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1. A holistic evaluation of patients with chronic Hepatitis D virus (HDV) infection enrolled in the Italian PITER-B and delta cohort

Author

Loreta A. Kondili, Giuseppina Brancaccio, Maria Elena Tosti, Barbara Coco, Maria Giovanna Quaranta, Vincenzo Messina, Alessia Ciancio, Filomena Morisco, Valentina Cossiga, Ernesto Claar, Valerio Rosato, Marianna Ciarallo, Irene Cacciola, Francesca Romana Ponziani, Lucia Cerrito, Roberta Coppola, Francesco Longobardi, Elisa Biliotti, Alessia Rianda, Francesco Barbaro, Nicola Coppola, Maria Stanzione, Francesco Barchiesi, Stefano Fagiuoli, Mauro Viganò, Marco Massari, Francesco Paolo Russo, Alberto Ferrarese, Diletta Laccabue, Vito Di Marco, Pierluigi Blanc, Aldo Marrone, Giulia Morsica, Alessandro Federico, Donatella Ieluzzi, Alba Rocco, Francesco Giuseppe Foschi, Alessandro Soria, Ivana Maida, Luchino Chessa, Michele Milella, Elena Rosselli Del Turco, Salvatore Madonia, Liliana Chemello, Ivan Gentile, Pierluigi Toniutto, Matteo Bassetti, Lorenzo Surace, Leonardo Baiocchi, Adriano Pellicelli, Adriano De Santis, Massimo Puoti, Elisabetta Degasperi, Grazia Anna Niro, Anna Linda Zignego, Antonio Craxi, Giovanni Raimondo, Teresa Antonia Santantonio, Maurizia Rossana Brunetto, Giovanni Battista Gaeta, Alessio Aghemo, Chiara Baiguera, Pier Maria Battezzati, Sara Battistella, Maria Grazia Bavetta, Costanza Bertoni, Carolina Boni, Paola Brambilla, Antonella Bray, Federica Briano, Enrico Carmenini, Francesco Castelli, Luisa Cavalletto, Federica Cerini, Luciana Chidichimo, Elisa Colella, Giuliana Cologni, Silvia Como, Romina Corsini, Chiara Costa, Rosa Cotugno, Silvia Cretella, Fernando De Angelis, Pasqualina De Leo, Giovanni Di Perri, Elisabetta Falbo, Luigina Ferrigno, Ezio Fornasiere, Daniela Francisci, Pietro Gatti, Pietro Lampertico, Ilaria Lenci, Anna Licata, Alfredo Marzano, Antonio Mastroianni, Cesare Mazzaro, Monica Monti, Gerardo Nardone, Laura Ambra Nicolini, Nicola Passigato, Maria Bruna Pasticci, Piera Pierotti, Biagio Pinchera, Teresa Pollicino, Carmen Porcu, Giulia Quartini, Gabriele Rancatore, Mario Romeo, Maria Grazia Rumi, Annalisa Saracino, Ornella Schioppa, Ilaria Serio, Roberta Soffredini, Xhimi Tata, Marco Tizzani, Matteo Tonnini, Carlo Torti, Daniela Valenti, Serena Zaltron, and Alessia Zoncada

Subjects
Cohort, IFN treatment, Comorbidities, Infectious and parasitic diseases, RC109-216
Abstract

Background and Aims: We aimed to characterize the epidemiologic and comorbidities profiles of patients with chronic Hepatitis D (CHD) followed in clinical practice in Italy and explored their interferon (IFN) eligibility. Methods: This was a cross-sectional study of the PITER cohort consisting of consecutive HBsAg-positive patients from 59 centers over the period 2019-2023. Multivariable analysis was performed by logistic regression model. Results: Of 5492 HBsAg-positive enrolled patients, 4152 (75.6%) were screened for HDV, 422 (10.2%) were anti-HDV positive. Compared with HBsAg mono-infected, anti-HDV positive patients were more often younger, non-Italians, with a history of drug use, had elevated alanine transaminase (ALT), cirrhosis, or hepatocellular carcinoma (HCC). Compared with Italians, anti-HDV positive non-Italians were younger (42.2% age ≤ 40 years vs. 2.1%; P < 0.001), more often females (males 43.0% vs. 68.6%; P < 0.001) with less frequent cirrhosis and HCC. HDV-RNA was detected in 63.2% of anti-HDV-positive patients, who were more likely to have elevated ALT, cirrhosis, and HCC. Extrahepatic comorbidities were present in 47.4% of anti-HDV positive patients and could affect the eligibility of IFN-containing therapies in at least 53.0% of patients in care. Conclusions: CHD affects young, foreign-born patients and older Italians, of whom two-thirds had cirrhosis or HCC. Comorbidities were frequent in both Italians and non-Italians and impacted eligibility for IFN.

