HIV prevention pill

Reader · 05-14-2012, 05:33 PM

Do the benefits outweigh the risks? Will this give people a false sense of security?

http://www.nytimes.com/2012/05/15/he...ith-risks.html

Truvada for HIV prevention backed by advisory panel, FDA may decide by June

In a landmark decision, an advisory panel to the Food and Drug Administration voted to recommend approval of Truvada to prevent HIV infection. The FDA is not required to the follow the panel of experts' advice, though it typically does.

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.

A final decision on Truvada is expected by June 15, but the FDA doesn't confirm such action dates and says the review of the application is ongoing, a spokesperson told CBS News.

"I think this is a huge milestone," Dr. Robert Grant, associate director of the Center for AIDS Research at the University of California, San Francisco, who led the panel's research, told CBS News medical correspondent Dr. Jon LaPook. "I think we are in an era for the first time when we can see the end of the AIDS epidemic."

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.

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

While panelists ultimately backed Truvada for prevention, Thursday's 12-hour meeting highlighted 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.

The panel 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.

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 it 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.

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.

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 nearly two-thirds of cases.

princessbelle · 05-14-2012, 06:31 PM

Well Hmmmm, that's interesting. Not sure how i feel about that but at first glance i have a couple of thoughts...

1. It's about time.

2. Lightly reading over the article it appears that it is of course possible to become resistant to this drug and it may make it unsuccessful in treating HIV if someone should ever get it. And this drug is part of the cocktail that keeps HIV at bay as long as possible...so that part is a little scary.

It is something worth following for sure.

Great thread!!!!

deedarino · 05-14-2012, 06:39 PM

It will all come down to cost. If the cost analysis says it is worth it to provide prevention then it will pass. If not....

Oh and if the government gets involved...still about $$$.

aishah · 05-14-2012, 07:30 PM

i'm worried about the fact that so many people wouldn't be able to afford it because of lack of insurance and even if you have insurance, lack of ability to afford the copay :\ the issue belle raised about drug resistance is worrisome too. it does give me hope that maybe there may be more accessible options in the future (in terms of both cost and eventually developing a drug that doesn't have to be taken daily). it would be amazing to have something like this available in communities where hiv infection among women of color is really on the rise, too.

princessbelle · 05-14-2012, 07:53 PM

I certainly know nada about this drug. But, what jumps to the front of my mind is what happened/is happening with Penicillin. Sure it is still a wonderful drug and helps many people but there are so many, many types of bacteria now that it doesn't touch and people build up resistance to it when they take it for the wrong reasons.

HIV is a virus not a bacteria. But, the theory is still relative, i think. If this drug prevents the virus, and we build resistance to the drug, if we do then get the virus, it may not do anything to help cure it. Since there are so few combo drugs that actually do help slow the HIV process down for decades prior to getting Aids, to me that is what is standing out in the forefront of this article.

I don't really know much about it....just something to consider.

Toughy · 05-14-2012, 08:27 PM

The reason Gilead is going to FDA for approval of this new use as prevention is so insurance companies will pay for the drug. It is very rare that an insurance company will pay for what is called 'off-label' use. 'Off-label' means the drug is not approved by the FDA for that use.

Truvada is currently approved for treatment but not prevention. If the FDA follows the advisory committee recommendation and approves it for prevention.............BINGO...health insurance will add it to their drug formularies for prevention and pay for it. This has HUGE profit potential for Gilead. Imagine how many people taking it daily for years....$$$$$$$$$

Now lets get to the brass tacks of the problem..........compliance....you must take it every day without fail...period. full stop. No one I know is ever 100% compliant with prescriptions for anything ever. AND if you are not compliant and end up HIV infected then you will have 50/50 chance of a drug resistant strain. It cuts down the number of antivirals available by 3 drugs. And then if you don't have health insurance and rely on Medicare/Medicaid/AIDS Drug Assistance Programs you are in even bigger trouble especially since ADAPs across the country are being gutted by budget cuts.

