Pre-exposure prophylaxis

from Wikipedia, the free encyclopedia

Oral HIV pre-exposure prophylaxis (PrEP) refers to the use of systemically effective antiviral drugs by HIV- negative people with a substantial HIV infection risk to reduce the likelihood of HIV transmission. Medical guidelines are available for the indication and implementation of the treatment. According to a study published in 2014, a 92% reduction in the likelihood of infection can be demonstrated when used properly and monitored.

According to the medical guidelines for Germany and Austria, there is a substantial risk of HIV infection, among other things, with appropriate risk behavior for men who have sex with men (MSM), for transgender people, with certain constellations of HIV-positive and HIV-negative partners Refraining from using condoms for intercourse with partners who are likely to have an undiagnosed HIV infection, and for people who inject drugs without the use of sterile injection materials.

The drug Truvada (a combination of the active ingredients emtricitabine and tenofovir ) and corresponding generics for pre-exposure prophylaxis have been approved in the European Union since August 22, 2016 . This indication was approved in the USA in 2012. According to the approval, a combination tablet must be taken once a day. The intermittent, i.e. event-related, intake represents a non-approval application , which is to be regarded as less safe. In Germany, since September 1, 2019, the statutory health insurance companies have had to cover the costs for PrEP in accordance with Section 20j SGB ​​V introduced by the Appointments Service and Supply Act .

Pre-exposure prophylaxis is only one of several preventive measures against HIV. Other measures include, for example, condoms , therapy as prevention and post- exposure prophylaxis . PrEP does not work against other sexually transmitted diseases .

Protective effect

The effectiveness depends largely on the drug used and the adherence to therapy, i.e. the discipline in taking it. In the largest PrEP study to date (VOICE 003) with over 5000 participants from Uganda, Zimbabwe and South Africa, only 50% adherence to therapy was determined by measuring drug levels, which severely limits the protective effect. As the blood tests showed, the pre-exposure prophylaxis was taken less and less in the course of the study - although there were monthly consultations on medication.

A study examining the protective effects of the drug Truvada found that the effectiveness of PrEP was 50% in study participants who had taken more than half of all tablets. With adherence above 90% (i.e. 90% of the tablets were taken), the rate of new HIV infections even fell by 73%. Of the men who became infected with HIV during the study despite the prophylaxis, only 9% had an effective drug level in the blood. In contrast, of the participants who did not become infected with HIV, 51% had effective drug levels. The researchers calculated that with an adherence of 100%, i.e. H. not a single tablet is forgotten or taken too late, up to 95% of infections could be prevented.

study Active ingredient Study participants Results
CAPRISA 004 Pericoital tenofovir gel south african women 39% fewer infections
iPrEx Emtricitabine / tenofovir tablet Men who have sex with men 42% fewer infections
Partners PrEP Emtricitabine / tenofovir tablet; Tenofovir tablet heterosexual couples in Africa 73% and 62% fewer infections, respectively
TDF2 Emtricitabine / tenofovir tablet heterosexual couple in Botswana 63% fewer infections
FEM-PrEP Emtricitabine / tenofovir tablet african women No reduction in infections (study discontinued due to poor adherence to therapy)
VOICE 003 Emtricitabine / tenofovir tablet; Tenofovir tablet; Tenofovir vaginal gel Women in Zimbabwe, South Africa and Uganda No reduction in infections (very low adherence to therapy)
Bangkok Tenofovir Study Tenofovir tablet male iv drug users in Thailand 48.9% fewer infections
iPrEX OLE Emtricitabine / tenofovir tablet Men / transgender women who have sex with men 84% fewer infections with high compliance
PROUD Emtricitabine / tenofovir tablet MSM in the UK 86% fewer infections
IPERGAY Emtricitabine / tenofovir tablet MSM in France and Canada 86% fewer infections

Cost-benefit analysis

In the first year after EU approval in 2016, the cost of 30 tablets of the original product Truvada in Germany was 819 euros; the first generics came onto the German market in 2017 at prices around 600 euros. In 2019, the Federal Ministry of Health puts the cost of a monthly pack of a copycat drug at 50 euros.