Published
2024
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2. Monoclonal antibodies against SARS-CoV-2 to prevent COVID-19 worsening in a large multicenter cohort

Author

Alessandro Soria, Francesca Graziano, Giulia Ghilardi, Giuseppe Lapadula, Daniela Dalla Gasperina, Simone Vasilij Benatti, Eugenia Quiros-Roldan, Maurizio Milesi, Francesca Bai, Marco Merli, Davide Minisci, Marco Franzetti, Erika Asperges, Filippo Chiabrando, Daria Pocaterra, Alessandro Pandolfo, Fabio Zanini, Domenico Lombardi, Anna Cappelletti, Alban Rugova, Maria Lucia Borghesi, Nicola Squillace, Luigi Pusterla, Stefania Piconi, Paola Morelli, Patrizia Rovere Querini, Raffaele Bruno, Stefano Rusconi, Salvatore Casari, Alessandra Bandera, Fabio Franzetti, Giovanna Travi, Antonella D'Arminio Monforte, Giulia Marchetti, Angelo Pan, Francesco Castelli, Marco Rizzi, Francesco Dentali, Maria Mallardo, Emanuela Rossi, Maria Grazia Valsecchi, Stefania Galimberti, and Paolo Bonfanti

Subjects
Monoclonal antibodies, COVID-19, SARS-CoV-2, Hospitalization, Immunodeficiency, Omicron variant, Science (General), Q1-390, Social sciences (General), H1-99
Abstract

Objective: Monoclonal antibodies (mAbs) against Severe Acute Respiratory Syndrome Coronavirus 2 (SARS-CoV-2) reduced Coronavirus Disease 2019 (COVID-19) hospitalizations in people at risk of clinical worsening. Real-world descriptions are limited. Methods: CONDIVIDIAMO, a two-year multicenter observational study, consecutively enrolled SARS-CoV-2 outpatients with ≥1 risk factor for COVID-19 progression receiving mAbs. Demographic data, underlying medical condition, type of mAbs combination received, duration of symptoms before mAbs administration, COVID-19 vaccination history, were collected upon enrolment and centrally recorded. Data on outcomes (hospitalizations, reasons of hospitalization, deaths) were prospectively collected. The primary endpoint was the rate of hospitalization or death in a 28-day follow-up, whichever occurred first; subjects were censored at the day of last follow-up or up to 28 days. The Kaplan-Meier method was used to estimate the incidence rate curve in time. The Cox regression model was used to assess potential risk factors for unfavorable outcome. Results were shown as hazard ratio (HR) along with the corresponding 95 % Confidence Interval (95%CI). Results: Among 1534 subjects (median [interquartile range, IQR] age 66.5 [52.4–74.9] years, 693 [45.2 %] women), 632 (41.2 %) received bamlanivimab ± etesevimab, 209 (13.6 %) casirivimab/imdevimab, 586 (38.2 %) sotrovimab, 107 (7.0 %) tixagevimab/cilgavimab. After 28-day follow-up, 87/1534 (5.6 %, 95%CI: 4.4%–6.8 %) met the primary outcome (85 hospitalizations, 2 deaths). Hospitalizations for COVID-19 (52, 3.4 %) occurred earlier than for other reasons (33, 2.1 %), after a median (IQR) of 3.5 (1–7) versus 8 (3–15) days (p = 0.006) from mAbs administration.In a multivariable Cox regression model, factors independently associated with increased hospitalization risk were age (hazard ratio [HR] 1.02, 95%CI 1.00–1.03, p = 0.021), immunodeficiency (HR 1.78, 95%CI 1.11–2.85, p = 0.017), pre-Omicron calendar period (HR 1.66, 95%CI 1.02–2.69, p = 0.041). Conclusions: MAbs real-world data over a 2-year changing pandemic landscape showed the feasibility of the intervention, although the hospitalization rate was not negligible. Immunosuppressed subjects remain more at risk of clinical worsening.

