Target Audience:

Who should attend:

• Clinical faculty from the University of Pittsburgh School of Pharmacy
• Clinical staff pharmacists employed by the University of Pittsburgh Medical Center and deployed throughout the hospital campus in unit based roles and centrally in the department of pharmacy's main pharmacy
• Student pharmacy interns currently working within the department of pharmacy
• Certified Pharmacy Technicians

Abstract
Human Immunodeficiency Virus (HIV) Pre-exposure prophylaxis (PrEP) has demonstrated efficacy in reducing the rate of HIV infection in key high risk populations including men who have sex with men, transgender people, high risk women and men in serodiscordant relationships, people who engage in transactional sex, and people who inject drugs. The growing body of evidence supports the use of tenofovir disoproxil fumarate with or without emtricitabine in daily and on demand dosing as the antiretroviral of choice for pre-exposure prophylaxis. Tenofovir disoproxil fumarate is a prodrug that is rapidly converted to the active metabolite tenofovir, in plasma reaching high plasma concentrations plasma and in CD4+ cells to prevent HIV infection. However, concerns of adverse effects associated with tenofovir disoproxil fumarate including nephrotoxicity and decreased bone mineral density have lead to interest in other antiretrovirals that may have better adverse effect profiles.

Tenofovir alafenamide is an alternative prodrug of tenofovir that is metabolized in CD4+ cells reducing total systemic exposure to the active metabolite. Tenofovir alafenamide has a favorable side effect profile in regard to nephrotoxicity and bone mineral density compared to tenofovir disoproxil fumarate in the treatment of HIV+ patients. Preliminary results from a recent study on the safety and efficacy of tenofovir alafenamide and emtricitabine compared to tenofovir disoproxil fumarate and emtricitabine for PrEP calls into question whether tenofovir alafenamide based regimens should replace tenofovir disoproxil fumarate as first line therapy for PrEP in high risk populations.

Educational Objectives:

Upon successful completion of this continuing pharmacy education program, the participant should be able to:

• Define the clinical question discussed during this presentation.
• Discuss the current available literature to support or refute current clinical practice.
• Express a conclusion and/or recommendation for addressing the clinical question.

Pharmacy Continuing Education Credits This program is sponsored by the University of Pittsburgh Center for Continuing Education in the Health Sciences. The University of Pittsburgh Center for Continuing Education in the Health Sciences is accredited by the Accreditation Council for Pharmacy Education (ACPE) as a Provider of continuing pharmacy education. The assigned universal program number(s) is JA4008223-0000-23-065-H02-P This module is a webcast of an ACPE approved live presentation. The minimum credit awarded for this module (1 contact hour) is determined by the length of the entire live presentation inclusive of the post-test.

Suggested Additional Reading:

1. Centers for Disease Control and Prevention (CDC). Diagnoses of HIV Infection in the United States and Dependent Areas, 2018. CDC website. https://www.cdc.gov/hiv/pdf/library/reports/surveillance/cdc-hiv-surveillance-report-2018-vol-30.pdf.
2. Phanuphak, Nittaya, and Roy M. Gulick. "HIV treatment and prevention 2019: current standards of care." Current Opinion in HIV and AIDS 15.1 (2020): 4-12.
3. Chou, Roger, et al. "Preexposure prophylaxis for the prevention of HIV infection: evidence report and systematic review for the US Preventive Services Task Force." Jama 321.22 (2019): 2214-2230.
4. Atta, Mohamed G., Sophie De Seigneux, and Gregory M. Lucas. "Clinical Pharmacology in HIV Therapy." Clinical Journal of the American Society of Nephrology 14.3 (2019): 435-444.
5. Pantaleo, Giuseppe, Cecilia Graziosi, and Anthony S. Fauci. "The immunopathogenesis of human immunodeficiency virus infection." New England Journal of Medicine 328.5 (1993): 327-335.
6. Hall, Andrew M., et al. "Tenofovir-associated kidney toxicity in HIV-infected patients: a review of the evidence." American journal of kidney diseases 57.5 (2011): 773-780.
7. Gallant, Joel E., et al. "Efficacy and safety of tenofovir alafenamide versus tenofovir disoproxil fumarate given as fixed-dose combinations containing emtricitabine as backbones for treatment of HIV-1 infection in virologically suppressed adults: a randomised, double-blind, active-controlled phase 3 trial." The lancet HIV 3.4 (2016): e158-e165.
8. Saag MS, Benson CA, Gandhi RT, et al. Antiretroviral drugs for treatment and prevention of HIV infection in adults: 2018 recommendations of the International Antiviral Society-USA Panel. JAMA. 2018;320(4):379-396
9. Panel on Antiretroviral Guidelines for Adults and Adolescents. "Guidelines for the use of antiretroviral agents in adults and adolescents with HIV." (2019).U.S. Food and Drug Administration. FDA briefing document: meeting of the Antimicrobial Drugs Advisory Committee, August 7, 2019. Accessed at www.fda.gov/media/129607/download.
10. U.S. Food and Drug Administration. Descovy for HIV pre-exposure prophylaxis: Antimicrobial Drugs Advisory Committee meeting briefing document. 4 July 2019. Accessed at www.fda.gov/media/129609/download.