CT changes in a randomized trial comparing early therapies in an outpatient population at high risk of severe COVID19 disease.

Although in vitro studies suggest that neutralization by monoclonal antibodies (mAbs) against SARS CoV2 Omicron sub lineages is reduced, in vivo virological response data are lacking. MONET (EudraCT: 2021-004188-28) was multi-centric phase 4 open-label parallel randomized clinical trial, conducted in Italy over 2022-2023, to assess the efficacy of sotrovimab (SOT), tixagevimab/cilgavimab (TIX/CIL) and Nirmatrelvir/ritonavir (NMV/r), in outpatients at high risk for severe COVID-19. The outcome (secondary in the trial protocol) was SARS-CoV-2 variation in cycle threshold (CT) values over the first 7 days (D1-D7) of the trial.

Burden of advanced HIV disease among antiretroviral therapy-experienced persons with HIV in Italy over the past 20 years.

Introduction: Data on the burden of advanced HIV disease (AHD) among people with HIV (PWH) already in care remain limited in high-income settings.

Methods: We included all PWH from the Icona Cohort who started ART between 2004 and 2024, with CD4≥200 cells/mm and no prior AIDS-defining event (ADE). Probability of AHD (CD4<200 cell/mm or ADE) occurring ≥3 months after ART initiation was estimated by Kaplan-Meier curves.

All-cause and Cause-specific Mortality in People With HIV in Italy in 1997-2022: Data From the Icona Cohort.

Background: Understanding the evolution and dynamics of deaths in people with HIV (PWH) is crucial to tailor interventions aiming at improving PWH long-term well-being. We aimed to assess all-cause and cause-specific mortality in PWH in Italy.

Methods: PWH enrolled before antiretroviral start from Icona cohort (78 Italian HIV clinics) between 1997 and 2021 (last observation December 2022) were included.

Switching to bictegravir/emtricitabine/tenofovir alafenamide from efavirenz/emtricitabine/tenofovir disoproxil in virologically suppressed people with HIV: findings from a non-randomized clinical trial (EBONY study).

Objectives: No previous studies specifically explored the switch from efavirenz to bictegravir (BIC)-containing three-drug antiretroviral regimens. This study aimed to evaluate the efficacy and safety outcomes of a treatment switch from efavirenz/emtricitabine/tenofovir disoproxil fumarate (EFV/FTC/TDF) given once daily (OD) or on alternate days (ATAD) to BIC/emtricitabine/tenofovir alafenamide (BIC/FTC/TAF) in virologically suppressed people with HIV (PWH).

Methods: A pilot, single-arm, prospective study was conducted.

Comparative Analysis of Early COVID-19 Treatment Efficacy in a Multicentric Regional Cohort in Italy: Emulation of a Series of Target Trials.

Studies comparing all available strategies for the early treatment of mild-to-moderate COVID-19 during the Omicron era are lacking. We included people with mild-to-moderate COVID-19 and at high risk of progressing to severe disease attending five outpatient clinics in Italy over 2022-2023. The primary outcome was the proportion of participants who experienced Day-30 hospitalization due to COVID-19 or death.

Effectiveness and Tolerability of DOR/3TC/TDF in Experienced People with HIV Switching from RPV/FTC/TDF: A Retrospective, Single Center Cohort Study.

With advances in antiretroviral therapy for HIV treatment, newer drug combinations provide improved efficacy, safety, and compliance. This study evaluates switching to a regimen of doravirine (DOR), tenofovir disoproxil fumarate (TDF), and lamivudine (3TC) in a cohort of people living with HIV (PLWH). this Italian retrospective study included 426 PLWH who switched from rilpivirine (RPV)/TDF/emtricitabine (FTC) to DOR/3TC/TDF.

Safety and Pharmacokinetic Profiles of Subcutaneous Administration of Beta-Lactams: A Systematic Review.

Beta-lactams are extensively used antibiotics known for their safety and effectiveness. The rise in patients who receive care in outpatient settings has increased the interest in subcutaneous administration (SA). The aim of the study is to assess the safety and pharmacokinetic (PK) profiles of SA of beta-lactams compared with other routes.

Renal function and its impact on the concentration of ceftazidime-avibactam: A cross-sectional study.

Objective: This study measured the effect of renal function on the plasma concentrations of ceftazidime and avibactam in critically ill patients. We also sought to measure the concentration ratio of ceftazidime to avibactam.

Methods: This was a cohort study at a tertiary referral centre in Italy, on patients treated with continuous infusion of ceftazidime-avibactam (CAZ-AVI) between November 2019 and December 2023.

Pooled analysis of the MANTICO2 and MONET randomized controlled trials comparing drug efficacy for early treatment of COVID-19 during Omicron waves.

Background: The clinical effectiveness of early therapies for mild-to-moderate COVID-19, comparing antivirals and monoclonal antibodies (mAbs) during the Omicron era, has not been conclusively assessed through a post-approval comparative trial. We present a pooled analysis of two randomized clinical trials conducted during Omicron waves.

