WARNINGS: SEVERE ACUTE EXACERBATIONS OF HEPATITIS B, PATIENTS CO-INFECTED WITH HIV AND HBV, and LACTIC ACIDOSIS AND HEPATOMEGALY
Severe acute exacerbations of hepatitis B have been reported in patients who have discontinued anti-hepatitis B therapy, including entecavir. 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, initiation of anti-hepatitis B therapy may be warranted [see Warnings and Precautions ].
Limited clinical experience suggests there is a potential for the development of resistance to HIV (human immunodeficiency virus) nucleoside reverse transcriptase inhibitors if BARACLUDE is used to treat chronic hepatitis B virus (HBV) infection in patients with HIV infection that is not being treated. Therapy with BARACLUDE is not recommended for HIV/HBV co-infected patients who are not also receiving highly active antiretroviral therapy (HAART) [see Warnings and Precautions ].
Lactic acidosis and severe hepatomegaly with steatosis, including fatal cases, have been reported with the use of nucleoside analogues alone or in combination with antiretrovirals [see Warnings and Precautions ].
Baraclude® (entecavir) Tablets
Baraclude® (entecavir) Oral Solution
BARACLUDE™ is the tradename for entecavir, a guanosine nucleoside analogue with selective activity against hepatitis B virus (HBV).
BARACLUDE (entecavir) is indicated for the treatment of chronic hepatitis B virus infection in adults with evidence of active viral replication and either evidence of persistent elevations in serum aminotransferases (ALT or AST) or histologically active disease.
This indication is based on histologic, virologic, biochemical, and serologic responses after one year of treatment in nucleoside-treatment-naive and lamivudine-resistant adult patients with HBeAg-positive or HBeAg-negative chronic HBV infection with compensated liver disease and on more limited data in adult patients with HIV/HBV co-infection who have received prior lamivudine therapy.
Published Studies Related to Baraclude (Entecavir)
Efficacy and safety of entecavir versus adefovir in chronic hepatitis B patients with hepatic decompensation: a randomized, open-label study. [2011.07]
A randomized, open-label comparative study of entecavir versus adefovir therapy was performed in subjects with chronic hepatitis B who had hepatic decompensation (Child-Turcotte-Pugh score >/=7). Adult subjects were randomized and treated (n = 191) with entecavir 1.0 mg or adefovir 10 mg daily for up to 96 weeks from the date of last subject randomization...
Recommendation of lamivudine-to-entecavir switching treatment in chronic hepatitis B responders: Randomized controlled trial. [2011.06]
Aim: In the 2007-2008 guidelines of the study group (Ministry of Health, Labor and Welfare of Japan), lamivudine (LAM)-continuous treatment was recommended in patients treated with LAM for more than 3 years who maintained hepatitis B virus (HBV) DNA less than 2.6 log copies/mL, because in these patients LAM resistance might exist and switching treatment to entecavir (ETV) might cause ETV resistance...
Pooled model-based approach to compare the pharmacokinetics of entecavir between Japanese and non-Japanese chronic hepatitis B patients. [2011.05]
This study evaluated the population pharmacokinetics (PK) of entecavir in Japanese patients with chronic hepatitis B infection enrolled in 2 Japanese phase IIb clinical trials and compared them to non-Japanese patients enrolled in global phase II trials...
Randomized trial of lamivudine versus entecavir in entecavir-treated patients with undetectable hepatitis B virus DNA: outcome at 2 Years. [2011.04]
CONCLUSION: Sequential therapy using entecavir followed by lamivudine resulted in virological rebound in 24% of patients after 96 weeks. Prior optimal viral suppression with entecavir did not confer any significant advantage in patients who switched to lamivudine. 2011 American Association for the Study of Liver Diseases.
Kinetics of hepatitis B surface antigen differ between treatment with peginterferon and entecavir. [2011.03]
BACKGROUND & AIMS: We aimed to investigate serum hepatitis B surface antigen (HBsAg) levels in patients with chronic hepatitis B virus (HBV) infection during peginterferon (PEG-IFN) and entecavir (ETV) monotherapy... CONCLUSIONS: In HBeAg-positive patients, the decline in serum HBsAg is mainly confined to patients who clear HBeAg, by either PEG-IFN or ETV treatment. In HBeAg-negative patients, PEG-IFN therapy resulted in a significant reduction in HBsAg levels, whereas HBsAg did not decrease in ETV-treated patients. Copyright A(c) 2010 European Association for the Study of the Liver. Published by Elsevier B.V. All rights reserved.
