HHS Dr Koh releases update to National Viral Hepatitis Action Plan & highlights 10 big advances propelling progress

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Updated Viral Hepatitis Action Plan Released

Dr. Howard K. Koh
Assistant Secretary for Health, U.S. Department of Health and Human Services

Posted: 04/02/2014 4:18 pm EDT Updated: 04/03/2014 9:59 am EDT

Today we are pleased to release an updated version of the nation's first comprehensive cross-governmental action plan to combat chronic viral hepatitis, initially launched in 2011. The Action Plan for the Prevention, Care and Treatment of Viral Hepatitis (2014-2016) builds upon the substantial progress accomplished over the past three years by agencies and offices across the Department of Health and Human Services - as well as within the Departments of Justice and Veterans Affairs. (Read a brief factsheet about the updated plan.)

Chronic viral hepatitis (hepatitis B [HBV] and hepatitis C [HCV]) is a largely preventable and treatable disease. Yet it affects between 3.5 and 5.3 million Americans, most of them unaware of their infection. As a result, untreated chronic viral hepatitis represents the leading cause of liver cancer and the most common reason for liver transplantation in the United States. In addition, it is a leading infectious cause of death in the U.S., claiming the lives of 12,000-18,000 Americans each year.

But we are making progress against this "silent epidemic." The release of the first Action Plan has galvanized progress on many fronts. Here are just 10 of the recent accomplishments in the field:

1. Establishment of National Hepatitis Testing Day. The original Action Plan called for the establishment of this annual observance, which we've now observed on May 19th each year since 2012. National Hepatitis Testing Day raises greater awareness among both health care providers and communities and we look forward to another outstanding observance next month.

2. New hepatitis C testing recommendations. Both the CDC and the U.S. Preventive Services Task Force have issued recommendations to test all individuals born between 1945 and 1965. As these so-called "Baby Boomers" are five times more likely to be infected with hepatitis C, this single recommendation could save over 120,000 lives. The alignment of these CDC and USPSTF recommendations and their widespread dissemination were called for in the 2011 Action Plan.

3. Expanded, culturally appropriate hepatitis B outreach and educational materials. Produced by CDC in partnership with community organizations, the Know Hep B campaign materials, available in several Asian languages, enable health care providers and community organizations to reach more individuals at risk about the importance of testing for HBV.

4. Greater attention to hepatitis C among persons who inject drugs (PWID). Of new cases of HCV infection reported to the CDC, injection drug use represents the most commonly identified risk factor. An estimated 64 percent of PWID are chronically infected with HCV, and 2.7-11 percent are chronically infected with HBV. Recent consultations and research funding announcements are strengthening our understanding of this problem. We are identifying better ways to prevent new infections in this vulnerable population.

5. Opposing discrimination against health care professionals and students with chronic hepatitis. In a great example of the cross-agency collaboration fostered by the Action Plan, the Offices of Civil Rights from the Departments of Justice, Education, and Health and Human Services sent a joint letter last year to health professions schools. The letter highlighted new CDC guidance on the management of health care professionals and students with chronic HBV and outlined steps to eliminate discrimination against those infected.

6. Greater attention to the elimination of perinatal hepatitis B transmission. We have the tools to further reduce the number of infants perinatally infected with HBV. Motivated and active partners have engaged to ensure the administration of a dose of HBV vaccine to all newborns before discharge from hospitals or birthing centers.

7. New hepatitis C treatments. Late last year, the FDA approved two new HCV treatments, which are simpler to use, require a shorter treatment duration, and have fewer side effects than earlier treatment regimens. These treatments lead to a cure in more than 90 percent of patients who complete them - a major advance. Our FDA colleagues are working along with the pharmaceutical industry to make new HCV therapies available safely and as quickly as possible by using the Fast Track program. This special designation facilitates development and review of drugs with the potential to address unmet medical needs in those with serious conditions.

8. Affordable Care Act. The Affordable Care Act is contributing to efforts to combat chronic viral hepatitis in the U.S. For example, because the law prohibits most plans from denying health coverage based on preexisting conditions, those with chronic viral hepatitis who had previously been uninsured will now have the opportunity to get covered and obtain access to needed prevention, care and treatment services. Moreover, hepatitis vaccinations and testing for HBV for pregnant women are among the covered preventive services that must be offered free of cost-sharing or co-pays. Later this year, one-time HCV screening for persons born between 1945 and 1965 will be added to this list. In addition, the law calls for a substantial investment in the HHS community health center program, which is a vital partner in delivering viral hepatitis prevention, diagnosis, care and treatment to vulnerable populations.

