May 3, 2012

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By Howard K. Koh, M.D., M.P.H., Assistant Secretary for Health, U.S. Department of Health and Human Services

This month we are observing both Asian and Pacific Islander Heritage Month and Hepatitis Awareness Month. The dual observances are an important opportunity to bring attention to the disproportionate burden of viral hepatitis among the Asian American and Pacific Islander communities in the United States and to renew our commitment and call to action to address this disparity.

Viral Hepatitis Disparities in the Asian American and Pacific Islander Communities

Liver cancer and other liver problems caused by viral hepatitis (for example, cirrhosis) affect some U.S. populations more than others, resulting in substantial health disparities. This is especially true for Asian and Pacific Islanders Americans (APIs). In fact, an estimated 1 in 12 APIs are living with chronic hepatitis B. So, although Asian/Pacific Islander Americans make up only some 5 percent of the total U.S. population, they represent 50 percent of the estimated 800,000—1.4 million persons who are infected with hepatitis B in the United States. These health disparities are further reflected in viral hepatitis–associated illness and death. For example, liver cancer incidence is highest among the API population. Despite these high rates, many APIs are not tested for hepatitis B, thus remaining unaware of their infection and not accessing lifesaving medical care and appropriate treatment. Read more about this health disparity and what can be done at CDC’s Viral Hepatitis and APIs page.

What HHS Is Doing

The good news is that we do have effective tools to eliminate hepatitis B; there is a vaccine to prevent hepatitis B and effective treatments are available for people with chronic hepatitis B infection. Culturally appropriate outreach and education, including testing, vaccination for hepatitis B virus and care and treatment for those who are infected has been shown to decrease the burden of liver cancer. These are among our viral hepatitis priorities here at the Department of Health and Human Services as reflected in the Action Plan for the Prevention, Care and Treatment of Viral Hepatitis. Since I announced that plan last year, colleagues from across the Department of Health and Human Services, along with partners from the Department of Veterans Affairs and the Department of Justice’s Bureau of Prisons, have been working to coordinate and implement a number of strategies to educate healthcare providers and communities about viral hepatitis and reduce hepatitis health disparities. The Action Plan identifies the API community as one of its priority populations.

These efforts are complemented and enhanced by the HHS Plan for Asian American, Native Hawaiian and Pacific Islander (AANHPI) Health, which was also initiated last year. The HHS Plan identifies four over-arching health issues that the Department is pursuing to improve the health and well-being of AANHPIs. Significantly, the first of these four issues is: Prevent, treat and control Hepatitis B viral infections in AANHPI communities. The plan identifies specific strategies, lead agencies, and benchmarks that are now being pursued to achieve this goal. This plan was developed as part of the White House Initiative on Asian Americans and Pacific Islanders, which aims to improve quality of life and enhance opportunities for Asian American and Pacific Islanders to participate in Federal programs.

Finally, the Affordable Care Act, the new healthcare law, has become another vital tool in our fight against viral hepatitis in the API community. By expanding health insurance coverage, the health care law is improving patient access to comprehensive viral hepatitis-related prevention and treatment services. Its focus on expanding access to preventive care will require new health plans to cover the hepatitis B vaccine for many individuals, which will keep people healthy and prevent the spread of the disease.

What You Can Do

Improved coordination of viral hepatitis activities across HHS and other Federal departments and expanded health insurance coverage will have a positive impact on our efforts to reduce viral hepatitis disparities in the API population. But, as important as those efforts are, they are not sufficient, by themselves, to achieve the goals of the Action Plan. The active engagement of state and local partners, as well as people like you, is absolutely critical. Please join us in raising awareness about hepatitis B among your families, friends, colleagues and co-workers. Make hepatitis B part of your conversations during the month of May. To help you, the CDC is releasing several helpful tools this month. Visit the CDC’s Hepatitis Awareness Month Partner Resources page to learn more. Working together, we can bring to life the Action Plan’s vision: “A Nation committed to combating the silent epidemic of viral hepatitis.”

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HIV Gene Therapy Safe Over Time

By Michael Smith, North American Correspondent, MedPage Today

Published: May 03, 2012

Reviewed by Zalman S. Agus, MD; Emeritus Professor, Perelman School of Medicine at the University of Pennsylvania and Dorothy Caputo, MA, BSN, RN, Nurse Planner

Action Points

  • This report evaluates results from three clinical trials designed to use retroviral-modified chimeric antigen receptor T cells for treatment of HIV.
  • Note that genetically modified immune cells were still present and active 11 years after they were infused without any obvious toxicity.

