Clinical and immunological outcomes of SARS-CoV-2-infected vaccine responders, vaccine non-responders, and unvaccinated patients evaluated for neutralizing monoclonal antibody treatment at a single German tertiary care center: a retrospective cohort study with prospective follow-up.

PURPOSE: This study assessed the clinical and immunological outcomes of SARS-CoV-2-infected patients with risk factors for severe disease depending on their immunological status. METHODS: In this retrospective study with single follow-up visit, clinical outcome and humoral immunity was monitored in SARS-CoV-2 infected patients at risk. The results were compared based on the patients' initial immunological status: unvaccinated (UV), patients who did not develop neutralizing antibodies after vaccination (vaccine non-responders, VNR), and patients who expressed neutralizing antibodies after vaccination (vaccine responders, VR). Patients who lacked neutralizing antibodies (VNR and UV) were treated with nMABs. RESULTS: In total, 113 patients at risk of severe COVID-19 consented to participate in the study. VR and UV were not admitted to the hospital. During the observation period, UVs had the highest rate of SARS-CoV-2 re-infections. Three of 41 VNRs (7.3%) were hospitalized due to severe COVID-19, with two of them having undergone iatrogenic B-cell depletion. The humoral immune response after infection was significantly lower in the VNR group than in the VR group in terms of anti-N, anti-receptor-binding domain (RBD), anti-S antibody titers, and anti-S antibody avidity. In a sub-analysis of VNR, B cell-deficient non-responders had significantly lower levels of anti-N antibodies and anti-S avidity after infection than other VNRs. CONCLUSION: VNR, particularly B-cell-depleted VNR, remained at risk of hospitalization due to COVID-19. In the VR group, however, no clinical complications or severe disease were observed, despite not receiving nMAbs. Tailoring the administration of nMABs according to patient vaccination and immunological status may be advisable.

Rapid point-of-care detection of SARS-CoV-2 infection in exhaled breath using ion mobility spectrometry: a pilot study.

BACKGROUND: An effective testing strategy is essential for pandemic control of the novel Coronavirus disease 2019 (COVID-19) caused by infection with severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2). Breath gas analysis can expand the available toolbox for diagnostic tests by using a rapid, cost-beneficial, high-throughput point-of-care test. We conducted a bi-center clinical pilot study in Germany to evaluate breath gas analysis using multi-capillary column ion mobility spectrometry (MCC-IMS) to detect SARS-CoV-2 infection. METHODS: Between September 23, 2020, and June 11, 2021, breath gas measurements were performed on 380 patients (SARS-CoV-2 real-time polymerase chain reaction (PCR) positive: 186; PCR negative: 194) presenting to the emergency department (ED) with respiratory symptoms. RESULTS: Breath gas analysis using MCC-IMS identified 110 peaks; 54 showed statistically significant differences in peak intensity between the SARS-CoV-2 PCR-negative and PCR-positive groups. A decision tree analysis classification resulted in a sensitivity of 83% and specificity of 86%, but limited robustness to dataset changes. Modest values for the sensitivity (74%) and specificity (52%) were obtained using linear discriminant analysis. A systematic search for peaks led to a sensitivity of 77% and specificity of 67%; however, validation by transferability to other data is questionable. CONCLUSIONS: Despite identifying several peaks by MCC-IMS with significant differences in peak intensity between PCR-negative and PCR-positive samples, finding a classification system that allows reliable differentiation between the two groups proved to be difficult. However, with some modifications to the setup, breath gas analysis using MCC-IMS may be a useful diagnostic toolbox for SARS-CoV-2 infection. TRIAL REGISTRATION: This study was registered at ClinicalTrials.gov on September 21, 2020 (NCT04556318; Study-ID: HC-N-H-2004).

[Integrated care concepts and multidisciplinary process chains in a radiological context]. / Integrierte Behandlungskonzepte und multidisziplinär organisierte Prozessketten im radiologischen Kontext.

