The European preexposure prophylaxis revolution

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Abstract

Purpose of review

The review describes the European epidemic and the challenges in moving from clinical trials of preexposure prophylaxis (PrEP) to routine practice.

Recent findings

Two European trials conducted in gay and other MSM and transgender women reported a high and consistent reduction in HIV incidence using oral PrEP with tenofovir/emtricitabine (TDF/FTC). The incidence of HIV infection in the control group was much higher than anticipated, based on routine surveillance data in MSM, in spite of the highest standard of HIV prevention available.

Summary

Recent results have highlighted the urgent need to make PrEP available to key populations in Europe as an additional prevention tool. Gilead has not yet submitted an application to use TDF/FTC as PrEP in Europe. Although regulatory approval would accelerate implementation, countries are already dispensing TDF/FTC as postexposure prophylaxis without this. Services for prevention are diverse across countries ranging from free, walk-in services for the diagnosis and treatment of HIV and other sexually transmitted infections, to insurance-dependent reimbursement of private clinical services. Momentum is gathering in Europe with PrEP demonstration projects in MSM and a growing demand from community organizations. Each Member State urgently needs to identify their key populations and determine the service best placed to provide this new prevention strategy within a comprehensive prevention package.

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Most cited references 34

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Preexposure Chemoprophylaxis for HIV Prevention in Men Who Have Sex with Men

Robert M Grant, Javier R Lama, Peter L Anderson … (2010)

Antiretroviral chemoprophylaxis before exposure is a promising approach for the prevention of human immunodeficiency virus (HIV) acquisition. We randomly assigned 2499 HIV-seronegative men or transgender women who have sex with men to receive a combination of two oral antiretroviral drugs, emtricitabine and tenofovir disoproxil fumarate (FTC-TDF), or placebo once daily. All subjects received HIV testing, risk-reduction counseling, condoms, and management of sexually transmitted infections. The study subjects were followed for 3324 person-years (median, 1.2 years; maximum, 2.8 years). Of these subjects, 10 were found to have been infected with HIV at enrollment, and 100 became infected during follow-up (36 in the FTC-TDF group and 64 in the placebo group), indicating a 44% reduction in the incidence of HIV (95% confidence interval, 15 to 63; P=0.005). In the FTC-TDF group, the study drug was detected in 22 of 43 of seronegative subjects (51%) and in 3 of 34 HIV-infected subjects (9%) (P<0.001). Nausea was reported more frequently during the first 4 weeks in the FTC-TDF group than in the placebo group (P<0.001). The two groups had similar rates of serious adverse events (P=0.57). Oral FTC-TDF provided protection against the acquisition of HIV infection among the subjects. Detectable blood levels strongly correlated with the prophylactic effect. (Funded by the National Institutes of Health and the Bill and Melinda Gates Foundation; ClinicalTrials.gov number, NCT00458393.).

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Antiretroviral Prophylaxis for HIV Prevention in Heterosexual Men and Women

Jared Baeten, Deborah Donnell, Patrick Ndase … (2012)

New England Journal of Medicine, 367(5), 399-410

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Antiretroviral preexposure prophylaxis for heterosexual HIV transmission in Botswana.

Michael Thigpen, Poloko M. Kebaabetswe, Lynn Paxton … (2012)

Preexposure prophylaxis with antiretroviral agents has been shown to reduce the transmission of human immunodeficiency virus (HIV) among men who have sex with men; however, the efficacy among heterosexuals is uncertain. We randomly assigned HIV-seronegative men and women to receive either tenofovir disoproxil fumarate and emtricitabine (TDF-FTC) or matching placebo once daily. Monthly study visits were scheduled, and participants received a comprehensive package of prevention services, including HIV testing, counseling on adherence to medication, management of sexually transmitted infections, monitoring for adverse events, and individualized counseling on risk reduction; bone mineral density testing was performed semiannually in a subgroup of participants. A total of 1219 men and women underwent randomization (45.7% women) and were followed for 1563 person-years (median, 1.1 years; maximum, 3.7 years). Because of low retention and logistic limitations, we concluded the study early and followed enrolled participants through an orderly study closure rather than expanding enrollment. The TDF-FTC group had higher rates of nausea (18.5% vs. 7.1%, P<0.001), vomiting (11.3% vs. 7.1%, P=0.008), and dizziness (15.1% vs. 11.0%, P=0.03) than the placebo group, but the rates of serious adverse events were similar (P=0.90). Participants who received TDF-FTC, as compared with those who received placebo, had a significant decline in bone mineral density. K65R, M184V, and A62V resistance mutations developed in 1 participant in the TDF-FTC group who had had an unrecognized acute HIV infection at enrollment. In a modified intention-to-treat analysis that included the 33 participants who became infected during the study (9 in the TDF-FTC group and 24 in the placebo group; 1.2 and 3.1 infections per 100 person-years, respectively), the efficacy of TDF-FTC was 62.2% (95% confidence interval, 21.5 to 83.4; P=0.03). Daily TDF-FTC prophylaxis prevented HIV infection in sexually active heterosexual adults. The long-term safety of daily TDF-FTC prophylaxis, including the effect on bone mineral density, remains unknown. (Funded by the Centers for Disease Control and Prevention and the National Institutes of Health; TDF2 ClinicalTrials.gov number, NCT00448669.).

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Author and article information

Journal

Journal ID (nlm-ta): Curr Opin HIV AIDS

Journal ID (iso-abbrev): Curr Opin HIV AIDS

Journal ID (publisher-id): COHIV

Title: Current Opinion in HIV and AIDS

Publisher: Lippincott Williams & Wilkins

ISSN (Print): 1746-630X

ISSN (Electronic): 1746-6318

Publication date (Print): January 2016

Publication date (Electronic): 10 March 2016

Volume: 11

Issue: 1

Pages: 74-79

Affiliations

[a ]NAM Publications/Aidsmap.com, London, UK

[b ]European AIDS Treatment Group, Brussels, Belgium

[c ]Medical Research Council Clinical Trials Unit at UCL, University College London, London, UK

[d ]INSERM U941, University of Paris Diderot, Sorbonne Paris Cité

[e ]Department of Infectious Diseases, Hôpital Saint Louis, APHP, Paris, France

Author notes

Correspondence to Sheena McCormack, Medical Research Council Clinical Trials Unit at UCL, Institute of Clinical Trials and Methodology, Aviation House, 125 Kingsway, London WC2B 6NH, UK. Tel: +44 207 670 4708/14; fax: +44 207 670 4690; e-mail: s.mccormack@ 123456ucl.ac.uk

Article

Accession ID: 00012

DOI: 10.1097/COH.0000000000000223

PMC ID: 4888928

PubMed ID: 26599164

SO-VID: aeffe959-785a-4895-98cd-a1295cdf1105

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This is an open-access article distributed under the terms of the Creative Commons Attribution-NonCommercial-NoDerivatives 4.0 License, where it is permissible to download and share the work provided it is properly cited. The work cannot be changed in any way or used commercially. http://creativecommons.org/licenses/by-nc-nd/4.0

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Keywords: europe,health services,key populations,msm,preexposure prophylaxis

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Keywords: europe, health services, key populations, msm, preexposure prophylaxis

The European preexposure prophylaxis revolution

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Abstract

Purpose of review

Recent findings

Summary

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UCL: UN SDG 05 Gender Equality

Most cited references 34

Preexposure Chemoprophylaxis for HIV Prevention in Men Who Have Sex with Men

Antiretroviral Prophylaxis for HIV Prevention in Heterosexual Men and Women

Antiretroviral preexposure prophylaxis for heterosexual HIV transmission in Botswana.

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