Patient Advocates, Noted Liver Physician Criticize Arizona Policy as Lacking Scientific Basis
WASHINGTON, Oct. 4 /PRNewswire-USNewswire/ -- A controversial new policy by the Arizona Health Care Cost Containment System depriving hepatitis C patients coverage for liver transplants is effectively a death sentence that, left unchecked, could have far-reaching consequences for millions of Americans afflicted with chronic viral hepatitis, the National Viral Hepatitis Roundtable (NVHR) said today. The new coverage exclusion governing liver transplants took effect Friday as part of broader Medicaid coverage changes made by the state of Arizona in response to budgetary pressures.
"The Arizona Medicaid program's decision to deprive hepatitis C patients coverage for liver transplants is inhumane and will have devastating consequences for Arizona's Medicaid beneficiaries," said Ms. Lorren Sandt, NVHR Chair and Executive Director of Caring Ambassadors Program, based in Portland, Oregon. "NVHR recognizes that both public and private health care programs are struggling with the burden of rising costs and a challenging economic environment. However, the cruel costs associated with Arizona's Medicaid coverage changes do not appear to be based on sound science and far exceed any supposed benefit."
"The standard of care for centers and practitioners is to offer liver transplants to patients with hepatitis C. All insurance providers – including state Medicaid programs – need to provide coverage for what is the standard of care. With new curative therapies on the horizon, it is imperative not to discriminate against patients with hepatitis C when selecting patients for a liver transplant," said Robert G. Gish, M.D., Co-Director Center for Hepatobiliary Disease and Abdominal Transplantation (CHAT), University of California, San Diego School of Medicine.
Arizona Medicaid's transplant coverage exclusion is the first of its kind in the nation for hepatitis C patients. NVHR is deeply troubled that the new Medicaid coverage exclusion inflicts catastrophic consequences that go far beyond any supposed savings. According to news reports, Arizona faces a budgetary shortfall this year of as much as $825 million. The entire package of Medicaid benefit changes, including the hepatitis C liver transplant exclusion, is expected to yield about $5 million in savings – or about 1/2 of one percent of the projected budgetary shortfall.
An estimated 5.3 million Americans have been infected with chronic viral hepatitis B or C – and with most unaware of their infection, millions are at risk of developing life-threatening complications, especially African Americans and Asian Americans. Without detection and prompt treatment, chronic viral hepatitis leads to liver cancer, cirrhosis, or liver failure.
NVHR is a coalition of more than 170 public, private, and voluntary organizations dedicated to reducing the incidence of infection, morbidity, and mortality from chronic viral hepatitis that afflicts more than 5 million Americans. http://www.nvhr.org/
SOURCE National Viral Hepatitis Roundtable
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October 4, 2010
Dynavax's HEPLISAV Demonstrates Superior Seroprotection in Diabetics Compared to Engerix-B
Late-Breaker AASLD Abstract and New Diabetic Data Published Online
BERKELEY, CA, Oct 04, 2010 (MARKETWIRE via COMTEX) -- In an abstract published today on the website of the 61st Annual Meeting of the American Association for the Study of Liver Diseases (AASLD), Dynavax Technologies Corporation /quotes/comstock/15*!dvax/quotes/nls/dvax (DVAX 1.89, +0.03, +1.61%) reported that its novel hepatitis B vaccine candidate, HEPLISAV(TM), given as two doses over four weeks demonstrated superior seroprotection in persons with diabetes mellitus compared to Engerix-B given as three doses over 24 weeks. The subset analysis of 62 adults with diabetes in Dynavax's previously reported Phase 3 multicenter study (PHAST or Phase 3 HEPLISAV Short-regimen Trial), showed that at 12 weeks, 84 percent of adult diabetics treated with HEPLISAV achieved seroprotection as compared to 0 percent of adult diabetics treated with Engerix-B. At week 28, 93 percent of the HEPLISAV-treated group versus 35 percent in the Engerix-B group achieved seroprotection. HEPLISAV's significantly higher rate of seroprotection was achieved without further immunization past four weeks while the Engerix-B group received a third immunization at 24 weeks. A poster presentation (LB-17) entitled, "Immunogenicity of Two Doses of Investigational HEPLISAV(TM) Compared to Three Doses of Licensed Hepatitis B Vaccine (ENGERIX-B(R)) in Diabetics", will be made in a late-breaker session on November 1, 2010 at the AASLD in Boston, Massachusetts.
