New International Report on HIV Prevention Urges Localized Consideration of Antiretroviral Strategies

First Report on Antiretroviral Drugs for HIV Prevention to Bring Science Together with the Wisdom of Communities

June 19, 2013 – To make an impact on new HIV infections globally, antiretroviral (ARV)-based HIV prevention strategies need to be closely tailored to local contexts and cultures, according to a new report released today by RAND Europe and AIDS Foundation of Chicago.

“‘Mapping Pathways: Developing Evidence-Based, People-Centred Strategies for the Use of Antiretrovirals as Prevention’ [available by open access online on the RAND Europe website, and on the Mapping Pathways blog] provides an important resource to help communities, prevention programmers, funders and policymakers decide whether, and how, an ARV-based strategy could work in their locality,” said Jim Pickett, director of prevention advocacy at AIDS Foundation of Chicago and project director.

Last year, more than 2 million people globally became infected with HIV suggesting current prevention strategies are not doing enough to halt HIV transmission. Research suggests that some of the most promising prevention strategies are based on ARV drugs, such as pre-exposure prophylaxis (PrEP) and treatment.

“However, just because we know that ARVs can prevent HIV infection does not mean that we will, in practice, successfully implement their use in communities that need them,” said lead author Molly Morgan Jones, research leader at RAND Europe in Cambridge, UK.

Mapping Pathways is a community-led research project on the strategic use of ARV drugs for HIV prevention, involving RAND Europe, AIDS Foundation of Chicago and other partners in India, South Africa and the United States.

The group engaged more than 1,000 community respondents with an online survey and interviewed several dozen key stakeholders, including policy experts, program implementers, health care professionals and advocates. Participants rated the importance of various ARV-based prevention strategies, shared their perspectives regarding barriers to implementation and suggested the kinds of information they needed to make informed decisions about whether to implement any ARV-based strategy.


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Additionally, an extensive literature review was conducted during 2011 and 2012 to assess the published scientific evidence. Detailed snapshots from these activities are highlighted in the report and provide rich, localized context that reveal the opinions and concerns of a wide array of individuals and underscore important gaps in the evidence.

Community members and key stakeholders in each country consistently agreed they must address three key challenges in order to maximize the prevention potential of ARV drugs:

• First, structural issues such as community-level living conditions that affect access, such as proximity to appropriate health care and other social determinants of health, are as important as individual-level behaviors.

• Second, more information about implementation is needed by policymakers, funders and prevention programmers in order to determine what mix of ARV-based prevention strategies, if any, are appropriate.

• The third challenge is to adapt ARV-based prevention strategies for local contexts, as reflected in the book’s foreword written by Archbishop Desmond Tutu (“All science is local”).

The research found that within each country, and among varied types of people, the same sets of scientific data were interpreted and framed in different ways depending on the local context and perspectives. For instance, participants in South Africa and India tended to view the scientific data with more skepticism than individuals from the United States, so the successful adoption of ARV-based prevention strategies, such as PrEP, requires consideration of both the science and the local context.

 “It is important to marry the published evidence with the wisdom of communities to make decisions on prevention programming that make sense locally, for communities to map out their own, unique pathways,” Jones said.

Moving forward, there are many considerations for the use of ARVs as prevention in localities.

“Different countries and communities are at different places,” said Dr. Linda-Gail Bekker, deputy director of the Desmond Tutu HIV Foundation in South Africa and a Mapping Pathways partner. “We all have to ask policymakers, funders, and ourselves a host of questions. How will we implement a certain strategy? How will we pay for it? Is it for the generalized epidemic or is it only for certain key populations? What are the social factors that make certain populations vulnerable? Is this strategy ethical? Does it make sound public health sense? What won’t be afforded if we go this route? Who will benefit if we do?

“Meanwhile, we must continue to advocate and conduct implementation science so that we can show policymakers what is feasible and what the impact in the public sector could be.”


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Sustainable HIV prevention possibilities present choices, challenges

via Science Speaks, by Antigone Barton

When he looks at what biomedical science can do in the next decade to prevent HIV transmission, Jim Turpin of the National Institutes of Health said, he thinks of the lyrics of a Timbuk3 song: “The future’s so bright I gotta wear shades.”

