hepatitis B virus infection. Expert Rev Clin Pharmacol 2017; 10(7): 707-16.
13. Buti M, Gane E, Seto WK, Chan HL, Chuang WL, Stepanova T, 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, noninferiority trial. Lancet Gastroenterol Hepatol 2016; 1(3): 196–206.
14. Henry L, Maria B, Robert F, Stephen R, Adrian S, John F, et al. Efficacy and safety of tenofovir alafenamid at 96 weeks in chronic HBV patients with risk factors for use of tenofovir disoproxil fumarate. Therap Adv Gastroenterol. 2010 Mar; 3(2): 73–76.
15. Samir K, Frank A, Jose R, Joseph J, David A, Amanda E, et al. Renal safety of tenofovir alafenamide vs. tenofovir disoproxil fumarate: a pooled analysis of 26 clinical trials. AIDS 2019; 33(9): 1455-65.
16. Kaneko S, Kurosaki M, Tamaki N, Itakura J, Hayashi T, Kirino S, et al. Tenofovir alafenamide for hepatitis B virus infection including switching therapy from tenofovir disoproxil fumarate. J Gastroenterol Hepatol 2019; 34(11): 2004-10.
17. Kim SU, Seo YS, Lee HA, Kim MN, Lee YR, Lee HW, et al. A multicenter study of entecavir vs tenofovir on prognosis of treatment chronic hepatitis B in South
Korea. J Hepatol 2019; 71(3): 456-64
18. Soheil T, Mohammad D, Shahnaz S. Tenofovir alafenamide: a new drug with various ambiguous aspects in treatment of chronic hepatitis B infection. Arch clin infect dis. 2018; 14(1): e65343-4.
19. Chan HL, Fung S, Seto WK, Chuang WL, Chen CY, Kim HJ, et al. Tenofovir alafenamide versus tenofovir disoproxil 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): 185-95.
20. Cathcart AL, Chan HL, Bhardwaj N, Liu Y, Marcellin P, Pan CQ, et al. No Resistance to Tenofovir Alafenamide Detected through 96 Weeks of Treatment in Patients with Chronic Hepatitis B Infection. Antimicrob Agents Chemother. 2018; 62(10): e01064- 18.
21. Shafran SD, Di Perri G, Esser S, Lelièvre JD, Parczewski M. Planning HIV therapy to prevent future comorbidities: patient years for tenofovir alafenamide. HIV Med 2019; 20(7): 1-16.
22. Millan J, Pinto X, Munoz A, Zuniga M, RubiesPrat J, Pallardo LF, et al. Lipoprotein ratios: Physiological significance and clinical usefulness in cardiovascular prevention. Vasc Health Risk Manag 2009; (5): 757-65.
23. Tungsiripat M, Kitch D, Glesby MJ, Gupta SK, Mellors JW, Moran L, et al. A pilot study to determine the impact on dyslipidemia of adding tenofovir to stable
background antiretroviral therapy: ACTG 5206. AIDS. 2010; (24): 1781-4.
24. 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.
Available at: https://apps.who.int/iris/bitstream/handle/10665/154590/9789241549059.
2. Dashtseren B, Bungert A, Bat-Ulzii P, Enkhbat M, Lhagva-Ochir O, Jargalsaikhan G, et al. Endemic prevalence of hepatitis, B and C in Mongolia: A nationwide survive amongst Mongolian adults. J Viral Hep 2017; 24(9): 759-67.
3. Hill A, Hughes S, Gotham D, Pozniak A. Tenofovir alafenamide versus tenofovir disoproxil fumarate is there a true difference in efficacy and safety? J Virus Erad 2018; (4): 73-80.
4. Ogawa E, Furusyo N, Mindie HN. Tenofovir alafenamide in the treatment of chronic hepatitis B design, development, and place in therapy. Drug Des Devel Ther 2017; (11): 3197–204.
5. Basit SA, Dawood A, Ryan J, Gish R. Tenofovir alafenamide for the treatment of chronic hepatitis B virus infection. Expert Rev Clin Pharmacol 2017; 10(7): 707–16.
6. Ruth B, Ivana C, Kosh A. Tenofovir alafenamide in the treatment of chronic hepatitis B virus infection: rationale and clinical trial evidence. Ther Adv Gastroenterol 2018; (11):1–12.
7. Buti M, Riveiro M, Esteban R. Tenofovir alafenamide fumarate: a new tenofovir prodrug for the treatment of chronic hepatitis B infection. J Infect Dis 2017; 216(8): S792-96.
