From Tiffany Ryan, VP, Account Services, Palio

It’s no secret here at the Agency that I love working in HIV. Prior to working at Palio I had no experience in HIV. To say that working with the HIV community ignites a passion that you never knew existed within you would be an understatement. Working with the HIV community was eye-opening, personally fulfilling, and completely rewarding.

We’ve come a long way – both medically and socially. As a pointed reminder of how things have changed, I watched the movie Philadelphia last night. It wasn’t my first time watching the movie, but it still moved me. If you want to understand just how far we’ve come, check out the Kaiser Family Foundation Web site, which includes reports and timelines on every aspect of HIV/AIDS, including media coverage, disease state information, and events that have occurred since the start of the epidemic in 1981.

I go there frequently, and find much of the information to be heartbreaking and much of it to be awe-inspiring. That’s the thing about this disease state. It’s charged with emotion and wrought with stigma, but on the flip side, has created a community that is awe-inspiring.  We participated as a team in the local AIDSWalk for a few consecutive years. We worked with AIDS Service Organizations and HIV positive patients for photoshoots and educational initiatives. And the experience as a whole was incredible.

From a clinical standpoint, we are far from solving this issue. I was disappointed this week with the announcement of the failure of viciviroc to meet its primary efficacy endpoints in two pivotal phase III trials in treatment-experienced patients.

I had been extremely excited about the development of CCR5 inhibitors. Blocking entry of the virus into a human cell seemed to have great potential and was a great differentiator from the current products, who worked once the virus was in the cell replicating. If I was in a room and someone mentioned CCR5 vs. CXCR4 tropism, I could feel my hands begin to sweat. The science was that exciting. The possibilities seemed endless. And every breakthrough in this category seems to lead to another. While the drug will continue to be studied in treatment naïve patients, not being able to offer it as an option for those patients who really need it – patients for whom treatment options are limited due to resistant virus – is disappointing.

This is not the first CCR5 inhibitor to disappoint. GlaxoSmithKline had a CCR5 in development, aplaviroc, that looked promising due to limited toxicities and viral load reductions in short-term monotherapy studies. In the phase 2b studies, however, severe hepatotoxicity was identified. In the end, the drug never made it to market.

The CCR5 class is not completely lost. Pfizer’s CCR5 product, Selzentry, is on the market and in clinical use. Coreceptor tropism assays allow physicians to prescreen patients for CCR5 tropism, ensuring the right patients get the drug. And as the clinical usage increases, we’ll begin to truly understand the utility of this class. Current DHHS guidelines classify CCR5-Antagonist-based regimens as “may be acceptable but more definitive data are needed.” I would agree with their evaluation, and can’t wait for the “definitive data” to help us better understand this product.

2009 was not a banner year for HIV drug development. From mixed reviews on the HIV vaccine trial results, to products not making it to market, to limited HIV product pipelines, we are far from a cure. On the flip side, we have to count the little victories, and remember that with each new product that becomes available, we are advancing the science of HIV medicine and getting one step closer.