Cited by 1,878HIV/AIDS Research and InterventionsHIV/AIDS drug development and treatmentHIV, Drug Use, Sexual Risk

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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.

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McCormack, Sheena, Dunn, David T, Desai, Monica, Dolling, David I, Gafos, Mitzy, Gilson, Richard, Sullivan, Ann K, Clarke, Amanda, Reeves, Iain, Schembri, Gabriel, Mackie, Nicola, Bowman, Christine, Lacey, Charles J, Apea, Vanessa, Brady, Michael, Fox, Julie, Taylor, Stephen, Antonucci, Simone, Khoo, Saye H, Rooney, James, Nardone, Anthony, Fisher, Martin, McOwan, Alan, Phillips, Andrew N, Johnson, Anne M, Gazzard, Brian, Gill, Owen N·2016·The Lancet

DOI 10.1016/s0140-6736(15)00056-2PMC PMC4700047

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Abstract

BACKGROUND: Randomised placebo-controlled trials have shown that daily oral pre-exposure prophylaxis (PrEP) with tenofovir-emtricitabine reduces the risk of HIV infection. However, this benefit could be counteracted by risk compensation in users of PrEP. We did the PROUD study to assess this effect. METHODS: PROUD is an open-label randomised trial done at 13 sexual health clinics in England. We enrolled HIV-negative gay and other men who have sex with men who had had anal intercourse without a condom in the previous 90 days. Participants were randomly assigned (1:1) to receive daily combined tenofovir disoproxil fumarate (245 mg) and emtricitabine (200 mg) either immediately or after a deferral period of 1 year. Randomisation was done via web-based access to a central computer-generated list with variable block sizes (stratified by clinical site). Follow-up was quarterly. The primary outcomes for the pilot phase were time to accrue 500 participants and retention; secondary outcomes included incident HIV infection during the deferral period, safety, adherence, and risk compensation. The trial is registered with ISRCTN (number ISRCTN94465371) and ClinicalTrials.gov (NCT02065986). FINDINGS: We enrolled 544 participants (275 in the immediate group, 269 in the deferred group) between Nov 29, 2012, and April 30, 2014. Based on early evidence of effectiveness, the trial steering committee recommended on Oct 13, 2014, that all deferred participants be offered PrEP. Follow-up for HIV incidence was complete for 243 (94%) of 259 patient-years in the immediate group versus 222 (90%) of 245 patient-years in the deferred group. Three HIV infections occurred in the immediate group (1·2/100 person-years) versus 20 in the deferred group (9·0/100 person-years) despite 174 prescriptions of post-exposure prophylaxis in the deferred group (relative reduction 86%, 90% CI 64-96, p=0·0001; absolute difference 7·8/100 person-years, 90% CI 4·3-11·3). 13 men (90% CI 9-23) in a similar population would need access to 1 year of PrEP to avert one HIV infection. We recorded no serious adverse drug reactions; 28 adverse events, most commonly nausea, headache, and arthralgia, resulted in interruption of PrEp. We detected no difference in the occurrence of sexually transmitted infections, including rectal gonorrhoea and chlamydia, between groups, despite a suggestion of risk compensation among some PrEP recipients. INTERPRETATION: In this high incidence population, daily tenofovir-emtricitabine conferred even higher protection against HIV than in placebo-controlled trials, refuting concerns that effectiveness would be less in a real-world setting. There was no evidence of an increase in other sexually transmitted infections. Our findings strongly support the addition of PrEP to the standard of prevention for men who have sex with men at risk of HIV infection. FUNDING: MRC Clinical Trials Unit at UCL, Public Health England, and Gilead Sciences.

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Figure 1 Trial profile *First to deferred and subsequently to immediate; considered in the deferred group for analyses but continued on pre-exposure prophylaxis. †19 pairs of partners were allocated to the same group (14 to immediate, five to deferred) including six pairs (all assigned to the immediate group) not enrolled concurrently. ‡One participant who was allocated to the deferred group was prescribed immediate pre-exposure prophylaxis in error; he was included in the deferred group for analyses but continued on pre-exposure prophylaxis. §Includes unable to contact, moved away, and non-attendance as no longer at risk. ¶HIV status ascertained if confirmed HIV-positive or HIV-negative test after 48 weeks or after Oct 13, 2014.CC BY · PubMed Central

