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Leishmaniases are a clinically heterogeneous group of diseases caused by protozoa of the genus Leishmania . There is growing evidence that the true incidence of the disease is underestimated, especially in hyperendemic regions. Moreover, climate changes together with the increasing movement of humans and animals raise concerns about the possible introduction of Leishmania infection in previously spared areas. The disease is emerging in immunocompromised patients undergoing bone marrow or solid organ transplantation or treatment with biologic drugs. Furthermore, the deployment of military troops and travel to endemic areas are associated with the observation of a growing number of patients with cutaneous disease. Improvement in diagnostic methods, both in the field and in specialized laboratories, has been obtained through the implementation of molecular amplification methods and using the rK39 antigen as the substrate. Finally, new therapeutic approaches are gaining attention, such as the use of miltefosine for cutaneous leishmaniasis and paromomycin for visceral leishmaniasis, as well as the use of various antileishmanial drugs in combination.

Background. To overcome some of the limitations of conventional microbiologic techniques, polymerase chain reaction (PCR)-based assays are proposed as useful tools for the diagnosis of visceral leishmaniasis. Patients and methods. A comparative study using conventional microbiologic techniques (i.e., serologic testing, microscopic examination, and culture) and a Leishmania species-specific PCR assay, using peripheral blood and bone marrow aspirate samples as templates, was conducted during an 8-year period. The study cohort consisted of 594 Italian immunocompetent (adult and pediatric) and immunocompromised (adult) patients experiencing febrile syndromes associated with hematologic alterations and/or hepatosplenomegaly. Identification of the infecting protozoa at the species level was directly obtained by PCR of peripheral blood samples, followed by restriction fragment-length polymorphism analysis of the amplified products, and the results were compared with those of isoenzyme typing of Leishmania species strains from patients, which were isolated in vitro. Results. Sixty-eight patients (11.4%) had a confirmed diagnosis of visceral leishmaniasis. Eleven cases were observed in human immunodeficiency virus (HIV)-uninfected adults, 20 cases were observed in HIV-infected adults, and the remaining 37 cases were diagnosed in HIV-uninfected children. In the diagnosis of primary visceral leishmaniasis, the sensitivities of the Leishmania species-specific PCR were 95.7% for bone marrow aspirate samples and 98.5% for peripheral blood samples versus sensitivities of 76.2%, 85.5%, and 90.2% for bone marrow aspirate isolation, serologic testing, and microscopic examination of bone marrow biopsy specimens, respectively. None of 229 healthy blood donors or 25 patients with imported malaria who were used as negative control subjects had PCR results positive for Leishmania species in peripheral blood samples (i.e., specificity of Leishmania species-specific PCR, 100%). PCR and restriction fragment-length polymorphism analysis for Leishmania species identification revealed 100% concordance with isoenzyme typing in the 19 patients for whom the latter data were available. Conclusions. PCR assay is a highly sensitive and specific tool for the diagnosis of visceral leishmaniasis in both immunocompetent and immunocompromised patients and can be reliably used for rapid parasite identification at the species level.

Chest radiography showed multiple bibasilar pulmonary nodules while a CT scan of the lungs showed a wide area of increased density with irregular margins located in the right inferior pulmonary lobe ( fig 2 ).

The clinical and epidemiological characteristics of 111 consecutive cases of visceral leishmaniasis identified from 1980 to 2000 in a Sicilian pediatric hospital were analyzed retrospectively. The mean age of the patients was 1.7 years. All children were HIV negative, but 15% were severely malnourished. Fever and splenomegaly were present in all cases and hepatomegaly in 101 (90.1%) cases. Thrombocytopenia and anemia were both observed in 78 (70.2%) cases and leukopenia in 47 (42.3%) cases. A bone marrow aspirate was obtained in all cases; Leishmania amastigotes were detected in 89 (80.2%) cases. Initial treatment consisted of meglumine antimoniate in 99 (89.2%) patients and amphotericin B in 12 (10.8%) patients. Only two children treated with meglumine antimoniate relapsed. The findings highlight the differences between the cases of visceral leishmaniasis observed in the Mediterranean basin and those observed in other regions. The use of the term \"Mediterranean visceral leishmaniasis\", rather than the term \"kala-azar\", is proposed for cases observed in the Mediterranean area.

