I wonder what Anderson Cooper is wearing today . . .
That is amazing. I just watched the movie, "Long-Time Companion", and what a great film.
Wow! This is excellent news.
It was originally slated to be called Tru Data.
How long before a pharmacist refuses to administer on moral grounds and which state will s/he live in?
So now even fewer people will wear condoms, which will help to spread other STDs. Terrific.
The thing about this drug is that you still need to use condoms with it.
But no one will hear the last part.
The Voice of the Night
Reduces, not eliminates, the risk of infection. Isnt that what condoms do?
Yes and we've all sen how well condoms are working. This isn't a drug for everyone. But there are people at very high risk who would benefit from the extra protection that [an important drug google will not allow us to mention] can provide. Couples where one person is positive and the other is negative. Men who've already been diagnosed, often multiple times, with an STD, and for whom it is a matter of when, not if, they will become infected with HIV. Sex workers. Women who don't have control over condom use.
That's great since HIV doesn't cause AIDS, you will now pay extra to get cured from something that is benign to begin with.
The FDA should re-name it "The Ass of Louis Tomlinson" and more people would pay attention.
so this is a drug that will just be taken by people who tend to bareback or have sex with poz guys?
Can you just buy a 2 week supply for your next jaunt to Mykonos?
I doubt insurance companies are going to pay for an expensive drug that is voluntary.
$14K a year. Condoms are much cheaper.
A one-month supply of [an important drug google will not allow us to mention] for someone who's taking it as an antiretroviral therapy costs about $1300. I was curious, so I looked it up.
But that presupposes that the prophylactic dose is the same.
It's also worth pointing out that the study that was done that supported these results was among heterosexual couples in sub-Saharan Africa, and HIV in the United States has a different footprint.
The Voice of the Night
[quote]So now even fewer people will wear condoms, which will help to spread other STDs. Terrific.
Exactly. Other STDs like the new AIDS, whatever that turns out to be, which could be ten times worse. I'm not celebrating this news—not even close to it.
Condoms are always necessary. And anyone who thinks otherwise (although I don't know how anyone could be that dumb) is a fool.
Will someone do a poll asking how many people will be replacing condoms with this medication or some variation thereof.
[quote]Will someone do a poll asking how many people will be replacing condoms with this medication or some variation thereof.
Well, do I just wrap the pills around my dick?
VotN, there was data from 5 studies that was available to FDA and 2 studies that presented at the hearing for their decision. The first, landmark, study was among gay and bisexual men in the US, South American and Thailand.
As far as the trial serodiscordant couples, the majority, but not all, were heterosexual couples. The reason the trial was conducted in Africa, as many HIV prevention trials are, is that the high prevalence and incidence of the disease are the only feasible was to conduct a randomized clinical trial that will cost millions instead of billions. But the biology of humans in Africa is the same as it is throughout the planet, so there's no reason to assume that if a drug worked on one continent, it wouldn't on another.
The prophylactic dose of [an important drug google will not allow us to mention] is the same as it is for treatment, except for treatment, a third drug woold be included. Future studies are looking at alternate dosing strategies (such as peri-coitally dependant dosing), possible long-acting injectables, and other drugs.
Insurance companies have so far indicated that they see know reason they would not cover [an important drug google will not allow us to mention] for prevention. Frequently, they have drugs on their formularies that are used for the treatment of more than one condition, and they are not able to tell what condition the drug has been prescribed for. Several have commented that they would not restrict the use of the drug if providers prescribe it.
It's not a drug to replace condoms. Before anyone can get a prescription, their doctor will have to determine that they are uninfected, and will have to continue to test to make sure the person remains uninfected.
The MOST important thing to know about [an important drug google will not allow us to mention] is that while the effectiveness based on the studies was modest, 44% in iPrEx, 74 (I think) in Partners PrEP, among study participants who had detectable drug, the effectiveness at preventing HIV was higher. Like 90% or higher. FDA re-analyzed the iPrEx data independently and determined that among drug adherers, the protection was 100% with 100% adherence. The worst thing someone could do would be to start and stop and re-start taking the drug. They not only risk getting infected, but also developing resistance to [an important drug google will not allow us to mention], limiting their treatment option if they do become infected.
