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pre-exposure HIV prophylaxis

Indications: - multiple sexual partners in a population with annual HIV incidence >= 2% [14] - sexually active men who have sex with men not in a monogamous relationship - seronegative patients whose HIV-infected partners have not achieved viral suppression [14] - injection drug users who share needles [5,6] - not cost-effective for injection drug users in general [13] - heterosexually active adults who rarely use condoms during sex with high-risk partners of unknown HIV status [6] - postexposure prophylaxis more than twice in the past year [8] Contraindications: - breast-feeding [4] Benefit/risk: - NNT = 13 for daily tenofovir-emtricitabine to prevent 1 HIV1 infection in men who have sex with men [10] - no serious treatment-related adverse events observed [10] - pre-exposure prophylaxis among men who have sex with men in New South Wales Australia reduced new HIV infections [18] Laboratory: - HIV test prior to beginning pre-exposure HIV prophylaxis & every 3 months [4,6] - those who acquire HIV1 should discontinue pre-exposure prophylaxis & begin treatment of HIV1 - HIV-1 RNA [27] - pregnancy test for women at each follow-up visit - screen for other STDs Complications: - pre-exposure HIV prophylaxis (PrEP) appears to be associated with increased risk sexually transmitted infections chlamydia, gonorrhea, & syphilis Management: - chemoprophylaxis - tenofovir disoproxil fumarate/emtricitabine (TDF/FTC, Truvada, Descovy) - cost effectiveness of emtricitabine/tenofovir disoproxil fumarate (FTC/TDF) vs emtricitabine/tenofovir alafenamide (FTC/TAF) discussed [24] - emtricitabine/tenofovir alafenamide for women & injection drug users unknown [12] - has not been studied in women who practice receptive vaginal sex - use emtricitabine/tenofovir disoproxil fumarate - once daily - may be 75% effective [1,2] - no more thn a 90 day supply [4] - may not be effective for women [1,2] - cabotegravir IM every 8 weeks - on demand schedule - 2 pills 2-24 hours before sex, 1 pill 24 hours after 1st dose, & a 4th pill 24 hours later [11] - requires knowing in advance when sex will occur - circumcision (voluntary) [8] - sexually active heterosexual males,particularly in areas with high prevalence of HIV - with men who have sex with men * general HIV precautions - safe sex & use of condoms Notes: - reduces risk of HSV2 infection & HIV1 infection in serodiscordant couples [7] - daily oral pre-exposure prophylaxis with tenofovir, tenofovir/emticitabine &/or pericoital vaginal tenofovir gel ineffective in African women due to low compliance [9] - pre-exposure HIV prophylaxis associated with less condom use [16] - patients who acquire HIV1 infection during pre-exposure prophylaxis do not show resistance to tenofovir/emticitabine [17] - minorities underserved with pre-exposure HIV prophylaxis [19] - California allows pharmacists to dispense HIV prevention meds without prescription [22]

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post-exposure HIV prophylaxis

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prevention of HIV

References

  1. Grant RM et al. Preexposure chemoprophylaxis for HIV prevention in men who have sex with men. N Engl J Med 2010 Nov 23; PMID: 21091279 http://dx.doi.org/10.1056/NEJMoa1011205 - Michael NL. Oral preexposure prophylaxis for HIV - Another arrow in the quiver? N Engl J Med 2010 Nov 23; PMID: 21091280 http://dx.doi.org/10.1056/NEJMe1012929 - Prescriber's Letter 18(1): 2011 Truvada for Pre-Exposure Prophylaxis of HIV Infection Detail-Document#: 270106 (subscription needed) http://www.prescribersletter.com - Centers for Disease Control and Prevention (CDC) Interim Guidance: Preexposure Prophylaxis for the Prevention of HIV Infection in Men Who Have Sex with Men Morbidity and Mortality Weekly Report (MMWR) January 28, 2011 / 60(03);65-68 PMID: 21270743 http://www.cdc.gov/mmwr/preview/mmwrhtml/mm6003a1.htm