We describe 2 human immunodeficiency virus- infected patients who developed hypertension and severe neurological abnormalities while receiving successful antiretroviral therapy. Neuroimaging findings were characteristic of reversible posterior leukoencephalopathy syndrome, a brain-capillary leak syndrome with hypertension and endothelial damage. We discuss the role of antiretroviral therapy-associated metabolic alterations in endothelial damage, hypertension, and reversible posterior leukoencephalopathy syndrome.

We conducted an open-label randomized controlled trial to compare the efficacy and safety of clarithromycin (15/mg/kg/day in 2 divided doses for 7 days) with those of azithromycin (10 mg/kg/day in 1 dose for 3 days) in the treatment of children with Mediterranean spotted fever. Until now, there has not been a gold-standard therapy for this rickettsial disease in children. Eighty-seven children were randomized to receive 1 of the 2 drugs. The mean time to defervescence (± standard deviation) was 46.2 ± 36.4 h in the clarithromycin group and 39.3 ± 31.3 h in the azithromycin group. These differences were not statistically significant and both drugs were equally well-tolerated. Clarithromycin and azithromycin could be acceptable therapeutic alternatives to chloramphenicol and tetracyclines for children aged ⩽8 years with Mediterranean spotted fever. Azithromycin, because it has a long half-life, offers the advantages of administration in a single daily dose and a shorter duration of therapy, which could increase compliance in children.

IntroductionUncontrolled HIV infection has been linked to a higher risk of AIDS-defining cancer (ADC). With the introduction of antiretroviral therapy an increasing occurrence of non-AIDS-defining cancers (NADCs) has been observed in people with HIV (PWH). We aimed to assess the incidence of NADCs in PWH.MethodsWe performed a single center observational retrospective study from January 2000 to December 2023 including PWH included in the cohort of the III Infectious Disease Unit of Luigi Sacco Hospital, Milan, Italy. Three 8-year calendar periods were chosen to assess changes in cancer incidence (2000–2007, 2008–2015, 2016–2023). NADCs were further stratified in virus-related and smoking-related. If more than one NADC occurred only the first was considered in the analysis. Cancer incidence was estimated with Poisson regression models and expressed as rate per 100,000 person years of follow-up (PYs). The relative risk of cancer incidence per calendar period was estimated with multivariable Poisson regression model adjusting for age, mode of HIV acquisition and previous AIDS.ResultsOverall, 580 cases of malignancy were observed among 4,642 PWH contributing for 50.052 PYs. Characteristics of the study population are reported in table 1. Most of the malignancies were NADC (371/580, 63.9%) and the remaining were ADC (209/580, 36.1%). NADCs incidence significantly increase from 580.5/100.000PYs in first period to 974.4/100.000PYs in third period (RR 1.42, 95%CI 1.07–1.88). The same was observed for virus-related cancers (236.7/100.000PYs in first period to 333.4/100.000PYs in third period, [RR 1.67, 95%CI 1.03–2.72]), and smoking-related cancers (450.9/100.000PYs in first period to 859/100.000PYs in third period [RR 1.64, 95%CI 1.2–2.24]). Regarding NADCs, increasing age (RR 1.25, 95%CI 1.14–1.38) was significantly associated with an increased incidence such as a previous AIDS (RR 1.33, 95%CI 1.06–1.68) and mode of HIV acquisition (PWID vs HE; RR 1.70, 95%CI 1.32–2.18). In the analysis restricted to lung cancer only aged appeared to be significantly associated (RR 1.50, 95%CI 1.19–1.88). Regarding, virus-related cancers mode of HIV acquisition (people who inject drugs (PWID) and men who have sex with men (MSM) vs heterosexual (HE); RR 2.83, 95%CI 1.8–4.43 and RR 1.95, 95%CI 1.26–3.01 respectively) and previous AIDS (RR 1.73, 95%CI 1.2–2.5) resulted associated to a higher incidence. Regarding anal cancer, mode of HIV acquisition (MSM vs HE; RR 3.28, 95%CI 1.75–6.16) and prior AIDS (RR 3.18, 95%CI 1.87–5.41) were associated with a higher risk. Regarding smoking related cancers, increasing age (RR 1.25, 95%CI 1.13–1.39), mode of HIV acquisition (PWID vs HE; RR 1.79, 95%CI 1.37–2.36) and previous AIDS (RR 1.51, 95%CI 1.18–1.93) emerged to be associated to a higher incidence (table 2).Abstract OC40 Table 1Characteristics of the study populationAbstract OC40 Table 2Multivariable analysis with Poisson regressionConclusionsWe observed that the incidence of NADCs has increased over time with people with previous AIDS and PWID showing a disproportionately higher risk of NADCs.

