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Baraclude (Entecavir) - Summary

 
 



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 SUMMARY

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.


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NEWS HIGHLIGHTS

Media Articles Related to Baraclude (Entecavir)

Clarifying optimal use of combination therapy in chronic hepatitis B patients: 3 new studies
Source: Liver Disease / Hepatitis News From Medical News Today [2014.04.15]
Three new studies presented at the International Liver CongressTM 2014 have helped clarify the optimal use of combination therapy with peginterferon and nucleoside analogues (NUCs) to achieve the...

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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.

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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-naïve 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 treatment.

more trials >>

Reports of Suspected Baraclude (Entecavir) Side Effects

Hepatic Neoplasm Malignant (36)Pregnancy (21)Death (17)Renal Impairment (9)Blood Creatine Phosphokinase Increased (7)Drug Ineffective (7)Hepatic Failure (6)Exposure VIA Father (6)Fatigue (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

  Rating
Overall rating:  
Effectiveness:   Highly Effective
Side effects:   No Side Effects
  
Treatment Info
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
  
Reported Results
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.

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Page last updated: 2014-04-15

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