Phase IIIb Comparison of BARACLUDE
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.
Contacts:
Bristol-Myers Squibb
Media: Annie Simond, +33 1 58 83 65 66, annie.simond(at)bms(dot)com
Note:
(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
###
©Copyright 1997-
, Vocus PRW Holdings, LLC.
Vocus, PRWeb, and Publicity Wire are trademarks or registered trademarks of Vocus, Inc. or Vocus PRW Holdings, LLC.
Related Breast Cancer Prevention Press Releases
Winning Edge Designs Breast Cancer Prevention Rose Head CoverBreast Cancer Prevention Rose 460cc Golf Headcover Nice…
Day-timer Products – Desk Calendar Refill, 2PPD, 2-Hole Punched, 3-1/2″x6″ – Sold as 1 EA – Show your support for breast cancer research with a Pink Ribbon Desk Calendar Refill. Day-Timer contributes 10 percent of the proceeds to The Breast Cancer Research Foundation to achieve the prevention and cure of breast cancer. Pink Ribbon design on white 3-1/2″ x 6″ pages coordinates with other Pink Ribbon products. Each two-page-per-day offers hourly appointment times from 7 AM to 5 PM and past, currenDay-timer Products – Desk Calendar Refill, 2PPD, 2-Hole Punched, 3-1/2″x6″ – Sold as 1 EAShow your support for breast cancer re…
Breast Cancer: Risks and Prevention, Diagnosis & TreatmentsWhat are the risk factors for breast cancer and what decisions will a woman need to make on the basis of an abnormal mammogram res…
Categories: Breast Cancer Prevention Tags: , Arms, BARACLUDE, between, Combination, Comparison, Difference, entecavir, IIIb, Monotherapy, Phase, plus, Shows, Statistical, Study, Tenofovir, versus
Study identifies an expanded role for PKM2 in helping cancer cells survive
In recent years, the field of cancer metabolism has found that cancer cells can manipulate the PKM2 enzyme to grow and thrive. Now a new study finds that cancers also use PKM2 to withstand oxidative stress.
ScienceDaily: Cancer News
When Someone You Love Has Cancer: Comfort and Encouragement for Caregivers and Loved OnesWhen you’re caring for someone with cancer, it’s difficult to know how to truly be there and how best to respond to the unexpe…
No More Secs!: Living, Laughing, & Loving Despite Multiple SclerosisWhen 44 year-old Ann Pietrangelo is diagnosed with multiple sclerosis, all previous assumptions about health, work, and her new ro…
21st Century Understanding Cancer Toolkit: Coping with Advanced Cancer – Metastatic Cancer, Caregiver Support, Palliative Care and Hospice, Advance Directives, End-of-Life Care, Pain Control, GriefThis massive guide, with over 600 pages and 23 chapters, has authoritative information and practical advice from the nation’s canc…
Categories: Breast Cancer Caregiver Tags: Cancer, cells, Expanded, Helping, Identifies, PKM2, role, Study, Survive
Albert Einstein College Of Medicine Receives $8 Million From NIH To Study How Cancer Spreads
The National Cancer Institute (NCI) has awarded Albert Einstein College of Medicine of Yeshiva University two grants totaling $ 8 million to study the microenvironments that drive the spread of cancer from the primary tumor to other parts of the body in the process known as metastasis…
Cancer / Oncology News From Medical News Today
MEDLINE PINK BREAST CANCER AWARENESS ROLLATOR 4 WHEELED WALKER WITH SEAT PINK COLOR WITH PINK RIBBON LOGO ON SEAT AND BACKREST. SUPPORTS NATIONAL BREAST CANCER FOUNDATIONBreast Cancer Awareness Rollator: Comfortable padded seat – 12″ wide x 12″ deep with loop brakes – pull to stop, push to lock. Hei…