Modern patient-centered and cost-efficient care concepts in hospitals require the mapping of multidisciplinary process chains into clinical pathways. Clinical decision support systems and operations research methods use algorithms to classify patients into homogeneous groups and to model a complete clinical pathway for scheduling individual procedures. An improvement of the economic situation of the care facility can be achieved through improved resource utilization, reduced patient waiting times and a shortening of the length of stay. The interdisciplinary use of centrally stored interoperable information and comprehensive care management via information technology (IT) services lay the foundation for the dissolution of traditional IT system architectures in medicine and the development of flexibly integrable modern system platforms. New IT approaches such as the semantically standardized definition of procedures and resource properties, the use of clinical decision support systems and the use of service-oriented system architectures form the basis for the deep integration of radiology services into comprehensive interdisciplinary care concepts.

[Role of university hospitals in Bavaria during the COVID-19 pandemic]. / Die Universitätsmedizin in Bayern im Rahmen der COVID-19-Pandemie.

BACKGROUND: In early 2020 the German healthcare system was put into a state of emergency due to the coronavirus disease 2019 (COVID-19) pandemic. Bavaria had to deal with more severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) infections than any other German state during the first wave and currently has over 270,000 cases, accounting for about one fifth of all COVID-19 cases in Germany. The Bavarian Ministry of Interior together with the Bavarian Sate Ministry of Health and Care issued a general ruling at the beginning of the first wave that ordered the centralised organisation of hospital capacity, a redesign of the information technology (IT) management system and introduced reporting obligations for SARS-CoV-2/COVID-19. The goal of this analysis was to investigate the role that university hospitals played in the inpatient treatment of COVID-19 patients. METHODS: A retrospective evaluation of all inpatient COVID-19 cases that were reported through the "IVENA Sonderlage" (Ivena eHEALTH, [IVENA, interdisziplinärer Versorgungsnachweis, mainis IT-Service GmbH, Offenbach am Main, Germany]), a special module for the "Interdisciplinary Medical Care Capacity Management System" designed for extraordinary events and circumstances, was conducted by analysing the number of reported treatment days of all Bavarian hospitals that participated in the treatment of COVID-19 patients. RESULTS: During the first wave university hospitals provided relevant scientific contributions and played an important role in advising physicians, hospitals and politicians on the pandemic. In all, 20% of intensive care unit (ICU) and intermediate care (IMC) treatment days were provided by the university hospitals in particular for treatment of complex courses of COVID-19.

A proof of concept study for the differentiation of SARS-CoV-2, hCoV-NL63, and IAV-H1N1 in vitro cultures using ion mobility spectrometry.

Rapid, high-throughput diagnostic tests are essential to decelerate the spread of the novel coronavirus disease 2019 (COVID-19) pandemic. While RT-PCR tests performed in centralized laboratories remain the gold standard, rapid point-of-care antigen tests might provide faster results. However, they are associated with markedly reduced sensitivity. Bedside breath gas analysis of volatile organic compounds detected by ion mobility spectrometry (IMS) may enable a quick and sensitive point-of-care testing alternative. In this proof-of-concept study, we investigated whether gas analysis by IMS can discriminate severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) from other respiratory viruses in an experimental set-up. Repeated gas analyses of air samples collected from the headspace of virus-infected in vitro cultures were performed for 5 days. A three-step decision tree using the intensities of four spectrometry peaks correlating to unidentified volatile organic compounds allowed the correct classification of SARS-CoV-2, human coronavirus-NL63, and influenza A virus H1N1 without misassignment when the calculation was performed with data 3 days post infection. The forward selection assignment model allowed the identification of SARS-CoV-2 with high sensitivity and specificity, with only one of 231 measurements (0.43%) being misclassified. Thus, volatile organic compound analysis by IMS allows highly accurate differentiation of SARS-CoV-2 from other respiratory viruses in an experimental set-up, supporting further research and evaluation in clinical studies.

[S2k Guideline - Recommendations for Inpatient Therapy of Patients with COVID-19]. / S2k-Leitlinie ­ Empfehlungen zur stationären Therapie von Patienten mit COVID-19.

