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Panel recommends approving Truvada to prevent HIV infection

By Saundra Young, CNN

July 17, 2012 -- Updated 0119 GMT (0919 HKT)

STORY HIGHLIGHTS

Advisory committee recommends Truvan be approved as a preventive

The FDA does not have to follow the recommendations of its advisory committees

The panel looked at safety and efficacy data from 3 clinical trials

(CNN) -- A drug already approved for treatment of AIDS might one day be approved for prevention of the deadly disease in individuals at high risk.

A U.S. Food and Drug Administration advisory committee recommended Thursday that the agency approve the drug, Truvada, for pre-exposure prophylaxis, or PrEP.

The committee voted 19-3 in favor of approval for the prevention indication -- PrEP for HIV-uninfected men who have sex with men and 19-2 with one abstention for HIV-uninfected partners in couples where the other partner is infected. The committee recommended by 12-8 with two abstentions in favor of approving the drug for individuals who engage in risky sexual behavior that could result in their contracting the virus.

Truvada, manufactured by Gilead Sciences, Inc., is a once-a-day pill used in combination with other HIV drugs. The nucleoside reverse transcriptase inhibitor does not rid the body of HIV. Instead, it prevents the virus from replicating in the body.

The FDA doesn't have to follow the recommendations of its advisory committees, but it often does.

Most of the more than 40 health care professionals, AIDS advocates and patients who addressed the committee implored its members not to recommend the drug for the new indication.

"There is no question that, if efforts on using PrEP is widespread, condom use and other means of preventing HIV infection will decrease," said Robert Elliott, a registered nurse. "At this point we simply don't know enough about how to increase adherence rates to work with the PrEP or how to counteract the risk compensation and the use of PrEP. Until then, PrEP is not and cannot be considered safe and effective for preventing HIV infections."

AIDS Activist Miki Jackson agreed. "A recommendation for the use of Truvada as PrEP is akin to issuing an engraved invitation for lawsuits," she said. "To knowingly recommend a drug as powerful as Truvada with such serious serious side effects and given to people who are perfectly healthy is frightening."

Michael Weinstein, president and founder of the AIDS Healthcare Foundation, said he was concerned that approval could lead a decrease in condom use. "Approving PrEP would be a reckless act," he said.

The FDA panel looked at safety and efficacy data from three clinical trials:

-- iPrEx, a study of men who have sex with men, found 43.8% fewer infections in men who got the drug versus those who got placebo;

-- in a Truvada study carried out by the Centers for Disease Control and Prevention in Botswana, infection rates were reduced by 63% overall in healthy men and women considered to be at high risk of infection;

-- the University of Washington's Partners in PrEP study of serodiscordant couples in Kenya saw 62% fewer infections in those taking Truvada and a 73% reduction in those who took a combination of Truvada and the HIV drug tenofovir.

Committee members also heard concerns about the drug's side effects, which can include nausea, vomiting, dizziness, loss of appetite and diarrhea, liver and kidney toxicity and loss of bone density.

But, after assessing the data, they concluded that Truvada is safe for men and women and effective in preventing infection.

And they had supporters. "What we need currently is additional tools for our powerful tool box," said Dr. Richard Elion, director of clinical research at the Whitman Walker Clinic in Washington. "We are not winning the battle. Please, were asking today to allow a modality that's still being developed to be added to our toolbox."

Kirk Myers, founder and CEO of Abounding Prosperity Inc., made a plea on behalf of African-Americans. "People need to be given the option to choose," said Myers, who is HIV-positive. "This drug is wanted. Another tool we can use. The right thing to do. Without this option, desperation will continue to drive up statistics of new incidents."

Chris Collins, vice president and director of public policy for the American Foundation for AIDS Research, said the data on the drug's prophylactic use were compelling and urged the committee not to limit access to it. "We need new tools to fight this epidemic that include treatment, condoms and education," Collins said. "PrEP is certainly not for everyone, but it may have a role in bringing HIV-infection rates down. It's time to learn how PrEP may be useful in the real world."

According to Dr. Peter S. Miele, a medical officer in the agency's Center for Drug Evaluation and Research, Truvada's safety and efficacy for the prevention of HIV-1 infection in high-risk individuals is supported by two large clinical trials. "Regular HIV testing, adherence and behavioral counseling on safer sex practices, including condom use, are essential components of healthcare delivery around PrEP," he said.

Truvada is not cheap. A month's supply costs about $1,200.

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Showing 25 of 143 comments

Krozar 5 comments collapsed Collapse Expand

And this is why there will never be a cure. Preventative medication makes so much more money.

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2 months ago

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smartguy101 1 comment collapsed Collapse Expand

yea Larry a cure for AIDS, cancer and other chronic diseases like those would cut into the profits of the pharmaceutical companies profits in a major way. A 2 week dosage of pills to cure and ailment versus a lifetime dependency on a drug translates a lot of dollars. However there are a lot of scientists working hard for cures to these diseases but the funding is not at a level it should be comparing the seriousness and number of people it affects.

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LarryRollins 1 comment collapsed Collapse Expand

Smartguy---

Just so you know, most research is done at Universities, pharmacutical companies only buy the patent to sell the drug...

A cure for aids would make any university research a nobel prize and be fabulosly rich.

And frankly that what the researcher care about.

Anyone to claim differently has no clue about my business.

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2 months ago

in reply to Krozar

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motoarzan 1 comment collapsed Collapse Expand

There is already cures for Cancer but no company would be dumb enough to share it. And think off all the different industries and jobs dependant on cancer treatment.

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2 months ago

in reply to Krozar

1 Like

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LarryRollins 1 comment collapsed Collapse Expand

Lol...