Published
2024
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3. Early prone positioning does not improve the outcome of patients with mild pneumonia due to SARS-CoV-2: results from an open-label randomised controlled trial – the EPCoT study

Author

Miriam Fezzi, Laura Antolini, Alessandro Soria, Luca Bisi, Francesca Iannuzzi, Francesca Sabbatini, Marianna Rossi, Silvia Limonta, Alban Rugova, Paola Columpsi, Nicola Squillace, Sergio Foresti, Ester Pollastri, Maria Grazia Valsecchi, Guglielmo Marco Migliorino, Paolo Bonfanti, and Giuseppe Lapadula

Subjects
Medicine
Abstract

Background Prone positioning is routinely used among patients with COVID-19 requiring mechanical ventilation. However, its utility among spontaneously breathing patients is still debated. Methods In an open-label randomised controlled trial, we enrolled patients hospitalised with mild COVID-19 pneumonia, whose arterial oxygen tension to inspiratory oxygen fraction ratio (PaO2/FIO2) was >200 mmHg and who did not require mechanical ventilation or continuous positive airway pressure at hospital admission. Patients were randomised 1:1 to prone positioning on top of standard of care (intervention group) versus standard of care only (controls). The primary composite outcome included death, mechanical ventilation, continuous positive airway pressure and PaO2/FIO2

Published
2023
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4. Dysmetabolism, Diabetes and Clinical Outcomes in Patients Cured of Chronic Hepatitis C: A Real‐Life Cohort Study

Author

Luca Valenti, Serena Pelusi, Alessio Aghemo, Sara Gritti, Luisa Pasulo, Cristiana Bianco, Claudia Iegri, Giuliana Cologni, Elisabetta Degasperi, Roberta D’Ambrosio, Paolo delPoggio, Alessandro Soria, Massimo Puoti, Isabella Carderi, Marie Graciella Pigozzi, Canio Carriero, Angiola Spinetti, Valentina Zuccaro, Massimo Memoli, Alessia Giorgini, Mauro Viganò, Maria Grazia Rumi, Tiziana Re, Ombretta Spinelli, Maria Chiara Colombo, Tiziana Quirino, Barbara Menzaghi, Gianpaolo Lorini, Angelo Pan, Antonella D’Arminio Monforte, Elisabetta Buscarini, Aldo Autolitano, Paolo Bonfanti, Natalia Terreni, Gianpiero Aimo, Monia Mendeni, Daniele Prati, Pietro Lampertico, Massimo Colombo, Stefano Fagiuoli, and for the NAVIGATORE‐Lombardia Network

Subjects
Diseases of the digestive system. Gastroenterology, RC799-869
Abstract

The aim of this study was to examine the impact of features of dysmetabolism on liver disease severity, evolution, and clinical outcomes in a real‐life cohort of patients treated with direct acting antivirals for chronic hepatitis C virus (HCV) infection. To this end, we considered 7,007 patients treated between 2014 and 2018, 65.3% with advanced fibrosis, of whom 97.7% achieved viral eradication (NAVIGATORE‐Lombardia registry). In a subset (n = 748), liver stiffness measurement (LSM) was available at baseline and follow‐up. Higher body mass index (BMI; odds ratio [OR] 1.06 per kg/m2, 1.03‐1.09) and diabetes (OR 2.01 [1.65‐2.46]) were independently associated with advanced fibrosis at baseline, whereas statin use was protective (OR 0.46 [0.35‐0.60]; P

Published
2022
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5. Helmet CPAP to treat hypoxic pneumonia outside the ICU: an observational study during the COVID-19 outbreak

Author

Andrea Coppadoro, Annalisa Benini, Robert Fruscio, Luisa Verga, Paolo Mazzola, Giuseppe Bellelli, Marco Carbone, Giacomo Mulinacci, Alessandro Soria, Beatrice Noè, Eduardo Beck, Riccardo Di Sciacca, Davide Ippolito, Giuseppe Citerio, Maria Grazia Valsecchi, Andrea Biondi, Alberto Pesci, Paolo Bonfanti, Davide Gaudesi, Giacomo Bellani, and Giuseppe Foti

Subjects
Helmet continuous positive airways pressure CPAP, Noninvasive ventilation, Covid-19, Positive end expiratory pressure PEEP, Coronavirus pneumonia, Medical emergencies. Critical care. Intensive care. First aid, RC86-88.9
Abstract

