Registration for AIDS 2012 in Washington, D.C. Opens December 1

Registration, abstract and programme activity submissions for the XIX International AIDS Conference (AIDS 2012), to be held from 22 to 27 July 2012 in Washington, D.C., open December 1 online at www.aids2012.org.

More than 25,000 participants and 2,000 journalists from approximately 200 countries are expected to convene at the conference, which is predicted to be a landmark event in the history of HIV and AIDS both in the United States and globally.

“Turning the Tide Together”, the theme of the conference, emphasises that we have reached a pivotal moment in time and that seizing this potential and actually turning the tide on HIV and AIDS will require commitment and action on many levels. The conference will be an important and high profile opportunity to reflect on the tension between recent scientific advances which could theoretically end the epidemic, and the current global economic crisis which threatens the funding necessary to implement this scientific knowledge.

“In the last couple of years we have seen some incredibly important breakthroughs in science,” said. Elly Katabira, International Chair of AIDS 2012 and President of the International AIDS Society (IAS). “The results of the CAPRISA trial presented at AIDS 2010 and the data from IAS 2011 proving beyond a doubt that treatment is prevention have shown us that we now have the real potential to change the direction of HIV. Science has provided us with the tools, what we need now is a global political and economic commitment to action. A turbulent economic climate must not halt funding for research and implementation”.

The return of the International AIDS Conference to the United States after more than 20 years represents a victory for public health and human rights and it is the result of dedicated advocacy to end the nation’s misguided entry restrictions on people living with HIV.

“Hosting AIDS 2012 in the U.S will be an occasion to highlight the disparities in access to treatment and care which exist in the country.” said Diane Havlir, Local Co-Chair of AIDS 2012. “We hope for a broad and active participation from all of those affected by the HIV epidemic, particularly people living with HIV and AIDS, policy-makers and key affected populations”.

Together with delegate and media registration, 1 December is the opening day for online abstract submissions. Over half of all conference sessions will be abstract-driven and all of the submissions will go through an extensive peer-reviewed process in order to guarantee the highest caliber of state-of-the-art science. The online abstract submission closes on 15 February 2012 and reopens on 19 April 2012 for late breaker abstract submissions.

In addition to the conference sessions, AIDS 2012 will feature a set of workshops open to delegates. Workshops will fall under professional development, community skills and leadership skills. Online submissions for workshops open on 1 December 2011 and close on 15 February 2012.

AIDS 2012 will host a Global Village, open to conference delegates and the general public, aimed at intensifying the involvement of key affected populations and other stakeholders in the conference. The conference also presents a Youth Programme with the goal of strengthening the participation of young people and youth issues in the conference through activities such as youth-driven sessions. From today it is possible to submit applications for both the Global Village and the Youth Programme. Both the submissions close on 15 February 2012.

With over 7,000 square metres of prime exhibition space AIDS 2012 offers both commercial and non-commercial organizations the opportunity to showcase their products and services to a wide public. Exhibitor applications open on December 1 and close on 25 May 2012. Exhibition space is limited so early bookings are strongly encouraged.

Various satellite meetings will take place in the conference centre during AIDS 2012. These satellite meetings are fully organized and coordinated by the organization hosting the satellite. The satellite slots are available for a fee and the applications open on 1 December and close on 31 March 2012.

From 8 December online applications for scholarships will be open. The International and Media Scholarship Programme is open to everyone around the world and is aimed at making the conference accessible to people from resource-limited settings and communities. Priority is given to those whose participation will help enhance their work in their own communities. A limited number of scholarships will be also available for media representatives.

More information on registration process and registration fees is available here: http://www.aids2012.org/Default.aspx?pageId=368

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

Mapping Pathways South Africa: What we’re hearing so far

Original content from our Mapping Pathways blogs team

An important part of the Mapping Pathways project is to learn what people think and feel about ARV-based prevention strategies (such as PrEP), not just through academic streams and studies but also through everyday experience and wisdom. What do the people who work daily with treatment and prevention and/or have first-hand experience of living with HIV think? What are their concerns? What information do they need about PrEP, TLC+ (testing, linkage to care, plus treatment), and microbicides? Do they think these prevention tools can be useful for their community or country? Would they use them or prescribe them?

The Mapping Pathways online survey and in-depth stakeholder interviews are important ways for us to gain knowledge on these questions. Both processes took place over the year, and we’re starting to unpack a number of some interesting observations and ideas now that the interviews have finished and the survey is closed. Of course, this data is still preliminary but we thought we’d share some snapshots of what we’re hearing from South African doctors, policymakers, and activists on the ground.

Thoughts on the Mapping Pathways project
Although each person we spoke with had very different views on ARV-based strategies and HIV prevention within the South African context, most agreed that Mapping Pathways was an excellent and timely initiative. People thought the project was “inclusive”, “collaborative”, “captures everything that’s going on at the moment”, “well thought through”, “urgently needed”, “spot on”, and “a project worth doing”. One South African researcher felt it “hits the nail on the head about what needs to be done in the field”, and a South African policymaker said research like this is “the only way forward”. Concerns included the fact that only three countries are participating and that the field may be moving too fast to document everything effectively.

Thoughts on TLC+
Nearly everyone we spoke with agreed that TLC+ was scientifically valid – that is, to expand treatment access for people living with HIV as a way to reduce onward infections to others. “The prevention benefits of treatment are absolute,” said one South African clinician. However, some felt that it was tough to implement TLC+ in a resource-limited setting like South Africa, and there were concerns about infrastructure, cost, staffing, and sustainability. One South African pathologist said it was “a quantum leap”, a policymaker mentioned it was “operationally far away”, and an activist said that “financial sustainability in this context is unlikely”.