Haha

Crazy conspiricy!

Seriously?

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2 months ago

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OjaiRobear 3 comments collapsed Collapse Expand

Ask any HIV-positive person who takes this drug daily and the great majority will say that they take it reluctantly. Yes, it helps keep them alive by preventing the virus from multiplying, but the toll of the side effects is staggering. Truvada is TOXIC to the liver and kidneys and slowly destroys them, and that's besides the migraines, nausea, changes in distribution of body fat etc.

Truvada is NOT like a contraceptive pill one can take to prevent pregnancy; it is a poison that somehow keeps HIV patients alive a little longer.

The FDA would be totally irresponsible to approve the .prophylactic use of Truvada. But then again, they've proven themselves irresponsible before...

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2 months ago

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Stevehi 1 comment collapsed Collapse Expand

Your description of the side effects are over blown and there is no body fat redistribution associated with truvada. Don't speak about things which you know nothing about and obviously have no expierience with. Spreading ignorance isn't a virtue.

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2 months ago

in reply to OjaiRobear

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Moelen 1 comment collapsed Collapse Expand

Agree.  What people do not understand about any new medication introduced by big pharma is that it really is not proven to work, we all know about the big pharma tests...slanted at best.   All we have is the FDA seal of approval which is not good enough for me.  I always tell my Doctor I want older and proven medications...nothing that just came on the market.  Anyone in the medical professsion knows what I am talking about, or at least they should.  Doctors for the most part only know what the pharma reps are telling them about a new drug...over lunch of all things.

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2 months ago

in reply to OjaiRobear

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Michael Ma 2 comments collapsed Collapse Expand

I think they can make more money by marketing it as an gay-prevention drug.  Republicans will be taking that until they die of liver failure.  But at least they'll be gay-free.

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2 months ago

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Tex71 1 comment collapsed Collapse Expand

Republicans have a problem with reality. They would be better off taking antipsychotic drugs until their vision clears.

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2 months ago

in reply to Michael Ma

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Ikemefuna Muokebe 2 comments collapsed Collapse Expand

Looks like people become more stupid with time. The reverse civilization theory might be true after all.
People now live like savages and we make drugs to protect them for using thier bodies aganst all natural laws? Whats the anus made for? or did i miss my biology classes? The drugs works less than 60% of the time and someone is trying to get it approved? What manner of bribes has passed under the table????

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2 months ago

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Adan2012 1 comment collapsed Collapse Expand

..bend over will show you what your anus is made for..

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2 months ago

in reply to Ikemefuna Muokebe

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torrek 4 comments collapsed Collapse Expand

Come on people! This is unquestionably a good thing. Think of all the monogamous couples out there where only one partner is HIV+. This drug in addition to whatever protection they are already using will make it safer for them. For people who engage in risky business (which is perfectly fine if it is their decision) like being a porn star or prostitute or just promiscuous, this will also help. Did people stop wearing seat belts when cars got airbags? Some, yes. But most, no. It's stupid to anticipate widespread decline in condom usage because of this drug. Will some people stop? Of course. But one great thing about this country is that people can do what they want. And the side effects? It's not like this drug is being advertised as free from side effects. Let people have their choices.

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2 months ago

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Tilda 1 comment collapsed Collapse Expand

Exactly... this virus affects all humans: gay, straight, unborn. If there is a drug that can prevent one person from having a death sentence due to natural, human inclinations (sex, having children), let alone educate the young and uneducated, then this should be at least available to people who are willing to sign a waiver for the side effects. Yay, SCIENCE.

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2 months ago

in reply to torrek

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torrek 1 comment collapsed Collapse Expand

I don't know, but that's why this is a prescription drug that you'd only take if you want to after speaking with your doctor and they agree.

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2 months ago

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kinderlove 1 comment collapsed Collapse Expand

What are those side effects that have been advertised?

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2 months ago

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SayNoToAlPAC 1 comment collapsed Collapse Expand

Thank you to gay people for sponsoring all the research.

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2 months ago

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jdubden 2 comments collapsed Collapse Expand

There are cheaper ways to avoid HIV infection already in existence.  This medication is sickeningly expensive.  Why waste all that money when you can just avoid risky behavior to begin with; use condoms, don't be excessively promiscuous, etc.

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2 months ago

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Farscape1 1 comment collapsed Collapse Expand

Because all medications always stay expensive or can't be subsidized to be more affordable for those that can't afford them.

How about you go to Africa and tell all of those children with HIV or already dying of AIDS that they should have just used a condom?

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2 months ago

in reply to jdubden

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vincern2 2 comments collapsed Collapse Expand

Woohoo! Now rich people can have unprotected sex!

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A Like

2 months ago

9 Likes

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ObamasJulia 1 comment collapsed Collapse Expand

Huh?

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2 months ago

in reply to vincern2

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bloodawg 1 comment collapsed Collapse Expand

If you mix it with Viagra the GOP will fund it

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A Like

2 months ago

9 Likes

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JackSkell 1 comment collapsed Collapse Expand

Just do what Magic Johnson did and throw tons of cash at the virus.

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2 months ago

9 Likes

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SevenTX 3 comments collapsed Collapse Expand

Let's see... take an expensive and powerful pill (with side-effects) everyday of your life or just wear a rubber....  hmmm... decisions-decisions.

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2 months ago

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Tilda 1 comment collapsed Collapse Expand

So, if I wear a rubber during a blood transfusion, or if a child who was born with HIV wears one (no fault of his/her own), that works for them?

P.S. "Side effects" doesn't have a hyphen, nor does "decisions, decisions"...

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2 months ago

in reply to SevenTX

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