Find Mapping Pathways at AIDS 2012

Original content from the Mapping Pathways blog team

The Mapping Pathways team will be participating in a number of sessions at the International AIDS Conference (AIDS 2012) in Washington, DC this July. Please check out our list of activities below, and join us!

We will be sharing data we collected in 2011 from India, South Africa and the United States - all related to the utilization of ARVs as HIV prevention. Community and stakeholder perspectives from the "grassroots" and the "grasstops" will be highlighted in each of our focus countries, and sharing an analysis of an extensive literature review conducted by RAND.

Mapping Pathways at AIDS 2012

Click on "View on slideshare" to download the PDF. We hope to see you in DC!

[Content that is linked from other sources is for informational purposes and should not construe a Mapping Pathways position. Please look for us on Facebook here www.facebook.com/MappingPathways and you can follow us on Twitter @mappingpathways as well.]

AVAC Updates: Newest Issue of Px Wire and M2012 Road Map are Now Available!

via AVAC.org

This update provides a summary of and link to download the newest issue of Px Wire, as well as a roadmap for advocacy and communications-related sessions at the upcoming International Microbicides Conference (M2012).

Px Wire

Download the current issue of Px Wire (Volume 5, Issue 2), a quarterly update on biomedical HIV prevention research worldwide.

In this issue of Px Wire, we are excited to showcase a new ARV-based prevention timeline graphic, just in time for M2012. The timeline shows estimated efficacy trial end-dates, related confirmatory studies and dates of possible regulatory submission for a range of prevention options including oral PrEP with TDF, oral PrEP with TDF/FTC, vaginal and rectal formulations of tenofovir gel and the dapivirine-containing vaginal ring.

We also hope you enjoy reading the feature story in Px Wire where we describe the ongoing work of advocates who are working to influence PEPFAR Country Operating Plans.

Other highlights in this issue of Px Wire include:

• Information on how advocates can contribute their voices to the US FDA’s May 10 public meeting on Gilead Science’s submission for TDF/FTC (Truvada) as PrEP for HIV-negative adults

• Summaries of new AVAC resources: PrEP Using Daily Oral TDF/FTC or TDF in Women (and Men) — What the science tells us in March 2012, and new advocacy resources for voluntary medical male circumcision

• Upcoming events

2012 International Microbicides Conference (M2012)

Next week advocates, policy makers, researchers and funders will meet at the 2012 International Microbicides Conference taking place April 15-18 in Sydney, Australia. Building on past conferences, M2012 is a platform to discuss the latest in microbicides, PrEP and other ARV-based prevention research, as well as the basic science, structural, social and community issues that affect research and eventual rollout of these new tools. M2012 will feature several sessions that focus on advocacy and the role community advocacy and communication plays in the field. Our online conference “roadmap” highlights a number of these sessions. If you will be attending the conference, we invite you to join us at these events. Please visit the AVAC M2012 page for updates on these activities.

If you are not able to participate in M2012 in Sydney, please watch out for information on special AVAC post-M2012 webinars covering critical issues that emerge at the conference. For key updates during the conference visit NAM/AIDSMAP.

As always, if you have any questions please contact us at avac@avac.org.


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

CROI 2012: Results of iPrEx Trial Show Effective Dosage of PrEP

via AidsMap.com, by Gus Cairnes

Further testing of drug levels in the blood and immune cells of gay men participating in the iPrEx trial of tenofovir/FTC (Truvada) pre-exposure prophylaxis (PrEP) has found that HIV infection in men assigned to Truvada was associated with a lapse in taking the drug after initially adhering reasonably well, rather than never having taken it at all, which was what the researchers originally thought. The research was presented at the 19th Conference on Retroviruses and Opportunistic Infections (CROI), in Seattle.

The testing also found that only a minority of participants appeared to be taking their drugs as prescribed, seven days a week, but that protection levels were very high – in the order of 96% of infections prevented – as long as participants took four or more doses a week.

Drug levels plummet three months before infection

 The results of iPrEx, a large multi-country study of PrEP in gay men, were announced in 2010 and showed an overall efficacy of 42% – in the trial subjects as a whole, four out of ten HIV infections that would otherwise have happened were prevented if subjects were given Truvada pills to take daily rather than placebo pills. When drug levels were tested in the 48 participants who became HIV-infected on Truvada, and a random sample of uninfected participants, it was found, perhaps not surprisingly, that drug was detectable in only 10% of the infected participants but also, perhaps more surprisingly, in only 50% of the uninfected ones.

New measurements have now looked back at drug levels in stored samples in the months prior to infection and compared with drug levels in the same time period in uninfected participants. In the uninfected participants, consistently 45% or so had detectable drug in their samples across the whole length of the study – confirming that at least half of the participants simply never took their pills. In the infected participants average adherence rates started off the same as in the uninfected. They showed a slight decline in the first year of the trial but then declined to 10% in the three months preceding infection. This suggests a role for quarterly adherence reinforcement.

What levels of tenofovir are protective?

 The researchers also wished to find out what levels of tenofovir in the blood were associated with protection against HIV. They did this by comparing drug levels in iPrEx participants with drug levels in a small study called STRAND, presented at last year’s conference (Liu),which gave participants directly-observed doses of tenofovir twice, four time or seven times a week and then measured drug levels in their hair. By then comparing the levels of protection seen in participants with specific drug levels in iPrEx, the researchers were able to compute what drug level was protective.