Others thought it could be done. “The programme will pay for itself,” stated a South African pathologist. Another added, “Keeping patients well is always a good thing financially.”Many people felt more research still needed to be conducted on such as side-effects, resistance, drug delivery, and adherence/acceptability. One South African epidemiologist pointed out the importance of operational research: “We do know enough to start finding out how we can do it.”

Thoughts on oral PrEP
There was a fair amount of concern about how oral PrEP could work within the South African context, especially given the country’s limited resources and high incidence rate. People were also confused by the seemingly conflicting results from various trials. (Read Daniella Mark’s thought-provoking interview on this here and here.) One South African researcher said, “The iPrEx and FEM-PrEP results have left us wondering.” Some people felt rolling out oral PrEP to high-risk populations was the right step; however, there were concerns expressed on how these populations would be defined and traced, e.g., adolescent girls, sex workers, and truckers.

Thoughts on microbicides
Microbicides evoked interesting and varied reactions from the people we spoke with. Most agreed that there still needs to be more evidence on their efficacy. “We’re not there yet,” said one South African epidemiologist. Some people felt a microbicide might be easier to implement than oral PrEP. One South African activist felt microbicides have the potential for much greater use. “If they’re like condoms and can be handed out freely to everyone, it would be easier,” said a South African policymaker.

Others thought differently, saying that a microbicide might be more difficult to implement than oral PrEP since it is a new modality and people are not used to topical prevention. “It might be difficult to know if you’ve put on enough,” said one South African pathologist. There were also concerns about acceptability and adherence. Read more about this here and here. What was also interesting was the view that a vaginal microbicide is female-controlled. “We’ve been seeking a female-controlled prevention methodology for a long time,” said a South African activist. “It is some small degree of female empowerment,” added a South African policymaker.

[Editors note: the VOICE trial announced November 25 the closure of its study arm testing tenofovir gel. The decision was made due to futility – while tenofovir gel was found to be safe, the trial was not able to prove the gel worked to prevent HIV. See the statement from the Microbicide Trials Network for more information. The Truvada tablet arm in the trial is continuing.]

Thoughts on HIV prevention funding allocation
The consensus on funding seemed to be that there was no “silver bullet” and South Africa should focus on multiple, concurrent strategies. “A one-size-fits-all approach won’t work,” said one South African researcher. There was also a general feeling that funds should go into proven, effective strategies. “Funders should think about where they will get the ‘biggest bang for their buck,’” said a South African policymaker. One South African activist remarked that the country doesn’t yet have a proper prevention strategy or prevention targets, which “leads to a scattergun approach and we miss people”. Some people strongly felt that the focus should be on treatment first. Others felt that funds should go to strategies that are female-controlled.

For more analysis on South African reactions towards ARV-based prevention  and HIV prevention in general, read our two-part interview with Daniella Mark from the Desmond Tutu HIV Foundation, a Mapping Pathways partner organisation: In Conversation with Daniella Mark: It’s a question of “how” in South Africa and In Conversation with Daniella Mark – Part 2: Climbing “Mount Everest”.

Mapping Pathways is presenting two posters at the ICASA 2011 conference showcasing some of the data collected. Stay tuned to this blog to see the actual posters – next week.

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

In Conversation with Daniella Mark—Part 2: Climbing “Mount Everest”

 Original content from our Mapping Pathways blog team

"This is a huge undertaking. It’s like saying, 'Alright, we’re climbing Mount Everest', and so we need the team to be on board and we need the team to be walking in the same direction." We checked in with our colleague Daniella Mark from the Desmond Tutu HIV Foundation in South Africa, a Mapping Pathways partner organisation. For the past year, she has been conducting in-depth stakeholder interviews with South African policymakers, advocates, community leaders, physicians, academics, and scientists. As Daniella puts it, “All of these people are essentially gatekeepers; they have the ability to either push forward or halt a particular HIV prevention strategy or technology.” We spoke with her about some of the trends she’s observing from her conversations, and her insights on HIV prevention within the South African context, specifically what we can look forward to in 2012. This is the last part of a two-part interview. You can read the first part here.

Personally, what do you feel towards PrEP? How have your feelings changed or evolved from the beginning of this year to now? 

DM: This project has been the most unbelievable learning experience for me. I’ve gotten to sit and speak with the experts in the country about these topics that are very hot right now (learn about the various HIV prevention studies here). So I’ve been very shaped by the interviews that I’ve done and the data that I’ve seen coming out. My feeling is that I’m hopeful and excited by the results, and in the absence of a working microbicide and a working vaccine, I think PrEP has the potential to be an important tool (once we have consistent data on its efficacy, that is). But at the moment, I just don’t know how this is going to happen.

For my doctorate, I looked at adherence to antiretrovirals and interviewed patients before they started ARVs and then followed them for the first two years of their treatment. And I just saw how challenging it is for HIV positive people, who are motivated, to take their pill –how challenging adherence was for them. So what happens when you give a healthy person a pill that makes them feel not too great (though most side effects generally resolve after a month), and they’re not even feeling sick from the disease? What happens if they don’t adhere to the treatment so well, and then you run into the problem of resistance and the overlapping concerns of drug availability, lack of resources, etc. So I’m concerned about how PrEP is actually going to be implemented, what adherence will be like, the potential for resistance, who’s going to pay for it, and where’s it going to happen. It just seems like the implementation of PrEP in the general population will bea minefield. But I think antiretrovirals seemed that way 20 years ago, so I’m hopeful that we can overcome these challenges. We just need to work harder at mapping out a country-specific way of doing this.

In your interviews, did anyone have any specific ideas on how to go about implementing PrEP? 

