It’s been three years since the Food and Drug Administration approved PrEP (Pre-Exposure Prophylaxis) for use by HIV-negative individuals to prevent them from being infected with HIV.
When PrEP as treatment was first introduced, there was a great deal of excitement in the provider community, particularly among those of us who specialize in treating people with HIV and those at higher risk of contracting it. In its original clinical trials, PrEP showed remarkable efficacy as a prevention tool.
Earlier this month, researchers at Kaiser Permanente Medical Center in San Francisco released what I believe is the most compelling study yet on PrEP, which is also known by its brand name, Truvada. In the first “real world” study (meaning it wasn’t a clinical trial), their researchers followed more than 600 participants who take PrEP daily to prevent the virus. Ninety-nine percent of the people they studied were men who have sex with men. Their average age was 37. After two-and-a-half years, not a single person in the study had contracted HIV.
That’s zero HIV transmissions. Put simply, that is an amazing result. It certainly doesn’t mean that PrEP is foolproof protection against being infected with HIV, but it seems to be doing an incredibly effective job at keeping people negative.
What is Pre-Exposure Prophylaxis?
“Prophylaxis” means “to prevent or control the spread of an infection or disease” — that’s why condoms are sometimes referred to as prophylactics.
Truvada is the brand name of the pill that acts as “PrEP” by effectively preventing HIV infection in an HIV-negative individual, when taken every day. It is also a combination pill used to treat people who already have HIV. PrEP is a way for people who don’t have HIV to take an active role in preventing HIV infection by taking a pill every day.
PrEP, or Truvada, is a single pill that contains two medicines, tenofovir and emtricitabine, that have been used for years in combination with other medicines, to treat HIV. If you’re taking PrEP regularly and you are exposed to HIV either through sex or injection-drug use, these medicines can work to keep the HIV virus from establishing a permanent infection in your body. It works by blocking the virus from being able to make more of itself, which in turn keeps an exposure to HIV from becoming an HIV infection.
PrEP is a truly powerful HIV-prevention tool, but it’s important to note that this drug is only as effective as the person taking it — following the regimen is extremely important, in order to ensure its effectiveness. There are some possible side effects, which means you must be monitored by a clinician if you are going to take PrEP. It is also important to note that PrEP doesn’t prevent other kinds of sexually transmitted infections, so condoms are still important to protect against those.
At Mazzoni Center, the number of patients we treat who have chosen to start PrEP has grown dramatically in the past year, from about 75 to 270. (That doesn’t account for people who may have already been taking PrEP when they came to our practice). For those who don’t have HIV but have a partner who does, PrEP has had an especially powerful impact.
Most private insurances and Pennsylvania Medicaid cover the medication, but without insurance the drug runs about $1,300 a month. However, not having health insurance does not mean you can’t find another way to access this treatment. At Mazzoni Center we have a case-management team that helps patients navigate the manufacturer’s program that provides the drug to the uninsured.
Getting the word out
We know that many men who have sex with men are reluctant to talk with their provider about HIV risk, and there are some providers who wouldn’t understand the concept of prescribing antiretroviral medication (which is what PrEP is made of) to someone who is not infected with HIV. Unfortunately this kind of stigma and/or misconception can have a dramatic impact on who learns about PrEP and who gets access to it. A 2012-13 survey (supported by the NIH) of young single men who have sex with men showed that just 27 percent had heard about Truvada and fewer than 3 percent were taking it.
There’s a lot of work to be done in training primary-care clinicians about PrEP as well as better educating the community. Primary-care clinicians are much more likely to see HIV-negative patients and have the opportunity discuss safer sex.
It is essential that providers create relationships with their patient where they feel they can be honest about very personal behavior. I’ve had several patients tell me that they had asked a non-Mazzoni provider about PrEP, only to be told no. Some providers claim they don’t know how to effectively prescribe or monitor the drug. Unfortunately, some providers also create a lot of shame surrounding the patient’s sexuality or sexual practices.
In the wake of its FDA approval back in 2012, there was concern from some corners of the medical establishment, and even from some people within the LGBT community, about PrEP. Some predicted it would usher in an era of “reckless” promiscuity, others feared it would lead to a decrease in condom use or an increase in the incidence of other (non-HIV) sexually transmitted infections.
As medical providers, it is not our role to police or judge a patient’s sexual behavior. Our imperative should be to educate and inform our patients, to listen to them without judgment and to offer the most appropriate advice to help patients achieve the best possible health outcomes.
Given the remarkable effectiveness PrEP has shown, and the underlying goal we all have of preventing HIV infection, this is a tool that all providers should be talking about with their patients who may be at risk. I believe it’s our role to help educate patients about the protection it can offer, and whether or not it’s right for them.
Robert J. Winn, MD, is medical director at Mazzoni Center.