Pre-exposure prophylaxis

(Redirected from PROUD (clinical trial))

Pre-exposure prophylaxis (PrEP), is the use of medications to prevent the spread of disease in people who have not yet been exposed to a disease-causing agent. Vaccination is the most commonly used form of pre-exposure prophylaxis; other forms of pre-exposure prophylaxis generally involve drug treatment, known as chemoprophylaxis. Examples include taking medication to prevent infection by malaria or HIV. In particular, the term PrEP is now synonymous in popular usage with the use of pre-exposure prophylaxis for HIV prevention.

In general, the use of pre-exposure prophylaxis requires balancing the risks of the treatment (e.g., side effects from a drug) to healthy individuals with the risk of the disease.

It should be contrasted with post-exposure prophylaxis, which is used once the patient has already been exposed to the infectious agent.

Use of pre-exposure medication against specific diseases

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Malaria

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The use of pre-exposure drug treatment to prevent malaria using antimalarial drugs is well-established,[1] with the use of quinine as a prophylactic treatment dating back at least to the 19th century.[citation needed]

HIV/AIDS

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The abbreviation PrEP now typically refers to pre-exposure prophylaxis for HIV prevention, the use of antiviral drugs as a strategy for the prevention of HIV/AIDS.[2] PrEP is one of a number of HIV prevention strategies for people who are HIV negative but who have a higher risk of acquiring HIV, including sexually active adults at increased risk of contracting HIV, people who engage in intravenous drug use (see drug injection), and serodiscordant sexually active couples.[3]

When used as directed, PrEP has been shown to be highly effective at preventing HIV infection, reducing the risk of acquiring HIV by up to 99%.[4] A large-scale study in the UK has shown that PrEP remains effective at preventing HIV infection, even when used in uncontrolled environments.[5]

COVID-19

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Pre-exposure prophylaxis against infection by SARS-CoV-2, the virus that causes COVID-19, has been studied as a possible preventive measure for high-risk groups.[6]

In December 2021, the US FDA granted emergency use authorization (EUA) of the antibody drug tixagevimab/cilgavimab (Evusheld) to prevent COVID-19 in immunocompromised people who cannot be fully vaccinated due to a history of a severe reaction to coronavirus vaccines.[7][8] However, due to the high levels of non-susceptible SARS-CoV-2 variants present in the US, the FDA announced on 6 January 2023 that tixagevimab/cilgavimab was no longer currently authorized for emergency use in the US.[9]

In March 2024, pemivibart (Pemgarda), a monoclonal antibody drug, received an emergency use authorization from the US FDA to protect certain moderately to severely immunocompromised individuals against COVID-19.[10][11]

Pre-exposure prophylaxis for post-mortems

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Since conducting autopsies may involve inadvertent cuts, and the incidence of hepatitis-B can be very high in certain populations, it is advisable for all autopsy personnel to get their hepatitis-B antibody status tested. If antibodies are not present in sufficient concentration, hepatitis-B vaccine must be taken.[12]

References

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  1. ^ "Malaria | CDC Yellow Book 2024". wwwnc.cdc.gov. Retrieved 2023-11-30.
  2. ^ "Pre-Exposure Prophylaxis". HIV.gov. 2019-12-03. Retrieved 2020-08-03.
  3. ^ US Public Health Service. "Preexposure prophylaxis for the prevention of HIV infection in the United States - 2014" (PDF). Centers for Disease Control and Prevention (CDC). Archived from the original (PDF) on 11 April 2018. Retrieved 15 December 2017.
  4. ^ "Effectiveness of Prevention Strategies to Reduce the Risk of Acquiring or Transmitting HIV". Centers for Disease Control and Prevention (CDC). 2019-11-12. Archived from the original on 10 December 2019. Retrieved 9 December 2019.
  5. ^ Sullivan, Ann K; Saunders, John; Desai, Monica; Cartier, Andrea; Mitchell, Holly D; Jaffer, Sajjida; Ogaz, Dana; Chiavenna, Chiara; Charlett, Andre; Diamente, Victor; Golombek, Rainer; Manavi, Kaveh; Priestley, Cecilia; Waters, Laura J; Milinkovic, Ana (December 2023). "HIV pre-exposure prophylaxis and its implementation in the PrEP Impact Trial in England: a pragmatic health technology assessment". The Lancet HIV. 10 (12): e790–e806. doi:10.1016/s2352-3018(23)00256-4. ISSN 2352-3018. PMID 38040478.
  6. ^ "Pre-exposure prophylaxis (PrEP) and COVID-19: independent advisory group report". GOV.UK. Retrieved 2023-11-30.
  7. ^ "Evusheld- azd7442 kit". DailyMed. AstraZeneca. 20 December 2021. Archived from the original on 5 January 2022. Retrieved 20 January 2022.
  8. ^ Mishra M, Satija B (8 December 2021). Dasgupta S (ed.). "U.S. FDA authorizes use of AstraZeneca COVID-19 antibody cocktail". Reuters. Archived from the original on 13 January 2022. Retrieved 18 January 2022.
  9. ^ "Latest FDA Updates for Evusheld". U.S. Food and Drug Administration. 6 January 2023. Retrieved 8 April 2024.
  10. ^ MacMillan, Carrie (5 April 2024). "FDA Authorizes COVID Drug Pemgarda for High-Risk Patients". Yale Medicine. Retrieved 8 April 2024.
  11. ^ Cavazzoni, Patrizia (3 April 2024). "EUA 122 Invivyd Pemgarda LOA". U.S. Food and Drug Administration. Archived from the original on 8 April 2024. Retrieved 8 April 2024.
  12. ^ Gill JR (2016). "Autopsy: Infectious and Serious Communicable Diseases". Encyclopedia of Forensic and Legal Medicine: 279–284. doi:10.1016/B978-0-12-800034-2.00039-2. ISBN 978-0-12-800055-7. PMC 7149624.