[Evaluating the introduction of HIV pre-exposure prophylaxis as a benefit of statutory health insurance (EvE-PrEP) : Highly effective protection against HIV without an increase in sexually transmitted infections].

We investigated the impact of HIV pre-exposure prophylaxis (PrEP) as a new service of the statutory health insurance (SHI) on the incidence of HIV and other sexually transmitted infections (STIs) in Germany. In addition, PrEP needs and access barriers were analyzed. The following data were evaluated as part of the evaluation project: HIV and syphilis notification data and extended surveillance by the Robert Koch Institute (RKI), pharmacy prescription data, SHI routine data, PrEP use in HIV-specialty care centers, Checkpoint, the BRAHMS and PrApp studies, as well as a community board. The majority of PrEP users were male (98-99%), primarily aged between 25-45 years, and predominantly of German nationality or origin (67-82%). The majority were men who have sex with men (99%). With regard to HIV infections, PrEP proved to be highly effective. There were only isolated cases of HIV infections (HIV incidence rate 0.08/100 person years); in most cases the suspected reason was low adherence. The incidences of chlamydia, gonorrhea, and syphilis did not increase but remained almost the same or even decreased. A need for information on PrEP for people in trans*/non-binary communities, sex workers, migrants, and drug users emerged. Needs-based services for target groups at increased risk of HIV are necessary. PrEP proved to be a very effective HIV prevention method. The partly feared indirect negative influences on STI rates were not confirmed in this study. Due to the temporal overlap with the containment measures during the COVID-19 pandemic, a longer observation period would be desirable for a conclusive assessment.

Schmidt D ，Kollan C ，Schewe K ，Hanhoff N ，Rüsenberg R ，Friebe M ，Schikowski T ，Schink SB ，Marcus U ，Koppe U ，Jansen K ，Streeck H ，Ottensmeyer P ，An der Heiden M ，Bannert N ，M'Bayo R ，Ceres M ，Weber L ，Sweers H ，Schmidt AJ ，Tietz H ，Danan E ，Bendig J ，Kloep S ，Neumann A ，Valbert F ，Wasem J ，Bartmeyer B ，Bremer V ，NEPOS Studiengruppe ... -  《-》

Low incidence of HIV infection and decreasing incidence of sexually transmitted infections among PrEP users in 2020 in Germany.

Objectives of this study, as part of a nation-wide HIV pre-exposure prophylaxis (PrEP) evaluation project, were to determine the incidence of infections with HIV, chlamydia, gonorrhea, syphilis, hepatitis A/B/C in persons using PrEP, and to describe the health care funded PrEP use in Germany. Additionally, factors associated with chlamydia/gonorrhea and syphilis infections were assessed. Anonymous data of PrEP users were collected at 47 HIV-specialty centers from 09/2019-12/2020. Incidence rates were calculated per 100 person years (py). Using longitudinal mixed models, we analyzed risk factors associated with sexually transmitted infections (STIs). 4620 PrEP users were included: 99.2% male, median age 38 years (IQR 32-45), 98.6% men who have sex with men (MSM). The median duration of PrEP exposure was 451 days (IQR 357-488), totaling 5132 py. Four HIV infections were diagnosed, incidence rate 0,078/100py (95% CI 0.029-0.208). For two, suboptimal adherence was reported and in the third case, suboptimal adherence and resistance to emtricitabine were observed. One infection was likely acquired before PrEP start. Incidence rates were 21.6/100py for chlamydia, 23.7/100py for gonorrhea, 10.1/100py for syphilis and 55.4/100py for any STI and decreased significantly during the observation period. 65.5% of syphilis, 55.6% of chlamydia and 50.1% of gonorrhea cases were detected by screening of asymptomatic individuals. In a multivariable analysis among MSM younger age, PrEP start before health insurance coverage and daily PrEP were associated with greater risk for chlamydia/gonorrhea. Symptom triggered testing and a history of STI were associated with a higher risk for chlamydia/gonorrhea and syphilis. A significantly lower risk for chlamydia/gonorrhea and syphilis was found for observations during the COVID-19 pandemic period. We found that HIV-PrEP is almost exclusively used by MSM in Germany. A very low incidence of HIV infection and decreasing incidence rates of STIs were found in this cohort of PrEP users. The results were influenced by the SARS-CoV-2 pandemic. Rollout of PrEP covered by health insurance should be continued to prevent HIV infections. Increased PrEP availability to people at risk of HIV infection through the elimination of barriers requires further attention. Investigation and monitoring with a longer follow-up would be of value.

Schmidt D ，Kollan C ，Bartmeyer B ，Bremer V ，Schikowski T ，Friebe M ，Schellberg S ，Scholten S ，Bickel M ，Hanhoff N ，Rüsenberg R ，Schewe K ，NEPOS study group ... -  《-》

Routine Data Analysis of HIV Pre-Exposure Prophylaxis Use and Rates of Sexually Transmitted Infections Since Coverage of HIV Pre-Exposure Prophylaxis by the Statutory Health Insurance in Germany.

