References

Treatment guidelines for PrEP

BHIVA/BASHH guidelines on the use of PrEP (2024)

Major update of UK PrEP guidelines online for public consultation. (HTB October 2024).
https://i-base.info/htb/48804

BHIVA/BASHH. BHIVA/BASHH. guideline on the use of HIV pre-exposure prophylaxis – 2024: Draft out for consultation. (27 September 2024).
https://www.bashh.org/resources/126/bhivabashh_guideline_on_the_use_of_hiv_preexposure_prophylaxis_2024_draft_out_for_consultation (web page)
https://www.bashh.org/_userfiles/pages/files/draft_bashh_bhiva_prep_guidelines_240924_v30_final.pdf (PDF direct link)

EACS (European AIDS Clinical Society) – Version 12.1, October 2024.

https://www.eacsociety.org/guidelines/eacs-guidelines

The guidelines can only now be viewed using the EACS guidelines app or online:
https://eacs.sanfordguide.com

Everyone can start PrEP with a double dose (2 pills) to be protected in two hours.
Cisgender women, transgender and non-binary people can use on-demand 2:7 dosing. Start with a double dose and take daily PrEP for seven days to stop.
PrEP is recommended in adults at high risk of HIV when condoms are not used consistently.

Stresses importance of testing for HIV (with 4th-generation test) and HBV before starting PrEP.

International Antiviral Society USA (IAS-USA).
Antiretroviral Drugs for Treatment and Prevention of HIV Infection in Adults: 2022 Recommendations of the International Antiviral Society–USA Panel. JAMA. 2022; doi:10.1001/jama.2022.22246. (1 December 2022).
https://www.iasusa.org/2022/11/30/antiretroviral-drugs-treatment-prevention-hiv-infection-adults-2020-recommendations-of-the-international-antiviral-society-usa-panel-2022/ (webpage)
https://watermark.silverchair.com/jama_gandhi_2022_sc_220007_1671563383.14209.pdf (PDF)

World Health Organization (WHO). Numerous guidelines relating to PrEP are linke to this page.
https://www.who.int/hiv/pub/prep/en

What’s the 2+1+1? Event-driven oral pre-exposure prophylaxis to prevent HIV for men who have sex with men: Update to WHO’s recommendation on oral PrEP. July 2019.
Consolidated guidelines on the use of antiretroviral drugs for treating and preventing HIV infection – Recommendations for a public health approach (June 2016)
WHO expands recommendation on oral pre-exposure prophylaxis of HIV infection (PrEP) – Policy brief (November 2015)

In 2014, WHO first recommended PrEP to men who have sex with men (MSM). On the basis of further evidence of the effectiveness and acceptability of PrEP, WHO later broadened the recommendation to include all population groups at substantial risk of HIV infection.

US CDC guidelines. PreExposure prophylaxis for the prevention of HIV infection in the United States, May 2021 update.
https://www.cdc.gov/hiv/risk/prep/index.html (resource page)
US PrEP guidelines and other documents (page for updated guidelines)

UKHSA. HIV testing, PrEP, new HIV diagnoses and care outcomes for people accessing HIV services: 2023 report. Publication number GOV-15487.(October 2023)
A report in PrEP use and uptake in the UK.
https://www.gov.uk/government/statistics/hiv-annual-data-tables/hiv-testing-prep-new-hiv-diagnoses-and-care-outcomes-for-people-accessing-hiv-services-2023-report

Key PrEP research

2024 update: supporting new dosing options (see also the IAS-USA 2022 guidelines above).

Zhang L et al. Model-based predictions of protective HIV pre-exposure prophylaxis adherence levels in cisgender women.Nat Med 29, 2753–2762 (2023). https://doi.org/10.1038/s41591-023-02615-x

Cottrell ML et al. A translational pharmacology approach to predicting outcomes of preexposure prophylaxis against HIV in men and women using tenofovir disoproxil fumarate with or without emtricitabine. J Infect Dis. 2016 Jul 1;214(1):55-64. doi: 10.1093/infdis/jiw077. Epub 2016 Feb 24.
https://pubmed.ncbi.nlm.nih.gov/26917574

