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.]

AIDS Treatment is a Good Value!

via PLoS ONE and Results for Development Institute, by Stephen Resch1, Eline Korenromp, John Stover, Matthew Blakley, Carleigh Krubiner, Kira Thorien, Robert Hecht, Rifat Atun

Despite the remarkable scale-up of AIDS treatment and prevention programs in low and middle income countries in recent years, each year two million people die from AIDS (most without ever having received antiretrovirals ART) and 2.7 million are newly infected by HIV.

A study released in PLoS ONE, co-authored by a group from Results for Development Institute and the Global Fund, argues that large scale investment in ART in low and middle income countries yields a stream of economic benefits that is likely to offset substantially or exceed the costs of delivering AIDS treatment to millions of patients in these countries.

The study, The Economic Returns to Investment in AIDS Treatment in Low and Middle Income Countries, is one of the first efforts to look systematically at the expected economic benefits (returns) to large scale investment in AIDS treatment.

The study models three streams of future economic benefits accruing to the roughly 3 million persons who were on Global Fund supported treatment in 2010 in 98 countries around the world: (1) restored labor productivity amongst workers with AIDS, (2) orphan care expenditures avoided because parents remain alive on ART, and (3) delayed end-of-life care costs associated with death from AIDS. These streams of economic benefits were selected because they offset the cost of treatment over short time horizons and therefore may be especially salient to policy-makers concerned with health budgets, household economic stability and societal-level economic growth.

Using recent ART prices and program costs, the study estimates that the discounted resource needs required for this cohort of patients over the coming decade are US$14.2 billion.This investment is expected to save 18.5 million life years and return $12-34 billion. This yields economic benefits from ART ranging from 80% to 290% of program costs

Read the rest.


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How Much Would it Cost to End AIDS?

via Bloomberg, by Simeon Bennet

Michel Kazatchkine and Eric Goosby may be able to halt the spread of HIV. They just need the money.

The two men control the funds that buy drugs for most of the world’s AIDS patients. Studies in July provided the strongest evidence yet that medicines used since 1994 to treat HIV can almost eliminate the chance an infected person will pass the virus to a sex partner. Given to healthy people, the treatments can also protect against infection, offering the potential to end a pandemic that has killed 30 million people in 30 years.

Governments are now planning projects to assess whether those findings can be replicated in the real world, and what that might cost. Getting the drugs just to those patients who should be treated under existing guidelines would cost another $6 billion a year, according to the United Nations. Treating all those infected, in some of the world’s poorest countries, would cost tens of billions more.

Finding more money will be difficult with economic growth stalling and nations including the U.S., the biggest donor to the AIDS fight worldwide, trying to curtail overall spending to rein in debt. Funding for AIDS in poorer nations fell 10 percent to $6.9 billion in 2010 from 2009 levels, according to the UN.

“We may well be able to overcome AIDS,” Kazatchkine, the director of the Geneva-based Global Fund to Fight AIDS, Tuberculosis and Malaria, said in an interview. Still, “the gap between what the science is telling us we can achieve and what we would be able to achieve is at risk of increasing.”

Read the rest.


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Kaiser/UNAIDS study finds drop in overall disbursements for AIDS response in 2010, seven out of 15 governments report reductions

Via the Kaiser Family Foundation.

Funding disbursements from donor governments for the AIDS response in low- and middle-income countries fell in 2010, dropping 10% from the previous year’s level, according to an annual funding analysis conducted by the Kaiser Family Foundation and the Joint United Nations Programme on HIV/AIDS (UNAIDS).

The study found that donor governments disbursed US$ 6.9 billion in 2010 for HIV prevention, treatment, care and support--US$ 740 million less than in 2009. The decrease was due to a combination of three main factors: actual reductions in development assistance, currency exchange fluctuations, and a slowdown in the pace of U.S. disbursements, which was not a budget cut.

Of the 15 governments surveyed, seven--Australia, Germany, the Netherlands, Norway, Spain, Sweden and the United States--reported a year over year decrease in their disbursements as measured in their own currencies. The figures presented in the report are in US dollars, consistent with international standards and other reporting mechanisms.