Please excuse all my typos and obvious grammar errors. I'm a quadriplegic who types with a straw in his teeth and sometimes the thoughts come faster than I can move the straw.
Are you serious, R24/25?!
[quote]But the biology of humans in Africa is the same as it is throughout the planet, so there's no reason to assume that if a drug worked on one continent, it wouldn't on another.
That's not entirely what I meant. I don't know the exact number off the top of my head, and I'm too lazy to go and dig through my notes to find the information, but I'm pretty sure that the percentages of US HIV cases that were acquired through homosexual sex or IV drug use are an order of magnitude higher than the percentages of African HIV cases.
The only study that was mentioned in the report on the FDA ruling that I saw was, I think, the Patient PrEP study, which looked rates of seroconversion in Kenya and Tanzania. If there actually are data that says that it works with gay/bi men, that's great, and if insurance companies are going to pay for it, that's even better.
I mean, I can see that authorizing a scrip for [an important drug google will not allow us to mention] to keep a person from seroconverting is probably cheaper in the long run than not covering them and then having to pay for treatment for a person with an advanced infection.
Although, if they think the PrEP protocol would be even more effective if there was a third drug being used, why didn't they look at Atripla instead?
The Voice of the Night
Well the study in gay men was mentioned in the huffpo piece above. The reason for not using Atria is that Efavirenz is really. Really. Tough at the beginning. Too many people would probably stop taking immediately. The other main reason is that you don't want to risk triple drug resistance. [an important drug google will not allow us to mention] resistance is a serious problem for people who are taking the drug haphazardly.
And percentages, yes. By raw numbers, no. In some of the settings where the trials were conducted, the prevalence of HIV is as high as 40% of the population. In the US it's about 0.3% of the overall population. Many places have been so overwhelmed by the epidemic that they are just realizing they have hidden epidemic s among MSM and IDU. In the US, populations of MSM have prevalence on the order of 25% among African Americans. The incidence in young black gay and bisexual men is staggering. And it's not that they arent using condoms more than their white counterparts. They actually are having fewer partners and more condom use, but the community is at such great risk there's no room for mistake.
Again. Teeth typing. Sorry.
God dammit are you being serious? Are you really a quadriplegic? That's more interesting than a drug that slightly reduces the risk of HIV infection.
I'm sorry. That was a lie. I'm on an iPhone. It's autocorrecting the fuck out of everything I type. I am an AIDS researcher, though. But the other thing was a terrible lie.
AIDS researcher, does [an important drug google will not allow us to mention] have serious side effects? Is this a mild drug any gay man who is sexually active should take "just in case" or does it kill your kidneys / affect your fat composition etc?
It was ready in 1989. They just wanted to make sure enough fags died first.
I think a placebo would be more effective than this drug.
My pitch: This pill that may look like an M&M is the most potent anti HIV pill there is and ever will be and it will only cost you 20,000 bucks. One pill will last for a lifetime. it's a steal. Buy it. Now.
[an important drug google will not allow us to mention] was chosen because it has a very good safety profile. Few side effects (mainly nausea, vomiting, diarrhea -usually goes away after a few weeks. It can cause serious problems in a small percentage of people with underlying kidney disease, but the package insert gives guidelines for checking creatinine clearance. It can cause bone mineral density loss, which could be serious if taken for a prolonged period. People with HIV face the same risks, but without [an important drug google will not allow us to mention] would of course have much more serious problems from HIV.
Not everyone is going to need it. Not everyone should take it. Everyone who does take it is going to get free condoms and vouchers for HIV testing and have to get tested every three months.
I'm a single gay man. I'm not going to take it. I know that I'm going to use condoms because they are effective when used properly and I know I don't need it (special sidenote: I hear a lot of people who think they aren't at risk and are surprised to find out they are infected. People are really bad at determining thieir own risk. Really bad. I consider myself an exception because my job is to, among other thigs, figure out exactly,how bad people are at determining their risk. If my doctor told me I should take [an important drug google will not allow us to mention], though, I'd be surprised, but Id consider it)
PrEP is going to be for people,who just absolutely never will use condoms (but want to protect th,emselves from HIV. Some gay men are already serosorting, and that's ODDLY provided some protection. But really, it's just a matter of time for them) and they're going to be give condoms and counseled. It's going to be for people who will use condoms but are still at risk. If condoms were a perfect answer, we wouldn't have an epidemic. It's going to be for people who are in serodiscordant couples and use condoms but who have a greater risk of getting infected because their main partner already is.
