FDA Approves First Drug that Wholly Prevents HIV Infection

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    Default FDA Approves First Drug that Wholly Prevents HIV Infection

    FDA panel backs first pill to block HIV infection | Fox News

    Quote Originally Posted by Fox News
    The first drug shown to prevent HIV infection won the endorsement of a panel of federal advisers Thursday, clearing the way for a landmark approval in the 30-year fight against the virus that causes AIDS.

    In a series of votes, a Food and Drug Administration advisory panel recommended approval of the daily pill Truvada for healthy people who are at high risk of contracting HIV, including gay and bisexual men and heterosexual couples with one HIV-positive partner.

    The FDA is not required to follow the panel's advice, though it usually does. A final decision is expected by June 15.

    Gilead Sciences Inc., based in Foster City, Calif., has marketed Truvada since 2004 as a treatment for people who are infected with the virus. The medication is a combination of two older HIV drugs, Emtriva and Viread. Doctors usually prescribe it as part of a drug cocktail to repress the virus.

    While panelists ultimately backed Truvada for prevention, Thursday's 12-hour meeting highlighted a number of concerns created by the first drug to prevent HIV. In particular, the panel debated whether Truvada might lead to reduced use of condoms, the most reliable defense against HIV. The experts also questioned the drug's effectiveness in women, who have shown much lower rates of protection in studies.

    Panelists struggled to outline steps that would ensure patients take the pill every day. In clinical trials, patients who didn't take their medication diligently were not protected, and patients in the real world are even more likely to forget than those in studies.

    "The trouble is adherence, but I don't think it's our charge to judge whether people will take the medicine," said Dr. Tom Giordano of Baylor College of Medicine, who voted in favor of the drug. "I think our charge is to judge whether it works when it's taken and whether the risks outweigh the benefits."

    Panelists stressed that people should be tested to make sure they don't have HIV before starting therapy with Truvada. Patients who already have the virus and begin taking Truvada could develop a resistance to the drug, making their disease even more difficult to treat. The experts grappled with how to protect patients while avoiding hurdles that could discourage them from seeking treatment.

    "If we put up too many hoops to jump through, there will be people who don't make it through those hoops," said Daniel Raymond, the panel's patient representative.

    Truvada first made headlines in 2010, when government researchers showed it could prevent people from contracting HIV. A three-year study found that daily doses cut the risk of infection in healthy gay and bisexual men by 42 percent, when accompanied by condoms and counseling. Last year 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.

    Because Truvada is on the market to manage HIV, some doctors already prescribe it as a preventive measure. FDA approval would allow Gilead Sciences to formally market its drug for that use.

    But Truvada's groundbreaking preventive ability has exposed stark disagreements on prevention among those in the HIV community. While Truvada's supporters say the drug is an important new option, critics worry that the drug could give users a false sense of security, and encourage risky behavior.

    During the meeting's public comment period, FDA panelists heard from more than two dozen doctors, nurses and patients who said patients would not take the drug as recommended - every day, in addition to using condoms.

    "Truvada needs to be taken every day, 100 percent of the time, and my experience as a registered nurse tells me that won't happen," Karen Haughey told the panel. "In my eight years, not one patient that I've cared for has been 100 percent adherent."

    Other speakers worried that wide scale use of Truvada would divert limited funding from more cost-effective options. Truvada sells for about $900 a month, or just under $11,000 per year. The AIDS Healthcare Foundation, which opposes approval of Truvada, estimates that 20 HIV-positive patients could be treated for the cost of treating one patient with preventive Truvada.

    "Truvada for prevention will squeeze already-constrained health care resources that can be better spent on cheaper and more effective prevention therapies," the group states in a petition to the FDA.

    The FDA is legally barred from considering cost when reviewing drugs. Medicare and Medicaid, the nation's largest health insurance plans, generally cover all drugs approved by the FDA and many large insurers take their cues for coverage from the government plans.

    An estimated 1.2 million Americans have HIV, which develops into AIDS unless treated with antiviral drugs. AIDS causes the body's immune system to breakdown, leading to infections which are eventually fatal. Gay and bisexual men account for the majority of cases - nearly two-thirds.