Abstract Background Respiratory failure due to COVID-19 pneumonia is associated with high mortality and may overwhelm health care systems, due to the surge of patients requiring advanced respiratory support. Shortage of intensive care unit (ICU) beds required many patients to be treated outside the ICU despite severe gas exchange impairment. Helmet is an effective interface to provide continuous positive airway pressure (CPAP) noninvasively. We report data about the usefulness of helmet CPAP during pandemic, either as treatment, a bridge to intubation or a rescue therapy for patients with care limitations (DNI). Methods In this observational study we collected data regarding patients failing standard oxygen therapy (i.e., non-rebreathing mask) due to COVID-19 pneumonia treated with a free flow helmet CPAP system. Patients’ data were recorded before, at initiation of CPAP treatment and once a day, thereafter. CPAP failure was defined as a composite outcome of intubation or death. Results A total of 306 patients were included; 42% were deemed as DNI. Helmet CPAP treatment was successful in 69% of the full treatment and 28% of the DNI patients (P

Published
2021
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6. The high volume of patients admitted during the SARS-CoV-2 pandemic has an independent harmful impact on in-hospital mortality from COVID-19.

Author

Alessandro Soria, Stefania Galimberti, Giuseppe Lapadula, Francesca Visco, Agata Ardini, Maria Grazia Valsecchi, and Paolo Bonfanti

Subjects
Medicine, Science
Abstract

BackgroundDuring the Coronavirus disease 2019 (COVID-19) pandemic, advanced health systems have come under pressure by the unprecedented high volume of patients needing urgent care. The impact on mortality of this "patients' burden" has not been determined.Methods and findingsThrough retrieval of administrative data from a large referral hospital of Northern Italy, we determined Aalen-Johansen cumulative incidence curves to describe the in-hospital mortality, stratified by fixed covariates. Age- and sex-adjusted Cox models were used to quantify the effect on mortality of variables deemed to reflect the stress on the hospital system, namely the time-dependent number of daily admissions and of total hospitalized patients, and the calendar period. Of the 1225 subjects hospitalized for COVID-19 between February 20 and May 13, 283 died (30-day mortality rate 24%) after a median follow-up of 14 days (interquartile range 5-19). Hospitalizations increased progressively until a peak of 465 subjects on March 26, then declined. The risk of death, adjusted for age and sex, increased for a higher number of daily admissions (adjusted hazard ratio [AHR] per an incremental daily admission of 10 patients: 1.13, 95% Confidence Intervals [CI] 1.05-1.22, p = 0.0014), and for a higher total number of hospitalized patients (AHR per an increase of 50 patients in the total number of hospitalized subjects: 1.11, 95%CI 1.04-1.17, p = 0.0004), while was lower for the calendar period after the peak (AHR 0.56, 95%CI 0.43-0.72, pConclusionsThe pressure of a high volume of severely ill patients suffering from COVID-19 has a measurable independent impact on in-hospital mortality.

Published
2021
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7. miRNA Expression Profiling in Subcutaneous Adipose Tissue of Monozygotic Twins Discordant for HIV Infection: Validation of Differentially Expressed miRNA and Bioinformatic Analysis

Author

Elena Bresciani, Nicola Squillace, Valentina Orsini, Roberta Piolini, Laura Rizzi, Laura Molteni, Ramona Meanti, Alessandro Soria, Giuseppe Lapadula, Alessandra Bandera, Andrea Gori, Paolo Bonfanti, Robert John Omeljaniuk, Vittorio Locatelli, and Antonio Torsello

Subjects
combined highly antiretroviral therapy (cART), HALS (HIV-associate lypodistrophy syndrome), miRNA, metabolic disorders, Biology (General), QH301-705.5, Chemistry, QD1-999
Abstract

Combined AntiRetroviral Treatments (cARTs) used for HIV infection may result in varied metabolic complications, which in some cases, may be related to patient genetic factors, particularly microRNAs. The use of monozygotic twins, differing only for HIV infection, presents a unique and powerful model for the controlled analysis of potential alterations of miRNAs regulation consequent to cART treatment. Profiling of 2578 mature miRNA in the subcutaneous (SC) adipose tissue and plasma of monozygotic twins was investigated by the GeneChip® miRNA 4.1 array. Real-time PCR and ddPCR experiments were performed in order to validate differentially expressed miRNAs. Target genes of deregulated miRNAs were predicted by the miRDB database (prediction score > 70) and enrichment analysis was carried out with g:Profiler. Processes in SC adipose tissue most greatly affected by miRNA up-regulation included (i) macromolecular metabolic processes, (ii) regulation of neurogenesis, and (iii) protein phosphorylation. Furthermore, KEGG analysis revealed miRNA up-regulation involvement in (i) insulin signaling pathways, (ii) neurotrophin signaling pathways, and (iii) pancreatic cancer. By contrast, miRNA up-regulation in plasma was involved in (i) melanoma, (ii) p53 signaling pathways, and (iii) focal adhesion. Our findings suggest a mechanism that may increase the predisposition of HIV+ patients to insulin resistance and cancer.