Due to currency fluctuations, when measured in US dollars, Australia showed a slight increase in its AIDS funding contribution even though it contributed less in its own currency. Conversely, there was a slight decrease in Denmark’s contribution despite the country’s increased funding level in its own currency.

"AIDS is a smart investment even in this difficult economic environment. We have to look beyond the near-term costs and recognize the long-term benefits," said Michel Sidibé, Executive Director of UNAIDS. "Donors need to make and follow through on commitments today to reduce costs in the future."

The overall drop in disbursements was primarily attributed to a reduction in disbursements by the United States, the largest donor nation, which accounted for 54% of total donor disbursements in 2010. While the United States Congress appropriated similar levels of funding for the AIDS response in 2010 as in 2009 (approximately US$ 5.5 billion in each year), disbursements from the United States declined from US$ 4.4 billion in 2009 to US$ 3.7 billion in 2010. This slowdown stems from new requirements established by Congress for the United States President’s Emergency Plan for AIDS Relief (PEPFAR). Some funds appropriated in 2010 will be disbursed in later years.

"With U.S. funding delayed but not eliminated to this point, this year’s drop in spending may be a temporary blip, though its impact on services may be real," said Drew Altman, Kaiser Family Foundation President and CEO.

Read the rest here.

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A Trade Barrier to Defeating AIDS

Via the New York Times, by Tina Rosenberg.

Earlier this month, [the Medicines Patent Pool, a new organization trying to make AIDS drugs better, cheaper and available sooner to people who need them in poor countries] received its first donation of rights from a pharmaceutical manufacturer, Gilead Sciences.   It is an important step  — but the terms Gilead negotiated are also confirmation of a dangerous new trend: middle income countries as a target market for drug makers.  In the past, pharmaceutical companies have lowered prices in these countries to increase sales.  The new strategy is to treat people in Egypt, Paraguay, Turkmenistan or China — middle-income countries, all — as if they or their governments could pay hundreds or even thousands of dollars a year each for AIDS drugs.   This low-volume high-profit strategy might make  business sense.   But in terms of the war against AIDS, it means surrender.

In the world’s most impoverished countries, AIDS drugs are cheap.   It wasn’t always that way.  Until well into the Clinton administration, the United States government pressured even the poorest countries shamelessly if they tried to bring down the prices of medicine.   Even newly democratic, AIDS-ravaged South Africa became the object of an all-out assault by the Clinton administration to get the country to repeal a law allowing it to break medical patents, a step that was perfectly legal under world trade rules.  Washington was not interested in the health consequences.   (A U.S. trade negotiator who worked on South Africa at the time told me that he had been unaware that AIDS was a major problem there.)    Public outrage over South Africa ended Washington’s pressure on poor countries.   In 2000, President Clinton issued an executive order pledging that sub-Saharan African countries would not face trade sanctions for laws promoting access to AIDS medicines.

The order continues to be largely respected, and the group of countries who are generally able to get access to the cheapest drugs has grown to include the poorest countries from around the world — Afghanistan, Tajikistan, Bangladesh, Burma.    Gilead’s agreement with the Medicines Patent Pool covers these countries.

But countries just above this cutoff line are on their own.  “There are countries that are considered to be “middle income” that will never be able to afford the high prices charged by innovative pharma companies,” said reader A. Grant of New York.  These nations are also losing the discounts that major manufacturers of AIDS drugs used to offer them.  According to Médecins Sans Frontières, which tracks drug prices, prominent manufacturers of AIDS drugs have stopped offering discounts to middle-income countries, or now require that countries negotiate those discounts one by one.

Read the rest here.

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

The Economic Effect: HIV/AIDS in the US

At the CROI conference earlier this year, Julie Davids asked a question that lies at the very heart of HIV prevention – “What needs to happen to ensure that PrEP doesn’t become a hard-to-get intervention?” Now, halfway through the year, we checked in with her. Below, Julie shares her thoughts on how dollars-and-cents issues have serious repercussions with regard to the HIV/AIDS situation in the US.

