The days of taking Truvada once-a-day may soon be over.
Past research has claimed that daily use of PrEP can dramatically lower one’s chances of being infected with HIV. Now, two new studies support those claims, but one of the studies takes it a step further.
500 gay men in the U.K. participated in a study retest the effectiveness of taking the standard, once-a-day dose of PrEP. Researchers found this strategy lowered one’s risk for HIV infection by 86 percent.
400 gay men participated in second study jointly conduced in France and Canada and looked at what happened when PrEP was taken on a less regimented schedule. Rather than taking a pill everyday, they took two pills between 2 and 24 hours prior to having sex with another man, followed by another two pills 24 and 48 hours after sex. The second study found the exact same degree of protection — 86 percent — as the standard, once-a-day regime.
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“These results are extremely exciting and show PrEP is highly effective at preventing HIV infection in the real world,” said Sheena McCormack, Professor of Clinical Epidemiology at the MRC Clinical Trials Unit at UCL, and Chief Investigator of the U.K. study. “Concerns that PrEP would not work so well in the real world were unfounded. These results show there is a need for PrEP, and offer hope of reversing the epidemic among men who have sex with men.”
But don’t get too excited yet, fellas.
In a statement released by the CDC, Dr. Jonathan Mermin said that it’s still too soon for people to completely abandon the once-a-day regimen, saying more research needs to be conducted.
Mermin noted that the new strategy was only tested on men who were having sex an average of 10 times per month with eight partners every two months, which means that some of them were taking as many as eight pills per week, exceeding the once-per-day dosage.
“Researchers do not yet know if this regimen will work among MSM who have sex less frequently and would therefore be taking PrEP less often,” Mermin said.
Still, the new results are encouraging.
“I am immensely pleased and overwhelmed, a little emotional even,” said study participant Stefan Laros. “[F]or the first time in 30 years I feel there is hope for people like me, who struggle with consistent condom use, but who want to protect themselves — and just as importantly — their sex partners against HIV infection.”
Related stories:
QUESTION: Is It Finally The Right Time For HIV Negative Guys To Start PrEP?
Ben Patrick Johnson Blames Larry Kramer’s Resistance To PrEP On “Generational Gap”
Is Truvada As Effective At Preventing HIV Infection As We Thought? Maybe not.
Kieru
Uhh… 86% is still significantly lower than the protection rate offered by condoms, not to mention the statistical protection theorized by previous studies. If anything this makes me question the general efficacy of the drug, and only reinforces the necessity of continued condom usage during sex.
redcarpet30
Actually its on par with condoms, they are only about 85 percent effective once failures and imperfect use are factored in.
http://www.aidsmap.com/Do-condoms-work/page/1746203/
Which isn’t to say we should give up condoms, thats just what the statistic is.
I think this is promising, especially for people who have sex infrequently. Coupled with condoms it will be pretty damn effective. I know lots of people are looking for a reason to throw them away, but there are a few like me who would love the idea of having a secondary backup just for peace of mind.
SportGuy
If everyone used this in conjunction with condoms, as took it every single day, then it would be great! However, the vast majority quit using condoms and who knows if they take it every day. To each his own, but I will continue to use condoms with every single person.
QJ201
Every dude I know on PrEP is not using condoms, some are being selective and others have just become bareback cum dumps or stick in anything power tops.
The good news that in the US, you have to get tested for STDs as well as HIV every time you get your PrEP prescription renewed
vive
Protection should be higher than 84% if taken every day.
You can google the U.K study. The guys on PrEP obtained only about enough of the drug to cover 86% of the days. In other words, they skipped 14% (or more) of their doses.
Only 3 of the 239 guys prescribed PrEP got infected. It is quite possible that these three were among the guys who skipped doses.
Also, about a third of the guys in the placebo arm took PEP, so the protection in the PrEP arm compared to nothing (including no PEP) would already be higher than 84%.
vive
@vive, just to clarify, my comments are regarding the once-a-day PrEP regimen used in the PROUD study.