Published
2022
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8. A dual regimen of ritonavir/darunavir plus dolutegravir for rescue or simplification of rescue therapy: 48 weeks’ observational data

Author

Amedeo F. Capetti, Maria Vittoria Cossu, Giancarlo Orofino, Gaetana Sterrantino, Giovanni Cenderello, Giuseppe V. De Socio, Anna Maria Cattelan, Alessandro Soria, Stefano Rusconi, Niccolò Riccardi, Gian Maria Baldin, Fosca P. Niero, Giorgio Barbarini, and Giuliano Rizzardini

Subjects
Dolutegravir, Darunavir, Ritonavir, Switch, Dual, Salvage, Infectious and parasitic diseases, RC109-216
Abstract

Abstract Background Dolutegravir (DTG) plus darunavir/ritonavir (DRV/r) is a simple combination of drugs that has the best genetic barrier to HIV-1 resistance and may be fit for salvage therapy. Methods All HIV-1-infected subjects treated with DTG plus DRV/r between March 2014 and September 2015 in eight Italian centres were included in the analysis. The main metabolic data, efficacy parameters and safety data routinely collected were provided. This observational study is aimed to assess the efficacy of such approach. The primary end-point was the proportion of subjects achieving or maintaining virologic suppression

Published
2017
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9. Correction: Real-life data on potential drug-drug interactions in patients with chronic hepatitis C viral infection undergoing antiviral therapy with interferon-free DAAs in the PITER Cohort Study.

Author

Loreta A Kondili, Giovanni Battista Gaeta, Donatella Ieluzzi, Anna Linda Zignego, Monica Monti, Andrea Gori, Alessandro Soria, Giovanni Raimondo, Roberto Filomia, Alfredo Di Leo, Andrea Iannone, Marco Massari, Romina Corsini, Roberto Gulminetti, Alberto Gatti Comini, Pierluigi Toniutto, Denis Dissegna, Francesco Paolo Russo, Alberto Zanetto, Maria Grazia Rumi, Giuseppina Brancaccio, Elena Danieli, Maurizia Rossana Brunetto, Liliana Elena Weimer, Maria Giovanna Quaranta, Stefano Vella, and Massimo Puoti

Subjects
Medicine, Science
Abstract

[This corrects the article DOI: 10.1371/journal.pone.0172159.].

Published
2018
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10. Real-life data on potential drug-drug interactions in patients with chronic hepatitis C viral infection undergoing antiviral therapy with interferon-free DAAs in the PITER Cohort Study.

Author

Loreta A Kondili, Giovanni Battista Gaeta, Donatella Ieluzzi, Anna Linda Zignego, Monica Monti, Andrea Gori, Alessandro Soria, Giovanni Raimondo, Roberto Filomia, Alfredo Di Leo, Andrea Iannone, Marco Massari, Romina Corsini, Roberto Gulminetti, Alberto Gatti Comini, Pierluigi Toniutto, Denis Dissegna, Francesco Paolo Russo, Alberto Zanetto, Maria Grazia Rumi, Giuseppina Brancaccio, Elena Danieli, Maurizia Rossana Brunetto, Liliana Elena Weimer, Maria Giovanna Quaranta, Stefano Vella, and Massimo Puoti

