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.

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'Treatment As Prevention' Rises As Cry In HIV Fight

via NPR, by Richard Knox

AIDS researchers, policymakers and advocates are increasingly convinced that treating HIV is one of the best ways of preventing its spread.

The rallying cry is "treatment as prevention," and it's the overarching theme of this month's International AIDS Conference in Washington, D.C.

The idea is that identifying people infected with HIV and getting them in effective treatment as soon as possible not only prevents them from getting sick but almost eliminates the risk they'll pass the virus on to others.

Last summer a big study showed that people with HIV are 96 percent less likely to pass the virus on if they faithfully take antiviral medicine. Momentum behind treatment-as-prevention has grown since then.

This is a big change. For a long time in the world of HIV and AIDS, the conventional wisdom has been to delay treatment until people show signs of damage to their immune system. Partly this is because the drugs have side effects (although some are now easier to take), and partly because few people thought medical treatment itself could slow the spread of HIV.

"After many years of frustration, it is a transformational moment in the course of this epidemic," says Kevin Cranston, head of infectious disease control at the Massachusetts Department of Public Health. "Universal treatment can in fact result in an epidemic that looks to be petering out."

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PrEP: time to rethink prevention, effectiveness and ethics?

via Somatosphere, Marsha Rosengarten

One of the more controversial interventions proposed for HIV prevention in those who test HIV antibody negative and perceived to be at risk is pre-exposure prophylaxis (PrEP) – a daily pill comprising one or two antiretroviral drugs manufactured by Gilead Inc.  Besides the mixed results from multi-site randomised controlled trials (RCTs) seeking to establish the efficacy of PrEP (see iPrEX versus Fem-PrEP), concerns have been raised about PrEP’s potential to undermine condom use, its cost implications in locales where treatment provision is still lacking and elsewhere, its potential to cause unwanted drug side-effects as well as possible drug resistance in those it fails to protect.

Nevertheless, continuing new infections and evidence that high adherence produces a strong protective effect are mobilising many public health authorities to devise feasible implementation models.

Most remarkable about the growing interest in PrEP is the exclusion of the social sciences from major forums where this work is taking place.  One such example is a two-day forum held in the UK by IAPAC on the dual topics of treatment as prevention (TasP) and PrEP.  The only non-biomedical speakers listed on the programme were a psychologist (speaking on adherence), a bioethicist, activists and public health officials linked to various national epidemics.

Indeed it won’t come as a surprise to many to know that despite the millions of dollars to support RCTs for PrEP, the Bill and Melinda Gates Foundation have so far declined to support a substantial programme of social research on PrEP.  In fact if we consider the bioethical requirements imposed on the conduct of RCTs for PrEP and other biomedical interventions, there is no ethical requirement for research on the social dimensions of the intervention during or post RCTs. This applies even when RCTs demonstrate candidate efficacy.

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WHO Updates Treatment-As-Prevention Plan for HIV and TB

via iasociety.org, by Mark Mascolini

“It is certain that TasP [Treatment as Prevention] needs to be considered as a key element of combination HIV prevention and as a major part of the solution to ending the HIV epidemic.”

With that statement, the World Health Organization (WHO) issued its June 2012 Programmatic Update on Antiretroviral Treatment as Prevention (TasP) of HIV and TB, available at the link below.

As countries continue to expand antiretroviral therapy (ART) programs for HIV-positive children and adults, WHO says, “it is expected that they will concurrently identify opportunities to maximize the use of ART for prevention purposes.”

TasP should focus on specific populations—such as HIV-discordant couples and pregnant women—in whom prevention should have the greatest impact. UNAIDS issued updates and guidance for these populations “and is working with countries to address programmatic and operational challenges to inform the consolidated guidelines to be released in mid-2013.”

The Programmatic Update includes guiding principles, the evidence base for TasP, a review of the current status of national HIV treatment guidelines and implementation experience with TasP, programmatic and operational considerations, and WHO’s three priority areas:

• Develop norms and standards for treatment as prevention
• Inform programmatic and operational decisions
• Define metrics for monitoring and evaluating the impact of TasP

WHO’s Gottfried Hirnschall told attendees at a London meeting that the new TasP recommendations will almost double the number of people judged to need antiretroviral therapy, aidsmap.com reports.

