Research Article
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Year 2021, , 239 - 245, 14.07.2021
https://doi.org/10.38053/acmj.951923

Abstract

References

  • Global Hepatitis Report 2017. Geneva: World Health Organization; 2017. Available at: http://apps.who.int/iris/handle/10665/255016. Accessed April 23, 2021.
  • Karagoz E, Tanoglu A. Clinical usefulness of HBsAg quantification in patients with chronic hepatitis B infection. Hepat Mon 2017; 17: e12293. 
  • Hyun Kim B, Ray Kim W. Epidemiology of hepatitis B virus infection in the United States. Clin Liver Dis (Hoboken) 2018; 12: 1-4.
  • Konerman MA & Lok AS: Epidemiology, Diagnosis, and Natural History of Hepatitis B. In Sanyal AJ, Boyer TD, Lindor KD & Terrault NA (Eds.), Zakim and Boyer’s Hepatology: A textbook of liver disease, 7th edition, Philadelphia; Saunders/Elsevier; 2018: pp. 474-84.
  • Abdul Basit S, Dawood A, Ryan J, Gish R. Tenofovir alafenamide for the treatment of chronic hepatitis B virus infection. Expert Rev Clin Pharmacol 2017; 10: 707-16.
  • Wright TL. Clinical trial results and treatment resistance with lamivudine in hepatitis B. Semin Liver Dis 2004; 24: 31–6.
  • Liaw YF. The current management of HBV drug resistance. J Clin Virol 2005; 34: 143–6.
  • Tenney DJ, Rose RE, Baldick CJ, et al. Two-year assessment of entecavir resistance in Lamivudine-refractory hepatitis B virüs patients reveals different clinical outcomes depending on the resistance substitutions present. Antimicrob Agents Chemother 2007; 51: 902-11.
  • Tenney DJ, Rose RE, Baldick CJ, et al. Long-term monitoring shows hepatitis B virus resistance to entecavir in nucleosidenaïve patients is rare through 5 years of therapy. Hepatology 2009; 49: 1503-14.
  • Liu Y, Corsa AC, Buti M, et al. No detectable resistance to tenofovir disoproxil fumarate in HBeAg+ and HBeAg- patients with chronic hepatitis B after 8 years of treatment. J Viral Hepat 2017; 24: 68-74.
  • Gara N, Zhao X, Collins MT, et al. Renal tubular dysfunction during long-term adefovir or tenofovir therapy in chronic hepatitis B. Aliment Pharmacol Ther 2012; 35: 1317–25.
  • Liu Y, Chang S, Martin R, Flaherty J, Mo H, Feierbach B. Characterization of hepatitis B virus polymerase mutations A194T and CYEI and tenofovir disoproxil fumarate or tenofovir alafenamide resistance. J Viral Hepat 2021; 28: 30-9.
  • Agarwal K, Fung SK, Nguyen TT, et al. Twenty-eight day safety, antiviral activity, and pharmacokinetics of tenofovir alafenamide for treatment of chronic hepatitis B infection. J Hepatol 2015; 62: 533–40.
  • Chan HLY, Fung S, Seto WK, 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: 185–95.
  • 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: 196–06.
  • Lampertico P, Buti M, Fung S, et al. Switching from tenofovir disoproxil fumarate to tenofovir alafenamide in virologically suppressed patients with chronic hepatitis B: a randomised, double-blind, phase 3, multicentre non-inferiority study. Lancet Gastroenterol Hepatol 2020; 5: 441-53.
  • Chan HLY, Marcellin P, Pan CQ, et al, editors. No Resistance to Tenofovir Alafenamide Detected Through 144 Weeks of Treatment in Patients With Chronic Hepatitis B [Poster 386]. AASLD: The Liver Meeting® 2018; 2018 09-13 November; San Francisco, CA.
  • Amanzadeh J, Reilly RF Jr. Hypophosphatemia: an evidence-based approach to its clinical consequences and management. Nat Clin Pract Nephrol 2006; 2: 136-48.
  • Levey AS, Coresh J, Greene T, et al. Chronic Kidney Disease Epidemiology Collaboration. Using standardized serum creatinine values in the modification of diet in renal disease study equation for estimating glomerular filtration rate. Ann Intern Med 2006; 145: 247-54.
  • Ishak KG, Baptista A, Bianchi L, et al. Histological grading and staging of chronic hepatitis. J Hepatol 1995; 22: 696-9.
  • Karasahin O, Akdemir Kalkan I, Dal T, et al. Real-life data for tenofovir alafenamide fumarate treatment of hepatitis B: the pythagoras Cohort. Hepat Mon 2021 21: e104943.
  • Papatheodoridis GV, Lampertico P, Manolakopoulos S, Lok A. Incidence of hepatocellular carcinoma in chronic hepatitis B patients receiving nucleos(t)ide therapy: a systematic review. J Hepatol 2010; 53: 348–56.
  • Chang TT, Liaw YF, Wu SS, et al. Long-term entecavir therapy results in the reversal of fibrosis/cirrhosis and continued histological improvement in patients with chronic hepatitis B. Hepatology 2010; 52: 886–93.
  • Lin CL, Kao JH. Risk stratification for hepatitis B virus related hepatocellular carcinoma. J Gastroenterol Hepatol 2013; 28: 10–7.
  • Terrault NA, Bzowej NH, Chang KM, et al. AASLD guidelines for treatment of chronic hepatitis B. Hepatology 2016; 63: 261–83.
  • Jafri SM, Lok AS. Antiviral therapy for chronic hepatitis B. Clin Liver Dis 2010; 14: 425–38.
  • Scaglione SJ, Lok AS. Effectiveness of hepatitis B treatment in clinical practice. Gastroenterology 2012; 142: 1360–8.
  • Casado JL. Renal and bone toxicity with the use of tenofovir: understanding at the end. AIDS Rev 2016; 18: 59-68.
  • Hall AM, Hendry BH, Nitsch D, Connolly JO. Tenofovir-associated kidney toxicity in HIV – infected patients: a review of the evidence. Am J Kidney Dis 2011; 57: 773-80.
  • Fernandez-Fernandez B, Montoya-Ferrer A, Sanz AB, et al. Tenofovir nephrotoxicity: 2011 update. AIDS Res Treat 2011; 2011: 354908.
  • Koklu S, Gulsen MT, Tuna Y, et al. Differences in nephrotoxicity risk and renal effects among anti-viral therapies against hepatitis B. Aliment Pharmacol Ther 2015; 41: 310-9.
  • Haskelberg H, Hoy JF, Amin J, Ebeling PR, Emery S, Carr A; STEAL Studey Group. Changes in bone turnover and bone loss in HIVinfected patients changing treatment to tenofovir-emtricitabine or abacavir-lamivudine. PLoS ONE 2012; 7: e38377.
  • 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: 2004-10.
  • Agarwal K, Brunetto M, Seto WK, et al. GS-US-320-0110; GS-US-320-0108 Investigators. 96 weeks treatment of tenofovir alafenamide vs. tenofovir disoproxil fumarate for hepatitis B virus infection. J Hepatol 2018; 68: 672-81.
  • Fong TL, Lee BT, Tien A, et al. Improvement of bone mineral density and markers of proximal renal tubular function in chronic hepatitis B patients switched from tenofovir disoproxil fumarate to tenofovir alafenamide. J Viral Hepat 2019; 26: 561-7.
  • Seto WK, Asahina Y, Brown TT, et al. Improved Bone Safety of Tenofovir Alafenamide Compared to Tenofovir Disoproxil Fumarate Over 2 Years in Patients With Chronic HBV Infection. Clin Gastroenterol Hepatol 2018: S1542-3565(18)30633-5.
  • 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 2020; 5: 258-63.

