August 3, 2008
One of the most provocative sessions of the XVII International AIDS Conference likely took place before the conference even officially began. In a charged satellite event, a panel of researchers and a huge audience took part in a debate over whether it's safe for an HIV-positive person in a monogamous relationship to have unprotected sex with an HIV-negative partner, provided they have an undetectable viral load, are on stable antiretroviral therapy and have no sexually transmitted diseases.
One of the most fascinating portions of this event was the lengthy period in which the speakers opened up the floor to questions from the audience. Here is the discussion that ensued.
[In addition to this question-and-answer session, you should also read the transcript of this excellent summary of the issues by the final speaker, Bernard Hirschel, M.D.]
Ulrich Marcus: My name is Ulrich Marcus. I'm from Germany. I'm working at the Robert Koch-Institut in Berlin. This is more a general statement, not a specific question. In Germany, we made the experience after the publication of this restatement that there is some expectation from the community that we adopt a similar statement in Germany. What we see is that the pressure to adopt a similar statement comes mostly from the MSM community, not from heterosexual people who are infected with HIV. What do people understand if they hear the message from the Swiss statement, whose first desire is not to get a child in a serodiscordant relationship, who are not monogamous, and who come from a community? HIV-positive MSM have, in recent years experienced, in Europe and in North America, a rise of co-epidemics of other sexually transmitted infections.1 We have STI in HIV-positive MSM, bacterial STIs in the range of 30% to 50% per year. That's very high incidences of STI, of bacterial STI co-infections.
Again, how do people understand this message? And how do they want to act on these messages? If you look at HIV serodiscordant couples in MSM, then we can see from studies we did that the HIV-positive partner in such a serodiscordant couple has higher STI incidence than the HIV-negative partner in such a serodiscordant couple, which is related to another strategy that has evolved in recent years, mainly in HIV-positive MSM, which is sero-sorting: not taking condoms if they think their partner has the same sero status.2,3
You have a lot of issues for us, for the panel to look at. So let's stop there. There's another question. Do we have other questions from the audience?
Ron Bayer: My name is Ron Bayer. I'm from the United States, from Columbia University. I think there is a little confusion on the panel, actually, because the statement by Nancy Padian,4 and the statement that I thought I understood as coming from the Swiss statement,5 were completely different. My understanding was that the Swiss statement did not say that couples should continue to use condoms and be on therapy, but rather that the option was available, where a discussion had taken place about whether to use condoms or not. That's a very, very different statement. I think we have to be clear about what the Swiss statement was saying.
The other thing about potential risks with viral blips, etc.: There is no such thing as risk-free existence. The question is, if there is the potential for a viral blip, and if there is the potential for a viral blip in conjunction with an STI -- I'm not talking about Africa, now -- then the question is, how often will these occur and, on a population basis, what risk is created? That, it seems to me, is the question; not whether there is zero risk. Pregnancies aren't zero risk. Having penicillin isn't zero risk. So I think the idea of trying to place the level of risk in the context of what, in research, we described as negligible risks, is precisely the way to go.
Thank you. And one last question?
Manuel Battegay: Manuel Battegay, Switzerland. Actually, as a disclosure, I was in a subclinical commission, also, regarding these guidelines. Just a very short statement, and then a question: First, I would like to say that these guidelines are really an excellent instrument for physicians to have really very good thoughts about this situation. So my question to all non-Swiss panelists is: Is there a movement now to do guidelines, at least, I say now, for the Western world, as there are treatment guidelines for developing countries and developed countries? They may differ, but you have comprehensive guidelines, which take into account some very good thoughts of this excellent symposium. I congratulate the organizers because I think the time is ripe. I see that there is not a real, great contradiction in what is said. There are very good caveats we discuss with patients and nevertheless, I think it would be very useful not to just say the guidelines are not optimal, or this and that; but that we go on a way, even if data is lacking, as we did before, in all fields of medicine where evidence is not complete to have comprehensive, worldwide guidelines. I think the time would be ripe. [applause]
So we have a number of key questions to the panel. The first was the example of Germany, where there was pressure within Germany not to make a statement from, in this case, the MSM community for, among other reasons, STI epidemic or other co-infections. There was a question of how the message has been received in Switzerland, in terms of the statement. What has been the response? There was a question about the movement in other countries, from our last questioner here. Will this have an impact on other countries to follow suit or continue further study? And then a question specific to the Swiss statement. What did it say about condoms, relative to transmission? And questions about viral blips and risk levels. So why don't we start from this end of the panel and see who else wants to respond to these many questions.
