Predictive factors for HIV infection among men who have sex with men and who are seeking PrEP: A secondary analysis of the PROUD trial

Ellen White; David T. Dunn; Monica Desai; Mitzy Gafos; Peter Kirwan; Ann K. Sullivan; Amanda Clarke; Sheena McCormack

doi:10.1136/sextrans-2018-053808

Predictive factors for HIV infection among men who have sex with men and who are seeking PrEP: A secondary analysis of the PROUD trial

Ellen White^*, David T. Dunn, Monica Desai, Mitzy Gafos, Peter Kirwan, Ann K. Sullivan, Amanda Clarke, Sheena McCormack

^*Corresponding author for this work

Pillar Testing Staff budget centre

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Abstract

Objectives Pre-exposure prophylaxis (PrEP) is a highly effective method of HIV prevention for men who have sex with men (MSM). However, uncertainty remains around the optimal eligibility criteria for PrEP, specifically whether there are subgroups at low risk of HIV for whom PrEP might not be warranted. Methods PROUD was an open-label waitlist trial design that randomised MSM attending participating sexual health centres in England to receive PrEP immediately (IMM) or after a deferral period of 1 year (DEF). This analysis is based on participants who were randomised to the deferred arm, when they did not have access to PrEP. HIV incidence was compared between subgroups defined by baseline characteristics. Results Overall, 21 participants acquired HIV infection over 239.3 person-years (PY) follow-up, yielding an incidence rate of 8.8/100 PY (95% CI 5.4 to 13.4). Two highly significant predictors for HIV acquisition were identified. Men with a self-reported diagnosis of syphilis, rectal chlamydia (CT) or rectal gonorrhoea (GC) in the previous 12 months had an incidence of 17.2/100 PY (95% CI 9.7 to 28.5); those reporting receptive anal intercourse without a condom (ncRAI) with two or more partners in the previous 3 months had an incidence of 13.6/100 PY (95% CI 7.9 to 21.7). The incidence rate among participants lacking both of these risk factors was 1.1/100 PY (1/87.6, 95% CI 0.03 to 6.4). Conclusions The high HIV incidence in PROUD suggests that most participants appropriately judged their need for PrEP. Eligibility criteria for a PrEP programme can therefore be broad, as in the current guidelines. However, a recent history of syphilis or rectal CT/GC, or multiple ncRAI partners indicates a high imminent risk of HIV infection. MSM with any of these characteristics should be offered PrEP as a matter of urgency.

Original language	English
Pages (from-to)	449-454
Number of pages	6
Journal	Sexually Transmitted Infections
Volume	95
Issue number	6
DOIs	https://doi.org/10.1136/sextrans-2018-053808
Publication status	Published - 1 Sept 2019

Bibliographical note

Funding Information:
Competing interests the PrOUD study was provided drug free of charge by gilead Sciences which also distributed it to participating clinics and provided funds for additional diagnostic tests for HcV and drug levels. eW’s university fees and stipend were funded by gilead Sciences. DtD has received fees for participation on advisory boards and educational workshops from ViiV Healthcare and gilead Sciences. PK was part funded by gilead Sciences during 2017/2018. ac received advisory board fees from gilead Sciences and gSK/ViiV; speaker fees from gilead and conferences bursaries from gilead & Janssen. SM reports grants from the european Union H2020 scheme, eDctP 2, the national institute of Health research and gilead Sciences; other support from gilead Sciences, and the Population council Microbicide advisory Board; and is chair of the Project advisory committee for USaiD grant awarded to cOnraD to develop tenofovir-based products for use by women (non-financial).

Funding Information:
UK Medical Research Council (MRC-UU-12023/23)

Funding Information:
Contributors SM led the study. DtD, MD, Mg and SM conceived and designed the study. aKS, ac and SM recruited participants and collected data. eW conducted the analyses and led the writing on this paper. PK conducted the participant matching. all authors read and approved the final manuscript. eW had full access to all the data in the study and had final responsibility for the decision to submit for publication. Funding the PrOUD trial was supported by ad hoc funding from the Medical research council (Mrc) clinical trials Unit at University college london and an innovations grant from Public Health england, and most clinics received support through the UK niHr clinical research network. gilead Sciences provided truvada, distributed drug to clinics and awarded a grant for the additional diagnostic tests including drug concentrations in plasma. eW, DtD and SM were supported by the UK Medical research council (Mrc_UU_12023/23) during preparation of and outside the submitted work.

Publisher Copyright:
© Author(s) (or their employer(s)) 2019. Re-use permitted under CC BY. Published by BMJ.

