News: FDA approval for HIV preventative pill on its way?

DejaVu

Quote:

Pill to prevent HIV gets an FDA endorsement
An advisory panel recommends approval for Truvada, a daily pill that is the first drug shown to protect from the virus that causes AIDS. Critics worry the pill could lead to risky behavior.

Associated Press

May 11, 2012

SILVER SPRING, Md. — The first drug shown to prevent HIV infection won the endorsement of an FDA advisory panel Thursday, clearing the way for a landmark approval in the 30-year fight against the virus that causes AIDS.

The Food and Drug Administration 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, but it usually does. A final decision is expected by June 15.

Gilead Sciences, based in Foster City, Calif., has marketed Truvada since 2004 as a treatment for people who are infected with the virus.

Although panelists ultimately backed Truvada for prevention, Thursday's 12-hour meeting highlighted a number of concerns. In particular, they 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."

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%, when accompanied by condoms and counseling. Last year another study found that Truvada reduced infection by 75% in heterosexual couples in which one partner was infected with HIV and the other was not.

But Truvada's groundbreaking preventive ability has exposed stark disagreements within 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, some speakers worried that wide 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, estimates that 20 HIV-positive patients could be treated for the cost of treating one patient with Truvada.

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 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 break down, leading to infections that are eventually fatal. Gay and bisexual men account for nearly two-thirds of cases.

http://www.latimes.com/health/la-na-...,5295464.story

next step, a pill that cures!

Shapes

So many people are going to end up poz because of this

It's giving people an excuse to have unprotected sex

Did you know that between 1/4-1/2 of the NY queer population has HIV?

stooki3

Watch ppl start having careless unprotected sex even more.

But Im glad for the breakthrough.

Dephira

So we should just stop researching and not develop a cure for HIV just cause people might have more unprotected sex?

This is an important breakthrough

Kworb

Quote:

A three-year study found that daily doses cut the risk of infection in healthy gay and bisexual men by 42%, when accompanied by condoms and counseling. Last year another study found that Truvada reduced infection by 75% in heterosexual couples in which one partner was infected with HIV and the other was not.

Eh, not that great.

Preventing HIV isn't really the problem. We already know how to prevent HIV.

AshleeSimpsonFan

Quote:

Originally posted by Shapes

It's giving people an excuse to have unprotected sex

But what about the kids that got HIV from transimision from their mother? It's not their fault

I think this is awesome, I hope it works

Shapes

Quote:

Originally posted by AshleeSimpsonFan

But what about the kids that got HIV from transimision from their mother? It's not their fault

I think this is awesome, I hope it works

It's to prevent sexual transmission

It has nothing to do with genetic inheritance

Shapes

Quote:

Originally posted by Dephira

So we should just stop researching and not develop a cure for HIV just cause people might have more unprotected sex?

This is an important breakthrough

Find the part in my post where I said "we shouldn't even bother" or "we should stop researching".

Oh that's right, you can't.

This is a breakthrough, sure, but I'm concerned about the change in sexual habits because of the availability of this medication, and I'm concerned that the 42% decline isn't nearly safe enough to begin to excuse the forthcoming potential changes in sexual behavior.

I'll post a "clap3" smiley when there's a cure, and HIV is 100% eradicated.

Wick

I know how to prevent HIV--condoms!
No but this is a good extra precaution. Even if you're on birth control you still use protection, same goes for Truvada.

Shapes

Quote:

Originally posted by Wick

I know how to prevent HIV--condoms!
No but this is a good extra precaution. Even if you're on birth control you still use protection, same goes for Truvada.

But how many people say "**** it" to condoms because they're on birth control?

Quite a few

DejaVu

Quote:

Originally posted by Kworb

Eh, not that great.

Preventing HIV isn't really the problem. We already know how to prevent HIV.

But it means a step in the right direction as far as a cure goes

Kworb

Quote:

Originally posted by DejaVu

But it means a step in the right direction as far as a cure goes

Not really. The drug already exists and has been approved to treat HIV positive people. It's way too expensive and pointless to use for prevention. FDA approved drugs are usually covered by insurance companies, so this is only a way to funnel many more millions of dollars from the American citizen to the already corrupt insurance companies and drug companies.

Oxidane

Quote:

Originally posted by DejaVu

But it means a step in the right direction as far as a cure goes

Quote:

Originally posted by Kworb

Not really. The drug already exists and has been approved to treat HIV positive people. It's way too expensive and pointless to use for prevention. FDA approved drugs are usually covered by insurance companies, so this is only a way to funnel many more millions of dollars from the American citizen to the already corrupt insurance companies and drug companies.

Not necessarily true. At the moment there is no cure for HIV. Yes, treatment regimens have been developed which are very successful in managing HIV infections and preventing the subsequent development of AIDS once infected but it does not eradicate HIV completely from the body which is what a cure is.
But this is definitely a breakthrough in research - if you can't cure it, then try and prevent it; if you can't prevent it then cure it. The ideal situation would be to have options to achieve both.

Kworb

From a medical point of view it might be a step forward, depends if they were also able to figure out why it helps prevent infection and whether this information helps in the development of future drugs. But from a practical point of view it isn't, there's absolutely no reason for any HIV-negative person to ever take this drug. It's not even near complete prevention, it just lowers the chance a bit. Complete waste of $900 a month.