It’s a game-changing move that’s come as something of a shock to HIV advocates: the U.S. Food and Drug Administration (FDA) just approved a generic version of Gilead’s antiretroviral drug Truvada (tenofovir disoproxil fumarate/emtricitabine).
What that means as far as what the drug will cost is still up in the air, but it’s bound to have significant implications for consumers as well as insurers.
Poz reports the approval allows Teva Pharmaceuticals to produce a generic version of the drug, which is used as a component of HIV treatment as well as pre-exposure prophlyaxis (PREP.) It would come in the same form as the current brand name version: a fixed-dosed combo tablet.
Talking to Poz, Jeffrey S. Murray, MD, MPH, deputy director of the Division of Anti-Viral Products at the FDA, says:
“Yes, the first generic for Truvada has been approved and will now be available in the U.S. Usually, it takes several generics before full cost-savings potential is reached though. Hopefully, this will help to expand PrEP availability for many.”
ACT UP and Treatment Action Group veteran Peter Staley is concerned there will be a backlash of sorts.
“While this is stunning news that AIDS activists didn’t expect until 2021, I’m worried about the fallout,” he says.
“Gilead’s patient and copay assistance programs have become central pillars in patient access. They must maintain these programs, and Teva must establish equivalent or better assistance programs for their generic version.”
We’ll keep you up to date as more information becomes available.