Pre-exposure prophylaxis

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Pre-exposure prophylaxis (PrEP) is any medical or public health procedure used before exposure to the disease causing agent, its purpose is to prevent, rather than treat or cure a disease. An example would be if a doctor gave a medication used to treat a disease to a healthy person who is not thought to have that disease, but is at risk for contracting it. More specifically, this practice is common with people who are about to travel from an area without malaria to an area where malaria is a risk. In the U.S., it is approved by the FDA and recommended by the CDC as a tool to prevent persons from contracting HIV.

Pre-exposure prophylaxis can also refer to the aggressive use of vaccination, for example in an attempt to prevent rabies in people such as laboratory workers who are high risk for being bitten by rabid animals.

PrEP for malaria[edit]

The CDC publishes recommendations for travels advising about the risk of contracting malaria in various countries.[1]

Some of the factors in deciding whether to use chemotherapy as malaria PrEP include the specific itinerary, length of trip, cost of drug, previous adverse reactions to antimalarials, drug allergies, and current medical history.[1]

PrEP for HIV[edit]

The terms pre-exposure prophylaxis or PrEP most commonly refer to an HIV-prevention strategy that uses antiretrovirals to protect HIV-negative people from HIV infection. The HIV antiviral Truvada was approved by the FDA for PrEP on July 16, 2012.[2] The CDC added Truvada for PrEP to its guidelines for HIV prevention on May 14, 2014.[3]

Another rationale of PrEP comes from strategies to prevent mother-to-child transmission, which use ARVs given to the mother and the infant to help reduce the risk of transmission.[4]

PrEP Studies[edit]

Most PrEP studies utilize the drug tenofovir or a tenofovir/emtricitabine combo (Truvada) that is delivered orally. Initial studies of PrEP strategies in non-human primates showed a reduced risk of infection among animals that receive ARVs prior to exposure to a simian form of HIV. A 2007 study at UT-Southwestern (Dallas) and the University of Minnesota showed PrEP to be effective in "humanized" laboratory mice.[5] In 2008, the iPrEx study demonstrated 42% reduction of HIV infection among men who have sex with men,[6] and subsequent study of the data indicated 99% protection with daily adherence. [7]

PrEP approaches with agents besides oral Truvada are currently in clinical trials not listed here.

StudyType of PrEPStudy PopulationFindings
CAPRISA 004Pericoital tenofovir gelSouth African females39% reduction of HIV infection[8]
iPrExOral emtricitabine/tenofovirMen who have sex with men42% reduction of HIV infection.[9] 99% reduction estimated with daily adherence[10]
Partners PrEPOral emtricitabine/tenofovir; oral tenofovirAfrican heterosexual couples73% and 62% reduction of infection[4]
TDF2Oral emtricitabine/tenofovirBotswana heterosexual couples63% reduction of infection[11]
FEM-PrEPOral emtricitabine/tenofovirAfrican femalesNo reduction (study halted due to low adherence)
VOICE 003Oral emtricitabine/tenofovir; oral tenofovir; vaginal tenofovir gelAfrican femalesNo reduction in oral tenofovir or vaginal gel arms [oral emtricitabine/tenofovir arm ongoing][11]
Bangkok Tenofovir StudyOral tenofovirThai male injection drug users48,9% reduction of infection[12]

Criticism of PrEP[edit]

Criticisms of PrEP have included biomedical concerns (such as safety and effectiveness), adherence, behavioral repercussions, and cost.

