Telbivudine protects renal function in patients with chronic hepatitis<scp>B</scp>infection in conjunction with adefovir‐based combination therapy

Lee, Minhyea; Oh, Se‐jin; Lee, H. J.; Yeum, Tae Sung; Lee, J. H.; Yu, Su Jong; Kim, H. Y.; Yoon, Jung Hwan; Lee, Hoi-Seon; Kim, Y. J.

doi:10.1111/jvh.12217

Cited by 26 publications

(32 citation statements)

References 42 publications

(45 reference statements)

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“…The finding of improvement in eGFR with telbivudine treatment was consistent with that reported in previous studies where telbivudine significantly improved while adefovir and lamivudine worsened renal function[25,26]. CHB patients with impaired renal function at baseline have also shown an eGFR improvement after 1 year[27] and 2 years of treatment with telbivudine[11,28]. Similar results for telbivudine have also been reported in patients with cirrhosis, patients with compensated cirrhosis, or patients with no cirrhosis[29,30].…”

Section: Discussionsupporting

confidence: 88%

Telbivudinevstenofovir in hepatitis B e antigen-negative chronic hepatitis B patients: OPTIMA roadmap study

Krastev

Petrova

Kotzev

et al. 2016

WJH

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AIMTo make efficacy and safety comparison of telbivudine-raodmap and tenofovir-roadmap in hepatitis B e antigen (HBeAg)-negative chronic hepatitis B (CHB) patients.METHODSThis was the first prospective, randomised, two-arm, open-label, non-inferiority study in HBeAg-negative CHB patients that compared telbivudine and tenofovir administered as per roadmap concept. Patients were treated up to 24 wk and, depending on virologic response, continued the same therapy or received add-on therapy up to 104 wk. Eligible patients received an additional 52 wk of treatment in the extension period (i.e., up to 156 wk). Patients who developed virologic breakthrough (VB) while on monotherapy also received add-on therapy. The primary efficacy endpoint was the rate of patients achieving hepatitis B virus (HBV) DNA < 300 copies/mL at week 52. Secondary efficacy endpoints included the rates of HBV DNA < 300 and < 169 copies/mL, HBV DNA change from baseline, alanine aminotransferase normalisation, hepatitis B surface antigen (HBsAg) loss, HBsAg seroconversion, VB, and emergence of resistance at various timepoints throughout the study. Safety and estimated glomerular filtration rate (eGFR) were also analysed.RESULTSA total of 241 patients were randomised. Non-inferiority of telbivudine arm to tenofovir arm was demonstrated at week 52 (± 7 d window), with over 91% of patients in each treatment arm achieving HBV DNA level < 300 copies/mL. Both arms were similar in terms of key secondary efficacy variables at weeks 104 and 156. The percentage of patients achieving HBV DNA < 300 copies/mL remained high and was similar in the telbivudine and tenofovir arms at both weeks 104 and 156. Over 82% of patients in both arms achieved alanine aminotransferase normalisation at week 52, and this percentage remained high at weeks 104 and 156. Telbivudine treatment progressively reduced serum HBsAg levels from baseline while no change was reported in quantitative HBsAg during therapy with tenofovir. Both treaments showed acceptable safety profiles. The telbivudine arm showed eGFR improvement unlike the tenofovir arm.CONCLUSIONEfficacy was shown for both telbivudine-roadmap and tenofovir-roadmap regimens in HBeAg-negative CHB patients over 156 wk. Telbivudine arm was associated with renal improvement.

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Section: Discussionsupporting

confidence: 88%

Telbivudinevstenofovir in hepatitis B e antigen-negative chronic hepatitis B patients: OPTIMA roadmap study

Krastev

Petrova

Kotzev

et al. 2016

WJH

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“…We found that after 2 years of treatment, the median eGFR increased by 22.3 ml/min/1.73m 2 and the percentage of patients with an eGFR > 90 ml/min/1.73m increased from 60% to 92.3% over 2 years, which is agreement with Gane et al [15] and Lee et al [29]. In addition, 23 patients (88.5%) in whom the eGFR was < 90 ml/min/1.73m 2 at baseline in the LDT-treated group, returned to normal renal function after oral LDT administration, which was significantly higher than the ETV-treated group (n=8 [34.7%]).…”

Section: Discussionsupporting

confidence: 82%

“…Mauss et al [27] showed that in 200 CHB patients undergoing LAM, ADV, ETV, and TDF monotherapy for 24 months, the median eGFR decreased by 0.92, 1.02, 1.00, and 0.92 ml/min every year, respectively, according to the Chronic Kidney Disease Epidemiology Collaboration (CKD-EPI) calculation, indicating that mild renal failure may occur during therapy. Recently, some retrospective studies have reported that except for anti-viral treatment, LDT can also help improve the GFR in patients [28,29]. A doubleblind randomized controlled study showed that the mean eGFR increased 8.5% compared to baseline after LDT treatment for 2 years and this improvement persisted for 4-6 years, especially in elderly patients with mild renal impairment at baseline [15].…”

