Intimate partner violence (IPV) is a significant barrier to HIV prevention service utilization, yet little is known about its impact on pre-exposure prophylaxis (PrEP) adherence among gay, bisexual, and other men who have sex with men (GBMSM). This study examines the association between IPV victimization and PrEP adherence using data from an online survey of 937 current PrEP users in Ukraine, conducted in early 2022, a few days before Russia's invasion. Participants reported on six types of IPV experienced in the past six months, physical, sexual, emotional, and financial abuse as well as partners' monitoring and controlling behaviors. Further, they self-reported their PrEP adherence and were asked to describe the reasons for missing PrEP medications through an open-ended question. Nearly 40% of respondents experienced at least one form of IPV, with sexual and emotional IPV being most common. Only 35.4% reported excellent or very good adherence to PrEP medication. Self-reported reasons for missed doses included COVID-19 restrictions, changes in sexual behavior, use of alternative HIV prevention methods, and health or psychological factors. In multivariable models adjusting for sociodemographic and behavioral factors, sexual IPV, monitoring, and controlling IPV were associated with higher PrEP adherence. The positive association may suggest that IPV survivors increase their PrEP adherence as a protective strategy against HIV infection. These findings highlight the importance of integrating trauma-informed IPV screening and support within PrEP programs and adopting flexible service models to sustain adherence, especially during social and political crises. Future longitudinal research should explore mechanisms linking IPV and PrEP adherence and develop structural interventions to better support this vulnerable population.

Seit September 2019 ist die HIV-Präexpositionsprophylaxe (PrEP) im Leistungskatalog der Gesetzlichen Krankenversicherung (GKV) enthalten. Ziel des präsentierten Moduls der PrEP-Surv-Studie war ein Monitoring des PrEP-Geschehens in den Jahren 2019 bis 2022 sowie eine Untersuchung der Eignung von GKV-Routinedaten für ein jahrweises Monitoring der PrEP-Versorgung. PrEP-Nutzende wurden in anonymen Daten der BARMER aus den Jahren 2019 bis 2022 identifiziert und analysiert. Gegenstand der Analysen waren jahrweise eine Bestimmung der Anzahl der PrEP-Nutzenden, eine Deskription der Kohorten hinsichtlich Alter, Geschlecht und Therapietreue, eine Identifikation von HIV-Infektionen sowie die Ermittlung der Raten sexuell übertragbarer Infektionen beziehungsweise Infektionskrankheiten (STI). Von 2019 bis 2022 wurde ein Anstieg der PrEP-Nutzendenanzahl von 1058 auf 3194 beobachtet. Demografische Merkmale blieben dabei weitgehend unverändert, während die durchschnittliche zensierte Therapietreue von 98

BACKGROUND:Since September 2019, HIV pre-exposure prophylaxis (PrEP) has been covered by statutory health insurance (SHI) in Germany. The objectives of the PrEP-Surv study module presented here were to monitor PrEP usage from 2019 to 2022 and to examine the feasibility of using SHI claims data for an annual monitoring of PrEP provision. METHODS:PrEP users were identified and analyzed using anonymized BARMER data from 2019 to 2022. The analyses included determining the number of PrEP users each year; describing the cohorts by age, gender, and treatment adherence; identifying HIV infections; and calculating the rates of sexually transmitted infections or infectious diseases (STIs). RESULTS:The number of PrEP users increased from 1058 in 2019 to 3194 in 2022. Demographic characteristics remained largely unchanged, while the average censored treatment adherence decreased from 98% in 2019 to 91% and 92% in the subsequent years. Two HIV infections were observed in two individuals, but the transmissions presumably occurred outside of PrEP use. No clear changes in STI rates were observed. DISCUSSION:The observed cohort appears to be comparable to other PrEP cohorts in Germany. The stability of the demographic characteristics possibly indicates that groups eligible for PrEP that were not reached at the beginning of PrEP reimbursement were subsequently also not reached. In addition to a description of PrEP care, a possible approach for the annual monitoring based on SHI claims data is presented.

