Navigation Links
BARACLUDE data show low resistance over 5 years in nucleoside-naive hepatitis B patients
Date:3/24/2008

(PRINCETON, NJ, March 24, 2008) New BARACLUDE (entecavir) data presented today demonstrated a continued low incidence of resistance in nucleoside-nave patients through five years of treatment. In the nucleoside-nave chronic hepatitis B patients analyzed, no additional patient developed resistance in the fifth year (n=108). Through five years of treatment, the cumulative probability of developing mutations in the virus that confer resistance to BARACLUDE (also called genotypic resistance) was 1.2 percent. Bristol-Myers Squibb Company (NYSE: BMY) announced the results at the 18th Conference of the Asia-Pacific Association for the Study of the Liver (APASL) in Seoul, Korea.

In lamivudine-refractory patients who received BARACLUDE after treatment with lamivudine failed, the cumulative probability of genotypic BARACLUDE resistance was 51 percent through the fifth year. This finding is consistent with prior observations that the pre-existence of lamivudine-resistant mutations results in an increase in the rate of BARACLUDE resistance.

Many chronic hepatitis B patients require long-term treatment. Unfortunately, the initial benefits of therapy can be lost after the development of resistance. These five-year BARACLUDE data that demonstrate long-term minimal resistance at 1.2 percent in nucleoside-naive patients can be of great importance for patients, said Professor Ching-Lung Lai, Chief, Division of Gastroenterology and Hepatology, University of Hong Kong.

Drug resistance occurs when the hepatitis B virus (HBV) mutates, thereby avoiding the effects of the medication. This can decrease the efficacy of the current medication and may compromise future treatment options. To date, studies have shown that multiple mutations are required to develop BARACLUDE (entecavir) resistance.

These long-term BARACLUDE data continue to support the observations seen in the first years of treatment and are reflective of BARACLUDEs high genetic barrier to resistance, said Helena Brett-Smith, M.D., Group Director of Clinical Research at Bristol-Myers Squibb. More importantly, we believe the data support BARACLUDE as an important initial treatment choice for chronic hepatitis B, which is a disease that results in a large global health burden.

About the Analysis

More than 700 patients across six studies initiated therapy on BARACLUDE and were monitored for treatment response and resistance. The year five analysis expands upon previous analyses, adding in information on patients who received treatment with BARACLUDE during the fifth year of follow-up (n=108 for patients in nucleoside-nave studies and n=33 for patients in lamivudine-refractory studies).

In this comprehensive analysis, all patients enrolled in Bristol-Myers Squibb clinical trials ETV-014, -015, -022, -027, -026 and -901 who experienced a virologic breakthrough1 or whose virus had not yet reached undetectable levels2 at weeks 48, 96, 144, 192, 240 or end of dosing, were sequenced to determine if any changes occurred in the genetic code of the virus that would result in resistance or loss of effectiveness of BARACLUDE.

Nucleoside-nave patients in this analysis were initially treated with BARACLUDE 0.5 mg in studies ETV-022 and -027 and continued treatment with BARACLUDE 1 mg by enrolling in study ETV-901 with a treatment gap of less than or equal to 35 days. Lamivudine-refractory patients in this analysis initiated therapy on BARACLUDE 1 mg in studies ETV-014, -015, and -026 and continued treatment in study ETV-901 with a treatment gap of less than or equal to 35 days.

1 Virologic breakthrough is defined as a greater than or equal to 1 log increase in HBV DNA from nadir, as measured by the polymerase chain reaction or PCR assay.

2 Undetectable viral load is defined as HBV DNA levels less than 300 copies/mL, as measured by PCR assay.

Viral load reduction in chronic hepatitis B patients treated with BARACLUDE (entecavir) in nucleoside-nave and lamivudine-refractory studies was also evaluated.

Data Results

Results from these studies prior to this year five analysis were previously announced on April 14, 2007.

