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
BARACLUDEÖ 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)
Entecavir for Patients With Decompensated Hepatitis B Virus (HBV)-Related Cirrhosis [Enrolling by invitation]
Hepatitis B Virus (HBV) Viral Suppression by Entecavir in Adefovir Partial Responders [Recruiting]
We propose a largely retrospective study with short-term prospective follow-up in a subgroup
of patients who have not yet been treated with 48 weeks of entecavir following partial
response to adefovir. The aim of the study is to describe sequential virologic response to
adefovir and entecavir.
Suboptimal Responders to Adefovir Switching to Entecavir [Recruiting]
Switching to Entecavir will result in superior antiviral efficacy as compared to continuing
with Adefovir in patients with a suboptimal response to Adefovir
Comparison Between Lamivudine and Entecavir Treatment in Patients [Not yet 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.
Tenofovir vs. Tenofovir Plus Entecavir in Entecavir-Resistant Chronic Hepatitis B [Recruiting]
With the availability of potent nucloes(t)ide analogues (NA), such as tenofovir disoproxil
fumarate (TDF) and entecavir (ETV), suppression of serum HBV DNA to undetectable levels by
polymerase chain reaction (PCR) assays became achievable in most NA treatment-na├»ve
patients. Until recently, however, many patients commenced antiviral treatment with inferior
NAs prior to the availability of TDF or ETV, such as lamivudine (LAM) which has a low
genetic barrier to resistance.
ETV resistance increase up to 51% of patients after 5 years of ETV treatment in
lamivudine-refractory patients. Resistance to ETV appears to occur through a two-hit
mechanism with initial selection of M204V/I mutation followed by amino acid substitutions at
rtT184, rtS202, or rtM250.
In vitro studies showed that ETV-resistant mutations are susceptible to TDF, but there are
little clinical data on the efficacy of TDF monotherapy in patients with ETV-resistance.
On the other hand, there was a retrospective cohort study reporting that, with the
combination of TDF and ETV, most of patients became HBV DNA undetectable after median 6
months of treatment. Probability of reaching complete HBV DNA suppression was not decreased
in patients with ADV or ETV-resistance.
Thus, there is no consistent treatment recommendation for patients with ETV-resistance.
In this clinical trial, the investigators will clarify whether tenofovir monotherapy is as
effective as tenofovir plus entecavir in inducing complete virologic response in CHB
patients with genotypic resistance to ETV and partial virologic response to ongoing
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