Treatment Outcome and Renal Safety of 3-Year Tenofovir Disoproxil Fumarate Therapy in Chronic Hepatitis B Patients with Preserved Glomerular Filtration Rate
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Background/Aims: To investigate the treatment efficacy and renal safety of long-term tenofovir disoproxil fumarate (TDF) therapy in chronic hepatitis B (CHB) patients with preserved renal function. Methods: The medical records of 919 CHB patients who were treated with TDF therapy were reviewed. All patients had preserved renal function with an estimated glomerular filtration rate (eGFR) of at least 60 mL/min/1.73 m2. Results: A total of 426 patients (184 treatment-naïve and 242 treatment-experienced) were included for analysis. A virologic response (VR) was defined as achieving an undetectable serum hepatitis B virus (HBV) DNA level, and the overall VR was 74.9%, 86.7%, and 89.4% at the 1, 2, and 3-year follow-ups, respectively. Achieving a VR was not influenced by previous treatment experience, TDF combination therapy, or antiviral resistance. In a multivariate analysis, being hepatitis B e antigen positive at baseline and having a serum HBV DNA level ≥2,000 IU/mL at 12 months were associated with lower VR rates during the long-term TDF therapy. The overall renal impairment was 2.9%, 1.8%, and 1.7% at the 1, 2, and 3-year follow-ups, respectively. With regard to renal safety, underlying diabetes mellitus (DM) and an initial eGFR of 60 to 89 mL/min/1.73 m2 were significant independent predictors of renal impairment. Conclusions: TDF therapy appears to be an effective treatment option for CHB patients with a preserved GFR. However, patients with underlying DM and initial mild renal dysfunction (eGFR, 60 to 89 mL/min/1.73 m2) have an increased risk of renal impairment.
Abstract
Background/Aims: To investigate the treatment efficacy and renal safety of long-term tenofovir disoproxil fumarate (TDF) therapy in chronic hepatitis B (CHB) patients with preserved renal function. Methods: The medical records of 919 CHB patients who were treated with TDF therapy were reviewed. All patients had preserved renal function with an estimated glomerular filtration rate (eGFR) of at least 60 mL/min/1.73 m2. Results: A total of 426 patients (184 treatment-naïve and 242 treatment-experienced) were included for analysis. A virologic response (VR) was defined as achieving an undetectable serum hepatitis B virus (HBV) DNA level, and the overall VR was 74.9%, 86.7%, and 89.4% at the 1, 2, and 3-year follow-ups, respectively. Achieving a VR was not influenced by previous treatment experience, TDF combination therapy, or antiviral resistance. In a multivariate analysis, being hepatitis B e antigen positive at baseline and having a serum HBV DNA level ≥2,000 IU/mL at 12 months were associated with lower VR rates during the long-term TDF therapy. The overall renal impairment was 2.9%, 1.8%, and 1.7% at the 1, 2, and 3-year follow-ups, respectively. With regard to renal safety, underlying diabetes mellitus (DM) and an initial eGFR of 60 to 89 mL/min/1.73 m2 were significant independent predictors of renal impairment. Conclusions: TDF therapy appears to be an effective treatment option for CHB patients with a preserved GFR. However, patients with underlying DM and initial mild renal dysfunction (eGFR, 60 to 89 mL/min/1.73 m2) have an increased risk of renal impairment.