“While there has been much debate over the use of antiretrovirals (ARVS) for HIV prevention, the entire HIV prevention and treatment landscape overall is also in a state of flux in the US. In the era of the National HIV/AIDS Strategy, many questions have arisen. Perhaps the most important is this – what prevention/treatment methods can be brought to scale for population-level impact? There has been lots of effective work that has helped prevent HIV and save lives, but what can be scaled up to a point where it can start to reduce incidence? There are initiatives that work very well but are too expensive to bring to larger scale. People are also wondering if there are targeted ways of delivering PrEP to ensure maximum impact without incurring enormous amounts of expenditure.

The global economic crisis has only exacerbated the situation. The effects of the sustained downturn in the US are deep and hard to untangle. In some areas, the impact is specific and tangible: many organizations and initiatives that provide HIV prevention, treat and care are shutting down and others are under lot of duress. So, understandably, when it comes to using ARVs for prevention, people are saying, “We’ve been told not to expect any new money – in fact, we’ve braced ourselves for cuts in funding. If we’re talking about adding something new, where is the money going to come from? And is this the best use of the available resources?”

But the effects are also larger and more intangible, in terms of a generalized anxiety and fear. The recession is hitting the most marginalized the most severely. One of the main drivers of HIV incidence in the US is poverty – and we’re seeing a sharp increase in poverty and homelessness. People are scrambling to find housing and put food on table, to retain a sense dignity as they struggle to provide for their families. These factors create vulnerability to health challenges and in this regard HIV/AIDS is more the rule than the exception. We may sharpen and tailor HIV prevention to be more effective, but I fear this could be counterbalanced by the effects of the downturn, leading to persistently high HIV incidence.

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’re being told that other things in the country, such as the income of bankers, remain more important than people’s health. 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. In the history of the HIV/AIDS epidemic, there have been some excellent ideas but they have languished because they just aren’t resourced at the appropriate level – I think we may see a lot of this in the next few years. The impact of economic injustice, which was already driving the epidemic, will remain a deciding factor in the HIV/AIDS context for some time to come.”

Julie Davids is the Director of National Advocacy and Mobilization at AIDS Foundation of Chicago, a Mapping Pathways partner organization. She coordinates the HIV Prevention Justice Alliance (HIV PJA).

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

The Importance of Affordable Antiretroviral Therapy

by Aldona Martinka

The UN high-level meeting on HIV/AIDS last week highlighted the importance of accessable and affordable ARVs in developing countries. These hold potential for both treatment and prevention, but their availability in impoverished areas may soon be threatened.

Before CIPLA in India began to produce ARV cocktails for around a dollar a day in 2001, the treatment could be thousands of dollars, completely out of reach for the vast majority of the world. Since then the competition has greatly increased the affordability of these treatments, making them viable options for countless people that would not have had access to them otherwise.

Free Trade Agreements may restrict production and distribution of the more affordable generic versions of antiretrovirals through the Trade-Related Aspects of Intellectual Property Rights (TRIPS) agreement. This agreement already restricts access to recently developed pharmaceuticals in the southern hemisphere, but negotiations could worsen the situation according to Modern Ghana, "Studies show that FTAs with US resulted in 79% of 103 off-patent medicines not having any generic equivalent in Jordan and in price differences of up to 845,000% in the same therapeutic segment in Guatemala."

The EU is also pushing to create clauses in a trade agreement with India that would limit pharmaceutical production. This has potentially devastating effects in developing countries which depend on affordable drugs from manufacturers like those in India that would be affected. The reason for this is member states pushing to prop up the interests of their own pharmaceutical enterprises, often at the expense of the countries that most need these treatments.

Hope comes in the form of the Bangkok Declaration on Free Trade Agreements and Access to Medicines, a declaration supported by people and groups from Asia, Africa, and Latin America, some of the most-affected areas. The Bangkok Declaration opposes the creation of any more Free Trade Agreements, saying that they put corporate welfare above the welfare of millions living with AIDS that would be denied treatment.

To find out more about Free Trade Agreements and generic pharmaceuticals, visit here, here and here.

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

Bloomberg Editorial: After 30 Years of AIDS, Push Harder for HIV Prevention

via Bloomberg

AIDS has been with us, officially, for 30 years, since the U.S. Centers for Disease Control and Prevention reported the first cases. This unhappy anniversary is perhaps as good a time as any to spell out why the global response to AIDS is in need of serious adjustment.