Valbert F ，Schmidt D ，Kollan C ，Dröge P ，Klein M ，Schneider U ，Friebe M ，Wasem J ，Neumann A ... -  《-》

Sexually transmitted diseases in people living with HIV after implementation of cost coverage of HIV pre-exposure prophylaxis by statutory health insurance in Germany.

After pre-exposure prophylaxis (PrEP) was introduced, rates of sexually transmitted infections (STIs) increased among PrEP users. However, data on STI trends in people living with HIV since then are limited. Since September 2019, PrEP has been covered by statutory German health insurance (SHI) in vulnerable groups. This study aimed to determine whether this coverage of PrEP costs affected STI rates in people living with HIV (specifically, men who have sex with men). All patients of the HIVCENTER Frankfurt diagnosed with at least one STI within the observation period were retrospectively enrolled in the study. STIs included infection with Treponema pallidum, Chlamydia trachomatis, Neisseria gonorrhoeae, and/or Trichomonas vaginalis. The observation period covered 1 year before and 1 year after the coverage of PrEP costs by German SHI. Data were collected from outpatient clinic records. In total, 143 patients were enrolled in the study. The observation period was September 2018 to August 2019 for group 1 (n = 73) and September 2019 to August 2020 for group 2 (n = 70). The most frequent STIs were syphilis and infections due to chlamydia, gonococci, and trichomonads, in descending order. Infections with T. pallidum occurred more often in group 2 than in group 1 (60.0% vs. 50.7%; p = 0.253) as did chlamydia (37.1% vs. 28.8%; p = 0.286). A tendency for an increased ratio of STIs in people living with HIV was observed after the introduction of PrEP coverage by German SHI. STIs should be discussed intensively with people living with HIV, since the communities of PrEP users and people living with HIV overlap, and changes in risk behaviour might influence both groups.

Schuettfort G ，Groh A ，Kann G ，Haberl A ，Herrmann E ，Wetzstein N ，Vehreschild MJGT ，Stephan C ... -  《-》

HIV pre-exposure prophylaxis and diagnoses of sexually transmitted infections - observational data from German checkpoints, 01/2019-08/2021.

The impact of starting HIV pre-exposure prophylaxis (PrEP) on diagnoses of sexually transmitted infections (STI) remains unclear. We used data from German HIV/STI Checkpoints collected from 01/2019 to 08/2021 to determine the impact of PrEP use on syphilis, gonorrhoea and chlamydia diagnoses. We used self-reported data on demographics, sexual behaviour, testing and PrEP use, as well as lab-confirmed diagnoses from visits to HIV/STI Checkpoints in Germany. PrEP use was categorized as (1) never used; (2) intention to use; (3) former use; (4) current on-demand use; (5) daily use. In multivariate regression analyses (MRA) with gonorrhoea, chlamydia, and syphilis diagnoses as outcomes, we controlled for age, number of sexual partners, number of condomless anal intercourse (CAI) partners in the last six months, and testing recency. For the analysis, we included 9,219 visits for gonorrhoea and chlamydia testing and 11,199 visits for syphilis testing conducted at checkpoints from 01/2019 to 08/2021. MRA identified age (aOR 0.98; 95%CI 0.97-0.99), number of sexual partners in the past six months (aOR 4.90; 95%CI 2.53-9.52 for 11 + partners), and use of chemsex substances (aOR 1.62; 95%CI 1.32-2.00) as risk factors for gonorrhoea, while age (aOR 0.99; 95%CI 0.98-1.00), number of CAI partners (aOR 3.19; 95%CI 2.32-4.41 for 5 + partners), partner sorting (aOR 1.30; 95%CI 1.09-1.54), and use of chemsex substances (aOR 1.29; 95%CI 1.05-1.59) were risk factors for chlamydia infections. For syphilis, the number of CAI partners (aOR 3.19; 95%CI 1.60-6.34 for 5 + partners) was found to be the only significant risk factor. There was a strong association between PrEP use and the number of sexual partners (≤ 5 vs.>5: aOR 3.58; 95%CI 2.15-5.97 for daily PrEP use), the number of CAI partners in the past six months (≤ 1 vs.>1: aOR 3.70; 95%CI 2.15-6.37 for daily PrEP use), and the number of STI tests performed (suggesting higher testing frequency). Both outcomes were also related to partner sorting, chemsex, and selling sex. Checkpoint visits reporting current PrEP use or intention to start PrEP correlated with eligibility criteria for PrEP, i.e. high partner numbers, inconsistent condom use during anal intercourse, and use of chemsex drugs. Use of HIV-specific prevention methods such as HIV serosorting, PrEP sorting, and viral load sorting was reported more frequently. (Daily) PrEP use was an independent risk factor for a chlamydia diagnosis only.

Marcus U ，Schink SB ，Weber C 《BMC PUBLIC HEALTH》