    The number of new HIV infections in the U.S. has held steady for 15 years at about 50,000 per year. But with no vaccine in sight and an estimated 240,000 HIV carriers unaware of their status, doctors and patients say new methods are needed to fight the spread of the virus.

    Nick Literski, a federal worker in Seattle, has been taking Truvada for HIV prevention for more than a year. His partner is HIV-infected and his doctor prescribes the drug as a precautionary measure, even though it is not yet FDA-approved for that use. Literski pays a $40 monthly co-pay for the once-daily pill.

    FDA approval of the drug for prevention would be "a huge step forward" in the fight against AIDS, he said in an interview Thursday. But he said rejection would be devastating, threatening gay relationships like his that involve one partner who is HIV infected and one who isn't.

    "Many HIV-positive men end up ending their relationships with HIV-negative men out of fear of infecting their partner," Literski said, and he worried about that happening to him before he started using Truvada.
    This is a fantastic and large step forward in the battle against HIV/AIDS. The only thing now to figure out is how to make the drug more efficient and cheaper. Then, we need to get it to Africa ASAP.

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    Default Re: FDA Approves First Drug that Wholly Prevents HIV Infection

    This is great and all, but what really needs to be done is more people practicing safe sex and using condoms and stuff. Nobody would even be getting HIV/AIDS if this happened because it's totally preventable this way. The virus can't spread through any means except needles and sexual contact.

    Aka, totally preventable without the need of drugs.

    What we really need is a CURE for the damn virus, not more ways to simply prevent it.

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    Default Re: FDA Approves First Drug that Wholly Prevents HIV Infection

    Prevention should take into account drugs. Some women get HIV via rape unfortunately, some people are prostitutes and come into contact with STDs regularly, and if they have a pill that can help prevent HIV then I say it better. Contraceptives do not protect 100% against STDs and HIV. Plus, if women are worried about getting HIV before getting pregnant, this is a good way to help prevent HIV before having a baby (if it determined safe by the drug makers).

    Cures are great, and any company that finds a cure will hit the jackpot, but until it is found, prevention at any way possible is better than none.

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    Default Re: FDA Approves First Drug that Wholly Prevents HIV Infection

    The only problem I see is people might come to depend on this drug to prevent HIV, not practice safe sex or use condoms, thinking they can just take a drug to keep from getting HIV, people already dont practice safe sex, this might even discourage them from doing so. Plus, people may forget to take the medicine and still get infected. This isnt a cure and people will still get HIV, but it's a step in the right direction.

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    Default Re: FDA Approves First Drug that Wholly Prevents HIV Infection

    Quote Originally Posted by Nicoleta01 View Post
    Prevention should take into account drugs. Some women get HIV via rape unfortunately, some people are prostitutes and come into contact with STDs regularly, and if they have a pill that can help prevent HIV then I say it better. Contraceptives do not protect 100% against STDs and HIV. Plus, if women are worried about getting HIV before getting pregnant, this is a good way to help prevent HIV before having a baby (if it determined safe by the drug makers).

    Cures are great, and any company that finds a cure will hit the jackpot, but until it is found, prevention at any way possible is better than none.
    True, but if more people used contraceptives, A LOT less people would be getting infected anyway.

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    Default Re: FDA Approves First Drug that Wholly Prevents HIV Infection

    Quote Originally Posted by Kelleo View Post
    The virus can't spread through any means except needles and sexual contact.
    Those are the most common ways, but it can spread through other ways. For example, blood contact (before the blood has been oxidized). Lots of people are born with HIV (because the blood from the HIV-infected mother transferred to the baby) and sometimes (although very rarely) people get it by simply contacting HIV-infected blood). The former won't be preventable with this drug but the latter is. And like Nicoleta01 said, there's rape. Although this drug won't really help in the case of rape unless the rape victim has already been taking the drug before hand... I know for one that I most certainly wouldn't be taking the drug just for the off-chance that I end up raped by someone who has HIV (and end up having that virus transfer to myself in the process).

