Who's Looking Into PrEP for Women?
June 21, 2013
PrEP is often talked about in terms of: How are women going to take this every day for the rest of their lives? But I once heard an expert speak on a panel who referenced PrEP as being very useful for "seasons of risk," which I thought was an interesting way to think about it. I'm surprised at how infrequently PrEP is mentioned, at least publicly and in the literature around PrEP, in the context of being a potential temporary prevention method for women who are with HIV-positive male partners and are trying to get pregnant. Could you speculate as to whether it could be an alternative to some of the other methods of getting pregnant that discordant couples may already be employing?
I know, seasons of risk: that's kind of an interesting concept. I have had discordant couples in my practice, where they did sperm washing and in vitro to get pregnant, where the woman was negative and the man was positive. If taking PrEP were a reasonable thing to do it would be certainly a lot cheaper than in vitro. I had one patient who spent lots and lots of money trying to get pregnant. She did finally get pregnant. But for the second one, she was unable to conceive the second and third time she tried -- and spent a lot of money trying to do that, and was very committed to the process.
Would that be a reasonable alternative? I don't think there's any way to know if that's a reasonable alternative, frankly. I can't really look into my crystal ball. But I think that ultimately people may end up thinking about that.
You know, both tenofovir and the drug that we're studying in HPTN 069, maraviroc (Selzentry), are both category B. And what that means is, who knows? Nobody knows. So, how long do you take it after you try conception? It's a very good question. That's a definite unknown. That's a very interesting question.
Please talk about the PrEP studies that you've been involved with at Cornell. What other meds are you looking at? How was it decided what different medications would be tried now that the concept has been proven with Truvada?
The study we're running is called HPTN 069. It's our first prevention study at Cornell Clinical Trials. And this study compares the standard of care, Truvada, against a newcomer to the prevention arena. Its name is maraviroc. That drug was developed to block a coreceptor in the human cell called the CCR5 coreceptor. And it's required that you have to have that coreceptor in order to complete attachment. The virus needs it to complete attachment in order to complete infection.
It was developed as deep salvage therapy for people who had failed other antiretroviral therapies -- obviously, for people who were infected. So it's been looked at. I think one of the reasons why it's so interesting is because this drug achieves very much higher levels in rectal and vaginal fluids than it does in the blood. That could partly be because it's attached to the lymphocyte; and lymphocytes are hanging out in those areas. But, for whatever reason, it's there. And that's the point of infection. So in some ways it seems kind of intuitive to use a drug like that.
In any case, HPTN 069 compares, once again, Truvada -- in this case, everything is given in separate pills, so it's not really Truvada, it's a component of Truvada, which is tenofovir and FTC. So you have three pills: maraviroc, tenofovir, FTC. And it's a double blind, randomized study, where you don't get to choose what you're taking. You get assigned, as though by a flip of a coin. So I don't know what meds you're getting, and you don't know what meds you're getting. Everybody's getting an active drug of some sort or another.
And so the arms are: the maraviroc, or Selzentry, alone; the maraviroc plus tenofovir; the maraviroc plus FTC; or tenofovir plus FTC ... which is, once again, Truvada, or the standard of care. So it looks like three pills once a day. And there are some built-in adherence measures, such as a pillbox called the Wisepill that, when it opens, it sends a signal to a computer and downloads the date and time that it's been opened.
There are some sexual activity measures. Because there's always the question of, when you put people on PrEP, do they throw away the latex, or do they continue to use it, or ... what's going on here? So they're trying to correlate those two things. There are tolerability measures, in terms of interviews that are done at every visit and questionnaires that are done on the computer.
All those things are built into the study. Each individual is on the study for about a year. And all the medication, of course, is provided, all the physical exams and blood tests. However, we do test for HIV a lot more frequently than in the standard of care; we do it at every visit, basically. So it really ends up being a lot more than every three months.
So, that's the study. And it certainly is open and enrolling right now. It's enrolling kind of nicely.
What are the enrollment criteria? Is it women who are in relationships with people who are positive?
Well, you have to be having some sort of risk for HIV. So either you're in a relationship with somebody you know is positive, or don't know, or having sex with people whose HIV status you don't know, or do know that they're positive. So there has to be some sort of risk involved.
A woman would have to be HIV negative, obviously, to start with, and could never have received an HIV vaccine. So anybody who had participated in any of the vaccine studies would not be eligible because it would sort of muddy the waters in terms of trying to figure out about antibody status.