참고문헌 (44)
- Korean Association for the Study of the Liver, "KASL clinical practice guidelines : management of chronic hepatitis B", Clin Mol Hepatol, 22, pp.18~75 (2016)
- Dienstag JL, "Benefits and risks of nucleoside analog therapy for hepatitis B", Hepatology, 49(5 Suppl), pp.S112~S121 (2009)
- Ghany MG, "Antiviral resistance and hepatitis B therapy", Hepatology, 49(5 Suppl), pp.S174~S184 (2009)
- European Association for the Study of the Liver, "EASL 2017 Clinical Practice Guidelines on the management of hepatitis B virus infection", J Hepatol, 67, pp.370~398 (2017)
- Tenney DJ, "Two-year assessment of entecavir resistance in Lamivudine-refractory hepatitis B virus patients reveals different clinical outcomes depending on the resistance substitutions present", Antimicrob Agents Chemother, 51, pp.902~911 (2007)
- Tenney DJ, "Long-term monitoring shows hepatitis B virus resistance to entecavir in nucleosidenaïve patients is rare through 5 years of therapy", Hepatology, 49, pp.1503~1514 (2009)
- Kayaaslan B, "Adverse effects of oral antiviral therapy in chronic hepatitis B", World J Hepatol, 9, pp.227~241 (2017)
- Zoulim F, "Management of treatment failure in chronic hepatitis B", J Hepatol, 56(Suppl 1), pp.S112~S122 (2012)
- Duarte-Rojo A, "Efficacy and safety of tenofovir disoproxil fumarate in patients with chronic hepatitis B", Therap Adv Gastroenterol, 3, pp.107~119 (2010)
- Woo G, "Tenofovir and entecavir are the most effective antiviral agents for chronic hepatitis B : a systematic review and Bayesian meta-analyses", Gastroenterology, 139, pp.1218~1229 (2010)
- Marcellin P, "Regression of cirrhosis during treatment with tenofovir disoproxil fumarate for chronic hepatitis B : a 5-year open-label follow-up study", Lancet, 381, pp.468~475 (2013)
- Corsa AC, "No resistance to tenofovir disoproxil fumarate through 96 weeks of treatment in patients with lamivudine-resistant chronic hepatitis B", Clin Gastroenterol Hepatol, 12, pp.2106~2112 (2014)
- Buti M, "Seven-year efficacy and safety of treatment with tenofovir disoproxil fumarate for chronic hepatitis B virus infection", Dig Dis Sci, 60, pp.1457~1464 (2015)
- Berg T, "Long-term efficacy and safety of emtricitabine plus tenofovir DF vs. tenofovir DF monotherapy in adefovir-experienced chronic hepatitis B patients", J Hepatol, 60, pp.715~722 (2014)
- Berg T, "Tenofovir is effective alone or with emtricitabine in adefovir-treated patients with chronichepatitis B virus infection", Gastroenterology, 139, pp.1207~1217 (2010)
- Lim YS, "Tenofovir monotherapy versus tenofovir and entecavir combination therapy in adefovir-resistant chronic hepatitis B patients with multiple drug failure : results of a randomised trial", Gut, 65, pp.1042~1051 (2016)
- Fung S, "Randomized comparison of tenofovir disoproxil fumarate vs emtricitabine and tenofovir disoproxil fumarate in patients with lamivudine-resistant chronic hepatitis B", Gastroenterology, 146, pp.980~988 (2014)
- Cho HJ, "Tenofovir-based rescue therapy in chronic hepatitis B patients with suboptimal responses to adefovir with prior lamivudine resistance", J Med Virol, 87, pp.1532~1538 (2015)
- Ahn HJ, "Treatment efficacy and safety of tenofovir-based therapy in chronic hepatitis B : a real life cohort study in Korea", PLoS One, 12, pp.e0170362~ (2017)
- Lovett GC, "Efficacy and safety of tenofovir in chronic hepatitis B : Australian real world experience", World J Hepatol, 9, pp.48~56 (2017)
- Marcellin P, "Effectiveness and safety of tenofovir disoproxil fumarate in chronic hepatitis B : a 3-year, prospective, real-world study in France", Dig Dis Sci, 61, pp.3072~3083 (2016)
- Petersen J, "Effectiveness and safety of tenofovir disoproxil fumarate in chronic hepatitis B : a 3-year prospective field practice study in Germany", Dig Dis Sci, 61, pp.3061~3071 (2016)