Keep-A-Breast 1 Inch I Love Boobies Bracelet Green/WhiteBy purchasing this product from the merchant LOSERKIDS only, you are supporting The Keep A Breast Foundation. 100% of the net proc…
Categories: Breast Cancer Foundation Tags: Albert, Cancer, College, Einstein, From, Medicine, Million, Receives, Spreads, Study
Local wine lovers take breast cancer study in stride – NorthJersey.com
Janice Strub, 54, likes her evening glasses of wine. She was at home cooking dinner this week when she heard news reports of the recent study that said women who drink even light amounts of alcohol are at a higher risk for breast cancer. The …
cancer – Bing News
Coping With Breast Cancer.: A Husband’s PerspectiveIn the mid-nineties, my wife was diagnosed with invasive breast cancer, which had metastasized to her lymph nodes. The essay “Co…
Artsmith, Inc. Men’s Embroidered Jacket Cancer Pink Ribbon Support Breast Cancer Awareness – Black, XLProduct Number: 030-544742285 Exercise your right to look great — and feel great — while on the go. Lightweight and easy to get …
24 PINK Ribbon BREAST CANCER Awareness Rubber Bracelets/HOPE/Strength/SURVIVOR/FAITH/New in Package/EXCELLENT for FUND RAISING24 Brand new in package PINK 8″ Rubber Bracelets imprinted with an assortment of different inspirations; COURAGE, DREAM, LOVE, HOP…
Categories: Breast Cancer Tags: Breast, Cancer, Local, lovers, NorthJersey.com, stride, Study, Take, wine
Sister Study helps find the causes of breast cancer!!
The Sister Study, conducted by the National Institute of Environmental Health Sciences, is seeking 50000 women whose sisters had breast cancer to help find the causes of breast cancer. For more information visit www.sisterstudy.org, or for Spanish www.estudiodehermanas.org. Call toll-free 1-877-4SISTER (877-474-7837). Deaf/Hard of Hearing call 1-866-TTY-4SIS (866-889-4747).
NOMINATED AS BEST SHORT FILM OF THE BREAST FEST BREAST CANCER FILM FESTIVAL 2010! Make this film a winner. Vote this film THE BEST of Breast Fest! Voting Open September 15-October 15, 2010 www.breastfestfilmfest.com Each year more than 1300000 women are diagnosed with breast cancer world wide. “Why are all of these women getting breast cancer?” Our best hope for curing, and preventing breast cancer is to complete the research on the mouse mammary tumor virus. www.breasthealthandhealing.org
Video Rating: 5 / 5
This digital document is an article from Women’s Health Letter, published by Thomson Gale on February 1, 2005. The length of the a…
Dressed To Kill: The Link between Breast Cancer and BrasPresents evidence supporting the authors’ theory that bras suppress the lymphatic system, causing toxins to accumulate in the tiss…
Cancer Disparities: Causes and Evidence-Based SolutionsCancer is not randomly distributed in the United States. Its incidence varies by race, ethnicity, socioeconomic status, and other…
Recipients of organ transplants at increased risk for broad range of cancers, study finds
Patients who have received a solid organ transplant, such as kidney, liver, heart or lung, have an overall cancer risk that is double that of the general population, with an increased risk for many different types of malignancies, according to a new study.