Section: Discussionmentioning

confidence: 99%

Comparison of Telbivudine and Entecavir Therapy on Nephritic Function and Drug Resistance in Patients with Hepatitis B Virus-Related Compensated Cirrhosis

Shen

Ding

Wang

et al. 2016

Cell Physiol Biochem

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Background: To compare the impact of telbivudine (LDT) and entecavir (ETV) administration on nephritic function. Method: One hundred thirty patients diagnosed with hepatitis B virus (HBV)-related compensated cirrhosis were randomly divided into LDT (600 mg/d) or ETV (0.5 mg/d) groups. Results: The drug resistance rate was higher following LDT treatment compared to ETV treatment (16.9% vs. 1.5%, P=0.0006). The mean creatinine level decreased compared to baseline in the LDT group (0.81 vs. 0.94 mg/dl, P=0.000). The change in median glomerular filtration rate (eGFR) compared to baseline in the LTD and ETV groups was 22.3 and -3.3, respectively, at 2 years (P=0.000). In patients with mild nephritic injury (eGFR< 90 ml/min/1.73m²), the median eGFR increased by 28.0 ml/min/1.73m² in the LDT group and decreased by 4.3 ml/min/1.73m² in the ETV group (p=0.000). The eGFR in 88.5% of patients (23/26) from the LDT group increased > 90 ml/min/1.73m². The percentage of patients with an eGFR > 90 ml/min/1.73m² increased from 60.0% to 92.3% in the LDT group and from 64.6% to 69.2% in the ETV group. Conclusion: In patients with HBV-related compensated cirrhosis, LDT treatment was more effective in protecting nephritic function and was associated with a higher drug resistance rate, but did not contribute to a better outcome compared with ETV treatment.

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“…Decrease in estimated glomerular filtration rate (eGFR) was also found in TDF and ETV-treated patients [14]. In contrast, long-term LdT therapy was closely related to sustained improvement of renal function, particularly among patients with high risk of renal dysfunction, such as decompensated cirrhosis [15] and combination therapy with ADV [16]. However, controversy remains as to safety profile with findings either an increase or a decrease in eGFR during long-term and various classes of antiviral agents in real-life study.…”

Section: Introductionmentioning

confidence: 99%

Effect of 48-week pegylated interferon α-2a or nucleos(t)ide analogue therapy on renal function in Chinese patients with chronic hepatitis B

Zhang

Weilu

Pang

et al. 2017

Virol J

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BackgroundControversy remains as to whether antiviral agents contribute to renal dysfunction in patients with chronic hepatitis B virus (HBV) infection. Thus, the aim of study was to analyze the changes in renal function of chronic hepatitis B (CHB) patients in response to anti-HBV therapy and the association with treatments.MethodWe performed a retrospective observational cohort study to investigate factors associated with renal function in 249 Chinese CHB patients who were treated with pegylated interferon α-2a (PEG-IFN-α-2a) or nucleos(t)ide analogues for 48 weeks. Changes of estimated glomerular filtration rate (eGFR), which was computed with both the Chronic Kidney Disease Epidemiology Collaboration and the Modification of Diet in Renal Disease formulas, were tested by repeated measures One-way analysis of variance within groups. A linear mixed effects model for repeated measures was also used to evaluate the association between baseline information and eGFR changes over time in all enrolled patients. The model considered the baseline age, sex, HBV DNA, aminotransferase, blood urea nitrogen, treatment group, time, and group-by-time interaction as fixed effects and incorporated random effects for individual subjects.ResultsThe eGFR increased in patients given PEG-IFN-α-2a, decreased in patients given adefovir, but remained stable in patients given entecavir. Age and blood urea nitrogen were significant negative predictive factors for eGFR changes.ConclusionIn real-life study, PEG-IFN-α-2a therapy in CHB patients increased eGFR, thus may associate with renoprotective effects when compared with adefovir or entecavir therapies.

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Telbivudine protects renal function in patients with chronic hepatitisBinfection in conjunction with adefovir‐based combination therapy

Cited by 26 publications

References 42 publications

Telbivudinevstenofovir in hepatitis B e antigen-negative chronic hepatitis B patients: OPTIMA roadmap study

Telbivudinevstenofovir in hepatitis B e antigen-negative chronic hepatitis B patients: OPTIMA roadmap study

Comparison of Telbivudine and Entecavir Therapy on Nephritic Function and Drug Resistance in Patients with Hepatitis B Virus-Related Compensated Cirrhosis

Effect of 48-week pegylated interferon α-2a or nucleos(t)ide analogue therapy on renal function in Chinese patients with chronic hepatitis B

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