DM: I think there’s a general feeling that we need to understand the data’s inconsistencies, and before that we don’t move into the “how”. Though, even were the data to be consistent, there’s a remaining fear around the “how” – mainly because we can’t even follow the lead of the countries we normally follow sinceour situation with the HIV epidemic is so different. In South Africa, all you need to do to find people at risk is go into a township community and find adults who are sexually active. That’s the state of the epidemic in this country. So, during the course of my interviews, there weren’t a lot of specific ideas about implementation because people are stumped about how, and how financially, and who do we give PrEP to in a country with a generalised epidemic and limited resources?

Interestingly, people were more hopeful about microbicides. The feeling was that we are probably further away in terms of an effective working microbicide, but it might be more feasible if the microbicide was something that didn’t need a doctor to administer it. And this is something I hadn’t even thought about. To me, I always thought of microbicides as the same as PrEP, that you would need a doctor to prescribe and manage it, but a few experts seem to feel that it’s something that might be made available in the same way that condoms are available—you could then just pick it up like a condom or a lube and use it. And if that were to be the case, and I don’t know if it is, then many of the resource and logistical challenges would fall away.  

People also liked the fact that microbicides could be used in secret, without disclosure and the risk of stigma. The concern around PrEP is that it would be similar to taking antiretrovirals, in that it’s quite visible—you’d need your pills, and people might hide them to avoid the stigma of being thought of as HIV-positive by others. Whereas a microbicide could look like a sex toy; it could look like a lube and not seem quite so invasive. 

Though, in the South African context, a few people did mention how microbicides might run into a cultural challenge as far as adherence is concerned. In some African cultures, one of the things that people like is dry sex, which is the opposite of lubrication. In such a case, a microbicide would go against that, since it would likely be in the form of a lube or gel. So, within some African cultures, when seen in the context of enhancing sexual pleasure, microbicides might not always be seen as a good thing (Learn more about microbicides within the South African context here and here).

What do you think the big trends or questions about PrEP will be for 2012? What are people looking forward to learning or waiting to learn more about?

DM: People are waiting for WHO guidelines because people aren’t sure how to interpret the data on PrEP from the various trial results (learn more about the various HIV prevention studies here). Also, South Africa in December is going to be releasing our next set of guidelines, which happens every three years and is a big milestone. Essentially, this next set of guidelines is going to dictate what happens in the next three years in South Africa in terms of HIV. So there’s a timing question. We have got some data, but is it enough to implement anything? Should we be rolling out PrEP in men who have sex with men (MSM) who are self-identified high-risk? Should treatment move to 500 CD4 count? Are there little things that we can action? Or do we need more data?

We’re just waiting for more efficacy data around PrEP and microbicides specifically. We’re also waiting for more country-specific implementation data. There’s a general feeling that we need implementation studies, because even if the scientific data is not quite there, we can still work on things like, “If a microbicide becomes available, how will we roll it out?” So the next step is implementation studies—for modalities that are ready, like early treatment for prevention, and for modalities that are still in the pipeline, like microbicides. 

What do you think the South African guidelines coming out in December are going to say? Are there any rumours or thoughts about them amongst the people you spoke with?

DM: I’m not sure what the guidelines are going to say. I think they might say that we’re going to move treatment up to 500 CD4 count, and I think they might say, “Oral PrEP in MSM, who are self-identified, high-risk, and who come forward.” Which, when you think about it, is really all that the guidelines can say. A lot of these discussions that we’re having are theoretical at the moment because we don’t have a working microbicide and we don’t have a PrEP drug with great efficacy. 

I think what will be needed going forward are comparisons between the different modalities—it would be fantastic if we could have a trial that compares not necessarily efficacy, but just acceptability and feasibility of an early treatment vs. PrEP vs, microbicides vs. PEP even, and how these would work in the South African context. This is the research we need to start doing, though it requires a bit of a mind shift. We normally start doing implementation studies once we know that something works. But in the case of HIV, every day counts in terms of infection, certainly with an incidence rate like South Africa’s. So HIV might be a unique disease in that it requires implementation studies running concurrently with efficacy studies. We need to get cracking on these implementation studies!

Any other thoughts or observations you’d like to share? 

DM: After speaking with so many different people, what was interesting to me was how they all had strongly different points of view. The thing is, if we want to start implementing these strategies, this is a huge undertaking. It’s like saying, “Alright, we’re climbing Mount Everest”, and so we need the team to be on board and we need the team to be walking in the same direction. And I don’t know how we are going to get that consensus. For instance, 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? I think guidelines might help—if WHO puts out a nice set of guidelines, people might get in line.  

Read the first part of Daniella’s interview here. And stay tuned to the Mapping Pathways blog for a detailed snapshot of the various opinions amongst the South African HIV prevention community.

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

Global Fund to Fight AIDS, TB and Malaria Cancels Funding

via The Guardian, by Sarah Boseley

"If we lose the ground we have gained, we will be back to square one – all that effort and investment, lost. The decisions you make here today will determine the outcome."

In what must be seen as a serious setback in the progress made against the major infectious diseases in poor countries, a board meeting of the Global Fund to Fight Aids, TB and Malaria in Accra, Ghana, has effectively cancelled its next round of grant-making.

The fund has been staring at a financial black hole ever since its big replenishment meeting in New York a year ago failed to deliver the sums it hoped for. It wanted $20bn. It got $11.7bn. That was in spite of exhortations to donors to pledge money from the UN secretary general, Ban Ki-moon, who warned that the stakes were high and that lives would be lost if pressure on the big killer diseases was not maintained.

It once seemed unthinkable that the money would not continue to stream into programmes to treat people with Aids, TB and malaria and to prevent others becoming infected. But that is what is happening. There is no doubt that people who could have been spared will instead fall ill and die as a result of the drying up of funds. There is also a Damoclean sword hanging over the heads of people who are alive and well thanks to drug treatment for their HIV infection. The Global Fund – together with Pepfar (the President's Emergency Plan for Aids Relief) – has been the main source of money to pay for drugs. Those who start the combination treatments to prevent HIV causing Aids must stay on the drugs for life. If they stop, there is a danger the virus will become resistant to the drugs they are on.