Pietro Vernazza: I take the liberties to start. One thing that I would like to make sure -- that these shouldn't be questions and answers. It's not that we have the answers. I think there's a big group of experts in the room, and I would just enjoy if we could discuss these issues. So for the German experience, I don't really know what the problem is. But one thing I can tell you from the experience in Switzerland after this statement: I think we have never talked so much about STDs after this statement. So I think what the statement really made is to stress the importance of STDs. And it is my big hope that patients and partners would actually understand the importance and implement that, and take this into their daily life. So there are many other collateral effects that we haven't expected, actually. So I wouldn't be too much concerned. I have many other issues, too, that I have dealt with.
Catherine Hankins: Yeah, I'd just like to make a comment about the communications issue here. There's no doubt that physicians worldwide who are dealing with patients who have undetectable viral loads and no STDs and are in committed, monogamous relationships need to be equipped to counsel them, both about conception risks, and about HIV transmission risks. But when one holds a press conference, we live in a very global world; that message goes out worldwide.
Now, I've heard a lot of anecdotes about the effects of the statement. I'll just mention two, one from Geneva, where the organization working with sex workers in Geneva said they were having trouble explaining on the ground the meaning of the statement, that sex workers who were HIV positive and on treatment interpreted it to mean that they did not have to use condoms and therefore could make more money. The other was from the head of a national AIDS commission who said -- I asked, "What happened in your country? How did you deal with the statement?" -- and he said, "We suppressed it. Journalists contacted us and we said, 'We have no comment. This has no relevance for our population.'"
So I think we have to be very careful to be very sure about what we're saying, and to whom it applies, because there are many negative -- unintended, but negative -- consequences.
Myron Cohen: I would just add a few points. One point is, of course, the study that was shown by several different speakers was focused on heterosexual vaginal intercourse. So the probability number that was described does not relate to receptive anal intercourse. Receptive anal intercourse is much more efficient. The discussion of whether ART has the power to suppress receptive anal intercourse -- we don't understand that transmission very well. It's just worth keeping in mind, based on our German colleague's statement.
I'm a little concerned. Kate Hankins indicated one of her big concerns -- I'm going to criticize another panelist, take the liberty -- one of her big concerns was a technical concern. That is, having the ability in a country outside the developed countries, or less resource-constrained countries, of measuring minimal viral load, for example. I think that's a technical problem but there is a lot of work going on and within a couple of years, I suspect there will be tests that are cheaper and more widely available. So I think that it would not be a reason not to pursue this line of reasoning, that technical limitation. I think that would be a soluble problem.
Third, I'm a little concerned. I'm much more confident that the population level benefits -- again, I'm going to argue with Kate a little -- I think the population level benefits of more testing, people knowing their status, using more antivirals, that we will see reduced prevalence. And I know Julio plans on doing this study in British Columbia that I really think is worth just mentioning. Because your hypothesis is a population-level hypothesis; not a per-couple hypothesis.6 And I'm going to turn the microphone over to you and force you to mention what you're interested in in a second.
Lastly, in terms of the U.S. guidelines: The U.S. guidelines are policy statements that come from the U.S. Centers for Disease Control and Prevention.7 They are having a panel meeting in October. I don't know the full scope of what will be discussed, but it certainly is related to the benefits of ART, as they relate to prevention. But I don't know that they will get into this issue. So we'll see. But they are having a meeting. Julio?
Julio Montaner: It doesn't take much to force me to talk about these issues, so I'll gladly accept. A few years ago, we were struggling with some of these same issues, and we took the position that while we are not a hundred percent confident at the individual level how all this works, and you can tell in the degree of your controversy around it, it's a lot easier to understand that at a populational level, if we lower the population of viral load through the use of antiretroviral therapy, we could act as an added second sort of layer of protection, and therefore see decreases in HIV transmission.8
I don't want to take too long to explain where that comes from but, at the end of the day, we use populational data to model these, and the data is quite compelling, in the sense that we expect that the direction or the effect of wider coverage of antiretroviral therapy in the population to be associated with increase in transmission.9
There is a unique window of opportunity to do this because, with the newer guidelines that greatly expand the number of people who meet a medical indication of antiretroviral therapy, and with the greater willingness of our bureaucrats and politicians to really drive an effort to expand antiretroviral therapy, we think we are in a position to make a demonstration project out of this.