Garrett KL et al. A pharmacokinetic/pharmacodynamic model to predict effective HIV prophylaxis dosing strategies for people who inject drugs. J Pharmacol Exp Ther. 2018 Nov;367(2):245-251. doi: 10.1124/jpet.118.251009. Epub 2018. (27 August 2018).
https://pubmed.ncbi.nlm.nih.gov/30150483/

Cespedes MS et al. (2024) Gender affirming hormones do not affect the exposure and efficacy of F/TDF or F/TAF for HIV preexposure prophylaxis: a subgroup analysis from the DISCOVER trial Transgender Health 9:1 46–52 DOI: 10.1089/trgh.2022.0048.
https://www.liebertpub.com/doi/full/10.1089/trgh.2022.0048

Patel N et a. No observed bidirectional effect between tenofovir diphosphate concentrations and gender-affirming hormone concentrations among transgender persons switching from tenofovir disoproxil fumarate/emtricitabine to tenofovir alafenamide/emtricitabine for HIV pre-exposure prophylaxis. Br J Clin Pharmacol. 2024 Apr 22. doi: 10.1111/bcp.16071.
https://pubmed.ncbi.nlm.nih.gov/38646796/

Marrazzo J et al. HIV Preexposure Prophylaxis With Emtricitabine and Tenofovir Disoproxil Fumarate Among Cisgender Women. JAMA. doi:10.1001/jama.2024.0464. (1 March 2024).
https://jamanetwork.com/journals/jama/fullarticle/2816036

Impact of PrEP in reducing HIV incidence

Four London clinics report dramatic drops in HIV incidence in gay men: PrEP, early testing and early ART likely to be key.
https://i-base.info/htb/31126

No new HIV cases in 398 people using PrEP at Dean Street clinic. (April 2017)
https://i-base.info/htb/31571

TAF as PrEP – including DISCOVER study

Collins S. NHS England approves use of F/TAF as alternative PrEP. HTB (1 June 2023).
https://i-base.info/htb/45555

Mayer K 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;396:239–254.
https://www.ncbi.nlm.nih.gov/pmc/articles/PMC9665936/

Hare CB et al. The phase 3 discover study: daily F/TAF or F/TDF for HIV preexposure prophylaxis. CROI 2019, 4–7 March 2019, Seattle, Washington. Oral abstract LB 104LB.
http://www.croiconference.org/sessions/phase-3-discover-study-daily-ftaf-or-ftdf-hiv-preexposure-prophylaxis (abstract)
http://www.croiwebcasts.org/console/player/41210 (webcast)

Spinner C et al. DISCOVER study for HIV pre-exposure prophylaxis (PrEP): F/TAF has a more rapid onset and longer sustained duration of HIV protection compared with F/TDF. 10th IAS Conference on HIV Science. Mexico City. 21–24 July 2019. Oral late breaker abstract TUAC0403LB.
http://programme.ias2019.org/Abstract/Abstract/4898

US approves F/TAF for PrEP (Descovy): indication excludes risk from receptive vaginal sex
https://i-base.info/htb/36734

Cabotegravir injections as PrEP – including HPTN 083 and 084 studies

NICE guidelines. Cabotegravir injections for preventing HIV-1 in adults and young people. ID6255. In development.
https://www.nice.org.uk/guidance/indevelopment/gid-ta11304

Collins S. EU approves cabotegravir as injectable PrEP. HTB (1 October 2023).
https://i-base.info/htb/45555

Landovitz RJ et al. Efficacy and safety of long-acting cabotegravir compared with daily oral tenofovir disoproxil fumarate plus emtricitabine to prevent HIV infection in cisgender men and transgender women who have sex with men 1 year after study unblinding: a secondary analysis of the phase 2b and 3 HPTN 083 randomised controlled trial. Lancet HIV. (9 November 2023).
DOI:https://doi.org/10.1016/S2352-3018(23)00261-8

Delany-Moretlwe S et al. Cabotegravir for the prevention of HIV-1 in women: results from HPTN 084, a phase 3, randomised clinical trial. The Lancet, 399(10337);1779 to 1789. Open Access. (7 May 2022).
https://doi.org/10.1016/S0140-6736(22)00538-4

TDF as PrEP – including PROUD and IPERGAY studies

PROUD Study – UK study finding significant protection in gay men and trans women.