Since December 2019, the novel coronavirus SARS-CoV-2 (Severe Acute Respiratory Syndrome - Corona Virus-2) has been spreading rapidly in the sense of a global pandemic. This poses significant challenges for clinicians and hospitals and is placing unprecedented strain on the healthcare systems of many countries. The majority of patients with Coronavirus Disease 2019 (COVID-19) present with only mild symptoms such as cough and fever. However, about 6 % require hospitalization. Early clarification of whether inpatient and, if necessary, intensive care treatment is medically appropriate and desired by the patient is of particular importance in the pandemic. Acute hypoxemic respiratory insufficiency with dyspnea and high respiratory rate (> 30/min) usually leads to admission to the intensive care unit. Often, bilateral pulmonary infiltrates/consolidations or even pulmonary emboli are already found on imaging. As the disease progresses, some of these patients develop acute respiratory distress syndrome (ARDS). Mortality reduction of available drug therapy in severe COVID-19 disease has only been demonstrated for dexamethasone in randomized controlled trials. The main goal of supportive therapy is to ensure adequate oxygenation. In this regard, invasive ventilation and repeated prone positioning are important elements in the treatment of severely hypoxemic COVID-19 patients. Strict adherence to basic hygiene, including hand hygiene, and the correct wearing of adequate personal protective equipment are essential when handling patients. Medically necessary actions on patients that could result in aerosol formation should be performed with extreme care and preparation.

High prevalence of comorbidities and use of concomitant medication in treated people living with HIV in Germany - results of the BESIDE study.

Due to demographic changes in people living with HIV (PLHIV), physicians are challenged with age-related comorbidities and their management. In the absence of comprehensive data collection, the burden of comorbidities and co-medication in addition to antiretroviral therapy (ART) remains unclear for the German real-world setting. BESIDE was an observational, cross-sectional study evaluating the prevalence of comorbidities and use of co-medication in treated PLHIV. Regional distribution of study centers (n = 20), consecutive patient recruitment, and age-stratified sampling in alignment with national epidemiologic data aimed to ensure a representative sample (n = 453). The overall prevalence of comorbidities was 91.2%; 31.6% of patients had ≥4 comorbidities. The most common diagnoses were vitamin D deficiency (29.1%), depressive episode (27.8%), arterial hypertension (16.3%), and hypercholesterolemia (10.8%). 83.7% of patients were on co-medication; 21.2% taking ≥4 medications. The most common medications or supplements were vitamins (31.6%), anti-inflammatory agents (16.1%), renin-angiotensin system agents (12.1%), acid suppressants (11.7%), lipid modifying agents (10.8%); 1.3% of patients were on co-medication that should not be co-administered with ART, 41.5% on co-medication with potential for drug-drug interactions. The prevalence of comorbidities and use of co-medication among treated PLHIV in Germany is consistently high and increases across age groups, illustrating the complexity of HIV care involving appropriate ART selection.

[Numbers of emergency room patients during the COVID-19 pandemic]. / Patientenzahlen im Rahmen der COVID-19-Pandemie in einer zentralen Notaufnahme.

BACKGROUND: Since end of March, the health care system in Germany has been placed into a state of emergency in order to gain resources for the spreading coronavirus disease 2019 (COVID-19) pandemic. The overall goal of this study is to evaluate the number of emergency room patients at the time of the pandemic in order to draw conclusions about the influence of the COVID 19 pandemic on the number of patients in an emergency department. MATERIALS AND METHODS: With this descriptive epidemiologic study we collected and analyzed anonymized patient-related data of 19,357 cases presenting to the emergency department of the Klinikum rechts der Isar (Munich) from 01 February 2019 to 30 April 2019 and from 01 February 2020 to 30 April 2020. RESULTS: Despite an increase in the number of patients from 2019 to 2020, there was a significant drop in the number of emergencies from February to March 2020 and proceeding in April to a level below that of 2019. This was particularly observed in the field of trauma surgery, with a 40% decrease in the number of patients. With regard to the individual complaint patterns in March 2020, it was found that an increased incidence of malaise (+47%) and breathing problems (+36%) was recorded, whereas back pain (-41%), wounds (-29%), thoracic (-24%) and abdominal pain (-23%) were significantly less common than in the previous year. In terms of the severity of the complaints, the decline was mainly due to complaints with a low degree of urgency. CONCLUSION: In the course of the COVID-19 pandemic we observed a significant decline in the number of patients in one of the largest emergency rooms in Munich. This has to be avoided with existing hospital capacities, in order to prevent potential damage to health caused by postponed or missing emergency presentations.

