March 22, 2012

How HIV remains a puzzle

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"Even in early infection when the virus population is low, HIV rapidly evolves to evade immune defences and treatments." Image: skodonnell/iStockphoto

The University of Adelaide

Friday, 23 March 2012

New research from the University of Adelaide shows why the development of a cure and new treatments for HIV have been so difficult for scientists to crack.

Dr Jack da Silva from the University's School of Molecular & Biomedical Science has used computer simulations to discover that even in early infection when the virus population is low, HIV rapidly evolves to evade immune defences and treatments.

These results - published in this month's issue of the prestigious journal GENETICS - challenge the commonly held belief that evolution of the virus under these circumstances is very slow.

"I believe the search for a cure for AIDS has failed so far because we do not fully understand how HIV evolves," Dr da Silva said.

To make this discovery, Dr da Silva used computer simulations to determine whether, under realistic conditions, the virus could evolve rapidly if an infection started from a single virus.

This was done by constructing a model of the virus population, then simulating the killing of virus-infected cells by the immune system, along with mutation, recombination (the process by which genetic material is broken and joined to other genetic material), and random genetic changes.

Results show that for realistic rates of cell killing, mutation and recombination, and a realistic population size, the virus could evolve very rapidly even if the initial population size is one.

"At low population levels, viruses have reduced genetic variation and therefore it should be harder for them to evolve rapidly. However, it appears that the evolution of HIV goes against conventional wisdom," Dr da Silva said.

"We now need further insight into the precise genetic mechanisms that enable the virus to so readily adapt to all the challenges we throw at it. Such knowledge will, hopefully, lead to novel strategies for vaccines and other control measures."

Mark Johnston, Editor-in-Chief of GENETICS, said: "Now that we know HIV rapidly evolves, even when its population size is small, we may be able to interfere with its ability to evolve so we can get the most out of the treatments that are developed."

The full report from Dr Jack da Silva can be read online.

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Public release date: 22-Mar-2012

Contact: Dawn Peters
healthnews@wiley.com
781-388-8408
Wiley-Blackwell

Experts call for evaluation of current criteria for allocating organs for transplantation

New research shows increasing disparity in mortality among candidates with and without hepatocellular carcinoma (HCC) who are on the waiting list for liver transplantation. The study available in the April issue of Liver Transplantation, a journal published by Wiley-Blackwell on behalf of the American Association for the Study of Liver Diseases, found that liver cancer patients are less likely to die on the wait list than non-HCC candidates, prompting transplantation specialists to suggest a reevaluation of current allotment criteria for those with HCC.

In 2002, the United Network for Organ Sharing (UNOS) implemented the Model for End Stage Liver Disease (MELD) scoring system to prioritize candidates on the waiting list for liver transplantation in the U.S. While MELD accurately predicts 90-day waitlist mortality, there are some candidates with extensive disease symptoms, such as those with HCC, who need additional prioritizing criteria to assess clinical risk. These candidates receive MELD exception points, of which HCC patients on the wait list could gain 22 points based on increased mortality risk, meaning HCC patients may be transplanted before other patients at greater risk of death.

"With the scarcity of available livers for transplantation, it is vital that allocation criteria ensure those candidates at greatest mortality risk are first to receive a life-saving organ," said Dr. David Goldberg with the University of Pennsylvania and lead author of the current study. "Our study investigated appropriate designation of exception points for transplant candidates with HCC, comparing mortality risk to those with similar MELD scores, but without liver cancer."

The team analyzed data from the Organ Procurement and Transplantation Network (OPTN) UNOS database, including candidates eighteen years of age and older who were on the waiting list for liver transplantation between January 2005 and May 2009. The HCC group was comprised of 6,246 candidates who received exception points for stage two (T2) liver cancer. These candidates were more likely to be older, male and Caucasian or Asian compared to those without liver cancer. In the non-HCC cohort, candidates were categorized by MELD score with 2,564 candidates with a score of 21-23; 4,655 with 24-26; and 2,737 with MELD 27-29.