Read the rest.

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IAPAC Summit - If people who need HIV drugs aren’t getting them now, why should the prevention benefit of treatment be the reason that the drugs become available?

via Aidsmap, by Roger Pebody

The issue of ‘treatment as prevention’ raises a number of ethical issues, Richard Ashcroft, professor of bioethics at Queen Mary University of London told the IAPAC Controlling the HIV Pandemic with Antiretrovirals Evidence Summit in London this week.

He reminded the audience that it is rare for a doctor to give a patient a medicine that will primarily benefit a third party. He went on to highlight situations in which, at present, antiretroviral treatment is not universally available to all people who need it for their own health. In such circumstances, why should treatment’s prevention benefit be “the clincher” that convinces funders and policy makers to make the drugs more widely available?

At the same meeting, Kevin Fisher of AVAC noted that the ethical concerns tended to differ in different parts of the world. In settings where there is already good access to HIV treatment, the concerns are often related to individuals experiencing external pressure or compulsion to take treatment. In resource-limited settings, the concerns focused more on the cost of and access to treatment.

Read the rest.

And check out the Mapping Pathways slides that were presented at the same meeting, on the issue of PrEP.

[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.]

HIV Treatment as Prevention Biologically Plausible Using Ritonavir-Boosted Darunavir (Prezista) and Etravirine (Intelence)

via aidsmap.com, by Michael Carter

A pharmacokinetic study suggests that ritonavir-boosted darunavir (Prezista) and etravirine (Intelence) achieve high concentrations in semen and rectal tissue, and could therefore help avert HIV transmission and infection, especially in gay men. Concentrations of these antiretrovirals were monitored over an eight-day period in HIV-negative volunteers. The study is published in the online edition of the Journal of Acquired Immune Deficiency Syndromes.

The US investigators believe their findings “provide pharmacologic plausibility for the use of darunavir plus ritonavir and etravirine in secondary HIV prevention, in both infected and uninfected individuals”.

Antiretroviral therapy has a central role in combination HIV prevention efforts. Treatment that suppresses viral load has been shown to reduce the risk of transmission in heterosexual couples by 96%. Anti-HIV drugs can also reduce the risk of infection with HIV when used a pre-exposure prophylaxis (PrEP) or post-exposure prophylaxis (PEP). Incidence of HIV remains high in gay men and they are therefore a priority for the use of HIV treatment as prevention.

It is currently unknown if specific combinations of antiretroviral drugs are more effective at preventing infection with HIV or onward transmission of the virus. “Defining the antiretroviral exposures in biological compartments that are vulnerable to acquisition and are sources of infection, such as rectal tissue and semen, could assist in selecting regimens for HIV prevention,” explain the authors.

They therefore designed a pharmacokinetic study lasting eight days involving twelve healthy HIV-negative men. Concentrations of darunavir/ritonavir and etravirine in blood, semen and rectal tissue were monitored intensively on day one and again on days seven/eight.

The participants had a median age of 27 years and were racially diverse. All tolerated the medications well.

After the first dose, all three drugs were detected in blood, semen and rectal tissue.

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The Lancet:PrEP for HIV prevention reaches key milestone

via the Lancet.com, by Salim S Abdool Karim and Quarraisha Abdool Karim

On May 10, 2012, a US Food and Drug Administration (FDA) advisory committee voted in support of the use of tenofovir-emtricitabine for HIV prevention.1 If the FDA, which is scheduled to make its decision by June 15, adopts the committee's recommendations, tenofovir-emtricitabine will become the first antiretroviral drug to be approved as pre-exposure prophylaxis (PrEP) for the prevention of HIV, paving the way for implementation.

PrEP has a unique advantage in young women in southern Africa, who bear a disproportionate burden of the HIV epidemic. In much of this region, young women are often unable to convince their male partners to use condoms, remain faithful, or have an HIV test. To rely on her HIV- positive discordant male partner to come forward to test, to agree to take antiretroviral therapy (ART), and to take his ART with high adherence, all for her protection, puts a woman's risk of acquiring HIV back in the hands of men, thereby disempowering women and undermining their efforts to control their risk of HIV.