Real-life data of tenofovir disoproxil fumarate and tenofovir alafenamide fumarate in the patients with chronic hepatitis B: a single-center experience

Year 2021, , 239 - 245, 14.07.2021
https://doi.org/10.38053/acmj.951923

Abstract

Background & Aims: Chronic hepatitis B (CHB) infection can cause liver cirrhosis and hepatocellular carcinoma. In this study, it was aimed to evaluate the efficacy of tenofovir disoproxil fumarate (TDF) and tenofovir alafenamide fumarate (TAF) on clinical parameters, glomerular filtration rate (GFR), and phosphorus metabolism in the patients with CHB.
Materials and Methods: Eighty-one patients with CHB treated with TDF were included in the study. 27 of them switched from TDF to TAF during the follow-up was considered as TAF group. 54 patients continued TDF were evaluated as TDF group. Demographic, clinical, and laboratory data of the patients were obtained from outpatient follow-up files.
Results: The mean ages of the patients were 45±12 and 48±15 in the TDF and TAF groups, respectively. The mean durations of TDF treatment were 31±20 and 52±32 months, respectively. The mean duration of TDF use was significantly higher in the TAF group (0.01). The mean aspartate aminotransferase (AST), alanine aminotransferase (ALT), GFR, and serum phosphorus levels of the patients before/after the TDF treatment were 48/23 U/L, 67/25 U/L, 99/103 ml/min, and 2.9/3.1 mg/dl in the TDF group, respectively. The mean AST, ALT, GFR, and serum phosphorus levels of the patients before the TDF treatment/at the time of the switch/after the TAF treatment were 42/22/21 U/L, 48/23/22 U/L, 90/100/102 ml/min, and 2.8/2.3/2.9 mg/dl in the TAF group, respectively. Decrease in the mean values of the transaminases after the TDF treatment in the both groups and increase in the mean level of phosphorus after the switching were found significant (p <0.05). There was no significant change in GFR values under the TDF treatment in the TDF group. But, a significant increase in GFR levels was seen after the switch in the TAF group (p<0.05). In addition, the mean GFR values of 3 patients switched due to low GFR showed a significant decrease under the TDF treatment and a significant increase after the TAF treatment. A significant improvement was observed in the total hip and spine T score of 2 patients who were switched to TAF due to osteoporosis. While detectable HBV DNA was detected in 2 (7%) patients under TDF treatment, this was not observed in any patient after switching to TAF treatment.
Conclusions: TAF used in the treatment of chronic hepatitis B has a similar efficacy with TDF, and it has more positive effects on creatinine clearance, bone mineral density, and phosphorus metabolism than TDF.