Background:Primary sclerosing cholangitis (PSC) is associated with biliary obstructions that can require endoscopic retrograde cholangiopancreatography (ERCP). While the beneficial effects of ERCP are well documented, follow-up interventional strategies are less defined, and their long-term impact is debated.Methods:We evaluated the outcome of a scheduled program of ERCP-guided interventions that have been developed and implemented at our tertiary liver center for more than 20 years. Within our center, follow-up ERCPs were performed at regular intervals to treat previously detected morphological stenosis independent of clinical symptoms. We calculated the transplant-free survival (TFS) of patients who were enrolled in the scheduled ERCP program and compared it to patients who received follow-up ERCPs only on clinical demand. Moreover, we documented the occurrence of hepatic decompensation, recurrent cholangitis episodes, hepatobiliary malignancies, and endoscopy-related adverse events.Results:In our retrospective study, we included 201 patients with PSC who all received an ERCP. In all, 133 patients received scheduled follow-up ERCPs and 68 received follow-up ERCPs only on demand. The rates of TFS since initial diagnosis (median TFS: 17 vs. 27 y;P= 0.020) and initial presentation (median TFS: 16 vs. 11 y;P= 0.002) were higher in patients receiving scheduled versus on-demand ERCP. Subgroup analysis revealed that progression in cholangiographic findings between the first and second ERCP was associated with a poorer outcome compared to patients without progression (17 y vs. undefined;P= 0.021).Conclusion:In conclusion, we report the outcome data of a scheduled follow-up ERCP program for patients with PSC in an experienced high-volume endoscopy center. Our data suggest the initiation of multicenter randomized controlled prospective trials to explore the full potential of regular endoscopic follow-up treatment as a strategy to prevent disease progression in patients with PSC.

The impact of ustekinumab (UST) on mucosal- and fistula healing and extraintestinal manifestations (EIM) in Crohn’s disease (CD) were not fully elucidated in the registration trials. In this prospective, multicenter study (EudraCT number: 2017-005151-83) we evaluated the German label real-world-effectiveness of UST to achieve the primary endpoint of combined clinical and endoscopic response at week 52 and several secondary endpoints. Of 79 screened we enrolled 52 patients (female n = 28, bionaïve n = 13, biologic n = 39). At week 52 (per protocol analysis), 52% (n = 13/25) of patients achieved the primary endpoint [50% (n = 3/6) in the bionaïve, 45.5% (n = 5/11) biologic, 62.5% (n = 5/8 ) multiple biologics cohorts, respectively with age as independent predictor [OR 95% CI 0.933 (0.873, 0.998) p = 0.043], 60% (n = 15/25) achieved endoscopic response [50% (n = 3/6) in the bionaïve, 54.5% (n = 6/11) biologic, 75% (n = 6/8) multiple biologics cohorts, respectively], 36% (n = 9/25) achieved endoscopic remission [50% (n = 3/6) in the bionaïve, 27.3% (n = 3/11) biologic, 37.5% (n = 3/8) multiple biologics cohorts, respectively], 48% (n = 12/25) achieved mucosal healing [50% (n = 3/6) in the bionaïve, 36.4% (n = 4/11) biologic, 62.5% (n = 5/8) multiple biologics cohorts, respectively]. All achieved a fistula response and 33.3% (n = 1/3) in the multiple biologics group fistula remission at week 52. EIM decreased (week 0 28.2% vs. week 52 8%). CRP, FCP, PRO-2, EQ-5D-5L improved throughout. 36 patients (69.2%) experienced ≥ 1 treatment emergent adverse event, in 8 (15.4%) cases rated as severe and in 5 (9.6%) leading to UST discontinuation, but no very severe events or deaths. The effectiveness of UST was better than in the registration trials.

