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Phase IIIb Comparison of BARACLUDE® (entecavir) Monotherapy versus BARACLUDE plus Tenofovir Combination Shows No Statistical Difference Between Study Arms
San Francisco, CA (PRWEB) November 09, 2011
Bristol-Myers Squibb Company (NYSE: BMY) today announced 96-week results from the BE‐LOW™ study, a Phase IIIb clinical trial comparing BARACLUDE monotherapy (0.5mg once daily) with BARACLUDE (0.5mg once daily) plus tenofovir (300mg once daily) in treatment-naïve adult patients with HBeAg-positive and HBeAg-negative chronic hepatitis B (CHB) with compensated liver disease. In this study, no statistically significant difference was observed between the two treatment arms in the primary efficacy endpoint of HBV DNA
“In these 96-week data comparing entecavir monotherapy to combination of entecavir plus tenofovir, we found that combination therapy did not result in statistically significant difference in virologic response compared to entecavir monotherapy. The BE-LOW study data confirmed the results of previous studies showing limited or no benefit of combination therapy compared to monotherapy for treatment-naïve patients with chronic hepatitis B,” said principal investigator Anna Lok, MD, FRCP, director of clinical hepatology and professor in the department of internal medicine at the University of Michigan Medical School in Ann Arbor.
Study Results
In this study, 379 nucleos(t)ide-naïve patients with CHB were randomized to receive either BARACLUDE (entecavir) 0.5 mg once daily (n=182) or BARACLUDE 0.5 mg plus tenofovir 300 mg once daily (n=197). Key findings at week 96 are:
A comparable proportion of patients in both treatment arms achieved the primary efficacy endpoint of HBV DNA
Among HBeAg-positive patients, the proportion achieving HBV DNA
Among HBeAg-negative patients, the proportion achieving HBV DNA
Secondary efficacy endpoints measured in the study included alanine aminotransferase (ALT) normalization, HBeAg seroconversion, and HBeAg loss. ALT normalization was observed in 81.9% (149/182) of patients in this study in the BARACLUDE (entecavir) monotherapy arm versus 69% (136/197) in the BARACLUDE plus tenofovir arm. HBeAg seroconversion was observed in 32.5% (41/126) of patients in the BARACLUDE (entecavir) monotherapy arm versus 21.7% (30/138) in the BARACLUDE plus tenofovir arm in this study.
Two patients (1.1%) in the BARACLUDE monotherapy arm compared to five patients (2.5%) in the BARACLUDE plus tenofovir arm discontinued treatment prior to week 96. Patients who discontinued therapy prior to week 96 were considered treatment failures.
The overall adverse event profiles were similar across study arms. A total of three deaths occurred among treated patients, all on the BARACLUDE plus tenofovir arm: one due to bile duct tumor; one due to a late-onset exacerbation of hepatitis which was associated with breakthrough viremia while on continued treatment; and one due to cardiac arrest. One patient (0.5%) in the BARACLUDE monotherapy arm and two patients (1.0%) in the BARACLUDE plus tenofovir arm experienced on treatment ALT flares, defined as greater than 2 x baseline ALT and greater than 10 x ULN. No patients (0.0%) in either arm experienced off-treatment ALT flares. Six patients (3.3%) in the BARACLUDE monotherapy arm and four (2.0%) patients in the BARACLUDE plus tenofovir arm experienced serum creatinine increase ≥0.3 mg/dL. A total of five malignancies occurred among patients in the study: four (2.2%) patients in the BARACLUDE monotherapy arm and one (0.5%) patient in the BARACLUDE plus tenofovir arm. In the BARACLUDE monotherapy arm, there were three diagnoses of hepatocellular carcinoma (two on-treatment and one off-treatment) and one case of gastric cancer. In the BARACLUDE plus tenofovir arm there was one case of breast cancer.
Two patients (1.0%) in the BARACLUDE monotherapy arm and seven patients (3.6%) in the BARACLUDE plus tenofovir arm experienced virologic breakthrough. No recognized genotypic resistance mutations were observed in either treatment arm.
About The Study
The BE-LOW study is an open-label, multicenter, Phase IIIb study of 379 nucleos(t)ide-naïve patients with CHB. The patients were randomized 1:1 and treated with either BARACLUDE 0.5 mg once daily (n=182) or BARACLUDE 0.5 mg plus tenofovir 300 mg once daily (n=197). Nucleos(t)ide-naïve, HBeAg-negative CHB patient enrollment was capped at 30%. The primary efficacy endpoint was the proportion of patients with HBV DNA
About Chronic Hepatitis B
Approximately 350 million people worldwide are chronically infected with hepatitis B (approximately 5% of the world’s population) and 75% of these cases occur in the Asia-Pacific region.(2) Most people with chronic hepatitis B show no signs or symptoms, so many of those chronically infected are unaware of their status. A blood test can diagnose chronic hepatitis B. Patients should speak with their doctor about options available for this condition.
