To compare efficacy and safety of topical trichloroacetic acid (TCA) versus electrocautery (ECA) for the treatment of human papillomavirus (HPV)-associated anal intraepithelial neoplasia (AIN) in people living with HIV (PLWH). The TECAIN-study was a prospective, multicentre, randomised (1:1 block-randomisation), open-label, non-inferiority trial in PLWH with histologically confirmed AIN recruited from seven German proctological units. The primary endpoint (PE) was therapeutic success defined as a combination of complete clinical response evaluated by high-resolution-anoscopy and histological AIN-clearance/regression four weeks after the end-of-treatment (4-weeks-follow-up, 4WFU). Secondary endpoints were assessed at 4WFU and 24WFU. Efficacy was analysed in the intention-to-treat-population as primary analysis with a non-inferiority margin of -12
People with HIV are up to 100 times more likely to develop anal carcinoma compared to the general population. Diagnosing and treating precursor lesions, specifically high-grade anal dysplasia, can significantly reduce the risk of developing anal carcinoma. This S2k-guideline outlines the factors that increase the likelihood of developing anal carcinoma and its precursors, including advancing age, a low CD4+ T-lymphocyte nadir, active cigarette smoking, receptive anal intercourse, or persistent infection with high-risk (HR) types of human papillomavirus (HPV). Screening is primarily recommended for all men who have sex with men (MSM) and transgender women with HIV starting at age 35, and all people with HIV starting at age 45. After inspection and digital anorectal examination, anal cytology is collected. An HR-HPV test may be performed. If clinical abnormalities are present or if cytology shows "ASC-US or worse", a referral for high-resolution anoscopy (HRA) is indicated. If lesions are found during HRA, a biopsy should be obtained. Anal intraepithelial neoplasia (AIN) grade-III or AIN-II p16-positive correspond to high-grade dysplasia and require treatment. The most strongly recommended therapeutic options are electrocautery, 85% trichloroacetic acid, and surgical excision. Finally, the guideline discusses how these screening recommendations can be applied to individuals without HIV.
To quantify virologic failure (VF), identify predictors, characterize resistance patterns at failure, and evaluate time to resuppression in the RESINA cohort. ART-naïve adults initiating ART in 2001–2024 were followed. VF was defined as at least one HIV-1 RNA > 200 copies/mL after suppression or ≥ 0.5-log₁₀ rebound. Participants were grouped by treatment era (2001–2007, 2008–2013, ≥ 2014), reflecting availability of drug classes. Genotypes at baseline and VF were interpreted using the HIV-GRADE algorithm. Predictors of VF were assessed with logistic regression; time to resuppression (< 50 copies/mL) after first VF with Cox models and Kaplan–Meier plots. Among 5136 participants, 139 (2.7
Menschen mit HIV sind im Vergleich zur Allgemeinbevölkerung bis zu 100‐mal häufiger von Analkarzinomen betroffen. Werden Vorläufer, das bedeutet hochgradige anale Dysplasien, diagnostiziert und therapiert, kann das Risiko für das Auftreten eines Analkarzinoms statistisch signifikant reduziert werden. Faktoren für eine höhere Wahrscheinlichkeit für Analkarzinome und deren Vorläufer sind beispielsweise zunehmendes Alter, ein niedriger CD4+ T‐Lymphozyten Nadir, aktives Zigarettenrauchen, rezeptiver Analverkehr oder persistierender Nachweis von Hoch‐Risiko (HR)‐Typen des humanen Papillomavirus (HPV). Eine Screening‐Empfehlung besteht vorwiegend für alle Männer, die Sex mit Männern haben und Transgender‐Frauen mit HIV ab dem 35. Lebensjahr sowie für alle Menschen mit HIV ab dem 45. Lebensjahr. Nach Inspektion und digital rektaler Untersuchung wird eine anale Zytologie angefertigt. Ein HR‐HPV‐Nachweis kann ergänzend erfolgen. Bei klinischen Auffälligkeiten sowie ab „ASC‐US“ ist die Zuweisung zur hochauflösenden Anoskopie indiziert. Stellen sich hierbei Läsionen dar, ist eine histopathologische Diagnosesicherung anzustreben. Bei analen intraepithelialen Neoplasien (AIN) Grad III und AIN II mit p16‐Positivität entspricht der Befund einer hochgradigen Dysplasie und erfordert eine Therapie. Die stärksten Therapieempfehlungen bestehen für die Elektrokaustik, die Anwendung von 85%iger Trichloressigsäure sowie die operative Abtragung. Abschließend wird in dieser Leitlinie darauf eingegangen, wie das Analkarzinom‐Screening auf Menschen ohne HIV übertragen werden kann.
