Lubricants and the Development of Rectal Microbicides
August 6, 2008
Since its inception in 2005, the organization International Rectal Microbicide Advocates (IRMA) has been committed to advancing rectal microbicide research and development worldwide. As part of this commitment, IRMA conducted an online, international survey of lubricant use for anal sex. Data from the female participants in this survey were presented in a poster called "International Lubricant Use Behaviors for Anal Intercourse: Focus on Women"1 by IRMA at the XVII International AIDS Conference (AIDS 2008).
At the poster session, Jim Pickett, the chair of IRMA, walked us through IRMA's poster and discussed with us the topic of lubricants and its relation to the development of rectal microbicides.
In 2007, IRMA did a huge survey on lubricants used for anal sex, in which we had about 9,000 people respond from 107 countries, in six languages (including 1,000 in Turkish). Out of all of those who responded, we had 911 women respond. From those, 428 reported that they had engaged in anal intercourse or anal sex with toys in the last six months.
Interestingly -- in terms of getting a sense of how people use lubricants and what they might find acceptable in terms of potential rectal microbicides in the future, which is really what this is about -- is the substances we found that people add to their lube.
A large number of people indicated that they added vaginal fluid, saliva or water to their lube. What does that mean in terms of testing for efficacy and safety? We're going to have to figure out how to do that in the lab, because vaginal fluid could change some of the properties [of a rectal microbicide]. Maybe it enhances it. Maybe it makes it toxic. That was an interesting "Aha!" moment: We can't just test the actual product; we have to test it in the ways that people are really using it, before we get to people really using it.
It's curious to me that you're studying lubricant use. Is that a critical part of figuring out aspects of future rectal microbicides? What's the connection?
A rectal microbicide could very well be formulated as a lubricant. There would be some kind of chemical or agent put into a lube that would provide protection against HIV. It could also be delivered rectally through an enema, a douche or a suppository. We were sussing out, in the overall, huge survey, how people use lubes and what lubes they use, in order to figure out how acceptable it would be among both men and women to use a lube for [anal sex].
We really wanted to get a sense of what lubes people were using because, in fact -- and this could be another project for more researchers -- the lubes that we use for sex aren't tested for safety. These are FDA [U.S. Food and Drug Administration]-regulated products, but they are not testing them for safety. They're considered cosmetic, even though they're going "in" places [in people's bodies] and staying there.
So we wanted to get a sense of what people are actually using, and then push researchers -- such as at Population Council -- to test them. We need safety data on the lubes that we're already using.
Microbicides are the next step, or a couple of steps away. We need information on lubes right now.
I see. I haven't been keeping up on rectal microbicide research. I didn't know that they are considering formulating them as lubricants.
Yes -- a gel formulation. Actually, the rectal microbicide field just had its very first human safety trial. It took place at UCLA [the University of California at Los Angeles]. It ended, and data from the trial will probably be coming out officially around the time of CROI [Conference on Retroviruses and Opportunistic Infections, to take place in February 2009 in Montreal]. It was testing an antiretroviral therapy, UC781, in gel formulation. It was looking at how it reacts to rectal tissues. A lubricant is definitely a way we could potentially go.
One of the big questions is how much lubricant we're going to need to use. A vagina is an enclosed pouch; we know how much space is in there. A rectum is big and open. Do we need to cover two feet of the rectum? Do we need to put in a gallon of microbicide, or will 10 mL cover what we need covered? Will it move? We do see that [substances] move up the rectum. Will it move fast enough to stay ahead of HIV when it comes? Those are the sorts of questions we have to get a handle on.
Lubes are very accepted; people already use them. They make anal sex a lot better. So if we can harness behavior that's already happening [and develop a prevention method around that behavior], that's the way to go. That's why I mentioned enemas. A lot of gay men who are bottoms, or receptive partners, do some kind of enema or cleanse in advance [of anal sex]. Having to create something new is tough, behavior-wise. But if it's something you're already doing, and you like doing it? You could give it a plus-plus.
You had so many responses to your survey, I see: Why were there so few women? Also, why are these data only from the very few women who did respond?
We sent it out broadly, through every network we could think of: LISTSERVs, Web sites, newsletters, word of mouth and we got press on it. We thought we weren't going to get this many people all together. We really thought we would have 200 or 300 people. We thought no one would want to take it. It sounds boring. It went crazy.
This was hosted on Survey Monkey?
We did it on Survey Monkey, and we were going to have it up for a month. It ended up being up for around seven months, because responses just kept rolling in. Every day, we would get 100 new responses.
We wrote it in a way that men or women could respond to it. We were actually surprised at the overall total, and we were really pleased that 10% were women. Certainly, 10% doesn't represent how many women are having anal intercourse. There are a lot more. Depending on the population, it could be 30% or 40%. It's a very common behavior. For women especially, around the world, most of it is unprotected. Most anal intercourse, in general, is unprotected. And unprotected anal intercourse is very efficient at transmitting HIV.
I see that on your poster you detail exactly how efficient anal intercourse is in transmitting HIV.
Yes. An act of unprotected anal intercourse is 5 to 80 times more likely to result in HIV transmission when compared to an act of unprotected vaginal intercourse. A lot of it is due to biology.