9. World Hepatitis Day proclamations from the President. President Obama has lent his support to the global observance of World Hepatitis Day for the past three years, issuing annual proclamations. The White House has also hosted events to commemorate these observances, helping to raise awareness and mobilize action to address viral hepatitis not only in the U.S. but around the globe.

10. An updated Action Plan for the Prevention, Care, & Treatment of Viral Hepatitis. Now, the updated Action Plan will build upon all the important advances noted above, and identify further opportunities for public and private sector stakeholders. So many can engage in efforts to break the silence surrounding viral hepatitis and improve prevention, diagnosis, care and treatment.

New partners have joined in launching the updated Action Plan. We are pleased that from the federal government, the Department of Housing and Urban Development and the White House Office of National Drug Control Policy have joined our efforts along with the HHS Office of Disease Prevention and Health Promotion, Office of Population Affairs, and our Regional Health Administrators. Many others can join as well. As my colleague Dr. Ronald Valdiserri, Deputy Assistant Secretary for Health, Infectious Diseases observes, "Active involvement by a broad mix of partners from various sectors, both public and private, is essential to fully realizing the potential of this plan. The updated plan provides a framework around which all of us can engage in aligned and focused action."

I hope you, too, will join us in this important moment. It is a critical time. We have the potential to save many lives. The era of health care reform provides a historic setting to strengthen the rapid progress we're making in the diagnosis and treatment of chronic hepatitis. Working together, we can successfully leverage all of our resources to help the nation become fully committed to combating the silent epidemic of viral hepatitis.

Share your ideas about how you or your organization can contribute to this national effort in the comments section below or on social media using the hashtag #ViralHepAction.

Follow Dr. Howard K. Koh on Twitter: www.twitter.com/@HHS_DrKoh

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Also See: Updated Action Plan to Combat Viral Hepatitis Released

The next frontier in 3-D printing: Human organs

By Brandon Griggs, CNN
updated 9:43 AM EDT, Thu April 3, 2014

(CNN) -- The emerging process of 3-D printing, which uses computer-created digital models to create real-world objects, has produced everything from toys to jewelry to food.

Soon, however, 3-D printers may be spitting out something far more complex, and controversial: human organs.

For years now, medical researchers have been reproducing human cells in laboratories by hand to create blood vessels, urine tubes, skin tissue and other living body parts. But engineering full organs, with their complicated cell structures, is much more difficult.

Enter 3-D printers, which because of their precise process can reproduce the vascular systems required to make organs viable. Scientists are already using the machines to print tiny strips of organ tissue. And while printing whole human organs for surgical transplants is still years away, the technology is rapidly developing.

"The mechanical process isn't all that complicated. The tricky part is the materials, which are biological in nature," said Mike Titsch, editor-in-chief of 3D Printer World, which covers the industry. "It isn't like 3-D printing plastic or metal. Plastic doesn't die if you leave it sitting on an open-air shelf at room temperature for too long."

Lawrence Bonassar, a professor of biomedical engineering at Cornell University, with an artificial ear made via 3-D printing and injectable molds.

The idea of printing a human kidney or liver in a lab may seem incomprehensible, even creepy. But to many scientists in the field, bioprinting holds great promise. Authentic printed organs could be used for drug or vaccine testing, freeing researchers from less accurate methods such as tests on animals or on synthetic models.

Then there's the hope that 3-D printers could someday produce much-needed organs for transplants. Americans are living longer, and as we get deeper into old age our organs are failing more. Some 18 people die in the United States each day waiting in vain for transplants because of a shortage of donated organs -- a problem that Anthony Atala, director of the Wake Forest Institute for Regenerative Medicine and a pioneer in bioprinting, calls "a major health crisis."

An 'exciting new area of medicine'

Bioprinting works like this: Scientists harvest human cells from biopsies or stem cells, then allow them to multiply in a petri dish. The resulting mixture, a sort of biological ink, is fed into a 3-D printer, which is programmed to arrange different cell types, along with other materials, into a precise three-dimensional shape. Doctors hope that when placed in the body, these 3-D-printed cells will integrate with existing tissues.

The process already is seeing some success. Last year a 2-year-old girl in Illinois, born without a trachea, received a windpipe built with her own stem cells. The U.S. government has funded a university-led "body on a chip" project that prints tissue samples that mimic the functions of the heart, liver, lungs and other organs. The samples are placed on a microchip and connected with a blood substitute to keep the cells alive, allowing doctors to test specific treatments and monitor their effectiveness.

"This is an exciting new area of medicine. It has the potential for being a very important breakthrough," said Dr. Jorge Rakela, a gastroenterologist at the Mayo Clinic in Phoenix and a member of the American Liver Foundation's medical advisory committee.

