Positively Aware, Current HIV news magazine

Positively Aware, The HIV News Journal published by the Test Positive Aware Network

POSITIVELY AWARE January/February 2013

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A pill to prevent HIV - A conversation gay men need to have

Last week a friend posted on Facebook: “It’s been an interesting life. HIV+ (positive). 10/9/2012.” He is 24.

Later, I asked my young friend if he had heard of Truvada, the drug recently approved by the FDA for use as pre-exposure prophylaxis, or PrEP, against HIV. A pill to prevent HIV transmission. Like most people I know, he hadn’t ever heard about PrEP and didn’t understand it was an option available to him.

Sadly, I’m not surprised. The information that has come out about PrEP over the past year has been so vague or confusing that millions of gay men at risk for getting HIV may not understand it. The fact is, a daily dose of Truvada can statistically protect against contracting HIV.

If taken properly and consistently over a period of time prior to an exposure, an HIV-negative person is protected in roughly equivalent rates of protection provided by a condom, or over 90%. Researchers have estimated that for gay men, taking Truvada daily (seven pills per week) may be 99% effective; four pills a week might be as good as consistent condom use (96%).

So why isn’t there a more expansive conversation happening in the gay community about this drug? Where are the front-page headlines? I spoke to some of my own friends about PrEP and quickly realized that many people, both HIV-positive and HIV-negative, have a knee-jerk negative reaction to PrEP—a combination of healthy skepticism, fear, misinformation, and confusion.

I’m writing this article because I don’t want to read any more Facebook postings like that of my young friend. I want people of all ages to have the information they need to decide for themselves about the risks and benefits of Truvada and PrEP.

The condom conundrum

Despite decades of safer sex messages, over 50,000 Americans are still newly infected with HIV every year. Gay men, who represent less than 2% of the U.S. population, account for over 60% of new infections.

With statistics like these, you might think that public health departments and HIV organizations would be doing much more to educate the public about this powerful, new tool in the fight against HIV. I asked my own doctor’s assistant about PrEP and he admitted he didn’t know much about it—and I live in New York City, arguably a health and medical treatment capital of the world.

I can’t help but wonder if the reluctance to promote PrEP may be that there are real limits to what PrEP can and cannot do. PrEP is not a vaccine that can give you 100% protection. It is not Viagra that can be taken 15 minutes before intercourse. It is not a cure for HIV. And it cannot protect you against hep B or C, herpes, syphilis, Chlamydia, or gonorrhea. And still, for many of us, PrEP could be a game-changer.

For as long as I can remember, the only real protection we have had against HIV, other than abstinence, has been condoms. But as protective as they are, condoms are also imperfect. They break. They are used incorrectly. They are at every bar when you don’t need them, and nowhere to be found when you do.

I also don’t know a lot of people who are able to use condoms “100%” of the time. Do you? Like anything we try to do 100% of the time, it’s actually human to be less than 100% successful. That being said, I am constantly amazed at how many presumably negative people I encounter who seem to think nothing of having sex without a condom. Something else is going on—namely that people are inherently unable to adhere to the “wear a condom every time” warnings. How many times did you slip in the past year? Once? Twice? Too many to count?

It’s high time for a different approach.

A new approach to prevention

PrEP has the potential to dimensionalize our approach to HIV prevention, principally because taking a drug daily, as a woman might take birth control, more accurately addresses sex in the real world. The same world where people slip up and condoms break.

In reproductive health for heterosexuals, men and women have many options to protect against unwanted pregnancy, from condoms and birth control to the morning-after pill. PrEP as pre-exposure prophylaxis and PEP as post-exposure prophylaxis are both powerful, valuable tools that give gay men, and anyone worried about contracting HIV, additional avenues of protection. Perhaps most important is that like oral contraception for women, but unlike condoms for protection against pregnancy or HIV, PrEP is not taken at the same complicated moment when sexual intimacy occurs; it can be taken at routine daily times before and after those less predictable moments. That is what most makes PrEP a unique addition to condoms in our struggle against HIV: It is neither better nor worse as much as it is a different strategy, one that may protect some people at some points in their lives when condoms are either impractical, unavailable, or insufficient protection.