Nucleoside-nave data

  • The incidence of BARACLUDE resistance in patients in nucleoside-nave studies over time is low, with a cumulative probability of genotypic BARACLUDE resistance of 1.2 percent through five years.
  • No nucleoside-naive patient developed resistance (n=108) in year five.
  • 93 percent of the nucleoside-naive patients taking BARACLUDE were able to achieve and maintain an undetectable viral load (HBV DNA < 300 copies/mL) through year five (n=108).

Lamivudine-refractory data

  • The results in lamivudine-refractory patients in years one through five were consistent with the finding that the pre-existence of lamivudine-resistant substitutions resulted in an increase in the emergence of BARACLUDE resistance, with a cumulative probability of genotypic resistance of 51 percent through five years.
  • In year five, 43 percent of lamivudine-refractory patients had virologic breakthrough with BARACLUDE resistance (n=33).
  • During this resistance monitoring program, 72 of the 187 lamivudine-refractory patients achieved undetectable viral load ( < 300 copies/mL) and of these, three patients subsequently developed genotypic resistance to BARACLUDE.

Indication and Important Safety Information About BARACLUDE (entecavir) 0.5 mg/1 mg Tablets


'/>"/>

Contact: Hilary Mra
mrah@ruderfinn.com
212-593-6414
Ruder Finn Public Relations
Source:Eurekalert

Related biology news :

1. Researchers discover new strategies for antibiotic resistance
2. St. Jude finds factors that accelerate resistance to targeted therapy in lymphoblastic leukemia
3. Binghamton University researchers investigate evolving malaria resistance
4. Drug could improve pregnancy outcomes in wider range of women with insulin resistance
5. Feline virus, antiviral drug studied to understand drug resistance
6. Manure management reduces levels of antibiotics and antibiotic resistance genes
7. High degree of resistance to antibiotics in Arctic birds
8. Gene that controls ozone resistance of plants could lead to drought-resistant crops
9. First orchid fossil puts showy blooms at some 80 million years old
10. ESA celebrates 100 years of insect science journals
11. Researchers detect hint of oxygen 50 to 100 million years earlier than first believed
Post Your Comments:
*Name:
*Comment:
*Email:
(Date:10/4/2017)... , Oct. 4, 2017  GCE Solutions, a global clinical ... data and document anonymization solution on October 4, 2017. Shadow is ... field to comply with policy 0070 of the European Medicines Agency ... data. ... GCE Solutions ...
(Date:8/15/2017)... 2017   ivWatch LLC , a medical device company focused ... announced receipt of its ISO 13485 Certification, the global standard for ... for Standardization (ISO®). ... 400 Continuous Monitoring device for the early detection of IV infiltrations. ... "This is an important milestone for ivWatch, ...
(Date:6/30/2017)... June 30, 2017 Today, American Trucking ... supplier of face and eye tracking software, became ... provider program. "Artificial intelligence and ... to monitor a driver,s attentiveness levels while on ... able to detect fatigue and prevent potential accidents, ...
Breaking Biology News(10 mins):
(Date:10/12/2017)... ... October 12, 2017 , ... ... with the addition of its newest module, US Hemostats & Sealants. , SmartTRAK’s ... hemostats, absorbable hemostats, fibrin sealants, synthetic sealants and biologic sealants used in surgical ...
(Date:10/12/2017)... ... October 12, 2017 , ... ... analysis platform specifically designed for life science researchers to analyze and interpret ... Rosalind Franklin, who made a major contribution to the discovery of the ...
(Date:10/11/2017)... ... 11, 2017 , ... The CRISPR-Cas9 system has ... and avoiding the use of exogenous expression plasmids. The simplicity of programming this ... gain-of-function studies. , This complement to loss-of-function studies, such as with RNAi ...
(Date:10/11/2017)... ... 11, 2017 , ... ComplianceOnline’s Medical Device Summit is back for its 4th ... in San Francisco, CA. The Summit brings together current and former FDA office bearers, ... and government officials from around the world to address key issues in device compliance, ...
Breaking Biology Technology: