From Revolution to Reality: How Will New Science Impact the US National HIV/AIDS Strategy?

via wiredforchange.com

AIDS 2012 Conference Satellite - Free and open to the public

RSVP requested

Sunday, July 22, 2012, 11:15 AM -1:15 PM

Mini Room 4, Walter E. Washington Convention Center, Washington, DC

Hosted by the Coalition for a National HIV/AIDS Strategy

Moderator: Gregorio Millett, Senior Scientist, CDC/HHS Liaison to White House Office of National AIDS Policy DONE

Presenters include (list still in formation):

- Carlos del Rio, MD, Hubert Professor and Chair, Hubert Department of Global Health, Emory University: Treatment Cascade
- Keith R. Green, MSW, Director of Federal Affairs, AIDS Foundation of Chicago: PrEP and the NHAS 
- David R. Holtgrave, PhD, Chair, Department of Health Behavior and Society, Johns Hopkins Bloomberg School of Public Health: Costs, Consequences and Feasibility of Achieving the NHAS Goals
- Molly Morgan Jones, PhD, Senior Analyst, RAND Europe: Mapping Pathways: Exploring strategies in the use of ARV-based prevention

Please register here.

The U.S. National HIV/AIDS Strategy (NHAS) has been in place for two years, and since its release, scientific breakthroughs and new research have transformed our thinking about the US HIV epidemic.  HPTN 052 and successful PrEP and microbicide trials demonstrate that biomedical interventions hold promise that were unthinkable just 2 years ago. 

At the same time, Gardner and his coauthors shine a spotlight on the human factors impacting the epidemic-half of people with HIV are not in medical care, and just 1 in 4 achieves treatment success.  Key researchers, including some who contributed to these breakthrough findings, will weigh in on the implications of new research on the US strategy.

Click here to register.

This session will be immediately followed by the satellite session, "Achieving the Goals of the United States National HIV/AIDS Strategy: Next steps", organized by the U.S. Department of Health and Human Services. 

This symposium is conducted in collaboration with and funded by Bristol-Myers Squibb with no editorial review of content. 


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UNAIDS: TRIPS and the potential impact of free trade agreements

via UNAIDS.org

For long-time HIV activist and Coordinator of the Asia Pacific Network of People Living with HIV (APN+) Shiba Phurailatpam, the importance of sustained access to affordable AIDS medicines is more than a trade, legal or logistical issue: “It is literally a matter of life and death for people living with HIV,” Phurailatpam says. “More than 60% of people in need of HIV treatment in Asia-Pacific still don’t have it.

Across the world, millions of people need access to HIV treatment, today, to keep them alive.

Antiretroviral drugs have changed the way in which HIV is viewed—from a death sentence to a chronic illness. That achievement was propelled by a surge in donor funding and by the drastic reduction of the cost of first-line antiretroviral regimens from around US$ 10 000 to under US$ 100 per person per year over the past decade, due in part to the increased availability of low-cost generic medicines.

Over the past decade, more than 6.6 million people have received antiretroviral therapy in developing countries across the world.  At the UN General Assembly High Level Meeting on AIDS in New York in June 2011, governments from around the world made a bold pledge to get all people eligible—an additional nine million people living with HIV—on treatment by 2015.

But at this time of opportunity, the sustainable future of HIV treatment programmes remains of serious concern. Countries are facing mounting challenges to produce or procure affordable HIV treatment, including cutbacks in AIDS funding and a proliferation of increasingly restrictive intellectual property measures in free trade agreements.

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[Content that is linked from other sources is for informational purposes and should not construe a Mapping Pathways position. Please look for us on Facebook here www.facebook.com/MappingPathways and you can follow us on Twitter @mappingpathways as well.]

PEPFAR Program Outlines End of Year Progress to the Congress

via Science Speaks, by Meredith Mazzotta

PEPFAR releases 8th annual report to Congress: The U.S. President’s Emergency Plan for AIDS Relief (PEPFAR) program delivered its 8th annual report to Congress recently. The five-page document outlines the program’s progress as of the end of fiscal year 2011 in various areas including:  supporting 3.9 million people on antiretroviral treatment; testing 9.8 million pregnant women for HIV in the course of the year; providing prevention of mother-to-child transmission services to more than 660,000 HIV-infected pregnant women allowing 200,000 babies to be born HIV-free; and providing care and support for nearly 13 million people, including more than 4.1 million orphans and vulnerable children. The report also stressed the importance of “leading with science” as we respond to the pandemic, smart investments including spurring private-sector engagement, country ownership, and shared responsibility.

TB institute confirms 8 patients resistant to all known TB drugs:  According to this article in the Hindustan Times, eight of the 12 patients originally reported as having what was coined “totally” or “extremely” drug resistant TB (neither term is recognized by the World Health Organization) have received confirmatory sputum sample testing that show resistance to all first- and second-line TB drugs. Since the original diagnoses of the dozen patients, three have died and, according to a city TB officer, of the six patients that remain in Mumbai, five are undergoing treatment for extensively drug-resistant TB, and one is being treated at Hinduja hospital.

Nonprofit TB Vaccine Developers Sign MOU to Accelerate Progress: Aeras announced it will be joining with the Tuberculosis Vaccine Initiative (TBVI) to “enhance and strengthen collaborative efforts to advance the world’s most promising TB vaccine candidates.” The memorandum of understanding between the two organizations will work to address opportunities and challenges in TB vaccine development that were outlined in the strategic blueprint released by advocates in late March, and published in the journal Tuberculosis, just before World TB Day. According to the Aeras press release, the two organizations will advise each other on vaccines in development, work to streamline the process of candidate selection and review, as they work together to achieve the goals outlined in the blueprint.

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FDA Reports that Truvada May Be A Safe and Effective HIV Prevention Method

via Bloomberg, by Ryan Flinn and Shannon Pettypiece

Gilead Sciences Inc. (GILD)’s pill Truvada was safe and effective when used to protect uninfected people from getting HIV, U.S. regulators said in a report indicating the main concerns are when and how it should be used.

Truvada was “well tolerated” and its ability to reduce the risk of infection was backed by two studies, the Food and Drug Administration staff said in a report today. Gilead, based in Foster City, California, is seeking to sell the drug as the first pill to keep people from becoming infected.

The FDA asked its advisers to suggest who should get Truvada; what testing would be needed for administration; and what educational material should be used for patients and doctors. The advisers will meet May 10 to discuss the drug, the subject of debates over its appropriate use and cost.

Decisions to prescribe Truvada “should carefully weigh the individual risks for acquiring HIV, their understanding of the importance of adherence to medication, and their potential for development of renal toxicity,” the FDA staff said today in a report on the agency’s website. Education and counseling will be “critically important.”

Gilead fell less than 1 percent to 9:57 a.m. New York time. The FDA isn’t required to follow what the advisory panel suggests.

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The Affordable Care Act's Impact on People Living With HIV

via Associated Press, by David Crary

For many HIV-positive Americans, and those who advocate on their behalf, these are days of anxious waiting as the Supreme Court ponders President Barack Obama's health care overhaul.

This loose-knit community — made up of activists, health professionals and an estimated 1.2 million people living with HIV — has invested high hopes in the Affordable Care Act, anticipating that it could dramatically improve access to lifesaving care and treatment. The act is now in limbo as the high court deliberates on its constitutionality, notably its requirement that most Americans obtain health insurance. A ruling could come in June.

"The HIV treatment community sees the act as a critical step in our fight against the AIDS epidemic," said Scott Schoettes of Lambda Legal, a national gay-rights advocacy group. "People have been counting on it, making plans based on its implementation, so for it to be pulled out from under their feet at this point would be a tremendous loss."

Among its many provisions, the health care law has two major benefits for HIV-positive people: It expands Medicaid so that those with low incomes can get earlier access to treatment, and it eliminates limits on pre-existing conditions that have prevented many people with HIV from obtaining private insurance.

Under current policies, low-income HIV-positive people often do not qualify for Medicaid if they are not yet sick enough to be classified as disabled.

In the view of advocacy groups, this creates a cruel Catch 22 — at a stage when they are still active and productive, these people can't afford the antiretroviral treatments that could help them stay that way. Only when their condition worsens are they able to qualify for Medicaid and get treatment that might have prevented the deterioration.


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Statements from New US AIDS Policy Director, Dr. Grant Colfax, Causes Mixed Reactions

via The Colorado Dependent, by Todd A. Heywood

With a president who has declared the end of AIDS is in reach, Dr. Grant Colfax has a massive job in front of him. But his first interview with The American Independent has some activists challenging his take on controversial elements of the epidemic impacting an estimated 1.2 million Americans.

The former director of the San Francisco Department of Public Health HIV programs was appointed by President Barack Obama to run the Office of National AIDS Policy (ONAP), March 14.

In a brief phone interview with The American Independent, Colfax praised the National HIV/AIDS Strategy (NHAS) and said he was looking forward to implementing the plan. NHAS was released by the Obama administration in July of 2010 and is the first time in the 30 year history of the epidemic that the federal government has developed a comprehensive plan to address HIV in the United States.

HIV-specific criminalization

A key segment of the plan calls for addressing HIV-related stigma and discrimination, including addressing the bevy of HIV-specific criminal state laws that activists have identified as stigmatizing.

“Certainly, criminalization is one of the issues we’ll be looking at as we engage stakeholders in a broader conversation about how stigma and discrimination are contributing to HIV risk and core health outcomes,” Colfax said.

Asked what his personal take on criminalization and its impact on the HIV epidemic was, Colfax demurred.

“I think it’s really premature for me to speak specifically about that beyond what I just said,” Colfax said.

That response did not sit will with activists.

“Dr. Colfax’s boiler-plate reaction to the criminalization issue is disappointing,” said Catherine Hanssens, executive director of the Center for HIV Law and Policy, which houses the anti-HIV criminalization group Positive Justice Project. “Prosecuting and incarcerating people with HIV for years and decades for consensual and no-risk conduct is a profoundly serious form of discrimination that has been stigmatizing people with HIV for decades.”

Sean Strub, a board member for the Global Network of People with HIV– North America, was also disappointed.

“To have any discussion about stigma that doesn’t start with removing HIV-specific criminal statutes is hollow,” Strub said. “Those statutes, which create a viral underclass, are the most extreme manifestation of stigma.”

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[Content that is linked from other sources is for informational purposes and should not construe a Mapping Pathways position.]

The Impact 'The Affordable Care Act' Will Have on HIV Treatment and Care

via HuffPost Chicago, by Gregory Trotter

For the 1.2 million Americans living with HIV, the Affordable Care Act will be utterly life-changing. For some, it will be life-saving.

Just ask Will Wilson, 58, who was diagnosed with "full-blown AIDS" in 2002.
"It will basically mean freedom," said Wilson, a Chicago resident and an advocate for the Illinois Alliance for Sound AIDS Policy.

For the first time, Wilson will be able to purchase private insurance without fear of being rejected for his preexisting condition. The former graphic designer will be able to aggressively re-enter the job market without risking his continuous access to lifesaving HIV drugs that cost him $3,000 a month.

He'll have options he's never had.

This week, the Supreme Court has heard oral arguments on the constitutionality of the Affordable Care Act, specifically the legality of the individual mandate provision and the expansion of Medicaid. It is slated to rule in June on what is widely considered to be the most important Supreme Court case in decades. Many people living with HIV/AIDS and other preexisting conditions will be hoping and praying that the court rules in favor of health care reform.

In January, the AIDS Foundation of Chicago (AFC) signed on to a legal brief -- along with 130 other HIV/AIDS organizations throughout the country -- asserting that the Affordable Care Act is, in fact, constitutional. It's also necessary to stopping the AIDS epidemic in the United States.

"The list of supporters for our brief urging the court to uphold the ACA continues to grow because of the law's enormous potential to impact the domestic AIDS epidemic," said Scott Schoettes, HIV Project Director for Lambda Legal, the legal firm that submitted the brief.

About 24 percent of people living with HIV are uninsured, according to data from the U.S. Department of Health and Human Services. The majority of people living with HIV depend on Medicaid and Medicare for medical treatment.

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[Content that is linked from other sources is for informational purposes and should not construe a Mapping Pathways position.]

Activists Protest Against Obama's PEPFAR Budget Cuts

via Plus News

Almost a thousand Swazi and South African HIV activists marched to the United States consulate in Johannesburg on 22 March 2012 to demand that the US continue supporting the Global Fund to Fight AIDS, Tuberculosis (TB) and Malaria, and safeguard funding of its President's Emergency Plan for AIDS Relief (PEPFAR), which US President Barack Obama's latest proposed budget will cut by 12 percent.

The march organizers - a coalition of international and regional HIV organizations, including the global medical charity, Médecins Sans Frontières (MSF), the World AIDS Campaign, and the AIDS Rights Alliance Southern Africa - also called on the British and Australian governments to join their American counterparts in kick-starting a response to solve the Global Fund's financial crisis.

Without an emergency donor meeting, the Fund - already in need of at least US$ 2 billion - will only secure additional funding at its next scheduled replenishment in 2014.

"We're not asking for charity, we are asking for social justice," said Daygan Eagar, a researcher at the South African human rights organization, Section27. "The US spends more money in one day of war than we're asking for the Global Fund."

Representatives from MSF, Section27 and the South African AIDS lobby group, Treatment Action Campaign, were to meet with consular and PEPFAR representatives to discuss their concerns.
The demonstration was also endorsed by the two million-member Congress of South African Trade Unions (COSATU). It followed similar protest action at US representative offices in Swaziland, according to Siphiwe Hlophe, a founder of the NGO, Swaziland for Positive Living (SWAPOL).

"If we are here, if we are laughing, it is because we are on drugs," she told the crowd. "Before the Global Fund we didn't have food, we didn't have pyschosocial support, we didn't disclose our HIV status - that all started when the Global Fund came. Look at how many of us are here today - that is the Global Fund."

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[Content that is linked from other sources is for informational purposes and should not construe a Mapping Pathways position.]

Jim Yong Kim: Obama's Choice for President of the World Bank

via The Washington Post, by By Elizabeth Flock and Hayley Tsukayama

President Obama’s surprise choice to head the World Bank is a physician and a major figure in the global health world.

Jim Yong Kim has served as Dartmouth College’s president for the past three years, but has devoted much of his life to improving health outcomes in the developing world. Obama highlighted Kim’s health development background as major factors in his nomination.

Along with Paul Farmer and others, Kim co-founded Partners in Health, an international health and social justice organization. He served as Director of the World Health Organization’s HIV/AIDS department, where he scaled up treatment, prevention, and care programs in developing countries. He has also worked on international tuberculosis policy.

“Dr. Kim has been a strong supporter of global public health,” said Tarik Jasaveric, a spokesman for the World Health Organization. “At WHO, Dr. Kim was instrumental in creating and implementing the 3 by 5 Initiative, which saw millions of people in the developing world gain access to anti-retroviral Therapy for HIV for the first time.”

The initiative, launched in 2003, sought to treat 3 million new patients infected by the disease by 2005. It reached its goal in 2007, The Washington Post reported. In 2006, he was named as one of Time Magazine’s “100 Most Influential People” for his work on that campaign and his efforts combating drug-resistant tuberculosis in Peru.

Kim also co-founded the Global Health Delivery Project, a joint initiative designed to improve public health in disadvantaged populations by “systematizing the study of global health delivery” and “rapidly disseminating knowledge to practitioners.”

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Researchers at CROI 2012 Report an Increase of ARV Drug Resistance in the U.S.

via Aidsmeds.com, by Tim Horn

New surveillance data from the U.S. Centers for Disease Control and Prevention (CDC) suggest that about two in 10 individuals infected with HIV in recent years involved strains of the virus harboring mutations conferring at least partial resistance to one ore more available antiretroviral (ARV). The report was presented Wednesday, March 7, at the 19th Conference on Retroviruses and Opportunistic Infections in Seattle.

The U.S. Variant, Atypical, and Resistant HIV Surveillance (VARHS) system, in which HIV specimens from newly diagnosed individuals are tested for drug-resistance mutations, was established by the CDC to provide the clearest picture to date of the scope and type of resistance in the United States.

The analysis reported at CROI included a total of 10,338 resistance profiles from eight U.S. regions; this consisted of 2,339 profiles from individuals with recent infections (confirmed using a specialized antibody test or a negative HIV test results within six months before diagnosis) and 7,999 profiles from individuals with confirmed long-standing HIV infection (individuals diagnosed with AIDS within six months of testing positive for the virus). Regions represented in the analysis were Seattle, Los Angeles, Chicago, Colorado, Michigan, Louisiana, New York and South Carolina.

The system uses standard genotypic resistance testing, which identifies specific viral mutations associated with drug resistance. Because neither the recently infected individuals nor the subjects with established infection included in the analysis had yet started treatment, the presence of any HIV drug resistance mutations in their blood would indicate that the resistant virus was transmitted to them at the time of their infection.
Overall, 15.2 percent of all samples included in the analysis had evidence of at least one transmitted drug resistance mutation.

Among the recently infected individuals, 19.1 percent had evidence of at least partial resistance to at least one drug in a particular ARV class, compared with 14.7 percent of the individuals with long-standing HIV infection. This difference was found to be statistically significant, meaning it was too great to have occurred by chance.

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Mapping Pathways 2011: The year in voices

Original content from the Mapping Pathways blog team

“We are on the verge of a significant breakthrough in the AIDS response. The vision of a world with zero new HIV infections, zero discrimination, and zero AIDS-related deaths has captured the imagination of diverse partners, stakeholders and people living with and affected by HIV. New HIV infections continue to fall and more people than ever are starting treatment. With research giving us solid evidence that antiretroviral therapy can prevent new HIV infections, it is encouraging that 6.6 million people are now receiving treatment in low- and middle-income countries: nearly half those eligible.” - Michel Sidibe, UNAIDS Executive Director, World AIDS Day report


Earlier this month, WHO and UNAIDS released a World AIDS Day report providing a snapshot of goals and progress made in 2011 toward HIV/AIDS prevention. We thought we’d provide a snapshot of the Mapping Pathways project as well – but through the voices of some of the most memorable and inspiring people we spoke with this year.

APRIL:
“It’s been like Christmas every day since July at the International AIDS Conference in Vienna when the CAPRISA study results came out… We’ve gotten over this first hurdle; we’ve proven that we can create new ways to prevent HIV through the use of ARVs taken orally or applied topically but now we have to figure out how to get that pill, or gel, or whatever into the right hands in the right place at the right time. We’re grappling with all the problems that come with success.” - Jim Pickett: ‘Success! Now what?’
   
MAY:
“There is a threat – still distant but definitely visible – that we will lose this astonishing success through complacency… We can make AIDS rare – and eliminate it entirely from rich countries – using technologies that we already have. The question is whether we have the will to do it.”  - Mark Chataway: Using antiretrovirals to prevent new infections

“There’s still so much we don’t know, and these are open questions rather than being settled questions… we can’t prove that the intervention worked, and we can’t prove that the intervention didn’t work … There are still things to be learned.”  - Julie Davids: FEM-PrEP closure update – What does ‘futility’ mean exactly?

“I think whenever the field starts to go on emotion, we get into trouble… Human behavior keeps messing up the plot.”  - Dr. Linda-Gail Bekker: Of Mice, men, and microbicide trials   

JUNE:
 “I put the word MSM on the board, and do you know what one woman participant said? She said, ‘By MSM do you mean men who have sex with men? Yes, they must die; and if not, they must be killed!’ I was so taken aback. I thought, ‘Oh my God, this is where the advocacy has to start from.’” - Brian Kanyemba: A snapshot of advocacy in Africa

“The level of efficacy seen in the HPTN052 study is stunning, and is extremely important on several fronts. First, in terms of the potential of this strategy to reduce transmission, it is clearly an effective option… Of course, there are some issues associated with this strategy as well.”  - Dr. Joe Romano: Thoughts on the microbicide pipeline and the recent HPTN 052 results

“I believe that it is a political, economic and human tragedy that the first time our country has had a national HIV/AIDS strategy is exactly at the same time that we’re being told there are no resources to put it fully into place... We are, in significant ways, being restrained from putting our best minds and hearts at the forefront of this effort. When we get to the end of the day, there are good ideas, and then there are good ideas that are fully funded.”  - Julie Davids: The economic effect of HIV/AIDS in the US

JULY:
“Sex sells. People in the commercial world use sex to sell things like cars, toothpaste, pens…almost anything! Why not use sex to sell safer sex?”  - Anne Philpott: How sexy sex can help prevent HIV transmission

“Working with vulnerable populations like transgender individuals and men who have sex with men (MSM) was really an eye opener. These are people who often have nothing to their name (often not even a roof over their head), are disowned by society and their families and are completely discriminated and stigmatized against. Yet a number of them were keen to help spread awareness about HIV/AIDS, prevention options and vaccines so that others may benefit from the information and not get infected with HIV. This degree of humanity is truly remarkable.”  - Dr. Sonali Kochhar: PrEP in India

AUGUST:
“My sense is that many people are still very uncomfortable and not quite able to figure out why we’re talking about PrEP in the Indian context. Many senior people in the field feel the focus needs to be on TLC+.”  - Anjali Gopalan: Notes from India – concerns and challenges around PrEP

“The matchmaking started because people living with HIV don’t disclose their status to their parents. In India, when the boy is 30 or the girl is 24-25, the parents want them to get married. They start looking for partners and the person who is infected is unable to talk freely to them and say, ‘Look, I have HIV and I can’t get married.’ That’s when they come to me and ask, ‘My parents are planning to get me married to an HIV-negative person – now what do I do?’ So we say okay, we’ll look for someone for you."  - Dr. Suniti Solomon: A modern-day HIV love story

“Clearly if people abstained from sex, or had sex with partners they knew to be uninfected, or used condoms 100% of the time, we wouldn’t have the HIV epidemic. But obviously, spreading billboards all over the world has not cut it.” - Dr. Linda-Gail Bekker: Safe-sex education – too little, too much?

“Placebo controlled trials are essential for the evaluation of the safety and efficacy of new products.  The placebo control group in a clinical trial provides the means of establishing any specific safety issues with a product, as well as the effectiveness of the product at preventing HIV transmission… Once a microbicide product has been adequately shown to prevent HIV transmission, it will no longer be possible to run placebo controlled trials, and the “window” will be closed."  - Dr. Joe Romano: What happens when the ‘placebo window’ closes?

SEPTEMBER:
“It boggles me that I still have to make the case for understanding the relational and contextual nature of HIV transmission and the need to recognize that people and technologies are interactive and interdependent."  - Judith Auerbach: Addressing social drivers of HIV/AIDS

“Even among groups of experts, I have noticed people getting confused – misapplying data, conclusions, or assumptions...”  -  Lori Heise: Tricky Terminology in HIV Prevention – Microbicides and Oral PrEP

“Giving gay men more information about their health only empowers them to make informed decisions. The fear that gay men will take PrEP, forego condoms and become out of control disease spreaders, harkens to the days when men feared women would become crazed nymphomaniacs thanks to the new birth control pill.” -Alex Garner: Open letter Urges that PrEP debate should be based on ‘facts not misinformation’

OCTOBER:
“Firstly, we need to work out whether this result is true or not. But even if it is true, it’s quite possible that we need to balance the benefits of avoiding an unwanted pregnancy against the small increased risk of acquiring HIV infection.”  - Dr. Tim Farley: Hormonal contraceptives and HIV – the grey area

“It’s really critical we know what research is and is not being done, what evidence does and does not exist, so that we have a solid understanding of the implications of these technologies in various social, economic, cultural, and political contexts that exist in different countries. It’s only then that we can begin to think about investing in them and the best ways to implement them."  - Molly Morgan Jones: Mapping Pathways so far – the ‘literature review’

NOVEMBER:
“If you’re talking about early treatment, you’ll have one person saying, ‘This is a quantum leap from where we are now, and it’s operationally impossible.’ And then you’ll have another person saying, ‘Well, if you have cancer, the doctor doesn’t wait till you’re half dead to give you the treatment, and so we should have been doing this years ago.’ And both are very valid points; it’s just how do you get those two people, who are equally important in making this happen, make it happen?” - Daniella Mark: It’s a question of ‘how’ in South Africa Part 1 & Part 2

DECEMBER:
“PrEP … is hard as hell to figure out. Hard as hell. But that’s what we have to do – we have to be right there, at the hardest place possible, trying to get the answers.” - Jim Pickett: Triumphs and Trials in 2011


[Content that is linked from other sources is for informational purposes and should not construe a Mapping Pathways position.]

Five hundred twenty-five thousand six hundred minutes: How do you measure a year?

Original content from the Mapping Pathways blog team

Another year winds down, and it is time to take stock, to reflect on all the moments that have made 2011 an important year for the HIV prevention community – and for all those of us who hope for and work toward the end of the HIV/AIDS epidemic.

The year began on a high note: the extremely encouraging results from the IPrEx and CAPRISA trials, announced in 2010, had us “jumping up and down” as Jim Pickett (Director of Prevention Advocacy and Gay Men's Health at the AIDS Foundation of Chicago, chair of International Rectal Microbicide Advocates [IRMA], and a member of the Mapping Pathways team) says in his memorable interview, Success! Now What? These results were the long-awaited proof of concept for new prevention technologies – the “first real ‘win’” after many years of hard work.

The first bump in the road was the discontinuation of the FEM-PrEP trial in April due to futility, when the trial’s Independent Data Monitoring Committee concluded that the study would be highly unlikely to prove the effectiveness of Truvada in preventing HIV infection among the study population, i.e., HIV-negative women who are at risk of infection through sexual transmission.

The unexpected development had everyone expressing their opinions and wondering about the implications – after all, what does “futility” mean exactly? Dr. Linda-Gail Bekker (an expert in the field of biomedical trials and research) cautioned against knee-jerk reactions to the trial closure in her interview with Mapping Pathways: “Wait for the evidence, I think that is the message. Extrapolate at your peril. We know only what we know, and we need to just work within that.”

Then came the HPTN 052 results – and we were jumping with excitement again! The study demonstrated that initiation of ART by HIV-infected individuals substantially protected their HIV-uninfected sexual partners from acquiring HIV infection, with a 96 percent reduction in risk of HIV transmission. In an interview with Mapping Pathways, microbicides expert Joe Romano captured the overall sentiment, saying, “The level of efficacy seen in the HPTN052 study is stunning, and is extremely important on several fronts.”

There was good news for India (a Mapping Pathways target country) too: a UNAIDS report stated that the rate of new HIV infections fell by more than 50% in India between 2001 and 2009, double of the average decline in the world. The PrEP debate in India continued through the year. “There is a lot of concern in the country, especially with global funding not available right now,” explains Anjali Gopalan (Executive Director of NAZ India, a Mapping Pathways partner organization), in Notes from India: Concerns and Challenges Around PrEP. Mapping Pathways also published a short post on what we’ve been hearing in India so far.

Soon after the HPTN 052 results, the FACTS 001 trial was announced in South Africa – a follow-up study to confirm the effectiveness of tenofovir and to verify the CAPRISA 004 results in “larger, more diverse populations.”

Around this time, Mark Chataway (co-chairman of Baird’s CMC, a Mapping Pathways partner organization) was in South Africa (a Mapping Pathways target country). “My visit to the country once again brought into sharp focus for me just how significant South Africa and the rest of the southern African region are in the context of HIV treatment and prevention strategies,” writes Mark in his insightful post about South Africa and the HIV epidemic.

July brought bad news: the drought in the Horn of Africa began, bringing the region into international focus as an estimated 11.6 million people struggled for basic nutrition and sanitation in the humanitarian crisis – experts have warned that this situation could have a serious effect on the health of people undergoing HIV treatment.

Prevention trials continued to stay in the news. The Partners PrEP study and the TDF2 Botswana study both showed that taking antiretrovirals can reduce the risk of HIV infection through sexual intercourse by 62-73 percent among heterosexual individuals and heterosexual couples.

As heartening news continued to pour in, the UK’s House of Lords Select Committee on HIV & AIDS gave us another reason to celebrate as they called for greater emphasis and funding toward prevention. “Prevention must be the key policy,” remarked Lord Fowler, chairman of the committee.

In the US, dollars-and-cents issues remained a key factor. “The entire HIV prevention and treatment landscape overall is also in a state of flux in the US … When we get to the end of the day, there are good ideas, and then there are good ideas that are fully funded,” explains Julie Davids (Director of National Advocacy and Mobilization at AIDS Foundation of Chicago, a Mapping Pathways partner organization) in The Economic Effect: HIV/AIDS in the US.

October brought news that rekindled an old debate: the Lancet published the results of a study conducted in Africa, which seemed to suggest that hormonal methods of contraception could lead to increased risk of HIV infection. “Now whether this is a disaster or not, that needs to be considered very carefully in context. There are huge benefits, particularly in the African region, of avoiding an unwanted pregnancy, not only for the morbidity issues but also for mortality reasons … Firstly, we need to work out whether this result is true or not,” points out Dr. Tim Farley (an expert in HIV and sexual and reproductive health) in Hormonal Contraceptives and HIV Prevention: The Grey Area.

Recently, the VOICE trial hit a speed bump: the oral tenofovir arm and the tenofovir vaginal gel arm were dropped from the study. Both decisions were based on reviews of study data, which concluded that they would not be able to demonstrate effectiveness in preventing HIV among the women in the trial (although both products were found to be safe). The reasons for this are still unclear and will be fully investigated when the trial concludes in the middle of 20112. The study continues to examine the oral Truvada tablet to determine whether it’s effective in preventing HIV in the trial population.

A recent highlight was US Secretary of State Hillary Clinton’s speech on HIV/AIDS – one that earned her both bouquets and brickbats from the HIV prevention community. On the upside, Secretary Clinton focused on scientific evidence and called for immediate action to take advantage of the “historic opportunity” to create an “AIDS-free generation.” Unfortunately, she completely omitted any reference to PrEP and rectal microbicides. The speech also failed to mention gay and MSM populations, two groups that are experiencing catastrophic rates of HIV globally.

The year wound up with IRMA’s rectal microbicide African strategy meeting and the big ICASA conference in Addis Ababa, Ethiopia in December. (Click here and here to read about some of the important developments at these events.)

All in all, 2011 has been a dynamic year: lots of excellent news as well as some troubling developments. From the Mapping Pathways blog team, here’s to celebrating our achievements, learning from our failures, and working to address the challenges.

Happy New Year!

[Content that is linked from other sources is for informational purposes and should not construe a Mapping Pathways position.]

Secretary Hillary Clinton on Creating an AIDS-Free Generation: Bouquets and Brickbats

* Original content from our Mapping Pathways blog team

“An AIDS-free generation would be one of the greatest gifts we could give to the future.Let's make it happen.”

On November 9, US Secretary of State Hillary Clinton delivered a speech on HIV/AIDS at the National Institutes of Health in Bethesda, Maryland – a speech that has triggered mixed reactions from people in the HIV/AIDS treatment and prevention field. Take a look at some excerpts:

“Today we are making major investments in the search for a vaccine; for tools like microbicides, which give women the power to protect themselves; and other lifesaving innovations.”

“… our efforts have helped set the stage for the historic opportunity the world has today: to change the course of this pandemic and usher in an AIDS-free generation.”

“… creating an AIDS-free generation has never been a policy priority for the United States Government until today, because this goal would have been unimaginable just a few years ago … It requires all of us to put a variety of scientifically proven prevention tools to work in concert with each other.”

“America's combination-prevention strategy focuses on a set of interventions that have been proven most effective: ending mother-to-child transmission, expanding voluntary medical male circumcision, and scaling up treatment for people living with HIV/AIDS.”

“… we now know that if you treat a person living with HIV effectively, you reduce the risk of transmission to a partner by 96 percent.”

“Treating HIV-positive people before they become ill also has indirect economic benefits.It allows them to work, support their families, and contribute to their communities; and it averts social costs, such as caring for orphans whose parents die of AIDS-related illnesses … In other words, treating people will not only save lives – it will generate considerable economic returns too.”

“… we need to let science guide our efforts. Success depends on deploying our tools based on the best available evidence.”

“An AIDS-free generation would be one of the greatest gifts we could give to the future. Let's make it happen.”

A number of HIV/AIDS activists have applauded Clinton’s “bold” speech, pointing out her emphasis on the prioritization of the fight against the epidemic, her focus on scientific evidence, and her call for immediate action to take advantage of the “historic opportunity” to create an “AIDS-free generation.” Many hope that this kind of public statement will help boost activism to preserve domestic and international funding.

On the other hand, while Clinton mentioned vaginal microbicides for women, she failed to talk about pre-exposure prophylaxis (PrEP) and rectal microbicides. These two prevention strategies are meant to protect uninfected people from the HIV virus – they have been the subject of numerous recent trials, with substantial success being demonstrated in many of them. (Take a look at our blog post on some of these studies.) Some feel Clinton’s decision give these new prevention technologies a miss can be attributed to political, financial, and social reasons.