However, there are several criticisms and concerns about PrEP. First, that data on the effectiveness of PrEP, especially in women, are inconsistent. This concern is based on the results of two PrEP studies—the FEM-PrEP2 and VOICE3, 4 trials—which were stopped, at least partly, earlier than planned when they did not show efficacy. To some extent, this concern has been allayed by recent data from the FEM-PrEP trial5 which show that adherence to daily tenofovir-emtricitabine in the trial was too low allow assessment of efficacy. Data to explain the VOICE trial, which still has an ongoing tenofovir-emtricitabine group, are not expected until 2013.

Second, some suggest that antiretroviral drugs should be provided to HIV-negative people only when all eligible HIV-positive patients are receiving ART. Although it is a legitimate concern that eligible HIV-positive patients should be prioritised for ART for their own health and to save their lives, it is spurious to trade off treatment and prevention as if these drugs are being taken away from sick and dying patients to be given to healthy people. Treatment and prevention strategies are a continuum in their use of antiretroviral drugs—both are needed in conjunction with each other to ensure ART provision is sustainable in the long term and to realise the quest to end the HIV epidemic.

Read the Rest.


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

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 'Treatment as Prevention' has on HIV Incidence in Africa

via AidsMap.com, by gus Cairns

A longitudinal study from KwaZulu Natal province in South Africa is the first study from the global south to relate an increase in the proportion of adults on HIV treatment to a fall in HIV incidence, the 19th Conference on Retroviruses and Opportunistic Infections was told last week.

The study found evidence of a threshold effect; incidence started to fall once the proportion of all adults diagnosed with HIV in the area who were on treatment exceeded 30%.

Meanwhile, a study that took place in a week-long intensive health campaign in Uganda, as well as studies from areas as diverse as San Francisco and Swaziland, documented large increases in the proportion of people with HIV who are on treatment.

Falls in incidence in KwaZulu Natal

National surveys in South Africa have found evidence of significant falls in HIV incidence in recent years, but have related this to behavioural change rather than treatment. In the study presented at CROI, of a rural area of northern KwaZulu Natal centred on the mining town of Somkhele (Tanser), the researchers found a relationship between HIV treatment and a fall in infections.

They made use of a population-based HIV surveillance survey that has sampled 10,000 adults a year from 2004 onwards, by identifying 16,558 people who had taken at least two HIV tests during this period in order to gauge incidence rates. They then compared these data to individually linked data from the district-based HIV treatment and care programme.

Adult HIV prevalence in the area is high – 24%. The rate of new infections peaks at 8% a year in women in their early 20s and 5% a year in men in their late 20s. HIV testing rates are also high; researchers estimate that only 30% of the HIV-positive population is undiagnosed, a low proportion for Africa, and 75% of HIV-negative adults who have tested for HIV have done so more than once.

Since 2004, there has been a huge scale-up of HIV treatment, with 20,000 patients starting antiretroviral therapy since then, and by 2001 more than 40% of all adults diagnosed with HIV were on antiretroviral therapy (ART), and over 60% with a baseline CD4 count below 350 cells/mm3. HIV treatment at this CD4 threshold was only introduced in August 2011; previous to this it was 200 cells/mm3.

HIV incidence between 2004 and 2011 averaged 2.64% a year but was lower after 2009, when for the first time more than 30% of the diagnosed population was on ART. It was 3.0 to 3.5% 2007-09 but fell to 2.5% in 2010 and 2.0% in 2011.

After adjusting for HIV prevalence in the immediate area and demographic and behavioural variations, the researchers found that for every 10% increase in the proportion of adults on ART, the HIV incidence rate fell by 17%. Incidence was 40% lower when over 30% of the adult population was treated than when fewer than10% were. 

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

Open Letter to FDA Urging Immediate Review of PrEP

via AIDS Foundation of Chicago

This is an open letter to the Food and Drug Administration, urging the priority review of the drug Truvada for use in PrEP (pre-exposure prophylaxis). The AIDS Foundation of Chicago and 25 other organizations signed this letter to counter the AIDS Healthcare Foundation's protest of the FDA regarding this review. To read the PDF of the letter, with footnotes, click here.

