It’s the little blue pill that could!  TIME magazine’s “Top Medical Breakthrough” of 2010 was a study called iPrEx which showed that taking a pill a day, called Truvada^®, can reduce the risk of contracting the virus by an average of 42% in men who have sex with men at risk for HIV.  This approach, called pre-exposure prophylaxis (or PrEP), has the potential to be a promising new tool we can add to the HIV prevention tool box.

But the study raised as many questions as it answered.  Now that the dust has settled a little, I want to probe a little deeper into the results and highlight some of the important points about what we do and don’t know about PrEP.

The pill that was used in the study is called Truvada^® and is widely used to treat people living with HIV.  It is one of many medication options to treat HIV and was chosen for the study in part because it is generally well-tolerated, can be taken once a day, and has few interactions with other medications.

But because it is already on the market, it means that people may use the drug in ways that are different than the reasons it was licensed.  The pill is not a “morning after” pill and it’s not a “right before” pill either.  It’s actually a fairly rigorous regimen that requires people take the pill consistently.  Your doctor may prescribe it to you “off-label” for preventive use if you ask him or her, but the fact of the matter is we still don’t know yet if that’s a good idea for most people.  The CDC (Centers for Disease Control and Prevention) is gathering together experts and community members to discuss whether this pill should be recommended for PrEP use for men who have sex with men and trans females. They may have a decision about their recommendation late 2011 or early 2012.

If a person does decide to use PrEP, it’s very important to be sure of the person’s HIV status prior to starting PrEP because in the study there were cases of drug resistance when people began Truvada^® after they were already infected.  It’s also important to be regularly tested for HIV and monitored by a physician for safety while taking PrEP.

The study shows a 42% overall reduction of HIV infections when taking Truvada^®.  This number includes everyone who participated in the study even if people didn’t take the drug every day or hardly at all for that matter.  How is that number calculated?  The 42% reflects the difference in the number of infections between the people who were in the placebo arm vs. those who received Truvada^®.  Specifically, there were 83 men who acquired HIV in the placebo arm and 48 from the active arm; participants in the group that received Truvada^® had 35 fewer HIV infections when compared with participants in the placebo arm.

Keep in mind this study shows that PrEP is only partially effective for men who have sex with men and trans females, and cannot be generalized to other populations.  Studies are currently underway testing PrEP in other populations like injection drug users in Asia and serodiscordant couples (where one partner is HIV+ and the other is HIV-) in Africa. One study in high-risk women in Africa was stopped early because PrEP was not working to prevent HIV infection in that study.

Make that very expensive.  At a cost of about $12,000 per year in the United States, one of the biggest questions yet to be answered is who will pay for it.  This will be another major barrier that will prevent people from using the pill. There are discussions underway about whether or not insurance will pay for this. Stay tuned.

As mentioned above, the study showed a 42% reduction in overall infections in the group that received Truvada^®, in combination with a comprehensive package of prevention services.  But they also did an analysis suggesting that participants who took the pill more consistently achieved a higher level of protection.

These results are encouraging and suggest that the pill works best if you take it consistently.  Other dosing regimens have not yet been proven effective, but studies are underway to test intermittent dosing schedules.  But is taking a pill every day to prevent HIV really going to happen?  See my next point.

In fact, some are arguing that if people can’t remember to use a condom every time, then how in the world will they remember to take a pill every day?  My answer to that is I don’t think people are “forgetting” to use condoms.  Condoms may not be accessible, people may be too drunk or high to be concerned about their safety, or it’s a conscious decision by one or both parties to not use a condom (because they believe they’re in a monogamous relationship, it feels better, etc.).

PrEP should not be thought of as a replacement for condoms but rather as a back-up plan of sorts.  In the study, PrEP was provided in the context of comprehensive prevention services.  Participants were given HIV risk reduction counseling and testing; free condoms; and regular monitoring and treatment for STDs.  So there are still a lot of questions about how PrEP can be taken in real-life settings; and there are currently studies being planned to test just that.

Trials & Vials: An HIV Research and Education Blog is sponsored by the HIV Research Section, SFDPH.  Read more about our HIV vaccine studies and UNITY study.