Keywords

Eligibility criteria
HIV
Msm
Prep

UN SDGs

This output contributes to the following UN Sustainable Development Goals (SDGs)

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10.1136/sextrans-2018-053808

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title = "Predictive factors for HIV infection among men who have sex with men and who are seeking PrEP: A secondary analysis of the PROUD trial",

abstract = "Objectives Pre-exposure prophylaxis (PrEP) is a highly effective method of HIV prevention for men who have sex with men (MSM). However, uncertainty remains around the optimal eligibility criteria for PrEP, specifically whether there are subgroups at low risk of HIV for whom PrEP might not be warranted. Methods PROUD was an open-label waitlist trial design that randomised MSM attending participating sexual health centres in England to receive PrEP immediately (IMM) or after a deferral period of 1 year (DEF). This analysis is based on participants who were randomised to the deferred arm, when they did not have access to PrEP. HIV incidence was compared between subgroups defined by baseline characteristics. Results Overall, 21 participants acquired HIV infection over 239.3 person-years (PY) follow-up, yielding an incidence rate of 8.8/100 PY (95% CI 5.4 to 13.4). Two highly significant predictors for HIV acquisition were identified. Men with a self-reported diagnosis of syphilis, rectal chlamydia (CT) or rectal gonorrhoea (GC) in the previous 12 months had an incidence of 17.2/100 PY (95% CI 9.7 to 28.5); those reporting receptive anal intercourse without a condom (ncRAI) with two or more partners in the previous 3 months had an incidence of 13.6/100 PY (95% CI 7.9 to 21.7). The incidence rate among participants lacking both of these risk factors was 1.1/100 PY (1/87.6, 95% CI 0.03 to 6.4). Conclusions The high HIV incidence in PROUD suggests that most participants appropriately judged their need for PrEP. Eligibility criteria for a PrEP programme can therefore be broad, as in the current guidelines. However, a recent history of syphilis or rectal CT/GC, or multiple ncRAI partners indicates a high imminent risk of HIV infection. MSM with any of these characteristics should be offered PrEP as a matter of urgency.",

keywords = "Eligibility criteria, HIV, Msm, Prep",

author = "Ellen White and Dunn, {David T.} and Monica Desai and Mitzy Gafos and Peter Kirwan and Sullivan, {Ann K.} and Amanda Clarke and Sheena McCormack",

note = "Funding Information: Competing interests the PrOUD study was provided drug free of charge by gilead Sciences which also distributed it to participating clinics and provided funds for additional diagnostic tests for HcV and drug levels. eW{\textquoteright}s university fees and stipend were funded by gilead Sciences. DtD has received fees for participation on advisory boards and educational workshops from ViiV Healthcare and gilead Sciences. PK was part funded by gilead Sciences during 2017/2018. ac received advisory board fees from gilead Sciences and gSK/ViiV; speaker fees from gilead and conferences bursaries from gilead & Janssen. SM reports grants from the european Union H2020 scheme, eDctP 2, the national institute of Health research and gilead Sciences; other support from gilead Sciences, and the Population council Microbicide advisory Board; and is chair of the Project advisory committee for USaiD grant awarded to cOnraD to develop tenofovir-based products for use by women (non-financial). Funding Information: UK Medical Research Council (MRC-UU-12023/23) Funding Information: Contributors SM led the study. DtD, MD, Mg and SM conceived and designed the study. aKS, ac and SM recruited participants and collected data. eW conducted the analyses and led the writing on this paper. PK conducted the participant matching. all authors read and approved the final manuscript. eW had full access to all the data in the study and had final responsibility for the decision to submit for publication. Funding the PrOUD trial was supported by ad hoc funding from the Medical research council (Mrc) clinical trials Unit at University college london and an innovations grant from Public Health england, and most clinics received support through the UK niHr clinical research network. gilead Sciences provided truvada, distributed drug to clinics and awarded a grant for the additional diagnostic tests including drug concentrations in plasma. eW, DtD and SM were supported by the UK Medical research council (Mrc_UU_12023/23) during preparation of and outside the submitted work. Publisher Copyright: {\textcopyright} Author(s) (or their employer(s)) 2019. Re-use permitted under CC BY. Published by BMJ.",

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doi = "10.1136/sextrans-2018-053808",

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journal = "Sexually Transmitted Infections",

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T1 - Predictive factors for HIV infection among men who have sex with men and who are seeking PrEP

T2 - A secondary analysis of the PROUD trial

AU - White, Ellen

AU - Dunn, David T.

AU - Desai, Monica

AU - Gafos, Mitzy

AU - Kirwan, Peter

AU - Sullivan, Ann K.