Taskebab
I want to avoid HIV so I DON’T have to take pills…I’m not gonna take pills to avoid not having to take pills…
SportGuy
@QJ201:
Eactly! That is why this drug does more harm, because as expected, the majority is using this as a reason to bareback, when it is just in case a condom breaks!
Mike
I’m still suspicious…plus I don’t want to commit myself to a drug that costs $1500/month -even if I do have insurance. I also am not sure about the long-term health effects of having to take something like this every day for years…..what if I miss a dose? what if I accidentally take two? What if insurance stops covering it, or only covers part of it and I can’t afford the rest? I don’t trust yet.
lauraspencer
In the article Stefan says… “For the first time in 30 years I feel there is hope for people like me, who struggle with consistent condom use”
If you struggle with condom use do you really think you can handle taking a pill regularly? It sounds like Stefan isn’t responsible enough to be having sex let alone take a pill on a regular basis.
pjm1
wow, I cannot understand how it is being spun, that is, a 14% failure
rate with VERY HIGH stakes is considered good news. Something is definitely
off and i am rather shocked at the CDC thinks a 14% fail rate for once a day users
is good. Would you eat at a restaurant where you have a 14% change of getting
food poisoning and you would have that the rest of your life?
Perhaps the testing agency in GB and the CDC are either paid by the pharma companies
or they are just to cozy.
The statistic is rather shocking.
pjm1
Just for statistics sake if
100 people were taking PreP once a day, and
each PreP user had intercourse with a person who is HIV positive, then,
14 of the 100 people would be infected with the virus.
That is staggering.
dhmonarch89
sticking with condoms- 1 break in 20 years- a hell of a lot better odds than 86%….they tell you to continue to use condoms with prep- eventhough most media sources, like the Advocate don’t, so why poison yourself with hardcore drugs and numerous side effects when you’re using something that is 99% effective- the condom!
dhmonarch89
weren’t they saying it was 90- 99% effective at the end of last year??? So, by the next study, it will be 80%, then 70 and so on and so on….plus- most insurance companies don’t cover it- and it’s very expensive!
jwtraveler
Great. A drug that gives a 14% chance of getting a life-threatening illness. Not to mention all the other STDs, known and yet to be discovered, that you can be at risk for. I’ll keep my condoms.
VampDC
Unfortunately I would like to take these pills but it would mean having to be more comfortable to talk about sex with my parents, which i am not.
blasted
@dhmonarch89: Yes they were saying that Protection with Prep was in the 90 percentile, last year and according to this studies information that number has dropped, How is this good news?
blasted
http://www.cdc.gov/hiv/prevention/research/prep/ It says 92% to be exact it dropped 6%…. Why would someone even try to spin this information as good news. Could it be the porn studio dollars???? Idk. This is really bad news.
Blackceo
@Taskebab:
THANK YOU….JESUS F’N CHRIST I got into a huge argument with a friend over this. What the hell is in PreEp anyway? What kind of longitudinal studies have been done to see if there are any long term affects by using this? None cuz it’s a new drug. So yeah…I’m not shoving a pill down my throat when condoms have been doing the job thus far.
Jody
Two different measurements at work here.
PrEP is 99% efficacious at stopping HIV infections in an individual when taken every day. That’s unchanged and was re-verified with these studies.
PrEP is 86% effective in stopping HIV at the population, macro level when you include all different cases of people taking the pills — those who skip no days, some days, many days, stop taking the drug, etc. That’s the boom here and its’s huge.
By contrast, while condoms are as efficacious on an individual level, the Smith study out at the end of 2014 showed condoms were 70% effective at the population level in stopping new HIV infections.
The 86% effectiveness rating for the studies released this week were gobsmackingly powerful. The very first effectiveness measures for PrEP, when people didn’t even know if the procedure would work on the individual level was only around 44%. It jumped to 73% when Smith ran the numbers after more data was in. We’re now at 86%, with people being highly compliant in taking the medicine. No one who took PrEP 4 or more days a week in any of these studies has seroconverted to HIV.