I'm not so sure it's an amazing possibility for those hardest hit by new infections. Barrier protection is still the best way to prevent infection...... either male condoms or female condoms, dental dams, etc.

And I haven't even addressed the issue of side effects of this combination of 3 drugs. I'm out of the loop so I don't know what this 3 drug cocktail (in one pill) has for a side effect/adverse events profile.

I do believe it should be approved, however serious education and strategies must be developed....barrier precautions plus truvada certainly looks to be good prevention as long as folks understand the danger of not taking your pill and use condoms.

ps...............there are at least 13 individual anti-viral drugs on the market....I actually think there are more than that now...it's a big tool box.....

05-14-2012, 05:33 PM	#1
Reader Timed Out How Do You Identify?: Butch, Dyke, Feminist, Contrarian Preferred Pronoun?: She, her Relationship Status: Single Join Date: May 2011 Location: New Jersey, The Garden State Posts: 732 My Photo Gallery Thanks: 1,308 Thanked 2,229 Times in 586 Posts Rep Power: 0	HIV prevention pill Do the benefits outweigh the risks? Will this give people a false sense of security? http://www.nytimes.com/2012/05/15/he...ith-risks.html Truvada for HIV prevention backed by advisory panel, FDA may decide by June In a landmark decision, an advisory panel to the Food and Drug Administration voted to recommend approval of Truvada to prevent HIV infection. The FDA is not required to the follow the panel of experts' advice, though it typically does. 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. A final decision on Truvada is expected by June 15, but the FDA doesn't confirm such action dates and says the review of the application is ongoing, a spokesperson told CBS News. "I think this is a huge milestone," Dr. Robert Grant, associate director of the Center for AIDS Research at the University of California, San Francisco, who led the panel's research, told CBS News medical correspondent Dr. Jon LaPook. "I think we are in an era for the first time when we can see the end of the AIDS epidemic." 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. Since Truvada is already on the market to manage HIV, some doctors have prescribed it as a preventive measure. FDA approval would allow Gilead Sciences to formally market its drug for that use. While panelists ultimately backed Truvada for prevention, Thursday's 12-hour meeting highlighted 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. The panel 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. 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 it 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. 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. 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 nearly two-thirds of cases.

05-14-2012, 06:31 PM	#2
princessbelle Infamous Member How Do You Identify?: femme Preferred Pronoun?: femme ones Join Date: Nov 2009 Location: Tennessee Posts: 6,100 My Photo Gallery Thanks: 29,380 Thanked 30,496 Times in 5,198 Posts Rep Power: 21474858	Well Hmmmm, that's interesting. Not sure how i feel about that but at first glance i have a couple of thoughts... 1. It's about time. 2. Lightly reading over the article it appears that it is of course possible to become resistant to this drug and it may make it unsuccessful in treating HIV if someone should ever get it. And this drug is part of the cocktail that keeps HIV at bay as long as possible...so that part is a little scary. It is something worth following for sure. Great thread!!!! __________________ ~ I've learned that people will forget what you said, people will forget what you did, but people will never forget how you made them feel. ~ Maya Angelou

05-14-2012, 06:39 PM	#3
deedarino Member How Do You Identify?: Femme Preferred Pronoun?: Woman Relationship Status: In recovery. Join Date: Feb 2012 Location: Oregon Posts: 632 My Photo Gallery Thanks: 3,518 Thanked 1,955 Times in 496 Posts Rep Power: 21474850	It will all come down to cost. If the cost analysis says it is worth it to provide prevention then it will pass. If not.... Oh and if the government gets involved...still about $$$. __________________ Squint your eyes and look closer. I'm not between you and your ambitions. I am a poster girl with no poster. I am thirty-two flavors and then some. And I'm beyond your peripheral vision, so you might want to turn your head~Ani I want to think again of dangerous and noble things; I want to be light and frolicsome; I want to be improbable, beautiful and afraid of nothing as if I had wings Mary Oliver