The rectum is very tender. It's one-cell layer thick. The vagina has 40 cell layers. It's a tougher character; it's a tougher customer. In the rectum, right below that one-cell layer is essentially CD4 cells. So it's the Welcome Wagon. It's a very tender area. It's easily breached, which HIV loves; and then the Welcome Wagon is there, going, "Hello! Welcome! Welcome to my body!"
When you say "breached," do you mean there might be some blood, or some tears?
Sure. Even in the most gentle, loving, slow and smooth anal intercourse, you can have small, microscopic tears in the rectal lining. If you don't use a lot of lube, or if there's something else going on, it could be easier to tear. That's what HIV wants: a breach, or a little place to get in. It's just easier for that to happen in the rectum than in the vagina.
Just to clarify: I think most people don't understand that women and men have the same kind of rectum, right? They are identical, in the sense of the way they are formed.
Yes, they are very similar. But there is some interesting stuff that we're just learning about: There may be different pHs [in men's and women's rectums]. It's not clear that a single rectal microbicide will actually work for a boy booty and a girl booty, because of the pH issue.
We just don't know a lot about it. This is a field that has been under-examined. Anal health, anal intercourse: There's a lot of denial and stigma. Funders don't want to fund it, so researchers don't want to submit grants that say things like that. It's getting better, but we don't have a lot of data. But there is that thing about the pH. It could become complicated.
Are you going to be analyzing the rest of the 8,000 responses?
And it's on The Body.
And it's on The Body, thank you very much -- talks about the entire set of data, all 9,000 or so responses, and breaks it down in the third section. It's pretty complete. There are tons of data here, so we're going to keep spinning stuff off of it.
There was a ton of qualitative data that we haven't gotten to yet -- hundreds of different kinds of lubricants, and we have not actually written down each one. There are so many lubricants in the world. Who knew? We were thinking it was just K-Y jelly and ID.
We want to do something that lets people know how many there are and who's using them. We have a lot more work to do on this. This is just "Round Two." We presented at the CDC [U.S. Centers for Disease Control and Prevention] Prevention Conference in the winter of last year, and we just keep spinning off. There's a lot to do with 9,000 responses. We could do just the Turkish responses.
Is this the first time this kind of thing has been done?
It is. No one has ever done this. One thing we wanted to do: There are four languages that are really prevalent in India, but Survey Monkey wouldn't allow us to use them, because of the characters [in the written languages]; we couldn't find a survey system that would allow for that. We have our survey translated into the four Indian languages, ready to go. There are a billion people on the Indian subcontinent, a lot of whom are having anal sex. If anyone out there knows about a survey system that allows you to use these sorts of characters, we would love to get that data [from India], and we'll put the survey up again.
Jim, before I let you go, can you explain exactly what is a microbicide?
They don't exist yet, so I want to be very clear. Microbicides are products in development that could provide protection against HIV, with condoms or in the absence of condoms. For instance, they could be formulated as a lube, an enema, a douche or a vaginal ring that would have an agent or a chemical that would attack HIV, neutralize HIV or not allow HIV to gain a hold in your body.
Why are microbicides important? We need new prevention technologies. Having the female condom and the male condom is simply not enough. People don't like to use condoms, or they don't use them for a number of reasons: They can't use them; they're in situations where violence would be wreaked upon them if they suggest using them; they're not available, etc.
We need to have choices. We need to have a buffet of choices, and microbicides would be part of that buffet, in addition to vaccines and pre-exposure prophylaxis (i.e., the idea of taking an antiretroviral pill every day to ward off HIV before it comes). It's all part of that spectrum of new things, just to give people options. I think it's insane that, 27 years into the epidemic, I can order 500 kinds of coffee, but I basically have only latex to protect me against something that's important while doing something that every human does -- most of us are sexual. It's just sort of crazy.
How many microbicides are currently in development?
If you look at the whole pipeline, there are probably 30 or 40 products in development, from preclinical through phase 3 trials.
What's interesting is that we're starting to look at antiretroviral [ARV] therapies topically, in gel or lubricant formulation. That's the next generation of microbicides. We're looking at that a lot. We're going to see tenofovir [TDF, Viread] as a gel, actually.
That's very exciting.
It's very exciting. It won't have a broad spectrum of protection. For instance, some people want microbicides to offer protection against other STDs [sexually transmitted diseases], to be contraceptive or to be non-contraceptive. An antiretroviral-based microbicide won't offer all that on its own, but we may be able to combine those things. I think what will be most acceptable to people will be microbicides that meet several needs.
How many of the microbicides that are being developed are for rectal use? Aren't most of them for vaginal use?
Yes. The rectal agenda is significantly -- excuse the pun -- behind. We just had our first phase 1 trial. You have to go a long way before you get to a phase 3 efficacy trial, but we're moving in that direction. Actually, as I mentioned, there's a phase 1 trial that just finished. That is an ARV-based microbicide. There was some very interesting stuff that came out of the safety data, so we'll likely see that one advance [to the next phase].
Our first rectal microbicide could be ARV based. I am not going to predict when, though. The field has predicted when many times, and you know the nature of science: It's challenging, and it's slow, so I will not predict.
Thank you very much.
This transcript has been lightly edited for clarity.
- Pickett J, LeBlanc M-A, Gorbach P, Murphy R, Javanbakht M. International lubricant use behaviors for anal intercourse. In: Program and abstracts of the XVII International AIDS Conference; August 3-8, 2008; Mexico City, Mexico. Abstract WEPE0275.
View poster: Download PDF
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