Launch of HHS Action Plan to Prevent, Care and Treat Viral Hepatitis
from Jules: I attended the 2 meetings yesterday in Wash DC. I flew down early in the morning to catch the Congressional Briefing for the HHS Viral Hepatitis Action Plan which took place in a briefing room in Cannon House Building at 9:30am. The room was packed, about 150 people including community advocates from the B and C communities who have have working for many years to get the federal government to fund HCV & HBV programs in an effective way. Also in attendance were Congressional staffers and other interested parties. Several Congresspeople including Mike Honda, Barbara Lee, Bill Cassidy and Judy Chu spoke about this Action Plan and the problems of viral hepatitis B and C. Bill Cassidy is actually a hepatologist so he spoke eloquently about his suffering patients & the need to secure more funding from Congress. Cong Mike Honda chaired & moderated the briefing as he has been a key sponsor of the movement to secure funding from Congress for viral hepatitis, he has been a close ally apparently for the B community and Barbara Lee spoke on C at this briefing. Howard Koh, Asst Sec of Health at HHS and Kevin Fenton from the CDC spoke also. When they opened up for Q&A I was the first person to ask a question and asked 'what will they do immediately before & if Congress actually allocates funding to support the plan'. Fenton said in response he plans to broaden testing and education right away. At the 1pm Press Conference which was for the Press & the public not invited to the morning briefing I believe I heard there was a commitment to do more perinatal HBV vaccinations immediately after birth which apparently is how to prevent HBV transmission, the major transmission route, by vaccination immediately after birth. A Viral Hepatitis Bill is expected to be introduced soon to the Senate requesting a large sum of money, I think about $100 mill. The speakers at the morning briefing made it clear that additional funding from Congress [or the White House] is required to have a major impact with the Action Plan, otherwise they said what they plan to do is 'leverage' resources within the CDC & the HHS to try to implement changes. In my estimation we need at least $100 million just to implement a national hepatitis screening program for HBV & HCV. Will Congress provide this funding? Will Congress provide $10 million for C & B screening? I don't know, times are tough. You can call your House & Senate representatives and tell them to support these requests. I have been working on HCV policy since 1999 in New York State & in Wash DC and we have yet to receive a large amount of money for HCV. There is no large scale HCV testing/screening project anywhere in the USA. At the morning briefing the need for better surveillance was mentioned several times & I think Fenton said they were going to beef this up, surveillance in HCV is very difficult without large scale testing/screening programs because without large scale testing you really have no idea how many people actually have HCV and without large scale awareness education programs people don't test. So these are expensive propositions that require large monetary investments not incremental improvements which is what I heard that will come from this Plan unless Congress or the White House provides large scale funding of at the very least $100 million. The relatively small band of HCV & HBV advocates that have been working hard on this for years deserve much credit for getting HHS & the CDC to provide what so far is the biggest response I have seen yet from the federal government to HBV & HVC, but again to have the impact needed a lot of funding is required from Congress & the Administration. One more point, Dr Fenton addressed global needs regarding HCV & HBV and said he would work with the WHO and also said it is crucial to bring to the global community a similar commitment on HCV & HBV that is brought here in the USA.|
I estimate as many as 8 million people have HCV in the USA although the official estimates are up to 4-5 million. I base this on a small study in NYC that found high HCV prevalence among surprising immigrant communities including Russians, Koreans, Chinese, Africans and immigrants from the Indian peninsula countries, and the reason is not IVDU but because of use of unsanitary syringes in medical situations in their home countries so they came to the USA with HCV. Two-thirds to three-fourths of HCV-infected individuals in the USA remain undiagnosed. We need a national hepatitis testing day. And the same phenomena among immigrant communities has been found in HBV.
These discussions on HCV are very timely. The world of HCV is changing now as the first 2 HCV orallly administered drugs are expected to be approved by the FDA by May 23rd. These drugs are designed for patients with genotype 1, the hardest to treat patients. The drugs are boceprevir from Merck & telaprevir from Vertex, both are HCV protease inhibitors that will be used in combination therapy with pegylated interferon+ribavirin. In phase 3 clinical trials the SVR rates or 'cure' rates were 67-79% which compares to the 40% we have seen previously in clinical trials, but in the real world of the clinic setting we have seen SVR rates as low as 5-26% in African-Americans, the hardest to treat patient populations. But in the clinical trials response rates for African-Americans were greatly improved by adding the 3rd drug, the protease inhibitor, with 53-62% SVR rates. 44-58% of patients achieved SVR with only 24 weeks therapy, another major development because 48 weeks of peg/rbv has been necessary up until now for gentotype 1 patients. Two additional important points, there are another 10 drugs right behind in development in studies in patients, and it was recently announced at a major conference that 4 of 11 patients in a small proof of concept study were cured, achieved SVR, with 2 oral HCV BMS drugs without peg/rbv, and these were the toughest patients to cure, null responders, thus this study results provides proof of concept that at least some patients can achieve SVR without peg/rbv. Ongoing studies are examining this question now, so when you put all this together we expect to have in the future potent multidrug combinations like in HIV, perhaps without peg/rbv, that have the potential to cure 90% of those HCV-infected. And if peg/rbv is still required for some patients peg-lambda is in development, a new peginterferon that appears to have much less side effects. Finally, we need government supported testing/screening throughout the USA and government supported services for care and treatment, on a large scale to provide the access to care and treatment needed. Many individuals with HCV were infected 20-30 years ago and are aging out, meaning they have had HCV for up to 30 years and rates of HCC, liver cancer, and decompensated cirrhosis are increasing as these individuals face advancing HCV disease. So without awareness they should be tested and access to care & treatment & an increase in the number of treating clinicians because we have a severe shortage of these, these aging patients face dire consequences which will ultimately cost our health care system quite a lot of money as they go into the hospital for very expensive care. It is cost effective to provide timely & early screening and access to care & treatment.