According to Dr. Tyler Martin, President and Chief Medical Officer of Dynavax, "Diabetics are at risk for hepatitis B infection, and once infected, their disease frequently results in more severe chronic illness. The situation is complicated by the fact that patients with diabetes commonly do not respond well to currently licensed hepatitis B vaccines. The data we will report at the AASLD meeting is particularly exciting as our technology clearly represents a potential breakthrough in immunization regimens as well as a means of significantly expanding the number of individuals for whom protection against hepatitis B will be possible.
"It is well known that epidemic outbreaks of hepatitis B have occurred over the last several years in long-term care facilities. However, vaccination against the disease has been limited because patients in this setting simply do not respond to vaccination as well as healthy, younger adults in the general population. The Center for Disease Control and Prevention's Advisory Committee on Immunization Practices (ACIP) has been studying the issue for quite some time, and later this month will consider a new recommendation for hepatitis B vaccination of adults with diabetes," Dr. Martin continued.
Dynavax first reported the results of its PHAST multi-center, observer-blinded Phase 3 study in August 2008. Of the 2101 subjects in the overall per protocol study population, the seroprotection rate of the HEPLISAV-treated group was 95 percent at week 12 and 81 percent at week 28 in the Engerix-B group, indicating non-inferiority/superiority of HEPLISAV over Engerix-B. HEPLISAV is Dynavax's novel hepatitis B vaccine candidate, a TLR9 agonist; Engerix-B is a commercially available hepatitis B vaccine.
Engerix-B(R) is a registered trademark of GlaxoSmithKline
About HEPLISAV
HEPLISAV is an investigational adult hepatitis B vaccine. The vaccine candidate is being evaluated in two Phase 3 studies that are directed toward fulfilling licensure requirements in U.S., Canada and Europe. In a completed pivotal Phase 3 trial, HEPLISAV demonstrated increased, rapid protection with fewer doses than current licensed vaccines. Dynavax has worldwide commercial rights to HEPLISAV and is developing the vaccine for large, high-value populations that are less responsive to current licensed vaccines, including individuals with chronic kidney disease. HEPLISAV combines hepatitis B surface antigen with a proprietary Toll-like Receptor 9 agonist known as ISS to enhance the immune response.
About Dynavax
Dynavax Technologies Corporation, a clinical-stage biopharmaceutical company, discovers and develops novel products to prevent and treat infectious diseases. The Company's lead product candidate is HEPLISAV, an investigational adult hepatitis B vaccine designed to enhance protection more rapidly and with fewer doses than current licensed vaccines. For more information visit http://www.dynavax.com/.
Forward Looking Statements
This press release contains "forward-looking statements," including the potential for use of HEPLISAV that are subject to a number of risks and uncertainties. Actual results may differ materially from those set forth in this press release due to the risks and uncertainties inherent in our business, including whether the reported results can be replicated in prospective studies, whether successful clinical and regulatory development and approval of HEPLISAV can occur in a timely manner or without significant additional studies or difficulties or delays in development or clinical trial enrollment, whether the studies can support registration for commercialization of HEPLISAV; the results of clinical trials and the impact of those results on the initiation and completion of subsequent trials and issues arising in the regulatory process; the Company's ability to obtain additional financing to support the development and commercialization of HEPLISAV and its other operations, possible claims against the Company based on the patent rights of others; and other risks detailed in the "Risk Factors" section of our current periodic reports with the SEC. We undertake no obligation to revise or update information herein to reflect events or circumstances in the future, even if new information becomes available. Information on Dynavax's website at http://www.dynavax.com/ is not incorporated by reference in the Company's current periodic reports with the SEC.
Contact:
Michael Ostrach
Vice President and Chief Business Officer
510-665-7257
Email Contact
Source
BERKELEY, CA, Oct 04, 2010 (MARKETWIRE via COMTEX) -- In an abstract published today on the website of the 61st Annual Meeting of the American Association for the Study of Liver Diseases (AASLD), Dynavax Technologies Corporation /quotes/comstock/15*!dvax/quotes/nls/dvax (DVAX 1.89, +0.03, +1.61%) reported that its novel hepatitis B vaccine candidate, HEPLISAV(TM), given as two doses over four weeks demonstrated superior seroprotection in persons with diabetes mellitus compared to Engerix-B given as three doses over 24 weeks. The subset analysis of 62 adults with diabetes in Dynavax's previously reported Phase 3 multicenter study (PHAST or Phase 3 HEPLISAV Short-regimen Trial), showed that at 12 weeks, 84 percent of adult diabetics treated with HEPLISAV achieved seroprotection as compared to 0 percent of adult diabetics treated with Engerix-B. At week 28, 93 percent of the HEPLISAV-treated group versus 35 percent in the Engerix-B group achieved seroprotection. HEPLISAV's significantly higher rate of seroprotection was achieved without further immunization past four weeks while the Engerix-B group received a third immunization at 24 weeks. A poster presentation (LB-17) entitled, "Immunogenicity of Two Doses of Investigational HEPLISAV(TM) Compared to Three Doses of Licensed Hepatitis B Vaccine (ENGERIX-B(R)) in Diabetics", will be made in a late-breaker session on November 1, 2010 at the AASLD in Boston, Massachusetts.