By, which, actually, he means — don’t get blinded by the light; the search for answers will require focus.
“The challenge is not the lack of options,” he said, “but prioritizing the best options.”

Turpin, program officer and branch chief in the Prevention Sciences Program in the Division of AIDS at NIH”s  National Institute of Allergy and Infection Disease spoke this morning in webinar titled “The HIV Prevention Pipeline: A Future of Possibilities.” The webinar was sponsored by the International Rectal Microbicide Advocates (IRMA) and AVAC Global Advocacy for HIV Prevention.

After a series of disappointments in the quest for a vaccine or microbicide to prevent HIV transmission, the last two years offered hope, in strategies using antiretroviral medicine to prevent acquiring HIV, organizers point out. But, with a diversity of prevention needs and challenges among women and men worldwide still demanding answers, is that all there is?

Or, as Turpin put it, “Do we currently have what it takes to create a sustainable prevention pipeline?”

Read the rest.


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Policy Implications of The Lancet MSM & HIV Series

via Center for Strategic & International Studies

In light of the need to address key populations in the HIV epidemic, the Center for Strategic and International Studies is convening several authors to discuss a special issue of The Lancet focused on the global HIV epidemic among men who have sex with men (MSM).

Thursday, September 6th
3:00pm—5:00pm (EST)
B1 Conference Room
Center for Strategic and International Studies
1800 K Street NW, Washington, D.C.

CSIS will host a dialogue focusing on the domestic and global policy implications of the new research and modeling presented in this special issue. Articles examine the subject from a variety of perspectives, including epidemiology, biological and behavioral factors in HIV transmission, the success of various interventions, costing a comprehensive response, and HIV among black MSM in the United States and elsewhere. Authors will discuss why current programs are failing and HIV epidemics among MSM are still increasing. Sharon Stash, CSIS Global Health Policy Center Senior Advisor, will moderate the discussion with authors Chris Beyrer, Kenneth H. Mayer, Greg A. Millett, and Patrick S. Sullivan, and discussant Chris Collins. The session will open with concise presentations of the key findings and policy recommendations, with the majority of the time reserved for questions and discussion.

Please RSVP at: http://SmartGlobalHealth.org/Lancet

Thank you,

J. Stephen Morrison
Senior Vice President and Director, Global Health Policy Center
Center for Strategic and International Studies

Access the webcast here.


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U.S. Preventive Services Task Force May Soon Make HIV Testing Routine

via the Huffington Post, by Salimah Ebrahim

WASHINGTON, Aug 20 (Reuters) - A U.S. health panel may soon make HIV testing as standard a practice as checking cholesterol levels, a move that would fundamentally change how the virus is detected and treated.

The U.S. Preventive Services Task force, a government-backed group of clinicians and scientists, is expected to make a new recommendation on HIV screening available for public comment before the end of the year.

Health officials close to the panel, speaking on condition of anonymity, see it making a positive recommendation for routine screening, updating their current position, issued in 2005, which leaves the decision up to doctors.

Under President Barack Obama's healthcare law, passed in 2010, insurers are required to cover preventive services that are recommended by the task force.

"This would be one of those major sea changes ... moving away from what has been somewhat the segmentation of HIV - either by population, by geography," said Michael Kharfen, chief of community outreach for the Washington, D.C., Department of Health. Kharfen, who worked on the frontlines of the HIV epidemic in New York in the 1980s, recalls when the prognosis for the disease was "practically certain you were going to die.

"It still will take culture change for medical providers, but this will be a tremendous leap," he said

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Three-quarters of clinicians in the US willing to prescribe early HIV treatment for the purpose of prevention

via aidsmap.com, by Michael Carter

There is an overwhelming consensus among clinicians who prescribe HIV treatment in the US that people who are taking antiretroviral therapy are less likely to transmit HIV to their sexual partners, according to results of a study published in the online edition of the Journal of Acquired Immune Deficiency Syndromes. Results also showed that over three-quarters of care providers would be willing to prescribe early therapy to people with an HIV-negative partner for the purposes of prevention.

The study involved 165 prescribing clinicians working at HIV clinics in the Bronx, New York, and Washington DC. It was conducted in 2010 and 2011, well before the publication of the results of the HPTN 052 study in the summer of 2012, which showed that virologically suppressive HIV treatment reduced the risk of transmission by 96%. US HIV treatment guidelines were updated in 2012 to endorse early treatment to reduce the risk of transmission.