Clinical Trials Related to Baraclude (Entecavir)
Lamivudine Therapy in Patients With Prior Entecavir Treatment and Undetectable Viral Load [Active, not recruiting]
Patients with chronic hepatitis B and treated with entecavir for over 6 months (with no
previous other antiviral treatment) will be invited to participate in this study. They will
be eligible if their liver tests are normal and their viral load is undetectable. Patients
will be switched to lamivudine treatment to assess whether lamivudine can maintain adequate
suppression of the hepatitis B virus after successful treatment with entecavir. Patients
will be monitored closely after switching treatment at 1 months and then every 3 monthly. If
there is any evidence of increase in viral load then patients will be given the option of
changing back to entecavir.
Comparison Between Lamivudine and Entecavir Treatment in Patients [Recruiting]
This is a prospective, observational, open-label, 2-arm, parallel, multi-center study.
Patients with HBV-associated severe acute exacerbation for whom the treatment with NRTI
(such as lamivudine and entecavir) is medically recommended will be screened for
eligibility. To target 88 evaluable subjects, approximately 98 patients should be recruited
into this trial. After enrollment, all eligible subjects will be randomly assigned to one of
the antiviral treatments below.
- Cohort 1: Lamivudine 100 mg p. o. q. d.
- Cohort 2: Entecavir 0. 5 mg p. o. q. d. This process will be stratified by prolonged PT, <
4 sec / 4-6 sec / > 6 sec. Both lamivudine and entecavir will be taken once daily and
the first dose of observational drug should be administered on Day 1. The observational
period of individual subject will be 12 weeks; however, both treatments could be
continued after the end of study based on physician's clinical judgment.
The efficacy and safety data will be collected at baseline, 3, 5, 8, 15, 22, 29 and 85 days
after initiation of antiviral treatment. All assessments should be conducted based on
routine practice of each hospital. Only the analysis of HBV DNA and anti-HDV will be
performed in the central lab. For patients who are willing to provide the residual samples
of HBV DNA assessment, the blood samples will be preserved appropriately. All AE(s) and SAE
will be followed until resolution or the event is considered stable.
Using Entecavir to Reduce Hepatitis in Highly Viremic HBV Patients During Anti-tuberculous Treatment [Not yet recruiting]
Hepatitis during anti-tuberculous treatment (HATT) has been an obstacle in managing TB
patients, especially in those with viral hepatitis. A previous study revealed the risk of
HATT is significantly higher in TB patients with high serum hepatitis B virus (HBV) DNA
level than those with low HBV DNA level. Based on these findings, we thus hypothesize that
the risk of HATT in TB patients with high baseline serum HBV DNA level can be reduced by
concomitant use of anti-HBV agent. In this proposal, we will conduct a prospective
randomized clinical study to assess the reduction of HATT risk by using entecavir in TB
patients with high baseline serum HBV DNA level, and to evaluate the risk of other
treatment-related adverse events in two hospitals.
Suboptimal Responders to Adefovir Switching to Entecavir [Completed]
Switching to Entecavir will result in superior antiviral efficacy as compared to continuing
with Adefovir in patients with a suboptimal response to Adefovir
Study to Evaluate the Non-inferiority of Cavir in HBeAg(+)Chronic Hepatitis B Patients Treated With Baraclude [Recruiting]
Reports of Suspected Baraclude (Entecavir) Side Effects
Hepatic Neoplasm Malignant (36),
Renal Impairment (9),
Blood Creatine Phosphokinase Increased (7),
Drug Ineffective (7),
Hepatic Failure (6),
Exposure VIA Father (6),
Pruritus (5), more >>
PATIENT REVIEWS / RATINGS / COMMENTS
Based on a total of 1 ratings/reviews, Baraclude has an overall score of 10. The effectiveness score is 10 and the side effect score is 10. The scores are on ten point scale: 10 - best, 1 - worst.
Baraclude review by 36 year old male patient
|Overall rating:|| || |
|Effectiveness:|| || Highly Effective|
|Side effects:|| || No Side Effects|
|Condition / reason:|| || Hepatitis B|
|Dosage & duration:|| || 1 mg tablet taken 1 tab/day for the period of about a year|
|Other conditions:|| || None|
|Other drugs taken:|| || None|
|Benefits:|| || The viral load count was reduced from millions to less than a hundred within 9 months. Though the virus cannot be completely removed, reduction in number helped my physiological health in addition to the physical. I've been continuing taking the drugs, and would likely continue until 2 years.|
|Side effects:|| || None but cash and bank a/c were emptied!!!|
|Comments:|| || Daily intake of 1mg tab. Viral load check every 3 months together with ALT, AST and complete blood count.|
Page last updated: 2011-12-09