About BARACLUDE®
Discovered at Bristol-Myers Squibb, BARACLUDE® is indicated for the treatment of chronic hepatitis B virus (HBV) infection in adults with:
compensated liver disease and evidence of active viral replication, persistently elevated serum alanine aminotransferase (ALT) levels and histological evidence of active inflammation and/or fibrosis
decompensated liver disease
For full prescribing information for BARACLUDE®, please consult the Summary of Product Characteristics.
About Bristol-Myers Squibb
Bristol-Myers Squibb is a global biopharmaceutical company committed to discovering, developing and delivering innovative medicines that help patients prevail over serious diseases.
BARACLUDE® (entecavir) is a registered trademark of Bristol-Myers Squibb Company.
(1) HBV DNA carries the genetic blueprint of the hepatitis B virus. The number of HBV DNA “copies” found in a person’s blood, or “viral load,” indicates how rapidly the virus is reproducing in their liver. Low levels of HBV DNA, recognized as 300 copies per milliliter or less, indicate an “inactive” hepatitis B infection.
Reference:
(2) Hou J, Liu Z, Gu F. Epidemiology and Prevention of Hepatitis B Virus Infection. Int J Med Sci 2005; 2:50 – 57. Available from http://www.medsci.org/v02p0050.htm Accessed November 2011
Cancer treatment shows promise for rapid weight loss Los Angeles Times A synthetic peptide that inhibits blood supply, a strategy employed in many cancer drugs, is found to kill fat cells and improve metabolic function in trials involving monkeys. By Melissa Healy, Los Angeles Times A drug born of a revolutionary approach … Drug helps fat monkeys slim down – are people next?Reuters Rapid weight loss possible through cancer drug?HealthJockey.com
Meet Stefanie LaRue, who was diagnosed with stage 4 metastatic breast cancer at the age of 30 after being told by her doctors that she was too young to have breast cancer. After multiple surgeries and months of chemo, Stefanie’s doctors have classified her as having no evidence of the disease. Today, Stefanie acts as an advocate for breast cancer education and prevention, sharing her story with others and urging women to empower themselves as patients. For more information on breast cancer, and to learn how you can become an empowered patient, visit www.womenshealthcareforum.com/breastcancer.cfm. Video Rating: 4 / 5
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Circulating Cancer Biomarkers Event on 2012-01-25 09:30:00
Practical Applications to Drive Drug Development and Personalized Medicine in the Clinic and cellular level leading to the discovery of an ever increasing set of circulating cancer biomarkers. Hailed as the ‘liquid biopsy’, circulating cancer biomarkers embody the future of non-invasive testing. The applications for this range fromscreening, diagnosis, drug discovery and clinical management.
But how are these biomarkers being identified? What technologies can capture and characterise them? How can they be utilized in the clinical setting?
Designed by industry leaders at AstraZeneca, Genentech, GSK, NCI and MD Anderson amongst others, the Circulating Cancer Biomarker meeting will address the key challenges being faced in turning these novel cancer biomarkers into practical clinical tools.
Attend Circulating Cancer Biomarkers and you will:
• Discover how advances in technology are moving the industry away from simple enumeration and into characterization of CCBs to give more informed decision making in the clinic.
• Uncover the potential of circulating tumor DNA as a predictive biomarker for cancer treatment response, helping you select the right treatment options for the right patient.
• Hear from the leading companies employing micro-vesicles as a prognostic tool for cancer and how you can learn from their expertise.
• Get a master class in the best practices for clinical trial design to make better use of biomarkers.
• Understand the importance of implementing biomarker statistics to increase the power of clinical trials.
• Explore current use of miRNAs as blood based biomarkers within breast cancer. How they can aid early diagnosis and treatment choices.
• Have the opportunity to be involved in frank discussions about how international collaborations can be used to accelerate the use of CCBs in the clinic.
The death of boxing legend Joe Frazier from liver cancer on Nov. 7, 2011, shocked the sports world. He was recently diagnosed and was admitted to hospice care a few days before he died. Unfortunately, Joe Frazier is not the first athlete to suffer from … cancer – Bing News
Image by Christiana Care
June 2009: New construction has more than tripled the size of the Helen F. Graham Cancer Center to about 200,000 square feet. The expansion allows Christiana Care to include even more world-class cancer services and patient-centered care all in one location.