I must confess that at a private level, when we have been able, or asked to, counsel in the real world, specifically on the issues procreation, or for a variety of particularly reasons, even before the Swiss guidelines were out, we had taken a similar position: that there may be a risk and the risk will be relatively small, and probably acceptable within the risks that you are seeing in the real world, and have demonstrated comfort since you are already engaged in a serodiscordant couple where, as you pointed out earlier, condoms do break and accidents do occur, and so on and so forth. So I think that with that, I have come completely clean on this issue.
Bernard Hirschel: I have just one thought to add to the German colleague's statement about very elevated levels of STIs in German gays. Well, that must mean that they are not using condoms, doesn't it? And that is a problem, because, you know, I have heard it said that doing the same thing twice and expecting a different result is the essence of what is stupid. And if the result of 20 years of condom promotion in Germany is that we have a very high incidence of sexually transmitted infections, then maybe it's time to look for other means of prevention. I would add that the same is true of some studies from Africa, where infection rates in programs with condom promotion are shockingly high, and suggest that condoms have not been used, in spite of the promotion. [applause]
Just because he was not introduced ... He's also going to be summarizing this session. Who just spoke was Dr. Bernard Hirschel, who is a self-described dinosaur of the HIV/AIDS world. He's currently the director of the HIV/AIDS unit at the Geneva University Hospital in Geneva, Switzerland. I'm sorry, Niko?
Nikos Dedes: What I wanted to say, both about the statement from the German colleague, and from the Swiss physician, is that indeed these highlight the need to agree on how we communicate what the data show. And we have to agree on specific counseling guidelines for doctors or other communicators towards HIV-positive people.
I wanted to make a comment about some of the caveats that I see in many slides and that are mentioned many times. I wonder why Bernard [Hirschel] doesn't trash them. For example, these so-called blips. Blips in therapy mean that you have a detectable viral load of 80 or 150 or 200, but you cannot call a blip something which is 2,000. And for all the data that has been published, there is no transmission which has occurred when viral load is less than 1,500. Therefore, it is very probable that these blips are completely irrelevant for the increased risk of transmission.
The other point I wanted to make is about the acceptable risk. It was mentioned by Ron Bayer that we live in a life where we have to accept risk. I would like to remind the audience that young people today, if they are heterosexual, they pay no attention to condoms. Even if they engage in gay practices, they also don't pay any attention to use of condoms, one of the reasons being that HIV is no longer perceived as a terminal disease. So the perception of risk, even if one gets infected, has decreased very much.
But what we are discussing here is not this type of behavior. We are discussing whether it is an acceptable risk to have unprotected sex with someone who is on treatment, which is actually a lower risk than to have sex with a condom with someone of unknown status, or who is HIV positive. And for the prevention messages, and for the prevention interventions, it is vital that we understand that the people who do not know their HIV status are actually contributing to HIV infection much more than people who have diagnosed their HIV status. [applause]
Nancy Padian: Quickly: Just because my name was brought up, I feel like I have to say something. But it really just gets back to the issue about communication. Honestly, Ron, I don't understand what you thought that was a misunderstanding. Just to reinforce what everyone is saying: This is a tool, insofar as I understand it, and I don't want to speak for you guys; but this is a tool for people who are counseling to use to counsel people about potential risk. And that is, in fact, again, it's up to the negative partner, whether jointly or individually, whether they want to use condoms knowing that. If I screwed that up in my presentation, then I apologize.
Any more comments and questions from the audience? Please stand up behind the microphones.