Dear Commissioner Hamburg:

We write as a coalition of 25 leading HIV/AIDS and health organizations to request that FDA grant priority review of a supplemental New Drug Application1 (sNDA) for the approval of emtricitabine/tenofovir disoproxil fumarate (Truvada®) fixed dose combination for preexposure prophylaxis (PrEP) to reduce the risk of HIV infection among adults as part of a comprehensive prevention package including risk reduction counseling and condoms. The rigorous priority review process applicable to efficacy supplements is the best means to promote public health by recognizing the potential of PrEP to offer a major advance in HIV prevention and deserving this priority “where no adequate alternate therapy exists or as a significant improvement compared to marketed products … including nondrug products or therapies.”

Our organizations understand that granting priority review is not tantamount to a final approval. Nevertheless, we are hopeful that the full dossier of data on emtricitabine/tenofovir disoproxil fumarate fixed dose combination of PrEP from multiple clinical trials in different populations
can lead to a responsible regulatory and marketing plan that allows safe use in the populations that may benefit from this innovative development.

The need for significantly improved safe and effective HIV prevention tools is clear. Despite many years of efforts to reduce HIV incidence using available counseling methods, some 50,000 new infections occur annually. Disparities persist so that incidence continues to concentrate among African Americans and Latinos, men who have sex with men (including transgender individuals), and the poor. These grim and stubborn facts led to the creation of the White House directed National HIV/AIDS Strategy for the United States (NHAS), which lists enhanced prevention efforts as a primary objective.3 If emtricitabine/tenofovir disoproxil fumarate for
PrEP satisfies FDA approval criteria, health programs and individuals will have improved choices to address a domestic priority and save lives.

The PrEP sNDA for Truvada® meets criteria set out in FDA’s Manual of Policies and Procedures for priority review. As organizations committed to ending the AIDS epidemic, we appreciate how the history of FDA’s regulatory tools for fast track approval or for accelerated and priority review introduced the current suite of HIV therapeutic drugs to treat active infection. In the present case, there is a clear unmet need for new effective methods for preventing HIV infection, a need that is as urgent today as was the need for HIV therapeutics over the past two and more decades.

HIV advocacy organizations made it possible to launch such regulatory procedures for the benefit of all patient disease groups when those tools were not yet available. We are not aware of any legitimate reason to thwart the faster introduction of medicines FDA determines to be safe and effective to stop HIV, nor should anyone turn back the pages of history and act against the interests of patients to do so now. Unfortunately, recent actions by the AIDS Healthcare Foundation regarding PrEP would introduce unwarranted roadblocks in the FDA process of making responsible decisions about potentially useful medicines and public health. Those actions also foster misunderstandings of the careful balancing of risk and benefits that informs a mature marketing permission based on all available data. Those actions would also set an unhelpful precedent as PrEP research evolves in the future and the FDA is asked to review nontenofovir- based regimens (e.g. maraviroc), microbicide gels, and intermittent PrEP. We urge that FDA continue its public health promotion goals now in the service of the critical need to prevent, as well as treat, HIV and grant this priority review.

We would be happy to discuss the priority review process as applied to HIV prevention further at your convenience. Mitchell Warren, Executive Director of AVAC, acts as the contact person for the organizations signing this letter (tel: 1-212-796-6423 or email: Mitchell@avac.org).

Sincerely,
AIDS Foundation of Chicago
AIDS Legal Referral Panel
AIDS Resource Center Ohio
AIDS Research Consortium of Atlanta
AIDS United
amfAR, The Foundation for AIDS Research
Asian & Pacific Islander Wellness Center
AVAC: Global Advocacy for HIV Prevention
Black AIDS Institute
Caracole, Inc.
Chicago Black Gay Men’s Caucus
Fenway Health
HIV Prevention Justice Alliance
International Rectal Microbicide Advocates
Justice Resource Institute
LA Gay and Lesbian Center
Multicultural AIDS Coalition
National Alliance of State and Territorial
AIDS Directors
National Black Gay Men's Advocacy
Coalition
National Latino AIDS Action Network
National Minority AIDS Council
Ohio AIDS Coalition
Project Inform
San Francisco AIDS Foundation
SisterLove, Inc.
Ursuline Sisters of Youngstown HIV/AIDS Ministry
Us Helping Us

Read the PDF version of the article (with footnotes) here.