One of Organovo's engineers oversees the construction of a vascular tissue construct on a Novotel bioprinter.

"Three-D printing allows you to be closer to what is happening in real life, where you have multiple layers of cells," he said. With current 2-D models, "if you grow more than one or two layers, the cells at the bottom suffocate from lack of oxygen."

To accelerate the development of bioprinted organs, a Virginia foundation that supports regenerative medicine research announced in December it will award a $1 million prize for the first organization to print a fully functioning liver.

One early contender for the prize is Organovo, a California start-up that has been a leader in bioprinting human body parts for commercial purposes. Using cells from donated tissue or stem cells, Organovo is developing what it hopes will be authentic models of human organs, primarily livers, for drug testing.

The company has printed strips of human liver tissue in its labs, although they are still very small: four by four by one millimeter, or about one-fourth the size of a dime. Each strip takes about 45 minutes to print, and it takes another two days for the cells to grow and mature, said Organovo CEO Keith Murphy. The models can then survive for about 40 days.

Organovo has also built models of human kidneys, bone, cartilage, muscle, blood vessels and lung tissue, he said.

"Basically what it allows you to do is build tissue the way you assemble something with Legos," Murphy said. "So you can put the right cells in the right places. You can't just pour them into a mold."

Ethical concerns

Not everyone is comfortable with this bold new future of lab-built body parts, however.

A research director at Gartner Inc., the information-technology research and advisory firm, believes 3-D bioprinting is advancing so quickly that it will spark a major ethical debate by 2016.

A 3-D printer at Cornell University produces an artificial ear.

"Three-D bioprinting facilities with the ability to print human organs and tissue will advance far faster than general understanding and acceptance of the ramifications of this technology," Pete Basiliere said in a recent report.

"These initiatives are well-intentioned, but raise a number of questions that remain unanswered," Basiliere added. "What happens when complex 'enhanced' organs involving nonhuman cells are made? Who will control the ability to produce them? Who will ensure the quality of the resulting organs?"

Bioprinted organs are also likely to be expensive, which could put them out of reach of all but the wealthiest patients.

Murphy said Organovo only uses human cells in creating tissues, and doesn't see any ethical problems with what his company is doing.

"People used to worry about doing research on cadavers ... and that dissipated very quickly," he said. "We don't think there's any controversy if you're producing good data and helping people with health conditions."

Most experts, including Wake Forest's Atala, don't think we'll see complex 3-D-printed organs, suitable for transplants, for years if not decades. Instead, they believe the next step will be printing strips of tissue, or patches, that could be used to repair livers and other damaged organs.

Organovo also uses the Nuveen MMX Bio printer, which is small enough to fit into a cabinet.

"We are very eager to put pieces of tissue to work for surgical transplants," said Organovo's Murphy, who hopes his company will be ready to begin clinical trials within five years.

Of course, any use of 3-D-printed tissue in surgical procedures would require approval by the U.S. Food and Drug Administration. That review process could take up to a decade.

By then, the notion of a surgeon putting a 3-D-printed kidney into a patient may not seem so bizarre. Then again, this swiftly evolving technology may create new moral conundrums.

"The ethical questions are bound to be the same concerns we have seen in the past. Many major medical breakthroughs have suffered moral resistance, from organ transplants to stem cells," said Titsch of 3D Printer World.

"Will only the rich be able to afford it? Are we playing God? In the end, saving lives tends to trump all objections."

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Updated Action Plan to Combat Viral Hepatitis Released

FOR IMMEDIATE RELEASE
April 3, 2014

Contact: HHS Press Office
(202) 205-0143

A statement by Deputy Assistant Secretary for Health, Infectious Diseases,
Ronald O. Valdiserri, MD, MPH

Today, federal partners launched an updated Action Plan for the Prevention, Care and Treatment of Viral Hepatitis (2014-2016), building upon the nation’s first comprehensive cross-agency action plan to combat viral hepatitis.

The three-year renewal of the Action Plan builds upon the substantial progress accomplished since 2011 by agencies and offices from across the Department of Health and Human Services, as well as with our partners at the Departments of Justice, Housing and Urban Development, and Veterans Affairs, to prevent new infections and improve the diagnosis, care and treatment of individuals living with chronic hepatitis C in the United States.

Between 3.5 and 5.3 million Americans are living with chronic viral hepatitis, and most of them do not know that they are infected. Viral hepatitis is the leading cause of liver cancer and the most common reason for liver transplantation in the United States. In addition, it is a leading infectious cause of death in the U.S., claiming the lives of 12,000–18,000 Americans each year.