Rolande Hodel: My name is Rolande Hodel, and I run an organization. It's called AIDSfreeAFRICA. I do work in Africa. It's interesting to see that the entire panel is white. What I would like to beg you, and plead with you, is when you speak, always make clear which population you're speaking about. In Cameroon, where I work, two-thirds of positive people are female. And in the population I have never, ever seen a couple, where one person is positive and the other person is negative. The infection occurs immediately in couples. And I want somewhere here on the panel to answer the question: Have you ever calculated a percentage of people that you're actually talking about? We have 42 million people that are HIV-H positive.10 You are talking about 2-1/2 million on treatment. And from those 2-1/2 million, actually, it's only a very small part that's the one that has no STDs, no other infections, that are monogamous; and I can go on and on.
So you're speaking of a population of, what? .001 percent? [smattering of applause]
Pietro Vernazza: Just to make a brief comment here. I think you're perfectly right, and I would like to repeat what we said in our media letter: good news for a few individuals. And I think I couldn't agree more with what you said.
Graham Brown: I'm Graham Brown from the Australian Federation of AIDS Organisations. I also work in a school of public health. And my main question is that, I suppose, realistically what we're looking for is being able to open up the kind of discussions that we'd like to have between, within community, with doctors and so forth, so that it's actually clear, and it's honest, and it's up front, and we can actually start talking realistically about risk and things that have been happening for some time now.
My concern is that, with all the data, in Australia a lot of the concern and the reluctance and so forth around the statement, one of the major issues has been that the studies have been predominantly within heterosexual contexts, and haven't engaged. ... It's not a lot of data, apparently, around risks of anal intercourse. What I'd like to know, and on behalf of everyone else, is, what are we then doing about that? Because it concerns me often that we tend to sometimes go down the path that if we don't know the answer, therefore we can't go there. Of if there's not the evidence, that means we don't go there.
What I'd like to be knowing is, if this is already happening -- which we know it is, in couples, in relationships -- what do we know about how this translates within anal sex? And if we don't have all the answers, how are we going to get them?
Edwin Bernard: Edwin Bernard, from the U.K. I'd like to ask about the other part of the statement, which was driven by the draconian HIV exposure laws, both public health and criminal laws, in Switzerland.11 And I wonder whether there might actually be unintended negative consequences by your suggesting that the positive partner needs to disclose to the negative partner, and the negative partner needs to make the decision about whether condoms are used during unprotected sex. Because HIV exposure laws are actually disclosure laws. HIV exposure laws that happen in jurisdictions all around the world, particularly in many states in the U.S. and all over Canada; they actually force disclosure when and HIV-positive person has unprotected sex and people are being prosecuted and are in prison for just one incidence of unprotected sex without any transmission, just exposure. So, no actual harm.
I wonder whether your statement actually reinforces some of these HIV exposure laws by recommending that the HIV-positive person discloses that they are on treatment, discloses they have an undetectable viral load, and means that the HIV-negative person has to make the choice. Because good public health education suggests that the responsibility is equal. It lies with both the HIV-positive and the HIV-negative person. [smattering of applause]
I'm going to ask our panelists to take notes of issues or questions you want to respond to, and take a couple of more statements or comments from the audience.
Henner Geiss: My name is Henner Geiss and I'm from AIDS Free Denmark. And we are, in fact, one of the countries in the world which has exposure conversation in relation with HIV. And my question is very similar to the question before, but more specific. Because you have talked about condom use and kind of put up a measurement for that, and also for when people are on treatment. And I would like to just have a clear answer. Would you consider a condom breakage as the same as being on treatment? Because in Denmark, if you have a condom breakage, the law in Denmark doesn't apply anymore. So would you say that treatment will do the same in our case, of our law? Thank you.
Pietro Vernazza: Can you repeat the question? I wasn't quite ...? Condom breakage?
Are you saying that condom breakage is criminalized? Was that what you were trying to say?
Henner: No. The condom breakage is when the law doesn't apply anymore in Denmark -- when you can prove that you have condom breakage. Then the law doesn't apply anymore in the exposure law. But what I'm saying is the equivalent of condom breakage. Is that the same risk as being on treatment? Does that clarify?
Essentially, he's saying if you use a condom but it breaks, you're not liable. And so what is the relative of this statement to others, from a legal perspective? Yes. Sir? Have you spoken already? OK. Go ahead. I'd like to give the chance to folks who haven't asked a question yet, if you don't mind. Please, at the back?