Subjects
Medicine, Science
Abstract

BACKGROUND:There are few real-life data on the potential drug-drug interactions (DDIs) between anti-HCV direct-acting antivirals (DAAs) and the comedications used. AIM:To assess the potential DDIs of DAAs in HCV-infected outpatients, according to the severity of liver disease and comedication used in a prospective multicentric study. METHODS:Data from patients in 15 clinical centers who had started a DAA regimen and were receiving comedications during March 2015 to March 2016 were prospectively evaluated. The DDIs for each regimen and comedication were assigned according to HepC Drug Interactions (www.hep-druginteractions.org). RESULTS:Of the 449 patients evaluated, 86 had mild liver disease and 363 had moderate-to-severe disease. The use of a single comedication was more frequent among patients with mild liver disease (p = 0.03), whereas utilization of more than three drugs among those with moderate-to-severe disease (p = 0.05). Of the 142 comedications used in 86 patients with mild disease, 27 (20%) may require dose adjustment/closer monitoring, none was contraindicated. Of the 322 comedications used in 363 patients with moderate-to-severe liver disease, 82 (25%) were classified with potential DDIs that required only monitoring and dose adjustments; 10 (3%) were contraindicated in severe liver disease. In patients with mild liver disease 30% (26/86) used at least one drug with a potential DDI whereas of the 363 patients with moderate-to-severe liver disease, 161 (44%) were at risk for one or more DDI. CONCLUSIONS:Based on these results, we can estimate that 30-44% of patients undergoing DAA and taking comedications are at risk of a clinically significant DDI. This data indicates the need for increased awareness of potential DDI during DAA therapy, especially in patients with moderate-to-severe liver disease. For several drugs, the recommendation related to the DDI changes from "dose adjustment/closer monitoring", in mild to moderate liver disease, to "the use is contraindicated" in severe liver disease.

Published
2017
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11. Risk of Chronic Kidney Disease among Patients Developing Mild Renal Impairment during Tenofovir-Containing Antiretroviral Treatment.

Author

Giuseppe Lapadula, Davide Paolo Bernasconi, Salvatore Casari, Franco Maggiolo, Roberto Cauda, Massimo Di Pietro, Nicoletta Ladisa, Laura Sighinolfi, Sarah Dal Zoppo, Francesca Sabbatini, Alessandro Soria, Chiara Pezzoli, Annalisa Mondi, Silvia Costarelli, Maria Grazia Valsecchi, Carlo Torti, Andrea Gori, and Italian MASTER cohort

Subjects
Medicine, Science
Abstract

BACKGROUND:Tenofovir (TDF) can cause kidney injury through tubular dysfunction, with or without drop of estimated glomerular filtration rate (eGFR). Whether mild eGFR reductions during treatment should be considered a reason for prompt TDF discontinuation, however, remains unclear. METHODS:Patients with normal pre-TDF eGFR levels, who had developed mild renal impairment (i.e., two consecutive eGFR results between 89-60 ml/min) on TDF, were observed until onset of chronic kidney disease (CKD), defined as two eGFR6 months despite mild renal impairment, current TDF use was not associated with a significantly higher rate of CKD. Other significant predictors of CKD were older age, intravenous drug use, diabetes, hypertension, lower pre-TDF eGFR, higher eGFR drop since TDF introduction and longer exposure to TDF. CONCLUSIONS:Prompt discontinuation of TDF among patients developing mild renal impairment may prevent further progression of renal damage.

Published
2016
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12. Prospective immune dynamics during the first 24 weeks of efavirenz based-antiretroviral therapy in HIV-1-infected subjects, according to CD4+ T-cell counts at presentation: the IMMUNEF clinical trial.

Author

Alessandro Soria, Daria Trabattoni, Nicola Squillace, Veronica Rainone, Federica Gnudi, Mario Clerici, Andrea Gori, and Alessandra Bandera

Subjects
Medicine, Science
Abstract

Longitudinal characterization of immune recovery in the first-phase of antiretroviral therapy (ART) is poorly described. We compared immune kinetics in individuals who were diagnosed early or late with HIV-1 infection, (thus commencing ART with different CD4+ T-cell counts), in order to investigate possible mechanisms involved in subsequent poor immune recovery.Immunophenotyping, immune activation, proliferation, apoptosis, regulatory T-cells and intracellular cytokine production were compared at baseline and during 24-week follow-up in two groups of HIV-1-infected patients initiating the same ART (tenofovir/emtricitabine/efavirenz) and divided according to baseline CD4+ T-cell counts (late: ≤200/μL; early: >200/μL). Wilcoxon-rank sum test and analysis for repeated measures were used to evaluate differences between groups over time.Twenty-four out of 30 enrolled subjects were evaluable for the analysis, 13 late and 11 early presenters. Significantly lower CD4+ naïve and memory T-cells, and higher plasma viral load, as well as augmented percentages of activated (CD4+/CD25+ cells), apoptotic (CD4+/AnnexinV+/7AAD-, CD4+/caspase 8+ and CD4+/caspase 9+), and proliferating (CD8+/Ki67+ cells) lymphocytes were present at baseline in late presenters; ART resulted in a reduction of apoptotic and proliferating lymphocytes within the follow-up period.A skewing towards memory/activated/apoptotic phenotype is seen in HIV-1-infected subjects starting ART at low CD4+ T-cell counts; ART results in early (24 weeks) trend towards normalization of these parameters. Antiretroviral therapy may play a role in rapidly limiting aberrant immune exhaustion even in late presenters, while requiring more time for re-population of highly depleted naïve T-cells.EU Clinical Trial Register EUDRACT number 2008-006188-35 https://www.clinicaltrialsregister.eu/ctr-search/trial/2008-006188-35/IT.