“This survey of HIV clinicians in two US cities found most clinicians believe that ART [antiretroviral therapy] can reduce HIV transmission, even before the results of HPTN 052 demonstrated ART to be effective for this purpose, and before 2012 treatment guideline changes recommending ART for patients at risk for HIV transmission,” write the authors.

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Cipla launches HIV/AIDS treatment kit at Rs 158

via IBN Live

New Delhi: Drug major Cipla on Tuesday said it has launched 'Qvir', a four-drug kit priced at Rs 158 per kit to be used for treating HIV/AIDS. The kit consists of two tablets packaged together in one strip which represents a single day's treatment, Cipla said in a statement.

Commenting on the introduction Cipla Chairman and Managing Director YK Hamied said: "While we are committed to making drugs affordable and accessible, we also endeavour to have more options for HIV infected patients, which are potent, effective, patient-friendly and easy to take".

As the tablets are packaged together in one strip, the patient does not have to remember which tablet he took, and cannot mistakenly take two of the same tablet, the company said.

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Task shifting of antiretroviral treatment from doctors to primary-care nurses in South Africa (STRETCH): a pragmatic, parallel, cluster-randomised trial

via The Lancet, by Lara Fairall et al.

Background

Robust evidence of the effectiveness of task shifting of antiretroviral therapy (ART) from doctors to other health workers is scarce. We aimed to assess the effects on mortality, viral suppression, and other health outcomes and quality indicators of the Streamlining Tasks and Roles to Expand Treatment and Care for HIV (STRETCH) programme, which provides educational outreach training of nurses to initiate and represcribe ART, and to decentralise care.

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Newly infected individuals sustaining HIV epidemic in Geneva

via aidsmap, by Michael Carter

Individuals with recent HIV infection are sustaining the epidemic, a Swiss study published in the online edition of AIDS suggest. The investigators believe that their results further support the use of antiretroviral therapy as prevention, but also show that its impact on the epidemic will be blunted because of the high number of transmissions which can be attributed to individuals who have been recently infected with HIV and who are not yet taking treatment.

Phylogenetic analysis showed that only a handful of infections in individual diagnosed between 2008 and 2010 could be attributed to patients diagnosed before 2000. Patients with longer-term HIV infection were the group most likely to be taking antiretroviral therapy and to have an undetectable viral load.

“Recent HIV infections were a significant source of HIV spread,” comment the authors. “By contrast, HIV individuals diagnosed before 2000 were rarely the source of new infections before 2008.”

It is now widely accepted that patients who are taking HIV therapy that suppresses their viral load to undetectable levels are highly unlikely to transmit the virus to their sex partners.

Read the rest.


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CDC Issues Interim Guidance for Clinicians Considering the Use of Preexposure Prophylaxis for the Prevention of HIV Infection in Heterosexually Active Adults

via Morbidity and Mortality Weekly Report

In the United States, an estimated 48,100 new human immunodeficiency virus (HIV) infections occurred in 2009 (1). Of these, 27% were in heterosexual men and women who did not inject drugs, and 64% were in men who have sex with men (MSM), including 3% in MSM who inject drugs. In January 2011, following publication of evidence of safety and efficacy of daily oral tenofovir disoproxil fumarate 300 mg (TDF)/emtricitabine 200 mg (FTC) (Truvada, Gilead Sciences) as antiretroviral preexposure prophylaxis (PrEP) to reduce the risk for HIV acquisition among MSM in the iPrEx trial, CDC issued interim guidance to make available information and important initial cautions on the use of PrEP in this population.

Those recommendations remain valid for MSM, including MSM who also have sex with women (2). Since January 2011, data from studies of PrEP among heterosexual men and women have become available, and on July 16, 2012, the Food and Drug Administration (FDA) approved a label indication for reduction of risk for sexual acquisition of HIV infection among adults, including both heterosexuals and MSM.* This interim guidance includes consideration of the new information and addresses pregnancy and safety issues for heterosexually active adults at very high risk for sexual HIV acquisition that were not discussed in the previous interim guidance for the use of PrEP in MSM.