ScienceDaily: Cancer News
21st Century Understanding Cancer Toolkit: Life After Cancer Treatment, Valuable Advice and Support for Patients, Survivors, Families, Parents, Children, Caregivers, Young People, Advanced CancerThis massive compendium, with over 400 pages and eleven chapters, has authoritative information and practical advice from the nati…
For The Women We Love: A Breast Cancer Action Plan and Caregiver’s Guide for MenWhen a woman is diagnosed with breast cancer, it is vital that the men in their life move beyond traditional roles, adding new res…
Help Me Live: 20 Things People with Cancer Want You to KnowWhen we hear that someone close to us has been diagnosed with cancer, we want nothing more than to comfort them with words of hope…
Categories: Breast Cancer Caregiver Tags: Broad, Cancers, finds, Increased, organ, range, Recipients, Risk, Study, Transplants
Study ties booze to breast cancer – Philadelphia Daily News
LOS ANGELES – Drinking as few as three to six glasses of wine per week may increase a woman’s lifetime risk of breast cancer by 15 percent, according to an analysis by Harvard researchers. The study, published yesterday in the Journal of the …
cancer – Bing News
144 breast cancer awareness pink ribbon bracelets – bulk wholesale case lot for fundraising144 Breast Cancer Awareness bracelets…
Artsmith, Inc. Men’s Embroidered Jacket Cancer Pink Ribbon Support Breast Cancer Awareness – Black, XLProduct Number: 030-544742285 Exercise your right to look great — and feel great — while on the go. Lightweight and easy to get …
Breast Cancer Awareness Tac Pin Crystal Pink Ribbon NewShow your support for the fight against Breast Cancer with our all crystal pink ribbon tac pin. Genuine Austrian crystal, attac…
Categories: Breast Cancer Tags: booze, Breast, Cancer, Daily, News, Philadelphia, Study, ties
Tamoxifen prevents breast cancers–at a price. (Study of More than 7,000 Women).: An article from: Family Practice News Reviews
Tamoxifen prevents breast cancers–at a price. (Study of More than 7,000 Women).: An article from: Family Practice News
This digital document is an article from Family Practice News, published by International Medical News Group on October 15, 2002. The length of the article is 629 words. The page length shown above is based on a typical 300-word page. The article is delivered in HTML format and is available in your Amazon.com Digital Locker immediately after purchase. You can view it with any web browser.
Citation Details
Title: Tamoxifen prevents breast cancers–at a price. (Study of More than 7,000 Women).
Author: Mitchel L. Zoler
Publication: Family Practice News (Magazine/Journal)
Date: October 15, 2002
Publisher: International Medical News Group
Volume: 32 Issue: 20 Page: 35(1)
Distributed by Thomson Gale
List Price: $ 5.95
Price:
Categories: Breast Cancer Studies Tags: 7000, article, Breast, cancersat, Family, From, More, News, Practice, Prevents, PRICE, Reviews, Study, Tamoxifen, than, Women
Aspirin Can Cut Bowel Cancer Risk by Half, Study Says – FOX News
Aspirin cuts the chances of developing bowel cancer by more than half in people with a family history of the disease, British scientists said Friday. “We’ve now got the cherry on the cake — the randomized controlled trial that sets out to try …
cancer – Bing News
Pink Snuggie Blanket-The Breast Cancer Research FoundationAs Seen On TV, Cotton Candy Pink, Snuggie Fleece Blanket, The Blanket That Has Sleeves, Now With Pockets, Super Soft & Does Not Sl…
Thermos Intak Breast Cancer Awareness 26-Ounce Hydration BottleThermos Intak breast cancer awareness hydration bottle is made from bpa free, impact- resistant, dishwasher durable eastman tritan…
Artsmith, Inc. Women’s Embroidered Jacket Sock It To Cancer – Cancer Awareness Pink Ribbon – MediumProduct Number: 030-544734767 Work up a good sweat while still looking great. Made for the fashion-conscious lady on the go, this …
Lung cancer deaths not prevented by routine X-rays, study finds – CBS News
The 13-year study tracked more than 150,000 Americans between the ages of 55 and 74 and found those who had four annual chest X-ray screenings were just as likely to die of lung cancer as those who didn’t get screened. Whether they smoked didn’t …
cancer – Bing News
Artsmith, Inc. Women’s Embroidered Jacket Sock It To Cancer – Cancer Awareness Pink Ribbon – MediumProduct Number: 030-544734767 Work up a good sweat while still looking great. Made for the fashion-conscious lady on the go, this …
Pink Snuggie Blanket-The Breast Cancer Research FoundationAs Seen On TV, Cotton Candy Pink, Snuggie Fleece Blanket, The Blanket That Has Sleeves, Now With Pockets, Super Soft & Does Not Sl…
Coping With Breast Cancer.: A Husband’s PerspectiveIn the mid-nineties, my wife was diagnosed with invasive breast cancer, which had metastasized to her lymph nodes. The essay “Co…