We now have multiple tools — condoms, PrEP, PEP, and ARV / viral suppression — to stop new infections. This is an incredibly good thing.
pjm1
@Jody: Sorry, I cannot agree with what you say — the
data above says 86% effective in the study for if taken every day. The article says:
“The second study found the exact same degree of protection — 86 percent — as the standard,
once-a-day regime.” There it is.
You said “86% us gobsmackingly powerful.” Would the smallpox vaccine or the polio vaccine by
“powerful” with an 86% effective rate. No.
Is Travuda effective with a 14% fail rate. No.
My experience is that when people start to obfuscate throwing this and that number around
there is a reason. The numbers in the article are pretty clear and it is what it is.
It seems to me the pharma company making travuda wants to triple dip. (1) sell it to
those who are currently positive, (2) sell it to those who want to remain negative but
knowing there is a very significant infection rate, (3) then increase sales of those NEEDING
the drug by getting those in group 2 infected.
Wow. This is really quite stunning info.
Tackle
This study does NOT prove anything. Major problems and flaws with this. First, of the reported 500 men in the UK study, and the 400 men who participated in the French and Canadian studies, how many of their partners were even HIV positive?
This whole thing has BS written all over it. It just seems like they are hiding and ducking from the truth. You don’t need this many participants. This can be made a lot more simpler.They come off like they are trying to sway favorable opinion with the high number of participants used. All you need is around 100 men: on PrEP. Whether it’s once a day or the way the study here was conducted: the 2 pills between 2 & 24 hours prior to sex, and the two pills 24 to 48 hrs after sexual activity, just pair them up with partners with a high viral load.
Most people are are not even taking PrEP will not get HIV from someone who’s undetectable or who has the virus under control. What they are counting on is gullible people who are not asking any questions, not doing their own research and willing to swallow anything they say.
vive
@pjm1: “if 100 people were taking PreP once a day, and each PreP user had intercourse with a person who is HIV positive, then, 14 of the 100 people would be infected with the virus.”
No, that is not what it means. In the study, only only 3 of the 239 guys prescribed PrEP got infected, and the participants skipped on average at least 14% of their daily doses, so no, they were not taking it once a day as prescribed. Even so, they were 84% more protected than people not on PrEP (a lot of whom used PEP).
Kieru
@Tackle: I don’t understand what it is you’re trying to say. If the 500 or 400 person study was too small to be relevant, how would a study of 100 be purposeful? Also… you do know that in a proper study you HAVE to have a control group right? Not everyone can be paired with an HIV+ sexual partner.
Finally – even if this study has its flaws (and most all do) … I don’t think it makes the claims worthless. After all, the 96%+ efficacy that Truvada promotes wasn’t even real. It was the maximum statistical efficacy. The ‘real’ efficacy based on human usage was lower.
And yes – the company that makes Truvada is banking on your being afraid of HIV and buying their pill. If you’re going to bareback you probably should though, because without SOMETHING you’re being just as naive as you accuse purchases of Truvada to be.
vive
@Jody: “No one who took PrEP 4 or more days a week in any of these studies has seroconverted to HIV.”
Thanks for pointing this out again. Actually I was looking for any information on this detail in the PROUD study (the UK PrEP study) but couldn’t find it in the few docs I looked at. All I could find was that average compliance was (at most) 86% of days, based on how many pills were dispensed. Did they do any measurements correlating individual compliance with infections?
vive
@Tackle, you need large numbers of participants, because the average chance of infection for a negative bottom with a positive top (without PrEP or condoms) is only about one in 300. With just 100 participants, not enough infections would occur in a year to do any statistics with.
pjm1
@vive: well, i am confused b/c the article notes there
were 400 people in the study and the article said there is an 86% protection rate. So, if the infection
rate is 3 people out of 239 perhaps that needs to be stated somewhere in the article — 3 of 239 would
be very different. To me, 86% means it protected 86 out of 100 times.
Kieru
@pjm1: I’m not sure why you’re confused. 86% of 400 is 344. Your misunderstanding (86 out of 100) still works if you simply multiply that by 4 to get to 400 (86 * 4 = 344).
