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PrEParing for Controversy: Understanding the Limitations of Pre-exposure Prophylaxis

The history of the HIV/AIDS epidemic is marked by devastating losses and a disease burden that persists to this day. Though slow to emerge, both government policy and pharmaceutical research began to address the epidemic, and the resulting combinations of antiretroviral cocktails and outreach programs have helped make HIV infection a manageable, if inconvenient, chronic condition.

In 2012, however, the FDA approved a drug that had the potential to shift both the American and global strategies regarding HIV and AIDS. This drug, a mix of emtricitabine and tenofovir disoporixil fumarate, was produced by the pharmaceutical company Gilead and went by the name of Truvada. A pre-exposure prophylaxis, or PrEP, Truvada was designed to be taken by HIV-negative individuals to prevent contraction of HIV. What was once the world’s most insidious infection now had a pharmacological method of prevention — a literal “magic pill.”

Almost immediately, public health agencies and non-profit organizations began investigating PrEP’s potential — including its economic feasibility as a public health strategy, its usefulness among serodiscordant couples and its cultural impact among high-risk communities. At the same time, PrEP became a flashpoint in larger cultural conversations surrounding safe sex and risky behaviors. Most notably, Harvey Weinstein, the president of the AIDS Foundation, came out against PrEP as a preventive tool. In a New York Times editorial, Weinstein expressed skepticism that “[HIV-]negative men [will] take this medication every day” and openly worried that the drug would contribute to a culture of complacency and unprotected sex among the young gay men who “didn’t live through the holocaust of the [AIDS Epidemic].” Weinstein’s opinion was, and remains, controversial, even as PrEP continues to gain ubiquity in clinics around the country and around the world.

However, understanding PrEP’s potential as both a clinical and cultural force in the United States requires understanding the perspectives that regard it with a suspicious eye. Though Weinstein’s platform and specific portrayal of young gay men as complacent and irresponsible makes him one of PrEP’s more visible — and less nuanced — critics, he is not the drug’s only skeptic. Indeed, those wary of PrEP come from a variety of vantage points — some behavioral, some economic and some biochemical.

Though Weinstein’s reductionist approach to PrEP has made him somewhat of a pariah in certain AIDS activism circles, other journalists have linked the recent rise in STI incidence, particularly syphilis, among gay and bisexual men to the drug. Clinical researchers have also made this connection. A 2015 study published in Clinical Infectious Diseases, for example, followed men who have sex with men (MSM) taking PrEP for three years. Study participants had a higher rate of STI incidence compared to established controls, and 41 percent reported a decrease in their condom usage. More recently, a meta-analysis performed by Noah Kojima, Dvora Davey, and Jeffrey Klausner of UCLA examined 18 different studies pertaining to MSM. Though the studies used cannot be directly compared because the researchers did not correct for baseline risk of STI infection, they clearly established that those on PrEP were significantly more likely to acquire chlamydia, gonorrhea and syphilis than their counterparts not using PrEP. While concerning, it is important to note that these findings are not linked to the type of erratic PrEP use Weinstein described in his editorial. Rather, they are linked to behavioral changes accompanying a PrEP regimen. In fact, there were actually no new cases of HIV among PrEP users despite the decreased condom use, emphasizing the level of adherence to the drug.

Instead of taking these statistics as evidence enough to reject PrEP, many public health workers have instead incorporated them into more nuanced, integrated approaches towards the drug’s roll-out. For example, Michael Anthony, the coordinator of a PrEP outreach program for underserved gay and bisexual men in Camden, NJ, emphasizes the importance of support sessions and counseling alongside the introduction of a PrEP regimen. Though his organization does not have the funding to provide PrEP to each patient, Anthony’s program identifies individuals at high-risk for HIV contraction, and helps them work with either their insurance or Gilead’s Advancing Access program to obtain the drug. After that, he supports and counsels each individual — sometimes for a few weeks, sometimes for several months. During a conversation I had with Anthony while researching this article, he explained that “the support sessions are essential … because they help [to] monitor the patient and address unique problems and issues specific to them, including financial, housing, psychological and social issues.” Behavioral counseling is recommended by the United States Preventive Services Task Force due to its effectiveness in decreasing risk for STIs, and its incorporation into a PrEP roll-out program serves a similar function.