Analysis shows that within 90 days of listing 4.2% of HCC candidates were removed from the wait list for death or clinical deterioration compared to 11% of non-HCC candidates with MELD scores 21-23. For HCC candidates with 25 exception points (3-6 months wait-time) versus non-HCC candidates with MELD scores 24-26, close to 5% and 17% were removed from the waiting list, respectively. Of the HCC candidates with 28 exception points (6-9 months wait-time) 3% were removed for death or clinical deterioration compared to 24% of non-HCC candidates with MELD scores of 27-29.

Researchers determined that over time the risk of waitlist mortality or clinical decline was unchanged for HCC candidates, but increased significantly for non-HCC candidates. Dr. Goldberg concludes, "Our data suggest HCC candidates have substantially lower odds of waitlist removal for death or deterioration than non-HCC candidates, and strongly indicates that exception points currently allotted for HCC should be lowered."

In a related editorial also published this month in Liver Transplantation, Dr. Patrick Northup from the University of Virginia agrees and writes, "The Goldberg et al. study adds strength to the argument that the 'sickest first' policy may not be well served by the current allocation methods for HCC under the MELD system." He proposes that the transplantation community strive to develop a more fluid allocation system that is responsive to new medical evidence. "The allocation system should be managed as a whole, rather than as isolated pieces, to ensure patients on the waitlist are prioritized based on the desire to minimize waitlist mortality."

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This study and editorial is published in Liver Transplantation. Media wishing to receive a PDF of the articles may contact healthnews@wiley.com.

Full citations: "Increasing Disparity in Waitlist Mortality Rates with Increased MELD Scores for Candidates with versus without Hepatocellular Carcinoma." David Goldberg, Benjamin French, Peter Abt, Sandy Feng, Andrew M. Cameron. Liver Transplantation; (DOI: 10.1002/lt.23394) Published online: January 23, 2012; Print Issue Date: April 2012. http://onlinelibrary.wiley.com/doi/10.1002/lt.23394/abstract.

Editorial: "HCC and MELD Exceptions: The More We Understand, The More Challenging the Allocation Gets." Patrick G. Northup and Carl L. Berg. Liver Transplantation; (DOI: 10.1002/lt.23409) Published online: Februar 10, 2012; Print Issue Date: April 2012. http://onlinelibrary.wiley.com/doi/10.1002/lt.23409/abstract.

Author Contact: To arrange an interview with Dr. Goldberg, please contact Katie Delach with PENN Medicine at katie.delach@uphs.upenn.edu or 215-349-5964. Media wishing to speak with Dr. Northup may contact Jason Ellis with the University of Virginia at jasonellis@virginia.edu or 434-924-5679.

About the Journal

Liver Transplantation is published by Wiley-Blackwell on behalf of the American Association for the Study of Liver Diseases and the International Liver Transplantation Society. Since the first application of liver transplantation in a clinical situation was reported more than twenty years ago, there has been a great deal of growth in this field and more is anticipated. As an official publication of the AALSD and the ILTS, Liver Transplantation delivers current, peer-reviewed articles on surgical techniques, clinical investigations and drug research — the information necessary to keep abreast of this evolving specialty. For more information, please visit Liver Transplantation.

About Wiley-Blackwell

Wiley-Blackwell is the international scientific, technical, medical, and scholarly publishing business of John Wiley & Sons, with strengths in every major academic and professional field and partnerships with many of the world's leading societies. Wiley-Blackwell publishes nearly 1,500 peer-reviewed journals and 1,500+ new books annually in print and online, as well as databases, major reference works and laboratory protocols. For more information, please visit www.wileyblackwell.com or our new online platform, Wiley Online Library (wileyonlinelibrary.com), one of the world's most extensive multidisciplinary collections of online resources, covering life, health, social and physical sciences, and humanities.

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NASTAD: HIV and Viral Hepatitis Policy Watch

Volume 15, March 16, 2012

The Policy Watch provides timely updates and resources on Hill and Administration activities impacting HIV and viral hepatitis programs. Please go to NASTAD's website at www.NASTAD.org for more information.