“Doctors Claim HIV-Positive Man Cured by Stem Cell Transplant” – Fox News: December 14, 2010

“Stem Cell Transplant cures HIV in ‘Berlin Patient’”- Huffington Post:  December 14, 2010

“Evidence for the cure of HIV infection”- Blood: March 10, 2011

Beginning in 2009, rumors suggesting the discovery of a miraculous “cure for HIV” made their way to major news publications and scientific journals throughout the world. The exciting news revolves around Timothy Ray Brown, a forty year old resident of Berlin infected with both HIV and leukemia. Dubbed the “Berlin patient,” Brown received a stem cell transplant in 2007 to treat his leukemia. The cells he received lacked a key piece that HIV needs to infect cells- a molecule called CCR5. The result was astounding: follow up tests could not detect any active HIV in his blood. Over three years later, they still can’t! Finally, after 30 long years the world has found a cure for the treacherous HIV virus that has killed over 25 million people! Right?

Well…not quite. Before calling the Berlin patient’s treatment a cure for HIV, it is important to know that there are two different ways to use the word cure:

These two definitions actually make a difference in understanding what we can say about the Berlin patient. Using the verb form, we can say that the Berlin patient was “cured” of HIV because eliminating of the virus from his body relieved him of the infection. However, I don’t believe we can use the noun form to call stem cell treatment a “cure” for HIV because it is not a permanent solution to the HIV epidemic.

Firstly, the stem cell transplant Timothy Brown received is not simple and in fact, it can be deadly. The procedure involved taking special blood cells from a donor who is resistant to HIV and putting them into his own HIV infected blood. There are many dangers involved with this type of treatment, most notably the risk of transplanted stem cells recognizing the recipient’s body as foreign and attacking it. This process is extremely harmful to the recipient and can be fatal.

In addition to the health risks, there are several factors that make stem cell transplants an impractical cure for HIV. For instance, it is very rare to find donors with blood cells that are resistant to HIV in the first place. To find enough donors who are both resistant to HIV infection and also have matching blood types for the millions of HIV infected individuals is simply unrealistic. On top of that, the cost of stem cell treatment is so expensive that most HIV infected individuals would not be able to afford it. Even if it did cure the Berlin patient, considering all these limitations makes me reluctant to call stem cell treatment “a cure” for HIV.

The reason I am so careful about choosing how to use the word “cure” is because in the context of HIV, finding a cure means so much to over 33 million people infected with the virus today. It would be wrong for scientists to claim a cure for HIV unless it promises to eliminate HIV in a majority of these people. Anything less would be a disappointment for the hopeful individuals who find out this “cure” does not apply to them. In its current state, there are many barriers that prevent stem cell transplants from being a universal treatment and its effectiveness has only been proven in one person- the Berlin patient.

So the next time you hear a shocking headline that claims scientists have discovered “the cure for HIV,” take it with a grain of salt. Read the article and ask yourself: was a cure really found, or have you just read the story of a one man cure? While the Berlin patient is an example of a one man cure, it did have the positive effect of spurring enthusiasm for HIV research. In fact, the National Institutes of Health (NIH) and the American Foundation for AIDS Research (AMFAR) are funding new initiatives to learn information about the Berlin case that may inspire new ways to cure HIV. Hopefully one of these strategies will ultimately work and can be applied universally to help relieve suffering from the infection and eliminate the need for lifelong treatment.

Trials & Vials: An HIV Research and Education Blog is sponsored by the HIV Research Section, SFDPH.  Read more about our HIV vaccine studies and UNITY study.

Jack from Orange County asks, “I want to have anal sex!  How can I keep myself safe and make it feel good?”

Let’s Talk About Sex with Garza & Dulce is a safer sex video series that provides information and tips on how to minimize your risks of acquiring HIV and sexually transmitted infections in a variety of situations. Watch our resident sexperts Garza and Dulce de Leche as they address viewer questions about sex in a candid and fun format. Make sure to leave a comment below!

Let’s Talk About Sex with Garza & Dulce is sponsored by the HIV Research Section, SFDPH.  Read more about ourHIV vaccine studies and UNITY study.