Methods: The MANTICO2/MONET trial is a pooled analysis of two multicentric, independent, phase-4, three-arm, superiority, randomized, open-label trials.

Clinical and laboratory predictors of mpox severity and duration: an Italian multicentre cohort study (mpox-Icona).

Background: Severe and prolonged mpox courses have been described during the 2022-2023 outbreak. Identifying predictors of severe evolution is crucial for improving management and therapeutic strategies. We explored the predictors of mpox severity and tested the association between mpox severity and viral load in biological fluids.

Immunogenicity and reactogenicity of modified vaccinia Ankara pre-exposure vaccination against mpox according to previous smallpox vaccine exposure and HIV infection: prospective cohort study.

Background: Pre-exposure vaccination with MVA-BN has been widely used against mpox to contain the 2022 outbreak. Many countries have defined prioritized strategies, administering a single dose to those historically vaccinated for smallpox, to achieve quickly adequate coverage in front of low supplies. Using epidemiological models, real-life effectiveness was estimated at approximately 36%-86%, but no clinical trials were performed.

Risk Awareness as a Key Determinant of Early Vaccine Uptake in the Mpox Vaccination Campaign in an Italian Region: A Cross-Sectional Analysis.

Background: we aim to investigate attitudes toward vaccination by analyzing empirical factors associated with vaccine acceptance in the Lazio region mpox vaccination (MpoxVax) campaign in Italy.

Methods: all subjects who accessed MpoxVax and signed the informed consent were prospectively enrolled in the MPOX-VAC Study and were asked to fill out an anonymous survey. Two endpoints were selected: 'delayed acceptance' and 'early acceptance', defined as access for vaccination >60 and ≤30 days from the vaccination campaign starting (VCS), respectively.

Rapid ART initiation with bictegravir/emtricitabine/tenofovir alafenamide in individuals presenting with advanced HIV disease (Rainbow study).

Background: A rapid ART initiation approach can be beneficial in people with advanced HIV disease, in consideration of their high morbidity and mortality. The aim of our study was to evaluate the feasibility, efficacy and safety of rapid ART start with BIC/FTC/TAF in this setting.

Methods: Pilot, single-centre, single-arm, prospective, phase IV clinical trial conducted in a tertiary Italian hospital.

SARS-CoV-2 mRNA Vaccine Response in People Living with HIV According to CD4 Count and CD4/CD8 Ratio.

Background: Our aim was to estimate the rates of not achieving a robust/above-average humoral response to the COVID-19 mRNA vaccine in people living with HIV (PLWH) who received ≥2 doses and to investigate the role of the CD4 and CD4/CD8 ratio in predicting the humoral response.

Methods: We evaluated the humoral anti-SARS-CoV-2 response 1-month after the second and third doses of COVID-19 mRNA vaccine as a proportion of not achieving a robust/above-average response using two criteria: (i) a humoral threshold identified as a correlate of protection against SARS-CoV-2 (<90% vaccine efficacy): anti-RBD < 775 BAU/mL or anti-S < 298 BAU/mL, (ii) threshold of binding antibodies equivalent to average neutralization activity from the levels of binding (nAb titer < 1:40): anti-RBD < 870 BAU/mL or anti-S < 1591 BAU/mL. PLWH were stratified according to the CD4 count and CD4/CD8 ratio at first dose.

Effect of tecovirimat on healing time and viral clearance by emulation of a target trial in patients hospitalized for mpox.

Tecovirimat is a treatment option for severe mpox, although randomized clinical trials are ongoing. The aim of the study is to assess the effect of tecovirimat on healing time and the extent of viral clearance by target trial emulation using observational data. Clinical and virological data of patients hospitalized for mpox were collected.

The possible effect of sociobehavioral factors and public health actions on the mpox epidemic slowdown.

Objectives: A pre-exposure vaccination campaign to prevent the spread of the mpox virus was initiated in Italy in August 2022. We explore the possible factors affecting the trend of mpox cases in an Italian region (Lazio) with a rapid roll-out of the vaccination campaign.

Methods: We estimated the impact of the communication and vaccination campaign by fitting a Poisson segmented regression model.

Comparison of SARS-CoV-2 Detection in Nasopharyngeal Swab and Saliva Samples from Patients Infected with Omicron Variant.

To compare the detection of the SARS-CoV-2 Omicron variant in nasopharyngeal-swab (NPS) and oral saliva samples. 255 samples were obtained from 85 Omicron-infected patients. SARS-CoV-2 load was measured in the NPS and saliva samples by using Simplexa™ COVID-19 direct and Alinity m SARS-CoV-2 AMP assays.

Prolonged higher dose methylprednisolone conventional dexamethasone in COVID-19 pneumonia: a randomised controlled trial (MEDEAS).

Background: Dysregulated systemic inflammation is the primary driver of mortality in severe coronavirus disease 2019 (COVID-19) pneumonia. Current guidelines favour a 7-10-day course of any glucocorticoid equivalent to dexamethasone 6 mg daily. A comparative randomised controlled trial (RCT) with a higher dose and a longer duration of intervention was lacking.