For those of us who live in relatively affluent, urban centers, it’s sometimes easy to forget that safer-sex strategies and condoms are not “one size fits all.” There are many, many people at risk for HIV who don’t have the voice and power to always demand a condom during sex. There are people in serodiscordant relationships who could benefit from the practical and emotional protection of PrEP. Some people have fears around HIV that prevent them from loving. People with unfaithful and dishonest husbands and partners could be protected. People who “party” and take bigger risks, people who, for one reason or for many reasons, cannot “simply” use a condom 100% of the time. If you are one of those people, and you are lucky enough to have access to PrEP, you might decide that PrEP is a ray of light in an otherwise very dark place.

PrEP vs. condoms

A new ad campaign from prepfacts.org eloquently proclaims: Love has another form of protection. We’d like to think this means, universally, that people will use PrEP in conjunction with condoms to provide a second level of protection. That would make the most sense from a public health perspective, but PrEP presents us with a fundamental challenge to our way of thinking about protection and safer sex, namely that some people may use PrEP as a substitute for condoms although it does not provide all the same protections.

I spoke with Jeff McConnell of the Gladstone Institutes—he is a sociologist on the trial that showed Truvada effective against HIV infection in gay men. Mr. McConnell pointed out that a person who is taking Truvada consistently as recommended (daily) and having sex without a condom can no longer be considered to be having unprotected sex, at least for HIV.

It’s taken several weeks for me to wrap my head, and heart, around the idea espoused by sites like prepfacts.org and Mr. McConnell that taking PrEP daily and not using condoms could be considered, for some people, safer sex. This goes against everything I’ve been taught about HIV. Could it be that the language of safer sex, and perhaps sex as we know it, is fundamentally changing with PrEP?

The fear among many of us in the gay community and in public health is that people on PrEP will start taking more risks, risks they would not have taken otherwise. I understand these fears. And share them. But so far there aren’t data to support this fear. It could also be that the protection offered by this drug, when used properly, might actually offset any “riskier behavior.” Only time will tell. As mentioned earlier, condoms offer protection against a wider variety of sexually transmitted infections than just HIV, and have plenty of other advantages as well.

Caveat emptor
(Let the buyer beware)

I have never known a world without HIV. I came to sexual maturity in the late ’80s, at a time when HIV, sex, and gay identity were smashed into one. For me, the concept of sexual freedom without the fear and shame associated with HIV is both liberating—and scary.

The epidemic has traumatized us through loss of our loved ones and in our shame around the disease. It has traumatized us in our prejudices against our HIV-positive brothers and sisters. And I wonder if the trauma of HIV, fears for our own safety and the safety of our community, and our own shame are holding us back from being able to objectively consider this new prevention method.

PrEP has the potential to liberate us because it gives gay men who have managed to stay negative an opportunity to sever the cord between sex and HIV, perhaps for the first time. To understand the scars that HIV has made, consider that HIV fear is present among many of us even when we are 100% safe, regardless of status. If PrEP can help positive and negative people feel safer and protected, then PrEP will have made a profound contribution to our emotional and physical well-being.

As anyone who has lived through the AIDS epidemic knows—when it comes to HIV there have been few “home runs.” Only a series of singles, doubles, and more than our fair share of foul balls. Truvada is not the one ring to rule them all. And yet it might still be a game-changer for some of us—if we understand that PrEP is not a replacement for common sense.

Side effects

Truvada has been around for over a decade, used along with other drugs by HIV-positive people to reduce their virus to undetectable levels. When used alone and not as part of a cocktail by HIV-negative men to prevent HIV transmission, side effects are rare and often go away in weeks. Most common side effects are an upset stomach or nausea. In rare cases, there are significant kidney issues, but these side effects are reversible for people who simply stop taking the drug.