- Riveiro-Barciela M, "Effectiveness and safety of entecavir or tenofovir in a Spanish cohort of chronic hepatitis B patients : validation of the Page-B score to predict hepatocellular carcinoma", Dig Dis Sci, 62, pp.784~793 (2017)
- Levey AS, "A more accurate method to estimate glomerular filtration rate from serum creatinine: a new prediction equation. Modification of Diet in Renal Disease Study Group", Ann Intern Med, 130, pp.461~470 (1999)
- Lee JM, "2014 KLCSG-NCC Korea Practice Guidelines for the management of hepatocellular carcinoma : HCC diagnostic algorithm", Dig Dis, 32, pp.764~777 (2014)
- Marcellin P, "Tenofovir disoproxil fumarate versus adefovir dipivoxil for chronic hepatitis B", N Engl J Med, 359, pp.2442~2455 (2008)
- Liu Y, "No detectable resistance to tenofovir disoproxil fumarate in HBeAg+ and HBeAg-patients with chronic hepatitis B after 8 years of treatment", J Viral Hepat, 24, pp.68~74 (2017)
- 정고은, "Tenofovir has inferior efficacy in adefovir-experienced chronic hepatitis B patients compared to nucleos(t)idenaïve patients", Clinical and Molecular Hepatology, 23(1), pp.66~73 (2017), 대한간학회[DOI]
- Yang DH, "Tenofovir disoproxil fumarate is superior to lamivudine plus adefovir in lamivudine-resistant chronic hepatitis B patients", World J Gastroenterol, 21, pp.2746~2753 (2015)
- Lee SH, "Tenofovir disoproxil fumarate monotherapy is superior to entecavir-adefovir combination therapy in patients with suboptimal response to lamivudine-adefovir therapy for nucleoside-resistant HBV : a 96-week prospective multicentre trial", Antivir Ther, 23, pp.219~227 (2018)
- Wang H, "Comparison of the efficacy of tenofovir monotherapy versus tenofovir-based combination therapy in adefovir-experienced chronic hepatitis B patients : a systematic review and meta-analysis", Int J Clin Exp Med, 8, pp.20111~20122 (2015)
- Zoulim F, "Entecavir plus tenofovir combination therapy for chronic hepatitis B in patients with previous nucleos(t)ide treatment failure", Hepatol Int, 10, pp.779~788 (2016)
- Gordon SC, "Efficacy of tenofovir disoproxil fumarate at 240 weeks in patients with chronic hepatitis B with high baseline viral load", Hepatology, 58, pp.505~513 (2013)
- Kitrinos KM, "No detectable resistance to tenofovir disoproxil fumarate after 6 years of therapy in patients with chronic hepatitis B", Hepatology, 59, pp.434~442 (2014)
- Snow-Lampart A, "No resistance to tenofovir disoproxil fumarate detected after up to 144 weeks of therapy in patients monoinfected with chronic hepatitis B virus", Hepatology, 53, pp.763~773 (2011)
- Lee S, "Prediction of virologic response to tenofovir mono-rescue therapy for multidrug resistant chronic hepatitis B", J Med Virol, 88, pp.1027~1034 (2016)
- Lo AO, "Efficacy of tenofovir switch therapy for nucleos(t)ide-experienced patients with chronic hepatitis B", Aliment Pharmacol Ther, 41, pp.1190~1199 (2015)
- Coppolino G, "The case of chronic hepatitis B treatment with tenofovir : an update for nephrologists", J Nephrol, 28, pp.393~402 (2015)
- Terrault NA, "AASLD guidelines for treatment of chronic hepatitis B", Hepatology, 63, pp.261~283 (2016)
- Jung WJ, "Effect of tenofovir on renal function in patients with chronic hepatitis B", Medicine (Baltimore), 97, pp.e9756~ (2018)
- Wang HM, "Three-year efficacy and safety of tenofovir in nucleos(t)ide analog-naïve and nucleos(t)ide analog-experienced chronic hepatitis B patients", J Gastroenterol Hepatol, 31, pp.1307~1314 (2016)
- Lampertico P, "Review article : long-term safety of nucleoside and nucleotide analogues in HBV-monoinfected patients", Aliment Pharmacol Ther, 44, pp.16~34 (2016)
- Buti M, "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, 1, pp.196~206 (2016)
- Buti M, "Long-term safety and efficacy of nucleo(t)side analogue therapy in hepatitis B", Liver Int, 38(Suppl 1), pp.84~89 (2018)