HIV Pre-Exposure Prophylaxis (PrEP)
(modified August 2024)
Use this checklist to identify high-risk patients and safely prescribe and monitor HIV PrEP therapy.
Goal |
Suggested Approach |
Identify potential candidates |
|
Screen potential candidates |
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Be familiar with possible HIV PrEP regimens |
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Consider high-risk behaviors |
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Consider kidney function |
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Consider pregnancy and breastfeeding status |
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Consider drug-drug interactions |
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Consider cost |
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Determine if on-demand oral PrEP is an option |
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Monitor patients receiving oral PrEP |
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Monitor patients receiving injectable cabotegravir for PrEP |
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Counsel patients |
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Help patients afford PrEP |
|
- Oral cabotegravir (Vocabria, Apretude [Canada]) is FDA- and Health Canada-approved to treat HIV (in combination with rilpivirine). It is also approved for short-term PrEP as optional lead-in therapy prior to the first cabotegravir injection or as temporary coverage (up to two months) for patients receiving injectable cabotegravir if an injection is to be intentionally missed.27-29
Abbreviations: CrCl = creatinine clearance; HIV = human immunodeficiency virus; IV = intravenous; PrEP = pre-exposure prophylaxis; STI = sexually transmitted infection.
Levels of Evidence
In accordance with our goal of providing Evidence-Based information, we are citing the LEVEL OF EVIDENCE for the clinical recommendations we publish.
Level |
Definition |
Study Quality |
A |
Good-quality patient-oriented evidence.* |
|
B |
Inconsistent or limited-quality patient-oriented evidence.* |
|
C |
Consensus; usual practice; expert opinion; disease-oriented evidence (e.g., physiologic or surrogate endpoints); case series for studies of diagnosis, treatment, prevention, or screening. |
*Outcomes that matter to patients (e.g., morbidity, mortality, symptom improvement, quality of life).
[Adapted from Ebell MH, Siwek J, Weiss BD, et al. Strength of Recommendation Taxonomy (SORT): a patient-centered approach to grading evidence in the medical literature. Am Fam Physician 2004;69:548-56. https://www.aafp.org/afp/2004/0201/p548.pdf.]
References
- Riddell J 4th, Amico KR, Mayer KH. HIV preexposure prophylaxis: a review. JAMA 2018;319:1261-8.
- Clinical Pharmacology powered by ClinicalKey. Tampa (FL): Elsevier. 2022. http://www.clinicalkey.com. (Accessed January 20, 2022).
- CDC. US Public Health Service. Preexposure prophylaxis for the prevention of HIV infection in the United States – 2021 update. https://www.cdc.gov/hiv/pdf/risk/prep/cdc-hiv-prep-guidelines-2021.pdf. (Accessed January 20, 2022).
- Landovitz RJ. Donnell D, Clement ME, et al. Cabotegravir for HIV prevention in cisgender men and transgender women. N Engl J Med 2021;385:595-608.
- Tan DHS, Hull MW, Yoong D, et al. Canadian guideline on HIV pre-exposure prophylaxis and nonoccupational postexposure prophylaxis. CMAJ 2017;189:E1448-58. [Erratum CMAJ 2018;190:E782].
- Silapaswan A, Krakower D, Mayer KH. Pre-exposure prophylaxis: a narrative review of provider behavior and interventions to increase PrEP implementation in primary care. J Gen Intern Med 2017;32:192-8.
- University of California, San Francisco. CROI 2013 national perinatal HIV hotline lunch discussion. PrEP & Women: pregnancy, breastfeeding, implementation. http://nccc.ucsf.edu/wp-content/uploads/2014/04/Women_PrEP_CROI_2013_Discussion.pdf. (Accessed January 20, 2022).
- Product information for Truvada. Gilead Sciences. Foster City, CA 94404. June 2020.
- Product monograph for Truvada. Gilead Sciences. Mississauga L5N 2W3. July 2018.
- Chou, R, Evans C, Hoverman A, et al. Preexposure prophylaxis for the prevention of HIV infection: evidence report and systematic review for the US Preventive Services Task Force. JAMA 2019;321:2214-30.
