The Other “Little Blue Pill”

Cathy Spencer, PharmD, BCPS, AAHIVP

 What is PrEP?
HIV Pre-Exposure Prophylaxis, better known as PrEP, is when antiretroviral drugs are used to prevent HIV. The only FDA-approved drug for PrEP currently is Truvada®, which contains two antiretrovirals—tenofovir and emtricitabine. PrEP has also been referred to as “The Prevention Pill” because it is the only pill proven to prevent HIV infection when taken daily, as well as “The Other Little Blue Pill”… well, because it is in fact, a little blue pill.
Who needs PrEP?
There are three main populations of people that the Centers for Disease Control and Prevention (CDC) recommend to have PrEP: sexually active men who have sex with men and transwomen who have sex with men, sexually active heterosexual men and women, and persons who inject drugs. Among these populations, PrEP is only recommended for those considered to be at “substantial risk” for HIV infection.
Examples of “Substantial Risk”:  
PrEP is also one of several prevention strategies available for serodiscordant couples trying to conceive.
How effective is PrEP?
Results from trials assessing the efficacy of PrEP have one central theme—when patients take PrEP every day and are adherent to it (don’t miss doses), PrEP works. In trials, the level of protection has ranged from no significant protection at all, up to 100% effective; evidence shows that the effectiveness of PrEP at reducing HIV transmission is greatly dependent on whether or not patients were adherent to the drug.
The iPrEX OLE study evaluated daily Truvada use in men who have sex with men and a small population of transwomen and found no new HIV infections in patients taking at least four tablets per week.  Those taking only two doses per week had no significant reduction in HIV risk, which demonstrates the importance of adherence to PrEP.
Simply put, PrEP works when you take it. When you start missing doses, it doesn’t work.
Does PrEP work in the “Real World”?
Sure, PrEP has worked in controlled clinical trials, but does it work in the “Real World”? So far, studies suggest it does, and it works well. The PROUD study found a 86% relative risk reduction in new HIV infections for men who have sex with men who were on PrEP.
Since implementation of three PrEP clinics in San Francisco, rates of new HIV diagnoses dropped approximately 40% and are now the lowest ever recorded numbers in San Francisco since the beginning of the HIV/AIDS epidemic. This correlation is confounded by many possible factors and cannot be fully attributed to PrEP; however, it is very possible that PrEP played a significant role in reducing San Francisco’s HIV incidence rate.
What are the side effects of PrEP?
The most common side effects of Truvada are nausea, fatigue, and headache, which usually go away within the first few weeks. Truvada has been known to negatively affect kidney function and cause decreases in bone mineral density in patients with HIV; therefore, it requires monitoring of kidney function tests and screening for osteoporosis risk factors. Thus far studies have not shown these side effects to be common or significant in people without HIV using it as PrEP.  Truvada has been used for many years to treat HIV, but has only been FDA-approved for PrEP since 2012.  Therefore, the evidence is limited regarding long-term side effects of PrEP.
#TruvadaWhore… What’s That All About?
This term, #TruvadaWhore, was first coined by a David Duran, freelance writer, as a derogatory term, implying that men who use PrEP are doing so just so they can engage in “barebacking” (condomless anal sex). Many people worry that the use of PrEP will increase risky behavior. The concern is that patients on PrEP may choose to stop using condoms since they are no longer afraid of HIV; since PrEP only protects against HIV, these patients may be at increased risk of other sexually transmitted infections (STIs), such as gonorrhea, chlamydia, or syphilis. Thus far, there is no data to support this concern. The PROUD study found a high rate of STIs in those using PrEP; however, they also found a high rate of STIs in patients not using PrEP. Data from PrEP clinics around the nation suggest that most patients do not use PrEP so they can stop using condoms—they use PrEP because they weren’t using condoms in the first place.
Almost two years later David Duran issued another article titled “An Evolved Opinion on Truvada”, and changed the implications of this previously derogatory term. He redefined #TruvadaWhore to refer to someone who is a supporter of PrEP use. While the evolution of this term is a step in the right direction, there is still a significant amount of stigma associated with PrEP.
For years we have fought the stigma of HIV, and now we fight the stigma of PrEP. As a society, we need to remember that the fight is against HIV—not persons living with HIV, and not the method of protection. We shame those with HIV and we shame those trying to protect themselves from infection. It has to stop.
How do I pay for PrEP?
Many insurance companies cover Truvada for PrEP, but some do not. Co-pay assistance is available through Gilead Advancing Access, Patient Advocate Foundation, and Patient Access Network Foundation. The Gilead Medication Assistance Program is a great resource for patients without insurance.
As a pharmacist, I spend a lot of time helping patients overcome the financial obstacles of PrEP.  My best advice is to jump through the hoops one at a time—be persistent. Your health is worth the work and the wait.
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