FDA Set To Approve Popular HIV-Fighting Pill For Use As Preventative Measure

Sexually active people, including at-risk gay men, may soon be able to easily get their doctors to prescribe them a pill that prevents the contraction of AIDS.

In what ABC News hails as a major blow against the AIDS epidemic, the FDA has cleared the way for preventative uses of Truvada, a drug already prescribed to make AIDS manageable in HIV-positive patients:

The Food and Drug Administration said Tuesday that Gilead Sciences’ Truvada appears to be safe and effective for HIV prevention. It concluded that taking the pill daily could spare patients “infection with a serious and life-threatening illness that requires lifelong treatment.”

On Thursday a panel of FDA advisers will consider the review when it votes on whether Truvada should be approved as a preventative treatment for people who are at high risk of contracting HIV through sexual intercourse. The FDA is not required to follow the advice of its panels, but it usually does…

Researchers first reported that Truvada could prevent people from contracting HIV in 2010. A three-year study found that daily doses cut the risk of infection in healthy gay and bisexual men by 44 percent, when accompanied by condoms and counseling. Another study found that Truvada reduced infection by 75 percent in heterosexual couples in which one partner was infected with HIV and the other was not.

Is a reduction of 44 percent that impressive though, given that condoms were still being used? Condoms are 99.9 percent effective, unless used sloppily or in the oft chance they break, right?

We’d like to know what the risk reduction factor is when only condoms are used, in order to compare that to the Truvada-added study as a control. This is especially important given that the drug is very expensive as compared to condoms: about $12,000 a year (you have to take it daily for it to work, say doctors), which would cost the government $500 billion over 20 years to cover all gay men.

A 75 percent decrease in a couple where one is infected and the other not, well, that’s truly remarkable. Could the most promising use for Truvada be to alleviate the fears of HIV-positive people in relationships with negative partners?

Perhaps this would cause more infected partners to disclose their statuses to one-night stands and long-term lovers, too. We’ve heard around that a fair amount of positive gay men still take people home from bars and don’t tell them their status.

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  • QJ201

    Another way for corporate America to profit off the AIDS crisis.
    Three 12 packs of condoms for the month = $45.00.
    Once a day Truvada= Several hundred bucks.

  • MikeE

    @QJ201: not including the cost of treatment later in life for liver failure and its associated problems.

  • Jamie

    “We’ve heard around that a fair amount of positive gay men still take people home from bars and don’t tell them their status.”

    Putting the blame on someone does not help. It takes two to tango. If you choose to go home with a stranger for a one night stand, you have to have some accountability for your actions, even if they are HIV positive. Wear a condom, limit your sexual partners, get tested regularly(Remember window periods, saying you’re clean since March 2012 doesn’t mean A THING if you’ve had sex in February).

    You frame it like majority of people living with HIV are out to get everyone? They are just like you and I my friend. Let’s try to move forward from stigmatizing them.

  • Ryan

    “We’d like to know what the risk reduction factor is when only condoms are used, in order to compare that to the Truvada-added study as a control.”

    It would make sense if the 44% was in comparison to a control group that DID use condoms/counseling. Otherwise that number is pretty meaningless, and I can’t imagine a scientific study would be that sloppy.

  • QJ201

    …why would “negative” guys who bareback even take the damn pill. If they are having unsafe sex they clearly don’t care about getting HIV.

  • B

    The 44% drop in infections most likely refers to a comparison between two groups that are similar in their use of condoms, with similar levels of counseling – the objective was to determine how well the drug works. It would be silly not to use a condom as well.

    It is possibly cost effective for sexually active people at a young age who will eventually settle down in long-term monogamous relationships and will use the drug for only a few years.

  • Andy

    So people who can’t use a condom will take a pill regularly? LOL

  • Rob

    I agree with Andy. People will just think of this as a cure or think that it works 100% all the time to prevent HIV transmission and they’ll just do it BB/raw anyway.

    I want to stay HIV neg so I will just use condoms and use tried and true safer sex techniques, and assume that all of my sexual partners are or could be poz and have safer sex anyway.

    I have friends who are HIV+ and they take Truvada is very expensive, has not so fun side effects, and that HIV meds are not good for your body or certain internal organs such as your heart, liver, and kidneys.

  • Rob

    I found this quote from another news article and I agree with it.

    “I think it will be a catastrophe for HIV prevention in this country,” said Michael Weinstein, president of the Los Angeles-based AIDS Healthcare Foundation, the largest provider of AIDS and HIV care in the U.S. “Men don’t need more excuses to not use condoms.”

  • Rob

    As for people who are HIV+ lying, yes some do this but some also don’t know that they are HIV+ or get tested just once and think that when it shows up HIV- for just one test that it means that they or their partner are actually HIV- when they could be HIV+ and just not producing anti-bodies yet.

    I haven’t had a 1 night stand with a man or woman in years- I am bisexual; but this is why as I wrote in my previous post it’s best to assume that whoever you are having sex with is or could be HIV+ and still have safer sex with them anyway and I do this no matter the gender or sexual orientation of my sexual partners.

    I do know bisexual and gay men, and even straight men who have been with people who later turned out to be HIV+ and yes it does happen.

  • jj

    This is STUPID! Long term arv use causes damage to the liver, heart ect. And now young gay men are gonna ask their doctor for this so they can bb all the time. Just another way for big pharma to make more $$$.

  • B

    No. 12 · jj wrote, “This is STUPID! Long term arv use causes damage to the liver, heart ect. And now young gay men are gonna ask their doctor for this so they can bb all the time.”