Congress

FY2013 Budget Resolutions

The House and Senate are currently working on developing budget resolutions for FY2013. The budget resolutions serve as a spending blueprint for all government expenditures, including appropriations. The Budget Control Act set the FY2013 budget level at $1.047 trillion. Despite this level being signed into law, House Republicans are debating lowering the FY2013 spending cap below this level. These additional cuts would impact appropriations as there would be less money for the Labor, Health, and Human Services Appropriations bill which supports HIV and viral hepatitis programs. NASTAD will provide updates as they become available.

FY2013 Appropriations

Representatives Mike Honda (D-CA), Hank Johnson (D-GA) and Judy Chu (D-CA) are circulating a "Dear Colleague" urging Members of Congress to sign on to their letter asking the House Appropriations Committee to support increased funding for the Division of Viral Hepatitis (DVH) at the Centers for Disease Control and Prevention (CDC). The letter reiterates Congress' need to scale-up the viral hepatitis epidemic response in light of rising mortality rates attributable to viral hepatitis in the U.S. over the last decade. According to the letter, "[now] is not the time to be flat-funding this program."

Representative Bill Pascrell, Jr. (D - NJ) is circulating a "Dear Colleague" letter asking for increases in funding for domestic HIV/AIDS programs. The letter emphasizes the need for investments in CDC's HIV prevention program and Ryan White programs.

Additionally, NASTAD has signed on to letters supporting increased funding for domestic programs. The Sexuality Education Coalition letter requests increases for the CDC Division of Adolescent and School Health, including the restoration of funding cut in FY2012, and other sexuality education programs.

Medicaid Block

Grant House Republicans are expected to include a measure to cut and block grant the Medicaid program in their budget proposal. If successful, this effort would dismantle the current federal funding formula for Medicaid allocations and provide a set amount of resources to states, which may be less than they receive now. This proposal was included in the House FY2012 Budget , but was rejected by the Senate. NASTAD, along with the HIV Health Care Access Work Group, is watching this issue closely.

Congressional Inquiry on the 340B Program

Four Members of Congress have sent letters to several organizations including the Safety Net Hospitals for Pharmaceutical Access (SNHPA), which convenes the 340B Coalition, requesting information provided to their membership on specific aspects of the 340B program such as patient definition, contract pharmacies and additional documentation of SNHPA's interaction with their membership. The press release and the letters can be found on Senator Chuck Grassley's (R-IA) website. The 340B program is routinely under Congressional scrutiny, especially after a June Office of Inspector General report found that the program lacked adequate oversight. During the debate on health reform, Republicans advocated terminating the 340B program. NASTAD will continue to monitor Congressional actions related to this vital program.

CDC Hepatitis C Testing Guidelines

Representative Hank Johnson (D-GA) and a bipartisan group of 25 Members of Congress sent a letter to CDC urging the timely release of new testing guidelines for hepatitis C (HCV). The proposed age-based screening guidelines will identify many more Americans with HCV and enable them to access care and treatment, thereby reducing deaths and health care costs associated with the virus.

Administration

Director of the Office of National AIDS Policy (ONAP)

On March 14, the White House named Dr. Grant Colfax as the new director of ONAP. Dr. Colfax currently serves as Director of the HIV Prevention Section in the San Francisco Department of Public Health.

White House LGBT Conference on Housing & Homelessness

On Friday, March 9, 2012, the White House and the U.S. Department of Housing & Urban Development (HUD) held a conference at Wayne State University in Detroit to discuss housing and homelessness issues facing lesbian, gay, bisexual and transgender (LGBT) Americans. The conference drew approximately 125 people, and HUD Secretary Shaun Donovan gave the keynote address reaffirming the Obama administration's commitment to addressing issues with relevance to the LGBT community. Raphael Bostic, Assistant Secretary for Policy Development and Research at HUD, facilitated a workshop on engaging transgender people, LGBT elders and people living with HIV/AIDS. The session focused on keeping homelessness "on the radar screen" among LGBT advocates as attention moves towards implementing the National HIV/AIDS Strategy (NHAS).