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. The Lancet. 09 September, 2015.
http://dx.doi.org/10.1016/S0140-6736(15)00056-2
http://www.thelancet.com/journals/lancet/article/PIIS0140-6736(15)00056-2/fulltext

McCormack S et al. Long-term follow-up of PROUD: evidence for high continued HIV exposure and durable effectiveness of PrEP. 9th IAS Conference, 22-25 July 2017, Paris (IAS 2017). Oral abstract TUAC0101, July 2017.
http://programme.ias2017.org/Abstract/Abstract/3629

Gafos M et al. Experiences and perceptions of PrEP among gay and other men who sex with men (MSM) using PrEP in the PROUD study in England. 9th IAS Conference, 22-25 July 2017, Paris (IAS 2017). Oral abstract TUAC0101, July 2017.
http://programme.ias2017.org/Abstract/Abstract/3629

IPERGAY Study – French/Canadian study using event-based dosing in gay men and trans women.

Molina J-M et al. On-demand preexposure prophylaxis in man at high risk for HIV-1 infection. NEJM early online publication, DOI: 10.1056/NEJMoa1506273. 2015.
http://www.nejm.org/doi/full/10.1056/NEJMoa1506273

Antoni G et al. On-demand PrEP with TDF/FTC remains highly effective among MSM with infrequent sexual intercourse: a sub-study of the ANRS IPERGAY trial. 9th IAS Conference, 22-25 July 2017, Paris (IAS 2017). Oral abstract TUAC0102, July 2017.
http://programme.ias2017.org/Abstract/Abstract/3629

Molina J-M et al for the ANRS IPERGAY Study Group. Efficacy, safety, and effect on sexual behaviour of on-demand pre-exposure prophylaxis for HIV in men who have sex with men: an observational cohort study. Lancet HIV 2017; (published online July 23.)
http://dx.doi.org/10.1016/S2352-3018(17)30089-9

Prevenir study – including event-dased dosing

Molina JM et al. Incidence of HIV-infection with daily or on-demand PrEP with TDF/FTC in Paris area. Update from the ANRS Prévenir Study. 10th International AIDS Society Conference on HIV Science, Mexico City. Oral abstract TUAC0202, 2019.
http://programme.ias2019.org/Abstract/Abstract/1057

AMPrEP study – including event-dased dosing

Hoornenborg E et al. Sexual behaviour and incidence of HIV and sexually transmitted infections among men who have sex with men using daily and event-driven pre-exposure prophylaxis in AMPrEP: 2 year results from a demonstration study. Lancet HIV, http://dx.doi.org/10.1016/s2352-3018(19)30136-5.

iPrEX Study – International study finding significant protection in gay men and trans women.

Grant RJ et al. Preexposure chemoprophylaxis for HIV prevention in men who have sex with men. N Engl J Med 2010; 363:2587-2599. December 30, 2010, DOI: 10.1056/NEJMoa1011205
http://www.nejm.org/doi/full/10.1056/NEJMoa1011205

Grant RM et al. Uptake of pre-exposure prophylaxis, sexual practices, and HIV incidence in men and transgender women who have sex with men: a cohort study. Lancet Infect Dis 2014;14:820-829.
http://www.thelancet.com/journals/laninf/article/PIIS1473-3099(14)70847-3/abstract

PARTNERS PrEP Study – African study finding significant prtection from both FTC/TDF and TDF alone in heterosexuals.

Baeten JM et al. Antiretroviral Prophylaxis for HIV Prevention in Heterosexual Men and Women.N Engl J Med 2012; 367:399-410. August 2, 2012. DOI: 10.1056/NEJMoa1108524.
http://www.nejm.org/doi/full/10.1056/NEJMoa1108524

FEM-PrEP Study – Study in African women finding no benefit from PrEP due to low adherence.

