Carl Sandler: A Pill to Prevent HIV

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. It’s a pill to prevent HIV transmission. Like most people I know, he hadn’t ever heard about PrEP and didn’t understand that 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 percent. Researchers have estimated that for gay men, taking Truvada daily (7 pills per week) may be 99-percent effective; four pills a week might be as good as consistent condom use (96 percent).

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 piece 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 percent of the U.S. population, account for over 60 percent 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 that 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 because there are real limits to what PrEP can and cannot do. PrEP is not a vaccine that can give you 100-percent protection. It is not a Viagra-type pill that can be taken 15 minutes before intercourse. It is not a cure for HIV. And it cannot protect you against hepatitis C, herpes, syphilis, chlamydia or gonorrhea. But 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 percent of the time. Do you? Like anything we try to do 100 percent of the time, it’s actually human to be less than 100-percent. That being said, I am continually amazed by how many presumably HIV-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.

When it comes to 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 (pre-exposure prophylaxis) and PEP (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 than condoms; it is simply 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 sero-discordant 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 percent of the time, would benefit. 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 room.

PrEP vs. Condoms

A new ad campaign from prepfacts.org eloquently proclaims: “Love may have another protector.” 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 despite the fact that it does not provide all the same protections.

I spoke with Jeff McConnell of the Gladstone Institutes, a sociologist on the trial that demonstrated Truvada’s effectiveness 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 with regard to HIV.

It has 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 once they start taking the drug, risks they would not have taken otherwise. I understand these fears, and I share them. But so far there isn’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 fear and shame associated with HIV is both liberating — and scary.

The epidemic has traumatized us through loss of our loved ones, and that trauma is evident in our shame around the disease, and in our prejudices against our HIV-positive brothers and sisters. 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 drug.

PrEP has the potential to liberate us, because it gives gay men who have managed to stay HIV-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-percent safe, regardless of status. If PrEP can help HIV-positive and HIV-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, but 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 anti-retrovirals 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 HIV-negative and stay HIV-negative, then 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 HIV-positive but does not know it when he begins taking PrEP, the virus could develop resistance (which happened in the trials), or if he is taking too little Truvada (less than recommended) and becomes infected, 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 and then seroconverting. 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 in our community most vulnerable who do not have insurance and are unable to get access through another avenue.

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.