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

Concerns around Gilead's Truvada used as prevention

via Financial Times, by Christine Livoti

Gilead Sciences’ (NASDAQ: GILD) once-daily Truvada pill has seen only tepid interest for adoption in the HIV prevention setting, despite treatment guidelines by the Centers for Disease Control (CDC), experts told Biopharm Insight. This is largely related to issues around feasibility, cost and historical evidence for other prevention strategies, which may not be remedied even with the FDA label Gilead is seeking, infectious disease experts said.

Last December, the company announced a supplemental NDA (sNDA) regulatory application for its currently marketed HIV drug Truvada, a potential therapy to reduce the risk of acquiring HIV, commonly described as pre-exposure prophylaxis (PrEP). Truvada has been approved since 2004 for use in combination with other antiretroviral drugs to treat HIV infection.
Truvada has not been approved yet as a preventative therapy in HIV.

Results from the Phase III iPrEx study reported in the New England Journal Of Medicine in December 2010 showed prophylactic effect from Truvada given orally among men who have sex with men (MSM). In January 2011, the CDC issued interim guidance on the use of PrEP in this population.
While HIV therapy is much more manageable than previously, with fewer pills and side-effects, experts in recent years have begun to initiate therapy in earlier stages of the viral infection, and most recently in uninfected individuals to prevent infection. While multiple PrEP studies have reported encouraging data, multiple hurdles to adoption still remain.

Slow uptake thus far

This news service reported in December 2010 that uptake of Truvada as an HIV prophylaxis therapy would likely be slow, as non-HIV specialists would largely be responsible for prescriptions. Infectious disease specialists reported few, if any, prescriptions in this indication, when interviewed by this news service.

The University of North Carolina division of infectious disease has not been prescribing PrEP, said Dr Christopher Hurt, clinical assistant professor. He added there has been some talk in the medical community that primary care providers and potentially ob-gyns would be responsible for PrEP prescription, similar to how they are responsible for oral contraceptives.

He noted in some urban areas, particularly San Francisco, Boston, New York and Washington, DC, with stronger healthcare settings for MSM, have probably been prescribing PrEP more frequently as they regularly see those individuals at risk of HIV infection. He noted his clinic had some discussion about offering PrEP to partners of current patients, but no decision was finalized. Those partners need to be in care somewhere, where potential side effects can be monitored, he added.

Read the rest.


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

Microbicides 2012 Registration is Open!

"To share in the latest developments in HIV prevention through microbicides and other technologies, this is the conference to attend. The conference is the key event in the microbicides world, where cutting edge research will be presented by world experts, and you will have a chance to interact with people involved at every level of microbicides development "-Professor John Kaldor, The Kirby Institute and Conference co-Chair

Come to Sydney in April for the 2012 International Microbicides Conference - 'From Discovery to Delivery', with state of the art plenary lectures on microbicides and other aspects of HIV prevention research, cross-disciplinary symposia, oral abstracts, and poster sessions.

M2012 will be a global forum for the presentation and discussion of the latest information on microbicides and oral pre-exposure prophylaxis for HIV prevention and their interface with other prevention strategies. There will be a strong emphasis on the role of community in both research and implementation of scientific findings. The conference is interdisciplinary, and will include basic science, pharmacokinetics, formulation and delivery, clinical research, public health, prevention science, and social and behavioural research.

Why Should You Come?

1. LEARN... From experts from around the world who will speak on key issues in HIV prevention technologies.
2. NETWORK... with a cross-disciplinary group of researchers, community representatives and policy makers, to support you in applying new approaches and perspectives in your work.
3. PARTICIPATE... in sessions that will range from state of the art lectures, to debates on hot topics in microbicides development.

Learn more here!


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

Is a Shift From Behavioral to Biomedical Interventions the Answer?

via gaycitynews.com, by Perry N. Halkitis, Ph.D., M.S.

