WARNING: LACTIC ACIDOSIS/SEVERE HEPATOMEGALY WITH STEATOSIS AND SEVERE ACUTE EXACERBATIONS OF HEPATITIS B
Lactic acidosis and severe hepatomegaly with steatosis, including fatal cases, have been reported with the use of nucleoside analogue
s
alone or in combination with antiretrovirals
[
s
ee Warnings and Precautions (5.1)
]
.
Severe acute exacerbations of hepatitis B have been reported in patients who have discontinued anti
-
hepatitis B therapy, including Tyzeka. Hepatic function should be monitored closely with both clinical and laboratory follow
-up for at least several months in patients who discontinue anti
-
hepatitis B therapy. If appropriate,
resumption
of anti
-
hepatitis B therapy may be warranted [
see Warnings and Precautions (5
.2
)
].
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TYZEKA SUMMARY
TYZEKA™ is the trade name for telbivudine, a synthetic thymidine nucleoside analogue with activity against hepatitis B virus (HBV).
TYZEKA™ (telbivudine) is indicated for the treatment of chronic hepatitis B in adult patients with evidence of viral replication and either evidence of persistent elevations in serum aminotransferases (ALT or AST) or histologically active disease.
This indication is based on virologic, serologic, biochemical and histologic responses after one year of treatment in nucleoside-treatment-naïve adult patients with HBeAg-positive and HBeAg-negative chronic hepatitis B with compensated liver disease (See Description of Clinical Studies).
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NEWS HIGHLIGHTS
Published Studies Related to Tyzeka (Telbivudine)
Efficacy of switching to telbivudine in chronic hepatitis B patients treated previously with lamivudine. [2011.05]
BACKGROUND: Telbivudine showed greater antiviral suppression than lamivudine in phase II and III clinical trials. Aims: The present phase IIIb, randomized, double-blind, multicentre global trial assessed the antiviral efficacy and safety of telbivudine switch in chronic hepatitis B (CHB) patients who exhibited persistent viraemia under lamivudine therapy... CONCLUSIONS: Early (</= 24 weeks) switch to telbivudine improves virological outcomes in CHB patients with persistent viral replication under lamivudine treatment. (c) 2010 John Wiley & Sons A/S.
A 24-week, parallel-group, open-label, randomized clinical trial comparing the early antiviral efficacy of telbivudine and entecavir in the treatment of hepatitis B e antigen-positive chronic hepatitis B virus infection in adult Chinese patients. [2010.04]
BACKGROUND: Because drug-resistant strains of hepatitis B virus (HBV) have developed, and because serum HBV-DNA levels may rebound in patients who receive treatment with nucleoside/nucleotide analogues for up to 2 years, there remains a largely unmet clinical need for agents to induce potent virologic suppression in the initial stage of the disease course of HBV infection. OBJECTIVE: The aim of this work was to compare the early antiviral effectiveness of telbivudine and entecavir in the treatment of patients with hepatitis B e antigen (HBeAg)-positive HBV... CONCLUSION: In this study of ethnic Han Chinese adults with previously untreated HBeAg-positive HBV infection, there were no statistically significant differences in effectiveness or tolerability between telbivudine 600 mg and entecavir 0.5 mg at the end of 24 weeks of treatment. ChiCTR.org identifier: ChiCTR-TRC-00000341.
Early viral kinetics of telbivudine and entecavir: results of a 12-week randomized exploratory study with patients with HBeAg-positive chronic hepatitis B. [2010.03]
We characterized the early viral kinetic profiles of telbivudine and entecavir and the effects of these potent nucleoside analogs on hepatitis B virus (HBV) DNA and alanine aminotransferase levels in adults with hepatitis B e antigen-positive compensated chronic hepatitis B... Both medications were well tolerated.
Safety evaluation of telbivudine. [2010]
IMPORTANCE OF THE FIELD: Successful treatment of chronic hepatitis B (CHB) often
requires long-term oral nucleoside/nucleotide agents which can be associated with
viral resistance, patient non-compliance and adverse effects. Telbivudine is one
of the more potent options available, with a 6.5- to 6.6-log copies/ml hepatitis
B DNA reduction at 12 weeks in an early viral kinetic study, a potency comparable
to entecavir.
Absence of effect of telbivudine on cardiac repolarization: results of a thorough QT/QTc study in healthy participants. [2009.12]
The effect of telbivudine on cardiac repolarization was evaluated in healthy participants at clinical and supratherapeutic doses. Sixty-two participants were enrolled, stratified by sex, and randomized according to a crossover design among 4 treatment sequences: placebo, a single moxifloxacin 400-mg dose as positive calibrator, and telbivudine 600 and 1800 mg/d for 7 days...
Clinical Trials Related to Tyzeka (Telbivudine)
Telbivudine or Tenofovir Treatment in HBeAg-negative Chronic Hepatitis B Patients Based on the Roadmap Concept [Recruiting]
The purpose of this study is to evaluate the efficacy and safety following the Roadmap
Concept strategy with an initial monotherapy using either telbivudine or tenofovir in HBeAg
negative CHB patients. The data from the study should allow for the validation of the
Roadmap concept in a prospective manner, for both telbivudine and tenofovir treated HBeAg
negative CHB patients. As part of a post-approval commitment to the European Health
Authorities, the data will also be used to provide an optimized clinical treatment strategy
for better clinical use of telbivudine in European HBeAg negative patients. Furthermore, the
data from the study will contribute to a better scientific understanding, disease management
and treatment of HBeAg negative CHB patients.
Prospective Exploratory Study to Evaluate the Safety and Efficacy of Telbivudine in the Fifth Year of Treatment in Chinese Patients With Compensated Chronic Hepatitis B [Completed]
This study will explore efficacy and safety of Telbivudine in the fifth year of treatment.
Efficacy and Safety of Telbivudine in Treatment na�ve Patients With Hepatitis B e Antigen (HBeAg)-Positive Chronic Hepatitis B (CHB) [Terminated]
To evaluate the combination of telbivudine 600 mg orally (PO) once daily and peginterferon
alpha-2a 180 ug subcutaneous (sq) injection weekly for antiviral efficacy in comparison to
peginterferon alpha-2a monotherapy.
Telbivudine in Adults Previously Treated in Idenix-Sponsored Telbivudine Studies [Completed]
This trial is being conducted as an open-label, extended-term study for patients with
chronic hepatitis B who have previously completed an Idenix-sponsored trial with
telbivudine.
Study of Efficacy and Safety, Tolerability and Pharmacokinetics of Telbivudine in Children and Adolescents With Compensated Chronic Hepatitis B Virus Infection [Recruiting]
The purpose of the study is to assess the efficacy and safety of telbivudine at a dose of 20
mg/kg up to a maximum of 600 mg q. d. in compensated pediatric HBeAg-positive and negative
CHB patients aged 2 to <18 years with the indication of antiviral CHB treatment. This study
is part of the commitments of the pediatric development plan for telbivudine in Europe and
US.
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Page last updated: 2013-02-10
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