According to Dr. Tyler Martin, President and Chief Medical Officer of Dynavax, "Diabetics are at risk for hepatitis B infection, and once infected, their disease frequently results in more severe chronic illness. The situation is complicated by the fact that patients with diabetes commonly do not respond well to currently licensed hepatitis B vaccines. The data we will report at the AASLD meeting is particularly exciting as our technology clearly represents a potential breakthrough in immunization regimens as well as a means of significantly expanding the number of individuals for whom protection against hepatitis B will be possible.
"It is well known that epidemic outbreaks of hepatitis B have occurred over the last several years in long-term care facilities. However, vaccination against the disease has been limited because patients in this setting simply do not respond to vaccination as well as healthy, younger adults in the general population. The Center for Disease Control and Prevention's Advisory Committee on Immunization Practices (ACIP) has been studying the issue for quite some time, and later this month will consider a new recommendation for hepatitis B vaccination of adults with diabetes," Dr. Martin continued.
Dynavax first reported the results of its PHAST multi-center, observer-blinded Phase 3 study in August 2008. Of the 2101 subjects in the overall per protocol study population, the seroprotection rate of the HEPLISAV-treated group was 95 percent at week 12 and 81 percent at week 28 in the Engerix-B group, indicating non-inferiority/superiority of HEPLISAV over Engerix-B. HEPLISAV is Dynavax's novel hepatitis B vaccine candidate, a TLR9 agonist; Engerix-B is a commercially available hepatitis B vaccine.
Engerix-B(R) is a registered trademark of GlaxoSmithKline
About HEPLISAV
HEPLISAV is an investigational adult hepatitis B vaccine. The vaccine candidate is being evaluated in two Phase 3 studies that are directed toward fulfilling licensure requirements in U.S., Canada and Europe. In a completed pivotal Phase 3 trial, HEPLISAV demonstrated increased, rapid protection with fewer doses than current licensed vaccines. Dynavax has worldwide commercial rights to HEPLISAV and is developing the vaccine for large, high-value populations that are less responsive to current licensed vaccines, including individuals with chronic kidney disease. HEPLISAV combines hepatitis B surface antigen with a proprietary Toll-like Receptor 9 agonist known as ISS to enhance the immune response.
About Dynavax
Dynavax Technologies Corporation, a clinical-stage biopharmaceutical company, discovers and develops novel products to prevent and treat infectious diseases. The Company's lead product candidate is HEPLISAV, an investigational adult hepatitis B vaccine designed to enhance protection more rapidly and with fewer doses than current licensed vaccines. For more information visit http://www.dynavax.com/.
Forward Looking Statements
This press release contains "forward-looking statements," including the potential for use of HEPLISAV that are subject to a number of risks and uncertainties. Actual results may differ materially from those set forth in this press release due to the risks and uncertainties inherent in our business, including whether the reported results can be replicated in prospective studies, whether successful clinical and regulatory development and approval of HEPLISAV can occur in a timely manner or without significant additional studies or difficulties or delays in development or clinical trial enrollment, whether the studies can support registration for commercialization of HEPLISAV; the results of clinical trials and the impact of those results on the initiation and completion of subsequent trials and issues arising in the regulatory process; the Company's ability to obtain additional financing to support the development and commercialization of HEPLISAV and its other operations, possible claims against the Company based on the patent rights of others; and other risks detailed in the "Risk Factors" section of our current periodic reports with the SEC. We undertake no obligation to revise or update information herein to reflect events or circumstances in the future, even if new information becomes available. Information on Dynavax's website at http://www.dynavax.com/ is not incorporated by reference in the Company's current periodic reports with the SEC.
Contact:
Michael Ostrach
Vice President and Chief Business Officer
510-665-7257
Email Contact
Source
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