In recent years we have made significant progress in addressing these challenges.  With the new advances in hepatitis C treatment, more widespread availability of safe and effective vaccines for hepatitis A and B, and more opportunities for testing for hepatitis C under the Affordable Care Act, we have arrived at a critical moment. By harnessing these and other developments, we have the potential to reduce the toll of viral hepatitis in the U.S. and save many lives.

Thanks to the outstanding commitment of our public and private partners, we are closer than ever to realizing the potential of this plan.

To access the full Action Plan for the Prevention Care and Treatment of Viral Hepatitis (2014-2016) visit www.aids.gov/hepatitis.

For more information on viral hepatitis, see http://www.cdc.gov/hepatitis/.

Follow the conversation on social media using #ViralHepAction.

###

Note: All HHS press releases, fact sheets and other news materials are available at http://www.hhs.gov/news.

Like HHS on Facebook , follow HHS on Twitter @HHSgov , and sign up for HHS Email Updates.

Follow HHS Secretary Kathleen Sebelius on Twitter @Sebelius .

Last revised: April 3, 2014

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Also See: Updated Action Plan to Combat Viral Hepatitis Released

FDA approves new hand-held auto-injector to reverse opioid overdose

FDA NEWS RELEASE

For Immediate Release: April 3, 2014
Media Inquiries: Sandy Walsh, 301-796-4669, sandy.walsh@fda.hhs.gov
Consumer Inquiries: 888-INFO-FDA

First naloxone treatment specifically designed to be given by family members or caregivers

The U.S. Food and Drug Administration today approved a prescription treatment that can be used by family members or caregivers to treat a person known or suspected to have had an opioid overdose. Evzio (naloxone hydrochloride injection) rapidly delivers a single dose of the drug naloxone via a hand-held auto-injector that can be carried in a pocket or stored in a medicine cabinet.

It is intended for the emergency treatment of known or suspected opioid overdose, characterized by decreased breathing or heart rates, or loss of consciousness.

Drug overdose deaths, driven largely by prescription drug overdose deaths, are now the leading cause of injury death in the United States – surpassing motor vehicle crashes. In 2013, the Centers for Disease Control and Prevention reported the number of drug overdose deaths had steadily increased for more than a decade.

Naloxone is a medication that rapidly reverses the effects of opioid overdose and is the standard treatment for overdose. However, existing naloxone drugs require administration via syringe and are most commonly used by trained medical personnel in emergency departments and ambulances.

“Overdose and death resulting from misuse and abuse of both prescription and illicit opioids has become a major public health concern in the United States,” said Bob Rappaport, M.D., director of the Division of Anesthesia, Analgesia, and Addiction Products in the FDA’s Center for Drug Evaluation and Research. “Evzio is the first combination drug-device product designed to deliver a dose of naloxone for administration outside of a health care setting. Making this product available could save lives by facilitating earlier use of the drug in emergency situations.”

Evzio is injected into the muscle (intramuscular) or under the skin (subcutaneous). Once turned on, the device provides verbal instruction to the user describing how to deliver the medication, similar to automated defibrillators. Family members or caregivers should become familiar with all instructions for use before administering to known or suspected persons to have had an opioid overdose. Family members or caregivers should also become familiar with the steps for using Evzio and practice with the trainer device, which is included along with the delivery device, before it is needed. 

Because naloxone may not work as long as opioids, repeat doses may be needed. Evzio is not a substitute for immediate medical care, and the person administering Evzio should seek further, immediate medical attention on the patient’s behalf.

In one pharmacokinetic study of 30 patients, a single Evzio injection provided equivalent naloxone compared to a single dose of naloxone injection using a standard syringe. The use of Evzio in patients who are opioid dependent may result in severe opioid withdrawal. Abrupt reversal of opioid depression may result in nausea, vomiting, sweating, accelerated heart rate (tachycardia), increased blood pressure, uncontrollable trembling (tremulousness), seizures and cardiac arrest.

The FDA reviewed Evzio under the agency’s priority review program, which provides for an expedited review of drugs that appear to provide safe and effective therapy when no satisfactory alternative therapy exists, or offer significant improvement compared to marketed products. The product was granted a fast-track designation, a process designed to facilitate the development, and expedite the review of drugs to treat serious conditions and fill an unmet medical need.

Evzio is being approved ahead of the product’s prescription drug user fee goal date of June 20, 2014, the date the agency was originally scheduled to complete review of the drug application.

Evzio’s approval is also the result of efforts by several federal agencies. Naloxone has been a part of the White House’s Office of National Drug Control Policy’s National Drug Control Strategy since 2012. The FDA co-chairs an HHS inter-departmental working group on naloxone, which helped coordinate an April 12, 2012, meeting regarding access to naloxone products.

Evzio is manufactured for kaléo, Inc., of Richmond, Va. 
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