“The omissions were disappointing but not surprising,” says Jim Pickett, Director of Prevention Advocacy and Gay Men's Health at the AIDS Foundation of Chicago, chair of International Rectal Microbicide Advocates (IRMA), and a member of the Mapping Pathways team. “Her audience was international, which means predominately heterosexual, so I suppose it made strategic sense that she would steer clear of PrEP, which has been shown to be effective for gay/bisexual men but has produced conflicting results for heterosexuals. Nonetheless, with gay men and other men who have sex with men experiencing catastrophic rates of HIV the world over, it remains disturbing to me that this group was not even mentioned, whether in conjunction with PrEP or not.”

Another possible reason for the omission of PrEP is the fact that the global jury is still out on the feasibility of rolling out PrEP interventions while there are HIV-infected people who do not have access to treatment – a problem made all the more complex because of the crippling HIV/AIDS funding constraints over the last few years. However, Pickett firmly believes that the either/or stance taken by those nixing promising preventive technologies is dangerous and close-minded. “We’re continually working to get enough information and data to answer the big questions we’re grappling with – questions about efficacy, accessibility, funding, prioritization, and acceptability. These questions are extremely challenging, but it’s imperative that we work on solving them,” says Jim. “It’s not an option to stick our head in the sand. To turn the dream of an AIDS-free generation into a reality, it is absolutely clear that we must expand access to effective ARV drugs for all those who need them – whether they are HIV-positive or HIV-negative.”

To know more about Secretary Clinton’s speech and the responses to it, read the AIDS Foundation of Chicago’s story and Science Magazine’s article. You could also check out this letter to Secretary Clinton – a blog post written by an IRMA member.

You can read the entire speech here.

[Content that is linked from other sources is for informational purposes and should not construe a Mapping Pathways position.]

TLC+ Strategies in 4 US Cities: San Francisco, Los Angeles, Birmingham, and Washington D.C.

via Project Inform, by Mark R. Vogel

Despite significant advances in the treatment and prevention of HIV, the number of new HIV infections in the United States holds steady at about 50,000.1 Furthermore, 21% of individuals infected with HIV in the United States are not aware of their status, and an estimated 33% of those who know that they are HIV-positive are not engaged in care and treatment for their disease.2 Another 38% of newly diagnosed individuals test positive for HIV so late that they receive an AIDS diagnosis at the same time as, or within a year of testing positive.3 Clearly, novel prevention strategies, ways to engage individuals in care sooner after infection, and methods to maintain them in care and treatment needed.

One such strategy is the Test, Link to Care, Plus Treat (TLC-Plus) approach. TLC-Plus addresses several aspects of the healthcare system that can be improved to help those with HIV live longer and healthier lives while also reducing transmission of the virus to others. The National HIV/AIDS Strategy places testing, linkage to care, treatment and support services at the center of efforts to improve the health outcomes of HIV-positive individuals and to prevent new infections.4

This paper examines successful components of TLC-Plus programs in four jurisdictions and specific strategies used to achieve desired health outcomes, as described by public health officials in each. It is our hope that these strategies may be used to inform the development of TLC-Plus programs across the country. Consideration is also given to funding and to the role of electronic medical records, in Louisiana, in assisting patients who have fallen out of (or never entered into) care.

Read the rest.


[Content that is linked from other sources is for informational purposes and should not construe a Mapping Pathways position.] 

Fighting AIDS: At the Tipping Point

via The Huffington Post, by Ambassadors Eric Goosby, MD and Mark R. Dybul

Starting in 2005, a series of randomized clinical trials demonstrated that medical male circumcision significantly reduces a man's risk of acquiring HIV. A recent follow-on study suggests the reduction in risk may be as much as 68% and the protective effect is increasing over time. The U.S. President's Emergency Plan for AIDS Relief (PEPFAR) is sponsoring large programs in countries where rates of HIV prevalence are high and levels of circumcision are low to bring this inexpensive and life-saving intervention to millions of men.

In May, a National Institutes of Health (NIH) randomized control trial documented for the first time that treatment also works as an extraordinarily successful tool for prevention. Initiation of antiretroviral treatment (ART) by HIV-positive individuals substantially protected their HIV-negative sexual partners from acquiring HIV. Treatment lowers the viral load of HIV in a person with the virus, greatly reducing the risk of sexual transmission to a partner. ART produced an astonishing 96 percent reduction in risk of HIV transmission, on par with a vaccine.

Earlier this summer, two other studies confirmed an initial proof-of-concept trial demonstrating the effectiveness of antiretroviral medication for pre-exposure prophylaxis (PrEP) among couples. Individuals taking a daily tenofovir or tenofovir/emtricitabine combination experienced infection rates as much as 73% lower than those on a placebo, advancing potential options for prevention among couples where one partner is infected with HIV and the other is not.

Finally, last summer, the CAPRISA study of tenofovir gel microbicide -- funded by PEPFAR through USAID -- found that those using the gel with the active ingredient had an average of 39% fewer HIV infections and 51% fewer genital herpes infections compared to women who used a placebo gel. These results provided the first evidence that an antiretroviral drug in a microbicide preparation can reduce the risk of HIV in women.

Read the rest.

[Content that is linked from other sources is for informational purposes and should not construe a Mapping Pathways position.]

Safety Issues in PrEP: A Public Meeting

 You are invited to a public meeting with the Forum for Collaborative HIV Research in Washington D.C.:

Safety Issues in Pre-exposure Prophylaxis for HIV negative individuals, proposals for management of safety concerns, and pending plans for scale-up

Forum for Collaborative HIV Research

1608 Rhode Island Avenue, NW

Washington, DC 20036

August 19, 2011

8:30am - 4:00pm

The Forum for Collaborative HIV Research has been tasked by our collaborators in the public health community, including the US Food and Drug Administration, to convene an open public meeting to address safety issues that may surround the introduction of biomedical approaches to prevent HIV infection. Recent data from the iPrEx, Partners PrEP and CDC’s TDF2 studies support a conclusion that pre-exposure prophylaxis (PrEP) with antiretrovirals may be effective at preventing transmission of infection in otherwise healthy, vulnerable individuals upon exposure to HIV. This important finding may lead to scale-up, broad use of PrEP and, potentially, approval of a PrEP indication.