Despite our best attempts over the last 30 years, the HIV epidemic continues unabated. There are 1.2 million identified infections in the United States, with another several hundred thousand likely undiagnosed. The impact of this ongoing health challenge is noted most dramatically and definitively evidenced among gay men, who represent somewhere in the vicinity of two to five percent of the population — but constitute 50 percent of all AIDS-related deaths, over 50 percent of all infections and over 50 percent of newly diagnosed infections.

With millions and millions of dollars spent on HIV prevention and research — and despite the best attempts of behavioral researchers and leading AIDS service organizations to modify our risk behaviors — the epidemic continues. Initial campaigns focusing on using a condom have, over time, morphed into programs underscoring the importance of efficacy, temptation and motivation to help shape behavior. But the infections continue to spread. So what has gone wrong?

Some, including myself at times, have pointed the finger at behavioral change programs that are overly simplistic, focusing on sex as an act free of emotion or passion (and in many cases, drugs). But sex is more than simple logic, or rational decision-making. Many behavioral programs have oversimplified a very complex behavior — and the programs we have developed or the research we have enacted has ultimately failed to translate to real lives. I often wonder if the folks developing these programs actually have sex themselves.

Some may argue that we have contained the disease. But how true is that when young gay men, especially Blacks and Latinos, are seroconverting at such high rates? Even among White men, there is an uptick in the incidence of new infections as this group navigates its 30s. We simply haven’t gotten it right.

The Center for Disease Control and Prevention (CDC) might beg to differ. For the last several years they have documented programs they refer to as DEBIS (Demonstrated Effective Behavioral Interventions) — which have demonstrated some feasibility in research trails for changing risk behaviors. Small subsets of these were developed for gay men. At a lunch a few years ago, a colleague asked me, “What do you think is the best DEBIS?” My answer was quite simply, “None of them. We still have an HIV epidemic, so nothing is clearly working that well.” For me, these interventions are like a topical ointment or a Band-Aid used to treat a deep skin infection — when what is really needed is a powerful oral antibiotic.

With no effective behavioral change programs in sight, newly developed and tested biomedical interventions have captured the attention of the public, of our leading community-based agencies and of policy makers at all levels of government.

Read the rest.


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

Treatment as Prevention: How and When?

via Science Speaks, by Meredith Mazzotta

In the sixth in a series of debates hosted by the World Bank and the U.S Agency for International Development highlighting emerging issues in today’s HIV response, physician-scientists debated how best to transform the exciting results from the HIV Prevention Trials Network (HPTN) 052 study, which demonstrated that those with HIV infection who received immediate treatment with antiretroviral therapy (ART) were 96 percent less likely to transmit HIV to their uninfected sexual partners than those whose treatment was delayed.

The panelists were tasked with debating not only how to apply treatment as prevention (TasP) quickly, and how to add it to the combination prevention tool kit effectively, but more so whether or not it makes sense to have countries spend a majority of what is likely to be a flat or declining HIV prevention budget on TasP. Each panelist was assigned a pro or con stance.

Arguing “for,” Sten Vermund, MD, PhD, said that if there were a vast pool from which to spend, there would be no debate. The evidence is overwhelming of the efficacy of ART as prevention, and a lack of scientific evidence in other prevention areas. He also said that priority must be given to reaching those folks with a CD4 count less than 350.

Read the rest.


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

Optimal use of ARVs for Prevention in Serodiscordant South African Couples

via PLoS Medicine, by Timothy B. Hallett1, Jared M. Baeten, Renee Heffron, Ruanne Barnabas, Guy de Bruyn, Íde Cremin, Sinead Delany, Geoffrey P. Garnett, Glenda Gray, Leigh Johnson, James McIntyre, Helen Rees, Connie Celum

Background

Antiretrovirals have substantial promise for HIV-1 prevention, either as antiretroviral treatment (ART) for HIV-1–infected persons to reduce infectiousness, or as pre-exposure prophylaxis (PrEP) for HIV-1–uninfected persons to reduce the possibility of infection with HIV-1. HIV-1 serodiscordant couples in long-term partnerships (one member is infected and the other is uninfected) are a priority for prevention interventions. Earlier ART and PrEP might both reduce HIV-1 transmission in this group, but the merits and synergies of these different approaches have not been analyzed.

