Daily and event-driven pre-exposure prophylaxis for men who have sex with men in Belgium: results of a prospective cohort measuring adherence, sexual behaviour and STI incidence.

Pre-Exposure Prophylaxis (PrEP) is highly effective in reducing the risk for HIV infection among men who have sex with men (MSM) and may have an important impact in slowing down the HIV epidemic. Concerns remain however about low adherence, increased risk behaviour and reduced condom use when using PrEP. The aim of this study was to assess these factors prospectively among MSM using daily and event-driven PrEP in Belgium. An open-label prospective cohort study was conducted from October 2017 to May 2018 at the Institute of Tropical Medicine, in Antwerp, Belgium. At enrolment, MSM at high risk for HIV chose between daily or event-driven PrEP. They were allowed to switch regimens or stop taking PrEP at each of their tri-monthly visits. Data were collected on an electronic case report form, web-based diary and self-administered questionnaire. Screening for HIV and other Sexually Transmitted Infections (STIs) was also performed. Two hundred MSM were followed up for a total duration of 318 person-years. At month 18, 75.4% of the participants were on daily and 24.6% were on event-driven PrEP. The mean proportion of covered sex acts by PrEP for the complete follow-up period was 91.5% for all participants, 96.5% for daily and 67.0% for event-driven PrEP use. The number of casual and anonymous sex partners was significantly higher for daily users, as compared with event-driven users, but did not change over time. In contrast, the mean proportion of condomless receptive anal intercourse with casual and anonymous partners increased significantly during follow-up, for both daily and event-driven use (p < 0.0001 for all 4 trends). No new HIV infection was diagnosed during follow-up. The incidence of bacterial STIs was 75.4 per 100 person-years (95% CI 63.8 to 89.1). We did not detect a significant change in N. gonorrhoeae/C. trachomatis incidence over time. The incidence of hepatitis C was 2.9 per 100 person-years. PrEP is an effective and well adopted HIV prevention tool for MSM in Belgium. Participants adapted daily and event-driven regimens to their own needs and were able to adapt their PrEP adherence to risk exposure.

Vuylsteke B ，Reyniers T ，De Baetselier I ，Nöstlinger C ，Crucitti T ，Buyze J ，Kenyon C ，Wouters K ，Laga M ... -  《Journal of the International AIDS Society》

Sexual behaviour and incidence of sexually transmitted infections among men who have sex with men (MSM) using daily and event-driven pre-exposure prophylaxis (PrEP): Four-year follow-up of the Amsterdam PrEP (AMPrEP) demonstration project cohort.

An increasing number of countries are currently implementing or scaling-up HIV pre-exposure prophylaxis (PrEP) care. With the introduction of PrEP, there was apprehension that condom use would decline and sexually transmitted infections (STIs) would increase. To inform sexual health counselling and STI screening programmes, we aimed to study sexual behaviour and STI incidence among men who have sex with men (MSM) and transgender women who use long-term daily or event-driven PrEP. The Amsterdam PrEP demonstration project (AMPrEP) was a prospective, closed cohort study, providing oral daily PrEP and event-driven PrEP to MSM and transgender women from 2015 to 2020. Participants could choose their PrEP regimen and could switch at each three-monthly visit. STI testing occurred at and, upon request, in-between 3-monthly study visits. We assessed changes in numbers of sex partners and condomless anal sex (CAS) acts with casual partners over time using negative binomial regression, adjusted for age. We assessed HIV incidence and changes in incidence rates (IRs) of any STI (i.e., chlamydia, gonorrhoea, or infectious syphilis) and individual STIs over time using Poisson regression, adjusted for age and testing frequency. A total of 367 participants (365 MSM) commenced PrEP and were followed for a median 3.9 years (interquartile range [IQR] = 3.4-4.0). Median age was 40 years (IQR = 32-48), 315 participants (85.8%) self-declared ethnicity as white and 280 (76.3%) had a university or university of applied sciences degree. Overall median number of sex partners (past 3 months) was 13 (IQR = 6-26) and decreased per additional year on PrEP (adjusted rate ratio [aRR] = 0.86/year, 95% confidence interval [CI] = 0.83-0.88). Overall median number of CAS acts with casual partners (past 3 months) was 10 (IQR = 3-20.5) and also decreased (aRR = 0.92/year, 95% CI = 0.88-0.97). We diagnosed any STI in 1,092 consultations during 1,258 person years, resulting in an IR of 87/100 person years (95% CI = 82-92). IRs of any STI did not increase over time for daily PrEP or event-driven PrEP users. Two daily PrEP users, and no event-driven PrEP users, were diagnosed with HIV during their first year on PrEP. Study limitations include censoring follow-up due to COVID-19 measures and an underrepresentation of younger, non-white, practically educated, and transgender individuals. In this prospective cohort with a comparatively long follow-up period of 4 years, we observed very low HIV incidence and decreases in the numbers of casual sex partners and CAS acts over time. Although the STI incidence was high, it did not increase over time. The study was registered at the Netherlands Trial Register (NL5413) https://www.onderzoekmetmensen.nl/en/trial/22706.