Recently, the drug development paradigm has also shifted with more focus on safeguarding individuals on medications. Premarket studies can miss important safety signals, either because the patient population is different and limited by enrollment criteria, too small to see low incidence events, or exposure is not long enough to identify latent effects. Compensatory behavioral issues may also be a concern upon scale-up. Appropriate communication strategies to reach the intended healthcare provider and the intended vulnerable populations must be identified and formulated. Mechanisms to anticipate and/or control the development of resistant HIV are also important. Finally, public focus as a result of our meeting may identify additional public health issues that should be addressed as well.

The Forum meeting will follow our usual format of panel discussions featuring stakeholders, including academics, trialists, clinicians, community advocates, public health professionals, and others. Each will be asked by a moderator to address a set of pre-prepared questions. Four panels are planned: (1) What are the safety issues of concern with pre-exposure prophylaxis?; (2) what are potential remedies to control safety risks and their pros and cons?; (3) what are the public health implications?; and (4) finally, a panel will summarize and identify next step.

Because of limited space, public participation in the meeting room will be limited to one participant per organization. An overflow room will be available for attendees on an as-needed basis. The meeting will be webcast to enhance national dissemination. Written supplementary questions can be directed to the panels. Webcast attendees can also submit written questions via instant messaging.

Registration: Register online at http://prep-reg.com/ to attend the public meeting or to view the live webcast.

Location: 1608 Rhode Island Avenue NW, Washington, DC 20036
Date and Time: August 19, 2011 8:30 AM-4:00 PM

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Forum Announcements

Studies show new progress in HIV testing in emergency departments

July 29

A CDC sponsored supplement released in the Annals of Emergency Medicine details new HIV testing efforts in Emergency Departments. "Emergency departments play a critical role in helping people learn their HIV status, connecting them to life-prolonging care, and helping them avoid transmitting the virus to others"said Jonathan Mermin, MD, Director of CDC's Division of HIV/AIDS Prevention. Click here to read more

Controlling the HIV Epidemic - The Promise of ARV-Based Prevention: Presentations now available

July 28

Presentations made at the Forum co-sponsored IAS Satellite Symposium "Controlling the HIV Epidemic - The Promise of ARV-Based Prevention" are now available. Click here to read more

Statistical Methods for Causal Inference in Observational and Randomized Studies: Course fees increase on August 1

7/26/11 This course concerns statistical methods for causal inference using observational and experimental longitudinal data. The course will focus on the application of methodological advances in statistical and causal research to improve the design and interpretation of safety analyses. These analyses will become increasingly important in the post-marketing safety environment for new drugs.

Dates: September 26-28, 2011.
Location: UC Washington Center, Washington, DC.

To register, please use the following link: www.hivforum.org/stats2011

[Content that is linked from other sources is for informational purposes and should not construe a Mapping Pathways position.]

Models: Tools to Improve Decision Making about HIV

Via AIDS.gov, by Ronald Valdiserri, M.D., M.P.H.

For those of us who work in the HIV/AIDS field, the month of July was dominated by exciting HIV prevention news coming out of the International AIDS Society meeting in Rome. Results from the HPTN 052 study showed that early, compared to delayed, antiretroviral treatment resulted in a 96% reduction in HIV transmission to uninfected partners. The TDF2 study conducted by CDC in partnership with the Botswana Ministry of Health, found that a once-daily pill containing two anti-HIV drugs reduced the risk of acquiring HIV infection by about 63% in a study population of healthy, heterosexual men and women. These and other study findings continue to add weight to the notion that HIV treatment is prevention. All of us are encouraged when we think about how these findings could be translated into real world settings in a way that would bring us closer to achieving the goals of the National HIV/AIDS Strategy.

Without minimizing the tremendous enthusiasm that rightly attends the prevention breakthroughs that were presented in Rome, I would like to talk about another scientific discussion that took place in July. As it turns out, this meeting was also held in a world capital, although to a much smaller audience. And while the results of this two-day meeting didn’t garner media attention the same way as the Rome meeting did, the topics under discussion were no less consequential.  In mid-July, I was very fortunate to attend a two-day workshop on “Modeling and Evidence-Based Decision Making” sponsored by amfAR, the Foundation for AIDS Research and cosponsored by the Kaiser Family Foundation, the National Alliance of State and Territorial AIDS Directors, and the Urban Coalition for HIV/AIDS Prevention Services. Meeting participants included colleagues from state and local departments of health, academia, federal government, and professional and community-based organizations.

Colleagues from Los Angeles, San Francisco, Maryland, and New York City shared with us their experiences with using various models to assist in making decisions about “optimizing” HIV prevention investments. Using different approaches, each of these health departments was trying to answer the same question, “What combination of prevention services and activities will result in the greatest reduction of the number of new HIV infections?”

At the onset of the meeting, we were reminded that modeling is used in other areas of health and public policy decision-making, especially when leaders are trying to combine diverse information from a variety of sources in order to make sound decisions at a population level.  However, even the biggest fans of modeling reminded us that a model is not a “crystal ball” nor is it infallible.  Instead, what models do is provide a tool to help us make better decisions about complex realities. Good models should always be clear about the inputs and assumptions that were used to generate the results. And perhaps most importantly, they should be used to guide rather than to conclude any discussions about how best to allocate resources.

Read the rest here.

[Content that is linked from other sources is for informational purposes and should not construe a Mapping Pathways position.]