pre-exposure HIV prophylaxis
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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
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
- 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
- tenofovir disoproxil fumarate/emtricitabine (TDF/FTC, Truvada, Descovy)
- 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
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]
More general terms
Additional terms
References
- ↑ 1.0 1.1 1.2 Grant RM et al. Preexposure chemoprophylaxis for HIV prevention in men who have sex with men. N Engl J Med 2010 Nov 23; <PubMed> PMID: https://www.ncbi.nlm.nih.gov/pubmed/21091279 <Internet> 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; <PubMed> PMID: https://www.ncbi.nlm.nih.gov/pubmed/21091280 <Internet> http://dx.doi.org/10.1056/NEJMe1012929
Prescriber's Letter 18(1): 2011 Truvada for Pre-Exposure Prophylaxis of HIV Infection Detail-Document#: http://prescribersletter.com/(5bhgn1a4ni4cyp2tvybwfh55)/pl/ArticleDD.aspx?li=1&st=1&cs=&s=PRL&pt=3&fpt=25&dd=270106&pb=PRL (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 <PubMed> PMID: https://www.ncbi.nlm.nih.gov/pubmed/21270743 <Internet> http://www.cdc.gov/mmwr/preview/mmwrhtml/mm6003a1.htm - ↑ 2.0 2.1 2.2 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
- ↑ Baeten JM et al. Antiretroviral prophylaxis for HIV prevention in heterosexual men and women. N Engl J Med 2012 Jul 11 PMID: https://www.ncbi.nlm.nih.gov/pubmed/22784037
Thigpen MC et al. Antiretroviral preexposure prophylaxis for heterosexual HIV transmission in Botswana. N Engl J Med 2012 Jul 11; PMID: https://www.ncbi.nlm.nih.gov/pubmed/22784038
Van Damme L et al. Preexposure prophylaxis for HIV infection among African women. N Engl J Med 2012 Jul 11 PMID: https://www.ncbi.nlm.nih.gov/pubmed/22784040 - ↑ 4.0 4.1 4.2 4.3 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
- ↑ 5.0 5.1 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 <PubMed> PMID: https://www.ncbi.nlm.nih.gov/pubmed/23769234 <Internet> 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 - ↑ 6.0 6.1 6.2 6.3 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
- ↑ 7.0 7.1 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 <PubMed> PMID: https://www.ncbi.nlm.nih.gov/pubmed/24979446 <Internet> http://annals.org/article.aspx?articleid=1884529
- ↑ 8.0 8.1 8.2 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 <PubMed> PMID: https://www.ncbi.nlm.nih.gov/pubmed/25038358 <Internet> http://jama.jamanetwork.com/article.aspx?articleid=1889145
Mathers BM and Cooper DA Integrating HIV Prevention Into Practice. JAMA. 2014;312(4):349-350 <PubMed> PMID: https://www.ncbi.nlm.nih.gov/pubmed/25038352 <Internet> http://jama.jamanetwork.com/article.aspx?articleid=1889112 - ↑ 9.0 9.1 Marrazzo JM et al. Tenofovir-based preexposure prophylaxis for HIV infection among African women. N Engl J Med 2015 Feb 5; 372:509 <PubMed> PMID: https://www.ncbi.nlm.nih.gov/pubmed/25651245 <Internet> http://www.nejm.org/doi/full/10.1056/NEJMoa1402269
- ↑ 10.0 10.1 10.2 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 <PubMed> PMID: https://www.ncbi.nlm.nih.gov/pubmed/26364263 <Internet> http://www.thelancet.com/journals/lancet/article/PIIS0140-6736%2815%2900056-2/abstract
- ↑ 11.0 11.1 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 <PubMed> PMID: https://www.ncbi.nlm.nih.gov/pubmed/26624850 <Internet> 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 <PubMed> PMID: https://www.ncbi.nlm.nih.gov/pubmed/26624554 <Internet> 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 <PubMed> PMID: https://www.ncbi.nlm.nih.gov/pubmed/26624243 <Internet> http://www.nejm.org/doi/full/10.1056/NEJMms1513641 - ↑ 12.0 12.1 Medical Knowledge Self Assessment Program (MKSAP) 17, 18, 19. American College of Physicians, Philadelphia 2015, 2018, 2021.
- ↑ 13.0 13.1 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 <PubMed> PMID: https://www.ncbi.nlm.nih.gov/pubmed/27110953 <Internet> 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 <PubMed> PMID: https://www.ncbi.nlm.nih.gov/pubmed/27111241 <Internet> http://annals.org/article.aspx?articleid=2517408 - ↑ 14.0 14.1 14.2 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- <PubMed> PMID: https://www.ncbi.nlm.nih.gov/pubmed/27404187 <Internet> 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. <PubMed> PMID: https://www.ncbi.nlm.nih.gov/pubmed/27404182 <Internet> http://jama.jamanetwork.com/article.aspx?articleid=2533044 - ↑ Riddell J 4th, Amico KR, Mayer KH. HIV Preexposure Prophylaxis. A Review. JAMA. 2018;319(12):1261-1268 PMID: https://www.ncbi.nlm.nih.gov/pubmed/29584848 https://jamanetwork.com/journals/jama/article-abstract/2676116
- ↑ 16.0 16.1 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: https://www.ncbi.nlm.nih.gov/pubmed/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: https://www.ncbi.nlm.nih.gov/pubmed/29885814 https://www.thelancet.com/journals/lanhiv/article/PIIS2352-3018(18)30100-0/fulltext - ↑ 17.0 17.1 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: https://www.ncbi.nlm.nih.gov/pubmed/30096070
- ↑ 18.0 18.1 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: https://www.ncbi.nlm.nih.gov/pubmed/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: https://www.ncbi.nlm.nih.gov/pubmed/30343027 https://www.thelancet.com/journals/lanhiv/article/PIIS2352-3018(18)30253-4/fulltext - ↑ 19.0 19.1 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
- ↑ 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: https://www.ncbi.nlm.nih.gov/pubmed/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: https://www.ncbi.nlm.nih.gov/pubmed/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: https://www.ncbi.nlm.nih.gov/pubmed/37606666 https://jamanetwork.com/journals/jama/fullarticle/2808514 - ↑ 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: https://www.ncbi.nlm.nih.gov/pubmed/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: https://www.ncbi.nlm.nih.gov/pubmed/30964514 https://jamanetwork.com/journals/jama/fullarticle/2730096 - ↑ 22.0 22.1 Associated Press. Oct 7, 2019 California OKs pharmacists to dispense HIV prevention meds. https://www.apnews.com/a1491134e0c242bc95ef36ed0a9fa95e
- ↑ 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
- ↑ 24.0 24.1 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: https://www.ncbi.nlm.nih.gov/pubmed/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: https://www.ncbi.nlm.nih.gov/pubmed/32150617 https://annals.org/aim/article-abstract/2762809/how-much-we-willing-pay-preexposure-prophylaxis-united-states - ↑ 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: https://www.ncbi.nlm.nih.gov/pubmed/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: https://www.ncbi.nlm.nih.gov/pubmed/36454551 https://jamanetwork.com/journals/jama/fullarticle/2799240 - ↑ 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: https://www.ncbi.nlm.nih.gov/pubmed/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: https://www.ncbi.nlm.nih.gov/pubmed/37606667 https://jamanetwork.com/journals/jama/fullarticle/2808515 - ↑ 27.0 27.1 NEJM Knowledge+