Mic Rasmussen: I'm afraid this will just take a little bit longer. It's not really a question. It's a statement, because I supposed that you also wanted to hear about the organizations of PLHIVs. Not only the statement of Nikos Dedes; I think what you will experience now is a live comment to Ulrich Marcus's statement, as well as in support for at least the last statement in Nikos's very fine presentation. It's called the Mexico Manifesto, which has been a paper running around for the last several weeks, and under nondisclosure until today.12 The Mexico Manifesto is a call for action by people who live with HIV and AIDS. It has until now been subscribed by a considerable number of organizations, PLHIV organizations in Europe, as well as some individuals in the U.S. And I don't know whether my Brazilian friends are here and they have already decided to sign, as well.
Sir, can you tell us what the manifesto says?
Mic Rasmussen: What is the benefit of it? It's meant to support the EKAF statement, this statement by the Swiss Commission. We PLHIVs really, really welcome this statement and we also draw some conclusions in the sense of requests that we wish to address to all actors and key players in the field of HIV, as well as to the media. Finally, this could help improve some stigmatization and discrimination and criminalization effects that we are still suffering from.
I didn't want to tell it. But I was a member of LHIVE, the Swiss national organization, a member of the board. My name is Mic Rasmussen and I would like Michèle Meyer, who is the initial author of this manifesto, just to give you the six key sentences of this manifesto. She is actually the president of LHIVE, and I didn't want to tell it. She's also my partner. And here are two young girls. We are one of the serodiscordant partnerships, or different, we like to say, who really engage for this statement. So if I could give a word to Michèle now.
Sir, if we could, before going into that: I think you have physical copies of the manifesto. And perhaps give us the electronic link. There are many other issues to discuss, and I think we want to congratulate you for your action but continue with our discussion around a variety of issues, if that's OK. We have one more comment?
Elizabeth Kisani: I think that we -- to go back to this issue of risk -- everyone takes risks. We decide what risks we take in the light of the best available information that we have. Sero-strategic positioning: that wasn't something that came from public health professionals. It was something that came from a community that was trying to minimize its risk and maximize its pleasure in sexual relations as best they could in front of the data that they had. And the same thing with sero-sorting.
Now, sero-sorting actually is working quite well for people who are HIV positive, barebacking among people who are both positive. It's not working so well for people who are HIV negative. Why? Because if you are on Gaydar, or Gay.com three times a week, or four times a week, looking to bareback with another HIV-negative partner, you're quite likely to find a partner who is undiagnosed, newly infected, very highly infectious. And therefore, you put yourself at great risk. So in fact this statement is of enormous use to people who do make sophisticated decisions about the risks that they take every day of their lives. And this just gives them an extra piece of information, which is, oh, gosh; if I'm going to bareback, maybe I should do it with someone positive, on treatment, rather than someone who says they are negative. [applause]
I want to just, before we take more comments from the floor, ask our panel to make any responses to some of the many issues that were brought up. Hopefully you were taking notes. Some of the key issues were on criminalization and legalization issues. What were some of the outcomes about anal sex? How was this taken into context? And who was targeted by the statement? was the first comment that we had from the floor. So, all of the other issues that were brought up: Does anyone want to make some comments? Kate?
Catherine Hankins: Yeah, just two comments. One is that I agree with Nikos that if this puts the spotlight on undiagnosed people, and encourages knowledge of HIV status, then this is a positive consequence of all of this. And I would just like to clarify, for the woman that's working in Cameroon; I actually have in front of me data from DHS from five countries, including Cameroon.13 Basically, two-thirds of infected couples are discordant couples, two-thirds of them. In 30% to 40% of them it's the woman that's the HIV-positive person.
So I think there's an assumption among people that if one person is positive then the other one must be as well. We need to be really encouraging serodiscordant -- well, non-diagnosed -- couples to come forward and be tested. And if they are serodiscordant, there are things that we can offer. Part of it is treatment. Part of it might be male circumcision. Certainly, prevention of mother-to-child transmission. It creates a possibility for prevention and for treatment.
Does anyone have any comments about the criminalization issue that was brought up?
Pietro Vernazza: Maybe a short comment about the criminalization issue. I think the EKAF statement was not addressing couples that do not disclose HIV information. So I couldn't see how the statement could address those couples. The legal issue that we have in Switzerland is that you are liable even if you disclosed your information to your partner, and if you have sex with your partner without a condom, you actually are liable of trying to transmit an infectious disease.11 And we wanted to stop at least that point. I couldn't see the other problem ...
