WARNING: LACTIC ACIDOSIS / SEVERE HEPATOMEGALY WITH STEATOSIS & 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 ) ].
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).
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. 
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
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)
An Extension to Viral Kinetics Study of Telbivudine and Entecavir in Adults With Chronic Hepatitis B [Recruiting]
This study is to evaluate the safety of telbivudine for up to 21 months of open-label
treatment in patients with chronic hepatitis B who have completed the CLDT600A2407 trial.
Patients treated with telbivudine during core phase will continue telbivudine and patients
treated with entecavir during core phase will be switched to telbivudine if the patient is
willing to enroll this study.
Randomized Controlled Study of Tenofovir Plus Telbivudine Versus Monotherapy With Either Drug in HBeAg Negative Chronic Hepatitis B Patients [Recruiting]
Combination therapies using nucleos(t)ide analogues lead to higher viral suppression
although it may not be sustained for long. Also it remains unknown if combination of more
potent analogues is more beneficial than individual drugs. Thus this study is carried out to
determine the efficacy and safety of combination of tenofovir plus telbivudine (two most
potent nucleos(t)ide analogues)versus monotherapy with either drug alone. This is a 104 week
open labelled, prospective, randomized, multicentric study. The patient will receive either
tenofovir, telbivudine or the combination of two drugs. After completion of 24 weeks, the
non-responders (ie HBV-DNA > 300 copies/ ml) will be switched to combination arm and will
continue receiving tenofovir plus telbivudine for 104 weeks.
Efficacy and Safety of Telbivudine in Treatment naïve Patients With HBeAg-Positive Chronic Hepatitis B (CHB) [Terminated]
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 [Recruiting]
This study will explore efficacy and safety of Telbivudine in the fifth year of treatment.
Prospective Exploratory Study to Describe Hepatitis B Virus (HBV) Kinetics During Treatment With Telbivudine [Recruiting]
This study will explore HBV kinetics in CHB patients during the first 24 weeks of treatment
Page last updated: 2013-02-10