What Tackle is saying is that a small sample, regardless of the findings, is not enough representation. There are BILLIONS of people in this world in all stages of life. Medicine is only worthwhile if it works effectively across a large swath of people. So when you’re doing a study like “How safe and effective is PReP” you want a large sampling of a diverse range of people so your findings have something to stand on.
Wilberforce
Use condoms always. Drop your internalized homophobia and self-destructive behavior. Talk about hiv frequently with other gay people. Stop making excuses. Grow the f— up.
vive
@pjm1 “@vive: So, if the infection rate is 3 people out of 239 perhaps that needs to be stated somewhere in the article — 3 of 239 would be very different. To me, 86% means it protected 86 out of 100 times.”
Yes, I see how this is confusing and it should have been clarified in the article.
86% protection means 86% less THAN the non-PrEP people. There were 3 infection out of 239 people on PrEP, i.e.
1.02 infections per 100 people on PrEP
There were 19 infections out of 214 people NOT on PrEP, i.e.,
8.9 infections per 100 people NOT on PrEP
So PrEP brought down the infection rate from 8.9/100 to 1.02/100.
1.02 is 17% of 8.9, or equivalently
1.02 is 83% less than 8.9.
(They say 84%, not 83%, so there is probably a small rounding error in what I wrote.)
vive
@pjm1, also, keep in mind that some of the PrEP participants didn’t take their pills daily, so the infection rate for people who really do PrEP correctly would be lower than in this study.
TemptyK
This is why I don’t trust anyone!
Jody
@pjm1: I’m sorry you disagree. It doesn’t change the fact that your understanding is wrong.
There’s a difference between efficacy and effectiveness, just like there’s a difference between the word “theory” used in the scientific sense and it’s use in the colloquial sense. The researchers are very clear in their presentations regarding the differences.
PrEP is 99% effective for an individual when taken daily. If we give the drug to a large number of people, it will prevent HIV 86% of the time, because people make mistakes. The drug is fine.
Condoms work when an individual uses it. When lots of individuals set out to use them, they protect against HIV 70% of the time, because people make mistakes, don’t use the condoms, or create a situation for a condom to break.
As for your conspiracy? Ugh. That’s just silliness.
Jody
@vive: Yes. I believe study participants had blood draws to check the amount of Truvada in their serum.
The two study subjects who sero-converted admitted they’d stopped taking Truvada weeks before. Their blood confirmed this. And they also offered to give back their unused bottles of pills. 🙂
vive
@Jody: “The two study subjects who sero-converted admitted they’d stopped taking Truvada weeks before. Their blood confirmed this.”
Thank you, Jody. That is very useful to know.
pjm1
@Jody: well, i hope PreP works and everyone
that wants it/benefits will get it.
Perhaps one way to quantify its effectiveness down the road is to see whether HIV infection
rates go down in mid/large cities (like San Francisco) where Prep seems to be reasonably
available. If infection rates go down that would be an indicator. However, if HIV infection
rates go up it could also indicate more people are engaging in risky behavior and . . .and PreP
is not working/effective as intended. Hopefully, it will be a great benefit to the community and the
epidemic will end.
Hmmm, as for large corporations putting the health of people over profits, or rather profits
over people, there are more than plenty of times profits have trumped over health — start with
the tobacco industry . . . that’s just a start though.
Jody
@pjm1: That’s already underway. From earlier this week:
“Scale-Up of Preexposure Prophylaxis in San Francisco to Impact HIV Incidence
Grant, et.al (2015)
“Background: Since 2007, rates of new HIV diagnoses in San Francisco (SF) decreased with widespread HIV testing, pooled HIV RNA testing for high-risk seronegatives, increased viral suppression rates, and grass-roots initiatives. Consumer demand for pre-exposure prophylaxis (PrEP) has increased since mid-2013. Local goals for PrEP scale-up have not been established.
