UNAIDS: TRIPS and the potential impact of free trade agreements

via UNAIDS.org

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

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

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

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

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

Read the Rest.


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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.]