Rising Blackness is a program that draws on the collective strengths and wisdom of Black gay, same gender loving men and transgender women who live in the Tenderloin neighborhood of San Francisco.

For one year Rising Blackness engaged the Tenderloin community in educational, cultural and social activities as a means of implementing new HIV prevention activities. Over the course of the program, members of Rising Blackness held nine community events including a World AIDS Day community discussion, a march and community forum for Black HIV Awareness Day, a safer sex party and a community health fair.

This special that aired on KRON4 was conceived by Rising Blackness as a way of increasing the visibility of Black gay men and transgender women in the Tenderloin. The special highlights the lives of members of Rising Blackness and their work in the Tenderloin.

Trials & Vials: An HIV Research and Education Blog is sponsored by the HIV Research Section, SFDPH.  Read more about our HIV vaccine studies and UNITY study.

Chris Swanson is one of the first participants in the latest HIV vaccine trial. He spoke with me about his experiences with HIV, his experiences with the trial, and why he chose to participate.

Press PLAY to listen to the full interview:

Transcript:

David: You’re listening to the Trials & Vials Podcast, the official podcast of the HIV Research Section at the San Francisco Department of Public Health.  For more information about this podcast, including a full transcript, visit us at our blog at www.TrialsAndVials.org.  And for more information about the HIV Research Section, visit us atwww.HelpFightHIV.org.

This is David Nalos, Social Media Specialist at the HIV Research Section at the San Francisco Department of Public Health, and I wanna welcome you to the first Trials and Vials Podcast.  The HIV Research Section is a leader in HIV Prevention Research working with Bay Area communities to discover effective prevention strategies that will reduce the impact of HIV/AIDS globally.  Today we’re talking to Chris Swanson, one of the first participants in the latest HIV vaccine trial.

How are you Chris?

Chris: I’m doing very very well, thank you.

David: So let’s talk HIV.  Now, HIV, as you know, has been around for almost 30 years now and for almost as long we’ve been trying to find a vaccine to end the epidemic.  So tell me why did you decide to join the trial and why now.  Why is now the right time?

Chris: You know, like five, six years ago, I didn’t have any connection to the disease really.  Now it’s completely in my community, it’s engrained and, it’s in my personal life, and in relationships, and in friends and I mean I had a friend pass away on Friday from the disease …

David: Wow

Chris: …and my last relationship was a magnet relationship, you know, I was negative and he was positive and that’s why it was a big proponent for me to be a part of the study.  What really resonated was that it was time, I had the sense of feeling that it was just … it was time.  I mean when you’re 20 and you’re kind of figuring out who you are and coming out and kind of all over (laugh), it’s really not something you think about.  And then like I said when everything has kind of over the last couple of years really hit home and hearing the information it was just like okay, it’s time.   It’s definitely time to kind of grow up and time to give back.

David: You were talking a little bit about how it’s in your community, umm, you said it’s around you and people are talking about it.  But a lot of the research talks about the complacency that a lot of the younger generation has around HIV.  And you are … 20 years old?

Chris:  25

David: 25 years old.  People who are in your age group, do you find that that complacency is there?

Chris: Very much so.  I can recall when I was in my last relationship that he had a friend call him and tell him that he was positive.  And I just remember the kind of calming down of it’s not a death sentence, it’s not the end of the world.  And having a lot of friends in the older demographic who were those activists and who were those people who were extremely involved who saw people die within a very, very short amount of time; having them talk to my age group really kind of resonated with me.

But then with my friends recently, very close friends coming and finally admitting, you know, I’ve known for a year but I’m finally comfortable to talk about it, and it really being the sense of okay well I’m not gonna die tomorrow; the kind of feeling that it’s manageable.  Which I would tend to agree with that it isn’t a death sentence but I think that that also can put a spin on it not having such the influence that it is a problem.  It’s a disease that can take lives and does.

David: It’s a real double-edged sword.

Chris: Completely.

David: What did you know about HIV vaccines before actually you were in an HIV vaccine trial?

Chris: Nothing.  I really … I really hadn’t done a lot of research.  I mean personally I was, for the last three years, caught up with school and work and internship and things and so I really didn’t get to get as involved as I would have liked to.  And so one of my personal goals was as soon as I had that time, it was a goal of mine to get involved and it just so happened that within like a month of graduation I heard about the study and that’s when I contacted and really got involved and really kind of put the ball in motion, I guess.