The Global Fund's board is buying time by telling governments not to put in new applications for funding for round 11, which is supposed to provide money for 2011 to 2013. It is offering a "transitional funding mechanism", which will allow countries to ask for money to cover essential needs. In recognition of the danger of stopping HIV treatment, this should allow countries to continue to supply drugs to people who are already taking them.

But, as Secretary of State Hillary Clinton said in her recent address, the need now is to step up the fight against HIV by providing more drugs – not less. Scientific studies showed this year that treatment makes people with HIV less infectious. Failure to keep rolling out the drugs to more and more people will waste an opportunity to deliver what she and others have hopefully termed "an Aids-free generation".

Read the rest.


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

An AIDS Free Generation: Running Toward the Dream of a Lifetime

via The Chicago Tribune, by David Ernesto Munar

When I tested positive for HIV in 1994, I never would have imagined an AIDS-free generation to be possible in my lifetime.

I also didn't think I would live past 35.

And yet, I am 42 years old today and we have arrived at the precipice of that dream. With recent medical advances, and the promise of more soon to come, an AIDS-free generation is possible. Achieving this goal, as eloquently outlined by Secretary of State Hillary Clinton earlier this month, would save millions of American dollars and countless lives around the world.

The question is whether we have the political and social will to make it a reality.

No one is talking about what the deficit-reduction talks or the attempts to dismantle health care reform mean for stopping AIDS in this country. Now is the time for that conversation. Cutting funding for HIV/AIDS services, treatment and research would be devastating to our progress in defeating this 30-year-old epidemic.

And the full implementation of the Affordable Care Act is necessary to provide access to treatment for the thousands in our country who are on waiting lists because they cannot afford life-saving medications.
We need our political leaders to lead. We stand at the precipice of the AIDS-free dream but we're stuck. If HIV/AIDS funding is cut through the deficit reductions, our progress could, in the haunting words of poet Langston Hughes, "dry up like a raisin in the sun."

Backing up, why have the AIDS conversation now?

HIV/AIDS is no longer a death sentence. The drugs are better and those who take them are living longer, relatively normal lives. So, what's the problem?

The reality is that more than 1 million people still live with HIV in the United States, and more than half of them do not receive regular medical care that could save their lives and curb new infections. The rate of infections remains unchanged. The cost for antiretroviral drugs is exorbitant, ranging from $1,500 to $3,000 a month.

In fact, government programs to help HIV-positive people obtain lifesaving HIV medications are hamstrung by dangerous, growing waiting lists across the country. As of earlier this month, more than 6,000 people in 12 states were on the waiting lists for the AIDS Drug Assistance Program. Illinois does not have a waiting list, but state legislators recently approved a change in the program that will make fewer people eligible for assistance.

And stigma and systemic injustices also fuel new HIV infections.

Read the rest.


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

In Conversation with Daniella Mark: It's a question of “How?” in South Africa

* Original content from our Mapping Pathways blog team

We checked in with our colleague Daniella Mark from the Desmond Tutu HIV Foundation in South Africa, a Mapping Pathways partner organisation. For the past year, she has been conducting in-depth stakeholder interviews with South African policymakers, advocates, community leaders, physicians, academics, and scientists. As Daniella puts it, “All of these people are essentially gatekeepers; they have the ability to either push forward or halt a particular HIV prevention strategy or technology.”  We spoke with her about some of the trends she’s observing from her on-the-ground interviews, and her insights on HIV prevention within the South African context. This is the first part of a two-part interview.

Please briefly tell us a bit about yourself?

DM: Yes, of course. I’ve been with the Desmond Tutu HIV Foundation for six years now. My field of expertise is psychosocial research in the HIV field, which includes prevention — researching behavioural interventions or psychosocial issues around biomedical interventions (such as risk reduction counselling), as well as treatment — researching things like adherence and loss to follow-up and the psychosocial issues that impact them, like alcohol and drug abuse.

The Mapping Pathways research has been going on for almost a year now. What are some of the general trends you’re noticing for South Africa from the stakeholder interviews? 

DM: Because I’ve been doing the interviews myself, I am very close to the data. In general, what’s particular to South Africa is that while people are interested in different prevention technologies and strategies, there’s this huge concern about resources. It’s just that we have such a high incidence rate and, as of now, we have no prevention technology to effectively fight the disease apart from tools like condoms or, in some circumstances, circumcision. And we’ve been battling to make sure even these prevention strategies are effectively rolled out. So when you talk to people about something as far away from these existing prevention tools as PrEP, they can’t even imagine how we can incorporate this into our present strategy. 

So, I’m finding that capacity/resource concerns are present in each interview. People are in a state that they don’t know how we can pull this off. There’s also this ethical concern amongst researchers that we’re not effectively doing what we know works to curb the epidemic (condoms, etc), so there’s this ethical question over whether we can start revving up to bigger, more expensive prevention strategies if we’re not even giving sick people the treatment they need.

What is the general feeling about PrEP amongst the HIV advocacy community in SA right now?

DM: I’m finding that, as a whole, there is an interest in PrEP but there’s a lot of trepidation about “how”? I think people have this feeling that there are conflicting trial results, and it’s not quite clear how we put iPrEx and FEM-PrEP together, for instance. How do we understand these two conflicting results? We need to understand all this better. There’s a feeling that there’s a lot of excitement around PrEP, but it’s not particularly justified in the context of South Africa. In SA, we have a generalised epidemic, so we wouldn’t know which specific group to roll PrEP out too — we would need to give it to our entire population of 50 million people, or at least our adult population of 30 million, which is just not feasible. Whereas, in countries like the States or in India, you could find specific groups, such as gay men or men who have sex with men, to give PrEP to — which makes the question of resources and costs more manageable. So there is concern about the size of the group we would have to roll PrEP out to in South Africa, and also about the efficacy of the strategy. 