BackgroundSwitching antiretroviral treatment (ART) in the setting of HIV suppression may improve pill burden, dosing frequency, safety, tolerability, and/or food requirements. Real-life data on effectiveness and safety of bictegravir/emtricitabine/tenofovir alafenamide (BIC/FTC/TAF) in virologically suppressed (VS) people living with HIV (PWH) as second, third, and subsequent line of treatment in clinical practice from any regimen including non-nucleoside reverse transcriptase inhibitors (NNRTIs) are needed.MethodsThis is a single-site retrospective study in VS (HIV-RNA <50 copies/mL ≥3 months) PWH aged ≥ 18 years switched to BIC/FTC/TAF in clinical practice at ASST Fatebenefratelli Ospedale Luigi Sacco between July 2019 and February 2024 (Database freezing February 2025). Demographic, clinical and immune-virological characteristics were collected at the time of the switch and at 6 and 12 months thereafter. The primary objective of the study is to assess the effectiveness of BIC/FTC/TAF in virologically suppressed PWH at 6 and 12 months after the switch, based on an observed analysis. The secondary objectives were reasons of switch to BIC/FTC/TAF, changes in CD4 and CD8 at 6 and 12 months, and rate of virological failure (2 consecutive HIV-RNA >50 copies/mL or a single HIV-RNA >1,000 copies/mL). Virological suppression rates and 95% CI were estimated using the Wald asymptotic method.ResultsFive-hundred PWH were included in the analysis. Characteristics of the study population at the time of the switch to BIC/FTC/TAF are reported in table 1. PWH were frequently male (332, 66.4%), Italian born (399, 80.3%), with a median age of 54 years [IQR 47, 59], and most had ≥1 comorbidity (419, 83.8%). The median CD4 cell count at the time of the switch was 705 cell/mm3 [IQR 503, 903]. Reason of switch to BIC/FTC/TAF are depicted in figure 1 and regimens before the switch (including out-dated regimens) in figure 2. The virological suppression rate at 6 and 12 months was 97.9% (95% CI 96.6%-99.2%) (observed 459/469) and 98.2% (95% CI 97.0%-99.4%) (observed 443/451), respectively. The virological failure rate was 1.2% (95% CI 0.3%-2.2%) at 6 months and 0.6% (95% CI 0.0%-1.4%) at 12 months. The discontinuation rate for any reason at 6 months was 6.2% (95% CI 4.1% - 8.3%) (observed 31/500) and between 6 and 12 months was 3.8% (95% CI 2.1% - 5.6%) (observed 18/469). Reasons of discontinuations are reported in figure 3. Median CD4 cell count at 6 and 12 months were 713 cell/mm3 [IQR 517–893] and 727 cell/mm3 [543–931], respectively. Seven (1.4%) and 2 (0.4%) individuals experienced adverse events at 6 and 12 months, respectively.Abstract OC21 Table 1Bamun characteristics at the time of switchAbstract OC21 Figure 1–3ConclusionsIn a VS population of PWH with a high burden of comorbidities, BIC/FTC/TAF demonstrated excellent virological suppression rates (98% at 12 months) following the switch, with few drug-related discontinuations.DisclaimerESSENTIAL Study (GS-IT-380–7059) is sponsored by Gilead Sciences.