“Methods A simple model was developed to forecast HIV transmission with expanded PrEP use. The model considers infectiousness and partnering practices of diagnosed and undiagnosed persons with HIV infection, viral suppression rates, and transmission to uninfected people having low, moderate, or high numbers of partners. Model parameters for SF were derived from surveillance, local research on seroadaptive behaviors, and SF-specific data from cohort studies, including the iPrEx Open Label Extension (OLE). Adherence in OLE was monitored by drug concentrations in dried blood spots and mapped to efficacy using global iPrEx data. The optimistic scenario assumes PrEP uptake will attract and retain people with higher exposure to HIV, as was observed at SF’s OLE site. The realistic scenario assumes incidence rates that are typically observed in SF cohorts that did not include access to PrEP.
“Results: In SF, the HIV diagnosis rate is 94% with 67% viral suppression. Among 150 eligible participants in OLE in SF, 64% chose to start PrEP; People starting PrEP were more likely to report non-condom receptive anal intercourse (44% vs 26%; P=0.03). Adherence yielded substantially protective drug concentrations among 96% of users through week 24, falling slightly afterward. If PrEP were used by 6400 people in the optimistic scenario (incidence 1.3 to 4.2/100py), the number of new infections could fall by 50% city-wide; doubling the number on PrEP could reduce new infections to less than 50 per year, a 86% reduction. In the realistic scenario (incidence 0.8 to 2.5/100 py), the city-wide incidence falls by 30% with 6400 people on PrEP; getting to less than 50 cases a year requires that diagnosis rates increase to over 99% with 90% viral suppression, at which point PrEP’s impact on HIV incidence decreases because exposure to untreated HIV infection would be rare.
“Conclusions: Demand for PrEP is increasing in SF with high rates of adherence. Widespread use of PrEP could markedly decrease new HIV infections, especially if synergies between PrEP uptake and adherence, HIV exposure, and HIV testing continue during PrEP rollout.”
http://www.croiconference.org/sessions/scale-preexposure-prophylaxis-san-francisco-impact-hiv-incidence
AnitaMann
Stop having anonymous sex and you won’t need this medicine.
Tackle
@Kieru: I did not say that the study of 400 to 500 were too small. But I do believe that it’s relevancy is somewhat diminished
( a lot) by us, the public, not knowing the number of partners who had a high viral load or even if they were HIV positive in the first place. From what I’ve read, in one study, ( 500 UK ) men were given PrEP: The other, (400 French & Canadian) men. Did this study take in consideration of the participants sexual position/role? As we all know, a receptive Bottom is more at risk than a top. A bottom and top is more at risk if their partner is newly infected, or has a high viral load. But the bottom still more so. So what is this study proving by feeding these men PrEP , having them go out and about on their sexual adventures, when most of the men they will encounter will not even be HIV positive, let alone having a high viral load??
And I do agree that my original propose of 100 was/is too small.
And let me clarify, I did not say purchasers of Truvada are naive. The naivete in which I speak of, are people: buyers or otherwise, who swallow everything these people and their studies say, and never bother to question or research anything on their own…
Tackle
@vive: Thank you for this. This is exactly what I have been preaching. So if if there is a 1 in 300 chance of infection of a negative bottom by a positive without Truvada, then how can these studies say or prove it’s the Truvada working, rather than the natural resistance/blocking/halting/warding off of ones own body against HIV?
And whats the point of doing these studies without using positive tops with a high viral load?
And I agree that in this case, 100 participants would be too small.
vive
@Tackle: “This is exactly what I have been preaching. So if if there is a 1 in 300 chance of infection of a negative bottom by a positive without Truvada, then how can these studies say or prove it’s the Truvada working…”
They compared the people on Truvada to a similar number of people who weren’t on Truvada, and compared the difference in infection rates between the two groups. Assuming the two groups are large enough and random enough, the assumption is that they would have had similar rates and types of exposures to positive partners.
Tackle
@vive: And that’s the problem I have with these studies. They Assume. Assuming is very dangerous, when peoples health or lives are stake. And why the hell are they making an assured declaration, that Truvada is preventing this, or doing that on an assumption??
pjm1
@Jody: Thanks, you are on top of this
important issue, very knowledgable and I appreciate your info and thoughts on
the topic. All the best.
