Original content from the Mapping Pathways blog team
As the year 2012 passes its halfway mark, it is time to take stock of some of the key events this year in the field of HIV treatment and prevention as well as some of the highlights of the Mapping Pathways project.
The year opened on a slippery note with the January 2012 issue of Sexually Transmitted Diseases – Journal of the American Transmitted Diseases Association publishing data from a rectal health and behavior study whose findings “suggest some lubricant products may increase vulnerability to STIs.”
The paper fueled a tremendous amount of discussion in HIV treatment and prevention communities around the world, including the membership listserv run by IRMA (International Rectal Microbicide Advocates).
“We need to be clear – there are only associations between lube use for anal intercourse and STDs. There is no proof that lube use causes increased risk. We simply don’t know that. Because we don't know, IRMA has long been advocating for a lube safety research agenda to fill in our gaps in the science and the evidence base,” says Jim Pickett, Director of Prevention Advocacy and Gay Men’s Health at the AIDS Foundation of Chicago, chair of IRMA, and a member of the Mapping Pathways team. Click here for more info on lube safety.
Partners PrEP trials, was revealed at the 19th Conference on Retroviruses and Opportunistic Infections (CROI) in Seattle, Washington. All the webcasts and sessions from the conference can be viewed online here.
The FEM-PrEP trial’s independent data and safety monitoring board (DSMB) recommended that the trial be halted due to “futility” in April 2011 as the study could not answer the question of whether daily Truvada worked, or not, in terms of preventing HIV among the trial population. New information presented by investigators at CROI suggested that the lack of efficacy was related to low levels of adherence to medication.
While participants in the study stated that they took their pills 95% of the time, drug levels found in the blood of women assigned to the Truvada study wing indicated that less than 50% of the women had actually taken the drug in the last 12 days.
In contrast, the Partners PrEP study indicated adherence to medication at almost 97%. Early results reported in Rome last July showed high levels of effectiveness in both men and women. These findings were reviewed at CROI, with no major changes to the estimated effectiveness of the drug.
At CROI, the Partners PrEP team presented analyses of plasma tenofovir levels in trial participants who became HIV-positive and a group of 1,000 participants who did not.
Two key findings were that individuals who remained HIV-negative had detectable blood levels of tenofovir at 82% of their study visits and that having detectable tenofovir in your blood at any given study visit was highly predictive of being HIV-negative at that visit.
The trial had a tenofovir arm, a Truvada arm and a placebo arm. According to the Partners PrEP team, “TDF (tenofovir) and FTC/TDF (Truvada) PrEP definitely provided 67% and 75% protection, respectively, against HIV-1 acquisition in African men and women at risk for HIV-1 infection, when provided in the context of other HIV-1 prevention services.” In short, women and men who took daily tenofovir-based PrEP had a significant reduction in HIV risk.
The results of the iPrEX trial indicated that gay/MSM participants who took Truvada daily had a 44% reduction in HIV incidence over the course of 1.2 years of follow-up compared with placebo. For individuals who did take the drug, and had detectable levels of drug in their bodies, the efficacy of Truvada as PrEP was approximately 90%.
At CROI, researchers presented new results of a case-control analysis on drug levels of the iPrEx trial participants that indicated that the blood-drug level observed with a dosing frequency of four doses per week was associated with a 95% reduction in HIV risk.
Mapping Pathways presented an oral abstract at the Microbicides 2012 (M2012) conference in Sydney in April. Pickett says the abstract and presentation were well received and generated a lot of interest in work Mapping Pathways has been doing and is planning to do in the coming year.
The importance of adherence was further highlighted at M2012. Says Jim “Adherence, the A-word, was a very big topic throughout the entire conference. We realized that we have to make HIV-prevention or treatment products people like and will want to adhere to. We have to figure out how tools like PrEP and microbicides fit in people’s lives, and funding should be put in place to better understand what people want, how they have sex, and the role of pleasure, love and intimacy, among many other ‘real world’ realities.” (Read our entire interview with Jim here.)
In May, an important landmark was achieved when a panel of experts at the U.S. Food and Development Administration (FDA) recommended approval of Truvada for use in PrEP in HIV-uninfected gay men and MSM, HIV-uninfected partners in serodiscordant relationships and other individuals “at risk” of acquiring HIV through sexual activity.
The webcast can be seen here and copies of all the slide presentations are here. The final FDA decision is expected by mid September.
June saw Mapping Pathways team members disseminating findings at the International Association of Physicians in AIDS care (IAPAC) evidence summit on TasP and PrEP in London. Click here to see Jim’s slides and here to read more analyses of the meeting via aidsmap. .
In light of the FDA panel’s approval of Truvada for PrEP in May, Mapping Pathways U.S. partners, AIDS United and AIDS Foundation of Chicago, presented a webinar June 19 focusing on PrEP. Key U.S.-focused findings of the Mapping Pathways online survey and stakeholder interviews were presented at the webinar helping illuminate diverse perspectives of advocates, clinicians, policy makers and people living with HIV.
In a few weeks, Mapping Pathways team members will be presenting data collected in 2011 from India, South Africa and the U.S. at the International AIDS Conference (AIDS 2012) in Washington D.C. The data presented will include findings related to community stakeholder perspective on ARV-based prevention – “grassroots” and “grasstops” – as well as an extensive literature review conducted by RAND, a Mapping Pathways partner.
Please click here to see the complete list of Mapping Pathways activities at AIDS 2012. And join us! All posters and presentations from AIDS 2012 will be made available on the blog, and archived here.
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