- Medication pricing by Elsevier, accessed January 2022 (for US pricing).
- Molina JM, Capitant C, Spire B, et al. On-demand preexposure prophylaxis in men at high risk for HIV-1 infection. N Engl J Med 2015;373:2237-46.
- NIH. Drug and lactation database (LactMed). June 15, 2020. https://www.ncbi.nlm.nih.gov/books/NBK501548/. (Accessed January 20, 2022).
- US Preventive Services Task Force, Owens DK, Davidson KW, et al. Preexposure prophylaxis for the prevention of HIV infection: US Preventive Services Task Force recommendation statement. JAMA 2019;321:2203-13.
- Mayer KH, Molina JM, Thompson MA, et al. Emtricitabine and tenofovir alafenamide vs emtricitabine and tenofovir disoproxil fumarate for HIV pre-exposure prophylaxis (DISCOVER): primary results from a randomised, double-blind, multicentre, active-controlled, phase 3, non-inferiority trial. Lancet 2020;396:239-54.
- FDA. FDA briefing document. Meeting of the Antimicrobial Drugs Advisory Committee. August 7, 2019. https://www.fda.gov/media/129607/download. (Accessed January 20, 2022).
- Product information for Descovy. Gilead Sciences. Foster City, CA 94404. January 2022.
- Product monograph for Descovy. Gilead Sciences Canada. Mississauga, ON L5N 2W3. November 2020.
- FDA. FDA news release: FDA approves second drug to prevent HIV infection as part of ongoing efforts to end the HIV epidemic. October 3, 2019. https://www.fda.gov/news-events/press-announcements/fda-approves-second-drug-prevent-hiv-infection-part-ongoing-efforts-end-hiv-epidemic. (Accessed January 20, 2022).
- FDA. Food and Drug Administration Center for Drug Evaluation and Research. Final summary minutes of the Antimicrobial Drugs Advisory Committee Meeting. August 7, 2019. https://www.fda.gov/media/131002/download. (Accessed January 20, 2022).
- CDC. PrEP effectiveness. May 13, 2021. https://www.cdc.gov/hiv/basics/prep/prep-effectiveness.html. (Accessed January 20, 2022).
- Hughes C, Yoong D, Giguere P, et al. Canadian guideline on HIV preexposure prophylaxis for pharmacists. Can Pharm J (Ott) 2019;152:81-91.
- Workowski KA, Bachmann LH, Chan PA, et al. Sexually transmitted infections treatment guidelines, 2021. MMWR Recomm Rep 2021;70:1-187.
- Clinicalinfohiv.gov. Recommendations for the use of antiretroviral drugs in pregnant women with HIV and interventions to reduce perinatal HIV transmission in the United States. Pre-exposure prophylaxis (PrEP) to reduce the risk of acquiring HIV during preconception, antepartum, and postpartum periods. December 30, 2021. https://clinicalinfo.hiv.gov/en/guidelines/perinatal/prep. (Accessed January 20, 2022).
- US Department of Labor. FAQs about Affordable Care Act implementation part 47. July 19, 2021. https://www.dol.gov/sites/dolgov/files/EBSA/about-ebsa/our-activities/resource-center/faqs/aca-part-47.pdf. (Accessed January 20, 2022).
- CDC. HIV: on-demand PrEP. December 10, 2021. https://www.cdc.gov/hiv/basics/prep/on-demand-prep.html. (Accessed January 20, 2022).
- Product information for Apretude. ViiV Healthcare. Research Triangle Park, NC 27709. December 2021.
- Product information for Vocabria. ViiV Healthcare. Research Triangle Park, NC 27709. December 2021.
- Product monograph for Apretude. ViiV Healthcare. Montreal, QC H3C 2N6. May 2024.
Cite this document as follows: Clinical Resource, HIV Pre-Exposure Prophylaxis (PrEP). Pharmacist’s Letter/Prescriber’s Letter. February 2022. [380204]
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