Figure 2 Incident HIV infections Left bound for each HIV case represents last non-reactive HIV test; right bound represents first reactive HIV test. The dotted line represents time when participants in the deferred group became eligible for pre-exposure prophylaxis under the original protocol. *Had a stored enrolment sample that tested positive for HIV RNA but was retained in the analysis.CC BY · PubMed Central

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Antonucci S, Desai M, Dolling D, et al. The UK PROUD PrEP Pilot study: a baseline analysis. 20th International AIDS Conference; July 20–25, 2014; Melbourne, Australia. Abstract THPE197.
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Authors: McCormack, S., Dunn, D. T., Desai, M., Dolling, D. I., Gafos, M., Gilson, R., Sullivan, A. K., Clarke, A., Reeves, I., Schembri, G., Mackie, N., Bowman, C., Lacey, C. J., Apea, V., Brady, M., Fox, J., Taylor, S., Antonucci, S., Khoo, S. H., Rooney, J., Nardone, A., Fisher, M., McOwan, A., Phillips, A. N., Johnson, A. M., Gazzard, B., & Gill, O. N.
Affiliations: Chelsea and Westminster Hospital NHS Foundation Trust (GB)
MRC Clinical Trials Unit at UCL (GB)
Public Health England (GB)
Central and North West London NHS Foundation Trust (GB)
Royal Sussex County Hospital (GB)
Homerton University Hospital NHS Foundation Trust (GB)
Imperial College Healthcare NHS Trust (GB)
Sheffield Teaching Hospitals NHS Foundation Trust (GB)
University of York (GB)
Barts Health NHS Trust (GB)
King's College Hospital NHS Foundation Trust (GB)
Guy's and St Thomas' NHS Foundation Trust (GB)
Heart of England NHS Foundation Trust (GB)
University of Liverpool (GB)
Gilead Sciences (United States) (US)
University College London (GB)
Corresponding author: McCormack, Sheena
ORCID: McCormack, Sheena
Dunn, David T
Desai, Monica
Dolling, David I
Gafos, Mitzy
Gilson, Richard
Sullivan, Ann K
Clarke, Amanda
Lacey, Charles J
Apea, Vanessa
Brady, Michael
Fox, Julie
Taylor, Stephen
Khoo, Saye H
Rooney, James
Nardone, Anthony
Fisher, Martin
Phillips, Andrew N
Gill, Owen N
Venue: The Lancet
Publisher: Elsevier BV
Published: 2016-01
Volume: 387
Issue: 10013
Pages: 53-60
ISSN: 0099-5355 (ISSN-L)
0140-6736
DOI: 10.1016/s0140-6736(15)00056-2
PMC: PMC4700047
OpenAlex: W1413161224
Cited by: 1,878
References: 24
Citations by year: 2026: 61 · 2025: 122 · 2024: 136 · 2023: 163 · 2022: 174 · 2021: 201 · 2020: 181 · 2019: 240 · 2018: 207 · 2017: 213 · 2016: 152
FWCI: 154.11
Type: journal article
Language: en
Open access: hybrid
doi.org
Licence: cc-by
www.elsevier.com/tdm/userlicense/1.0/ (tdm)
creativecommons.org/licenses/by/4.0/ (vor)
Locations: The Lancet (publishedVersion, cc-by)
Europe PMC (PubMed Central) (publishedVersion, cc-by)
PubMed Central (publishedVersion, cc-by)
PubMed (publishedVersion)
White Rose Research Online (University of Leeds, The University of Sheffield, University of York) (acceptedVersion)
White Rose Research Online (University of Leeds, The University of Sheffield, University of York) (submittedVersion)
UCL Discovery (University College London) (submittedVersion)
Funders: National Institute for Health and Care Research (ACF-2008-20-002, NF-SI-0508-10244)
Public Health England
Topics: Health Sciences › Medicine › Infectious Diseases › HIV/AIDS Research and Interventions
Health Sciences › Medicine › Infectious Diseases › HIV/AIDS drug development and treatment
Health Sciences › Medicine › Epidemiology › HIV, Drug Use, Sexual Risk
Keywords: tenofovir disoproxil fumarate, emtricitabine, risk compensation, men who have sex with men, post-exposure prophylaxis, trial retention, PrEP adherence, sexual health clinics
MeSH terms: Emtricitabine, Tenofovir Disoproxil Fumarate Drug Combination, Adult, Bisexuality, England, Humans, Male, Pilot Projects, HIV-1, HIV Infections, Treatment Outcome, Condoms, Homosexuality, Male, Anti-HIV Agents, Unsafe Sex, Pre-Exposure Prophylaxis

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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.

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