8. Agarwal K, Brunetto M, Seto WK, Lim YS, Fung S, Marcellin P, et al. 96 weeks treatment of tenofovir alafenamide vs. tenofovir disoproxil fumarate for hepatitis B virus infection. J Hepatol 2018; 68(4): 672- 81.
9. Agarwal K, Fung SK, Nguyen TT, Cheng W, Sicard E, Ryder SD, et al. Twenty-eight day safety, antiviral activity and pharmacokinetics of tenofovir alafenamide for treatment of chronic hepatitis B infection. J Hepatol 2015; 62(3): 533-40.
10. Schweitzer A, Horn J, Mikolajczyk RT. Estimations of worldwide prevalence of chronic hepatitis B virus infection: a systematic review of data published between 1965 and 2013. Lancet Gastroenterol Hepatol 2015; 386: 1546–55.
11. Nikolaos P, Prodromos H, Lavrentios P, Emmanouil S, Ioannis K, Evangelos A. Antiviral therapy leads to histological improvement of HBeAgnegative chronic hepatitis B patients. Ann Gastroenterol 2015; 28(3): 374-8.
12. Abdul BS, Dawood A, Ryan J, Gish R. Tenofovir alafenamide for the treatment of chronic hepatitis B virus infection. Expert Rev Clin Pharmacol 2017; 10(7): 707-16.
13. Buti M, Gane E, Seto WK, Chan HL, Chuang WL, Stepanova T, 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, noninferiority trial. Lancet Gastroenterol Hepatol 2016; 1(3): 196–206.
14. Henry L, Maria B, Robert F, Stephen R, Adrian S, John F, et al. Efficacy and safety of tenofovir alafenamid at 96 weeks in chronic HBV patients with risk factors for use of tenofovir disoproxil fumarate. Therap Adv Gastroenterol. 2010 Mar; 3(2): 73–76.
15. Samir K, Frank A, Jose R, Joseph J, David A, Amanda E, et al. Renal safety of tenofovir alafenamide vs. tenofovir disoproxil fumarate: a pooled analysis of 26 clinical trials. AIDS 2019; 33(9): 1455-65.
16. Kaneko S, Kurosaki M, Tamaki N, Itakura J, Hayashi T, Kirino S, et al. Tenofovir alafenamide for hepatitis B virus infection including switching therapy from tenofovir disoproxil fumarate. J Gastroenterol Hepatol 2019; 34(11): 2004-10.
17. Kim SU, Seo YS, Lee HA, Kim MN, Lee YR, Lee HW, et al. A multicenter study of entecavir vs tenofovir on prognosis of treatment chronic hepatitis B in South
Korea. J Hepatol 2019; 71(3): 456-64
18. Soheil T, Mohammad D, Shahnaz S. Tenofovir alafenamide: a new drug with various ambiguous aspects in treatment of chronic hepatitis B infection. Arch clin infect dis. 2018; 14(1): e65343-4.
19. Chan HL, Fung S, Seto WK, Chuang WL, Chen CY, Kim HJ, et al. Tenofovir alafenamide versus tenofovir disoproxil 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): 185-95.
20. Cathcart AL, Chan HL, Bhardwaj N, Liu Y, Marcellin P, Pan CQ, et al. No Resistance to Tenofovir Alafenamide Detected through 96 Weeks of Treatment in Patients with Chronic Hepatitis B Infection. Antimicrob Agents Chemother. 2018; 62(10): e01064- 18.
21. Shafran SD, Di Perri G, Esser S, Lelièvre JD, Parczewski M. Planning HIV therapy to prevent future comorbidities: patient years for tenofovir alafenamide. HIV Med 2019; 20(7): 1-16.
22. Millan J, Pinto X, Munoz A, Zuniga M, RubiesPrat J, Pallardo LF, et al. Lipoprotein ratios: Physiological significance and clinical usefulness in cardiovascular prevention. Vasc Health Risk Manag 2009; (5): 757-65.
23. Tungsiripat M, Kitch D, Glesby MJ, Gupta SK, Mellors JW, Moran L, et al. A pilot study to determine the impact on dyslipidemia of adding tenofovir to stable
background antiretroviral therapy: ACTG 5206. AIDS. 2010; (24): 1781-4.
24. 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.
Published
2022-09-23
How to Cite
Tuvshinbayar, N, R Amaraa, B Burmaajav, B Gegeebadrakh, and O Baatarkhuu. 2022. “CLINICAL AND VIRUSOLOGICAL OUTCOMES OF TENOFOVIR ALAFENAMIDE TREATMENT IN PATIENTS WITH HEPATITIS B VIRUS INFECTION”. EurasianUnionScientists, September, 14-24. https://bio-med.euroasia-science.ru/index.php/Euroasia/article/view/827.
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