It's not going to be a good idea if somebody says they want to take it to stop using condoms.
But above all, it doesn't work if you don't take it as prescribed. You can't skip doses. You can't take it if you haven't been tested at least every three months.
Thanks HIV researcher. I have a few questions, if you don't mind. Why would you be more likely to develop resistance if you don't take it regularly?
If you do become resistant wouldn't you be totally screwed if you did become infected?
How long were these studies? Isn't there a chance that everybody who takes it might eventually become resistant?
And a final question: if you take it on and off, will that help to develop a 'super bug' similar to the way TB has become resistant because people don't take their meds properly?
You can only develop resistance if you become infected while you're not taking the drug, then start taking it. It takes three drugs to put enough selective pressure on the virus to prevent resistance in people taking it for treatment. They can develop resistance if they skip doses (takes quite a few missed doses with [an important drug google will not allow us to mention] to develop resistance, though. Neviripine, a different drug, can cause resistance with a single missed dose)
You can also become infected with transmitted resistant virus, but so far, nobody in any of the studies were infected with resistant virus while they were taking the drug, which is a good sign. the participants who,did,have drug resistance were found to have had undetected acute infections before taking the drug (so a recent infection, only a few weeks, old, that can't be picked up by regular HIV testing).
For those taking the drug with good adherence, nobody in the trials developed resistance, and can't develop resistance as long as they remain uninflected.
Most trials started around 2007. Saw the first results in 2010. Most people were on study drugs for about 2 years. There's a trial inThailand that should end this year where some people will have been on as long as 6 years almost.
If you developed drug resistance to tenofovir or emtricitabine (or both) you'd have to switch to different drugs. Drug resistance is a huge concern, because you don't want to have limited options for treatment.
The superbug is exactly that, multidrug resistant TB. You can have multiple mutations that cause resistance to the same drug.
Hope that helps. Gotta run. Watching Teen Wolf then heading to bed.
HIV researcher is a my new hero
This might lead to new infections; everyone's going to interpret this incorrectly.
HIV researcher is the new TaxTroll.
HIV researcher was hotter than Professor X when he was typing with his teeth.
Now, he's more the Natasha Lyonne character in Blade III - still pretty hot.
I heard HIV researcher is so hot that he was the real inspiration behind Magic Mike and Soderbergh's first choice to star, but he declined because they wouldn't film it in 3-D.
[quote]I hear a lot of people who think they aren't at risk and are surprised to find out they are infected.
I hear this too and it always fascinates me. "I always played safe." "I never did anything risky." Are these people a) lying, b) in denial, c) unaware of the basic facts of HIV transmission, or d) proof that HIV isn't just transmitted by bareback sex?
I think mainly b) denial. A lot of times you can ask someone and they can tell you what HIV risk is. They can say 'having multiple partners with unknown serostatus, having unprotected sex, alcohol and drug use, exchanging sex for money or drugs, sharing needles.' They're completely honest about what risks they've had (I had unprotected sex in exchange for drugs. I had unprotected sex with 6 partners in the last month. I've had syphilis and gonorrhea.) But then you ask if they are at risk and they'll say nope.
There's also a lot of social desirability in saying you were safe when you know that you weren't. It's a test. People want to do well on a test. They know the right answers and that's what they give. Sort of a white lie people tell they're doctors. As long as the test is negative, that one time I had unprotected sex doesn't count and they don't need to know about it.
I think a lot of it is that medical providers, especially primary care providers who are more concerned with BMI and cholesterol, diabetes, and smoking, HATE talking about sex and that message, directly or indirectly, gets sent to their patients.
Eh, but what do I know?
The International AIDS Conference starts Sunday in Washington DC. There's going to be tons and tons of news coming out. The word on everyone's lips is 'cure'. Not that there is one, but how close are we, what do we need to do to get there, how long until we are there.