There is also concern about how we don’t have all the drugs available for treatment. It takes time to get pharma companies to give drugs to us at third-world prices, and interlinked to this concern are the questions of adherence and resistance. Tenofovir, which is one of the main drugs for use as part of antiretroviral therapy combinations such as those used in PrEP, is also first-line treatment in South Africa; what happens when an individual becomes resistant to it before they even present for first-line treatment? Second-line is far more expensive and we have no third-line options. There is a further and related concern that patients who are not symptomatic might adhere more poorly to PrEP (since they are not HIV-positive and are not experiencing HIV-related symptoms that may act as adherence motivators). As a result, they may be more likely to become resistant to the drugs, and then we’ll have difficulty providing treatment options if they were to become infected.

Other questions about “how” revolve around where would we run this programme out of? Would we open more HIV clinics with capacity to serve the general population as well as those infected? But then we run into the problem of stigma, which is a huge problem in Africa. Would people want to come to an HIV clinic for PrEP and face the stigma of going to such a clinic if they are not even infected? There were some suggestions that we could run PrEP programmes out of family-planning clinics, but then the individuals in the clinic would need upscaled training, and do we have the resources and money to provide this training effectively? 

So, right now in South Africa, the feeling about PrEP is how, how, how? People are open to it, but want more consistent data or at least to understand the inconsistencies in the data. Mostly though, the feeling is that we have to figure out these questions for ourselves — we can’t even follow the lead of the countries we normally follow such as the United States, because our situation is different since we have such a high incidence rate and generalised epidemic.

Stay tuned to the Mapping Pathways blog for the second part of Daniella’s insightful interview on the HIV-prevention mood in South Africa, and what she thinks some of the big questions and trends for 2012 will be.

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

Model shows excellent prognosis for UK gay men with HIV

via aidsmap, by Michael Carter

New UK research provides further evidence of the dramatic impact of antiretroviral therapy on the prognosis of HIV-positive patients. Published in the online edition of AIDS, a simulated model showed that a non-smoking, 30-year-old gay man, whose HIV is diagnosed promptly, could expect to live until he is 78 years of age. A gay man who smoked, but whose HIV was detected early, had a life expectancy of 75 years.

The model also showed that late diagnosis of HIV cut life expectancy. Nevertheless, it showed the clear benefits of HIV therapy in these circumstances. A gay man whose HIV was detected when his CD4 cell count was just 140 cells/mm3 could still expect to live until he was 71.5 years old.

“Predicted life expectancy in people with HIV is high in settings with access to multiple antiretroviral drugs,” comment the investigators. “Delays in diagnosis pose the greatest risk of excess mortality for people with HIV.”

It is now well established that modern antiretroviral therapy significantly improves the life expectancy of patients with HIV. However, investigators from the UK were concerned that studies attempting to quantify prognosis may have underestimated the benefits of treatment because they did not take into account improvements in HIV therapy and care.

They therefore developed their own prognostic model. It was based on 10,000 theoretical gay men whose HIV was diagnosed in 2010. They selected this group because factors other than HIV impact on the prognosis of the other main groups affected by HIV in the UK.

Rates of HIV testing currently observed in UK gay men were incorporated into the model. These show that HIV is generally detected early, with median CD4 cell count at the time of diagnosis being 410 cells/mm3. It assumed that the patients had fully drug-sensitive HIV, had a 40% chance of being a smoker for life, were not co-infected with hepatitis and were never lost to follow-up. HIV treatment was started when the patients’ CD4 cell count fell to 350 cells/mm3 and the patients were fully adherent to this.

Higher rates of some non-HIV-related illnesses have been observed in patients with HIV. Therefore, the investigators assumed that their simulated patients were 50% more likely to die of such diseases than individuals in the general population.

The same scenario was considered for patients whose HIV was diagnosed late.

In ideal conditions, with timely diagnosis of HIV, the life expectancy of patients was 75 years (range, 63 to 83 years). This increased to 78 years if the patient did not smoke (range, 66 to 86 years).

Read the rest.


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

Activists Urge a Change in Patent Laws in South Africa

via PlusNews Global

Ten years ago, the Doha Declaration allowed countries to circumvent patent rights to access life-saving medicines, particularly those used to treat HIV/AIDS, tuberculosis and malaria. However, the South African government has failed to take advantage of these provisions, and increasingly important TB medication and second- and third-line antiretrovirals (ARVs) remain out of reach, activists warn.

"Pre-Doha, treating [HIV] without generics... meant HIV was a death sentence," said Gilles van Cutsem, medical coordinator for Médecins Sans Frontières (MSF).

In South Africa, with the world's highest HIV infection rate, the availability of generic first-line ARVs meant a drop from an annual cost of more than US$10,000 per patient to $60. Now, with more than one million people on treatment, the country will need to put more HIV-positive people on second- and third-line regimens.

Right to health

The Doha Declaration, or the Declaration on the TRIPS Agreement (Agreement on Trade-related Aspects of Intellectual Property Rights), was signed by members of the World Trade Organization (WTO) in response to concerns that patent protection granted by the TRIPS Agreement would undermine the ability of countries to protect their right to health and access to medicines.

The 1995 TRIPS Agreement made all WTO members beholden to a pharmaceutical patent period of 20 years, during which time no generic could be produced. Before TRIPS, countries such as Brazil and India did not respect patent periods at all, and many other nations observed shorter time-spans (16 years in South Africa).

With the 2001 Doha Declaration, provisions within the TRIPS agreement to protect public health were reaffirmed, as were the rights of member countries to "use, to the full, the provisions in the TRIPS Agreement, which provide flexibility for this purpose".