2012 White House Policy Briefing for Black LGBT Emerging Leaders

On Friday, February 24, 2012, the White House, in collaboration with the National Black Justice Coalition and the Human Rights Campaign, held a policy briefing for Black LGBT emerging leaders. The 150 participants heard from prominent national Black leaders ranging in topics from safe schools/bullying prevention, HIV/AIDS, faith outreach, and youth entrepreneurship. The HIV/AIDS session, led by Gregorio Millett from the CDC, provided an opportunity for community members to ask questions concerning the shifting landscape of HIV prevention at the federal level and what this means for Black LGBT young people. There was a focus on financial resources and how organizations receiving funding for the population can be held accountable for effective outreach and engagement among Black LGBT communities.

Federal Partners Update

HHS Southern Initiative

HHS is poised to release a demonstration project (using the Secretary's Minority AIDS Initiative funds) to target a set of jurisdictions outside of the 12 cities project. The three year program will focus on reducing health disparities among racial and ethnic minorities in the south, with a particular focus on mortality rates. CDC will disseminate the $14.5 million per year for three years to health departments with a required 25 percent or more of funding to be passed to Community Based Organizations (CBOs). An FOA is in the works and NASTAD will provide more information as it becomes available.

Indicators Update

A memo from HHS Secretary Sebelius directing the heads of Substance Abuse and Mental Health Services Administration (SAMHSA), CDC, Health Resources and Services Administration (HRSA), Office of Minority Health (OMH) and Office on Women's Health (OWH) to adopt a common set of indicators across HHS and streamline the number of grantee data requirements is currently in clearance at HHS. Agencies would have 90 days to finalize standard core metrics. In the subsequent 90 days, HHS would work to develop a plan to operationalize those core indicators and have them fully implemented by the beginning of FY2014. The plan also calls for a 20-25 percent reduction of indicators required for grantees. Andrew Forsyth of the Office of HIV/AIDS Policy presented on this plan at the Presidential Advisory Council on HIV/AIDS (PACHA) meeting on February 29, 2012.

Prevention FOA- Category C

The CDC awarded Category C (demonstration projects) as part of the new health department cooperative agreement, PS 12-1201Comprehensive HIV Prevention Programs for Health Department. Forty nine jurisdictions submitted 71 proposals with 30 jurisdictions receiving funding for a total of $20 million (taken from Category A). Four jurisdictions were awarded between $1 and $2 million; 8 jurisdictions were awarded between $500,000 and $1 million; and 18 jurisdictions were awarded less than $500,000.

NASTAD recently completed a funding memo and analysis of the Category A, core prevention services and Category B, expanded testing awards for PS12-1201.

HHS Viral Hepatitis Testing Consultation

The HHS Office of the Assistant Secretary for Health (ASH) held a consultation on viral hepatitis testing on February 23, 2012 at the Hall of the States. The day-long consultation featured a broad variety of discussions, including challenges to testing, state and local approaches, targeting specific populations as well as discussions with HHS agencies (e.g., SAMHSA) and other key stakeholders (e.g., the Veterans Administration and Departments of Corrections). The consultation was widely attended by federal, non-governmental, advocacy and industry partners, as well as Adult Viral Hepatitis Prevention Coordinators (AVHPCs) and other state health department staff. A meeting summary will be sent out upon availability.

Noteworthy

HAP/NVHR 2012 Viral Hepatitis Policy Summit

The Hepatitis Appropriations Partnership (HAP), which NASTAD convenes, partnered with the National Viral Hepatitis Roundtable (NVHR) for the second year in a row to hold the 2012 Viral Hepatitis Policy Summit. This year's meeting, which is an expansion of the HAP annual face-to-face meeting held in previous years, featured conversations with federal partners from the HHS, CDC, SAMHSA and the Office of Management and Budget (OMB)as well as viral hepatitis Congressional champions. The purpose of the summit was to continue Congressional advocacy while ramping up policy efforts with the Administration.