Van Damme L et al. Preexposure prophylaxis for HIV infection among African women. N Engl J Med 2012; 367:411-422. August 2, 2012. DOI: 10.1056/NEJMoa1202614.
http://www.nejm.org/doi/full/10.1056/NEJMoa1202614

Letter from UK doctor Mike Youle in 2003 on the potential of PrEP. Youle M, Wainberg MA. Could chemoprophylaxis be used as an HIV prevention strategy while we wait for an effective vaccine? AIDS 2003;17:937-938
http://journals.lww.com/aidsonline/Fulltext/2003/04110/Could_chemoprophylaxis_be_used_as_an_HIV.27.aspx

Cases of HIV transmission when taking PrEP

Collins S. 56 Dean Street reports M184V common with recent low adherence to PrEP and seven transmissions with good adherence. HTB (20 December 2021).
https://i-base.info/htb/41912

Girometti N et al. Rising rates of recent PrEP exposure among MSM newly diagnosed with HIV: antiviral resistance patterns and treatment outcomes. AIDS, doi: 10.1097/QAD.0000000000003143.
https://journals.lww.com/aidsonline/Abstract/9000/Rising_rates_of_recent_PrEP_exposure_among_MSM.96256.aspx

Jacobs DL.Reported ‘PrEP failure’ in Thailand may be a result of missing acute HIV infection: here’s what you need to know. TheBodyPro. (17 July 2018).
https://www.thebodypro.com/article/reported-prep-failure-in-thailand-may-be-a-result-

Karasz HN. Possible rare case of transmission of HIV resistance to pre-exposture prophylaxis (PrEP) medication. Public Health Insider, (12 March 2018).
https://publichealthinsider.com/2018/03/12/possible-rare-case-of-transmission-of-hiv-resistant-to-pre-exposure-prophylaxis-prep-medication/

Sullivan P et al. Acquisition of TDF-susceptible HIV despite high level adherence to daily TDF/FTC PrEP as measured by dried blood spot (DBS) and segmental hair analysis: a case report. IDWeek 2018, abstract 1298.
https://idsa.confex.com/idsa/2018/webprogram/Paper69862.html

Hoornenborg E et al. Acute infection with a wild-type HIV-1 virus in PrEP user with high TDF levels. CROI 2017, 13-16 February 2017, Seattle. Poster abstract 953.
http://www.croiconference.org/sessions/acute-infection-wild-type-hiv-1-virus-prep-user-high-tdf-levels

Hoornenborg E et al. Acquisition of wild-type HIV-1 infection in a patient on pre-exposure prophylaxis with high intracellular concentrations of tenofovir diphosphate: a case report, Lancet HIV. Published online: 14 September 2017.
http://dx.doi.org/10.1016/S2352-3018(17)30132-7

Grossman H et al. Newly acquired HIV-1 infection with multi-drug resistant (MDR) HIV-1 in a patient on TDF/FTC-based PrEP. Research for Prevention 2016, 17-21 October 2016, Chicago. Oral abstract OA03.06LB.
Links to abstract and webcast will be added when these become available.

Knox C et al. HIV-1 infection with multiclass resistance despite preexposure prophylaxis (PrEP). 23rd CROI 2016, Boston. Late-breaker poster abstract 479aLB.
http://www.croiconference.org/sessions/hiv-1-infection-multiclass-resistance-despite-preexposure-prophylaxis-prep

Amsterdam Public Health Service of Amsterdam (GGD). First year Amsterdam PrEP project complete – GGD Amsterdam. (20 October 2016).
http://www.ggd.amsterdam.nl/nieuwsoverzicht/een-jaar-amsterdam-p (Dutch website)
Link to English press release. (English PDF)

Koss CA et al. HIV incidence after pre-exposure prophylaxis initiation among women and men at elevated HIV risk: A population-based study in rural Kenya and Uganda. PLoS Medicine. DOI: 10.1371/journal.pmed.1003492. (9 February 2021).
https://journals.plos.org/plosmedicine/article?id=10.1371/journal.pmed.1003492

PrEP and side effects

Most information about side effects comes from the same studies on efficacy, listed above. The studies below are more recent and look at specific side effects.

Glidden DV et al. Brief report: Recovery of bone mineral density after discontinuation of tenofovir-based HIV pre-exposure prophylaxis. J Acquir Immune Defic Syndr. 2017;76(2):177-182. doi:10.1097/QAI.0000000000001475
https://www.ncbi.nlm.nih.gov/pmc/articles/PMC5597476

Havens PL et al. Changes in bone mass after discontinuation of preexposure prophylaxis with tenofovir disoproxil fumarate/emtricitabine in young men who have sex with men: extension phase results of adolescent trials network protocols 110 and 113. Clin Infect Dis. 2020;70(4):687-691. doi:10.1093/cid/ciz486. (15 February 2020).
https://www.ncbi.nlm.nih.gov/pmc/articles/PMC7319267