OBJECTIVES:Viral hepatitis co-infection among people living with HIV is known to accelerate the progression of liver disease and AIDS. An increased prevalence and incidence of hepatitis B virus (HBV) infection among people living with HIV demands continuous monitoring to adapt targeted prevention strategies to reach the global goals of eliminating viral hepatitis as a public health threat. METHODS:We determined the prevalence and incidence of HBV for the years 1996-2019 from yearly blood sample testing and questionnaire reports among people living with HIV belonging to a nationwide, multicentre observational, prospective cohort study. RESULTS:Among this study population of 3479 participants, the majority (87%) indicated that being men who have sex with men (MSM) was their likely HIV transmission route; 51% were recruited from Berlin. HBV prevalence for acute/chronic and resolved infections decreased from 4.1% and 45% in 1996-1999 to 1.3% and 16% in 2019, respectively. Simultaneously, participants with a serological status indicating HBV vaccination increased from 25% in 1996-1999 to 69% in 2019. Among vaccinated participants with relevant information (n = 1135), 38% received their first HBV vaccination after HIV infection. The HBV incidence rate in 565 eligible participants decreased from 6.9/100 person-years in 2004-2007 to 0.45/100 person-years in 2015. CONCLUSION:Increasing vaccination coverage because of a general HBV vaccination recommendation and catch-up vaccination efforts among risk groups decreased HBV infection prevalence over time among this study population of people living with HIV, primarily MSM and from Berlin. Despite this success, the prevalence and incidence of HBV remains higher than in the general population in Germany. This emphasizes the need for continued HBV prevention by promoting HBV vaccination and HBV screening at regular intervals based on the individual risk behaviour.

BACKGROUND:Recent patent losses for antiretroviral drugs (ARV) have led to the debate of cost-saving through the replacement of patented drugs with generic drugs. The split of recommended single-tablet regimens (STR) into their single substance partners is one of the considerations mentioned in said debate. Particularly, generic tenofovir disoproxil/emtricitabine (TDF/FTC) is expected to hold untapped cost-saving potential, which may curb increasing overall expenditures for combined antiretroviral therapy (cART) within the statutory health insurance (SHI) of Germany.METHODS:Data of ARV reimbursed by the SHI were used to describe the trends of defined daily doses (DDD) as well as the revenue within the German ARV market. They were also used to determine the cost-savings of moving to generic drugs. The time period observed was between January 2017 and June 2019. The potential cost-savings were determined with following assumption in mind: the maximum possible use of generic ARV, including 1) the split of STR and replacing all substance partners with generic ones, and 2) replacing patented tenofovir alafenamide/emtricitabine (TAF/FTC) with generic TDF/FTC.RESULTS:Throughout the observation period, the DDD of generic ARV increased nearly five-fold while their revenue increased more than four-fold. Total cost-saving showed a sharp increase over the same period, with generic TDF/FTC accounting for a share of around 70%. The largest potential cost-saving could have been achieved through replacing patented TAF/FTC with generic TDF/FTC, peaking at nearly 10% of total revenue, but showing decreasing trends in general.CONCLUSION:The progressive distribution of generic ARV ensured increasing cost-savings, but consequently curbed the potential cost-savings. Unique price reductions of generic TDF/FTC have played a pivotal role for these effects. In any case, substituting with generic ARV should not fail to adhere to the treatment guidelines and continue to consider the medical requirements for the treatment.

Abstract IntroductionObjectives 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.MethodsAnonymous 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).Results4620 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 observation 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 was 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.ConclusionsWe 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.

35/42 patients were treated with immunosuppressive drugs; 33 steroids, 1 azathioprine, 1 azathioprine + steroids; all but one being still on treatment.Mean follow-up is 5 months; one patient died of extrahepatic cause 7 months after the diagnosis of hepatitis.All treated patients responded satisfactorily.Conclusion: acute hepatitis arising after COVID-19 appears to be a heterogeneous condition: long-term follow-up will help understanding if in some cases the vaccine triggers autoimmune hepatitis or if it is a novel drug-induced nosological entity.

[This corrects the article DOI: 10.3389/fpubh.2021.667253.].

Treatment and prognosis of neuroendocrine neoplasia depends on tumor size, stage, grade, resectability, and extent of distant metastasis. In most cases a multimodality approach including surgical, locally invasive procedures, peptide-guided radioreceptor therapy (PRRT), and medical therapies represent the mainstay of treatment in advanced disease. In the reported case, a 68-year-old man was diagnosed in 2010 with an initially functional (histamine) neuroendocrine tumor of gastric type III, G2, stage IVB, cT4cN1cM1 (hepatic, peritoneal, nodal, osseous), including a hepatic tumor load of 25%. Intensive multimodality approaches including combined immunotherapy (vaccination and PD-1/CTLA-4 blockade) led to a survival of 8 years until now with a high quality of life and minimal residual disease (only a single, small paragastric recurrence) despite the dedifferentiation of the tumor into a neuroendocrine carcinoma G3 (Ki-67 of 80%) including a nonfunctional stage.