  2. FHI statement on the FEM-PrEP HIV prevention study [press release]. Durham, NC: Family Health International; Apr 18 , 2011 http://www.fhi.org/en/AboutFHI/Media/Releases/FEM-PrEP_statement041811.htm
  3. Baeten JM et al. Antiretroviral prophylaxis for HIV prevention in heterosexual men and women. N Engl J Med 2012 Jul 11 PMID: 22784037 - Thigpen MC et al. Antiretroviral preexposure prophylaxis for heterosexual HIV transmission in Botswana. N Engl J Med 2012 Jul 11; PMID: 22784038 - Van Damme L et al. Preexposure prophylaxis for HIV infection among African women. N Engl J Med 2012 Jul 11 PMID: 22784040
  4. Centers for Disease Control and Prevention Interim Guidance for Clinicians Considering the Use of Preexposure Prophylaxis for the Prevention of HIV Infection in Heterosexually Active Adults MMWR. August 10, 2012 / 61(31);586-589 http://www.cdc.gov/mmwr/preview/mmwrhtml/mm6131a2.htm
  5. Choopanya K et al Antiretroviral prophylaxis for HIV infection in injecting drug users in Bangkok, Thailand (the Bangkok Tenofovir Study): a randomised, double-blind, placebo-controlled phase 3 trial. The Lancet, Volume 381(9883), Pages 2083-2090, 15 June 2013 PMID: 23769234 http://www.thelancet.com/journals/lancet/article/PIIS0140-6736(13)61127-7/fulltext - Centers for Disease Control and Prevention (CDC) Update to Interim Guidance for Preexposure Prophylaxis (PrEP) for the Prevention of HIV Infection: PrEP for Injecting Drug Users. MMWR. June 14, 2013 / 62(23);463-465 https://mail.google.com/mail/u/0/?shva=1#inbox/13f425db09d8dfc1
  6. US Public Health Service Preexposure prophylaxis for the prevention of HIV infection in the United States - 2014 http://www.cdc.gov/hiv/pdf/prepguidelines2014.pdf
  7. Celum C et al Daily Oral Tenofovir and Emtricitabine - Tenofovir Preexposure Prophylaxis Reduces Herpes Simplex Virus Type 2 Acquisition Among Heterosexual HIV- - Uninfected Men and Women: A Subgroup Analysis of a Randomized Trial. Ann Intern Med. 2014;161(1):11-19 PMID: 24979446 http://annals.org/article.aspx?articleid=1884529
  8. Marrazzo JM et al HIV Prevention in Clinical Care Settings. 2014 Recommendations of the International Antiviral Society - USA Panel JAMA. 2014;312(4):390-409 PMID: 25038358 http://jama.jamanetwork.com/article.aspx?articleid=1889145 - Mathers BM and Cooper DA Integrating HIV Prevention Into Practice. JAMA. 2014;312(4):349-350 PMID: 25038352 http://jama.jamanetwork.com/article.aspx?articleid=1889112
  9. Marrazzo JM et al. Tenofovir-based preexposure prophylaxis for HIV infection among African women. N Engl J Med 2015 Feb 5; 372:509 PMID: 25651245 http://www.nejm.org/doi/full/10.1056/NEJMoa1402269
  10. McCormack S et al Pre-exposure prophylaxis to prevent the acquisition of HIV-1 infection (PROUD): effectiveness results from the pilot phase of a pragmatic open-label randomised trial. Lancet. Published Online: 09 September 2015 PMID: 26364263 http://www.thelancet.com/journals/lancet/article/PIIS0140-6736%2815%2900056-2/abstract
  11. Molina JM et al On-Demand Preexposure Prophylaxis in Men at High Risk for HIV-1 Infection. N Engl J Med 2015 Dec 3; 373:2237 PMID: 26624850 http://www.nejm.org/doi/full/10.1056/NEJMoa1506273 - Fauci AS, Marston HD Ending the HIV-AIDS Pandemic - Follow the Science. N Engl J Med. December 1, 2015 PMID: 26624554 http://www.nejm.org/doi/full/10.1056/NEJMp1502020 - Frieden TR et al Applying Public Health Principles to the HIV Epidemic - How Are We Doing? N Engl J Med. December 1, 2015 PMID: 26624243 http://www.nejm.org/doi/full/10.1056/NEJMms1513641
  12. Medical Knowledge Self Assessment Program (MKSAP) 17, 18, 19. American College of Physicians, Philadelphia 2015, 2018, 2021.