“The strategies we put in place have helped lower Delaware’s declining cancer rates and earned us national recognition as leaders in cancer care,” says Bank of America Endowed Medical Director Nicholas J. Petrelli, M.D. “With this new facility, we can take our fight against cancer to the next level.”
Bringing together the entire continuum of cancer care resources is the essence of the cancer program’s multidisciplinary approach. “Having all of a patient’s related cancer care services in one place facilitates interaction among specialists and promotes the transfer of knowledge about new technologies, drug regimens and treatments for cancer,” said Patrick Grusenmeyer, Sc.D., FACHE, senior vice president of Cancer and Imaging Services.
Accelerating cancer research
Among the most exciting aspects of the expansion is that it makes room for the Center for Translational Cancer Research , bringing advancements in the laboratory to the clinic, where they can help patients.
For patients, it means that doctors and scientists can collaborate closely and quickly. When a doctor discovers a new problem at the bedside, he is able to bring it to a scientist in the lab, where it can be analyzed, and a solution can be developed. The doctor can then bring the solution back to the bedside. This collaborative relationship creates the potential to make leaps forward in understanding and treating cancer in each individual patient.
“This move sets the stage for rapid advances in cancer stem cell biology and human cancer genetics,” said Robert Sikes, Ph.D., director of the Center for Translational Cancer Research and professor of biological sciences at the University of Delaware. “The Center for Translational Cancer Research begins a new chapter in a new space that allows for further synergy between the translational hub at the Helen F. Graham Cancer Center and the preclinical, basic science hub at University of Delware.”
More services, new technology
The expansion includes practice space for more surgeons, including gynecologic cancer surgeons, who can order diagnostic tests, perform biopsies to see if tumors are malignant and operate to remove cancer if necessary. It provides additional medical oncologists who can administer chemotherapy that kills cancer cells. And radiation oncologists who can pinpoint the places where cancer is growing and use precisely focused x-rays to reduce or destroy it.
The expansion brings the highly regarded Christiana Care Breast Center into the Helen F. Graham Cancer Center. The move has allowed the Breast Center to bring Delaware’s first dedicated breast MRI scanner to the spacious new facility.
Other highlights of the expansion:
The Community Health Outreach and Education Program anticipates launching new programs on-site for patients, families and employees, such as smoking cessation, counseling, health fairs and screenings.
The Oncology Data Center collects, analyzes and conducts lifetime follow-up for all cases of cancer and benign central nervous system tumors newly diagnosed or treated at Christiana Care.
The Center for Rehabilitation Oncology provides therapy programs for patients living with and recovering from cancer. This puts patients closer to their entire cancer care team, providing additional support and pain management on-site.
New chemotherapy infusion suites open to a beautifully landscaped rooftop garden, overlooking the pond and fountains.
A chapel and meditation room provide quiet, soothing space for patients and their families.
Member of anti-cancer SWAT Squad —–> Kutrallam 011 – The flora
Image by Pandiyan Madagascar Periwinkle Catharanthus roseus Formerly known as VInca rosea
This plant widely grows in the wastelands and gardens in India. Normally not given a second look, this has amazing properties. Traditionally used for bee/ wasp stings (in India) and eye infections in the Caribbeans.
However, scientists have discovered over 70 alkaloids and some of them have the ability to lower blood sugar, control cell growth etc. This has lead to discovery of a drug for blood cancer – leukaemia. Some of the alkaloids are used for treating advanced breast cancer and Hodgkin’s disease.
[EDIT] – My wife adds that these alkaloids are known as Vincristine and Vinblastine.
Antibiotics can prevent an insidious form of stomach cancer, but it’s a little-known piece of information that the Chapa family got too late. In retrospect, Lynette Chapa says the first sign of her husband’s risk for the gastric cancer – which killed him … cancer – Bing News
American children are being prescribed antibiotics too frequently, often for viral respiratory infections for which they provide no benefits, researchers reported in the journal Pediatrics. The authors add that the use of broad spectrum antibiotics has been on the rise for several years, adding extra avoidable costs to medical care, as well as encouraging antibiotic resistance. Over 10 million ineffective and unnecessary antibiotic prescriptions are written for children by doctors in the USA each year, the authors wrote… Health News from Medical News Today
2012 Blue Sky Breast Cancer Awareness Desk Pad 22 x 17
Bling Jewelry Glow in the Dark Breast Cancer Awareness Pink Ribbon Murano Glass Bead 925 Sterling Silver Fits Compatible with Pandora Chamilia Troll Beads
Lot Of 500 Breast Cancer Awareness Stickers Mega Roll
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