References

  • Global Hepatitis Report 2017. Geneva: World Health Organization; 2017. Available at: http://apps.who.int/iris/handle/10665/255016. Accessed April 23, 2021.
  • Karagoz E, Tanoglu A. Clinical usefulness of HBsAg quantification in patients with chronic hepatitis B infection. Hepat Mon 2017; 17: e12293. 
  • Hyun Kim B, Ray Kim W. Epidemiology of hepatitis B virus infection in the United States. Clin Liver Dis (Hoboken) 2018; 12: 1-4.
  • Konerman MA & Lok AS: Epidemiology, Diagnosis, and Natural History of Hepatitis B. In Sanyal AJ, Boyer TD, Lindor KD & Terrault NA (Eds.), Zakim and Boyer’s Hepatology: A textbook of liver disease, 7th edition, Philadelphia; Saunders/Elsevier; 2018: pp. 474-84.
  • Abdul Basit S, Dawood A, Ryan J, Gish R. Tenofovir alafenamide for the treatment of chronic hepatitis B virus infection. Expert Rev Clin Pharmacol 2017; 10: 707-16.
  • Wright TL. Clinical trial results and treatment resistance with lamivudine in hepatitis B. Semin Liver Dis 2004; 24: 31–6.
  • Liaw YF. The current management of HBV drug resistance. J Clin Virol 2005; 34: 143–6.
  • Tenney DJ, Rose RE, Baldick CJ, et al. Two-year assessment of entecavir resistance in Lamivudine-refractory hepatitis B virüs patients reveals different clinical outcomes depending on the resistance substitutions present. Antimicrob Agents Chemother 2007; 51: 902-11.
  • Tenney DJ, Rose RE, Baldick CJ, et al. Long-term monitoring shows hepatitis B virus resistance to entecavir in nucleosidenaïve patients is rare through 5 years of therapy. Hepatology 2009; 49: 1503-14.
  • Liu Y, Corsa AC, Buti M, et al. No detectable resistance to tenofovir disoproxil fumarate in HBeAg+ and HBeAg- patients with chronic hepatitis B after 8 years of treatment. J Viral Hepat 2017; 24: 68-74.
  • Gara N, Zhao X, Collins MT, et al. Renal tubular dysfunction during long-term adefovir or tenofovir therapy in chronic hepatitis B. Aliment Pharmacol Ther 2012; 35: 1317–25.
  • Liu Y, Chang S, Martin R, Flaherty J, Mo H, Feierbach B. Characterization of hepatitis B virus polymerase mutations A194T and CYEI and tenofovir disoproxil fumarate or tenofovir alafenamide resistance. J Viral Hepat 2021; 28: 30-9.
  • Agarwal K, Fung SK, Nguyen TT, et al. Twenty-eight day safety, antiviral activity, and pharmacokinetics of tenofovir alafenamide for treatment of chronic hepatitis B infection. J Hepatol 2015; 62: 533–40.
  • Chan HLY, Fung S, Seto WK, 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: 185–95.
  • 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: 196–06.
  • Lampertico P, Buti M, Fung S, et al. Switching from tenofovir disoproxil fumarate to tenofovir alafenamide in virologically suppressed patients with chronic hepatitis B: a randomised, double-blind, phase 3, multicentre non-inferiority study. Lancet Gastroenterol Hepatol 2020; 5: 441-53.
  • Chan HLY, Marcellin P, Pan CQ, et al, editors. No Resistance to Tenofovir Alafenamide Detected Through 144 Weeks of Treatment in Patients With Chronic Hepatitis B [Poster 386]. AASLD: The Liver Meeting® 2018; 2018 09-13 November; San Francisco, CA.
  • Amanzadeh J, Reilly RF Jr. Hypophosphatemia: an evidence-based approach to its clinical consequences and management. Nat Clin Pract Nephrol 2006; 2: 136-48.
  • Levey AS, Coresh J, Greene T, et al. Chronic Kidney Disease Epidemiology Collaboration. Using standardized serum creatinine values in the modification of diet in renal disease study equation for estimating glomerular filtration rate. Ann Intern Med 2006; 145: 247-54.