This included the granting of compulsory licences, which allow a government to formulate or import generic versions of medicines essential to public health but still under the 20-year patent period.

To take advantage of public health flexibilities such as compulsory licensing, however, it must be enacted into national legislation. Unfortunately, few countries, including South Africa, have taken advantage of their rights.

Read the rest.


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

How to get to zero: Faster. Smarter. Better - UNAIDS World AIDS Day Report 2011

[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.]

The Debate Surrounding PrEP

via a&u, by Jeannie Gibbons

Post-exposure prophylaxis (PrEP) is the provision of antiretrovirals (ARVs) to HIV-negative people in order to prevent HIV infection. In light of recently released data, a heated debate is raging in the HIV community on how and if PrEP should be implemented. A vast array of ethical, financial, and medical concerns have been expressed, in fact too many to address in one article. However, most agree that PrEP (with more research), although not a single solution to preventing the continued spread of HIV, should be added to the arsenal of HIV prevention strategies where it is needed most.

Many contend that PrEP cannot be justified at the present time in all populations while millions already living with HIV are in desperate need of treatment. At the same time, the need for additional effective prevention methods, particularly among serodiscordant couples, men who have sex with men who practice unsafe sex, and disenfranchised women is immense, leading most to agree that PrEP should be explored for these groups.

Despite the concerns regarding PrEP, many in the HIV community view the recent PrEP data as a dramatic step and a valuable tool in reducing HIV transmission. “We’re excited about PrEP,” states Frank Oldham, president and CEO, National Association of People with AIDS. “Not because it will end HIV in America. It won’t and can’t. The epidemic is caused as much by poverty, homophobia, and an unfair healthcare system as it is by a virus, and no prevention tool, however promising, is going to end it until we do something about those problems. But PrEP has real promise for people for whom other prevention tools aren’t working—like sex workers, homeless youths, and women who aren’t in a position to negotiate safer sex with their partners. PrEP isn’t for everyone. We need to know more about its safety for women and adolescents. We need safeguards to make sure it isn’t given to people who already have HIV. But used wisely PrEP will save lives.”

Michael Ruppal, executive director of The AIDS Institute, echoes NAPWA’s concerns for caution and more data as well as their enthusiasm for PrEP’s potential. “The study data about PrEP offers some of the most exciting hope for stopping the transmission of HIV. With that comes a responsibility to be diligent to do more to answer long-term questions such as drug safety, efficacy, cost, access and ensuring additional studies. We all have a responsibility to educate ourselves and others about the truths surrounding PrEP and not let myths and fear drive our actions.”

Perhaps the greatest concern voiced by those both supportive and critical of PrEP is the high cost of this prevention modality. Close monitoring is essential for those on PrEP, adding to the cost of its use. Frequent HIV testing is necessary to prevent drug resistance from occurring from the use of suboptimal therapy if a person unknowingly seroconverts. Routine monitoring for ARV-related toxicities and adverse events, particularly kidney damage, loss of bone density, and changes in fat metabolism, which have been observed in clinical trials, must be conducted, as well as additional research to measure the long-term effects of ARVs on HIV-negative individuals.

In the iPREX study condom use was reported at ninety percent. Although self-reported adherence is not always accurate, the question if this high rate could be sustained under real world circumstances where counseling and safe sex education is not provided frequently as it was in the iPREX study has arisen. Could PrEP actually increase the risk of infection for some who, under the guise of being protected from infection by PrEP, discontinue using condoms?

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.]

Secretary Hillary Clinton on Creating an AIDS-Free Generation: Bouquets and Brickbats

* Original content from our Mapping Pathways blog team

“An AIDS-free generation would be one of the greatest gifts we could give to the future.Let's make it happen.”

On November 9, US Secretary of State Hillary Clinton delivered a speech on HIV/AIDS at the National Institutes of Health in Bethesda, Maryland – a speech that has triggered mixed reactions from people in the HIV/AIDS treatment and prevention field. Take a look at some excerpts:

“Today we are making major investments in the search for a vaccine; for tools like microbicides, which give women the power to protect themselves; and other lifesaving innovations.”

“… our efforts have helped set the stage for the historic opportunity the world has today: to change the course of this pandemic and usher in an AIDS-free generation.”

“… creating an AIDS-free generation has never been a policy priority for the United States Government until today, because this goal would have been unimaginable just a few years ago … It requires all of us to put a variety of scientifically proven prevention tools to work in concert with each other.”

“America's combination-prevention strategy focuses on a set of interventions that have been proven most effective: ending mother-to-child transmission, expanding voluntary medical male circumcision, and scaling up treatment for people living with HIV/AIDS.”

“… we now know that if you treat a person living with HIV effectively, you reduce the risk of transmission to a partner by 96 percent.”

“Treating HIV-positive people before they become ill also has indirect economic benefits.It allows them to work, support their families, and contribute to their communities; and it averts social costs, such as caring for orphans whose parents die of AIDS-related illnesses … In other words, treating people will not only save lives – it will generate considerable economic returns too.”

“… we need to let science guide our efforts. Success depends on deploying our tools based on the best available evidence.”

“An AIDS-free generation would be one of the greatest gifts we could give to the future. Let's make it happen.”

A number of HIV/AIDS activists have applauded Clinton’s “bold” speech, pointing out her emphasis on the prioritization of the fight against the epidemic, her focus on scientific evidence, and her call for immediate action to take advantage of the “historic opportunity” to create an “AIDS-free generation.” Many hope that this kind of public statement will help boost activism to preserve domestic and international funding.

On the other hand, while Clinton mentioned vaginal microbicides for women, she failed to talk about pre-exposure prophylaxis (PrEP) and rectal microbicides. These two prevention strategies are meant to protect uninfected people from the HIV virus – they have been the subject of numerous recent trials, with substantial success being demonstrated in many of them. (Take a look at our blog post on some of these studies.) Some feel Clinton’s decision give these new prevention technologies a miss can be attributed to political, financial, and social reasons.