    The idea is to use Truvada in addition to condoms. A 44% reduction in the infection rate is not sufficient for bare backing to not be a high-risk practice. Ideally you would like to cut the infection rate to the point where the virus dies out over time. If you have some very horny 19 to 21 year olds having lots of sex for a few years before getting into a long-term relationship, a 44% risk reduction in addition to the risk reduction from using a condom could be cost effective – condoms aren’t a perfect solution.

  • Larkin

    I have hiv and I got it the old fashioned way, by barebacking without condoms.

    I used to take meds but have been med free for the last 6 years and fine stats currently.

    The important part here is that people should not and cannot think it a total preventative. It’s not, but it can help reduce the chance of infection.

    But since insurance doesn’t cover it, I’m quite curious who is gonna spend $12 grand a month for this med for prevention?!? I’m betting not a lot of people.

  • KV

    This is a terrible and dangerous idea for so many reasons!!! I knew the FDA was ruthless but DAMN. It’s about to hit the fan guys!

  • Mitch

    “Prep” or “truvada” or whatever we’re calling it is scary as hell. It says a lot about how what is good can be subverted by a few very powerful corporate interests, and it damns a lot of supposed HIV “activists”. I’m poz so I stay abreast of these issues, and I’ve watched this stuff get shoved down our throats as a “preventative measure”, with many questions left unanswered.

    The standard line is that Truvada is “good for serodiscordant couples”, but as far as I know, testing hasn’t been done on serodiscordant couples. Open and honest serodiscordants have a very low incidence of transmission, and treating the poz partner is more effective at prevention than even the most optimistic delusions of what this stuff can do. Actually, by some estimates, an effectively treated poz isn’t even infectious. Treating the neg partner instead of the poz one is WAY less effective and unethical on many levels.

    We also hear a lot of “this is great for people who can’t access condoms”, but let’s be realistic, there aren’t a lot of people out there who aren’t able to access condoms but CAN regularly access an expensive drug.

    The prevention rate of this drug is already being WILDLY distorted within the media, into the upper 90% range, but the reality is that in real life, very few people are sufficiently adherent to achieve that kind of prevention.

    While this drug’s ability to work in a research setting is indisputable, we don’t live in a research setting. Lots of things work on paper, but fail on their own. If that weren’t the case, we would’ve wiped out this virus years ago. I’ve yet to hear a single realistic example of who will benefit from Truvada in real life. The only real world application I can think for this is basically as a sex toy for the rich. In practice, I can only assume it will replace condoms and consequently will lead to MORE infections.

    There are tons of unanswered questions about what this will do when deployed in the general population over the course of years. For starters, there is a concern about whether this is going to lead to a surge in resistant HIV strains. We haven’t seen it, but we’ve really barely studied it, and common sense kinda dictates that Truvada usage will select for types of HIV that are resistant to Truvada in much the same way that excessive antibiotic usage selects for antibiotic resistance. Truvada constitutes 2/3 of most initial HIV regimes precisely becuase it is one of the least damaging drugs out there. We may very well see a surge in demand for older drugs with their worse side effects, simply because they’ll be the only things left that are effective. Anyone who brings this up is told, almost explicitly, to shut up, that because we haven’t seen it, its not going to happen. We get shut down as “anti sex”, or the implications of what we say is covered up by people who insinuate that we’re trying to “take a prevention option of the table”. Very few of us are opposed to further study, we just want to fully understand what this drug is going to do. We haven’t got that. Instead, we’ve got a drug that has been rammed through the approval process in record time, with no real world benefits, and potentially serious downsides.

    This type of “prevention”, called “chemoprophylaxis”, has historically led to a surge in new infections. We’ve actually seen it specifically with syphillis in the 70s. When you look at the drug pipeline being produced by Gilead, the company that owns Truvada, you see a fairly robust set of new HIV drugs. Since it supposedly costs a fortune to create these drugs, I just can’t believe that Gilead thinks Truvada is going to decrease the rate of new infections. There are a lot of concerns that what Gilead is really doing is seeking a “new use” so that it can renew its patent on this old drug, and continue charging exorbitant prices. Because HIV drugs are unaffordable to most HIV+, as well as most human beings, the burden of paying for care typically gets shifted to the government. The effect of renewing a patent on Truvada will be BILLIONS of additional dollars funnelled from your taxes to this company, and MILLIONS of people worldwide who will have to go without life saving medical therapy. Thus far, I have not seen cogent counteraguement to this claim, and all we have to go on is that Gilead’s assertion it “isn’t planning on doing that”. Any of us who raise these concerns, either online or in real life, is shouted down, and sometimes removed from the conversation entirely.

    Lastly, we just don’t know what these drugs do with long term usage. They’re typically approved for people with HIV because the only alternative is to let people die from AIDS. Truvada does NOT meet the standard approval process that other drugs meet because standard approval would condemn people to death. It has not been vetted like most of the other things we take, and we just don’t know enough about it for widespread consumption. Literally, just a few weeks ago, researchers discovered a complication of the kidneys that arises after extended use of one of the components of Truvada.

  • Mitch

    @B: Whose idea is that? Who is going to shell out a copay AND keep using condoms? Do we ask women to keep using condoms IN ADDITION to birth control, to ensure they don’t have unwanted pregnancy? Heck no. This “idea” is a great example of the sort of flimsy logic I see supporting this drug. The real world applications for this drug are MORE infections, MORE complications and MORE expenses.

  • Andy

    “Perhaps this would cause more infected partners to disclose their statuses to one-night stands and long-term lovers, too. We’ve heard around that a fair amount of positive gay men still take people home from bars and don’t tell them their status.”

    Ugh, the writers for this site really are scum…there are plenty of guys with plenty of deadly STDs who don’t talk about it. We don’t typically expect our tricks to protect us from our own stupidity. Singling out people with HIV only gives people who are at risk for it good reason to avoid the test.

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