High prevalence of recreational and illicit drug use in German people living with HIV with a potential for drug-drug interactions with antiretroviral therapy.

Recreational drug use is higher in people living with HIV (PLHIV) than in the general population in Europe. This use increases the risk for drug-drug interactions (DDIs) and adverse events. We assessed the prevalence and clinical consequences of substance abuse among PLHIV. BESIDE was a cross-sectional, multi-center study in 2016/18, evaluating comorbidities, polypharmacy and recreational/illicit drug use in PLHIV on antiretroviral therapy (ART) in Germany. Legal and illicit drug use was recorded using two anonymous patient questionnaires one year apart (Q1 and Q2). The BESIDE study population consisted of 453 PLHIV (22% female, median age 46 years). Recreational drug use was reported by the majority (Q1: ever used 73%, within previous 6 months 56%): nitrite inhalants ("poppers"), cannabis and PDE-5 inhibitors were common across all age groups; ecstasy, (meth-)amphetamine and gamma-hydroxybutyrate/gamma-butyrolactone were predominantly reported by younger PLHIV. Based on Q2, two-thirds of PLHIV (67%) had been informed about potential risks of drug abuse by their doctors, whereas one-third (33%) had talked to their doctors on their own initiative with only 7% considering drug use in combination with ART a problem. Strikingly, 44% and 42% had undergone medical treatment or had been hospitalized due to drug use. These data emphasize the high clinical relevance of recreational drug use in PLHIV and the need for treating physicians to pro-actively communicate the potential risks.

Influence of antiretroviral therapy and cardiovascular disease on the immature platelet fraction in patients living with HIV.

Cardiovascular disease is an important contributor to morbidity and mortality in people living with HIV . The immature platelet fraction (IPF) is increased in HIV-negative patients with cardiovascular disease and evidence suggests that an enlarged IPF is associated with adverse cardiovascular events. In this multi-center observational study, we aimed to investigate how the IPF in people living with HIV is influenced by antiretroviral therapy and cardiovascular disease. Subjects without cardiovascular disease that received antiretroviral therapy showed a smaller IPF accompanied by lower D-dimer and C-reactive protein (CRP) levels compared to therapy-naïve subjects (mean IPF: 2.9% vs. 3.9%, p = .016; median D-dimer: 252 µg/L vs. 623 µg/L, p < .001; median CRP: 0.2 mg/dL vs. 0.5 mg/dL, p = .004). No significant differences for the IPF, D-dimer or CRP were found between subjects on antiretroviral therapy with documented cardiovascular disease and therapy-naïve subjects. In conclusion, we observed a reduction in the IPF among subjects on therapy only in the absence of cardiovascular disease. In contrast, subjects receiving therapy that had documented cardiovascular disease showed an IPF comparable to therapy-naïve subjects. Future studies are needed to investigate if an enlarged IPF may serve as a biomarker in predicting adverse cardiovascular events in people living with HIV.

Happiness in dermatology: a holistic evaluation of the mental burden of skin diseases.