One thing: I'm very happy with the information that Kate Hankins just corrected from Africa. I was very surprised to hear those figures. And one thing that I also would like to correct, which you said; we did actually not meet at a conference. That was not our aim. We never did that. We actually wanted to respond, to meet the conferences that have taken place already. And that is one thing that you also mentioned.
Physicians: you think it's OK physicians talk to their patients. Our point was that we don't know what they talk to them, and what we have realized now: they haven't talked about STDs and adherence as we do it now. So I think the statement addresses these important parts that will also answer the concerns that Mike had with resistance. I don't see a single patient who develops resistance if he is six months suppressed, and remains with perfect adherence. That just doesn't exist.
No other comments from the panel? OK, from the floor? Yes, sir?
I would really welcome it if we could use the Swiss statement on reduced infectiousness under antiretroviral therapy if we adopted two populations like MSM; if we can use it to refocus the attention on the problem of the STI co-epidemics that have evolved in these populations. If that would be the outcome, I would welcome that very much.
So far, I think the health care systems in countries with MSM epidemics have been very inefficient to address the STI problems in the MSM communities. So in HIV-positive men who get antiretroviral therapy, so, who should see a health care provider at least four times per year, in Germany, they have just a slightly minor STI incidence than HIV-positive people who don't see a health care provider. So, much about the efficiency of the health care systems to address the STI epidemics in MSM communities.
Thank you. Sir?
Adrian Camacho: Hi. My name is Adrian Camacho (sp?). I'm an ADID Fellow here in Mexico. Just a brief question. How is the Swiss government planning on doing an evaluation on the outcome of this statement, positive or negative? And should we be waiting for another statement?
Thank you. Go ahead, sir.
Jim Pickett: Thank you for a great panel. My name is Jim Pickett. I'm the Chair of the International Rectal Microbicide Advocates. I haven't heard a lot of discussion about new prevention technologies, vaginal microbicides, rectal microbicides, prep. And I'm wondering how this, I think, fabulous statement and very important statement, might be a way to help us push forward in the need for more technologies to protect ourselves that go beyond condoms and speak to things like pleasure and enjoyment of sex. And that could be for anybody, but perhaps the gentleman who spoke on behalf of the community.
Any other comments from the floor, please?
Michèle Meyer: My name is Michèle Meyer, from Switzerland. I just wanted to say about communication: I think it's time to accept maturity of individuals and society. So I'm wondering, maybe we are asking what should be communicated and what not. And then I want just to say that the manifesto, you can find on www.lhive.ch. So you can see who has signed the manifesto.
Just to repeat: that would be www.lhive.ch.
Sidney Martinus: Sidney Martinus from Australia. I just wanted to firstly say thank you to Switzerland. [applause] I applaud you, I applaud, I applaud you. You are magnificent, courageous, and I will stand by you 100 percent all the way.
I would also like to ask some clarifying questions, as well. Could you please clarify to us the implications that this statement has for male-to-male sex? Because a lot of the studies were around heterosexual sex. And also, in the direction of how do we get research on clarifying these questions. So they are the two things I'd like the panel to maybe make some comments on.
Good. One more question?
David Gilden: I'm David Gilden, from New York City. Actually my question is a follow up to his question. It's also a clarifying question. There's been a lot of discussion about the role of STDs and whether that obviates protective effective treatment. Do we really know that? That people who are suppressed due to treatment then become unsuppressed, at least in their genital fluids, if they have an STD? Have there been studies, or have I missed them somehow, that detail that?
Pietro Vernazza: There are so many questions; I would like to start with the last one. That's the one I could remember. I would like to make this very clear. We did not say that an STD under completely suppressed treatment actually increases the risk of transmission. This is something we don't know. There is only one study I know from Birmingham, U.K., where they looked at urethritis, and they found 2 out of 20 patients under HAART had a slightly increased viral load in semen during the urethritis episode.14 Otherwise, it was always suppressed.
But we did not say those individuals are more infectious. We said if we are uncertain, if there is a confidence interval, if we are close to the place where we wouldn't be so confident, we would decide that those would be the individuals where we would be more careful. So we didn't say it is more infectious. We just made our concerns. I think that is an important difference.
