Efficacy and resistance to telbivudine treatment in chronic hepatitis B patients with favorable predictors: a multicenter study in Taiwan

Lin, Chun-Han; Hsieh, Tsai Yuan; Tseng, Kuo‐Chih; Peng, Cheng Yuan; Su, Tung‐Hung; Yang, Sheng‐Shun; Hsu, Ya-Chu; Chen, Tsung Ming; Kao, Jia‐Horng

doi:10.1007/s12072-015-9662-9

Cited by 3 publications

(9 citation statements)

References 37 publications

(34 reference statements)

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“…HBeAgpositive patients achieved favorable serological responses, and better virological responses were shown in both HBeAg-positive and HBeAg-negative patients (78.6% and 96.6%, respectively) ( Table 1). 35 In another study, when combining the baseline characteristics of ALT > 2 × ULN with on-treatment responses at week 24, telbivudine compared with entecavir showed significantly higher rates of HBeAg seroconversion (57.1% vs 41.7%, respectively) and ALT normalization (100% vs 66.7%, respectively) at week 48. 36 The combination used (baseline ALT and HBV DNA level at week 24) in this study led to a low rate of telbivudine resistance (6.7%).…”

Section: Treatment Response To Telbivudine In Patients With Chronic Hmentioning

confidence: 96%

“…In a real‐world study, super‐responder patients had satisfactory virological, biochemical, and serological responses after 2 years of treatment with telbivudine. HBeAg‐positive patients achieved favorable serological responses, and better virological responses were shown in both HBeAg‐positive and HBeAg‐negative patients (78.6% and 96.6%, respectively) (Table ) . In another study, when combining the baseline characteristics of ALT > 2 × ULN with on‐treatment responses at week 24, telbivudine compared with entecavir showed significantly higher rates of HBeAg seroconversion (57.1% vs 41.7%, respectively) and ALT normalization (100% vs 66.7%, respectively) at week 48 .…”

Section: Treatment Response To Telbivudine In Patients With Chronic Hmentioning

confidence: 98%

“…When considering super‐responder patients, telbivudine showed a good overall safety and tolerability profile (Table ). In a real‐world study, a small proportion of patients (7.8%) experienced adverse events and none was considered as severe . In another real‐world study, there were no serious adverse events reported and telbivudine improved renal function after 1 year of treatment .…”

Section: Safety Profile Of Telbivudinementioning

confidence: 99%

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Telbivudine therapy for chronic hepatitis B: A journey to identify super‐responders and to optimize treatment using the roadmap model

Kao

Asselah

Dou

et al. 2017

J of Gastro and Hepatol

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Hepatitis B virus (HBV) infection is one of the most serious health problems worldwide with a high risk for cirrhosis and liver cancer. Several antiviral agents have been approved for the treatment of chronic hepatitis B, leading to a rapid reduction in HBV DNA and normalization of serum alanine aminotransferase levels. Telbivudine, a potent inhibitor of HBV replication, has been shown to be well tolerated. Because of the emergence of drug resistance, optimization strategies for telbivudine therapy have been shown to improve patient responses. Optimal baseline characteristics in so-called super-responders have been used to predict the virological response. Baseline HBV DNA levels < 9 log 10 copies/mL (2 × 10 8 IU/mL) or alanine aminotransferase levels of more than or equal to twofold the upper limit of normal in HBeAg-positive patients and HBV DNA < 7 log 10 copies/mL (2 × 10 6 IU/mL) in HBeAg-negative patients were strong predictors for virological response. In addition, the roadmap model, based on early virological response at week 24 of therapy, is considered as a powerful tool to identify patients at risk of treatment failure (HBV DNA ≥ 300 copies/mL, i.e. 60 IU/mL) and to reduce the risk of antiviral resistance. When considering pre-treatment characteristics and on-treatment responses, telbivudine may provide physicians with a wide choice of options to effectively treat patients with chronic hepatitis B, especially those with or at risk of renal impairment, or women of childbearing age.