The PrEP studies have shown the drugs to be safe, with few side effects. Generally, minor side effects such as nausea or diarrhea resolve themselves within the first few months.[11] Effects of Truvada on kidney function have been shown to be temporary.[13] The level of effectiveness depends on the degree of adherence to the prescribed regimen. In iPrEx, persons with greater than 90% adherence to the drug had an efficacy of 68% protection versus persons with less than 50% adherence who had an efficacy of 16%.[11] Furthermore, the FEM-PrEP trial that was stopped early due to futility, found that the women's adherence to the drug was too low to find any effect on reducing HIV infections.[14]

Given mounting evidence of the effectiveness of PrEP among different populations when the drug is taken correctly, concern has turned more towards the practicalities of implementing PrEP as prevention. Since approximately 60% of people needing anti-retroviral therapy are not getting it, there are concerns that trying to deliver PrEP to many more people would be challenging.[11] It is also important to consider how programs might target those at highest risk of HIV exposure in order to provide PrEP.[4]

Effects of PrEP on behavioral changes, such as decreased condom use, are currently being studied. The CDC is conducting an extended safety trial in the U.S. to determine if men who have sex with men taking the drug are more likely to engage in riskier behaviors; preliminary results do not show any change in behavior.[15]

Cost has been cited as a concern as well. Truvada for PrEP is listed at more than $1000/month. While many insurers cover the treatment, and while Truvada's manufacturer, Gilead, maintains a co-pay assistance program, the treatment may be out of the reach of some persons. The effects of PrEP on overall health care costs are uncertain.

See also[edit]

References[edit]

  1. ^ a b Kathrine R. Tan, Sonja Mali, Paul M. Arguin (2010). "Malaria Risk Information and Prophylaxis, by Country". Travelers' Health - Yellow Book. Centers for Disease Control and Prevention. Retrieved 20 December 2010. 
  2. ^ http://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm312210.htm
  3. ^ http://www.cdc.gov/hiv/prevention/research/prep/
  4. ^ a b c Celum C, Baeten JM (February 2012). "Tenofovir-based pre-exposure prophylaxis for HIV prevention: evolving evidence". Curr. Opin. Infect. Dis. 25 (1): 51–7. doi:10.1097/QCO.0b013e32834ef5ef. PMC 3266126. PMID 22156901. 
  5. ^ Denton PW, Estes JD, Sun Z, et al. (January 2008). "Antiretroviral pre-exposure prophylaxis prevents vaginal transmission of HIV-1 in humanized BLT mice". PLoS Med. 5 (1): e16. doi:10.1371/journal.pmed.0050016. PMC 2194746. PMID 18198941. 
  6. ^ Grant RM, Lama JR, Anderson PL, et al. (December 2010). "Preexposure chemoprophylaxis for HIV prevention in men who have sex with men". N. Engl. J. Med. 363 (27): 2587–99. doi:10.1056/NEJMoa1011205. PMC 3079639. PMID 21091279. 
  7. ^ http://www.thebodypro.com/content/66547/prep-pk-modeling-of-daily-tdfftc-truvada-provides.html
  8. ^ Andrei G, Lisco A, Vanpouille C, et al. (October 2011). "Topical tenofovir, a microbicide effective against HIV, inhibits herpes simplex virus-2 replication". Cell Host Microbe 10 (4): 379–89. doi:10.1016/j.chom.2011.08.015. PMID 22018238. 
  9. ^ Grant RM, Lama JR, Anderson PL, et al. (December 2010). "Preexposure chemoprophylaxis for HIV prevention in men who have sex with men". N. Engl. J. Med. 363 (27): 2587–99. doi:10.1056/NEJMoa1011205. PMC 3079639. PMID 21091279. 
  10. ^ http://www.thebodypro.com/content/66547/prep-pk-modeling-of-daily-tdfftc-truvada-provides.html
  11. ^ a b c d e Celum, CL (December 2011). "HIV preexposure prophylaxis: new data and potential use.". Topics in antiviral medicine 19 (5): 181–5. PMID 22298887. 
  12. ^ Choopanya K, Martin M, et al. (June 2013). "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 381 (9883): 2083–2090. doi:10.1016/S0140-6736(13)61127-7. PMID 23769234. 
  13. ^ http://www.aidsmap.com/iTruvadai-PrEP-does-not-harm-the-kidneys-trial-shows/page/2827796/
  14. ^ "Advocates' Network Update". AVAC. Retrieved 10 May 2012. 
  15. ^ "CDC’s Clinical Studies of Pre-Exposure Prophylaxis for HIV Prevention". CDC. August 2008. Retrieved 21 January 2009. 

External links[edit]