By Jim Pickett,
Director of Prevention Advocacy and Gay Men’s Health

Decades of dogged research and passionate advocacy have led us to this day.

And while thrilling and revolutionary, the advancement of PrEP carries with it many questions, too.

On May 10, the FDA Antiviral Drug Advisory Committee strongly recommended that emtricitabine/tenofovir disoproxil fumarate (TDF/FTC or Truvada) be approved for use as pre-exposure prophylaxis (PrEP) among sexually active adult men and women – particularly gay men and other MSM, serodiscordant heterosexual couples, and other individuals at high risk. It is likely the FDA will follow the committee’s recommendations and issue a new prevention indication for the use of Truvada by mid-June. While doctors have been able to prescribe Truvada “off label” for the prevention of HIV, this new indication will make it official – and allow for greater access.
There are many unknowns. How will people take PrEP in the “real world,” outside the artificiality of a clinical trial? Will people adhere properly? What about drug resistance for people who unknowingly take PrEP when they are already HIV-positive? Who will pay for the intervention, and how will we deliver it to the populations most in need, with the appropriate mix of behavioral interventions and health monitoring?

And how many people will stop using condoms and use PrEP instead? Will there be more unsafe sex?

We’re thinking about these questions, and more.

On the flipside, many people already don’t use condoms for a number of reasons. The correct and consistent use of PrEP by these individuals would mean more protection than currently exists, not less. The tools we currently have available to prevent the sexual acquisition of HIV have proven to be inadequate – that is without question. While PrEP won’t be “the answer,” it will offer people an important new option they’ve never had before.

It could mean MORE SAFE SEX, NOT LESS.

AFC strongly supports moving forward with PrEP, including demonstration projects and further research to learn more about this intervention. We have been following this issue closely on multiple levels across local and global landscapes, including research, advocacy, policy, and program implementation. Our Mapping Pathways project is exploring both the policy and implementation ramifications of PrEP in three countries, in addition to other ARV-based prevention strategies such as vaginal and rectal microbicides and expanded testing, improved linkage to care, and the offer of earlier treatment.

Members of our policy team and IRMA project (International Rectal Microbicide Advocates) work closely with national partners on PrEP advocacy, and our prevention and care teams are thinking carefully about how PrEP can, will, and should be integrated into the programs we administer and deliver. We’re encouraging people who use PrEP to share their stories on My PrEP Experience. And we count ourselves very lucky to be close to the research in a tangible way – Chicago has a clinical trial site at Stroger Hospital of Cook County that is currently investigating the use of Truvada among gay men in an open label study.

Truvada as PrEP is the first new prevention technology out of the box, and it isn't perfect by any stretch. It’s certainly not the end of the road, it’s just the beginning of a new one. We really are in the "1970’s boombox, 1980's car phone" era of biomedical prevention at the moment – kind of big and clunky, and not ideal. Our early AIDS drugs were the same, and look how dramatically they’ve improved over time! We need new formulations and new ways to deliver biomedical prevention – rectal films, vaginal rings, long-term injectables, microbicide/vaccine combinations, vaccine/PrEP combinations, and vaccines. And we absolutely need options that utilize other types of compounds and chemicals, not just ARVs.

The work continues. It’s critical to make these new technologies easier, safer, and sexier to use. Think the latest version of the iPhone or iPod – that’s where we need to go in terms of biomedical prevention. It won’t be easy – it will be frustrating and scary, with mountains to climb we didn’t know existed – but we can be the generation that breaks the back of HIV.