Are there other HIV researchers here? I know I'm not the only one.
Will you be in DC HIV Researcher? If you are, can you please give us updates? You are our new hero.
I would think that use of this drug, especially inconsistent use, will promote the rapid development of a 'super hiv' bug. Could it be the same as how strep, etc. has become resistant because of over-use of antibiotics?
I'd rather just play safe, tbh.
Given the effectiveness of condom usage (correct usage) versus an extra 42% (presumably of the difference between effectiveness of correct condom usage and 100%) I don't see the value of this pill at all, and see a real danger of creating complacency in a stupid and at risk population.
What is the effectiveness WITHOUT correct condom usage? If it isn't as good as a condom, this is worthless and dangerous.
I will be at the conference and will happily report back. Usually someone will post the big news stories from the HIV conferences here anyway, and I'll weigh in and say what I heard, and someone will call me crazy, and I'll say I'm *at* the conference and heard it firsthand, then I get called crazy AND a liar...so this would speed things up and work out nicely for me.
The risk of resistance at the community level is pretty small. There's a very narrow window between the amount of drug that is too low to develop resistance and high enough to prevent infection. Basically, if someone is taking the drug enough to prevent getting infected, the chance of developing resistance is zero (because the resistance can only happen when someone is infected). When someone ISN'T taking the drug enough to prevent infection, the chance of them having enough drug on board to cause resistance is almost zero. The big risk of resistance would be if someone started taking the drug after they were already infected-maybe if they started, stopped for a period, got infected, and decided to start taking [an important drug google will not allow us to mention] again. That's a pretty dangerous prospect. But for the most part, the threat of widespread resistance seems to be small.
So effectiveness. Condoms have 97% efficacy (let's just say effectiveness) against HIV. But people don't use them consistently, so we're seeing increasing numbers of infections despite decades of promoting condom use. If condoms were evaluated in a clinical trial and they included all the times people didn't use condoms, efficacy would be lower than 97%-maybe something like 30%.
The studies of PrEP were to look at how much protection [an important drug google will not allow us to mention] added to the benefit that condoms already provide. With people being counseled and provided free condoms and tested monthly, [an important drug google will not allow us to mention] decreased the risk of getting infected between 44% and 74% IN ADDITION TO USING CONDOMS. So that alone is a pretty big benefit. But there is better news. The trials looked at participant's adherence and see that when people in the trial took the drug everyday, the efficacy was really greater than 90%. And when the FDA completed their own analysis, they said it was likely 100%.
So, on top of condom use, with perfect pill-taking, PrEP could prevent nearly 100% of infections in gay and bisexual men.
NPR had a good story about PrEP and who may need it.
Thanks for all of the info, HIV researcher. Very interesting.
I agree R19, people are just going to use this as an excuse to bareback or they'll think "Oh I can take this pill and I don't need to use condoms since it will protect me against HIV!" and more people will become Poz.
As for me I'll continue to use condoms and practice safer sex.
I know people who take this medication regularly and it's has some not so nice side effects.
HIV researcher, how safe is giving a man or woman oral sex if you don't swallow and it's not "that time of the month" for her?
Also if someone does cum in your mouth should you swallow or spit it out? Does using Listerine afterward help?
Honestly, r50, I really don't know. There's been so much back and forth about it. I think most agree that it's really, really, really low risk (but not zero risk) for HIV. But much bigger risk for syphilis, gonorrhea, HSV-2, HPV, and pretty much everything else found on someone's junk.
Spit. I don't know about listerine. My first thought was that's probably not good. But then my second thought was that probably is a good idea. But then I thought, no, probably not. But, wait, maybe it is. So I'm not really sure. Either way, I think that the risk of getting infected with HIV through oral sex is low and mouthwash probably wouldn't influence it one way or another.
I know a lot about HIV testing. Anybody want to talk about that?
HIV Researcher probably barebacks/has HIV. His quadriplegic "joke" was beyond crass.
STFU R52. HIV/R has taken the time to explain how this drug works and has tirelessly answered all of our inane questions.
What have you done for us lately - besides being snarky...