BACKGROUND: According to the World Health Organization, mental health is a state of well-being and not merely the absence of disease. However, studies exploring subjective well-being in patients with skin diseases are very rare. OBJECTIVES: To assess subjective well-being, i.e. 'happiness', in patients with different skin diseases and to compare them to other patient groups and healthy controls. METHODS: A cross-sectional study was conducted from 12/2017 to 04/2019. Patients receiving in- or outpatient care for psoriasis, atopic eczema, nummular eczema, mastocytosis, skin cancer (malignant melanoma and keratinocyte carcinoma), human immunodeficiency virus (HIV) or chronic inflammatory bowel diseases (Crohn's disease and ulcerative colitis) were recruited at two hospitals in Bavaria, Germany. Healthy individuals living in or near Munich served as a control group. All participants filled in a questionnaire assessing happiness, measured as positive affect (PA), negative affect and satisfaction with life (SWL; together representing subjective well-being) and a heuristic evaluation of one's own happiness. RESULTS: Data from 229 dermatologic patients (53.3 ± 18.5 years, 48% women), 49 patients with inflammatory bowel diseases (48.9 ± 18.7 years, 43% women), 49 patients with HIV (46 ± 10.1 years, 10% women) and 106 healthy controls (38.4 ± 13.4 years, 49% women) were analysed. Compared to the controls, dermatologic patients reported lower heuristic happiness (P = 0.023) and PA (P = 0.001) but higher SWL (P = 0.043). Patients with psoriasis and atopic eczema reported the lowest happiness, as they reported significantly lower PA (P = 0.032 and P < 0.001) and heuristic happiness (P = 0.002 and P = 0.015) than the control group. Patients with skin cancer reported higher SWL than the control group (P = 0.003). Dermatologic patients reported lower happiness than patients with HIV but reported greater happiness than patients with IBD. CONCLUSIONS: Dermatologic patients experience lower levels of happiness, especially PA, compared to healthy controls. As PA is linked to desirable health outcomes, targeting PA could be a promising holistic approach for the treatment of skin diseases.

Summary of German-Austrian HIV PrEP guideline.

OBJECTIVES: HIV Pre-Exposure prophylaxis (PrEP) is a strategy to reduce HIV transmission in people at risk. Aim of this first German-Austrian PrEP guideline is to provide professional guidance on: when and in whom to use PrEP, recommended laboratory tests before and while on PrEP, selection of drugs, prevention of adverse events as a consequence of missing accompanying medical care, and general handling of PrEP in adults and adolescents. METHODS: Commented summary of of the S2k PrEP consensus guidelines released by the German and Austrian HIV medical societies to highlight the key recommendations of the guidelines. CONTENT: Detailed information about effectiveness of PrEP, when and in whom to use PrEP, as well as about additional monitoring of HIV PrEP are included in the HIV PrEP guidelines. Therewith detailed guidance for people being involved in PrEP counseling and associated care is provided.

A retrospective clinical and microbial analysis of 32 patients with bilomas.

BACKGROUND: Bilomas are defined collections of bile fluids mainly caused by iatrogenic injuries of the bile duct system. Owing to the infrequency of this disease, studies addressing bilomas are rare. METHODS: By using an endoscopic database, this retrospective study identified 32 patients with bilomas treated between 2004 to 2015, in order to analyse aetiology, clinical presentation, spectrum of pathogens, and resolution rate of bilomas. RESULTS: 65.6% of the study population (21/32) developed bilomas after surgery and 21.9% (7/32) after endoscopic retrograde cholangiography (ERC). Icterus, fever, and abdominal pain were the leading symptoms. 93.9% (46/49) of microbiological bile cultures revealed a positive microbiology. The predominant microorganisms were the group of Enterobacteriaceae (43.0%, 52/121), followed by Enterococcus spp. (32.2%, 39/121), and Candida spp. (9.1%, 11/121). Multiresistant bacteria like Enterobacteriaceae were isolated from one quarter of all patients. Single or multimodal treatment resulted in an overall complication rate of 4.8% (9/188). Clinical follow-up analysis showed a complete resolution rate of 78.3% for interventional therapy and 80% in the non-interventional group. CONCLUSIONS: Pathogen spectrum of bilomas mainly comprises the group of Enterobacteriacae and Enterococcus spp., with a high proportion of multiresistant bacteria. Different interventional approaches are available for biloma drainage, which seem to be safe and effective for most patients. TRIAL REGISTRATION: German Clinical Trials Register DRKS00015208 , retrospectively registered.

Evaluation of anal carcinoma screening in male and female HIV patients at an interdisciplinary HIV therapy centre.