Chris
I’m not sure that I understand this the same as many other commentators here. I think of this as like driving and using some combination of seat belt and/or air bag in case of crashes.
Not every time I drive do I get into an accident; and not every time I get into an accident do I get hurt. Likewise, not every time I have sex do I get “hurt” (i.e., infected).
If I always drive without my seat belt and without my air bag functioning, I have a certain risk of having a serious accident. There is a similar statistic for people who have unprotected sex.
If I use my seat belt, the odds of my getting hurt drops; if my air bag is working, the odds also drop. This is the analog for relying on condoms or PrEP. The odds of becoming infected are cut drastically over unprotected sex (over 90% in both cases).
And if you look at population estimates, the odds are still cut byt not as much as for someone who uses protection because (as House would say) “people lie” (to themselves and to others) about whether or not they actually use protection and/or whether accidents happen in the use of that protection.
I think of the 80+and 70+% as cuts in the odds of becoming infected over NOT using any protection whatsoever.
Again, I think of these as having access to BOTH a seat belt and an air bag. Why not try to use both? And if one protection fails or someone doesn’t use it regulalry, at least there is the back up.
Jody
@Chris: Estimates very, but one of the most recent studies done showed 1 in 5 people used a condom consistently and without incident for two years running. Most people seem to cycle through six month periods where they use a condom, then have a span where, for multiple reasons, from forgetting to a relationship, don’t use a condom then go back to using condoms again.
PrEP offers one way to correct for this, separating the protection from needing to be used during the encounter -and- providing protection when doses are forgotten.
But it’s also wrong to think the argument is for replacing condoms with PrEP. Some people are going to use condoms. Some are going to use PrEP. Some are going to forget and use PEP (post exposure prophylaxis) and others are going to rely on viral suppression in their partner.
The point is, we now have multiple safe and effective methods for blocking new HIV infections. No matter what your situation — love condoms, hate condoms, want to use both, etc — there’s a method of protection against HIV that works.
jwtraveler
@AnitaMann: Right, because knowing someone’s name protects you from disease, YounitaBrain.
tarutan
You can get a lot more than HIV. The common std list doesn’t even begin to cover it all. Be safe guys and take care of yourselves. IMO prep is better for those who had a slip of judgment, have been forced, or seek more intimacy with their partner. Especially with it being one of the few tools protecting the general public from hiv it shouldn’t be used so freely or negligently because we don’t know yet if there are aggressive strains of HIV that it is ineffective against or if careless use can create such strains. Don’t take your health and wellbeing for granted.
o.codone
PrEP works, until it doesn’t. Someone above made the point that there are no long term studies of this medication, there can’t be, because it’s new. So, like many other anti-viral medications, there is a diminishing rate of return with long term use. The way this shows itself is slow and insidious. The 86% starts to erode, and then it comes to the attention of clinicians and the research communities. Oops. Then they say, we have new information about PrEP, it’s really not all that effective. I really don’t want to be in that sample of men who had confidence in medical science, and then find out I’m infected because the science was incomplete. No thanks, use condoms.
Jody
@o.codone: If you’ve decided condoms are best for you, that’s great. Keep using them. As statements of fact regarding the worth of Truvada for PrEP, you are in error.
PrEP is Truvada, which are two drugs that have been studied against HIV, in whole or in parts, for twenty years. This is a well understood and well tolerated drug, given to HIV+ people, expectant mothers, and new born babies at risk for contracting HIV.
PrEP’s efficacy — 99+% — isn’t going to change. That’s the singular measure of how well a drug works. Seatbelts on an individual level. When looked at across the entire population, their effectiveness, while still high, drops, because of all the variation in how -people- use them. Same holds for PrEP.
The 86% is a measure of how we can expect it to work at the population level, when everyone starts taking it, which includes when people skip doses and other incidents. That 86% is actually an improvement over the two earlier studies of the drug, showing that now that people know how efficacious PrEP is, use and compliance increased.
For MSM, in comparison, condoms have a 70% effectiveness at blocking HIV at the population level. (Smith, 2014). Having people use condoms or PrEP or both together are all great ways for HIV negative people to stay so.