Comparison of renal safety and efficacy of telbivudine, entecavir and tenofovir treatment in chronic hepatitis B patients: real world experience

Abstract

This study aims to assess the nephrotoxicity and efficacy of tenofovir disoproxil fumarate (tenofovir), telbivudine and entecavir. A retrospective study of 587 patients with chronic hepatitis B treated with tenofovir (n = 170), telbivudine (n = 184) and entecavir (n = 233) for at least 1 year. Renal function and efficacy were assessed. The estimated glomerular filtration rate (eGFR) decreased significantly in the tenofovir group after a mean of 17 months treatment (from 92.2 to 85.6 mL/min/1.73 m(2), p < 0.001), but increased in the telbivudine group after a mean of 32 months of treatment (from 86.1 to 95 mL/min/1.73 m(2), p < 0.001). There was no significant change in eGFR in the entecavir group after a mean of 44 months. By multivariate analysis, pre-existing renal insufficiency (p = 0.003), tenofovir (p = 0.007) and diuretic treatment (p = 0.001) were independent predictors for renal function deterioration. Cumulative virological breakthrough was 0% in tenofovir after 2 years, 3.4% in entecavir after 7 years and 22.9% in telbivudine after 5 years. Liver cirrhosis (p = 0.008) and virological breakthrough (p = 0.040) were independently associated with increased risk of hepatocellular carcinoma development. Tenofovir may lead to deterioration in renal function as assessed by serial eGFR measurements. Although telbivudine appeared to be associated with an improvement in eGFR, it was associated with high rates of virological breakthrough, which was an independent risk factor for HCC development. With low rates of virological breakthrough and preservation of renal function, entecavir could be the best choice among these three agents.

HBeAg Seroconversion in HBeAg-Positive Chronic Hepatitis B Patients Receiving Long-Term Nucleos(t)ide Analog Treatment: A Systematic Review and Network Meta-Analysis

“…Our results show that the rate of the long-term telbivudine treatment-induced HBeAg seroconversion is relatively higher than the other four NAs. However, the drug resistance rate of telbivudine increases with prolonged treatment time, thereby limiting its application [53]. Kranidioti et al .…”

Comparison of the Efficacies and Safety of Combined Therapy between Telbivudine Plus Adefovir and Lamivudine Plus Adefovir in Patients with Hepatitis B Virus Infection in Real-World Practice

“…However, the LdT+ADV group had a higher mean eGFR during 144 weeks of treatment ( P <0.05), which is compatible with a previous monotherapy study [14], which also showed that ADV monotherapy may impair renal function. Furthermore, although TDF had better antiviral potency than LdT and is the newest medication for hepatitis B recommended by the American Association for the Study of Liver Diseases (AASLD), LdT was found to have a more superior renal protection than TDF [48, 49]. The mechanism of improvement in renal function after combined therapy remains to be determined but may be related with HBV eradication.…”

Efficacia e sicurezza di entecavir dopo switch da tenofovir per comparsa di effetti collaterali renali: uno studio multicentrico italiano, di pratica clinica, su 103 pazienti con epatite cronica B

“…Sebbene negli studi clinici randomizzati, controllati, in pazienti selezionati con epatite cronica B, il trattamento con TDF si sia dimostrato ben tollerato e senza segnalazioni di tossicità renale clinicamente significativa, l'esperienza clinica real life ha riportato casi di compromissione della funzione renale fino all'insufficienza renale e alla sindrome di Fanconi [6,7,[10][11][12][13][14][15][16][17][18][19][32][33][34][35][36][37][38][39]. Spesso i fattori di rischio per un peggioramento della funzione renale sono l'età avanzata, l'ipertensione arteriosa e una preesistente riduzione del filtrato glomerulare.…”

“…Tra i NUC approvati, entecavir (ETV) e tenofovir disoproxil fumarato (TDF) sono raccomandati in prima linea nel trattamento dell'epatite cronica B, poiché entrambi sono antivirali potenti e con elevata barriera alla resistenza [1][2][3]. Negli studi registrativi e negli studi clinici a lungo termine, sia ETV che TDF hanno mostrato un profilo di sicurezza favorevole [4][5][6][7][8][9][10][11], anche se recentemente sono stati segnalati nella pratica clinica eventi avversi a livello Efficacia e sicurezza di entecavir dopo switch da tenofovir per comparsa di effetti collaterali renali M. Viganò renale e osseo nei pazienti trattati per lungo tempo con TDF [6,7,[10][11][12][13][14][15][16][17][18][19]. I meccanismi alla base della potenziale tossicità dei NUC sono legati alla loro capacità di inibire la DNA polimerasi ϒ mitocondriale umana quando le concentrazioni intracellulari dei NUC superano una soglia critica [12].…”