A gene therapy approach to HIV treatment is long-lasting and safe, researchers reported.

In long-term results from three small clinical trials, genetically modified immune cells were still present and active 11 years after they were infused, according to Carl June, MD, of the Perelman School of Medicine at the University of Pennsylvania, and colleagues.

And there have been more than 540 patient-years of follow-up without any toxicity related to the gene therapy, suggesting that the adverse event rate is extremely small, June and colleagues reported online in Science Translational Medicine.

The findings are in contrast to many other studies of gene therapy, in which modified cells lasted only weeks or months, the researchers noted. As well, in some high-profile studies, gene therapy led to serious adverse effects, including leukemia.

Those results had cast a shadow over gene therapy, but there has been renewed interest in the approach recently among HIV researchers, after a stem cell transplant apparently cured an HIV-positive patient by making his immune cells resistant to the virus.

Earlier this year, researchers reported that gene therapy with the same aim was both safe and well tolerated, with at least some hints of efficacy.

The findings don't bear directly on current gene therapy research in HIV, because investigators are mainly trying to modify stem cells, according to John Rossi, PhD, of City of Hope in Duarte, Calif.

"HIV doesn't infect just T cells," Rossi told MedPage Today. By modifying stem cells, he and other investigators hope to create an immune system in which all cells are resistant to HIV infection.

But he said it is good news that modified T cells can be safely used and made to last.

"If you have a safe way to modify cells in patients with HIV, you can potentially develop curative approaches," June said in a statement.

In the current study, he and colleagues report on what happened to 43 patients treated from 1998 to 2005 with infusions of their own CD4-positive T cells, genetically modified so they would bind specifically to envelope protein of HIV.

The so-called chimeric antigen receptor -- dubbed CD4-ζ (zeta) -- included native CD4 cells, linked to the CD3-ζ signaling chain, which is involved in antigen recognition.

As part of the study protocols, the researchers took yearly peripheral blood mononuclear cell samples, as well as monitoring the patients for toxicity related to the infusions.

The researchers reported that of 221 samples tested over 11 years, 212 still contained modified T cells. A mathematical model indicated that the half-life of the cells was greater than 16 years, suggesting they could persist for decades.

Continued observation of the patients has not turned up any sign of toxicity and the researchers said their analysis suggests an adverse event rate of less than 0.0068 per person-year.

That works out, they said, to about one event every 145 years.

They cautioned that the safety profile might not apply to all gene transfers; it might be specific for T cells or for the specific modification used in these studies.

The modified cells remain active against HIV, they added.

The studies were small and patients received a relatively small number of the cells, so the researchers did not observe a significant treatment effect, although viral loads did fall in the wake of the therapy, according to co-author Bruce Levine, PhD, also of the University of Pennsylvania.

But in the light of the safety and durability information, he told MedPage Today, it might be useful to try the approach again, this time with more modern techniques.

Among other things, he said, gene transfer techniques have improved and researchers would want to try to engineer a better chimeric receptor, as well as increasing the dose of engineered cells.

"If we gave [patients] more, we might well see an effect," Levine said.

While the gene transfer approach has been criticized as an expensive "boutique therapy," he said, if it could be done once or twice and result in control of HIV, it might be cost-effective compared with life-long anti-retroviral therapy.

One sidelight of the original studies is that the durable effect was achieved without having to destroy and re-seed the immune system, as has been needed in stem cell therapies and T cell treatment for cancer.

The study had support from the NIH, the University of Pennsylvania Center for AIDS Research, and the Department of Defense. The journal said June reported no competing interests.

Primary source: Science Translational Medicine
Source reference:
Scholler J, et al "Decade-long safety and function of retroviral-modified chimeric antigen receptor T cells" Sci Transl Med 2012; 4: 132ra53; DOI: 10.1126/scitranslmed.3003761.

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Annual event has raised more than $37 million for services for people living with HIV/AIDS -- expected to draw 15,000 participants this year.

Boston, MA (PRWEB) May 03, 2012

Registration is open and fundraising has begun for the 27th annual AIDS Walk Boston, From All Walks of Life™, Boston’s annual AIDS Walk, which will be held June 3, 2012. The annual Walk draws 10,000 to 15,000 participants and is AIDS Action’s largest annual fundraiser. WCVB-TV StormTeam 5 meteorologist David Brown will emcee the event, which also includes a Wellness Festival and the Larry Kessler 5K run. The 5K run is a competitive, timed event, and is fully sanctioned by the USA Track & Field Association. The 6.2-mile AIDS Walk and the Larry Kessler 5K run will begin and end at the DCR Hatch Memorial Shell on the Charles River Esplanade in Boston. Registration and check-in begins at 7:30 a.m. The Walk begins at 10 a.m.; the Larry Kessler run begins at 9:50 a.m. Participants can register for the AIDS Walk and 5K run at http://www.aidswalkboston.org. There is neither a registration fee nor a minimum funds raised requirement in order to participate.

