Analysis of Healthcare Provider Associated Barriers to Using Pre-Exposure Prophylaxis Medications to Prevent Human Immunodeficiency Virus Infections in the United States

Research Article

Austin J Pharmacol Ther. 2017; 5(1).1090.

Analysis of Healthcare Provider Associated Barriers to Using Pre-Exposure Prophylaxis Medications to Prevent Human Immunodeficiency Virus Infections in the United States

Anderson JJ¹, Vandergon J² and Bastianelli KMS¹*

¹Department of Pharmacy Practice and Pharmaceutical Science, University of Minnesota College of Pharmacy, USA

²Positive Care Center at Hennepin, USA

*Corresponding author: Karen MS Bastianelli, Department of Pharmacy Practice and Pharmaceutical Sciences, University of Minnesota College of Pharmacy, USA

Received: January 14, 2017; Accepted: March 03, 2017; Published: March 06, 2017


Objective: Human Immunodeficiency Virus infections occur at high rates within at-risk populations in the United States. Men who have sex with men continue to bear the burden of new infections, with nearly 70% of new cases being transmitted through MSM contact, despite estimates of only 4% of the total population. A fixed dose combination of the antiretroviral drugs tenofovir and emtricitabine, was approved for use for pre-exposure prophylaxis (PrEP) in 2012. This paper looks to identify healthcare provider associated barriers to care.

Methods: A literature review using PubMed, Academic Search Premier, Ovid, and Google Scholar to identify peer-reviewed journals published between 2010 and present.

Results: Adherence, costs, antiviral resistance, perception of patient behavior and efficacy were barriers that were identified consistently throughout the research.

Discussion: The results reflect a need for additional education and training on behalf of healthcare providers. Identification and education to address these barriers will provide an opportunity for PrEP to become a more useful and utilized first line pharmacological therapy.

Keywords: Human immunodeficiency virus; World health organization; Pre-exposure prophylaxis; Food and drug administration



Human Immunodeficiency Virus (HIV) has played a significant role in healthcare within the United States and around the world since the early 1980’s. The World Health Organization (WHO) estimates there are 36.7 million people worldwide living with HIV, 2.1 million who were infected in 2015 alone [1]. The Centers for Disease control estimates that there were nearly 40,000 new infections within the United States in 2015 and that 1.2 million people currently are living with HIV; moreover, 1 in 8 (12.8%) are not aware of their status [2]. Despite an estimated $25 billion annual budget for domestic response to HIV within the United States [3], some groups continue to show an increase in new infections.

Men who have sex with men (MSM) continue to bear the burden of new infections, with nearly 70% of new cases being transmitted through MSM contact, despite estimates of comprising only 4% of the total population [4,5]. For 2014, nearly 30,000 new infections can be attributed to MSM and reflect a 21% increase compared to 2008 new infections [4,5]. Specific populations within the MSM grouping that are disproportionally affected include Black/African Americans (38%) accounting for the largest number of new infections among MSM, despite the fact that African Americans only account for roughly 12% of the population [4]. Furthermore, nearly 20% of the new infections affect youths ages 13-24; consequently all tools to help prevent the spread of HIV need to be considered [4].

Tenofovir and emtricitabine combination formulation was approved by the Food and Drug Administration (FDA) in 2004 for use in initial treatment plans of newly infected HIV patients. It is considered first line therapy agent for initiation of antiretroviral therapy in treatment naïve patients [7]. In July 2012, the FDA approved it for prophylactic use to prevent HIV infections. It should be noted that the press release specifically stated “Truvada in combination with safe sex practices for Pre-Exposure Prophylaxis (PrEP) to reduce the risk of sexually acquired HIV-1 in adults at high risk” highlighting that the use of PrEP should not be a replacement for other forms of prophylaxis [8].

The approval came on the heels of high profile clinical trials studying the safety and effectiveness of the drug used prophylactic ally. The pre-exposure prophylaxis initiative (iPrEx) trial found that new HIV infections rate in HIV-negative gay men was reduced by 44% when given the two drugs (tenofovir and emtricitabine) compared to placebo9. Moreover, the efficacy of the combination drug therapy increased to 73% in patients who took the drugs more than 90% of the time [9]. An important note to this study reflects that although 93% of the patients reported to taking the medication correctly, druglevel monitoring in blood accounted for only 51% actually doing so [9]. In addition, only 3 out of 34 (~9%) of the subjects who became infected had drug levels that were detectable in the blood or cells [9]. In an extension to this study, the iPreExOLE (Open Label Extension) showed even more promising results, specifically as it relates to adherence and efficacy. While the group taking PrEP had half as many HIV infections compared to the placebo group, efficacy increased as number of doses per week increased. In patients who took 2-3 doses a week, the efficacy increased to 84% while they saw no new infections in patients who took at least four doses a week [10]. Modeling work completed on the data gathered from these studies provides close to 100% protection of the HIV Virus when PrEP is taken every day [10]. Additionally, a Cochrane Database System Review published in 2012, found a 51% decrease in risk for contracting HIV among high-risk individuals when taking tenofovir/emtricitabine or tenofovir alone compared to placebo. (RR 0.51; 95% CI 0.30 to 0.86) [11]. Finally, results from a recently published study of men within the Kaiser Permanente healthcare system found no new HIV infections in the 657 members who used PrEP between 2012 and 2015 prophylactically [11].

Following the release of several clinical studies that measured the safety of PrEP, the US Public Health Service released the first comprehensive guidelines for PrEP in May 2014. The new guidelines provided clarification on identification of at-risk populations, as well as providing guidelines for prescribing and monitoring the therapy. These guidelines “recommend that PrEP be considered for people who are HIV-negative and at a substantial risk for HIV” [12]. The high-risk groups can be found in Table 1 within the Summary of 2014 CDC Guidelines section. Despite the recommendations, the number of patients being prescribed PrEP is thought to be extremely low. A 2014 survey completed by the Kaiser Family Foundation measured the attitudes and knowledge of gay men in the U.S. as it related to HIV therapies. Eight out of ten responders said they have heard little or nothing at all about PrEP, and only one out of ten responders knew someone who has taken PrEP [13]. A survey of physician members of the Infectious Diseases Society of America’s (ISDA) Emerging Infections Network indicated that only 9% have actually prescribed PrEP [23]. While it never has been considered a replacement for safe sex practices, substantial debate regarding the use of PrEP has ensued. Understanding what barriers exist within the at-risks groups will provide an opportunity to utilize the therapy going forward.

Pharmacology of tenofovir/emtricitabine

Understanding the specific properties and pharmacology of the medication is a factor that needs to be considered when thinking about potential barriers for care. Tenofovir is a nucleotide analog HIV-1 reverse transcriptase inhibitor and an HBV reverse transcriptase inhibitor [14]. It is an acyclic analog of adenosine monophosphate. Tenofovir Disoproxil Fumurate (TDF) is the prodrug that is provided in the formulation. Upon hydrolysis and subsequent phosphorylation, tenofovir diphosphate is formed [14] as reflected in Picture 1 [15].