David: What were you expecting before you actually came in for your first visit?

Chris: That’s a good question.  Honestly, I didn’t know what to expect.  I think I’d played over like 8000 scenarios in my head, but that was before I really had the information that they give you because the first enrollment sessions you really are taken through Power Points and really kind of umpteenth signatures to make sure you understand everything.

So there’s never a feeling that I didn’t get an answer or I was left with a sense of uncertainty.  It was always, “Do you have any questions,” you know, “Is there anything else we can explain to you,” or “Do you understand this?”  So that you really feel that you’re being valued and it’s not just like, “Okay, you’re just, you know, a rat in a cage” kind of thing.  It’s a very honest, personable, experience.  My expectations going into it were … I don’t think I really had any.  I honestly did not know what to expect because I had never participated in a study before.

And I remember when I started the study a couple people were a little bit weary towards my involvement in it.  It was funny I remember having brunch with a friend and he was mentioning, he’s like, “Well it’s an HIV vaccine like the flu vaccine, like they’re gonna give it to you.”  And really having to educate them on what was happening, how it was being done, what was being utilized, and the fact that you can’t, I mean it’s all synthetic.  You’re not going to be injected by The Department of Public Health with HIV to see what happens.  I mean it … that’s just a reality, that’s not happening.  But really getting that stigma out of people’s head because they’re worried and I think the vaccine, that word, I think throws people.

Just cause you hear the word vaccine it doesn’t mean you’re getting it.  It’s been engrained in people’s heads about the flu vaccine, and about, well “we’re giving you a little bit of it,” when that’s really not the case.  And, I mean, when I called and talked to the people here at the Department of Public Health … that was all I needed.  Feeling just completely comfortable, completely accepted, my fears were addressed, everything was kind of put to rest, so to speak, and I was made to feel really comfortable and informed of what I was doing.  Any expectations just turned into this positive light so, it’s been good.

David: So did you have that fear that everyone talks to you about about being injected with the HIV virus.   Did that ever …

Chris: Yes!

David: Yeah?  Ok!  (Laughs)

Chris: (Laughs)  I remember sitting with Haley, sitting there and being like, “Okay, so you swear there’s like no way.”  She’s like, “Okay, we’ll go through it again.”  And I was like, “Alright, just so we’re on the same page.”  But, yeah, I mean as much as people have become complacent with it.  When you bring it up in a serious note, especially with younger people, it still can kind of hit.  My first reaction when I got in was I was nervous.  I had an extreme fear.  I was like, “Okay, so, I’m gonna get HIV from this.”

Then I thought there’s no way that, you know, The Department of Public Health for San Francisco is really gonna be allowed to just be like, “Here you go,” nor would they even consider doing something like that.  So, yeah, it was definitely a fear of mine but, like I said, those fears were definitely set aside.

David: So what are the visits actually like?

Chris: (Laughs)  It’s like therapy. Cause it’s funny cause you come in … the process, obviously, you check your physical health to make sure you’re able to be vaccinated.  They have to order the vaccine, and then in that time that you have to wait for it to be delivered from the pharmacy, that’s why I tell everyone it’s like therapy.

The nurse practitioners here I … I think are phenomenal.  They have a way of … they’ve been so genuine.  I mean aside from being phenomenal at what they do.  I mean just on a personal level, I mean, I told them I can’t thank them enough because they make you feel at home when you’re here and you really get to talk and they just have a way of bringing things out about you and getting you to just … not necessarily divulge information but they just make you feel so comfortable that you can actually talk and have an outlet to really express these things; especially when it has to do with HIV or the reasons why you’re doing the study.

So, you know, you come in here and in that time you get to kind of vent a little bit.  And it’s … I mean, you know, it’s checking vitals and it’s things like that and then it becomes your responsibility in taking part after words to really kind of monitor for three or five days; kinda checking the injection site or any possible side effects or symptoms and temperature.  It’s not super time intensive, I think, on our part as the participant but I think the information that’s being taken and the scientific research that’s coming out of it is immeasurable.  I mean, I think it’s invaluable.