Resistance

Drug resistance to antiretrovirals like Truvada is an important issue. In fact, it is the reason HIV-positive people are given a combination of drugs in order to prevent HIV from developing resistance and escaping the meds.

However, if you are negative, and stay negative, according to the scientific findings reviewed by the FDA, drug resistance is not a significant issue. You must have HIV in order to have drug resistance to HIV (the virus becomes resistant, not the people). Translation: An HIV-negative person can go on or off Truvada during periods of their life when they are more or less sexually active. However, if someone is taking too little Truvada (less than recommended) and becomes infected, or is HIV-positive but does not know it when he begins taking PrEP, the virus could theoretically develop resistance to one or both of the drugs in Truvada.

In the clinical trial data reviewed by the FDA there was no evidence that an HIV-negative person developed resistance to both of the drugs in Truvada after taking it for prevention. It seems that resistance is not as serious an issue as people seem to think. At least not yet.

Mr. McConnell suggested that someone could even take a daily dose once a day for at least a week prior to a potential exposure (e.g., a “party” weekend) and continue daily dosing throughout the month to get good protection against the virus. “As long as you stay negative,” he told me, “there is little problem going on or off the drug. You just need to test negative again before going back on.”

A tipping point

Price and access issues have yet to be resolved. Most insurance companies appear to be covering Truvada and drug companies may not want to risk the potential negative publicity associated with denying a breakthrough drug to at-risk populations. But there is also the issue of those most vulnerable in our community who do not have insurance and are unable to get access through another avenue. [Editor’s note: Gilead, the maker of Truvada, has a patient assistance program for those who don’t have insurance and meet eligibility requirements.]

Truvada appears to be a powerful new weapon in our fight against HIV. You may still be skeptical of this strategy. You may still have fears around resistance, side effects, abuse, misuse and access. There is much we still need to learn about PrEP. And yet, how many more 24 year-olds need to get HIV before we are willing to consider that PrEP could be a viable part of a larger safer sex movement? I am optimistic that if we are willing to look at this new strategy without prejudice and judgment we may be able to radically change the trajectory of new transmissions, as our queer brothers and sisters historically did in the 1980s. Perhaps with PrEP we can better protect the young men in their late teens and 20s (like my friend) and minority gay men who represent the largest and fastest growing segment of new HIV infections in the U.S. We could make history once again. 

What is PrEP?:
www.cdc.gov/hiv/prep

Interim guidance on PrEP for your doctor:
www.cdc.gov/mmwr/preview/mmwrhtml/mm6003a1.htm?s_cid=mm6003a1_w

Truvada website:
www.truvada.com

HuffPost Live segment “A Pill to Save Lives,” hosted by Alicia Menendez. Guests: Carl Sandler; Damon Jacobs, licensed marriage and family therapist at Private Practice Psychotherapy; Jeff McConnell, sociologist and iPrEx investigator; Robert Grant, iPrEx protocol chair; Tom Myers, chief of public affairs and general counsel for the AIDS Healthcare Foundation: live.huffingtonpost.com/r/segment/hiv-prevention-pill/5097f52802a7605939000154

The iPrEx Primary Report
www.nejm.org/doi/pdf/10.1056/NEJMoa1011205

“Emtricitabine-Tenofovir Concentrations and Pre-Exposure Prophylaxis Efficacy in Men Who Have Sex with Men” Science Translational Medicine:
www.ghdonline.org/uploads/Sci_Transl_Med-2012-Anderson-151ra125.pdf

“Preexposure chemoprophylaxis for HIV prevention in men who have sex with men.”  The New England Journal of Medicine:
www.nejm.org/doi/full/10.1056/NEJMoa1011205


CARL SANDLER has a degree in economics from Stanford University. He has spent the last 15 years designing, building, and using technology that helps gay men meet, first at Gay.com (later Planet Out Partners); then as Founder of Daddyhunt.com, a site for older guys; and most recently with the MISTER dating app. A version of this article originally appeared in the Gay Voices section of the Huffington Post.

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