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The battle against HIV and AIDS, selling sex in India, and what next for Ghana

via the Guardian, by Liz Ford

Funding for HIV and Aids treatment and prevention, and the barriers to receiving it, were the focus of two conferences last week.

World leaders and celebrities gathered at the International Aids Conference in Washington DC to discuss the issues. Among the attendees was the president of the World Bank, Jim Yong Kim, who told Global development that the long-term sustainable response to the Aids crisis needed to include discussions on how to spur growth in the private sector. He also talked about his mission to end poverty.

On another continent, sex workers from more than 40 countries held an alternative HIV summit to urge the case for their rights and protest at US visa restrictions barring them from attending the Washington conference. The week-long summit in Kolkata, India, highlighted the ways in which the fight against HIV has forced governments to talk to marginalised groups.

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Changing the way HIV prevention is delivered – a roadmap

via aidsmap, by Roger Pebody

In the last few years there has been a wealth of dramatic data on the efficacy of new HIV prevention methods, including male circumcision, pre-exposure prophylaxis and treatment as prevention. While last week’s 19th International AIDS Conference (AIDS 2012) didn’t deliver similar headline-grabbing studies, there were important discussions about how policy makers can implement effective HIV prevention strategies.

“We need to start thinking about the populations who are most at risk for targeted interventions,” Nelly Mugo of the University of Nairobi told a plenary session. “Then we will need to prioritize those interventions that work within those populations, and deliver them in combination with high coverage for us to get high impact.”

Speakers at other sessions gave numerous examples of the choices and dilemmas involved at each stage, drawing upon experience in the United States and in African countries.

Read the rest.


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Helen Epstein's wrong about SA's response to AIDS

via politicsweb, by Nathan Geffen

Helen Epstein is an influential journalist and regular contributor to one of the world's most prestigious literary journals, the New York Review of Books (NYRB). It is therefore unsettling that she has written an article on the NYRB blog that contains serious errors about the South African HIV epidemic and the important prevention benefits of antiretroviral treatment (ART) (see here).

In her first sentence Epstein writes, "When I first visited South Africa in 2000 to report on the AIDS epidemic there, one adult in five was HIV positive, and a million children had lost one or both parents to the disease." These numbers are simply wrong. UNAIDS estimates that by 2001 there were 580,000 children who had lost one or both parents to AIDS. This is a horrific figure, but substantially less than Epstein's. 2 The Actuarial Society of South Africa estimates the number of children who had lost a mother or both parents to AIDS by mid-2000 and they reach a considerably lower estimate of about 120,000. 3 Epstein also overstates the percentage of adults infected with HIV in 2000.

Epstein writes, "Although the HIV infection rate has finally begun to fall in neighboring countries like Botswana and Zimbabwe, it remains stubbornly high in South Africa. After studying the African epidemic for two decades, I've come to believe that shame and silence are the primary reasons ..."

She is wrong that South Africa's infection rate is not falling. Also wrong is her implication that shame and silence make the South African epidemic signally different from those in Botswana and Zimbabwe.

Read the rest.


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The Value Of HIV Treatment In Couples

via NPR, by Richard Knox

Dr. Rochelle Walensky thinks the 19th International AIDS Conference will be remembered as the moment when the world began to mobilize to end the pandemic.

The Harvard researcher probably speaks for many of the 23,000 scientists, activists and policy mavens who came to the Washington conference. But they're going home with a big question on their minds: Can the world afford it?

Walensky and her colleagues provided the beginning of an answer with a presentation on the final day of the conference. They looked at the cost implications of expanding anti-retroviral treatment to all HIV-positive people in couples where one partner is not infected.

"Is it worth paying for? The answer is yes, it's very cost-effective," Walensky told Shots. At least that's the case in South Africa and India, which the researchers chose for their analysis, and for the limited situation of these so-called discordant couples.

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A World Without AIDS, Still Worlds Away

via the New York Times, by Lawrence K. Altman

WASHINGTON — Is the world on the verge of ending the AIDS epidemic and creating an AIDS-free generation, even though a cure and a vaccine are still distant hopes?

Yes, roared enthusiasts among the nearly 24,000 participants at the 19th International AIDS Conference here last week. Their hopes are based on the extraordinary scientific gains made since the conference was last held in the United States, 22 years ago, when an AIDS diagnosis was a sure death sentence.