Speakers at 2nd meeting Press Conference:
Howard K. Koh, M.D., M.P.H., HHS Assistant Secretary for Health
Kevin Fenton, M.D., Ph.D., FFPH, Director, National Center for HIV/AIDS, Viral Hepatitis, STD, and TB Prevention, Centers for Disease Control and Prevention
Jim Macrae, M.A., M.P.P., Associate Administrator for Primary Health Care, Health Resources and Services Administration
Michael Ninburg, Community Perspective
Su Wang, M.D., Provider Perspective
Combating the Silent Epidemic of Viral Hepatitis: Action Plan for the Prevention, Care and Treatment of Viral Hepatitis
Hepatitis is a hidden epidemic with significant public health consequences.
· An estimated 3.5-5.3 million persons are living with viral hepatitis in the United States, and millions more are at risk for infection.
· Because viral hepatitis can persist for decades without symptoms, 65%-75% of infected Americans remain unaware of their infection status and are not receiving care and treatment.
· Hepatitis (which is largely preventable), is the leading cause of liver cancer. Without timely care, 1 in 4 persons with chronic hepatitis will develop liver cirrhosis or liver cancer.
Action Plan for the Prevention, Care and Treatment of Viral Hepatitis
The Department of Health and Human Services is committed to ensuring that new cases of viral hepatitis are prevented and that persons who are already infected are tested; informed about their infection; and provided with counseling, care, and treatment. This increasing commitment is evidenced in the new Healthy People 2020 (HP 2020) report, the first Healthy People publication to document increasing viral hepatitis awareness among infected persons as a formal HHS objective. In addition to moving the nation towards reaching HP 2020 objectives, by 2020, full implementation of the Viral Hepatitis Action Plan could result in:
· an increase in the proportion of persons who are aware of their hepatitis B virus infection, from 33% to 66%;*
· an increase in the proportion of persons who are aware of their hepatitis C virus infection, from 45% to 66%;**
· a 25% reduction in the number of new cases of HCV infection; and
· elimination of mother-to-child transmission of HBV.
On May 12, 2011, HHS issued Combating the Silent Epidemic of Viral Hepatitis: Action Plan for the Prevention, Care and Treatment of Viral Hepatitis [PDF, 672KB] which outlines actions, based on scientific evidence and extensive real-world experience that will serve as a roadmap for reaching the Healthy People objectives.
The Viral Hepatitis Action Plan presents robust and dynamic steps for improving the prevention of viral hepatitis and the care and treatment provided to infected persons and for moving the nation towards achieving Healthy People 2020 goals. Some of these life-saving actions already are well underway. Other actions, representing innovations in practice, technology, and therapy, will require new strategic directions and commitment.
The success of these actions is contingent on departmental and interagency collaboration, stakeholder support, and engagement of the diverse communities being served. Also critical to the success of the plan are policy-related support and system changes, which likely will be brought about by the Affordable Care Act.
In this unique era of unprecedented opportunity, viral hepatitis activities can be better coordinated and aligned with the nation's reformed infrastructure for health. This Viral Hepatitis Action Plan will serve as the guide for HHS agencies working to combat the silent epidemic of viral hepatitis.
*Data source: The Racial and Ethnic Approaches to Community Health (REACH) Risk Factor Survey (www.cdc.gov/reach)
*Data source: National Health and Nutrition Examination Survey (NHANES) (www.cdc.gov/nchs/nhanes.htm).
NIH For Immediate Release My 12 2011
HHS Announces Action Plan to Prevent and Treat Viral Hepatitis
The U.S. Department of Health and Human Services today launched its action plan to prevent and treat viral hepatitis, a silent epidemic affecting 3.5 - 5.3 million Americans.
