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.]

Gilead has submitted application for FDA approval of PrEP

via Bay Area Reporter, by Liz Highleyman

The company, which made the announcement December 15, has asked for priority review, meaning a decision could come as early as June. Clinicians can currently prescribe drugs "off label" as they see fit, but official approval of Truvada PrEP would have implications for public health programs and insurance coverage.

"The data from clinical trials clearly show that taking Truvada every day and using condoms can be very effective in preventing HIV for people at highest risk for infection," said Project Inform Executive Director Dana Van Gorder. "We believe in the right of HIV-negative people to choose the evidence-based prevention methods that best support their efforts to remain negative, and we urge quick FDA approval of Truvada for prevention."

PrEP trial results

Gilead's request is based on findings from a series of large international trials of oral PrEP using Truvada or the medications it contains, tenofovir (sold separately as Viread) and emtricitabine (Emtriva). Overall, results have been promising but several questions remain unanswered.

The large iPrEX trial, which enrolled nearly 2,500 gay and bisexual men and transgender women in six countries (including San Francisco and Boston in the U.S.), found that daily Truvada reduced the risk of acquiring HIV by 44 percent overall, with 36 new infections among men receiving PrEP compared with 64 among men taking a placebo pill.

Further data presented at the International AIDS Society conference this summer in Rome showed that risk reduction exceeded 90 percent for participants who had detectable drug levels in their blood, indicating good adherence.

"With 2.6 million new HIV infections occurring each year, and fewer than half of people with HIV receiving treatment, the world needs new and effective HIV prevention strategies," said iPrEx protocol chair Dr. Robert Grant from the Gladstone Institutes and UCSF. "Men who have sex with men have borne an enormous burden in this epidemic, and have also been consistently at the head of efforts to help reverse it."

Two other trials discussed in Rome – Partners PrEP and TDF2 – showed that the drugs in Truvada reduced the risk of HIV infection among heterosexual men and women in Africa by 60 percent to 75 percent.

In contrast, however, two studies of heterosexual African women have not seen a similar effect. The Fem-PrEP study of daily Truvada was halted earlier this year due to lack of effectiveness, as was an arm of the VOICE trial testing oral tenofovir alone (the tenofovir/emtricitabine combination is still being evaluated.)

Read the rest.


[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.]

Pause and Rewind with Jim Pickett: Triumphs and Trials in 2011

Original content from the Mapping Pathways blog team

“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.”

MP: Was 2011 a significant year with regard to new HIV prevention methods?

JP: Definitely. I think it’s been a really dynamic year. The discussion around ARV-based prevention has been heated, it’s been passionate, and it’s been very broad. The field as a whole has received so much attention this year because of all the studies that were reported, beginning in 2010. The lively discussion has put the research and advocacy that’s been ongoing for years on so many people’s radar for the first time.

MP: What were some of the biggest highlights in the prevention landscape this past year?

JP: In terms of the actual science that was reported out this year, a couple of studies were really important. The HPTN 052 trial proved beyond a shadow of a doubt that providing treatment to people can be very effective as a means of prevention as well as for treating the individual with HIV. It was something we all pretty much knew but we didn’t have a randomized controlled trial to prove it. Now we have one – and that’s really powerful.

There have also been significant results on the use of pre-exposure prophylaxis (PrEP) in heterosexual individuals. The Partners PrEP study and the TDF2 Botswana study have brought further proof that oral prevention – taking a pill every day – can work to prevent HIV, and can work quite well.

On the other side, we’ve had some confounding results as well. The FEM-PrEP trial closure, due to the fact it was unable to prove the effectiveness of Truvada in preventing HIV infection among HIV-negative women, has left us scratching our heads. The VOICE trial, which is investigating both microbicides and PrEP, had to close the tenofovir gel and pill arms due to futility – they weren’t going to be able to show these interventions work to prevent HIV.

We’ve come up against ‘futility’, and now there’s a huge question mark. We don’t yet know what is going on: Was it something biological? Was it because adherence was poor? Why did these products work in other trials? While there have been very encouraging results about PrEP, the jury is still out – for instance, is this a good intervention for heterosexuals, especially women? Both PrEP trials that have shown futility have been for women. These critical questions need to be addressed.

MP: What has the debate around PrEP been like? What are people saying?

JP: Like I mentioned, the debate around ARVs as prevention has been very dynamic. Wherever you are on the analysis of these new strategies, whether you are critical of these or really excited about them, much of the discussion has been fruitful and invigorating.