“The omissions were disappointing but not surprising,” says 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. “Her audience was international, which means predominately heterosexual, so I suppose it made strategic sense that she would steer clear of PrEP, which has been shown to be effective for gay/bisexual men but has produced conflicting results for heterosexuals. Nonetheless, with gay men and other men who have sex with men experiencing catastrophic rates of HIV the world over, it remains disturbing to me that this group was not even mentioned, whether in conjunction with PrEP or not.”

Another possible reason for the omission of PrEP is the fact that the global jury is still out on the feasibility of rolling out PrEP interventions while there are HIV-infected people who do not have access to treatment – a problem made all the more complex because of the crippling HIV/AIDS funding constraints over the last few years. However, Pickett firmly believes that the either/or stance taken by those nixing promising preventive technologies is dangerous and close-minded. “We’re continually working to get enough information and data to answer the big questions we’re grappling with – questions about efficacy, accessibility, funding, prioritization, and acceptability. These questions are extremely challenging, but it’s imperative that we work on solving them,” says Jim. “It’s not an option to stick our head in the sand. To turn the dream of an AIDS-free generation into a reality, it is absolutely clear that we must expand access to effective ARV drugs for all those who need them – whether they are HIV-positive or HIV-negative.”

To know more about Secretary Clinton’s speech and the responses to it, read the AIDS Foundation of Chicago’s story and Science Magazine’s article. You could also check out this letter to Secretary Clinton – a blog post written by an IRMA member.

You can read the entire speech here.

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

The Beginning of the End of AIDS

via The Huffington Post, by Sheila Nix

Everyone loves a good "they said it couldn't be done" story. From a man on the moon to a personal computer in every home, the nostalgic in each of us loves to reflect about how, throughout history, individuals have run up against the status quo, defied the odds, and achieved something inspirational for society at-large. Those of us in the AIDS advocacy community have experienced our fair share of doubters telling us "it can't be done."

30 years ago when HIV/AIDS cases were first documented, it was a mysterious infection that couldn't be treated. Positive diagnosis was a death sentence. With no treatment, stigma and fear grew, representing what Dr. Anthony Fauci calls "the dark years." But with scientific innovation came the discovery in 1987 of AZT, the first drug approved to treat HIV. Over the next few years, AZT was replaced with more sophisticated combination drug therapy, and by 1996 highly active antiretroviral therapy had been developed. The new drugs were hugely expensive, however, costing $10,000 per year or more. Many HIV-positive people feared that without Magic Johnson's checkbook, they wouldn't be able to get the drugs they needed to keep them alive. Today, AIDS treatment costs just a few hundred dollars per year in poor countries -- a victory for HIV-positive communities around the world.

In the early 2000s, as President Bush and bipartisan Congressional leaders were launching a program called PEPFAR and as the Global Fund to Fight AIDS, Tuberculosis, and Malaria was just getting started, the doubters loomed large. Many believed there was no way to get antiretroviral treatment to millions -- particularly in Africa where some infamously suggested "Africans don't have watches" and so couldn't be expected to take drugs in a consistent manner. Others argued that mobilizing the financing required to hit PEPFAR and Global Fund targets was impossible. Yet global funding for AIDS skyrocketed, growing six-fold between 2002 and 2008. African leaders also stepped up, committing to spend 15% of their budgets on health. Today, the results speak for themselves: 6.6 million HIV-positive people, including those in remote communities, are alive today because of treatment, and countless others have remained HIV-negative thanks to prevention efforts.

In spite of these achievements, economic recessions have a unique way of allowing the "it can't be done" mantra to reemerge. Indeed, as budgets constrict and leaders turn their attention inward, it's easy to see why a renewed push on global AIDS doesn't seem possible. Yet 2011 marks a critical inflection point in our fight against AIDS. Game-changing studies have offered exciting new tools in the fight to prevent HIV -- including new data that shows treatment works as prevention, reducing the likelihood of passing on HIV by as much as 96%. Collectively, these advances show that bending the curve on AIDS is possible in our generation.

Read the rest.

[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.

Read the rest.


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

Gay men/MSM & the HIV Epidemic: Microbicides, Funding, and Sex

* Original content from our Mapping Pathways blog team

Three interesting bits of news in the world of HIV prevention and treatment for gay men and other men who have sex with men (MSM):

Project GEL: According to the Centers for Disease Control, gay men/MSM constitute more than half the HIV cases in the US. In an effort to address the HIV vulnerability of the gay community, the US government recently began funding Project GEL, which aims to develop a more effective method of preventing HIV infection among gay/MSM. Already in three locations – Boston, Puerto Rico, and Pittsburgh – the project isfinding out and assessingwhy so many people don't use condoms each time they have sex. The end goal is to address this gap in HIV prevention by developing a microbicide product and applying it to a real-life setting.

Project GEL has three main phases:

• Study the sexual health of young gay men/MSM, particularly men of color.
• Examine how gay men/MSM feel about using the proposed gel prior to anal sex and whether or not they would actually use it before engaging in sexual activities.
• Research the microbicide gel itself, including side-effects and responses.

To know more about Project GEL, check out their website or this recent article about their work.


New funding resource from amfAR’s MSM Initiative: The Foundation for AIDS Research (amfAR)’s MSM Initiative provides financial and technical support to community-based organizations fighting HIV among MSM in low-and-middle income countries. Through this initiative, amfAR also “builds global understanding and awareness of HIV epidemics among MSM, and advocates for effective policies and increased funding”.

In October, the MSM Initiative launched a new fundraising toolkit to assist community-based organizations that provide HIV-related programs and services for gay and bisexual men, other MSM, and transgender individuals. It includes information about relevant donors and funders, snapshots of grant programs, and how to contact and approach funders. Read more and download the guide here.