Since pre-exposure prophylaxis causes considerable costs, the question arises as to how these relate to the savings that result from successfully preventing HIV infections. In 2014, an Australian study examined the use of PrEP among MSM - three years before the expiry of Truvada's patent protection and the expected cost reduction through the offer of copycat drugs - and came to the conclusion that a use in the large scale does not make sense. Instead, pre-exposure prophylaxis should be used in individuals who are exposed to a particularly high risk of HIV, such as B. the negative partner of a serodiscordant relationship.

Model calculations from the UK in 2015 and from the Netherlands in 2016 came to the result that the preventive treatment of risk groups among MSM with the expensive original preparation Truvada can be assessed as cost-effective.

Critical points

There are fears and critical questions from various quarters about pre-exposure prophylaxis as a strategy to prevent new HIV infections. The American health authority CDC fears that PrEP could also be carried out with drugs other than those that have been shown to be safe for HIV-negative people. The PrEP could also be carried out differently than prescribed (e.g. taking tablets just before or after sex). Other critical points include a. possible development of resistance and the effect of prophylaxis on risk behavior. In addition, PrEP does not protect against other sexually transmitted diseases. In the IPERGAY study there was a 30% incidence of STDs.

Significance for gay sex

Currently, PrEP is mostly used by gay men, often as an alternative to the condom. PrEP enables HIV-protected sex without condoms for the first time since the outbreak of the AIDS crisis and is therefore changing the gay sex culture: With the spread of PrEP, condom-free sex is increasing. Because the condom was the only effective HIV prevention tool for a long time, there is still a rejection of condom-free sex in parts of the gay community. On online dating platforms such as Grindr or PlanetRomeo , but also partly in the media, there is corresponding slutshaming of PrEP users, i.e. stigmatization of promiscuous sexuality through hate speech. However, PrEP itself can help reduce stigma and (internalized) homophobia because it can lead to dissolving the association between gay sex and disease risks that has been widespread in society since the outbreak of the AIDS crisis.