BACKGROUND:Torque teno virus (TTV) is part of the human virome. TTV load was related to the immune status in patients after organ transplantation. We hypothesize that TTV load could be an additional marker for immune function in people living with HIV (PLWH). METHODS:In this analysis, serum samples of PLWH from the RESINA multicenter cohort were reanalyzed for TTV. Investigated clinical and epidemiological parameters included human pegivirus load, patient age and sex, HIV load, CD4+ T-cell count (Centers for Disease Control and Prevention [CDC] stage 1, 2, or 3), and CDC clinical stage (1993 CDC classification system; stage A, B, or C) before initiation of antiretroviral therapy. Regression analysis was used to detect possible associations among parameters. RESULTS:Our analysis confirmed TTV as a strong predictor of CD4+ T-cell count and CDC class 3. This relationship was used to propose a first classification of TTV load with regard to clinical stage. We found no association with clinical CDC stages A-C. The human pegivirus load was inversely correlated with HIV load but not TTV load. CONCLUSIONS:TTV load was associated with immunodeficiency in PLWH. Neither TTV nor HIV load were predictive for the clinical categories of HIV infection.
Kaposi's sarcoma (KS) is a rare, malignant, multilocular vascular disease originating from lymphatic endothelial cells that can primarily affect the skin and mucous membranes, but also the lymphatic system and internal organs such as the gastrointestinal tract, lungs or liver. Five epidemiological subtypes of KS with variable clinical course and prognosis are distinguished, with increased incidence in specific populations: (1) Classical KS, (2) Iatrogenic KS in immunosuppression, (3) Endemic (African) lymphadenopathic KS, (4) Epidemic, HIV-associated KS and KS associated with immune reconstitution inflammatory syndrome (IRIS), and (5) KS in men who have sex with men (MSM) without HIV infection. This interdisciplinary guideline summarizes current practice-relevant recommendations on diangostics and therapy of the different forms of KS. The recommendations mentioned in this short guideline are elaborated in more detail in the extended version of the guideline (online format of the JDDG).
ZusammenfassungDas Kaposi‐Sarkom (KS) ist eine seltene, maligne, von lymphatischen Endothelzellen ausgehende, multilokuläre Gefäßerkrankung, die vor allem Haut und Schleimhäute, aber auch das lymphatische System und innere Organe wie den Gastrointestinaltrakt, die Lunge oder die Leber befallen kann. Fünf epidemiologische Subtypen des KS mit variablem klinischem Verlauf und unterschiedlicher Prognose werden unterschieden, die in spezifischen Populationen vermehrt auftreten: (1) klassisches KS, (2) iatrogenes KS bei Immunsuppression, (3) endemisches (afrikanisches) lymphadenopathisches KS, (4) epidemisches, HIV‐assoziiertes KS und mit einem Immunrekonstitutions‐Inflammations‐Syndrom (IRIS) assoziiertes KS und (5) KS bei Männern, die Sex mit Männern haben (MSM) ohne HIV‐Infektion. Diese interdisziplinäre Leitlinie fasst aktuelle praxisrelevante Empfehlungen zu Diagnostik und Therapie der verschiedenen Formen des KS zusammen. Die in dieser Kurzleitlinie genannten Empfehlungen werden in der Langfassung der Leitlinie (Online‐Version des JDDG) detaillierter ausgeführt.
Abstract Background Point-of-care (POC) polymerase chain reaction (PCR) tests have the ability to improve testing efficiency in the Coronavirus disease 2019 (COVID-19) pandemic. However, real-world data on POC tests is scarce. Objective To evaluate the efficiency of a novel severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) POC test in a clinical setting and examine the prognostic value of cycle threshold (CT) on admission on the length of hospital stay (LOS) in COVID-19 patients. Methods Patients hospitalised between January and May 2021 were included in this prospective cohort study. Patients’ nasopharyngeal swabs were tested for SARS-CoV-2 with Allplex™2019-nCoV (Seegene Inc.) real-time (RT) PCR assay as gold standard as well as a novel POC test (Bosch Vivalytic SARS-CoV-2 [Bosch]) and the SARS-CoV-2 Rapid Antigen Test (Roche) accordingly. Clinical sensitivity and specificity as well as inter- and intra-assay variability were analyzed. Results 120 patients met the inclusion criteria with 46 (38%) having a definite COVID-19 diagnosis by RT-PCR. Bosch Vivalytic SARS-CoV-2 POC had a sensitivity of 88% and specificity of 96%. The inter- and intra- assay variability was below 15%. The CT value at baseline was lower in patients with LOS ≥ 10 days when compared to patients with LOS < 10 days (27.82 (± 4.648) vs. 36.2 (25.9–39.18); p = 0.0191). There was a negative correlation of CT at admission and LOS (r[44]s = − 0.31; p = 0.038) but only age was associated with the probability of an increased LOS in a multiple logistic regression analysis (OR 1.105 [95% CI, 1.03–1.19]; p = 0.006). Conclusion Our data indicate that POC testing with Bosch Vivalytic SARS-CoV-2 is a valid strategy to identify COVID-19 patients and decrease turnaround time to definite COVID-19 diagnosis. Also, our data suggest that age at admission possibly with CT value as a combined parameter could be a promising tool for risk assessment of increased length of hospital stay and severity of disease in COVID-19 patients.