  • Ishak KG, Baptista A, Bianchi L, et al. Histological grading and staging of chronic hepatitis. J Hepatol 1995; 22: 696-9.
  • Karasahin O, Akdemir Kalkan I, Dal T, et al. Real-life data for tenofovir alafenamide fumarate treatment of hepatitis B: the pythagoras Cohort. Hepat Mon 2021 21: e104943.
  • Papatheodoridis GV, Lampertico P, Manolakopoulos S, Lok A. Incidence of hepatocellular carcinoma in chronic hepatitis B patients receiving nucleos(t)ide therapy: a systematic review. J Hepatol 2010; 53: 348–56.
  • Chang TT, Liaw YF, Wu SS, et al. Long-term entecavir therapy results in the reversal of fibrosis/cirrhosis and continued histological improvement in patients with chronic hepatitis B. Hepatology 2010; 52: 886–93.
  • Lin CL, Kao JH. Risk stratification for hepatitis B virus related hepatocellular carcinoma. J Gastroenterol Hepatol 2013; 28: 10–7.
  • Terrault NA, Bzowej NH, Chang KM, et al. AASLD guidelines for treatment of chronic hepatitis B. Hepatology 2016; 63: 261–83.
  • Jafri SM, Lok AS. Antiviral therapy for chronic hepatitis B. Clin Liver Dis 2010; 14: 425–38.
  • Scaglione SJ, Lok AS. Effectiveness of hepatitis B treatment in clinical practice. Gastroenterology 2012; 142: 1360–8.
  • Casado JL. Renal and bone toxicity with the use of tenofovir: understanding at the end. AIDS Rev 2016; 18: 59-68.
  • Hall AM, Hendry BH, Nitsch D, Connolly JO. Tenofovir-associated kidney toxicity in HIV – infected patients: a review of the evidence. Am J Kidney Dis 2011; 57: 773-80.
  • Fernandez-Fernandez B, Montoya-Ferrer A, Sanz AB, et al. Tenofovir nephrotoxicity: 2011 update. AIDS Res Treat 2011; 2011: 354908.
  • Koklu S, Gulsen MT, Tuna Y, et al. Differences in nephrotoxicity risk and renal effects among anti-viral therapies against hepatitis B. Aliment Pharmacol Ther 2015; 41: 310-9.
  • Haskelberg H, Hoy JF, Amin J, Ebeling PR, Emery S, Carr A; STEAL Studey Group. Changes in bone turnover and bone loss in HIVinfected patients changing treatment to tenofovir-emtricitabine or abacavir-lamivudine. PLoS ONE 2012; 7: e38377.
  • 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: 2004-10.
  • Agarwal K, Brunetto M, Seto WK, et al. GS-US-320-0110; GS-US-320-0108 Investigators. 96 weeks treatment of tenofovir alafenamide vs. tenofovir disoproxil fumarate for hepatitis B virus infection. J Hepatol 2018; 68: 672-81.
  • Fong TL, Lee BT, Tien A, et al. Improvement of bone mineral density and markers of proximal renal tubular function in chronic hepatitis B patients switched from tenofovir disoproxil fumarate to tenofovir alafenamide. J Viral Hepat 2019; 26: 561-7.
  • Seto WK, Asahina Y, Brown TT, et al. Improved Bone Safety of Tenofovir Alafenamide Compared to Tenofovir Disoproxil Fumarate Over 2 Years in Patients With Chronic HBV Infection. Clin Gastroenterol Hepatol 2018: S1542-3565(18)30633-5.
  • 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 2020; 5: 258-63.
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Details

Primary Language English
Subjects Health Care Administration
Journal Section Research Articles
Authors

Mustafa Akar 0000-0002-5589-2849

Publication Date July 14, 2021
Published in Issue Year 2021

Cite

AMA Akar M. Real-life data of tenofovir disoproxil fumarate and tenofovir alafenamide fumarate in the patients with chronic hepatitis B: a single-center experience. Anatolian Curr Med J / ACMJ / acmj. July 2021;3(3):239-245. doi:10.38053/acmj.951923

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