There was a question about evaluation. Would you speak to that?
Pietro Vernazza: One thing: We are not the Swiss government. We may make suggestions to the Swiss government. We, as a commission or not, in a status that we develop evaluations, but I realize that, not only in Switzerland, but also in other countries, this statement has stimulated a lot of research questions, and people are starting to address them. But I think we are not the right group to address that.
Other comments from the panel?
Myron Cohen: There was a question about the broader use of antivirals as preventive agents. And I think that's probably one of the most prolific and important topics going on right now. The meeting next door is about antivirals for pre-exposure prophylaxis. There are at least ten different topical microbicide trials that are involving different single or combination antiviral agents.
So this whole idea of antiviral therapy for prevention: We're focusing now on the infected person, but the package is post-exposure prophylaxis, pre-exposure prophylaxis. And it's a field that hasn't realized its potential, because there was so much -- I don't want to call it commitment -- there was so much belief that we would make a vaccine that was going to solve this problem, that perhaps the energy that's now being realized in the ART field is kind of surging. And because we can modify drugs, and because some of the newer drugs have very unusual and positive properties for prevention, it seems inevitable to me that the topic that one of the gentlemen asks; it's going to get broader and broader and broader. I think it's also inevitable that we're going to see success. And those successes are going to have to be measured, and become part of public health policy. So I think that was a very good question.
Dr. Cohen, someone asked about homosexual transmission. And the study that you're doing, will that include ...?
Myron Cohen: Let me clarify something. I think it's incredibly wrong to look at anal intercourse as limited to MSMs. This is wrong. This is about a sex act that is common among heterosexuals, as well. I think a recent study came out from Africa. I don't know the exact number; I think it was something like 12% to 14% of South African mature couples were actually engaging in heterosexual anal intercourse.15 So it's about the act, not about the selection of partner. So that's my number one, overriding concern -- that we not just focus on MSMs.
Now, recognizing, though, that obviously. ... Well, recognizing all the obvious, that this is a behavior that is not well studied. It's a difficult behavior to study. We don't understand the transmission events, the probabilities that occur in that, and we don't understand a lot about ART in that setting. So this is going to require more research. I'd be wrong to say more than that.
Julio Montaner: I want to say hi to my fellow treatment activists from the prevention field. Indeed, the EATG and the community, of course, we support very much the use of new, preventive technologies. And perhaps they will be the only solution for the next years. That was one of my statements from the public health impact of the guidelines; that actually, prevention is treatment, in the sense that, within the comprehensive package, with the ways that treatment can be used, as Myron mentioned.
I also wanted to say something about what Ully Marcus said about. ... Indeed, this statement, and what it says in there, should be used. We should turn this information into positive outcomes. And STIs are not regularly screened in HIV units, which, given the data, is criminal. I said that these are preventable and treatable. So screening should be one of the priorities for strategies for people who are followed in clinics.
Myron Cohen: For the sake of full, kind of, discussion, I have to add something. And this is complicated. And there is one additional paper that you didn't cite, by Nago, N-A-G-O, who is at the NRS (?). One problem we have is that HSV-2 is very ubiquitous. It's a lifelong disease. It's been very popular in the HIV/STD overlap field, because the shedding of HSV occurs quite silently. And some of the investigators believe that HSV shedding, while subclinical, drives HIV shedding, as well. What Nago showed in his paper was -- this is very recent -- that even paper on ART, unless they also received acyclovir, had in increased shedding. These were females, women. Whether that amount of virus is enough to cause a transmission event is totally unknown. There would be no way to get into that. And I want to separate those two issues. But it is also true that a substantial number of people around the world also have HSV-2 infections, which are chronic, asymptomatic, of very little clinical consequence to the average person. But it really has to weigh in to the whole discussion. So when you talk about screening, it would be very difficult to deal with HSV-2, in all candor.
Julio Montaner: Yes, but to answer to that, there was also this question of what kind of research do we need. And indeed, the presence of STIs does not necessarily result in increased risk of HIV transmission, and the other very important research question is: Is there a threshold under which transmission does not occur? Whether we need enough of an inoculum in order to have transmission.
Therefore, even this shedding that you are describing probably would be relevant.