National Day of Action for Syringe Exchange

With the return of the federal funding ban on Syringe Exchange Programs (SEPs), the Harm Reduction Coalition and their allies are organizing a National Day of Action for Syringe Exchange on March 21, 2012. The day of action will include meetings with Members of Congress, media events to highlight policy and public health issues and a National Call-in Day to highlight opposition to the ban.

Healthcare Reform Monitoring Report

NASTAD partner, Harvard Law School's Treatment Access Expansion Project (TAEP), developed a Healthcare Reform Monitoring Report, which focuses on aspects of Affordable Care Act (ACA) implementation. This can serve as a resource for health department planning for ACA implementation.

Sign-on Letters

NASTAD recently signed on to a letter to the Agency for Healthcare Research and Quality (AHRQ) regarding testing reimbursements.

NASTAD recently signed on to a letter to President Obama in regards to elevating the global and national response to the HIV pandemic by prioritizing the human rights of all persons at risk of and living with HIV.

Legislation of Interest Grid

Here is an updated legislation of interest grid for the most recent HIV, STD and viral hepatitis legislation that we are tracking.

National Alliance of State and Territorial AIDS Directors 444 North Capitol Street, NW • Suite 339 • Washington D.C. 20001 • ph: (202) 434-8090 www.NASTAD.org • em: nastad@nastad.org

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UPDATED EASL Abstracts Embargo Policy

UPDATED International Liver Congress TM 2012 EMBARGO POLICY

International Liver Congress™ 2012 abstracts will be made publicly available on the congress website two weeks in advance of the congress - Wednesday, 04 April 2012. Abstracts posted online on Wednesday, 04 April 2012 are NOT under embargo.

Abstracts selected to be highlighted during official EASL Press Office activities or in official EASL Press Office materials will be made publicly available on the congress website at 1800 (CET) on the day of their presentation at the congress. Abstracts selected to be highlighted during official EASL Press Office activities or in official EASL Press Office materials are under embargo until the date and time of their presentation at the congress.

On Wednesday, 04 April 2012 industry may issue a press release announcing that their abstract has been selected for inclusion in official EASL Press Office activities or in official EASL Press Office materials (abstract title only). Industry must not issue press releases ‑ even under embargo ‑ covering the data contained in abstracts selected to be highlighted during official EASL Press Office activities or in official EASL Press Office materials until the individual embargo for each data set lifts.

Media must not issue coverage of the data contained in abstracts selected to be highlighted during official EASL Press Office activities or in official EASL Press Office materials until the individual embargo for each data set lifts.

Journalists, industry, investigators and/or study sponsors must abide by the embargo times set by EASL.

Violation of the embargo will be taken seriously. Individuals and/or sponsors who violate EASL's embargo policies may face sanctions relating to current and future abstract submissions, presentations and visibility at EASL Congresses. The EASL Governing Board is at liberty to ban attendance and/or retract data.

Copyright for abstracts (both oral and poster) on the website and as made available during The International Liver Congress™ 2012 resides with the respective authors. No reproduction, re-use or transcription for any commercial purpose or use of the content is permitted without the written permission of the authors. Permission for re-use must be obtained directly from the author.

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Liver disease deaths reach record levels in England

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Many of the deaths from liver disease were alcohol related

By Helen Briggs Health editor, BBC News website

Deaths from liver disease in England have reached record levels, rising by 25% in less than a decade, according to new NHS figures.

Heavy drinking, obesity and hepatitis are believed to be behind the rise.

The report by the National End of Life Care Intelligence Network said more deaths were in men, with the highest number of fatalities in the North West.

The number of people who died from liver disease rose from 9,231 in 2001 to 11,575 in 2009, it said.

Other major causes of death, such as heart disease, are declining.

Prof Martin Lombard, national clinical director for liver disease, said: "This report makes for stark reading about the needs of people dying with liver disease.

"Over 70% end up dying in hospital and this report is timely in helping us understand the challenges in managing end-of-life care for this group of people.

"The key drivers for increasing numbers of deaths from liver disease are all preventable, such as alcohol, obesity, hepatitis C and hepatitis B. We must focus our efforts and tackle this problem sooner rather than later."