What has upset me, though, is that some people (whether they’re researchers, advocates, public health workers, or policymakers) have been drawing lines and pitting interventions against one other. For instance, PrEP, ARVs for HIV-negative people to prevent HIV acquisition, is being pitted against treatment, ARVs for HIV-positive people. There’s been a lot of discussion on who “deserves” the drugs and who doesn’t – I don’t think that’s helpful in any way. We should all be working to get ARVs to those who need them – HIV-positive people, of course, and also HIV-negative individuals who need them, can use them, and would find them very beneficial. It’s about ARV access writ large.

MP: Why do you think this has happened?

JP: This is what happens in times of scarcity and economic trauma. People say, “We can’t possibly do everything, so we should do only this and not that.” It’s not surprising, but it’s still disheartening. We need to think broadly, globally and not dismiss new interventions because they’re challenging or bring up lots of questions. PrEP does bring a ton of issues: It’s brand new, it’s just out of the box, we’ve never done this before, and it’s 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. That’s where we should be spending our energy.

When the female condom was first introduced, it wasn’t given the attention and support it needed and a lot of people dismissed it. I think that really hobbled its potential for a long time. I don’t want to see PrEP in the same place – being disparaged before we’ve had a chance to explore and fully understand its potential.

MP: How can the Mapping Pathways project help in this context?

JP: The Mapping Pathways project will be offering a synthesis of literature, real-world experience, and key stakeholder opinions from vastly different perspectives and regions of the world. This is going to be extremely helpful because we know that just having great science isn’t going to get any of these interventions rolling. This project is helping create and disseminate information that countries, regions, states, and cities can use to make informed decisions about how they engage with these new prevention technologies – or not. I think the key word here is “informed”. What we’re all hoping is that these decisions are made based on a combination of science, feasibility, and acceptability in each region.

The fact that we’re going to be able to play a role in that process is very exciting. Wearing my Mapping Pathways hat, I’m really proud of the work we’ve done this year. The first wave of data collection is done – we’re now analyzing our literature review, our survey results and stakeholder interviews, and results from our ExpertLens process. I’m very excited about the data and analysis that we’ve been able to pull together as a multinational team. And now we get to start sharing these great insights with the world!

Jim Pickett is the Director of Prevention Advocacy and Gay Men's Health at the AIDS Foundation of Chicago. He is chair of IRMA (International Rectal Microbicide Advocates), and a member of the Mapping Pathways team.

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

The Treatment Action Campaign (TAC) Shapes AIDS Policy in South Africa

via The Guardian, by Pierre de Vos

"The TAC case thus illustrates how social and economic rights can be used by civil society groups to mobilise public support for a worthy cause – even before a court is asked to adjudicate on what will often be very complex legal and moral issues – and that it can enhance democratic engagement and participation."

Shortly after Thabo Mbeki, the former South African president, began his flirtation with Aids dissidence in 2000, the Treatment Action Campaign (TAC) was created to respond to the HIV crisis in the country and the government's reluctance to deal with it.

Although closely aligned with the ANC government, the TAC engaged politically and launched various court challenges to force a change of heart on the part of the government and, ultimately, in order to ensure that every HIV-positive person who could not afford it was provided with antiretroviral (ARV) medicine by the state.

The TAC ran a brilliant and strategically astute campaign to mobilise the public, trade union organisations and other civil society groups behind its cause. Its trump card in this campaign was section 27(1) of the constitution , which states that everyone has the right to have access to healthcare services, including reproductive healthcare.

Like other social and economic rights contained in the South African bill of rights – including the right of access to housing, sufficient food and water; and social security – the right to healthcare is not absolute. It requires the state only to take reasonable legislative and other measures, within its available resources, to achieve the progressive realisation of each of these rights.

At the time of the drafting of the bill, some politicians and academics opposed the inclusion of these rights, arguing that it would not be possible for judges to enforce these claims as they would be required to make policy choices best left to the democratically elected branches of government. But given the vast discrepancies in wealth – often based on race – caused by apartheid and the fact that many citizens did not have access to basic services at the dawn of democracy, the drafters of the constitution believed that it was imperative to include not only traditional civil and political rights in the constitution, but also justiciable social and economic rights. Otherwise the very legitimacy of the constitutional enterprise would be at risk.

South Africa's constitutional court at first dealt cautiously with the interpretation and application of these rights, making it clear that it would not be feasible to interpret the rights in a way that provided individual claimants with a right to demand specific goods and services from the state.

The court was in a difficult position as it had to respect the separation of powers doctrine and could not dictate to the government how to allocate its budgets. At the same time it was required to ensure that the social and economic rights did not remain rights on paper alone, but were interpreted in a way that signalled their enforceability.

Read the rest.


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