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 ) ].
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TYZEKA SUMMARY
WARNING: LACTIC ACIDOSIS
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 HIGHLIGHTSMedia Articles Related to Tyzeka (Telbivudine)
Entecavir Achieves High Response Rate In Real-life Clinical Management Of Patients With Chronic Hepatitis B
Source: Liver Disease / Hepatitis News From Medical News Today [2009.11.04]
The nucleoside analogue entecavir (Baraclude, Bristol-Myers Squibb) achieves a high response rate and progressive decline in liver stiffness in patients with chronic hepatitis B, according to results from the first study in 'real-life' clinical practice reported at the Annual Meeting of the American Association for the Study of Liver Diseases (31 October - 3 November, 2009).
BARACLUDE(R) (entecavir) Demonstrated Greater Antiviral Efficacy Compared To Adefovir In New Study Of Chronic Hepatitis B Patients With Cirrhosis
Source: Liver Disease / Hepatitis News From Medical News Today [2009.11.03]
Bristol-Myers Squibb (NYSE: BMY) today announced 48-week data from an ongoing study (ETV-048) of chronic hepatitis B patients with decompensated cirrhosis, in which BARACLUDE demonstrated greater viral suppression compared to adefovir. The new BARACLUDE data were presented today at the 60th Annual Meeting of the American Association for the Study of Liver Diseases.
Published Studies Related to Tyzeka (Telbivudine)
2-Year GLOBE trial results: telbivudine Is superior to lamivudine in patients with chronic hepatitis B. [2009.02]
BACKGROUND & AIMS: The GLOBE trial has compared the efficacy and safety of telbivudine versus lamivudine treatment over 2 years in patients with chronic hepatitis B... CONCLUSIONS: Telbivudine is superior to lamivudine in treating patients with chronic hepatitis B over a 2-year period.
Telbivudine versus lamivudine in Chinese patients with chronic hepatitis B: Results at 1 year of a randomized, double-blind trial. [2008.02]
CONCLUSION: In Chinese patients with chronic hepatitis B, telbivudine treatment for 52 weeks provided greater antiviral and clinical efficacy than lamivudine, with less resistance.
Telbivudine versus lamivudine in patients with chronic hepatitis B. [2007.12.20]
BACKGROUND: Reducing hepatitis B virus (HBV) replication to minimal levels is emerging as a key therapeutic goal for chronic hepatitis B... CONCLUSIONS: Among patients with HBeAg-positive chronic hepatitis B, the rates of therapeutic and histologic response at 1 year were significantly higher in patients treated with telbivudine than in patients treated with lamivudine. In both the HBeAg-negative and the HBeAg-positive groups, telbivudine demonstrated greater HBV DNA suppression with less resistance than did lamivudine. (ClinicalTrials.gov number, NCT00057265 [ClinicalTrials.gov].). Copyright 2007 Massachusetts Medical Society.
Treatment of hepatitis B e antigen positive chronic hepatitis with telbivudine or adefovir: a randomized trial. [2007.12.04]
BACKGROUND: The efficacy of nucleoside and nucleotide analogues for hepatitis B has been linked to the magnitude and durability of hepatitis B virus (HBV) suppression. OBJECTIVE: To compare the antiviral efficacy of telbivudine and adefovir dipivoxil, and the effects of switching from adefovir to telbivudine, in hepatitis B e antigen (HBeAg)-positive patients with chronic hepatitis B... CONCLUSION: Telbivudine demonstrated greater and more consistent HBV DNA suppression than adefovir after 24 weeks of treatment. After 52 weeks, HBV DNA suppression was greater in patients who had received continuous telbivudine or were switched to telbivudine after 24 weeks than in those who received continuous adefovir.
Treatment of Hepatitis B e Antigen-Positive Chronic Hepatitis with Telbivudine or Adefovir: A Randomized Trial. [2007.10.01]
BACKGROUND: The efficacy of nucleoside and nucleotide analogues for hepatitis B has been linked to the magnitude and durability of hepatitis B virus (HBV) suppression. OBJECTIVE: To compare the antiviral efficacy of telbivudine and adefovir dipivoxil, and the effects of switching from adefovir to telbivudine, in hepatitis B e antigen (HBeAg)-positive patients with chronic hepatitis B... CONCLUSIONS: Telbivudine demonstrated greater and more consistent HBV DNA suppression than adefovir after 24 weeks of treatment. After 52 weeks, HBV DNA suppression was greater in patients who had received continuous telbivudine or were switched to telbivudine after 24 weeks than in those who received continuous adefovir. *For members of the 018 Study Group, see the Appendix. ClinicalTrials.gov registration number: NCT00115245.
Clinical Trials Related to Tyzeka (Telbivudine)
Efficacy and Safety of Telbivudine in Treatment naïve Patients With HBeAg-Positive Chronic Hepatitis B (CHB) [Terminated]
Telbivudine Versus the Combination of Telbivudine and Valtorcitabine in Patients With Chronic Hepatitis B [Active, not recruiting]
This study is being conducted to compare the effectiveness of the combination of
valtorcitabine and telbivudine to telbivudine alone in patients with chronic hepatitis B.
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.
Telbivudine in Adults Previously Treated in Idenix-Sponsored Telbivudine Studies [Active, not recruiting]
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.
Trial of Telbivudine Combination Therapy vs. Continued Adefovir Monotherapy [Withdrawn]
The purpose of this study is to find out if taking a combination of telbivudine and adefovir
or tenofovir and telbivudine can lower the amount of Hepatitis B virus in patients that have
been taking adefovir alone for at least 5 months and have had less than optimal responses.
The safety of taking telbivudine and adefovir together or tenofovir and telbivudine together
will also be studied.
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