Several recent reports have warned of rising deaths from liver disease, particularly in the young.

Regional breakdown

  • The age standardised mortality rates per 100,000 people in England were highest in the North West (24), the North East (22) and London (20); and lowest in the East (13), South West (14) and South East (15)

More men

The latest report follows figures published last December which showed a 60% rise in alcoholic liver disease in young people over seven years.

The National End of Life Care Intelligence Network, which analyses death rates and costs of care, looked at statistics for deaths from liver disease across England between 2001 and 2009.

They found most liver deaths were in people under 70, while one in 10 deaths of all people in their 40s were from liver conditions.

Men were disproportionately affected, especially when deaths from liver disease were due to heavy drinking, said the report.

Prof Julia Verne, lead author of the report and clinical lead for the National End of Life Care Intelligence Network, said: "It is crucial that commissioners and providers of health and social care services know the prevalence of liver disease in their local areas, so that more people can receive the care they need to allow them to die in the place of their choosing."

A Department of Health spokesman said: "These figures are a stark reminder of the preventable damage that eating too much and drinking too much alcohol can do.

"Urgent action is needed to halt this trend. Our upcoming liver strategy will set out our plans on this issue, drawing on our plans to tackle problem drinking and obesity."

Andrew Langford, chief executive of the British Liver Trust, said: "This report clearly highlights that liver patients have been, and continue to be, failed by our healthcare system.

"Liver disease has remained the poor relation in comparison to other big killers such as cancer and heart disease, yet liver disease is the only big killer on the rise."

The chief executive of Alcohol Concern, Eric Appleby, said: "This report shows that loss of life through alcoholic liver disease remains as big a problem as ever, with a worrying tendency for those with the highest deprivation to suffer most, leading to a distinct north/south divide.

"Minimum pricing of alcohol should do much to impact on the levels of drinking that lead to alcoholic liver disease, but health service commissioners must prioritise the disease at the local level too, focusing on ways to catch problem drinking early and so help to reduce the huge social and economic cost of the current death rate."

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New study aims to reduce stigma through community leadership

CHAMPResearcher

Henry Luyombya;research coordinator for the CHAMP study at the Committee for Accessible AIDS Treatment. Photo Credit: Yamri Taddese , Global News

Yamri Taddese, Global News : Wednesday, March 21, 2012 5:38 PM

TORONTO - One in almost 100 Torontonians is HIV positive, but most Toronto residents have never met a person who lives with HIV.

It could be because those who live with the disease never reveal their status.

For many, saying you are HIV positive can be like “sticking your neck out to be cut off,” said Dr. Alan Li, the co-principal investigator of a new study that aims to reduce stigma associated with the disease.

The CHAMP study will use Acceptance Commitment Therapy (ACT) to teach participants to be mindful of their perceptions toward HIV and acknowledging those perceptions.

The study is currently recruiting religious leaders, health and settlement workers as well as members of the media from the GTA’s immigrant communities, who are disproportionately affected by HIV.

While accounting for only 1% of the Canadian population, immigrants and refugees make up 20% of HIV infections each year. Forty percent of HIV-positive immigrants contracted the virus after their arrival to Canada.

The CHAMP study is a response to a previous study by the Committee for Accessible AIDS Treatment which found that HIV-related stigma and lack of community leaders to speak about the disease create a barrier for prevention efforts.

Dr. Li says the invisibility of the disease “breeds more stigma and more self-stigma.”

“But it doesn’t mean stigma always comes from hate, it’s about not having flexibility,” he said

Participants, including those who live with HIV, will undergo a series of trainings, which involves learning about issues around HIV and taking the first step toward acceptance by recognizing their own perceptions of the disease.

At the core of Acceptance Commitment Therapy is mindfulness, says Dr. Kelly Wilson, a Professor of Psychology at the University of Mississippi who is one of the co-founders of this therapy and has written extensively on the treatment.

“Mindfulness is opening up and allowing whatever arises with equanimity, with appreciation,” he said. “It’s about teaching people to change their relationship with their thoughts and emotions.”

