A comparison between entecavir and tenofovir in chronic hepatitis B in the clinical practice: a single-center experience

Salvatore Sollima, Alessandro Torre

DOI: https://doi.org/10.7175/cmi.v9i2.1191

Abstract

Chronic Hepatitis B (CHB) affects 350-400 million of patients worldwide. Entecavir (ETV) and tenofovir disoproxil fumarate (TDF) are two nucleoside/nucleotide analogs recommended as first-line treatments in CHB.

This retrospective study aimed at comparing effectiveness and renal safety of ETV and TDF through the analysis of data obtained from our CHB outpatients from June 2007 to September 2014. 41 out of 126 CHB outpatients were treated with ETV and 18 with TDF.

TDF showed greater, though not statistically significant, effectiveness, in the three groups considered, i.e. naïve, pretreated with nucleoside/nucleotide analogs other than ETV or TDF, and pretreated with ETV or TDF patients. In particular, in naïve patients, those treated with TDF attained not detectable levels of viremia more rapidly (7 months versus 9 months) than ETV-treated patients, even starting from higher HBV DNA levels. In addition, virologic failure was observed in 0 versus 11% in TDF and ETV group, respectively. Also in patients pretreated with nucleoside/nucleotide analogs other than ETV or TDF, virologic failure was observed just in ETV patients. In patients who switched from ETV or TDF the mean time to attain undetectable HBV DNA levels was shorter in TDF group (3 months versus 6 months).

Considering renal toxicity, there was no difference in creatinine and GFR levels between the two groups. Proteinuria and phosphaturia were greater in TDF patients, reaching statistical significance just in those pretreated with nucleoside/nucleotide analogs other than ETV or TDF.

 

