iPrEX OLE results are out! - Better than expected PrEP efficacy?

[rawfuckr]

Bear with me here as I'm posting this minutes after hitting the wires but I've been waiting for the results of iPrEX OLE for a couple of years. Reading the press release here http://www.prnewswire.com/news-releases/268053491.html but seems pretty fantastic on a first read. In particular:

"No study participant who took PrEP 4 or more times per week became HIV-infected"

Which I guess it means than daily dosing has to be very very prottective. iPrEX OLE recruited 1600 folks and they were followed over a year and half. PrEP starting to look really good?

[rawTOP]

So it seems 4+ per week is the goal, and at 2-3 per week you get about the same protection as sloppy condom usage.

Personally, I take PrEP Mondays, Wednesdays, Fridays and Sundays plus any off day when I'm planning to be a slut or was a slut the day before. I'm pretty religious about taking my pills since I've been taking daily meds for blood pressure for years now - it's no big deal.

[rawTOP]

Here's more info as various sites report on the findings…

http://betablog.org/prep-works-despite-missed-doses/

“Daily dosing of PrEP is recommended, because it helps foster the habit of consistent PrEP use and increases drug levels in the body, providing the best safety cushion for individuals who occasionally miss doses,” said Grant in an iPrEx OLE press release. “At the same time, these results demonstrate that PrEP remains highly effective, even in real-world circumstances in which adherence may not be perfect.”

This durable protective effect is one of PrEP’s unique strengths; as Grant said at a recent public forum in San Francisco, “Having used a condom yesterday provides no protection if you don’t use a condom today.”

The OLE demonstration project also shed light on sexual behavior in the context of PrEP use. Researchers saw no evidence of “risk compensation”—increased sexual risk-taking when using PrEP—in iPrEx OLE, and incidence of syphilis (a marker of condomless sex) was comparable between participants receiving PrEP and those not receiving PrEP. These findings lend weight to earlier data suggesting that PrEP does not promote sexual risk-taking.

And another page discussing the results - http://www.aidsmap.com/Overall-PrEP-effectiveness-in-iPrEx-OLE-study-50-but-100-in-those-taking-four-or-more-doses-a-week/page/2892435/

Forty-one people out of 1603 participants (2.6%) became HIV positive during the study. Thirteen of these were in the group that had elected not to take PrEP (annual incidence rate, 2.6%) while 28 were in the majority who had elected to receive PrEP (annual incidence rate 1.8%).

However, seven of these participants had actually stopped taking PrEP more than two months before they became HIV positive, in five cases because of side-effects.

This meant that HIV infection rates in people on PrEP were 36% lower than in people not on PrEP. However, people who chose not to take PrEP had, as one might expect, lower rates of HIV risk behaviour at the start of the study than those who elected to take PrEP. Adjusting for the higher risk of HIV acquisition in people taking PrEP resulted in an effectiveness of 49%.

As noted above, there were no infections in participants with drug levels cosonant with taking PrEP at least four times a week. However, only a third of participants actually achieved this level of adherence, underlining the fact that the biggest challenge for the usefulness of PrEP will be adherence. Adherence was higher in people with higher levels of education. It was 69% higher in participants reporting receptive anal sex without a condom, 57% higher in participants reporting more than five sexual partners in the previous three months, and 40% higher in participants with a known HIV-positive partner, indicating that people were adjusting their PrEP use according to their perceived risk of acquiring HIV.

Principal researcher Professor Robert Grant, commenting on this, said: "If people were at higher risk they took more PrEP and adhered to it better. I think this contradicts previous assumptions that people together enough to use PrEP would already be managing risk in other ways: it shows that people who are at risk can take reasonable and appropriate decisions on their own behalf."

Age, however, was the strongest determent of adherence: participants in their 30s were twice as likely to have detectable drug levels in their blood as participants under 25, and over-40s three times as likely. Rates of adherence were not associated with recreational drug use or alcohol.

One other big influence on adherence was whether people believed PrEP would work or not. News of the efficacy of PrEP from iPrEx and other RCTs was released about halfway through the follow-up period in iPrEx OLE and after this there was a substantial improvement in adherence seen in the men in Peru, who also tended to be younger than the other groups.

That last bit is quite important - In other words if you want guys to take PrEP you need to get the word out that it works. Messages that make it seem less effective will reduce the number of people who take their meds consistently and put guys at risk.

[wood]

Saw this yesterday, Really great news!

Im on 7x a week dosing, and almost never miss, so I am REALLY happy to hear these results. One thing I would like to know more of is late dosing, IE if I forget to take it in the morning and take it at night instead if that has any real effect. Im guessing no, but i am still curious.

Men and transgender women who have sex with men who took Truvada (tenofovir/emtricitabine) as pre-exposure prophylaxis (PrEP) four or more days a week were 100 percent protected against HIV in a recent study. However, participants actually took Truvada that frequently just 33 percent of the time during the 72-week trial, and overall adherence declined throughout the study

Still what this really does is serve as a model for chemoprophylaxis, hopefully soon we will have longer lasting, month long or more injections or other methods to provide the same benefit.

[rawTOP]

One thing I would like to know more of is late dosing, IE if I forget to take it in the morning and take it at night instead if that has any real effect. Im guessing no, but i am still curious.

Right, reading between the lines - if skipping it completely isn't that big of a deal then taking it late is even less of a big deal. We neg guys have a completely different relationship with meds than poz guys. We can be more relaxed about them. It's only a problem when we get completely complacent that there's reason to worry.

[rawfuckr]

Saw this yesterday, Really great news!

Im on 7x a week dosing, and almost never miss, so I am REALLY happy to hear these results. One thing I would like to know more of is late dosing, IE if I forget to take it in the morning and take it at night instead if that has any real effect. Im guessing no, but i am still curious.

Well, it really seems it's all about 'buildup' in your system of Tenofovir. It takes 7 days to get to levels that afford protection so missing a dose, and let alone taking at a different time shouldn't really matter much.

Still curious to see what the results of iPergay will be in France (just pop a pill before sex and 2 a couple of days later) but I'm wondering if that study is ever going to be finished. They are a placebo controlled study and the ethical implications of putting someone in placebo at this point are questionable. Also, the study is being done in France and to produce statistically significant results they are going to have to recruit zillions of people. They just announced they are having problems with recruiting and we are now looking at results in 2016.

[Guest beezee]

Argh, the thing that stands out for me is not the 99% thing (though that's grand), it's the stat that only 5% of their guys could be bothered to take the pill daily, despite them knowing they were taking PrEP (no placebo), getting it for free, and receiving special adherence counselling. Amazing.