Among those gains: antiretroviral drug combinations for women to prevent infection of their newborns; drugs to treat and prevent infection with H.I.V., the virus that causes AIDS, among adults; and evidence that voluntary male circumcision can reduce the risk of female-to-male transmission by 50 to 60 percent.

Today, H.I.V. has become a chronic disease that, if treated appropriately, can be held at bay in a newly infected young adult for decades — if the patient adheres to the rigid daily drug regimen.

Michel Sidibé, the executive director of the United Nations AIDS agency, said that the opportunity to end AIDS will “evaporate” if governments do not show greater political will and increase investments to make gains available to millions more people.

“All that can stop us now is indecision and lack of courage,” he said.

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PrEP debate is reminiscent of the past

via Global Post, by Emily Judem

WASHINGTON, DC—During the 1996 International AIDS Conference in Vancouver, Dr. David Ho announced that HIV could be suppressed to undetectable levels if patients took a “cocktail” of anti-retroviral drugs.

Time Magazine named him “man of the year,” and according to Rolling Stone, he became the most famous AIDS scientist in the world.

But in the years that followed, ARV distribution was also met with criticism, said Mitchell Warren, director of AVAC, a non-profit that advocates for HIV prevention programs.

“People said we can’t do treatment,” Warren said. “Too expensive. Not feasible. No one’s going to take their pill. What about drug resistance?”

For those who have attended sessions about pre-exposure prophylaxis (PrEP) this week at the 2012 International AIDS conference, this might sound familiar.

When the FDA approved Truvada as a preventative drug against HIV on July 16 this year, leaders of the AIDS fight and news outlets alike began posing questions. How will it be decided who takes the drug? How will the drug be distributed? How will we lower the price tag? Should we be concerned that those taking Truvada will stop using condoms and protecting themselves in other ways?

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HIV/AIDS: WHO issues guidelines on PrEP

via PlusNews

NAIROBI/KAMPALA, 20 July 2012 (PlusNews) - Days after US officials gave unprecedented approval for the use of an antiretroviral drug by HIV-negative people to reduce the risk of their acquiring the HI virus, the World Health Organization (WHO) has issued guidance to governments on so-called pre-exposure prophylaxis (PrEP).

WHO's guidelines, which call for a cautious and gradual roll-out, will likely see many countries begin to add PrEP to the growing arsenal of tools in the fight against HIV.

The guidance is based on evidence from clinical trials on the daily use of ARVs for HIV prevention among high-risk HIV-negative people. A 2010 study - Iniciativa Profilaxis Preexposicion, or Prexposure Prophylaxis Initiative (iPrEX) - among men who have sex with men (MSM) and transgender people, found that a daily dose of the ARV, Truvada - a combination of emtricitabine and tenofovir disoproxil fumarate - reduced HIV infection risk by about 42 percent.

The 2011 Partners PrEP study in Kenya and Uganda concluded that a daily dose of Truvada, taken by the HIV-negative partner in a heterosexual HIV-discordant relationship - where one sexual partner is infected and the other is not - could reduce the risk of HIV transmission by up to 75 percent.

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Save Lives: End the HIV Stigma

via CNN, by  Ronald Johnson

Ronald Johnson is vice president of policy and advocacy for AIDS United, a national nonprofit organization dedicated to ending the HIV/AIDS epidemic in our lifetimes. AIDS United is a Mapping Pathways partner.

As a gay black man who came of age just before the 1969 Stonewall riots, I've seen far too many examples of the inequalities that exist in America.


But I'm also highly encouraged by recent developments: same-sex marriage support from President Barack Obama and the NAACP, and a wave of federal court rulings -- from the Defense of Marriage Act being deemed unconstitutional to the rejection of California's Proposition 8 -- that have opened a promising new chapter in the gay rights movement.

All of this suggests that after many, many years, we are finally piercing the stigma surrounding being gay in America.

Now let's talk about erasing the stigma of HIV/AIDS.

Right now, 1.2 million Americans are living with HIV/AIDS. I am one of them.