Keywords

Entecavir; Tenofovir; Chronic Hepatitis B; Comparison; Retrospective analysis

Full Text

HTML PDF

References

  • European Association for the Study of the Liver. EASL clinical practice guidelines: Management of chronic hepatitis B virus infection. J Hepatol 2012; 57: 167-85; http://dx.doi.org/10.1016/j.jhep.2012.02.010
  • Ganem D, Prince AM. Hepatitis B virus infection - natural history and clinical consequences. N Engl J Med 2004; 350: 1118-29; http://dx.doi.org/10.1056/NEJMra031087
  • Hoofnagle JH, Doo E, Liang TJ, et al. Management of hepatitis B: summary of a clinical research workshop. Hepatology 2007; 45: 1056-75; http://dx.doi.org/10.1002/hep.21627
  • Liaw YF. Prevention and surveillance of hepatitis B virus-related hepatocellular carcinoma. Semin Liver Dis 2005; 25: 40-7; http://dx.doi.org/10.1055/s-2005-915649
  • McMahon BJ. The natural history of chronic hepatitis B virus infection. Semin Liver Dis 2004; 24: 17-21; http://dx.doi.org/10.1055/s-2004-828674
  • Fattovich G, Bortolotti F, Donato F. Natural history of chronic hepatitis B: special emphasis on disease progression and prognostic factors. J Hepatol 2008; 48: 335-52; http://dx.doi.org/10.1016/j.jhep.2007.11.011
  • Fattovich G, Stroffolini T, Zagni I, et al. Hepatocellular carcinoma in cirrhosis: incidence and risk factors. Gastroenterology 2004; 127: S35-S50; http://dx.doi.org/10.1053/j.gastro.2004.09.014
  • Chen CJ, Yang HI, Su J, et al. Risk of hepatocellular carcinoma across a biological gradient of serum hepatitis B virus DNA level. JAMA 2006; 295: 65-73; http://dx.doi.org/10.1001/jama.295.1.65
  • Iloeje UH, Yang HI, Su J, et al. Predicting cirrhosis risk based on the level of circulating hepatitis B viral load. Gastroenterology 2006; 130: 678-86; http://dx.doi.org/10.1053/j.gastro.2005.11.016
  • Marcellin P, Asselah T. Long-term therapy for chronic hepatitis B: hepatitis B virus DNA suppression leading to cirrhosis reversal. J Gastroenterol Hepatol 2013; 28: 912-23; http://dx.doi.org/10.1111/jgh.12213
  • Lok AS, McMahon BJ. Chronic hepatitis B: update 2009. Hepatology 2009; 50: 661-2; http://dx.doi.org/10.1002/hep.23190
  • Carosi G, Rizzetto M, Alberti A, et al. Treatment of chronic hepatitis B: update of the recommendations from the 2007 Italian Workshop. Dig Liver Dis 2011; 43: 259-65; http://dx.doi.org/10.1016/j.dld.2010.10.014
  • Liaw YF, Leung N, Kao JH, et al. Asian-Pacific consensus statement on the management of chronic hepatitis B: a 2012 update. Hepatol Int 2012; 6: 531-61; http://dx.doi.org/10.1007/s12072-012-9386-z; http://dx.doi.org/10.1007/s12072-012-9365-4
  • Fung J, Lai CL, Seto WK, et al. Nucleoside/nucleotide analogues in the treatment of chronic hepatitis B. J Antimicrob Chemother 2011; 66: 2715-25; http://dx.doi.org/10.1093/jac/dkr388
  • Chang TT, Gish RG, de Man R, et al. A comparison of entecavir and lamivudine for HBeAg-positive chronic hepatitis B. N Engl J Med 2006; 354: 1001-10; http://dx.doi.org/10.1056/NEJMoa051285
  • Lai CL, Shouval D, Lok AS, et al. Entecavir versus lamivudine for patients with HBeAg-negative chronic hepatitis B. N Engl J Med 2006; 354: 1011-20; http://dx.doi.org/10.1056/NEJMoa051287
  • Marcellin P, Heathcote EJ, Buti M, et al. Tenofovir disoproxil fumarate versus adefovir dipivoxil for chronic hepatitis B. N Engl J Med 2008; 359: 2442-55; http://dx.doi.org/10.1056/NEJMoa0802878
  • Chang TT, Lai CL, Kew Yoon S, et al. Entecavir treatment for up to 5 years in patients with hepatitis B e antigen-positive chronic hepatitis B. Hepatology 2010; 51: 422-30; http://dx.doi.org/10.1002/hep.23327
  • 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; http://dx.doi.org/10.1002/hep.23785
  • van Bommel F, de Man RA, Wedemeyer H, et al. Long-term efficacy of tenofovir monotherapy for hepatitis B virus-monoinfected patients after failure of nucleoside/nucleotide analogues. Hepatology 2010; 51: 73-80; http://dx.doi.org/10.1002/hep.23246
  • Marcellin P, Gane E, Buti M, et al. Regression of cirrhosis during treatment with tenofovir disoproxil fumarate for chronic hepatitis B: a 5-year open-label follow-up study. Lancet 2013; 381: 468-75; http://dx.doi.org/10.1016/S0140-6736(12)61425-1
  • Kitrinos KM, Corsa A, Liu Y, et al. No detectable resistance to tenofovir disoproxil fumarate after 6 years of therapy in patients with chronic hepatitis B. Hepatology 2014; 59: 434-42; http://dx.doi.org/10.1002/hep.26686
  • Buti M, Tsai N, Petersen J, et al. Seven-year efficacy and safety of treatment with tenofovir disoproxil fumarate for chronic hepatitis B virus infection. Dig Dis Sci 2015; 60: 1457-64; http://dx.doi.org/10.1007/s10620-014-3486-7
  • Zoutendijk R, Reijnders JG, Brown A, et al. Entecavir treatment for chronic hepatitis B: adaptation is not needed for the majority of naïve patients with a partial virological response. Hepatology 2011; 54: 443-51; http://dx.doi.org/10.1002/hep.24406