  13. Bernard CL, Brandeau ML, Humphreys K et al Cost-Effectiveness of HIV Preexposure Prophylaxis for People Who Inject Drugs in the United States. Ann Intern Med. Published online 26 April 2016 PMID: 27110953 http://annals.org/article.aspx?articleid=2517406 - Walensky RP Investing in People Who Inject Drugs: A PrEPonderance of Opportunities. Ann Intern Med. Published online 26 April 2016 PMID: 27111241 http://annals.org/article.aspx?articleid=2517408
  14. Gunthard HF et al Antiretroviral Drugs for Treatment and Prevention of HIV Infection in Adults. 2016 Recommendations of the International Antiviral Society. JAMA. 2016;316(2):191- PMID: 27404187 http://jama.jamanetwork.com/article.aspx?articleid=2533073 - Mayer KH, Krakower DS. Antiretrovirals for HIV Treatment and Prevention: The Challenges of Success. JAMA. 2016 Jul 12;316(2):151-153. PMID: 27404182 http://jama.jamanetwork.com/article.aspx?articleid=2533044
  15. Riddell J 4th, Amico KR, Mayer KH. HIV Preexposure Prophylaxis. A Review. JAMA. 2018;319(12):1261-1268 PMID: 29584848 https://jamanetwork.com/journals/jama/article-abstract/2676116
  16. Holt M, Lea T, Mao L et al Community-level changes in condom use and uptake of HIV pre- exposure prophylaxis by gay and bisexual men in Melbourne and Sydney, Australia: results of repeated behavioural surveillance in 2013-17. Lancet HIV. June 6, 2018 PMID: 29885813 https://www.thelancet.com/journals/lanhiv/article/PIIS2352-3018(18)30072-9/fulltext - Phanuphak N, Phanuphak P Time to focus more on condomless anal sex in non-PrEP users. Lancet HIV. June 6, 2018 PMID: 29885814 https://www.thelancet.com/journals/lanhiv/article/PIIS2352-3018(18)30100-0/fulltext
  17. Delaugerre C, Rodriguez C, Capitant C et al. Drug resistance among patients who acquired HIV infection in a PrEP trial. AIDS 2018 Aug 8; PMID: 30096070
  18. Grulich AE, Guy R, Amin J et al Population-level effectiveness of rapid, targeted, high-coverage roll-out of HIV pre-exposure prophylaxis in men who have sex with men: the EPIC-NSW prospective cohort study. The Lancet HIV. Oct 17, 2018 PMID: 30343026 https://www.thelancet.com/journals/lanhiv/article/PIIS2352-3018(18)30215-7/fulltext - McCormack S. What happens when PrEP is scaled up? Results from EPIC-NSW. The Lancet HIV. Oct 17, 2018 PMID: 30343027 https://www.thelancet.com/journals/lanhiv/article/PIIS2352-3018(18)30253-4/fulltext
  19. Huang YA, Zhu W, Smith DK, Harris N, Hoover KW. HIV Preexposure Prophylaxis, by Race and Ethnicity - United States, 2014-2016. MMWR Morb Mortal Wkly Rep 2018;67:1147-1150 https://www.cdc.gov/mmwr/volumes/67/wr/mm6741a3.htm
  20. US Preventive Services Task Force Preexposure Prophylaxis for the Prevention of HIV Infection: US Preventive Services Task Force Recommendation Statement. JAMA. 2019 Jun 11;321(22):2203-2213. PMID: 31184747 https://jamanetwork.com/journals/jama/fullarticle/2735509 - 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 Jun 11;321(22):2214-2230. PMID: 31184746 https://jamanetwork.com/journals/jama/fullarticle/2735508 - US Preventive Services Task Force Preexposure Prophylaxis to Prevent Acquisition of HIV. US Preventive Services Task Force Recommendation Statement. JAMA. 2023;330(8):736-745 PMID: 37606666 https://jamanetwork.com/journals/jama/fullarticle/2808514
