Monday, December 6, 2010

Critical reflections around PrEP: Questions, concerns, and next steps

by Keith R. Green, MSW (Co-Chair Elect, Chicago Black Gay Men’s Caucus)

As Project Director of the only U.S.-specific acceptability and feasibility pre-exposure prophylaxis (PrEP) trial in adolescents ages 18-24 - Project PrEPare - I must qualify the following statements by saying that my views are my own. They do not in any way reflect the thoughts or beliefs of the Adolescent Trials Network for HIV/AIDS Interventions (ATN), my current employer. My views on this topic are mine alone and, as a Black man who is sexually intimate with other men (diagnosed with HIV as an adolescent), they come from a very personal place.

Formalities aside, I should start by saying that I am very excited about the data that has come forth from the National Institutes of Health’s Pre-Exposure Prophylaxis Initiative (iPrEx). This international research study showed that the antiretroviral drug Truvada, when offered as a component of a comprehensive prevention package that includes condoms, counseling, and regular HIV/STI screening, was associated with a 44% reduction in HIV infections in participants who took it compared to those who took placebo. Additionally, a nearly 73 percent reduction in infections was seen in participants who took the study drug more than 90 percent of the time. I perceive PrEP to be a much needed weapon in our arsenal against the havoc that HIV is wreaking on gay, bisexual, and same gender loving communities, and this data demonstrating such a significant degree of efficacy fills me with hope.

I also very much appreciated the opinion piece that Dr. Kevin Fenton (Director of the National Center for HIV/AIDS, Viral Hepatitis, STD, and TB Prevention at the Centers for Disease Control and Prevention) wrote for CNNOpinion, outlining some of the cautions around this potential prevention option. I completely agree with him. This is just one study testing this intervention, and many unanswered questions remain, particularly with respect to what this data means for the populations most impacted by the epidemic in the United States.

Though the NIH iPrEX dataset is relatively large in numbers (2499 participants in total), U.S. men who have sex with men (MSM) are terribly underrepresented. In fact, less that 10 percent (less than 250 people) of the sample was from two U.S. cities combined (San Francisco and Boston). I have not seen the racial/ethnic background of the U.S. cohort—however, I think that it’s safe to say that the numbers get even smaller as it relates to people of color and young people of color in particular.

That said, the way that this data has been represented in the U.S. media is deeply disturbing. And the fact that the U.S. Centers for Disease Control and Prevention (CDC) immediately issued a fact sheet regarding the implications of this data, complete with incomplete guidelines for use and considerations for roll out, without a clear research agenda around these objectives, is downright scary. (I want to reiterate that I appreciate Dr. Fenton’s opinion piece, but it came nearly a week after the fact sheet. I understand the intent behind both, but from what I’ve read, a caution statement released on the same day as the data would have been much more in order than a fact sheet.)

One of the key messages from the NIH study is that adherence to the PrEP regimen is paramount to its success at combating the virus. I admit that I do not know a whole lot about the cultural variances around adherence (in Lima, Peru compared to Brooklyn, New York, per se), but I do know that African Americans, particularly those here in Chicago where I live, have a very rocky relationship with antiretrovirals. Recent surveillance data issued from the Chicago Department of Public Health found that only about 43 percent of African American MSM who knew their HIV status at the time of that survey were engaged in care that involves antiretrovirals. The reasons behind this are not clear, but anecdotally, we can speculate about them. Primarily, I believe, it has to do with our fragile history with the healthcare system, and the lack of trust that we have developed as a result. A lack of trust that all Americans can probably relate to, considering the abundance of malpractice suits and recalled prescription drugs that abound in our country.

That said, many critical concerns come to mind when I think about how the use of Truvada as PrEP could play out in the real world, particularly for the populations most impacted by the epidemic in this country at this time. Rocky relationships with antiretrovirals have equated to decreased engagement with them among African American gay, bisexual men, and same gender loving men. 

Truvada is one of the most widely prescribed antiretrovials (mostly due to its convenient dosing schedule and its presence in Atripla – the once-daily ‘miracle pill’). Therefore, considering the troubled relationship that African American MSM in Chicago have with antiretrovirals in general, is it possible that there are increased levels of resistance to Truvada among HIV positive men in the community? And, if so, could it be possible that an African American gay, bisexual, or same gender loving man who decided to take Truvada as PrEP (as a primary prevention with or without other proven prevention options), is at greater risk of being exposed to virus that is resistant to Truvada, leaving him not as protected as he believes he is? And, if he becomes infected and is infectious until he is diagnosed, is there not potential for him to pass on more resistant virus to others in the process?

I need to be clear that I understand that these concerns could be generalized to other populations. Much of this could be true for gay, white men or men from Lima, Peru, and that’s my whole point. We don’t have enough information to make any assumptions, really!

There are so many critical questions that must be answered before we allow those seeking to avoid contracting HIV to become convinced of the safety and efficacy of Truvada as PrEP:
•    Will African American MSM take PrEP as it must be taken in order for it to work? (Which includes taking it as a component of a comprehensive prevention package that includes condoms, counseling, and regular HIV/STI screening?
•    Does the general public understand that PrEP must be combined with other safe sex practices to derive the greatest protection from HIV?
•    Are we communicating, completely and honestly, the full range of risks involved with PrEP? Or do we really understand the full range of risks, particularly as it relates to resistance and how the potential for it varies from population to population?
•    What are the long-term effects associated with taking antiretrovirals preventatively?
•    Are we communicating effectively the fact that PrEP is not the ticket to a free ride on the “Sex Express”? (Condoms and other proven prevention strategies MUST be used)
•    Are we still advocating for regular HIV/STI screening and the power of knowing one’s status?

It is my sincere hope that the HIV/AIDS advocacy community will raise its voice LOUDLY to these concerns, and that the powers that be at the CDC, NIH, and other research institutions will explore the warnings and thoughtfully design research studies with strong behavioral and clinical outcomes that have these questions in mind. The future of HIV prevention in our country is dependent upon it. 

*** A community forum to discuss the iPrEX data and its potential impact on the future directon of Project PrEPare will take place in the Michael Leppen Theater at the Center on Halsted, 3656 N. Halsted, on Wednesday, December 15th 2010 from 6:30-8:30pm. The discussion will be co-facilitated by Jim Pickett, Director of Advocacy for the AIDS Foundation of Chicago and Chair of the International Rectal Microbicide Advocates.

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