Game changer

The FDA just approved generic Truvada, and the implications are immense

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.

Related: Republicans plan to jack up the price of PrEP because, hey, who needs HIV/AIDS prevention anyway?

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.”

Related: STUDY: Undetectable Guys Do Not Transmit HIV To Negative Sex Partners

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.

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  • QJ201

    Truvada is currently 1200 a month. My insurance pays 900 and the Gilead program pays 300.

    Let’s not get excited until we see the pricing and insurance coverage.

  • Rakkaus

    I was paying nothing for Truvada as PrEP when I was on it between insurance and the co-pay card. Stopped taking it because I went away to school in Virginia and no doctor would prescribe it, in fact the only doctor who ever prescribed it for me was at the LGBT-specific Callen Lorde Center in Manhattan. It was strange the first time I was on it I never really experienced side effects, but when I stopped and started again it always made me feel lousy so I would have stopped anyway. Put a good scare into me, if this is how bad it feels to just take one HIV medication to try to prevent HIV, can’t imagine how horrible it must be to 1) have HIV and 2) have to take more meds along with Truvada to treat HIV. I don’t like or even understand the appeal of barebacking as either top or bottom, so it’s been annoying being with guys who say they’re on PrEP so insist no need for condoms, and some group parties that used to require condoms now allowing bareback ASSuming guys must be on PrEP, so Truvada has been a negative influence on things from my perspective.

    • Bromancer7

      Most HIV drug combos no longer include Truvada. While it’s still the only drug that’s available for PrEP, it won’t be for long. Better drugs with fewer side effects are on their way.

    • Kieru

      The first couple of weeks taking Truvada can be pretty miserable for some people. Headaches, fatigue, generally feeling like “You’re coming down with something”. Then of course others have zero issues, can take it without food or any side-effects, etc.

      But the same can be said for virtually any medication. There are always going to be people who cannot take a medication because their physiology results in extreme side effects, just like there will be those whose bodies will acclimate, and those whose bodies exhibit zero side-effects.

  • Richard 55

    The FDA should be held legally responsible for any deleterious side effects.

    • Bromancer7

      All drugs have side effects. Every single one of them.

    • Buzz the Bear

      If that were the case, we wouldn’t have any life-saving drugs at all. What a ridiculous statement. Even vitamins and minerals have side effects. The fact is that the FDA actually slows down approval of many drugs which costs people time and lives.
      If I’m willing to take even an unapproved drug, it’s no one’s business but mine and my doctors.

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  • Bromancer7

    Cue the slut-shamers in 3…2…1…

  • 1898

    wake me up when a manufacturer other than teva starts making it. i’ve had way too many problems with teva generics. do a google search and see how many teva drugs have been recalled due to various problems with them.

  • theszak

    The Strategy. BEFORE sex test TOGETHER for A VARIETY OF STis Sexually Transmitted infections including HiV Human immunodeficiency Virus than make an iNFORMED decision, google… tested together before sex

  • theszak

    The Strategy. BEFORE sex test TOGETHER for A VARIETY OF STis Sexually Transmitted infections including HiV Human immunodeficiency Virus then make an iNFORMED decision, google… tested together before sex

  • brandon

    That’s fantastic. Hopefully, within the year, we’ll have a Truvada that will accessible to many more people. The cost of the med is the biggest barrier. Generic manufacturers don’t typically offer co-pay assistance because generic copays are much less than brand name co-pays and the chances that they’ll be covered, to begin with, will be much higher. Granted the co-pay probably won’t be zero, like Gilead’s co-pay assistance card, but I’d rather see more people have access with a small co-pay than a few have access to it with no co-pay.

  • porthuroncub

    I am not trying to slut shame but …how do they get people to test this drug out. Myself I am in a relationship with a single guy. We have been together for 4 years both tested for STDs and practice a safe sex life. But how do you tell a person ” Here take this pill and go out and have unprotected sex, it should protect you from HIV, and it worked great in animals. BTW you can’t sue us if it doesn’t work” How do they market this drug for human testing really I want to know. For me trusting my health too a pill is pretty crazy. I mean its bad I trust it too a condom but myself I don’t try too live with a risky sex life so anyways Anyone able too tell me how they market this stuff for human testing I want too know.

    • Buzz the Bear

      No one is told “Here take this pill and go out and have unprotected sex”.
      There ALWAYS must be human testing. And there will always be people willing to take those chances. I’d rather have something that “might” protect me than nothing at all.

      Everyone makes these decisions for themselves and to put yourself in a position of moral superiority. There is a think called “human frailty”. You or your boyfriend might slip some day and get your head turned by someone who you find attractive and flatters you….or the condom just might break. That’s life!

      So yeah…you are slut shaming simply by using the term slut-shaming. Some people are promiscuous at times. Some are promiscuous all the time. Some are celibate. They are the ones who decide what sexual behavior they want for themselves. In other words, IT’S NONE OF YOUR BUSINESS! Or anyone else’s. It sounds to me that you aren’t old enough to remember the time when thousands our our brothers were dying and there was no preventative pill that might reduce the risk. It was a scary time for the gay community. I thank God that we are moving towards a cure. Until then, anything that will prevent hiv contraction works for me.

      Do what you want and is right for you and get off your high horse about other’s sex lives.

    • Curtispsf

      Buzz The Bear. Thank you. I couldn’t have said it better so I won’t try.

    • ChrisK

      Statistics wise Prep is safer then condoms yet you put all your trust into them and you can’t sue them either.

    • Kieru

      Well with Truvada your Doctor is supposed to go over the risks and proper usage and you sign a document indicating that this has happened. Part of that document discusses that Truvada is NOT meant to be used as a replacement for condoms.

      In terms of clinical trials… it’s all about informed consent.

      There is another PrEP drug preparing to start (or having already started, I’m a bit out of the loop) human trials. It’s hoping to be “Truvada, but with even fewer side effects”. Patients taking part in the trial will have to get regular checkups and receive financial reimbursement at every checkup. The drug they are given (Which will either be Truvada or the new drug) will be paid for by the trial.

      Patients will be asked to use the drug as directed. No one is told “Don’t use condoms” or “Purposefully find an HIV+ partner to have sex with”.

  • Kieru

    As a generic drug it could extend the accessibility of PrEP far beyond what any copay assistance program can.

    Anyone with insurance is probably unable to make use of that program unless their plan simply does not cover Tier-2+ drugs. If it does, they are likely required to fill their prescription via mail order which excludes the ability to make use of any copay program (although you can apparently seek reimbursement after-the-fact, good luck with that).

    If it were a generic medication though it would be a Tier-1 drug. That would make it more likely to be covered by various health plans, and likely at a lower rate. For example, under my current prescription plan a 30-day supply of Truvada would run $50. Were it a generic it would cost me $20.

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