05-14-2012, 07:53 PM	#5
princessbelle Infamous Member How Do You Identify?: femme Preferred Pronoun?: femme ones Join Date: Nov 2009 Location: Tennessee Posts: 6,100 My Photo Gallery Thanks: 29,380 Thanked 30,496 Times in 5,198 Posts Rep Power: 21474858	I certainly know nada about this drug. But, what jumps to the front of my mind is what happened/is happening with Penicillin. Sure it is still a wonderful drug and helps many people but there are so many, many types of bacteria now that it doesn't touch and people build up resistance to it when they take it for the wrong reasons. HIV is a virus not a bacteria. But, the theory is still relative, i think. If this drug prevents the virus, and we build resistance to the drug, if we do then get the virus, it may not do anything to help cure it. Since there are so few combo drugs that actually do help slow the HIV process down for decades prior to getting Aids, to me that is what is standing out in the forefront of this article. I don't really know much about it....just something to consider. __________________ ~ I've learned that people will forget what you said, people will forget what you did, but people will never forget how you made them feel. ~ Maya Angelou

05-14-2012, 08:27 PM	#6
Toughy Senior Member How Do You Identify?: pervert butch feminist woman Preferred Pronoun?: see above Relationship Status: independent entity Join Date: Nov 2009 Location: Oakland Posts: 1,826 My Photo Gallery Thanks: 4,068 Thanked 7,653 Times in 1,522 Posts Rep Power: 21474853	The reason Gilead is going to FDA for approval of this new use as prevention is so insurance companies will pay for the drug. It is very rare that an insurance company will pay for what is called 'off-label' use. 'Off-label' means the drug is not approved by the FDA for that use. Truvada is currently approved for treatment but not prevention. If the FDA follows the advisory committee recommendation and approves it for prevention.............BINGO...health insurance will add it to their drug formularies for prevention and pay for it. This has HUGE profit potential for Gilead. Imagine how many people taking it daily for years....$$$$$$$$$ Now lets get to the brass tacks of the problem..........compliance....you must take it every day without fail...period. full stop. No one I know is ever 100% compliant with prescriptions for anything ever. AND if you are not compliant and end up HIV infected then you will have 50/50 chance of a drug resistant strain. It cuts down the number of antivirals available by 3 drugs. And then if you don't have health insurance and rely on Medicare/Medicaid/AIDS Drug Assistance Programs you are in even bigger trouble especially since ADAPs across the country are being gutted by budget cuts. I'm not so sure it's an amazing possibility for those hardest hit by new infections. Barrier protection is still the best way to prevent infection...... either male condoms or female condoms, dental dams, etc. And I haven't even addressed the issue of side effects of this combination of 3 drugs. I'm out of the loop so I don't know what this 3 drug cocktail (in one pill) has for a side effect/adverse events profile. I do believe it should be approved, however serious education and strategies must be developed....barrier precautions plus truvada certainly looks to be good prevention as long as folks understand the danger of not taking your pill and use condoms. ps...............there are at least 13 individual anti-viral drugs on the market....I actually think there are more than that now...it's a big tool box..... __________________ We are everywhere We are different I do not care if resistance is futile I will not assimilate www.butchfemmesocials.com/

05-14-2012, 07:30 PM	#4
aishah Member How Do You Identify?: queer stone femme shark baby girl Preferred Pronoun?: she, her, little one Relationship Status: dating myself. Join Date: Jan 2012 Location: dallas, tx Posts: 1,495 My Photo Gallery Thanks: 13,823 Thanked 6,442 Times in 1,288 Posts Rep Power: 21474851	i'm worried about the fact that so many people wouldn't be able to afford it because of lack of insurance and even if you have insurance, lack of ability to afford the copay :\ the issue belle raised about drug resistance is worrisome too. it does give me hope that maybe there may be more accessible options in the future (in terms of both cost and eventually developing a drug that doesn't have to be taken daily). it would be amazing to have something like this available in communities where hiv infection among women of color is really on the rise, too.