In iPrEx the average drug levels seen in infected people were consistent with less than one dose of tenofovir a week, but drug levels in those who were not infected were consistent with only about three doses a week. Only 18% of iPrEx participants had drug levels consistent with taking seven doses a week. The investigators used very sensitive tests to look at levels of metabolised tenofovir inside cells and found that a reduction of 90% in the risk of HIV infection correlated with a drug level of 16 femtomols per mol (fm/M – 16 in every million billion molecules by weight). The average level associated with seven doses a week in STRAND was about 38 fm/M and with four doses a week about 32 fm/M.

This enabled them to calculate that the protection offered by taking four doses of tenofovir a week was high, and more or less the same as taking seven doses – that is, in the order of 96%, with a minimum likely protectiveness of 90%. They also calculated that absolutely perfect adherence would offer 99% protection. Taking two doses a week (consistently) would still offer 72% protection, though within wide confidence intervals (56% to 96%) while the 42% level of protection actually seen in iPrEx was consistent with participants taking, on average, one dose a week.

This study has important limitations. STRAND did not measure FTC levels so the iPrEx researchers could not calculate what extra protection was offered by that drug. They also could not measure drug levels at the actual moment of exposure – they were measured at anything between 15 and 90 days after infection. And of course the ‘number of doses a week’ measure is purely an average – most participants probably had much more irregular patterns of taking their pills, with (amongst the 50% who took it at all) periods of good adherence interspersed by periods off drug, maybe correlated with times on and off sex. But it does give a guide to the likely minimum levels of tenofovir that people need to maintain in order to be protected from HIV.



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

The year ahead: Q&A with Jim Pickett

Original content from the Mapping Pathways team

MP: In terms of studies and projects, what are you most looking forward to this year?

JP: It’s going to be an eventful year in the HIV prevention world – I’m excited, energized, and daunted, all at the same time! I’m looking forward to just following the science and seeing where that takes us. For instance, rectal microbicide trials are taking an international leap and moving up into phase 2, which is HUGE.

The other big aspect we all need to focus on this year is getting into the implementation particulars around PrEP. There is a PrEP implementation project starting in the US – about 500 gay men split between San Francisco and Miami who will be given PrEP. This is an actual implementation project, NOT a research study, and we hope to learn a great deal from it. There are critical questions around delivering the intervention: How do you get the pill to people? How do you help make sure they’re adherent? How do you keep them in the loop for ongoing testing, so you know soon if they seroconvert? We don’t know the answers because we’ve never done it! It will be very interesting and informative to see how that plays out…what comes up, what works, what’s a problem, and what needs to be changed.

There are also studies (some are happening and some are scheduled to begin in 2012) looking at different ways of dosing PrEP. Right now, we have proof that PrEP used every day works. But what about intermittent dosing – a few times a week or just around the time of sex? What about those strategies? We won’t have hard data in this year but we’ll start learning more. If we can, in fact, do intermittent dosing, or dosing just around the time of sex, that could be great – it would reduce costs, and importantly, make it easier for people to adhere. We may also find out that intermittent dosing, or dosing around the time of sex, doesn’t work. Whatever we find out will be critical to assess as we move forward with PrEP as an HIV prevention strategy.

MP: What are your thoughts on the upcoming US presidential election?

JP: I’m daunted by the 2012 American elections. Whatever happens will be critical for the entire world in terms of how we move forward with the provision of services, science, and research. American elections are always important for everybody, with far-reaching implications – and this time, the stakes are really high. It’s a critical year. But I guess you could say that about every election. When wouldn’t we say it’s critical?

MP: What about the global political landscape?

JP: If you look at politics globally, with economic crises rolling across much of the world, how governments support this work or not will be really important. We don’t want to lose ground. UNAIDS put out a report in November – an annual global snapshot – that shows that 50% of people who need treatment are now on treatment. That’s a big jump up, a good number. We’re going in the right direction and we’ve been able to achieve that even in tough times. But you’re only as good as you are today and we don’t want to lose that ground – we want to move to a place where everyone who needs treatment has it, not just half. Half is better than where we were, but we need to move forward.

We all need to keep a close eye on global politics and how that affects priorities in terms of both provision of treatment for people with HIV and ongoing work in prevention. We can’t treat ourselves out of this. We have to have a solid mix of prevention and treatment and care. Our approach needs to be holistic; if we start throwing things to the side and looking at one or two “magical” solutions, we’re going to be in trouble. When you have new things, there’s a desire to say that the old things don’t work, let’s just look at the new things and throw everything else out. Also, in times of economic scarcity, there is a tendency to pare down. We have to be smarter, use our money more strategically. Does everything work equally well? No. Can we get rid of some things? Probably, yes. But that requires a lot of thought and analysis, and every decision needs to be localized.

I think that’s what this year is going to be characterized around...how we start to make sense – and use – of all this science we’re amassing. We’re getting more and more into the rubber-hits-the-road phase.

MP: In terms of conferences in 2012, what are the highlights for you?

JP: The 2012 International Microbicides Conference will take place in Sydney in April. And the granddaddy of all conferences, the International AIDS Conference, is being held in Washington, DC in July. It’s the first time it’s been in the US for a couple of decades because we had a ban on people with HIV traveling here, which precluded us from being able to host that conference. The ban was recently lifted by the Obama administration. This conference is going to be a big deal. It’ll put the spotlight on DC, in terms of DC’s support for HIV/AIDS both domestically and internationally. It’ll also be another great opportunity for Mapping Pathways to disseminate information and we’re hoping we’ll be able to utilize that huge stage – the biggest AIDS stage there is.

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.]