BACKGROUND: Incidence of anal carcinoma is increased in people living with HIV (PLWH). Due to the improved life expectancy in PLWH, identifying appropriate prevention strategies for non-AIDS-defining cancer types such as anal carcinoma has become a priority in managing PLWH today. OBJECTIVE: We aimed to evaluate anal cytology assessment as screening tool for anal dysplasia and/or carcinoma in PLWH, regardless of gender or sexual orientation. Additionally, we investigated the correlation between cancer risk factors and abnormal screening results in our patient cohort. METHODS: People living with HIV from the Interdisciplinary HIV Centre of the University Hospital rechts der Isar in Munich, Germany (IZAR), were screened for anal carcinoma by single cytobrush examination and anal Papanicolaou (PAP) smear assessment from 2013 to 2015. Patients with abnormal PAP smear result were offered a follow-up examination after 12 months. Differences between two groups were tested for statistical significance using Student's t-test and Mann-Whitney U-test, as appropriate. RESULTS: In total, 101 PLWH were included. 26.7% of subjects (n = 27) were PAP IIID, and 9.9% (n = 10) were PAP IVa. Seven female subjects had an abnormal finding at screening. Smoking was significantly associated with abnormal findings at screening (P = 0.005). In addition, our study found an association between sexually transmitted infections (STI) and anal dysplasia. Condylomata acuminata were increased in subjects with PAP IIID/PAP IVa (P = 0.045). Reactive syphilis serology was found to be significantly associated with abnormal screening results (P = 0.016), respectively. CONCLUSION: Our results demonstrate that smoking and two common STIs, condylomata acuminata and syphilis, are risk factors associated with advanced anal intraepithelial neoplasia (AIN) stages in our PLWH cohort. While further analysis is needed to determine diagnostic guidelines concerning AIN in PLWH, these results suggest that interdisciplinary lifestyle prevention strategies are required to reduce the risk factors for AIN in PLWH in an outpatient setting.

Primary and secondary prevention of skin cancer in mountain guides: attitude and motivation for or against participation.

BACKGROUND: Outdoor professionals such as mountain guides are at a substantial risk of developing non-melanoma skin cancer (NMSC) due to solar ultraviolet radiation (UVR) exposure. Despite major recent primary prevention efforts, studies on secondary skin cancer prevention efforts are limited and corresponding data on outdoor workers scarce. OBJECTIVE: To assess the sun protective behaviour and individual motivations for or against skin cancer screening examinations in the German mountain guide population to aid in the development of effective awareness and prevention strategies. METHODS: A cross-sectional study among all registered mountain guides in Germany was conducted using a 35-item online questionnaire on primary and secondary prevention of NMSC as well as perceived barriers for prevention. RESULTS: A total of 145 mountain guides participated in the study in January 2017. Of these, 86.2% reported using sunscreen often or always, 62.1% with a sun protection factor (SPF) of 30-50% and 60.7% had undergone dermatological examination by a medical professional. The most common reasons for using secondary prevention efforts were hope of an early diagnosis (77.3%), fear of skin cancer (73.9%) and the intention to be aware of one's own health (70.5%). The main reasons for not doing so were absence of conspicuous skin conditions (63.2%) and feeling healthy (59.6%). CONCLUSION: Awareness of prevention strategies recommended by the scientific community is low among affected occupationally high-risk mountain guide populations. Understanding the specific needs of this high-risk group is essential for the development of sustainable awareness and prevention strategies.

Addiction: an underestimated problem in psoriasis health care.