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    Default Re: FDA Approves First Drug that Wholly Prevents HIV Infection

    This sounds like good news, but we have to realize that we can't rely on the drug forever, because like other diseases, HIV could evolve to become immune to the stuff so they can continue infesting organisms in a slow, painful death, just as nature intended it to be.

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    Default Re: FDA Approves First Drug that Wholly Prevents HIV Infection

    Quote Originally Posted by Ghetsis-Dennis View Post
    This sounds like good news, but we have to realize that we can't rely on the drug forever, because like other diseases, HIV could evolve to become immune to the stuff so they can continue infesting organisms in a slow, painful death, just as nature intended it to be.
    The point of medicines isn't to rely on them indefinatly, but to use them as stepping stones to make further advancements towards cures.

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    Default Re: FDA Approves First Drug that Wholly Prevents HIV Infection

    Quote Originally Posted by dannyjenn View Post
    Those are the most common ways, but it can spread through other ways. For example, blood contact (before the blood has been oxidized). Lots of people are born with HIV (because the blood from the HIV-infected mother transferred to the baby) and sometimes (although very rarely) people get it by simply contacting HIV-infected blood). The former won't be preventable with this drug but the latter is. And like Nicoleta01 said, there's rape. Although this drug won't really help in the case of rape unless the rape victim has already been taking the drug before hand... I know for one that I most certainly wouldn't be taking the drug just for the off-chance that I end up raped by someone who has HIV (and end up having that virus transfer to myself in the process).
    That's true, but like I said, if more people used contraceptives and such, a lot less people would be getting infected.

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    Default Re: FDA Approves First Drug that Wholly Prevents HIV Infection

    Quote Originally Posted by Kelleo View Post
    That's true, but like I said, if more people used contraceptives and such, a lot less people would be getting infected.
    Ok, for one thing, only condoms, dental dams, and gloves protect against any sort of STDs. Contraceptives like birth control pills do not. And even then, physical barriers are not 100% effective. Your sex can be as safe as a swiss bank vault, but there is no way to guarantee that a virus won't be contracted unless both partners are tested and come out clean. Even then, that only covers vaginal-penile sex, which not everyone sticks to (homosexual couples obviously have a few problems with that, and some heterosexual couples are just into some kinky shit).

    This is a great step forward to finding a cure, and I really hope this product holds up as a stepping stone towards a cure. For now, it seems like something that would be very useful for people who have HIV-positive partners, and make their lives a lot easier.
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    Default Re: FDA Approves First Drug that Wholly Prevents HIV Infection

    Quote Originally Posted by Feliciano View Post
    Ok, for one thing, only condoms, dental dams, and gloves protect against any sort of STDs. Contraceptives like birth control pills do not. And even then, physical barriers are not 100% effective. Your sex can be as safe as a swiss bank vault, but there is no way to guarantee that a virus won't be contracted unless both partners are tested and come out clean. Even then, that only covers vaginal-penile sex, which not everyone sticks to (homosexual couples obviously have a few problems with that, and some heterosexual couples are just into some kinky shit).
    Exactly. Which means if these things were done more often, less people would be getting infected. I'm not saying they are 100% effective, obviously, I'm saying that if less people got infected, there wouldn't be such a need for this drug. Even if only a few people get infected, if they took the right precautions, that is to say, don't have sex or share needles and such, they wouldn't go infecting anyone else, and problem solved. The only way it would spread at all is through rape, and obviously, that's a lot less common than consensual sex.

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    Default Re: FDA Approves First Drug that Wholly Prevents HIV Infection

    That's all nice, but I just think people with HIV in Africa must stop having sex. I don't care how sexually depraved they will get, but they are multiplying like a colony of rabbits, and all the tiny rabbits get HIV as a result. Most of them refuse to use a condom, and so HIV spreads very fast. If all the HIV infected in Africa stop having sex until a safe cure has been found, that completely removes HIV from the body, then I'm okay with it, then they can have sex. I just don't want babies to be born with HIV, knowing they don't have long to live.
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