AU - Clarke, Amanda

AU - McCormack, Sheena

N1 - Funding Information: Competing interests the PrOUD study was provided drug free of charge by gilead Sciences which also distributed it to participating clinics and provided funds for additional diagnostic tests for HcV and drug levels. eW’s university fees and stipend were funded by gilead Sciences. DtD has received fees for participation on advisory boards and educational workshops from ViiV Healthcare and gilead Sciences. PK was part funded by gilead Sciences during 2017/2018. ac received advisory board fees from gilead Sciences and gSK/ViiV; speaker fees from gilead and conferences bursaries from gilead & Janssen. SM reports grants from the european Union H2020 scheme, eDctP 2, the national institute of Health research and gilead Sciences; other support from gilead Sciences, and the Population council Microbicide advisory Board; and is chair of the Project advisory committee for USaiD grant awarded to cOnraD to develop tenofovir-based products for use by women (non-financial). Funding Information: UK Medical Research Council (MRC-UU-12023/23) Funding Information: Contributors SM led the study. DtD, MD, Mg and SM conceived and designed the study. aKS, ac and SM recruited participants and collected data. eW conducted the analyses and led the writing on this paper. PK conducted the participant matching. all authors read and approved the final manuscript. eW had full access to all the data in the study and had final responsibility for the decision to submit for publication. Funding the PrOUD trial was supported by ad hoc funding from the Medical research council (Mrc) clinical trials Unit at University college london and an innovations grant from Public Health england, and most clinics received support through the UK niHr clinical research network. gilead Sciences provided truvada, distributed drug to clinics and awarded a grant for the additional diagnostic tests including drug concentrations in plasma. eW, DtD and SM were supported by the UK Medical research council (Mrc_UU_12023/23) during preparation of and outside the submitted work. Publisher Copyright: © Author(s) (or their employer(s)) 2019. Re-use permitted under CC BY. Published by BMJ.

PY - 2019/9/1

Y1 - 2019/9/1

N2 - Objectives Pre-exposure prophylaxis (PrEP) is a highly effective method of HIV prevention for men who have sex with men (MSM). However, uncertainty remains around the optimal eligibility criteria for PrEP, specifically whether there are subgroups at low risk of HIV for whom PrEP might not be warranted. Methods PROUD was an open-label waitlist trial design that randomised MSM attending participating sexual health centres in England to receive PrEP immediately (IMM) or after a deferral period of 1 year (DEF). This analysis is based on participants who were randomised to the deferred arm, when they did not have access to PrEP. HIV incidence was compared between subgroups defined by baseline characteristics. Results Overall, 21 participants acquired HIV infection over 239.3 person-years (PY) follow-up, yielding an incidence rate of 8.8/100 PY (95% CI 5.4 to 13.4). Two highly significant predictors for HIV acquisition were identified. Men with a self-reported diagnosis of syphilis, rectal chlamydia (CT) or rectal gonorrhoea (GC) in the previous 12 months had an incidence of 17.2/100 PY (95% CI 9.7 to 28.5); those reporting receptive anal intercourse without a condom (ncRAI) with two or more partners in the previous 3 months had an incidence of 13.6/100 PY (95% CI 7.9 to 21.7). The incidence rate among participants lacking both of these risk factors was 1.1/100 PY (1/87.6, 95% CI 0.03 to 6.4). Conclusions The high HIV incidence in PROUD suggests that most participants appropriately judged their need for PrEP. Eligibility criteria for a PrEP programme can therefore be broad, as in the current guidelines. However, a recent history of syphilis or rectal CT/GC, or multiple ncRAI partners indicates a high imminent risk of HIV infection. MSM with any of these characteristics should be offered PrEP as a matter of urgency.

AB - Objectives Pre-exposure prophylaxis (PrEP) is a highly effective method of HIV prevention for men who have sex with men (MSM). However, uncertainty remains around the optimal eligibility criteria for PrEP, specifically whether there are subgroups at low risk of HIV for whom PrEP might not be warranted. Methods PROUD was an open-label waitlist trial design that randomised MSM attending participating sexual health centres in England to receive PrEP immediately (IMM) or after a deferral period of 1 year (DEF). This analysis is based on participants who were randomised to the deferred arm, when they did not have access to PrEP. HIV incidence was compared between subgroups defined by baseline characteristics. Results Overall, 21 participants acquired HIV infection over 239.3 person-years (PY) follow-up, yielding an incidence rate of 8.8/100 PY (95% CI 5.4 to 13.4). Two highly significant predictors for HIV acquisition were identified. Men with a self-reported diagnosis of syphilis, rectal chlamydia (CT) or rectal gonorrhoea (GC) in the previous 12 months had an incidence of 17.2/100 PY (95% CI 9.7 to 28.5); those reporting receptive anal intercourse without a condom (ncRAI) with two or more partners in the previous 3 months had an incidence of 13.6/100 PY (95% CI 7.9 to 21.7). The incidence rate among participants lacking both of these risk factors was 1.1/100 PY (1/87.6, 95% CI 0.03 to 6.4). Conclusions The high HIV incidence in PROUD suggests that most participants appropriately judged their need for PrEP. Eligibility criteria for a PrEP programme can therefore be broad, as in the current guidelines. However, a recent history of syphilis or rectal CT/GC, or multiple ncRAI partners indicates a high imminent risk of HIV infection. MSM with any of these characteristics should be offered PrEP as a matter of urgency.

KW - Eligibility criteria

KW - HIV

KW - Msm

KW - Prep

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SN - 1368-4973

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Predictive factors for HIV infection among men who have sex with men and who are seeking PrEP: A secondary analysis of the PROUD trial

Abstract

Bibliographical note

Keywords

UN SDGs

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