When it comes to stigma, Dr. Wilson says people either cling on their beliefs or they deny that they have them.

“The harder you fight [the thought], the stronger it gets. The thought is not the enemy.”

The key, he added, is to acknowledge those thoughts “kindly” and act not upon them but upon one’s core values.

“Stigma is a product of a certain kind of history. It can be held lightly and then you can pick your values.

What if you had your thoughts instead of your thoughts having you?”
Acceptance Commitment Therapy has been used to treat anxiety, depression, eating disorder and chronic pain.

The CHAMP study will combine this therapy with another intervention which aims to build participants’ ability to take on advocacy roles on issues that are related to HIV. These include fighting homophobia, racism, poverty and social exclusion.

“We know these roles are not easy, otherwise everyone would have been doing it already,” said Dr. Li. “But part of breaking new ground is to challenge our comfort zone.”

Henry Luyombya, the CHAMP study coordinator, adds that this challenge is what makes the study important.

“The fact that it’s been partly hard to get participants from particular communities explains the urgency of our work,” he said.

Luyombya, who is HIV-positive, says the disease is a huge taboo in many communities.

“I can talk about my lived experience, but not many people can,” he said.

He added that revealing your status could mean losing job opportunities, facing discrimination from health care workers and other service providers.

“But the issue isn’t about assigning blame, that doesn’t get us very far. It’s about understanding the driving sources that make it difficult [to address the problem],” said Dr. Li.

The CHAMP training sessions will take place between April and May. The researchers will then check in with the participants to see if they are getting involved in any HIV-related interventions.
Several surveys and questionnaires will also be used to gauge the success of the study.

Global News

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EASL Backs Down, Will Publicly Disclose Key Hep C Data

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By Adam Feuerstein 03/22/12 - 07:36 AM EDT

BOSTON (TheStreet) -- The European Association for the Study of the Liver, better known as EASL, has backed down and will no longer unfairly and selectively disclose potentially stock-moving hepatitis C clinical data ahead of its important and closely followed conference next month.

In a total reverse of its previous policy, EASL said Thursday that research abstracts for its International Liver Congress, taking place April 18-22 in Barcelona, would be made publicly available online on April 4. Clinical data in the abstracts will not be under embargo, meaning journalists will be allowed to report on them.

"EASL is making these changes in light of recent criticism of its proposed policy, which suggests 'selective distribution' of officially accepted clinical data in advance of the Congress would make our proposed embargo policy untenable," EASL said in a statement issued Thursday.

The EASL meeting is where Gilead Sciences(GILD_), Bristol-Myers Squibb(BMY_), Abbott(ABT_), Idenix Pharmaceuticals(IDIX_), Vertex Pharmaceuticals(VRTX_) and Merck(MRK_) are among the companies expected to present new clinical data on experimental hepatitis C therapies. Therefore, the meeting is as vitally important to hepatitis C doctors and patients as it is to investors.

Yet under its old policy, EASL wanted to provide an advance look at potentially market-moving hepatitis C drug data to the medical society's members or registered attendees of the EASL meeting -- a group which includes hedge fund/mutual fund portfolio managers and sell-side analysts, all of whom can pay for early access.

EASL had planned to selectively distribute hepatitis C drug research abstracts to these folks today. The same documents were not going to be made available to the public, which meant that a select group of investors would have had access to potentially stock-moving clinical data while a majority of investors were to be kept in the dark.

In columns published Tuesday and Wednesday, I criticized EASL's abstract distribution policy as being misguided, unfair and quite frankly unworkable. Smarter medical and scientific groups like the American Society of Clinical Oncology (ASCO) realized years ago that trying to compartmentalize research abstracts was futile. Information cannot be selectivity disclosed and expected not to leak, especially information that will weigh on the market valuations of biotech and drug firms involved in new hepatitis C drug research.

EASL, to its credit, has now admitted the unfairness of its policy and took the necessary corrective steps.

In its statement Thursday, EASL said it "accepts that we must address this issue, and we acknowledge the efforts of several individuals to draw this to our attention."

--Written by Adam Feuerstein in Boston.

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