  • Yuen MF, Seto WK, Fung J, et al. Three years of continuous entecavir therapy in treatment-naïve chronic hepatitis B patients: VIRAL suppression, viral resistance, and clinical safety. Am J Gastroenterol 2011; 106: 1264-71; http://dx.doi.org/10.1038/ajg.2011.45
  • Buti M, Morillas RM, Prieto M, et al. Efficacy and safety of entecavir in clinical practice in treatment-naive Caucasian chronic hepatitis B patients. Eur J Gastroenterol Hepatol 2012; 24: 535-42; http://dx.doi.org/10.1097/MEG.0b013e3283511287
  • Pol S, Lampertico P. First-line treatment of chronic hepatitis B with entecavir or tenofovir in “real-life” settings: from clinical trials to clinical practice. J Viral Hepat 2012; 19: 377-86; http://dx.doi.org/10.1111/j.1365-2893.2012.01602.x
  • Ridruejo E, Marciano S, Galdame O, et al. Efficacy and safety of long term entecavir in chronic hepatitis B treatment naïve patients in clinical practice. Ann Hepatol 2014; 13: 327-36
  • Hall AM, Hendry BM, Nitsch D, et al. Tenofovir-associated kidney toxicity in HIV-infected patients: a review of the evidence. Am J Kidney Dis 2011; 57: 773-80; http://dx.doi.org/10.1053/j.ajkd.2011.01.022
  • Mauss S, Berger F, Filmann N, et al. Effect of HBV polymerase inhibitors on renal function in patients with chronic hepatitis B. J Hepatol 2011; 55: 1235-40; http://dx.doi.org/10.1016/j.jhep.2011.03.030
  • Viganò M, Brocchieri A, Spinetti A, et al. Tenofovir-induced Fanconi syndrome in chronic hepatitis B monoinfected patients that reverted after tenofovir withdrawal. J Clin Virol 2014; 61: 600-3; http://dx.doi.org/10.1016/j.jcv.2014.09.016
  • Hwang HS, Park CW, Song MJ. Tenofovir-associated Fanconi syndrome and nephrotic syndrome in a patient with chronic hepatitis B monoinfection. Hepatology 2015 [Epub ahead of print]; http://dx.doi.org/10.1002/hep.27730
  • Dogan UB, Kara B, Gumurdulu Y, et al. Comparison of the efficacy of tenofovir and entecavir for the treatment of nucleos(t)ide-naive patients with chronic hepatitis B. Turk J Gastroenterol 2012; 23: 247-52
  • Guzelbulut F, Ovunc AO, Oetinkaya ZA, et al. Comparison of the efficacy of entecavir and tenofovir in chronic hepatitis B. Hepatogastroenterology 2012; 59: 477-80; http://dx.doi.org/10.5754/hge11426
  • Batirel A, Guclu E, Arslan F 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; http://dx.doi.org/10.1016/j.ijid.2014.09.004
  • Ozaras R, Mete B, Ceylan B, et al. First-line monotherapies of tenofovir and entecavir have comparable efficacies in hepatitis B treatment. Eur J Gastroenterol Hepatol 2014; 26: 774-80; http://dx.doi.org/10.1097/MEG.0000000000000099
  • Liaw YF, Sheen IS, Lee CM, et al. Tenofovir disoproxil fumarate (TDF), emtricitabine/TDF, and entecavir in patients with decompensated chronic hepatitis B liver disease. Hepatology 2011; 53: 62-72; http://dx.doi.org/10.1002/hep.23952
  • Koklu S, Tuna Y, Gulsen MT, et al. Long-term efficacy and safety of lamivudine, entecavir, and tenofovir for treatment of hepatitis B virus-related cirrhosis. Clin Gastroenterol Hepatol 2013; 11: 88-94; http://dx.doi.org/10.1016/j.cgh.2012.10.003
  • Ceylan B, Yardimci C, Fincanci M, et al. Comparison of tenofovir and entecavir in patients with chronic HBV infection. Eur Rev Med Pharmacol Sci 2013; 17: 2467-73
  • Gao L, Trinh HN, Li J, et al. Tenofovir is superior to entecavir for achieving complete viral suppression in HBeAg-positive chronic hepatitis B patients with high HBV DNA. Aliment Pharmacol Ther 2014; 39: 629-37; http://dx.doi.org/10.1111/apt.12708; http://dx.doi.org/10.1111/apt.12629
  • Woo G, Tomlinson G, Nishikawa Y, et al. Tenofovir and entecavir are the most effective antiviral agents for chronic hepatitis B: a systematic review and Bayesian meta-analyses. Gastroenterology 2010; 139: 1218-29; http://dx.doi.org/10.1053/j.gastro.2010.06.042
  • Dakin H, Fidler C, Harper C. Mixed treatment comparison meta-analysis evaluating the relative efficacy of nucleos(t)ides for treatment of nucleos(t)ide-naive patients with chronic hepatitis B. Value Health 2010; 13: 934-45; http://dx.doi.org/10.1111/j.1524-4733.2010.00777.x
  • Wiens A, Lenzi L, Venson R, et al. Comparative efficacy of oral nucleoside or nucleotide analog monotherapy used in chronic hepatitis B: a mixed-treatment comparison meta-analysis. Pharmacotherapy 2013; 33: 144-51; http://dx.doi.org/10.1002/phar.1188
  • Ke W, Liu L, Zhang C, et al. Comparison of efficacy and safety of tenofovir and entecavir in chronic hepatitis B virus infection: a systematic review and meta-analysis. PLoS One 2014; 9:e98865; http://dx.doi.org/10.1371/journal.pone.0098865

Statistics

Abstract: 1867 views
HTML: 764 views
PDF: 541 views

Refbacks

  • There are currently no refbacks.




© SEEd srl