Methods and Findings

We constructed a mathematical model to examine the impact and cost-effectiveness of different strategies, including earlier initiation of ART and/or PrEP, for HIV-1 prevention for serodiscordant couples. Although the cost of PrEP is high, the cost per infection averted is significantly offset by future savings in lifelong treatment, especially among couples with multiple partners, low condom use, and a high risk of transmission. In some situations, highly effective PrEP could be cost-saving overall. To keep couples alive and without a new infection, providing PrEP to the uninfected partner could be at least as cost-effective as initiating ART earlier in the infected partner, if the annual cost of PrEP is <40% of the annual cost of ART and PrEP is >70% effective.

Conclusions

Strategic use of PrEP and ART could substantially and cost-effectively reduce HIV-1 transmission in HIV-1 serodiscordant couples. New and forthcoming data on the efficacy of PrEP, the cost of delivery of ART and PrEP, and couples behaviours and preferences will be critical for optimizing the use of antiretrovirals for HIV-1 prevention.

Read the full study here.


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

Mapping Pathways to Prevention

via AIDS Foundation of Chicago, by Gregory Trotter

There are many people talking about PrEP (pre-exposure prophylaxis) in the HIV/AIDS community. Some are all for it, others not so much.

“The conversations are happening but not in any focused way,” said Jessica Terlikowski, director of regional organizing for the AIDS Foundation of Chicago and AIDS United.

That’s the gap that Mapping Pathways intends to fill. The two-year multinational study is researching the efficacy and varied perceptions of oral PrEP, equally alongside other antiretroviral (ARV) prevention methods, such as testing and linkage to care plus treatment (TLC+), post-exposure prophylaxis (PEP), and vaginal and rectal microbicides.

At USCA on Thursday, Terlikowski and AIDS United’s Bill McColl presented early results of a 500-person survey on attitudes toward the various prevention methods.  It’s too early to draw conclusions from the data, Terlikowski said, but the study could ultimately be a difference maker. The HIV/AIDS epidemic is not identical from country to country and a one-size-fits-all prevention strategy is unlikely to work everywhere.

“This is about thinking about the full range of prevention tools and creating a space for community dialogue. … Mapping Pathways is not about promoting one strategy over another,” Terlikowski said.

The survey began in May and reflected perspectives from the United States, India and South Africa.
One interesting piece of data was nearly half of survey respondents felt that oral PrEP was very important – but an almost equal number had concerns.
In contrast, about 70 percent said they favored the use of microbicides.

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

Brave new world: Test, treat, and PrEP

via Bay Area Reporter, by Luke Adams and Race Bannon

We are both community organizers and spend a lot of time talking with the target populations of the long-awaited New Directions in HIV Prevention in San Francisco. As those changes take shape and the rest of the country looks on to see how we will make them work, we felt that it was time to address some misunderstandings. We also wish to address some reckless and deceptive misinformation in the AIDS Healthcare Foundation's ad campaign against Truvada and in the recent Guest Opinion ["DPH's risk behaviors: A case study," July 28] by Billay Tania and some members of Off the Grid.

Tania argues that the outgoing San Francisco HIV prevention model has proven successful – that HIV has decreased over the last decade, and so he questions the move to a new test-and-treat model. Tania's statistics fail to account for the following discrepancy. In the 1980s and early 1990s, when the "use a condom every time" message was being widely heeded amid the carnage of a barely treatable disease [Catania, 1991], San Francisco went from averaging over 600 to about 300 seroconversions per month [Coates & Collins, 1998]. But as of 2010, evidence tells us (depending on the study [Catania 1991, CDC 2002, Foster et al. 2011, Rosenberg et al. 2011]) that only one-third to one-half of sexually active gay and bi men are using condoms even "frequently." That's in the age of undetectable viral load thanks to effective medications. Yet last year, depending on which set of numbers you use, San Francisco had between 300 and 700 seroconversions all year [SFHIV/HPPC 2011; CDC 2011]. The outgoing model of risk/harm reduction hasn't been an ongoing success; it has been an increasing failure – biomedical science has succeeded far better.

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

PrEP Highly Accepted in the UK

via aidsmap, by Roger Pebody

"Just over half (52%) said they would consider it, while 30% weren’t sure and 17% wouldn’t consider taking PrEP."