Generic PrEP supplied by community-recommended online pharmacies

Wang X et al. InterPrEP: internet-based pre-exposure prophylaxis (PrEP) with generic tenofovir DF/emtricitabine (TDF/FTC) in London analysis of pharmacokinetics, safety and outcomes. Oral abstract O315. See:
https://i-base.info/htb/30888

Hill A. Generics: the facts. BHIVA invited lecture 1, Thursday 6 April 2017. 23rd BHIVA 4-7 April 2017, Liverpool.
http://www.bhiva.org/documents/Conferences/2017Liverpool/Presentations/170406/JohnFrater.pdf (PDF)
http://www.bhiva.org/170406AndrewHill.aspx (webcast)

Pharmacokinetic and early studies on PrEP for adherence timing, drug absorption and efficacy

Anderson PL et al. Nondaily preexposure prophylaxis for HIV prevention. Curr Opin HIV AIDS (2016); 11(1):94-101. doi: 10.1097/COH.0000000000000213. (January 2016).
https://www.ncbi.nlm.nih.gov/pubmed/26633641

Anderson PL et al. Pharmacologic considerations for preexposure prophylaxis in transgender women. J Acquir Immune Defic Syndr. (2016); 72(Suppl 3): S230–S234. doi: 10.1097/QAI.0000000000001105. (15 August 2016).
https://www.ncbi.nlm.nih.gov/pmc/articles/PMC4955879

García-Lerma JG, Otten RA, Qari SH, et al. Prevention of rectal SHIV transmission in macaques by daily or intermittent prophylaxis with emtricitabine and tenofovir. PLoS Med 2008;5:e28-e28.
http://journals.plos.org/plosmedicine/article?id=10.1371/journal.pmed.0050028

García-Lerma JG, Cong ME, Mitchell J, et al. Intermittent prophylaxis with oral Truvada protects macaques from rectal SHIV infection. Sci Transl Med 2010;2:14ra4-14ra4.
http://stm.sciencemag.org/content/2/14/14ra4

Hendrix, C. Exploring concentration response in HIV pre-exposure prophylaxis to optimize clinical care and trial design. Cell 155,515-517. DOI: 10.1016/j.cell.2013.09.030. (24 October 2013).
https://www.sciencedirect.com/science/article/pii/S0092867413011677

Sheth AN et al. HIV pre-exposure prophylaxis for women. J Virus Erad. 2016 Jul; 2(3): 149–155. (July 2016).
https://www.ncbi.nlm.nih.gov/pmc/articles/PMC4967966

Dosing for transwomen

Sheih E et al. Transgender women on oral HIV pre‐exposure prophylaxis have significantly lower tenofovir and emtricitabine concentrations when also taking oestrogen when compared to cisgender men. JIAS. 06 November 2019. doi: 10.1002/jia2.25405
https://onlinelibrary.wiley.com/doi/full/10.1002/jia2.25405.

Key research on treatment as prevention

Rodger AJ et al. Risk of HIV transmission through condomless sex in serodifferent gay couples with the HIV-positive partner taking suppressive antiretroviral therapy (PARTNER): final results of a multicentre, prospective, observational study. Lancet 2019; published online May 2. (Open access)
http://dx.doi.org/10.1016/S0140-6736(19)30418-0

Cohen MS et al. Prevention of HIV-1 infection with early antiretroviral therapy. N Engl J Med 2011;365:493-505.
http://www.nejm.org/doi/10.1056/NEJMoa1105243

Quinn TC, Wawer MJ, Sewankambo N, et al. Viral load and heterosexual transmission of human immunodeficiency virus type 1. N Engl J Med 2000;342:921-929
http://www.nejm.org/doi/10.1056/NEJM200003303421303

Prompt/early ART: Dean Street pilot project reports 75% uptake
https://i-base.info/htb/31577

Community resources

i-Base Q&As on PrEP in the UK. Selected questions and answers, 2015 to 2016.
https://i-base.info/qa/category/

Facebook community forums

PrEP facts: rethinking HIV Prevention
https://www.facebook.com/groups/PrEPFacts
PrEP Facts FAQs (PFFAQs
https://www.facebook.com/PrEPFactsFAQ