Research Article
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Year 2020, Volume: 6 Issue: 4, 270 - 275, 04.07.2020
https://doi.org/10.18621/eurj.645852

Abstract

References

  • 1. Chen CJ, Yang HI, Su J, Jen CL, You SL, Lu SN, et al. Risk of hepatocellular carcinoma across a biological gradient of serum hepatitis B virus DNA level. JAMA 2006;295:65-73.
  • 2. Iloeje UH, Yang HI, Su J, Jen CL, You SL, Chen CJ; Risk Evaluation of Viral Load Elevation and Associated Liver Disease/Cancer-In HBV (the REVEAL-HBV) Study Group. Predicting cirrhosis risk based on the level of circulating hepatitis B viral load. Gastroenterology 2006;130:678-86.
  • 3. Lok AS, Zoulim F, Locarnini S, Bartholomeusz A, Ghany MG, Pawlotsky JM, et al. Hepatitis B virus drug resistance working group. Antiviral drug-resistant HBV: standardization of nomenclature and assays and recommendations for management. Hepatology 2007;46:254-65.
  • 4. Tenney DJ, Rose RE, Baldick CJ, Pokornowski KA, Eggers BJ, Fang J, et al. Long-term monitoring shows hepatitis B virus resistance to entecavir in nucleoside-naive patients is rare through 5 years of therapy. Hepatology 2009;49:1503-14.
  • 5. Lok AS, McMahon BJ. Chronic hepatitis B. Hepatology 2007;45:507-39.
  • 6. European Association For The Study Of The Liver. EASL Clinical Practice Guidelines: management of chronic hepatitis B. J Hepatol 2009;50:227-42.
  • 7. Dienstag JL. Benefits and risks of nucleoside analog therapy for hepatitis B. Hepatology 2009;49:112-21.
  • 8. Zoulim F, Durantel D, Deny P. Management and prevention of drug resistance in chronic hepatitis B. Liver Int 2009;29:108-15.
  • 9. Liu Y, Corsa AC, Buti M, Cathcart AL, Flaherty JF, Miller MD, et al. No detectable resistance to tenofovir disoproxil fuma-rate in HBeAg+ and HBeAg_ patients with chronic hepatitis B after 8 years of treatment. J Viral Hepat 2017;24:68-74.
  • 10. Cai D, Pan C, Yu W, Dang S, Li J, Wu S,et al. Comparison of the long-term efficacy of tenofovir and entecavir in nucleos(t)ide analogue-naïve HBeAg-positive patients with chronic hepatitis B. A large, multicentre, randomized controlled trials. Medicine (Baltimore) 2019;98:e13983.
  • 11. Ha NB, Trinh HN, Rosenblatt L, Nghiem D, Nguyen MH. Treatment outcomes with first-line therapies with entecavir and tenofovir in treatment-naive chronic hepatitis B patients in a routine clinical practice. J Clin Gastroenterol 2016;50:169-74.
  • 12. Batirel A, Guclu E, Arslan F, Kocak F, Karabay O, Ozer S, et al. Comparable efficacy of tenofovir versus entecavir and predictors of response in treatment-naïve patients with chronic hepatitis B: a multicenter real-life study. Int J Infect Dis 2014;28:153-9.
  • 13. Chung SW, Chang Y, Lee HY, Cho EJ, Lee JH, Yu SJ, et al. Is combination antiviral therapy mandatory for maintenance therapy in fully suppressed multidrug-resistant hepatitis B patients? Gastroenterol Res Pract 2018;2018:6948235.
  • 14. Chen J, Zhao SS, Liu XX, Huang ZB, Huang Y. Comparison of the efficacy of tenofovir Versus tenofovir plus entecavir in the treatment of chronic hepatitis B in patients with poor efficacy of entecavir: a systematic review and meta-analysis. Clin Ther 2017;39:1870-80.
  • 15. Kim DY, Lee HW, Song JE, Kim BK, Kim SU, Kim DY, et al. Switching from tenofovir and nucleoside analogue therapy to tenofovir monotherapy in virologically suppressed chronic hepatitis B patients with antiviral resistance. J Med Virol 2018;90:497-502.
  • 16. Li X, Luo J, Zhu C, Wu Y, Li Z, Jie Y, et al. Efficacy of tenofovir disoproxil fumarate switch therapy in chronic hepatitis B patients with suboptimal response to adefovir-based combination therapy. Exp Ther Med 2019;17:1196-205.
  • 17. Terrault NA, Lok ASF, McMahon BJ, Chang K-M, Hwang JP, Jonas MM, et al. Update on Prevention, Diagnosis, and Treatment of Chronic Hepatitis B: AASLD 2018 Hepatitis B Guidance. Hepatology 2018;67:1560-99.
  • 18. Park JG, Park SY. Entecavir plus tenofovir versus entecavir plus adefovir in chronic hepatitis B patients with a suboptimal response to lamivudine and adefovir combination therapy. Clin Mol Hepatol 2015;21:242-8.
  • 19. Li W, Wang L, Liu Y, Li Y, Yu S. Efficacy of entecavir-based rescue therapy in lamivudine-resistant chronic hepatitis B patients in China: a retrospective study. Pharmazie 2018;73:223-47.