OK, let's take maybe three more comments, and then we're going to have a summation of the session. So please, go ahead.
Nick Archer: Nick Archer from the Terrence Higgins Trust in the U.K. I just want a clarification, if I may. I recognize that the statement is good news for a few people. Can I just be clear that those, anyone who enjoys anal sex, are not part of those few people that have good news in this statement? Because that was the suggestion I was getting from you, Mike. That actually, irrespective of sexuality, what the Swiss statement says excludes people who enjoy anal sex.
Because the question about anal sex has been sort of dodged. It's been asked four times now. So can we be clear about how the statement goes for serodiscordant couples who enjoy anal sex? Just to help me understand it.
Pietro Vernazza: I just would like to make very clear that we did not discern anal sex, vaginal sex, whatever sex. The reason why is that the most important source of our confidence was the fact that, after ten years of HAART, we don't see these cases, regardless of the mode of sexual content. So all the other biological arguments help to explain it, but the evidence is the same situation as with households' context, as I explained in 1986.
Yes, please go ahead, Julio.
Julio Montaner: One way to understand this is, if you start with the risk of mother to child transmission, which is from 20% to 40%, the introduction of one pill, or a two-pill combination, actually makes transmission very, very unlikely.16 When you compare that to sexual risk of transmission, which is much lower than the -- I'm talking about anal risk, which is much higher than vaginal, but still, it does not begin to compare with mother to child transmission. If you then have the same impact of the antiretrovirals, it goes to say that the risk is infinitesimal. So what the Swiss have been describing is that it is irrelevant. And that's why, in my presentation, I said that the reduction of risk is logarithmic, and parallels the logarithmic reduction of viral loads.17
Thank you. OK, two more comments. Yes?
Eric Fleutelot: Thank you. I'm Eric Fleutelot from Sidaction in France. And I share your concern, Kate, on privilege and viral load test access. The availability of viral load tests is very weak. But it remains for me that we need to improve access to viral load and that's it.
I have a very naïve question, and please be indulgent with me if you think it's a stupid question. How come it was possible last year to promote circumcision in many high prevalence countries, even if the efficiency of circumcision is lower -- if I remember well it's just 60% from women to men -- it's lower than the efficiency of prevention of HIV transmission with treatment. So I don't understand UNAIDS and WHO are so shy now, compared to what you did last year on circumcision. [applause]
You know, I think that listening and talking about this statement makes me realize how much this statement is about privilege and the privilege in access to medical care and doctors and regular treatment and intervention. I think that it comes with responsibility and acknowledgment that there's always a trickle-down effect. Having worked as a provider in both the States and what is considered the global south, I don't see that in a couple of years there's going to be a change and there's going to be a lot more viral load testing and there's going to be the possibility of access to medical care in a way that makes the statement relevant to a lot of places.
I guess what I'm asking is, what are the next steps? What is happening to make this statement true for everyone who is infected with HIV? How is that becoming a global statement, in a real and practical way?
Susanna Attia: My name is Susanna Attia. I'm from Houston, Texas, working with the Institute of Social and Preventive Medicine in Bern, Switzerland. And we're also looking at the evidence regarding transmissibility of HIV according to usage of HAART, viral load, and STIs. So far we have found, in a review of the literature, that the lowest transmitting viral load has been 362 copies per milliliter. If you'd like to know more, I'm actually presenting on Thursday at 5:15 in Session Room 11 on this exact topic. So I hope that it's of interest. Everyone can help in this discussion.18
Thank you. Kate, did you want to respond?
Catherine Hankins: I'll just respond. We're not shy. Don't worry about that. But what we want to do is to make sure that the messages are well contextualized. Anything that increases the choices for people, the options for people, for HIV prevention, is important. More people are getting infected each year than all of the ones that are on treatment so far. So we have got a real negative balance here. I think it's important to get the message across that this is for a select few people and, yes, we need to increase viral load testing in countries. We need to decrease the number of people with undiagnosed infection, because that's where the bulk of infections are occurring. And we need to look at options and combinations. So that's why male circumcision -- three randomized control trials, and now further phase 4 trials, showing very good results in the community -- that's really strong evidence.
We're not saying male circumcision replaces everything else. Everything has to be additive and synergistic with what we have.
This transcript has been lightly edited for clarity.