FDA approves Truvada, first pill to prevent HIV infections

[NFS4]

Cool stuff :thumbsup:

On Monday, the US Food and Drug Administration approved Truvada, the first medication intended to prevent HIV infections in people having sex with infected individuals.

When taken daily, Truvada (emtricitabine/tenofovir disoproxil fumarate) reduced the risk of HIV infection by 42 percent compared with a placebo. That was in a clinical trial where HIV-negative individuals had unprotected sex with multiple partners, including some HIV carriers, according to the FDA. Another trial involving heterosexual couples where one partner was infected -- and condoms were used routinely -- found that Truvada reduced the risk of infections by 75 percent.

“The data clearly demonstrate that Truvada as pre-exposure prophylaxis is effective at reducing the risk of HIV infection acquired through sexual exposure,” said Dr. Connie Celum, a professor of global health and medicine at the University of Washington who led the trial involving heterosexual couples. “It is exciting to consider the potential impact of this new HIV prevention tool, which could contribute to significantly reducing new HIV infections as part of a combination HIV prevention strategy.”

Truvada is already approved to be used in combination with other antiretroviral drugs for the treatment of HIV.

For prevention purposes, the drug should be used along with other prevention methods, the FDA said in a press statement, such as safe sex practices, risk reduction counseling, and regular HIV testing.

“Today’s approval marks an important milestone in our fight against HIV,” FDA Commissioner Dr. Margaret Hamburg said in a statement. “Every year, about 50,000 U.S. adults and adolescents are diagnosed with HIV infection, despite the availability of prevention methods and strategies to educate, test, and care for people living with the disease.”

The most common side effects reported with Truvada included diarrhea, nausea, abdominal pain, headache, and weight loss. In rare cases, the drug may cause kidney problems or bone toxicity.

As a condition of approval, the FDA is requiring Truvada’s manufacturer, Gilead Sciences, to study those who acquire HIV while taking Truvada to determine if anyone can develop a resistance to the drug. The company also needs to collect data on women who become pregnant while taking the drug since safety risks to the fetus remain unknown.

Truvada is expected to cost at least $13,900 a year for treatment in the U.S., according to Gilead Sciences.

http://www.boston.com/dailydose/201...-infections/75DvRnWqr7P81ccA10RVtJ/story.html

 

[Nintendesert]

$13,900 just to have risky or unprotected sex. GL getting anyone to really follow this to make any sort of a difference in the infection rates of the at risk groups.

 

[lxskllr]

The most common side effects reported with Truvada included diarrhea, nausea, abdominal pain, headache, and weight loss. In rare cases, the drug may cause kidney problems or bone toxicity.

Truvada is expected to cost at least $13,900 a year for treatment in the U.S., according to Gilead Sciences.

Combined with only 75% protection rate when using a rubber, I'm not super impressed.

 

[pelov]

$13,900 just to have risky or unprotected sex. GL getting anyone to really follow this to make any sort of a difference in the infection rates of the at risk groups.

That's crazy. If they're willing to pay that much to have unprotected sex than they'd have Magic Johnson'd their way out of AIDS anyway.

Queue South Park episode!

 

[Scouzer]

This sounds like it's mostly geared to porn stars. It's a good risk reduction for a profession that occasionally has nasty outbreaks.

 

[crashtestdummy]

I'm curious as to who the target clients for this drug are. It's not effective enough to be used as a regular prophylaxis for partners of people with HIV or for those seeking to have unprotected sex with multiple partners. So who is this drug for?

 

[pyonir]

It's a good start, but at $13,900 a year it isn't going to help lower infections worldwide. Although I'm sure the manufacturer doesn't give a shit about helping those without money.

 

[TheVrolok]

I'm curious as to who the target clients for this drug are. It's not effective enough to be used as a regular prophylaxis for partners of people with HIV or for those seeking to have unprotected sex with multiple partners. So who is this drug for?

I'm guessing it's still partners of hiv infected individuals. Increased protection is still increased protection.

 

[momeNt]

There are also many other STDs so just stopping one doesn't mean you can bareback every random person or start visiting your friendly neighborhood glory hole.

 

[Jeffg010]

Who was dumb enough to be part of this testing. Hey I don't have HIV but I'll test it and see if I get it with your drug and maybe I'll be the lucky one to be placed on the placebo.

 

[surfsatwerk]

Who was dumb enough to be part of this testing. Hey I don't have HIV but I'll test it and see if I get it with your drug and maybe I'll be the lucky one to be placed on the placebo.

Giving jobs to the homeless.

 

[BladeVenom]

Seems a complete waste of money, and unnecessarily risky.

AIDs tests are relatively cheap, and accurate.

 

[DisgruntledVirus]

Seems a complete waste of money, and unnecessarily risky.

AIDs tests are relatively cheap, and accurate.

Yes because a test to say you have it is the same as 42% less people getting infected...

 

[dougp]

Who was dumb enough to be part of this testing. Hey I don't have HIV but I'll test it and see if I get it with your drug and maybe I'll be the lucky one to be placed on the placebo.

I was thinking this exact thing when I saw the word placebo.

 

[vi edit]

Seems a complete waste of money, and unnecessarily risky. AIDs tests are relatively cheap, and accurate.

It's still an interesting breakthrough for others to try and improve on in both efficacy and cost. It's something that would be useful in AIDS riddled places like Africa where young women are routinely raped and infected that way. At least give them some added level of defense should it ever be something that is more cost effective and reliable.

 

[Platypus]

I was thinking this exact thing when I saw the word placebo.

The people who voluntarily participate in these studies already engage in high risk behavior as is, they're just offered a drug or placebo to help facilitate testing. They don't seek out people who arent already doing this.

 

[Deeko]

I'm curious as to who the target clients for this drug are. It's not effective enough to be used as a regular prophylaxis for partners of people with HIV or for those seeking to have unprotected sex with multiple partners. So who is this drug for?

People that are, say, married to someone with HIV. It reduces the risk of infection by 75% - that doesn't mean that the actual risk is 25%. Say the original risk with condoms was 2% (I made that up, no clue what the stat is), and then reduce it by 75% on top of that.

It'd still be pretty risky, but its a big improvement, and hey...if anything, its a step in the right direction.

 

[ichy]

The vast majority of people who contract HIV in the US nowadays are irresponsible idiots.

 

[GT1999]

This should be given to doctors and nurses free of charge since they deal with bodily fluids day in and day out...

 

[Anonemous]

Yea, how'd they setup the clinical trials and who would participate in them?

 

[soulcougher73]

Who was dumb enough to be part of this testing. Hey I don't have HIV but I'll test it and see if I get it with your drug and maybe I'll be the lucky one to be placed on the placebo.

This was my first thought as well reading the article. Im like who would willingly be exposed to HIV lol

 

[hiromizu]

The side effects pretty much kills the pleasures of high performance sex

 

[DrPizza]

Combined with only 75% protection rate when using a rubber, I'm not super impressed.

That's not what it means. The 75% reduction means, (making up numbers here) that if originally 40 out of 100 people would acquire HIV through protected sex with condoms that with the drug, it's now 75% less = 10 out of 100. It could be 4 out of 100 reduced to 1 out of 100. But it doesn't mean 100 out of 100 reduced to 25 out of 100.

 

[blankslate]

This sounds like it's mostly geared to porn stars. It's a good risk reduction for a profession that occasionally has nasty outbreaks.

You're probably right. I wouldn't be surprised if some studios start making their actors go on this medication.

 

[torpid]

An olympian can easily afford $14k for this.