Tenofovir plus entecavir combination therapy for chronic hepatitis B with nucleos(t)ide analogue failure

Year 2020, Volume: 6 Issue: 4, 270 - 275, 04.07.2020
https://doi.org/10.18621/eurj.645852

Abstract

Objectives: Currently, both entecavir (ETV) and tenofovir (TDF) are recommended first-line therapy for chronic hepatitis B treatment due to good tolerance, lower side-effect profile and high genetic barrier. However, mutations that may develop in the polymerase gene during treatment may result treatment failure. In this study, we aimed to evaluate the efficacy and virologic response of ETV plus TDF combination therapy in chronic hepatitis B patients with suboptimal response to nucleos(t)ide analogues (NAs) monotherapy.

Methods: A total of 813 patients who were followed-up with the diagnosis of chronic hepatitis B and who were treated with TDF or ETV monotherapy were screened. Patients who had a partial or non response to monotherapy during at least 12 months and who was the presence of serum HBV-DNA levels ≥ 2000 IU/mL at the time of initiation of the ETV plus TDF combination therapy were included.

Results: Ten (1.2%) patients (9 TDF, 1 ETV) were identified to have had partial response (50%) or breaktrough (40%) or virologic rebound (10%) to monotherapy. The median age was 36.8 years (range, 22-55 years), and 5/10 (50%) patients were male. Of 10 patients, nine of achieved undetectable HBV-DNA (< 15 IU/mL) levels (50% of in 6 months and 90% of in 18 months) with combination therapy. One patient showed no response.

Conclusions: Our results suggest that combination therapy is superior to the antiviral change in treatment failure with NAs. In addition, it is important to conduct HBV drug resistance analyzes to prevent false drug change in treatment. 