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PrEP Talk 101

via AIDSMEDS, by Trenton Straube

A pill prevents getting HIV? Here's what you need to know about Truvada, the HIV med the FDA just approved as pre-exposure prophylaxis (PrEP).

The HIV prevention toolbox just got a headline-grabbing addition. On July 16, the FDA approved Truvada as a pill that certain HIV-negative people can take to prevent them from getting HIV through sex. When taken as pre-exposure prophylaxis, or PrEP, Truvada, which is manufactured by Gilead Sciences, is supposed to be used daily along with safer-sex practices such as condoms and regular HIV testing. How does Truvada as PrEP work? Who is a good candidate for it, and what are the risks?

For answers, AIDSmeds spoke with three specialists: Jared Baeten, MD, PhD, an associate professor of global health and medicine at the University of Washington at Seattle and co-leader of the Partners PrEP study; Gal Mayer, MD, the medical director of the Callen-Lorde Community Health Center in New York City, whose primary focus is gay men; and Albert Liu, MD, MPH, the director of prevention interventions at the San Francisco Department of Public Health and also the medical director of the iPrEX study (more details on these studies later). Together, we break down the basic science and real-world application of Truvada as PrEP.

Read the rest.



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NIH to test maraviroc-based drug regimens for HIV prevention

via National Institute of Health

Scientists are launching the first clinical trial to test whether drug regimens containing maraviroc, a medication currently approved to treat HIV infection, are also safe and tolerable when taken once daily by HIV-uninfected individuals at increased risk for acquiring HIV infection.

The eventual goal is to see if the drug regimens can reduce the risk of infection.

The trial involves a strategy known as pre-exposure prophylaxis, or PrEP, in which HIV-uninfected individuals who are at risk for contracting the virus take one or two HIV drugs routinely in an effort to prevent infection. Called Novel Exploration of Therapeutics for PrEP, or NEXT-PrEP, the two-year study is sponsored and funded by the National Institute of Allergy and Infectious Diseases (NIAID), part of the National Institutes of Health.

"The NEXT-PrEP study will examine whether maraviroc-based PrEP is safe and well-tolerated. It is a necessary first step before we can test the effectiveness of maraviroc-based PrEP, and in the future, potentially expand the selection of drugs that may be used in this emerging HIV prevention strategy," said NIAID Director Anthony S. Fauci, M.D.

Led by principal investigator Roy M. Gulick, M.D., M.P.H., chief of the Division of Infectious Diseases and professor of medicine at Weill Cornell Medical College of Cornell University, the study team will enroll 400 HIV-uninfected men who have sex with men (MSM) ages 18 and older in 12 cities in the United States and Puerto Rico.

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Donor nation support for HIV stands firm but investments remain at 2008 levels

via Kaiser Family Foundation

               

U.S. continues to account for more than half of all donor government investments.

WASHINGTON, D.C., July 18, 2012— Donor nation funding in 2011 for HIV in low- and middle income countries returned to prior levels after a drop in 2010, but has been roughly flat since the recession hit world economies in 2008, according to an annual funding analysis from the Kaiser Family Foundation and the Joint United Nations Programme on HIV/AIDS (UNAIDS).

The study found that donor governments disbursed US$ 7.6 billion in 2011 for the AIDS response in low- and middle-income countries. Overall donor government support for AIDS has been flat since 2008, which marked the end of rapid increases in donor disbursements of more than six-fold over the 2002 to 2008 period.

"International investments still account for two thirds of funding for HIV in Africa, the continent most affected by the epidemic," said Paul De Lay, Deputy Executive Director, Programme at UNAIDS. "Although more and more countries are increasing domestic investments for HIV, investments from donor governments remain an essential resource."

"The benefits of early detection and treatment have never been more clear, but countries have never been more challenged to provide needed resources. This is a critical time to keep the focus on the HIV epidemic," said Drew Altman, Kaiser Family Foundation President and CEO.

The two largest donor governments – the United States and United Kingdom – reported funding increases. The United States, the largest donor nation, reported a US$785 million increase in disbursements over 2010, but only returned to 2009 levels after reporting a delay in disbursements as the reason for last year's decline. Australia, Canada, Denmark, France, Germany, Norway and Sweden maintained or slightly increased their support, while Ireland, Italy, Japan and the Netherlands decreased funding.

Read the rest here.


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