AIDS 2012 and FDA approval: Seminal events in the world of HIV prevention

Original content from the Mapping Pathways blog team

Even in the dynamic world of HIV prevention, July 2012 is already a landmark month – even before nearly 25,000 people descend on Washington, DC for the International AIDS Conference (AIDS 2012).

The news that has most advocates and program implementers excited is the U.S. Food and Drug Administration (FDA) approval of a new prevention indication for Truvada, an ARV drug commonly used for HIV treatment. Truvada can now officially be used as PrEP (pre-exposure prophylaxis) for people at high risk of acquiring HIV through sexual activity. These “at-risk” individuals include HIV-uninfected gay men and other men who have sex with men (MSM) and HIV-uninfected partners in seriodiscordant relationships.

In approving Truvada for PrEP, the FDA followed the recommendation of a panel of experts that voted to approve the drug on May 10.

Here is what the new Truvada label and prescribing information will look like.

The FDA directed drug maker, Gilead Sciences, to come up with a Risk Evaluation and Mitigation Strategy (REMS) to minimize the risk to uninfected individuals of acquiring HIV infection and to reduce the risk of resistance.

Some concerns remain, the most crucial of them being cost. Truvada is not a cheap drug – costing as high as $13,000 a year retail in the United States (it is available as a generic for a fraction of this cost outside the U.S.) – and it will be a challenge to get the drug to the most “at risk” groups, many of whom lack access to any healthcare. Adherence support, behavioral counseling, and regular HIV testing and monitoring for potential drug toxicities will also be very important. It is clear that PrEP needs to be embedded in a holistic healthcare construct – and it’s much more than individuals simply taking a pill every day.

Addressing these issues (and others) are paramount, and will occupy the energies of advocates, researchers and community organisers, many of whom will convene and share findings at AIDS 2012.

AIDS 2012, the “granddaddy of all conferences,” according to Jim Pickett, Director of Prevention Advocacy and Gay Men’s Health at the AIDS Foundation of Chicago, is a great opportunity for the Mapping Pathways project to disseminate information and findings.

The Mapping Pathways team will be participating in a number of sessions at AIDS 2012 starting with a satellite session on Sunday, July 22 titled “From Revolution to Reality: How Will New Science Impact the U.S. National HIV/AIDS Strategy?” Molly Morgan Jones from RAND Europe, a Mapping Pathways partner organisation, will be one of the presenters in this session and will share analyses specific to PrEP in the U.S. context. .

Jones, along with other Mapping Pathways team members, will also be presenting two new posters at AIDS 2012, which will include information gathered from the community surveys, policy interviews, the literature review and the ExpertLens.

Presentation slides and posters will be featured on the blog during the conference.

Stay tuned to the blog as we continue to bring you updates from AIDS 2012 as well as reactions from advocates and stakeholders on the FDA approval of Truvada.

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