IntroductionPeople with HIV (PWH) have twice the risk of developing atherosclerotic cardiovascular disease (ASCVD) compared to the general population. The European AIDS Clinical Society (EACS) guidelines emphasize the importance of achieving low-density lipoprotein cholesterol (LDL-C) targets based on individual cardiovascular risk. The objective of our study was to assess changes in achieving these targets in two consecutive years.MethodsWe conducted a retrospective, observational, single-center study, including all PWH over 40 years old included in the cohort of the III Infectious Disease Unit of Luigi Sacco Hospital (Milan, Italy) who had at least one visit to the Infectious Diseases outpatient clinics at Sacco Hospital during two consecutive periods: March 31, 2022 – March 31, 2023 (period 1), and March 31, 2023 – March 31, 2024 (period 2). Demographic, clinical, and laboratory data were collected. Individual cardiovascular risk was assessed according to the European Society of Cardiology (ESC) and EACS guidelines using risk scores (SCORE2, SCORE2-OP, SMART, SCORE2-DM, and ASCVD) or other clinical criteria (history of cardiovascular disease, diabetes mellitus, chronic kidney disease). PWH were classified into three risk categories: very high (VHR), high (HR), and non-high (no-HR). LDL-C target achievement was evaluated through a two-step approach, as defined by the ESC. Additionally, we assessed the prescription of lipid-lowering therapy (LLT) after one year in accordance with the latest EACS guidelines.ResultsA total of 1,105 PWH were included, predominantly male (74%) and Caucasian (87%), with a median age of 58 years (IQR 51–62). Most had HIV RNA <50 cp/mL (97% in period 1 and 95% in period 2), with a median CD4 lymphocyte count of 728 cell/m3 (550–928) and 708 cell/mm3 (522–894) in period 1 and 2, respectively (table 1). The distribution of risk categories remained stable (27% vs. 26% no-HR, 50% vs. 52% HR, 22% VHR in both period 1 and period 2). The median LDL-C decreased from 122 mg/dL (100–144) in period 1 to 115 mg/dL (91–138) in period 2, and the percentage of patients achieving at least one target phase increased from 49% to 58% (p <0.001) in period 1 and 2, respectively (figure 1). However, these percentages dropped when considering PWH on LLT who achieved phase two: 4% in HR and 4% in VHR in period 1, while 5% in HR and 9% in VHR in period 2 (figure 2). The prescription of at least one LLT increased from 38% to 48% from period 1 to period 2, with statins being the most commonly used drugs, often in combination with ezetimibe. Despite this, according to the updated EACS guidelines, only 11% in period 1 and 17% in period 2 received an appropriate LLT prescription.Abstract OC1 Table 1Characteristics of the study population. List of abbreviations: n, number; IQR, inter quartile range; MSM, men who have sex with men; HE, heterosexual; IDU, intravenous drug users; BMI, body mass index; DM2, type 2 diabetes; CKD, chronic kidney disease; ART antiretroviral treatment; INSTI, integrase inhibitors; PI, protease inhibitors; NNRTI, non-nucleoside reverse transcriptase inhibitors, TC, total cholesterol; HDL, high density lipoproteins; TG, triglycerides; LDL-c, calculated low density lipoproteins; LLT, lipid-lowering therapyAbstract OC1 Figure 1Comparison of achiveing the LDL-C target across both time periods[Figure omitted. See PDF]Abstract OC1 Figure 2Achievement of the LDL-C target in patients on lipid-lowering therapy, stratified by 10-year cardiovascular risk category, and prescription appropriateness according to the 2024 EACS guidelines. List of abbreviations: n, number; acc, according; LLT, lipid-lowering therapy; EACS, European AIDS clinical society[Figure omitted. See PDF]ConclusionsDespite the update of the EACS guidelines, the achievement of LDL-C targets in our cohort remains suboptimal. LLT prescription also remains insufficient, with a significant gap compared to the actual universal recommendation for statin use in PWH over 40.