References

  • 1. Chen CJ, Yang HI, Su J, Jen CL, You SL, Lu SN, et al. Risk of hepatocellular carcinoma across a biological gradient of serum hepatitis B virus DNA level. JAMA 2006;295:65-73.
  • 2. Iloeje UH, Yang HI, Su J, Jen CL, You SL, Chen CJ; Risk Evaluation of Viral Load Elevation and Associated Liver Disease/Cancer-In HBV (the REVEAL-HBV) Study Group. Predicting cirrhosis risk based on the level of circulating hepatitis B viral load. Gastroenterology 2006;130:678-86.
  • 3. Lok AS, Zoulim F, Locarnini S, Bartholomeusz A, Ghany MG, Pawlotsky JM, et al. Hepatitis B virus drug resistance working group. Antiviral drug-resistant HBV: standardization of nomenclature and assays and recommendations for management. Hepatology 2007;46:254-65.
  • 4. Tenney DJ, Rose RE, Baldick CJ, Pokornowski KA, Eggers BJ, Fang J, et al. Long-term monitoring shows hepatitis B virus resistance to entecavir in nucleoside-naive patients is rare through 5 years of therapy. Hepatology 2009;49:1503-14.
  • 5. Lok AS, McMahon BJ. Chronic hepatitis B. Hepatology 2007;45:507-39.
  • 6. European Association For The Study Of The Liver. EASL Clinical Practice Guidelines: management of chronic hepatitis B. J Hepatol 2009;50:227-42.
  • 7. Dienstag JL. Benefits and risks of nucleoside analog therapy for hepatitis B. Hepatology 2009;49:112-21.
  • 8. Zoulim F, Durantel D, Deny P. Management and prevention of drug resistance in chronic hepatitis B. Liver Int 2009;29:108-15.
  • 9. Liu Y, Corsa AC, Buti M, Cathcart AL, Flaherty JF, Miller MD, et al. No detectable resistance to tenofovir disoproxil fuma-rate in HBeAg+ and HBeAg_ patients with chronic hepatitis B after 8 years of treatment. J Viral Hepat 2017;24:68-74.
  • 10. Cai D, Pan C, Yu W, Dang S, Li J, Wu S,et al. Comparison of the long-term efficacy of tenofovir and entecavir in nucleos(t)ide analogue-naïve HBeAg-positive patients with chronic hepatitis B. A large, multicentre, randomized controlled trials. Medicine (Baltimore) 2019;98:e13983.
  • 11. Ha NB, Trinh HN, Rosenblatt L, Nghiem D, Nguyen MH. Treatment outcomes with first-line therapies with entecavir and tenofovir in treatment-naive chronic hepatitis B patients in a routine clinical practice. J Clin Gastroenterol 2016;50:169-74.
  • 12. Batirel A, Guclu E, Arslan F, Kocak F, Karabay O, Ozer S, et al. Comparable efficacy of tenofovir versus entecavir and predictors of response in treatment-naïve patients with chronic hepatitis B: a multicenter real-life study. Int J Infect Dis 2014;28:153-9.
  • 13. Chung SW, Chang Y, Lee HY, Cho EJ, Lee JH, Yu SJ, et al. Is combination antiviral therapy mandatory for maintenance therapy in fully suppressed multidrug-resistant hepatitis B patients? Gastroenterol Res Pract 2018;2018:6948235.
  • 14. Chen J, Zhao SS, Liu XX, Huang ZB, Huang Y. Comparison of the efficacy of tenofovir Versus tenofovir plus entecavir in the treatment of chronic hepatitis B in patients with poor efficacy of entecavir: a systematic review and meta-analysis. Clin Ther 2017;39:1870-80.
  • 15. Kim DY, Lee HW, Song JE, Kim BK, Kim SU, Kim DY, et al. Switching from tenofovir and nucleoside analogue therapy to tenofovir monotherapy in virologically suppressed chronic hepatitis B patients with antiviral resistance. J Med Virol 2018;90:497-502.
  • 16. Li X, Luo J, Zhu C, Wu Y, Li Z, Jie Y, et al. Efficacy of tenofovir disoproxil fumarate switch therapy in chronic hepatitis B patients with suboptimal response to adefovir-based combination therapy. Exp Ther Med 2019;17:1196-205.
  • 17. Terrault NA, Lok ASF, McMahon BJ, Chang K-M, Hwang JP, Jonas MM, et al. Update on Prevention, Diagnosis, and Treatment of Chronic Hepatitis B: AASLD 2018 Hepatitis B Guidance. Hepatology 2018;67:1560-99.
  • 18. Park JG, Park SY. Entecavir plus tenofovir versus entecavir plus adefovir in chronic hepatitis B patients with a suboptimal response to lamivudine and adefovir combination therapy. Clin Mol Hepatol 2015;21:242-8.
  • 19. Li W, Wang L, Liu Y, Li Y, Yu S. Efficacy of entecavir-based rescue therapy in lamivudine-resistant chronic hepatitis B patients in China: a retrospective study. Pharmazie 2018;73:223-47.
There are 19 citations in total.

Details

Primary Language English
Subjects Infectious Diseases, Medical Microbiology
Journal Section Original Articles
Authors

Bengü Tatar 0000-0003-3787-1734

Şükran Köse This is me 0000-0002-4228-1213

Publication Date July 4, 2020
Submission Date November 12, 2019
Acceptance Date January 31, 2020
Published in Issue Year 2020 Volume: 6 Issue: 4

Cite

AMA Tatar B, Köse Ş. Tenofovir plus entecavir combination therapy for chronic hepatitis B with nucleos(t)ide analogue failure. Eur Res J. July 2020;6(4):270-275. doi:10.18621/eurj.645852

e-ISSN: 2149-3189 


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