van den Elshout MAM ，Wijstma ES ，Boyd A ，Jongen VW ，Coyer L ，Anderson PL ，Davidovich U ，de Vries HJC ，Prins M ，Schim van der Loeff MF ，Hoornenborg E ，Amsterdam PrEP Project team in the HIV Transmission Elimination AMsterdam Initiative (H-TEAM) ... -  《-》

Sexual behaviour and incidence of HIV and sexually transmitted infections among men who have sex with men using daily and event-driven pre-exposure prophylaxis in AMPrEP: 2 year results from a demonstration study.

Pre-exposure prophylaxis (PrEP) for HIV might induce risk compensation, defined as increased sexual risk behaviour leading to increased incidence of bacterial sexually transmitted infections (STIs). We examined the incidence of HIV, STIs, and sexual behaviour after initiating daily and event-driven PrEP. AMPrEP is a demonstration study that assessed the incidence of HIV and bacterial STIs and sexual behaviour among PrEP users at the STI clinic of the Public Health Service of Amsterdam (Amsterdam, the Netherlands). Eligible adults (aged ≥18 years) were HIV-negative men who have sex with men (MSM) and transgender people who had reported one or more of the following in the previous 6 months: condomless anal sex with casual partners, at least one bacterial STI, use of post-exposure prophylaxis after a sexual risk incident, or an HIV-positive sexual partner with detectable viral load. Participants were given a choice of daily PrEP or event-driven PrEP regimens. Participants were seen every 3 months for HIV and STI testing. Participants also completed self-administered questionnaires about sexual behaviour at each visit. Over the first 2 years, we assessed the number and incidence rate of HIV and chlamydia, gonorrhoea, and syphilis, including STIs diagnosed in between study visits and assessed changes in incidence over time using piecewise exponential survival models. The number of sexual acts and sexual partners were also analysed and changes over time were assessed using negative binomial regression models. This study is ongoing; the data cutoff for this analysis was June 30, 2018. Between Aug 3, 2015, and May 31, 2016, 376 participants were recruited, of whom nine participants were lost to follow-up, thus 367 participants were included in the analysis. Overall, 365 MSM and two transgender women were included, contributing 681·7 person-years of follow-up. At enrolment, 269 (73%) of 367 participants chose daily PrEP and 98 (27%) participants chose event-driven PrEP. Two individuals in the daily PrEP group became HIV-positive; overall HIV incidence rate was 0·30 per 100 person-years (95% CI 0·07-1·19). 253 participants were diagnosed with one or more STI during the first 2 years (incidence rate 90·4 per 100 person-years). STI incidence did not change over time (adjusted incidence rate ratio [aIRR] 1·00 per 3 month follow-up, 95% CI 0·93-1·07). More than a quarter of all STIs were diagnosed from tests done in between study visits. STI incidence was lower in the event-driven PrEP group than the daily PrEP group (aIRR 0·59, 95% CI 0·46-0·75). The number of condomless anal sex acts with casual partners per 3 months increased, but the number of partners and sex acts remained stable. Although the overall incidence of STIs did not change during 2 years of PrEP use, the incidence of STIs was higher among participants using daily PrEP than those using event-driven PrEP, which is likely a result of differences in sexual behaviour. This finding suggests the need to tailor STI prevention interventions according to behavioural profiles. ZonMw, H-TEAM, Internal GGD research funds, Aidsfonds, Stichting AmsterdamDiner Foundation, Gilead Sciences, Janssen Pharmaceutica, M A C AIDS Fund, and ViiV Healthcare.