It was a terrible thing for me to say, r52. I agree with you on that.
Conference starts tomorrow.
I think we're going to hear big news about exactly when to start therapy (i.e. probably immediately after diagnosis) and bad news about how big a risk unprotected receptive anal intercourse is (bigger than previously thought).
I wouldn't be surprised if we heard that additional people with HIV and leukemia have received bone marrow transplants in the same manner as the Berlin patient (the first, only, potentially cured person).
And we'll definitely hear a lot about cure research and avenues for cure that involve gene therapy.
There have been a lot of events taking place over the weekend before the conference begins.
Any thoughts on the AIDS activist who accused researchers and prominent gay activists of being racist in their view of the high infection rates on AA males?
Hmm. I'm not sure i know this story. Do you mean this activist accused researchers and gay activists of racism and believe rates among AA are inflated (and racist)?
Mostly, the response from black AIDS activists has been to highlight the health disparities and disproportionate burden among black men, and acknowledge and try to make people aware of the high rates.
Or was this about the comment Phil Wilson of the Black AIDS Institute made recently about national gay organizations? Because I do agree with him. Take a look at the information on what HRC and the NGLTF have about HIV among gay and bisexual men in the country and there's hardly a mention of gay black men. Black MSM are only about 1% of the population but 40% of new HIV diagnoses. And the Black AIDS Institute released a report on HIV in black MSM and the figures are staggering. 25% prevalence among young black MSM, 60% of the overall population. That's fucking outrageous!
I think everyone agrees that factors like racism, homophobia, stigma, poverty, and other things are serious drivers of the epidemic. They're not the things that put people at risk (the behaviors that lead to transmission) but they increase risk. They make it harder to access services, be engaged in prevention activities, and remain negative. And they're synergistic, so if your poor and facing racism and homophobia, things are exponentially worse and your risk is even greater.
Not sure if either of those were what you were talking about.
The had it made world
She was the sleekest debonair
She lived a life without a care
She was an AIDS girl
She was alive and unafraid
That bitch gave everybody AIDS
She was an AIDS GIRL
She said, "If I am gonna die"
"I'm taking everyone with I"
And so her grammar wasn't great
She cared not, death had sealed her fate
She was an AIDS girl
She was alive and unafraid
That bitch gave everybody AIDS...
The only people I can see benefiting from this pill are prostitutes and extremely promiscuous people. But are they really going to be able to afford a $1300/month medication? Are they really going to take this pill properly, every time? I doubt it.
[quote]I think we're going to hear ... bad news about how big a risk unprotected receptive anal intercourse is ..
Authors of a new study estimate that If receptive anal intercourse were only as risky as vaginal intercourse, HIV cases would fall by 80 percent to 98 percent among gay and bisexual men over five years.
Cases would fall by 29 percent to 51 percent if more gay and bisexual men had sex in long-term relationships instead of casual encounters.
In North America, an estimated 15 percent of gay and bisexual men are infected with HIV; the rate is the highest, 25 percent, in the Caribbean.
r59 i was thinking the same thing. It's not clear to me who benefits from this.
The figure of 15% of gay/bi men having HIV is pretty shocking.
Thank you r60! That must be what I'm hearing about. I saw that there was something in teh Lancet, and if I were good, I would have read it, but I'm tired and I'm here reading about Katherine Jackson and Matt Bomer instead. I have priorities.
R61, I think the fact that 15% of gay/bi men are infected suggests how important additional prevention tools like PrEP are. Condom use alone isn't giving us the big reduction in new cases. It's time for combination prevention interventions that address behavioral, social, and biological issues. We have a new biomedical prevention internvention. It's the first one we have and it will lead to newer and better ones, but the need is there.
r62, why aren't the HIV prevention pros stressing knowing your status, and disclosure? Why isn't there a big PR push behind these simple and inexpensive public health ideas?
I think there has been a huge push to get people to know their status. CDC has several campaigns aimed at geting people to know their status and most large cities have adopted aggressive strategies around routine HIV testing. The CDC recommended that HIV testing be routinely conducted as part of a regular clinic visit for all persons 13-64. Where there's been failures are with the primary car, non-HIV care, providers who are not offering testing.