Men’s Sex Study: The Journal of Sexual Medicine recently published study results on the sexual behavior of gay and bisexual men. The community report assessed responses from nearly 25,000 users of Manhunt and DList – online social forums for gay and bisexual men. The parent company of these websites is now communicating this scientific data in a user-friendly manner through a creative yet informative website.

The effort has won a lot of praise in the HIV prevention community as well; the format makes it easy to understand serious study data on gay men’s sexual behavior – the first step in developing real-world HIV-prevention methods for MSM. The results also suggest that some popular misconceptions and stereotypes need to be examined and addressed. (You can also read the full report here.)

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

FACTS 001: A Quick Update

 * Original content from our Mapping Pathways blog team

Remember the FACTS 001 trial that was announced in South Africa in June 2011? (Read our blog post on it if you don’t.) We are very happy to share an exciting update about it!

On October 21, 2011, the first study participant was enrolled in this Phase III clinical trial of vaginal tenofovir gel (a microbicide, meant to protect women against HIV infection). The Desmond Tutu HIV Foundation brought the first participant on board. Five sites have begun screening women, in Cape Town, Johannesburg, Soweto, Rustenburg, and Pretoria.

To give you a quick recap, this landmark trial is a large-scale, randomized, placebo-controlled clinical study that is meant to test the safety and confirm the effectiveness of tenofovir gel used before and after sex to protect women against HIV infection, as well as HSV-2 (a virus that causes genital herpes). A total of 2,200 HIV-negative women between 18-30 years of age are going to be enrolled across nine sites in South Africa.

Essentially, the aim is to verify the CAPRISA 004 results in "larger, more diverse populations". The trial is being conducted by FACTS (Follow-on African Consortium for Tenofovir Studies) and led by Professor Helen Rees, the Executive Director of WHRI (Wits Reproductive Health and HIV Institute). FACTS 001 is sponsored by CONRAD and funded by the South African Department of Science and Technology, the U.S. Agency for International Development (USAID) and the South African Department of Health. CONRAD and Gilead Sciences, Inc. are providing the study products.

So, why is this trial such a milestone in the world of HIV prevention? If this study, along with VOICE which is testing the use of tenofovir gel and oral Truvada tablets, confirms that tenofovir gel is safe and effective, it could lead to the first licensed vaginal microbicide product. Women would then have access to and be able to control this brand-new HIV prevention method. Truly revolutionary developments!

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

Integrating ART in Patients with TB

via The New England Journal of Medicine, by Salim S. Abdool Karim, M.B., Ch.B., Ph.D., Kogieleum Naidoo, M.B., Ch.B., Anneke Grobler, M.Sc., Nesri Padayatchi, M.B., Ch.B., Cheryl Baxter, M.Sc., Andrew L. Gray, M.Sc.(Pharm.), Tanuja Gengiah, M.Clin.Pharm., M.S.(Epi.), Santhanalakshmi Gengiah, M.A.(Res.Psych.), Anushka Naidoo, M.Med.Sci.(Pharm.), Niraksha Jithoo, M.B., Ch.B., Gonasagrie Nair, M.B., Ch.B., M.P.H., Wafaa M. El-Sadr, M.D., M.P.H., Gerald Friedland, M.D., and Quarraisha Abdool Karim, Ph.D.

Background

We previously reported that integrating antiretroviral therapy (ART) with tuberculosis treatment reduces mortality. However, the timing for the initiation of ART during tuberculosis treatment remains unresolved.

Methods

We conducted a three-group, open-label, randomized, controlled trial in South Africa involving 642 ambulatory patients, all with tuberculosis (confirmed by a positive sputum smear for acid-fast bacilli), human immunodeficiency virus infection, and a CD4+ T-cell count of less than 500 per cubic millimeter. Findings in the earlier-ART group (ART initiated within 4 weeks after the start of tuberculosis treatment, 214 patients) and later-ART group (ART initiated during the first 4 weeks of the continuation phase of tuberculosis treatment, 215 patients) are presented here.

Results

At baseline, the median CD4+ T-cell count was 150 per cubic millimeter, and the median viral load was 161,000 copies per milliliter, with no significant differences between the two groups. The incidence rate of the acquired immunodeficiency syndrome (AIDS) or death was 6.9 cases per 100 person-years in the earlier-ART group (18 cases) as compared with 7.8 per 100 person-years in the later-ART group (19 cases) (incidence-rate ratio, 0.89; 95% confidence interval [CI], 0.44 to 1.79; P=0.73). However, among patients with CD4+ T-cell counts of less than 50 per cubic millimeter, the incidence rates of AIDS or death were 8.5 and 26.3 cases per 100 person-years, respectively (incidence-rate ratio, 0.32; 95% CI, 0.07 to 1.13; P=0.06). The incidence rates of the immune reconstitution inflammatory syndrome (IRIS) were 20.1 and 7.7 cases per 100 person-years, respectively (incidence-rate ratio, 2.62; 95% CI, 1.48 to 4.82; P<0.001). Adverse events requiring a switching of antiretroviral drugs occurred in 10 patients in the earlier-ART group and 1 patient in the later-ART group (P=0.006).

Conclusions

Early initiation of ART in patients with CD4+ T-cell counts of less than 50 per cubic millimeter increased AIDS-free survival. Deferral of the initiation of ART to the first 4 weeks of the continuation phase of tuberculosis therapy in those with higher CD4+ T-cell counts reduced the risks of IRIS and other adverse events related to ART without increasing the risk of AIDS or death. (Funded by the U.S. President's Emergency Plan for AIDS Relief and others; SAPIT ClinicalTrials.gov number, NCT00398996.)

Read the rest.


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