October 8, 2019 — TAG laments that development for the latest oral HIV pre-exposure prophylaxis (PrEP) left out cisgender women and transgender men, but welcomes the accountability provided—albeit belated—by the U.S. Food and Drug Administration (FDA) to rectify this inequity.
On October 3, 2019, the FDA approved F/TAF (brand name: Descovy) for PrEP “excluding individuals at-risk from receptive vaginal sex.”1 The limited indication is a direct result of Gilead’s decision, with poor guidance from the FDA, to exclude cisgender women and transgender men from phase III research. Studies of vaginal tissue concentrations following oral F/TAF have been mixed compared to TDF/FTC.2 As such, Descovy may work differently in vaginal exposures, so studying efficacy in these populations is important.
In a victory for community advocates, the FDA has required the company to conduct follow up research for vaginal exposures.3 TAG and PrEP4All had previously called for an FDA advisory committee hearing on Gilead’s supplemental new drug application, and issued a joint statement highlighting community outrage over the exclusion of key populations in Gilead’s research.4 However, the timeline for the study in cisgender women goes through 2025; this six-year delay will greatly complicate PrEP scale up for cisgender women and transgender men. Given Gilead’s entirely inadequate engagement with community previously as part of the phase III Discover trial that led to such an inequitable FDA approval, we are concerned the company will again fail to meaningfully engage community leadership to properly address all of our concerns regarding post-marketing research.
TAG calls on Gilead to immediately engage in open dialogue with advocates regarding concerns with post-marketing research in all communities that were excluded or underrepresented in the Discover trial—including cisgender women, people of color, transgender men and women, and youth. These discussions must be open to advocates who are critical of the company’s approach and reflect the diversity of the epidemic.
TAG also calls on Gilead to stick to the evidence, and immediately cease all messaging claiming that F/TAF is safer or more effective than its current marketed PrEP product TDF/FTC (Truvada), which will go off patent in 2020. In an effort to maintain its $2 billion in domestic PrEP profits, the company appears to be desperately trying to switch patients over to F/TAF by misrepresenting TDF/FTC.5 In fact, while the Discover trial showed minor improvements in bone density and renal health indicators in F/TAF compared to TDF/FTC, it has a worse obesity and cardiovascular risk profile than TDF/FTC.6 Particularly in light of F/TAF’s narrow indication as PrEP, it is essential for all to know that TDF/FTC is a safe and effective option for PrEP.
Finally, we call on the FDA to ensure that future pivotal trials include all necessary populations to avoid such inequity moving forward.
# # # FDA. FDA approves second drug to prevent HIV infection as part of ongoing efforts to end the HIV epidemic. FDA News Release [Internet]. 2019 October 3. Available from: https://www.fda.gov/news-events/press-announcements/fda-approves-second-drug-prevent-hiv-infection-part-ongoing-efforts-end-hiv-epidemic  Gilead Sciences. Descovy for PrEP. FDA Antimicrobial Drugs Advisory Committee Meeting. 7 August 2019. (See slide 133). Available from: https://www.fda.gov/media/129923/download  FDA supplement approval for Descovy as PrEP. 2019 October 3. https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2019/208215Orig1s012ltr.pdf  TAG. TAG and PrEP4All joint comment on Descovy for FDA hearing. 2019 August 7. Available from: https://www.treatmentactiongroup.org/content/tag-prep4all-joint-comment-descovy-fda-hearing-8-7-19  Spinner C. DISCOVER study for HIV pre-exposure prophylaxis (PrEP): F/TAF has a more rapid onset and longer sustained duration of HIV protection compared with F/TDF. (See slide 18: “F/TAF is..safer”). IAS 2019. Abstract TUAC0403LB. Available from: http://programme.ias2019.org/Programme/Session/167  Schafer J, et al. Changes in Body Mass Index and Atherosclerotic Disease Risk Score after Switching from Tenofovir Disoproxil Fumarate to Tenofovir Alafenamide. Open Forum Infectious Diseases. 4 October 2019.