In places like DC, buses and metros are covered with ads telling people to 'ask for the test'. Similar campaigns are taking place in the large cities that bear the highest numbers of cases.
The message around test may be getting lost in the news when newer things like PrEP get covered, but testing is major part of President Obama's National AIDS Strategy. In DC and the Bronx, there is a community randomized trial looking at Testing and Linkage to Care (plus other service) (TLC+). Sometimes people will refer to it as Test and Treat. The goal is to test everyone, and offer treatment immediately to everyone who tests positive to try to halt the epidemic.
Disclosure is a tougher nut to crack. You really won't see campaigns about disclosure because it's something that follows finding out you're infected. I'm not aware of any large scale social marketing campaigns on disclosure, but there may be some. Typically, after a person is diagnosed and linked to care, someone like a case manager may work with the person one-on-one to build skills around disclosure.
Nothing excited happened at the opening of the conference. I didn't stay until the end and missed the first 10 minutes of the opening session, but no science discussed and there were no protests.
Earlier in the week, the Washington Post and others were reporting that GW Bush would speak. Then they corrected and said he was invited but hadn't responded. If he had been there, there could have been fireworks! :)
I knwow he seems like a really unlikely person to invite, but he is the president that established PEPFAR, and that is probably the most significant public health program in history.
As much as I dislike GW Bush, he in fact did a lot for AIDS research.
[quote]why aren't the HIV prevention pros stressing knowing your status, and disclosure? Why isn't there a big PR push behind these simple and inexpensive public health ideas?
If you want to believe that it's everyone's responsibility but your own - to know and disclose one's status - suit yourself, invest your trust in it being the other man's responsibility.
In fact, that's pretty much how it works now. Men who don't really want to know and certainly don't want to ask leave it 100% up to the other guy. This system works out in a way that Barbara Bush might admire, but no one else.
Yeah, R65... in [italic]Africa[/italic]. At the urging of Bono.
I wouldn't say he did a lot for HIV research. He actually hindered research quite significantly. Researchers were seeing grant requests denied if the work involved sex workers, gay men, drug users. All populations very hard hit by HIV. He did however do more than had ever been done for treatment around the world. He did nothing for treatment in the US. And even PEPFAR came with strings attached (no sex workers, no clinics in Africa that provided abortions).
But PEPFAR was remarkable given the lack of investment in treatment to date. And it's been better under the stewardship of Obama. It's still vulnerable to cuts because of the current era of *cough* austerity.
And yeah, Bono is as much to thank as GWB.
I just saw Patrick Abner, Thomas Roberts' handsome husband (fiancé?). He works for Isentress? Something in my brain recognized him and I waved and smiled and then realized 'oh I don't really know him...'.
I'm taller. That's the only thing I took away from the encounter.
[quote]If you want to believe that it's everyone's responsibility but your own - to know and disclose one's status - suit yourself, invest your trust in it being the other man's responsibility.
How do you read that from my post? Whenever anyone brings up disclosure, someone will have this kind of knee-jerk response, as though disclosure = blaming or ostracizing HIV+ people.
Of course it's everyone's responsibility. My point is that honesty and disclosure should be the cultural norm among gay men, and it's not. "Don't talk about it and assume everyone is positive" is misguided.
HIV Researcher, if you don't mind, could you point me toward the studies about the efficacy of the PrEP protocols? Sometimes searching MedLine (if that's where they are) is a little daunting for me.
I decided a few weeks ago that I'd like to write my senior thesis on this, and even though I'm not supposed to really start digging in until my seminar (for all graduating seniors working on a thesis) meets at the end of the month, I'd kind of like to get a jump on it.
And if the answer is "Google it yourself, you lazy bitch!" I admit I deserve that.
Thank you so much! The only article I'd been able to find was one about PrEP being tested on Macaques exposed to SIV, which was helpful, but not quite what I needed, since my focus is human biology.
And every real mention of iPrEx on Medline was more scientific reaction to it.
The Voice of the Night
Hey, HIV Researcher--Would you mind pointing me toward the study about using a third drug for PrEP? I can't seem to find much information on PubMed, even though I've found a lot of failed and current vaccine trials.