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Section: Treatment Response To Telbivudine In Patients With Chronic Hmentioning

confidence: 96%

Section: Treatment Response To Telbivudine In Patients With Chronic Hmentioning

confidence: 98%

Section: Safety Profile Of Telbivudinementioning

confidence: 99%

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Telbivudine therapy for chronic hepatitis B: A journey to identify super‐responders and to optimize treatment using the roadmap model

Kao

Asselah

Dou

et al. 2017

J of Gastro and Hepatol

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“…Nevertheless, in some Asian countries where hepatitis B is endemic and treatment options are limited, telbivudine remains the drug most widely available for the treatment of CHB due to its good efficacy, good tolerability, and relatively low cost [21–23]. Thus, the following question must be asked: What kind of patients will benefit from telbivudine therapy with no compromise of renal safety and minimal drug resistance?…”

Section: Introductionmentioning

confidence: 99%

“…Thus, the following question must be asked: What kind of patients will benefit from telbivudine therapy with no compromise of renal safety and minimal drug resistance? As is well known, the roadmap approach will significantly decrease the risk of drug resistance in clinical practice in telbivudine-treated patients [23–29]. However, there is insufficient data regarding the renal protective effects of telbivudine therapy for special populations in real-world contexts.…”

Section: Introductionmentioning

confidence: 99%

Factors Related to Significant Improvement of Estimated Glomerular Filtration Rates in Chronic Hepatitis B Patients Receiving Telbivudine Therapy

Lin

Hsu

Lin

et al. 2017

Gastroenterology Research and Practice

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Background and Aim The improvement of estimated glomerular filtration rates (eGFRs) in chronic hepatitis B (CHB) patients receiving telbivudine therapy is well known. The aim of this study was to clarify the kinetics of eGFRs and to identify the significant factors related to the improvement of eGFRs in telbivudine-treated CHB patients in a real-world setting. Methods Serial eGFRs were calculated every 3 months using the Chronic Kidney Disease Epidemiology Collaboration (CKD-EPI) equation. The patients were classified as CKD-1, -2, or -3 according to a baseline eGFR of ≥90, 60–89, or <60 mL/min/1.73 m2, respectively. A significant improvement of eGFR was defined as a more than 10% increase from the baseline. Results A total of 129 patients were enrolled, of whom 36% had significantly improved eGFRs. According to a multivariate analysis, diabetes mellitus (DM) (p = 0.028) and CKD-3 (p = 0.043) were both significantly related to such improvement. The rates of significant improvement of eGFR were about 73% and 77% in patients with DM and CKD-3, respectively. Conclusions Telbivudine is an alternative drug of choice for the treatment of hepatitis B patients for whom renal safety is a concern, especially patients with DM and CKD-3.

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Efficacy and Long-term Safety of Telbivudine Usage During Second or Third Trimester in Hepatitis B Surface Antigen Positive Mothers With High Viral Load

Jiang

Chen

et al. 2022

Journal of Clinical Gastroenterology

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Goals: The study is to evaluate the efficacy and long-term safety of telbivudine (LdT) usage for hepatitis B surface antigen (HBsAg) positive pregnant women with high viral load. Background: The efficacy and safety of LdT during pregnancy were not assessed from a long-term perspective. Study: HBsAg-positive pregnant women were enrolled and grouped according to antiviral initiation time. Group A (n=100) and group B (n=100) were treated with LdT initiated in the second or third trimester. Group C (n=90) received no antiviral treatment. The efficacy and safety of LdT treatment were compared and infants were followed-up at 1, 5, and 10 years. Denver developmental screening test was conducted at 5 years. Results: Viral loads before delivery in LdT-treated groups were lower than that in group C and group A was lower than that in group B (P<0.001). No infants in LdT-treated groups were infected whereas 8.8% (8/90) infants in group C had positive HBsAg (χ2=23.20, P<0.001). All LdT-treated mothers were well tolerated and no LdT-related adverse events in infants were reported. Part of the physical growth index of infants was higher than Chinese standard values (SV) and showed significant differences. In groups A and B, the developmental screening test qualified rate of 100% (48/48) and 97.96% (48/49) showed no significant difference compared with 92% in normal Chinese children (χ2=5.72, P=0.06). Conclusions: Treatment initiated during the second trimester could strengthen the success of mother-to-child transmission blockage. LdT treatment during pregnancy is safe for both mothers and infants in the long term.

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Efficacy and resistance to telbivudine treatment in chronic hepatitis B patients with favorable predictors: a multicenter study in Taiwan

Abstract: The efficacy and resistance to LdT treatment in CHB patients with favorable predictors were comparable between a real-world clinical population and the GLOBE study. In addition, PCR negativity at week 24 could predict virologic response and genotypic resistance to LdT treatment.

Cited by 3 publications

References 37 publications

Telbivudine therapy for chronic hepatitis B: A journey to identify super‐responders and to optimize treatment using the roadmap model

Telbivudine therapy for chronic hepatitis B: A journey to identify super‐responders and to optimize treatment using the roadmap model

Factors Related to Significant Improvement of Estimated Glomerular Filtration Rates in Chronic Hepatitis B Patients Receiving Telbivudine Therapy

Efficacy and Long-term Safety of Telbivudine Usage During Second or Third Trimester in Hepatitis B Surface Antigen Positive Mothers With High Viral Load

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