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May 09 2012

New HIV pill offers hope at a steep price

Gilead Sciences (GLD) has a new pill that can be used by peole who are HIV negative to ward off the virus that causes AIDS. But there’s a catch: big time sticker shock.

(Bloomberg) — Truvada is safe and effective enough as a preventative medicine, Food and Drug Administration staff concluded in a report yesterday. An advisory panel recommendation for approval, set for debate tomorrow, hinges on who would get the pill and whether patients can be educated on the importance of following through with a prescription.

Doctors say the idea is to get healthy individuals in certain high-risk groups to take a $14,000-a-year pill every day to reduce the estimated 48,000 new U.S. cases of HIV each year. Some advocates say such a medicine to prevent the virus that can be avoided with condoms may encourage unprotected sex and increase infections.

I can see how that might work script vs insurance wise for someone whose partner has HIV, but how the hell is it going to work for anyone else in a nation run by sociopathic moral scolds? Prospective customer goes to doctor and tells them they might have sex regularly (Gasp!), so prescribe this incredibly expensive drug that must be taken everyday for as long as they are sexually active? Yeah, the HMOs will love that almost as much as the religious rightards …

3 comments

  1. 1
    Kevin

    Just to be clear. Truvada isn’t “new”.

    Truvada has been on the marketplace for years. It’s a combination pill with two separate HIV medications (emtricitabine and tenofovir) that is used along with at least one other drug for the treatment of HIV disease. It’s one of the recommended “backbone” treatments from the Department of Health and Human Services (DHHS) panel on HIV therapy, and has been for years.

    It’s the use of Truvada as a preventative that’s new.

    And whether insurance companies would pay for its use probably depends on the actuarial difference between paying for a single preventative versus a three-drug combination (Truvada plus something else) and all of the other attendant medications used in HIV disease. I don’t think the insurance company knees will jerk quite that hard, and I don’t think it will be based on any reflexive anti-sex (esp. gay sex) feelings.

    As far as physicians prescribing it — well, several thousand physicians specialize in HIV medicine. So, they’re quite used to the issues of sexuality and STDs by now. Many of those physicians are — gasp! — gay. So one would assume they wouldn’t be squicked out at the thought of prescribing a prophylactic medication to prevent HIV disease in an at-risk population.

    Just sayin’. I don’t think the issue as a black-and-white as you’re portraying it.

  2. 2
    Gregory in Seattle

    Speaking as someone who has been involved in HIV research for many years….

    Truvada is not a “new pill;” it has been on the market for 8 years. It contains two anti-retroviral drugs: tenofovir disoproxil fumarate, which has been around since 2001, and emtricitabine, which was approved for use in 2003.

    The research into pre-exposure prophylaxis (PrEP) for HIV has been going on for almost a decade, ever since the second generation of anti-retrovirals came to market. Last year’s report that established the effectiveness of this approach is the first advance in medical prophylaxis since AIDS first appeared 30 years ago: it really is the huge deal that the media has been making it out to be.

    While much of the research into PrEP was funded by Gilead Science, specifically using Truvada, there is no reason to think that Truvada, and only Truvada, have this effect: any of the drug combinations used for highly active anti-retroviral therapy (HAART) should have the exact same effect. Patents on some of the older drugs are starting to expire, which means that much less expensive generic drugs will soon be coming to market: this will drive down the cost of PrEP immensely, making it more likely that insurance companies will cover it and making the approach more viable for people without medical insurance. In addition, with PrEP now validated, there is research being done to see whether lower doses of the drugs offer a substantially similar effect. If this turns out to be the case — if we can use 2/3 of the drugs and still get 95% of the prophylaxis benefit — then the cost of PrEP drugs will be lowered even more.

    As far as who will be recommended for PrEP, that policy is still being investigated. Most likely, it will be limited to HIV- people who have an HIV+ partner and workers in situations where they might be exposed to HIV, such as EMTs and prison guards. The research into PrEP is also being referenced to improve established protocols for post-exposure prophylaxis, which tries to prevent HIV from taking hold after possible exposure, for example in rape victims and children born to HIV+ mothers.

    PrEP is NOT intended to replace other preventative measures, but to supplement them.

  3. 3
    anotheratheist

    There is a relevant blog post on scienceblogs:
    http://scienceblogs.com/erv/2012/05/14/the-pill-for-hiv-no-really-thi/

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