Hoornenborg E ，Coyer L ，Achterbergh RCA ，Matser A ，Schim van der Loeff MF ，Boyd A ，van Duijnhoven YTHP ，Bruisten S ，Oostvogel P ，Davidovich U ，Hogewoning A ，Prins M ，de Vries HJC ，Amsterdam PrEP Project team in the HIV Transmission Elimination AMsterdam (H-TEAM) Initiative ... -  《Lancet HIV》

Preexposure Prophylaxis for HIV Infection Integrated With Municipal- and Community-Based Sexual Health Services.

Liu AY ，Cohen SE ，Vittinghoff E ，Anderson PL ，Doblecki-Lewis S ，Bacon O ，Chege W ，Postle BS ，Matheson T ，Amico KR ，Liegler T ，Rawlings MK ，Trainor N ，Blue RW ，Estrada Y ，Coleman ME ，Cardenas G ，Feaster DJ ，Grant R ，Philip SS ，Elion R ，Buchbinder S ，Kolber MA ... -  《-》

HIV pre-exposure prophylaxis for men who have sex with men in west Africa: a multicountry demonstration study.

HIV pre-exposure prophylaxis (PrEP) data in men who have sex with men (MSM) in west Africa are essential to guide its large-scale implementation. We assessed the uptake of event-driven and daily PrEP, HIV incidence, and changes over time in sexual behaviours and prevalence of bacterial sexually transmitted infections (STIs) in MSM in Burkina Faso, Côte d'Ivoire, Mali, and Togo. We did a prospective cohort study from Nov 20, 2017, to April 14, 2020, in four community-based clinics in Abidjan (Côte d'Ivoire), Bamako (Mali), Lomé (Togo), and Ouagadougou (Burkina Faso). Participants were MSM aged 18 years or older at substantial risk of HIV infection. Participants could choose between event-driven (2+1+1 dosing) and daily oral PrEP (tenofovir disoproxil fumarate 300 mg plus emtricitabine 200 mg), switch regimen, and discontinue or restart PrEP. We compared HIV incidence in this study with that of the same cohort before the availability of PrEP (CohMSM). Statistical analysis included the Kaplan-Meier method and mixed-effects regression models. This study is registered with ClinicalTrials.gov, NCT03459157. We followed up 598 participants for a total of 743·6 person-years. At enrolment, 445 (74%) of 598 participants chose event-driven PrEP and 153 (26%) of 598 chose daily PrEP. 60 (13%) of 445 and 65 (42%) of 153 participants switched PrEP regimen at least once (p<0·0001). 159 participants (27%) were lost to follow-up. Overall HIV incidence was 2·3 per 100 person-years (95% CI 1·3-3·7; adjusted incidence rate ratio 0·21, 95% CI 0·12-0·36 compared with CohMSM). Adherence was optimal in 802 (41%) of 1946 measures with event-driven PrEP and in 394 (71%) of 554 measures with daily PrEP (p<0·0001). Coverage of sex acts with PrEP only and PrEP and condom decreased during follow-up (p=0·039 if PrEP only; p=0·0025 if PrEP and condom). The frequency of condomless anal sex remained stable (p=0·96). The number of male sexual partners (p<0·0001) and number of sex acts with casual male partners (p=0·0014 for 1-4 sex acts in previous 4 weeks; p=0·030 for ≥5 sex acts) decreased. The prevalence of gonorrhoea, chlamydia, and syphilis remained stable. PrEP availability helped prevent HIV infection and did not lead to an increase in risky sexual behaviours or other STIs. PrEP should be urgently implemented in west Africa. Retention in care and PrEP adherence require special attention to ensure PrEP reaches its full prevention potential. ANRS and Expertise France. For the French translation of the abstract see Supplementary Materials section.

Laurent C ，Dembélé Keita B ，Yaya I ，Le Guicher G ，Sagaon-Teyssier L ，Agboyibor MK ，Coulibaly A ，Traoré I ，Malan JB ，De Baetselier I ，Eubanks A ，Riegel L ，Rojas Castro D ，Fayé-Ketté H ，Koné A ，Diandé S ，Dagnra CA ，Serrano L ，Diallo F ，Mensah E ，Dah TTE ，Anoma C ，Vuylsteke B ，Spire B ，CohMSM-PrEP Study Group ... -  《Lancet HIV》