David: Have you had any side effects?

Chris: No, which has been great … I mean my arm hurts sometimes a little bit.  I mean I’d never had a Bioinjector before.  I didn’t even know what it was.

David: Can you tell people a little bit about what that is?

Chris: It’s … everyone’s like, “What is that?”  Umm, so a normal vaccination obviously would come with like a needle.  But it’s needle-less.  It’s essentially high pressured air that punctures less than a pinhole of your skin to inject the vaccine.  And it’s … it’s almost just like a weird pressure for a minute and that’s it.  The only side effects that I’ve ever experienced as a part of the study was my arm was sore for like a day or two that was it.

I mean I haven’t experienced anything that would cause me to lead to concern and be like, “Okay, well maybe I shouldn’t be doing this.”  But it’s been a very, a very good experience.

David: And have you told your friends, family, that you’re in this trial?  And what have their reactions been?

Chris: It’s all over Facebook!  (Laughs)

David: It’s… (laughs) What  have their reactions been?

Chris: Umm, at first, like I said, almost everybody has been a bit weary just because of vaccines and they think, you know, really taking that time and them understanding why I’m doing it, what it’s for, has helped them I think realize that it’s … you know, aside from the scientific aspect and really what’s going on … my emotional input into the situation and being a part of the study has helped them come to terms with something they may have been a bit weary about just on the surface.

David: Mmmhmm.

Chris: Not really knowing much about it, just hearing they’re like, “Ehhh,” you know, a little stand offish but really, I think, investing the time to take five minutes and just really explain what it’s about, why I’m doing it, why the others, you know, who are a part of the study are really involved.  Cause everybody has a unique story and everyone has a unique point of view as to why they’re doing it, what it means to them.

I’m not shy about it I’ll post it on Facebook for everyone, you know, it’s the next injection, you know, and the response is phenomenal.  Cause I get a lot of positive “congratulations,” “thank you for doing something.”  I think sometimes a lot of people don’t feel that they can do anything.  I didn’t think that I could really do anything in the beginning and then when I found out about this vaccine study I realized that I really almost effortlessly lend myself to do something about it.  I mean in all honesty it’s been a very enlightening experience.  It’s something I would do again if there was another opportunity down the road to participate in another study.  I think it’s great.

David: How has your sexual behaviors, your sexual practices, how has all of that changed since you participated.  If it has?

Chris: Very much so.  I mean … I say very much so and it’s really kind of helped me come to terms with my own questions that I might have.  Things that I might not have really fully understood until I got the information that you guys provide here.  So it’s helped, I think, more solidify who I identify as in the community, just overall the way I choose to live my life.  It’s definitely helped kind of solidify that.  Just with the information and everything that’s provided it’s phenomenal.

Essentially, it’s always been about safe behavior but I think everyone, I mean, I don’t think everyone’s safe all the time as they should be.  Especially with such a sex positive community, when you’re out having fun or doing what not you may not know.  People may not always feel comfortable to divulge that information and really taking ownership to protect yourself and get tested and if you’re sexually active, taking responsibility and ownership of that I think is extremely important.  It’s something that I’ve been very proud to have been doing and practicing for years.

I think it’s essential and I think you have one life to live, so to speak, and you really need to kind of take care of yourself and take care of those that are around you because if you are participating in a lot of sexual behavior it’s just the responsible thing to do.  And it’s respectful of not only your own body but those who you choose to share it with.  I think that’s really important.

David: So what would you like to tell others who might be thinking about joining?

Chris: To call.  To just inquire.  I would tell people who may not consider it to not assume things ‘till you really have the information.  I know it’s hard.  Take time, just make a phone call, it’s fifteen minutes.   You can get some information and you can decide if it’s for you and if it’s not for you.  I think people who are considering joining should just inquire.  Just do it because you have absolutely nothing to lose.

If anything you’ll maybe even join, hopefully, and provide a vast amount of information towards this research and towards this study.  Just don’t be fearful.  There really isn’t anything to be afraid of.  I say that now being someone in the study and someone who did have fear in the beginning.  I think it’s only natural to have that fear.  So I think realizing that you can acknowledge that fear and still inquire just to get more information does no one any harm.  It’s just a phone call.  So do it.