The other kind of perplexing thing for me is peanut and soy allergies. I actually had somebody in my office and it turns out that he was very allergic to peanuts and soy, so I couldn't proceed with the screening. If you're highly peanut allergic, this is not the study for you.
Is it something in the maraviroc? What is it that could activate that?
Yeah. Something in maraviroc, yeah.
Wow. Oh. Who knew? OK.
It's probably a soft finding. But it's one of those things; you don't want to play with people's allergies.
What are some of the challenges for women participating in a PrEP trial, and how have you addressed them in the implementation of this study?
I think that, in general, women have competing priorities. I mean, who doesn't? Even a working woman has to do the shopping, the cooking, the cleaning, and all of that -- at least to some degree. So a lot of women are just saying, "Oh, gosh; I'll do this another time," or, "I'll worry about this later," or, "I can't deal with it right now. I have to make sure my kid gets into so-and-so school, or that my kid gets to his or her doctor." So I think that that is a very, very big issue, not just for this study, but even for studies in women who are HIV positive ... and even regular health care for women who are HIV positive and might have an addiction issue, or might have any other kind of issue. When you have complicated, chaotic lives, taking care of yourself is really a challenge.
I think another one would be a possible backlash from partners. "Why do you have to take this PrEP? I know I'm HIV negative." And what if it turns out that her main partner is not her only partner, and she doesn't want to disclose that? So I think that there's that possibility. And some women just say, "Oh, I don't want to get into that drama. I'm not going to do it."
I think another really big one is the lack of connection to the issues of HIV and sexual health, in general. When you're talking about HIV-negative women, there are a lot of women who don't even know what their risk is for HIV, basically because in the United States sex is still such a taboo subject in places where women might learn practical ways of staying healthy, such as schools, even TV -- although, I have to say, I see some of these shows that talk about sexual health, like The Doctors: They're definitely getting better about talking about these things in a reasonable way. But I think that TV, and media, in general, still sort of snickers about sexual health issues. They're not treating them in a straightforward and adult way. So there's still a lot of stuff out there that is preventing people from coming forward and saying, "Hey, I'm a human being. I'm a sexual human being. Let me do what I can do to stay healthy."
Remember what it was like to try to roll out Gardasil for HPV prevention -- how much backlash there was, just for that? "Oh, my God! You want me to give this to my 12-year-old? That's like saying they can go out and have sex!" People took such a leap. So I know that there are still an awful lot of problems in terms of taboos and prejudices. And I think that that is something that we're going to have to work on. So I think that, in many ways, the odds are stacked against young, sexually active women to try to keep them ignorant, for some unknown reason.
And then, of course, young, sexually active women are often very busy women. They themselves don't have the time to start to look into this. So I think that we're going to need to go beyond traditional ways of educating women. I think that in some ways you have to avoid bureaucratic obstacles with schools and churches, and reach the women the way we've done from time immemorial, which is woman-to-woman.
One of the things I'd love to do would be to blanket hair and nail salons with posters and flyers; have posters in shops and on subways and buses; and in movie theaters and restaurants; blanket the Internet. But all of this stuff costs money.
The other thing I would love to do is to try to target and encourage professional sex workers to at least come and have a conversation with me, and see what there is I have to offer. I think that, in general, people who are sex workers, women who are sex workers, often feel very disenfranchised, and also feel very much like they don't want to engage health care providers because they feel like they're second-class citizens, in some ways -- which is certainly not the case. And if there was any message I could get out there, it's that this is a really important thing. Sex work is a reality; we have to address it. What are some of the possible complications?
I imagine that there may likely be some reticence to engage with any kind of institution if you're involved in commercial sex work. And if a sex worker wants to join a study and she says, "This is what I'm doing and I'd like to be in the study," maybe there's some concern or fear that whoever's running the study would not be sympathetic to her work situation, and might even call the cops.
I know. It's just very upsetting to hear that, because I know that somebody is telling these women that. And, you know, I think for the most part, often commercial sex workers have people who help them to work, who are actually getting paid the bulk of the money. I'm not saying the P word; but I'm just saying that a lot of times, these people are kept in the dark about what's good for them; because people don't always have their best interests at heart.
But for any professional sex worker who wants to be in the study, I absolutely welcome them. I would love to be able to reach them to have conversations about sexual health in general; and I think that they could help elucidate how we use PrEP.
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