See also

Individual evidence

  1. ↑ a b Clear rules for HIV prophylaxis. July 2, 2018, accessed October 23, 2019 .
  2. ↑ HIV guidelines - Deutsche AIDS Gesellschaft eV ( daignet.de [accessed on October 23, 2019]).
  3. ↑ Hans-Jürgen Stellbrink: German-Austrian guidelines for HIV pre-exposure prophylaxis. (PDF) AWMF no. 055-008. In: daignet.de. Deutsche AIDS-Gesellschaft , Österreichische AIDS-Gesellschaft, May 24, 2018, p. 10 , accessed on December 23, 2018 (comment on recommendation 1.1).
  4. ↑ Junjun Jiang, Xiaoyi Yang, Li Ye et al .: Pre-Exposure Prophylaxis for the Prevention of HIV Infection in High Risk Populations: A Meta-Analysis of Randomized Controlled Trials . In: PLOS ONE . tape 9 , no. 2 , 2014, p. e87674 , doi : 10.1371 / journal.pone.0087674 , PMC 3912017 (free full text) - (English).
  5. ↑ Truvada - emtricitabine / tenofovir disoproxil. European Public Assessment Report. EMA , September 18, 2018, accessed December 31, 2018 .
  6. ↑ List of the resolutions of the European Union on the approval of medicinal products from August 1, 2016 to August 31, 2016 , accessed on December 31, 2018
  7. ↑ Truvada (emtricitabine and tenofovir) FDA Approval History. Retrieved October 23, 2019 .
  8. ↑ Truvada (Emtricitabine / Tenofovir Disoproxil) - Overview of Truvada and why it is approved in the EU. (PDF) European Public Assessment Report - Overview. EMA , February 2018, accessed on December 31, 2018 : "The recommended dose for treating or preventing HIV1 infection is one tablet once a day, preferably with food."
  9. ↑ Jean-Michel Molina, Catherine Capitant, Bruno Spire, et al .: On-Demand Preexposure Prophylaxis in Men at High Risk for HIV-1 Infection . In: New England Journal of Medicine . tape 373 , no. 23 , December 3, 2015, p. 2237-2246 , doi : 10.1056 / NEJMoa1506273 , PMID 26624850 (English).
  10. ↑ #PrEPistDa: Cash-financed protection against HIV. German AIDS Help , August 30, 2019, accessed on September 2, 2019 .
  11. ↑ The health insurance fund now pays for HIV prophylaxis. German AIDS Help , August 30, 2019, accessed on September 2, 2019 .
  12. ↑ BGBl. 2019 I p. 646
  13. ↑ LADR informs: New services in the context of HIV pre-exposure prophylaxis (PrEP) from September 1, 2019 , edition 278 09/2019
  14. ↑ Hans-Jürgen Stellbrink: German-Austrian guidelines for HIV pre-exposure prophylaxis. (PDF) AWMF no. 055-008. In: daignet.de. Deutsche AIDS-Gesellschaft , Österreichische AIDS-Gesellschaft, May 24, 2018, p. 15 , accessed on December 23, 2018 (comment on recommendation 1.5).
  15. ^ Armin Schafberger: Quo vadis, HIV-PrEP? In: magazin.hiv. Deutsche AIDS-Hilfe , March 7, 2013, accessed on December 23, 2018 .
  16. ↑ a b Robert M. Grant, Javier R. Lama, Peter L. Anderson, Vanessa McMahan, Albert Y. Liu et al .: Preexposure Chemoprophylaxis for HIV Prevention in Men Who Have Sex with Men . In: The New England Journal of Medicine . tape 363 , no. 227 , December 30, 2010, p. 2587-2599 , doi : 10.1056 / NEJMoa1011205 , PMC 3079639 (free full text) - (English).
  17. ↑ Graciela Andrei, Andrea Lisco, Christophe Vanpouille, Robert Snoeck, Leonid Margolis, Jan Balzarini et al .: Topical Tenofovir, a Microbicide Effective against HIV, Inhibits Herpes Simplex Virus-2 Replication . In: Cell Host & Microbe . tape 10 , no. 4 , October 19, 2011, p. 379–389 , doi : 10.1016 / j.chom.2011.08.015 , PMC 3201796 (free full text) - (English).
  18. ↑ Connie Celum, Jared Baeten: Tenofovir-based Pre-Exposure Prophylaxis for HIV Prevention: Evidence and evolving questions . In: Current Opinion in Infectious Diseases . tape 25 , no. 1 , February 2012, p. 51–57 , doi : 10.1097 / QCO.0b013e32834ef5ef , PMID 22156901 , PMC 3266126 (free full text) - (English).
  19. ↑ a b Connie L. Celum: HIV Preexposure Prophylaxis: New Data and Potential Use . In: Topics in Antiviral Medicine . tape 19 , no. 5 , December 2011, p. 181-185 , PMC 6148898 (free full text) - (English).