Though viral hepatitis is a leading infectious cause of death in the U.S., many people who have it don't know they are infected, so they are at greater risk for severe - or even fatal - complications of the disease. Exacerbating the problem is the fact that health care providers often lack the appropriate training to conduct risk assessments, offer prevention counseling, provide diagnoses and treat viral hepatitis.
"These infections have fueled a tragic cascade of human suffering," said Howard K. Koh, MD, MPH. "The new HHS action plan on viral hepatitis represents an unprecedented call to action for better education, treatment and prevention."
In January 2010, the Institute of Medicine (IOM) released a report on hepatitis, highlighting barriers that impede efforts for hepatitis prevention and control. The new HHS plan -- Combating the Silent Epidemic: US Department of Health and Human Services Action Plan for the Prevention, Care and Treatment of Viral Hepatitis -- is a response to the IOM report. It outlines a comprehensive action plan to raise awareness about viral hepatitis; creates more opportunities to train health professionals to diagnose, treat, vaccinate, and ultimately save lives; and builds upon the new health insurance reform law to improve patient access to comprehensive viral hepatitis-related prevention and treatment services through expanded coverage.
The plan's success is contingent on leadership of government at all levels and the active and informed participation of communities, non-governmental organizations, health care providers, and the private sector.
"No one government agency can fight viral hepatitis alone, and here at CDC, we believe this action plan will not only strengthen the work we've been doing, but help all of us across the government collaborate to take our nation's prevention efforts to the next level," said CDC Director Thomas Frieden, MD, MPH. "Far too many Americans are unaware of the serious impact of viral hepatitis and the devastating consequences that can result from leaving it untreated. The time for action is now."
"We have seen the increasing prevalence of viral hepatitis in our network of health centers and among people living with HIV/AIDS in underserved areas and we know that minorities and medically vulnerable populations are disproportionately affected," said Health Resources and Services Administrator Mary K. Wakefield, RN, PhD. "This action plan is our best chance at stopping the disease with increased access to information and quality care for those at risk and those who are already infected.
HHS is committed to ensuring that new cases of viral hepatitis are prevented and that persons who are already infected are tested, informed about their infection, and provided with optimal counseling, care and treatment. This increasing commitment is evidenced in the new Healthy People 2020 plan, the first Healthy People publication to document increasing viral hepatitis awareness among infected persons as a formal HHS objective.
To read the plan, see http://www.hhs.gov/ash/initiatives/hepatitis
Release of HHS Viral Hepatitis Action Plan
May 12, 2011
The HHS released their Viral Hepatitis Action Plan to prevent, care, and treat viral hepatitis. Read the plan here.
NVHR Commends New HHS Plan for the Prevention and Treatment of Viral Hepatitis
A new Department of Health and Human Services (HHS) action plan for viral hepatitis takes the much needed step of establishing a roadmap to help improve response to this growing health problem. The HHS Action Plan for the Prevention and Treatment of Viral Hepatitis, released today by Assistant Secretary for Health Dr. Howard Koh, follows a 2010 Institute of Medicine (IOM) report,Hepatitis and Liver Cancer: A National Strategy for Prevention and Control of Hepatitis B and C. The IOM report found a troubling lack of knowledge about the devastating impact of this disease among health care and social services providers, at-risk populations, the general public and policymakers. The IOM report was commissioned in part by the National Viral Hepatitis Roundtable (NVHR).
"The release of the HHS Action Plan offers a tremendous opportunity to change the course of the viral hepatitis epidemic in the U.S.," said Martha Saly , Director of the National Viral Hepatitis Roundtable (NVHR), "However, this plan will only be effective if the Administration strongly supports its implementation and Congress demonstrates leadership by increasing resources for prevention, education, care and treatment services for Americans, especially vulnerable and underserved populations, who are most at risk for viral hepatitis infections and their consequences."
The CDC estimates that, 65% of people infected with hepatitis B and 75% of people infected with hepatitis C do not know that they have the disease, yet 1 in 12 Asian/Pacific Islander Americans is living with hepatitis B and African Americans are twice as likely to be infected with hepatitis C as the general population.
"With limited funds available for viral hepatitis, our nation does a poor job of screening and early intervention," Saly said, noting that "most infected individuals only become aware of their condition after it has progressed to cirrhosis, liver failure, or liver cancer. That is not only a tragedy for those afflicted, but it also winds up costing much more money for our health care system."
NVHR has prioritized viral hepatitis and liver cancer screening, along with tackling health disparities and barriers to care among Asian Americans, African Americans and other disproportionately affected populations; strengthening prevention efforts to confront a new wave of infections do to heroin use; and improving viral hepatitis services at community health centers as areas where the Federal Government can make an immediate impact on the burden of viral hepatitis in the United States.
NVHR is a coalition of more than 170 public, private and voluntary organizations dedicated to reducing the incidence of infection, morbidity and mortality from viral hepatitis in the United States. www.nvhr.org