“There are an estimated 25,000 to 27,000 people living with HIV/AIDS in Massachusetts, about 21 percent of whom do not know they are HIV positive. At any given time, AIDS Action is providing services to at least one-in-six of the 18,000 people who do know their status,” said Rebecca Haag, president and CEO of AIDS Action, who walks each year and contributes personally to every AIDS Action employee who walks or runs. “We connect people with health care, peer support, counseling, free HIV testing, housing and fuel assistance, and legal services. Since 1999, we have helped the state reduce new HIV diagnoses by 54 percent, which will save more than 5,600 a diagnosis of HIV, and will save the state more than $2 billion in health care costs. Money raised from the AIDS Walk is essential to this work, and we urge everyone in the Boston area to join us or donate to the thousands of walker and runners who do.”

Corporate sponsors of this year’s AIDS Walk and 5K Run include MOMS Pharmacy, Brystol-Myers Squibb, Whole Foods Market, EMD Serono, EMD, Beth Israel Deaconess Medical Center, The TJX Companies, Inc., Partners HealthCare, Dana Farber Cancer Institute, State Street, Eastern Bank, Abt Associates, Brigham and Women’s Hospital, Blue Cross Blue Shield of Massachusetts. This year’s media sponsors include WCVB-TV 5, JAM’N 95.5 FM, WFNX 101.7 FM, El Planeta, KISS 108 FM, and The Boston Phoenix. The VIP Breakfast Sponsor is Boloco. Additional sponsorship opportunities are still available. Call Jacoba van Heugten at 617-450-1512 begin_of_the_skype_highlighting 617-450-1512 end_of_the_skype_highlighting or email jvanheugten(at)aac(dot)org.

AIDS Action will support the Boston AIDS Walk with a robust social media outreach and fundraising plan:

  • For the fourth year in a row, walkers can fundraise through their Facebook pages by installing the Fundraising with Facebook application. Last year, walkers raised approximately $40,000 in donations through Facebook.
  • Follow @AIDSWalkBoston and the hashtag #AWB for information about HIV/AIDS and the Boston AIDS Walk.

FACTS ABOUT AIDS IN MASSACHUSETTS

  • The number of people known to be living with HIV/AIDS increased by 42% from 1999 to 2008.
  • Non-Hispanic blacks and Hispanics make up only 6% of the total population, but non-Hispanic blacks account for 29% of those living with HIV/AIDS, and Hispanics account for 25% of those living with HIV/AIDS
  • Among those recently diagnosed with HIV/AIDS, male-to-male sex is the leading reported cause of exposure, accounting for four out of 10 new diagnoses.

FACTS ABOUT AIDS NATIONALLY

  • There is a new HIV infection every 9.5 minutes and HIV continues to infect about 56,000 people annually.
  • There are more than 1.1 million people living with HIV/AIDS.
  • Gay and bisexual men are more than 44 times more likely to become infected with HIV than the general population.
  • About one in 16 Black American men and one in 30 Black American women can expect to become HIV positive in their lifetime.
  • AIDS is the third leading cause of death for African-American men and women age 35 to 44.
  • About one-third of all new HIV infections occur in people age 28 and younger.

FACTS ABOUT AIDS WALK Boston
The AIDS Walk was first held in 1986 and is one of the first walks to be introduced in Boston, as well as the country. The 5K run was added to open up fundraising to runners. Historically AAC’s largest fundraising event, it has raised nearly $37 million for programs and services to support those living with and at risk for contracting HIV/AIDS. In 2010:

About AIDS Action Committee of Massachusetts
AIDS Action Committee of Massachusetts is the state’s leading provider of prevention and wellness services for people vulnerable to HIV infection. It provides services to one in six people in Massachusetts living with an HIV diagnosis. These services include HIV counseling and testing; needle exchange; mental health counseling; housing assistance; and legal services. AIDS Action works to prevent new HIV infections, support those affected by HIV, and tackle the root causes of HIV/AIDS by educating the public and health professionals about HIV prevention and care; and advocating for fair and effective HIV/AIDS policy at the city, state, and federal levels. Founded in 1983, AIDS Action Committee of Massachusetts is New England’s first and largest AIDS service organization. Learn more at http://www.aac.org.

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