  20. ↑ Africa: HIV prevention study fails due to disinterest of young women. In: aerzteblatt.de. Deutsches Ärzteblatt, March 5, 2013, accessed on December 23, 2018 .
  21. ↑ Kachit Choopanya, Michael Martin, Pravan Suntharasamai, Udomsak Sangkum, Philip A Mock, Manoj Leethochawalit, et al .: Antiretroviral prophylaxis for HIV infection in injecting drug users in Bangkok, Thailand (the Bangkok Tenofovir Study): a randomized, double-blind , placebo-controlled phase 3 trial . In: The Lancet . tape 381 , no. 9883 , p. 2083-2090 , doi : 10.1016 / S0140-6736 (13) 61127-7 , PMID 23769234 (English).
  22. ^ Robert M. Grant, Peter L. Anderson, Vanessa McMahan, Albert Liu et al .: Pre-Exposure Prophylaxis (PrEP) Initiative: Open Label Extension. (pptx) (No longer available online.) July 22, 2014, archived from the original on March 4, 2016 ; accessed on December 23, 2018 (English).
  23. ↑ Robert M Grant, Peter L Anderson, Vanessa McMahan, Albert Liu, K Rivet Amico, Megha Mehrotra 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 . In: The Lancet . tape 14 , no. 9 , September 1, 2014, p. 820–829 , doi : 10.1016 / S1473-3099 (14) 70847-3 , PMC 6107918 (free full text).
  24. ↑ David I. Dolling, Monica Desai, Alan McOwan et al .: An analysis of baseline data from the PROUD study: an open-label randomized trial of pre-exposure prophylaxis . In: Trials . tape 17 , no. 163 , April 28, 2015, doi : 10.1186 / s13063-016-1286-4 , PMC 4806447 (free full text).
  25. ↑ Jean-Michel Molina, Catherine Capitant, Bruno Spire, Ph.D., Gilles Pialoux et al .: On-Demand Preexposure Prophylaxis in Men at High Risk for HIV-1 Infection . In: New England Journal of Medicine . tape 373 , no. 23 , December 3, 2015, p. 2237-2246 , doi : 10.1056 / NEJMoa1506273 , PMID 26624850 .
  26. ↑ Truvada generics are now available on the German market. July 27, 2017, accessed October 23, 2019 .
  27. ↑ Deutscher Ärzteverlag GmbH, editorial office of Deutsches Ärzteblatt: HIV pre-exposure prophylaxis should provide health insurance benefits ... July 20, 2018, accessed on October 23, 2019 .
  28. ^ Karen Schneider, Richard T. Gray, David P. Wilson: A Cost-effectiveness Analysis of HIV Preexposure Prophylaxis for Men Who Have Sex With Men in Australia . In: Clinical Infectious Diseases . tape 58 , no. 7 , April 1, 2014, p. 1027-1034 , doi : 10.1093 / cid / cit946 , PMID 24385445 .
  29. ↑ Sheena McCormack, David T. Dunn, Monica Desai, David I. Dolling, Mitzy Gafos: Pre-exposure prophylaxis to prevent the acquisition of HIV-1 infection (PROUD): effectiveness results from the pilot phase of a pragmatic open-label randomized trial . In: The Lancet . tape 387 , no. 10013 , January 2, 2016, ISSN  0140-6736 , p. 53-60 , doi : 10.1016 / S0140-6736 (15) 00056-2 ( thelancet.com [accessed October 23, 2019]).
  30. ↑ Brooke E. Nichols, Charles AB Boucher, Marc van der Valk, Bart JA Rijnders, David AMC van de Vijver: Cost-effectiveness analysis of pre-exposure prophylaxis for HIV-1 prevention in the Netherlands: a mathematical modeling study . In: The Lancet Infectious Diseases . tape 16 , no. 12 , December 1, 2016, ISSN  1473-3099 , p. 1423-1429 , doi : 10.1016 / S1473-3099 (16) 30311-5 , PMID 27665989 ( thelancet.com [accessed October 23, 2019]).
  31. ↑ Laura Sivitz Leifman: NIH to test maraviroc-based drug regimens for HIV prevention. In: nih.gov. National Institutes of Health , July 18, 2012, accessed December 23, 2018 .
  32. ↑ Karsten Schubert: HIV-PrEP as a democratic biopolitics. In: magazin.hiv. January 24, 2020, accessed on February 24, 2020 (German).
  33. ↑ Free travel for wild hookers: “PrEP is so dangerous!” Accessed on February 24, 2020 .
  34. ^ Karsten Schubert: The Democratic Biopolitics of PrEP . In: Biopolitics - Governments of Life Today (=  Political Enlightenment - Constructivist Perspectives ). Springer Fachmedien, Wiesbaden 2019, ISBN 978-3-658-25769-9 , pp. 121-153 , doi : 10.1007 / 978-3-658-25769-9_5 .