  21. Traeger MW, Cornelisse VJ, Asselin J et al Association of HIV Preexposure Prophylaxis With Incidence of Sexually Transmitted Infections Among Individuals at High Risk of HIV Infection. JAMA. 2019;321(14):1380-1390 PMID: 30964528 https://jamanetwork.com/journals/jama/fullarticle/2730113 - Gandhi M, Spinelli MA, Mayer KH. Addressing the Sexually Transmitted Infection and HIV Syndemic. JAMA. 2019;321(14):1356-1358 PMID: 30964514 https://jamanetwork.com/journals/jama/fullarticle/2730096
  22. Associated Press. Oct 7, 2019 California OKs pharmacists to dispense HIV prevention meds. https://www.apnews.com/a1491134e0c242bc95ef36ed0a9fa95e
  23. FDA News Release. Oct 3, 2019 FDA approves second drug to prevent HIV infection as part of ongoing efforts to end the HIV epidemic. https://www.fda.gov/news-events/press-announcements/fda-approves-second-drug-prevent-hiv-infection-part-ongoing-efforts-end-hiv-epidemic
  24. Walensky RP, Horn T, McCann NC, Freedberg KA, Paltiel AD. Comparative pricing of branded tenofovir alafenamide-emtricitabine relative to generic tenofovir disoproxil fumarate-emtricitabine for HIV preexposure prophylaxis: A cost-effectiveness analysis. Ann Intern Med 2020 Mar 9; PMID: 32150602 https://annals.org/aim/article-abstract/2762726/comparative-pricing-branded-tenofovir-alafenamide-emtricitabine-relative-generic-tenofovir-disoproxil - del Rio C, Armstrong WS. How much are we willing to pay for preexposure prophylaxis in the United States? Ann Intern Med 2020 Mar 9; PMID: 32150617 https://annals.org/aim/article-abstract/2762809/how-much-we-willing-pay-preexposure-prophylaxis-united-states
  25. Saag MS, Gandhi RT, Hoy JF, et al Antiretroviral Drugs for Treatment and Prevention of HIV Infection in Adults. 2020 Recommendations of the International Antiviral Society-USA Panel. JAMA. Published online October 14, 2020 PMID: 33052386 https://jamanetwork.com/journals/jama/fullarticle/2771873 - Gandhi RT, Bedimo R, Hoy JF et al Antiretroviral Drugs for Treatment and Prevention of HIV Infection in Adults. 2022 Recommendations of the International Antiviral Society - USA Panel. JAMA. Published online December 1, 2022. PMID: 36454551 https://jamanetwork.com/journals/jama/fullarticle/2799240
  26. US Preventive Services Task Force Preexposure Prophylaxis to Prevent Acquisition of HIV: US Preventive Services Task Force Recommendation Statement. JAMA. 2023;330(8):736-745 PMID: 37606666 https://jamanetwork.com/journals/jama/fullarticle/2808514 - Chou R, Spencer H, Bougatsos C, Blazina I, Ahmed A, Selph S. Preexposure Prophylaxis for the Prevention of HIV: Updated Evidence Report and Systematic Review for the US Preventive Services Task Force. JAMA. 2023;330(8):746-763 PMID: 37606667 https://jamanetwork.com/journals/jama/fullarticle/2808515
  27. NEJM Knowledge+