While few gay men in England are currently aware of pre-exposure prophylaxis (PrEP), most men who are introduced to the idea support PrEP being made available. Half would consider taking it themselves, but most would prefer to take it on a daily basis, rather than before and after each time they have sex. These findings come from a snapshot survey of gay men in England, published by Sigma Research this week.

Pre-exposure prophylaxis (PrEP) involves HIV-negative people taking anti-HIV drugs in order to reduce their risk of infection. Results of the iPrEX study into the safety and effectiveness of PrEP in gay and other men who have sex with men showed that, overall, it reduced infections by 43%. Much higher levels of efficacy were seen in men with good adherence to PrEP.

Recent studies with American gay men have shown that while only a minority of men is aware of PrEP, a majority would consider using it. Most men say PrEP would not affect their own use of condoms, particularly if it is only partially effective.

To investigate the views of gay men in England, researchers put a series of questions to members of the Sigma Panel in June 2011. The panel is made up of approximately 1500 gay men, bisexual men and other men that have sex with men (MSM) who respond to monthly cross-sectional online surveys about HIV and sexual health. The surveys have a short turnaround for analysis and reporting to health workers.
Only men who do not have diagnosed HIV were asked about PrEP; 1259 responded.

Read the rest.

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

Don't Delay HIV Prevention for Gay and Bi Men

via The Huffington Post, by David Ernesto Munar

Lives will be saved when the Food and Drug Administration puts its stamp of approval on a groundbreaking preventative approach called pre-exposure prophylaxis, or PrEP, recently found to reduce HIV infections.

With PrEP, people who are not infected with HIV take a daily pill, usually used to treat the disease, to help prevent infection -- as part of a broad HIV prevention approach that includes condoms and safer-sex counseling.

But the longer the FDA waits before beginning its review of the HIV medication Truvada for prevention, the more lives will be unnecessarily lost. This is particularly true for those at greatest risk: gay and bisexual men.
We urge the FDA to immediately begin its review for approval of Truvada for PrEP for gay and bisexual men.

Last year the iPrEX trial, touted as the scientific breakthrough of the year by TIME magazine, found that gay, bi and other men who have sex with men who took Truvada, along with counseling and condoms, had 42 percent fewer HIV infections than with counseling and condoms alone. Among those who used the prevention pill most consistently, the drop in infections was far greater.

And remember the sobering context: between 2006 and 2009, the number of young gay African-American men infected with HIV in the United States increased by 48 percent, according to the U.S. Centers for Disease Control.

Read the rest.


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

How Would a PrEP Rollout Impact the HIV Epidemic?

via AIDS: Official Journal of the International AIDS Society, by El-Sadr, Wafaa M.; Coburn, Brian J.; Blower, Sally M.

Background

The HPTN 052 study demonstrated a 96% reduction in HIV transmission in discordant couples using antiretroviral therapy (ART).

Objective

To predict the epidemic impact of treating HIV discordant couples to prevent transmission.

Design

Mathematical modeling to predict incidence reduction and the number of infections prevented.
Methods

Demographic and epidemiological data from Ghana, Lesotho, Malawi and Rwanda were used to parameterize the model. ART was assumed to be 96% effective in preventing transmission.

Results

Our results show there would be a fairly large reduction in incidence and a substantial number of infections prevented in Malawi. However, in Ghana a large number of infections would be prevented, but only a small reduction in incidence. Notably, the predicted number of infections prevented would be similar (and low) in Lesotho and Rwanda, but incidence reduction would be substantially greater in Lesotho than Rwanda. The higher the proportion of the population in stable partnerships (whether concordant or discordant), the greater the effect of a discordant couples intervention on HIV epidemics.

Conclusions

The effectiveness of a discordant couples intervention in reducing incidence will vary among countries due to differences in HIV prevalence and the percentage of couples that are discordant (i.e., degree of discordancy). The number of infections prevented within a country, as a result of an intervention, will depend upon a complex interaction among three factors: population size, HIV prevalence and degree of discordancy. Our model provides a quantitative framework for identifying countries most likely to benefit from treating discordant couples to prevent transmission.


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