BACKGROUND: Psoriasis is a disease of enormous socio-economic impact. Despite approval of numerous highly efficient and costly therapies, a minor proportion of severely affected patients actually receives sufficient treatment. OBJECTIVE: To investigate whether addictions are associated with psoriasis and to develop evidence-based recommendations for dermatologists in their daily clinical practice in order to improve medical assessment of psoriasis and patients' quality of life. PATIENTS AND METHODS: Psoriasis patients at the University Department of Dermatology were asked to fill out a paper-based self-reported anonymous questionnaire with 92 questions of validated screening tests for the six most common addictions in Germany (alcohol, nicotine, drugs and illegal drugs, gambling, food). Body weight and height as well as current Psoriasis Area and Severity Index (PASI) were documented as well. RESULTS: Between October 2015 and February 2016, 102 patients (65 males, 37 females; mean age 49.7 years (SD 13.4), range 18-83 years) participated in the study. Fifty-seven of the 102 patients showed addictive behaviour. Of these, 23.8% were high-risk drinkers, 41% regular smokers, 11% at risk of drug abuse, 4.1% at risk of food dependency and 19% compulsive gamblers. Compared with the general population, these results are significantly higher for alcohol abuse (P < 0.005), nicotine (P < 0.001) and gambling (P < 0.001). Body mass index was significantly higher in the study population (P < 0.001). CONCLUSION: Addictions and gambling are more prevalent in patients with psoriasis compared with the general population. Respective screening measures are recommended in daily practice for doctors treating psoriasis patients, and PeakPASI is suggested as a score to document patients' lifetime highest PASI. Parallel to new drug approvals and even more detailed insights into the pathomechanism of psoriasis, public health strategies and interdisciplinary approaches are essential for a general sustained psoriasis treatment.

PEPDar: A randomized prospective noninferiority study of ritonavir-boosted darunavir for HIV post-exposure prophylaxis.

OBJECTIVES: PEPDar compared the tolerability and safety of ritonavir-boosted darunavir (DRV/r)-based post-exposure prophylaxis (PEP) with the tolerability and safety of standard of care (SOC). The primary endpoint was the early discontinuation rate among the per-protocol population. METHODS: PEPDar was an open-label, randomized, multicentre, prospective, noninferiority safety study. Subjects were stratified by type of event (occupational vs. nonoccupational, i.e. sexual) and were randomized to receive DRV/r plus two nucleoside reverse transcriptase inhibitors (NRTIs) or SOC PEP. Twenty-two private or university HIV clinics in Germany participated. Subjects were ≥ 18 years old and had documented or potential HIV exposure and indication for HIV PEP. They initiated PEP not later than 72 h after the event and were HIV negative. RESULTS: A total of 324 subjects were screened, the per-protocol population was 305, and 273 subjects completed the study. One hundred and fifty-five subjects received DRV/r-based PEP and 150 subjects received ritonavir-boosted lopinavir (LPV/r)-based PEP for 28-30 days; 298 subjects also received tenofovir/emtricitabine. The early discontinuation rate in the DRV/r arm was 6.5% compared with 10.0% in the SOC arm (P = 0.243). Adverse drug reactions (ADRs) were reported in 68% of DRV/r subjects and 75% of SOC subjects (P = 0.169). Fewer DRV/r subjects (16.1%) had at least one grade 2 or 3 ADR compared with SOC subjects (29.3%) (P = 0.006). All grades of diarrhoea, nausea, and sleep disorders were significantly less frequent with DRV/r, while headache was significantly more frequent. No HIV seroconversion was reported during follow-up. CONCLUSIONS: Noninferiority of DRV/r to SOC was demonstrated. DRV/r should be included as a standard component of recommended regimens in PEP guidelines.

[Ophthalmological alterations at the initial diagnosis of HIV infection]. / Ophthalmologische Veränderungen im Rahmen der Erstdiagnose einer HIV-Infektion.

Acquired immunodeficiency syndrome (AIDS) caused by the human immunodeficiency virus (HIV), is one of the most important infectious causes of death in the twentieth and twenty-first centuries. Ocular manifestations can appear in particular when the CD4 cell count is low. This article presents a case report of a 38-year-old homosexual man in whom HIV microangiopathy retinopathy syndrome (MAPS) was found during the assessment of the initial HIV diagnosis. Typical findings in MAPS are conjunctival and retinal vessel abnormalities, cotton wool spots as well as intraretinal hemorrhages. Loss of vision is a rare complication but MAPS shows an impairment of the immune status and is also associated with a higher mortality.