Unfortunately, PrEP’s increasing availability has not necessarily increased its affordability or accessibility. In fact, in their evaluation of the barriers to PrEP usage among young men who have sex with men, Bauermeister et al. found that young men who have sex with men (YMSM) believed they could not afford both the medication and the associated toxicology screenings. Without adequate funding, PrEP (which can cost $13,000 a year) will only be accessible to those with the best private insurance. Though certain programs, including Medicaid, some state-funded programs and Gilead’s aforementioned Advancing Access program have helped increase access to PrEP, the drug is still unavailable to many; this could worsen what many activists have noted to be an increasing class stratification among the LGBT community in the wake of legal victories such as marriage equality. One solution to increase PrEP’s accessibility is for Gilead to simply reduce the cost of the drug. That, however, is unlikely. For now, the solution seems to lie in the public and private programs working towards making PrEP accessible despite its high price. However, in order to be as effective as possible, these programs need to be widespread, firmly established and well-marketed.

Though sharp and incisive, the behavioral and economic criticisms of PrEP are by no means a death knell for the drug. If anything, they help identify disparities, and contribute to more effective efforts to increase access to and responsible use of the drug. The prospect of PrEP-resistant strains of HIV, meanwhile, are much harder to address. Given PrEP’s increasing ubiquity, and disturbing trends indicating reduced condom use among those using the drug, the potential of a PrEP-resistant strain of HIV is troubling. In fact, the previously mentioned three-year study estimated that, if the conditions of their study were the same but PrEP was not as effective, the incidence of new HIV cases among their cohort could have been 8.9 per 100 person-years.

The possibility of a resistant strain of HIV has been a consideration since PrEP’s approval. In fact, when the World Health Organization began recommending PrEP for men who have sex with men and other group at risk for HIV infection, they included a stipulation that those already infected with the virus should avoid the drug in order to minimize nonprophylactic interaction between the virus and the drug. However, even those efforts may have been in vain. An abstract presented at the 2016 Conference on Retroviruses and Opportunistic Infections reported an HIV infection despite successful PrEP use. According to the researchers, this is the first known instance of HIV infection despite evidence of long-term adherence to PrEP. It is worth watching whether PrEP resistant-strains of HIV will emerge to become a major public health concern — much like MRSA or antibiotic-resistant gonorrhea. But in the meanwhile, such an instance emphasizes the importance of pairing PrEP with other preventive measures, particularly condom use.

As a public health solution, PrEP is far from perfect. Though the drug reduces HIV transmission to near-zero, the accompanying reduction in condom use places those on the drug at a higher risk for other STIs, particularly chlamydia, gonorrhea and syphilis. At the same time, PrEP’s relative unaffordability hinders its accessibility, particularly among communities who would benefit most from its rollout. Though both of these concerns can be alleviated by revamped approaches to the drug’s rollout and administration, they pale in comparison to the prospect of a drug-resistant strain of HIV. In spite of Truvada’s potential, understanding and addressing its limitations — both in the lab and in clinical practice — is essential to preventing complacency in the face of HIV and its tortured, problematic history. Though PrEP marks a much-needed victory in the fight against HIV/AIDS, it is just that. The war against the disease has yet to be won.

Neepam Shah Neepam Shah (3 Posts)


Rowan University School of Osteopathic Medicine

Neepam Shah is a New Jersey-based osteopathic medical student interested in Netflix binges, Spotify's eclectic recommendations, and examining the power structures and cultural trends that shape lived experiences. When he's not in class, you can find him in a Philadelphia coffee shop over-caffeinating and procrastinating.