To learn more about HIV vaccine studies in San Francisco visit http://sfisready.org

To learn more about HIV vaccine studies nationwide visit http://hopetakesaction.org

The impact of HIV on MSM has been widely documented, but the results from the latest study that measures the prevalence and awareness of HIV among MSM in 21 major US cities still comes as a shock for many.  According to a new report from the Centers for Disease Control (CDC), 19% of MSM in major metropolitan cities are HIV-positive, and 44% of these men are unaware of their infection (Smith, 2010).

Although these results are sobering to say the least, it’s important to put these numbers into context. An important thing to note is that these numbers are largely unchanged from the 2004-2005 report, which was the last time the CDC  collected this data (Smith, 2010, p. 1203). This is in my opinion a victory in and of itself; we’re not losing the battle as the case may be, we’re just not winning it either. I’ll take a stalemate over a loss any day.

That being said, 19% is far too high a prevalence rate and we’ve got a lot of work left to do. This statistic means that if I were to randomly pick out five MSM from my group of friends, chances are that one of them is suffering from this disease. Try this out yourself. Picture five of your gay or bisexual male friends … and then pick one. This exercise is probably difficult for most people, because none of us want to imagine a friend suffering from this life-threatening and life-altering disease. But statistically speaking one of those five friends you just imagined is suffering from HIV, whether he knows it or not, whether he has shared it with you or not.

That brings us to the second major part of these findings; that 44% of the men who were HIV-positive were not even aware of it. That’s almost half! Almost half of the MSM in major metropolitan cities in the U.S. who are HIV-positive don’t know it! As a public health professional, my knee-jerk reaction to this statistic is to launch a major “get-tested” campaign so that these men can find out their status and begin life-saving treatments. But in reality the problem runs deeper than this. Public health organizations have spent millions upon millions of dollars on campaigns like this and still the problem persists. So where do we go from here?

I believe that President Obama hit the nail on the head during his speech commemorating the launch of The National HIV/AIDS Strategy on July 13, 2010.

You can see the speech here:

A friend of mine recently asked me to come with him to get tested for HIV. At first when he asked me to go with him, I told him that I was terribly sorry but I wasn’t available because I had made plans with an old friend that was visiting from out-of-town that day. He fell silent on the other line, and after a few seconds, spoke again. I’ll never forget what he said:

My heart absolutely broke when I heard this. Here is this incredible person, handsome, smart, who always seemed to have people around him. He always had a social event to attend, always attracted a lot of attention when we went out, and was the last person who I would ever think would be short on friends. And here he was telling me with utmost sincerity that I was the only person he knew that he was sure wouldn’t abandon him if he tested positive? This statement spoke volumes on the state of the stigma surrounding this disease. It’s so powerful that people would rather risk not knowing their status, than to lose their friends. For so many people it’s an either/or proposition. We’ve come so far bio-medically with this disease, but sometimes it seems we are exactly where we started when it comes to the stigma surrounding it.

I postponed my plans with the friend from out-of-town and went with him to get tested. I held his hand while we waited in the waiting room. I filled out the forms for him. I literally had to remind him to breathe. I told him that whatever happens, it was going to be okay. The absolute fear and panic in his eyes was so painful to watch. This is some disease, I thought. If the virus doesn’t kill you, the fear of it will.

Everything turned out fine for him that day and we became much closer because of the experience. But I will never forget that day because it reminded me of why I do the work that I do. Not only to eradicate this disease someday, but to eradicate the stigma around it until that day comes. Only then can we get everyone tested without fear of isolation, judgment, or abandonment. If everyone knows their status, I believe that we can defeat this disease. And one day when I picture five of my friends I won’t have to picture one of them suffering from HIV, because HIV will be a thing of the past.

I’d love to hear from you.  What was your experience the last time you got tested?  Are you surprised by the results of this study?  Take the quick poll and leave your comments below.

Trials & Vials: An HIV Research and Education Blog is sponsored by the HIV Research Section, SFDPH.  Read more about our HIV vaccine studies and UNITY study.