After the euphoria of the discovery of the viral cause of AIDS (1984) came the growing (e.g. Dallas Buyer’s Club) desperation as that discovery failed to translate into an effective treatment for many years. Fortunately, the low hanging fruit was plucked, as several researchers (did the obvious? and) combined two or more anti-retrovirals into effective anti-retroviral treatment regimens (ART). That simple remedy had great legs, achieving viral control in most patients.
But it soon became clear that no matter how long one stayed on ART the virus always came back upon stopping it. And there is STILL no HIV vaccine. So, in fact, little progress has been made with this virus, and many were giving up the ghost in the aughts. Then, one of those “it’ll never work” tests worked. In a discordant couples study (one with HIV one without, both active so that risk of exposure to the uninfected one is high), that same seemingly limited ART was nearly completely effective in preventing HIV infection. The individuals taking ART daily in the trials basically never contracted it despite repeated exposures (hence Pre-Exposure Prophylaxis or PrEP).
A welcome surprise! But taking ART constantly to have it on board in the eventuality of HIV exposure would not generally be practical. However, for high risk groups, this could be a lifesaver. But those groups are among the most marginalized and diverse in our society. Last month, that complexity challenged the FDA committee reviewing Gilead Pharmaceuticals DESCOVY PrEP product. The panel approved the new PrEP product for men and transgender women, but split on approval for cisgender women because Gilead provided full data for the former but only pharmacokinetic data for the latter.
That raised suspicions of discrimination that quickly spread to other dimensions of class and race as well. Remembering that a similar suspicion of discrimination led to the powerful, industry-altering AIDS advocacy movement in the first place, Industry would do well to keep their eyes on the diversity of populations in this space. GeneCentrix’s appreciation for the oft-overlooked diversity of tissues in all such endeavors may have made us a little more sensitive than most to such considerations . . .