Annual spending on AIDS worldwide has risen to $15.9 billion. The bulk of this money goes to the treatment and care of indigent people who are HIV-positive. Without question, the investment in anti-retroviral therapy, or ART, has saved lives. Today, the treatment is provided to about 36 percent of those in the developing world who qualify for it under World Health Organization guidelines.

United Nations member states have pledged to raise that to almost 100 percent. Universal treatment has become the principal mission of many AIDS organizations around the world; governments and philanthropies have followed their lead.

The idea of treating everyone who has the human immunodeficiency virus, regardless of ability to pay, is laudable. The problem is, the laudable runs the risk of crowding out both the practical and the doable. As programs for treatment have grown, those focused on prevention have languished or gotten short-shrift.

Read the rest.

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

Lancet: Towards an improved investment approach for an effective response to HIV/AIDS

via The Lancet

Summary

Substantial changes are needed to achieve a more targeted and strategic approach to investment in the response to the HIV/AIDS epidemic that will yield long-term dividends. Until now, advocacy for resources has been done on the basis of a commodity approach that encouraged scaling up of numerous strategies in parallel, irrespective of their relative effects. We propose a strategic investment framework that is intended to support better management of national and international HIV/AIDS responses than exists with the present system. Our framework incorporates major efficiency gains through community mobilisation, synergies between programme elements, and benefits of the extension of antiretroviral therapy for prevention of HIV transmission. It proposes three categories of investment, consisting of six basic programmatic activities, interventions that create an enabling environment to achieve maximum effectiveness, and programmatic efforts in other health and development sectors related to HIV/AIDS. The yearly cost of achievement of universal access to HIV prevention, treatment, care, and support by 2015 is estimated at no less than US$22 billion. Implementation of the new investment framework would avert 12·2 million new HIV infections and 7·4 million deaths from AIDS between 2011 and 2020 compared with continuation of present approaches, and result in 29·4 million life-years gained. The framework is cost effective at $1060 per life-year gained, and the additional investment proposed would be largely offset from savings in treatment costs alone.

Click here for full text, free (just need to register.)

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

The end of AIDS? Are We There After 30 Years?

Thirty years on, it looks as though the plague can now be beaten, if the world has the will to do so...

via The Economist

Excerpt:

If AIDS is defeated, it will be thanks to an alliance of science, activism and altruism. The science has come from the world’s pharmaceutical companies, which leapt on the problem. In 1996 a batch of similar drugs, all of them inhibiting the activity of one of the AIDS virus’s crucial enzymes, appeared almost simultaneously. The effect was miraculous, if you (or your government) could afford the $15,000 a year that those drugs cost when they first came on the market.

Much of the activism came from rich-world gays. Having badgered drug companies into creating the new medicines, the activists bullied them into dropping the price. That would have happened anyway, but activism made it happen faster.

The altruism was aroused as it became clear by the mid-1990s that AIDS was not just a rich-world disease. Three-quarters of those affected were—and still are—in Africa. Unlike most infections, which strike children and the elderly, AIDS hits the most productive members of society: businessmen, civil servants, engineers, teachers, doctors, nurses. Thanks to an enormous effort by Western philanthropists and some politicians (this is one area where even the left should give credit to George Bush junior), a series of programmes has brought drugs to those infected.

The result is patchy. Not enough people—some 6.6m of the 16m who would most quickly benefit—are getting the drugs. And the pills are not a cure. Stop taking them, and the virus bounces back. But it is a huge step forward from ten years ago.

What can science offer now? A few people’s immune systems control the disease naturally (which suggests a vaccine might be possible) and antibodies have been discovered that neutralise the virus (and might thus form the basis of AIDS-clearing drugs). But a cure still seems a long way off. Prevention is, for the moment, the better bet.

There are various ways to stop people getting the disease in the first place. Nagging them to use condoms and to sleep around less does have some effect. Circumcision helps to protect men. A vaginal microbicide (none exists, but at least one trial has gone well) could protect women. The new hope centres on the idea of combining treatment with prevention.

Read the rest.
 
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