Published
2015
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13. Imported Ciprofloxacin-Resistant Neisseria meningitidis

Author

Giuseppe Lapadula, Franco Viganò, Paolo Fortuna, Alberto Dolara, Simone Bramati, Alessandro Soria, Sergio Foresti, and Andrea Gori

Subjects
Meningitis, Neisseria meningitidis, antimicrobial drug resistance, fluoroquinolones, ciprofloxacin, chemoprophylaxis, Medicine, Infectious and parasitic diseases, RC109-216
Published
2009
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14. Maraviroc as intensification strategy in HIV-1 positive patients with deficient immunological response: an Italian randomized clinical trial.

Author

Stefano Rusconi, Paola Vitiello, Fulvio Adorni, Elisa Colella, Emanuele Focà, Amedeo Capetti, Paola Meraviglia, Clara Abeli, Stefano Bonora, Marco D'Annunzio, Antonio Di Biagio, Massimo Di Pietro, Luca Butini, Giancarlo Orofino, Manuela Colafigli, Gabriella d'Ettorre, Daniela Francisci, Giustino Parruti, Alessandro Soria, Anna Rita Buonomini, Chiara Tommasi, Silvia Mosti, Francesca Bai, Silvia Di Nardo Stuppino, Manuela Morosi, Marco Montano, Pamela Tau, Esther Merlini, and Giulia Marchetti

Subjects
Medicine, Science
Abstract

BackgroundImmunological non-responders (INRs) lacked CD4 increase despite HIV-viremia suppression on HAART and had an increased risk of disease progression. We assessed immune reconstitution profile upon intensification with maraviroc in INRs.MethodsWe designed a multi-centric, randomized, parallel, open label, phase 4 superiority trial. We enrolled 97 patients on HAART with CD4+ResultsBy W48 both groups displayed a CD4 increase without a significant inter-group difference. A statistically significant change in CD8 favored patients in arm HAART+maraviroc versus HAART at W12 (p=.009) and W48 (p=.025). The CD4>200/µL and CD4>200/µL + CD4 gain ≥ 25% end-points were not satisfied at W12 (p=.24 and p=.619) nor at W48 (p=.076 and p=.236). Patients continuing HAART displayed no major changes in parameters of T-cell homeostasis and activation. Maraviroc-receiving patients experienced a significant rise in circulating IL-7 by W48 (p=.01), and a trend in temporary reduction in activated HLA-DR+CD38+CD4+ by W12 (p=.06) that was not maintained at W48.ConclusionsMaraviroc intensification in INRs did not have a significant advantage in reconstituting CD4 T-cell pool, but did substantially expand CD8. It resulted in a low rate of treatment discontinuations.Trial registrationClinicalTrials.gov NCT00884858 http://clinicaltrials.gov/show/NCT00884858.

Published
2013
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15. 96 Week follow-up of HIV-infected patients in rescue with raltegravir plus optimized backbone regimens: a multicentre Italian experience.

Author

Amedeo Capetti, Simona Landonio, Paola Meraviglia, Antonio Di Biagio, Sergio Lo Caputo, Gaetana Sterrantino, Adriana Ammassari, Barbara Menzaghi, Marco Franzetti, Giuseppe Vittorio De Socio, Giovanni Pellicanò, Elena Mazzotta, Alessandro Soria, Marianna Meschiari, Michele Trezzi, Lolita Sasset, Benedetto Maurizio Celesia, Patrizia Zucchi, Sara Melzi, Elena Ricci, and Giuliano Rizzardini

Subjects
Medicine, Science
Abstract

BackgroundLong term efficacy of raltegravir (RAL)-including regimens in highly pre-treated HIV-1-infected patients has been demonstrated in registration trials. However, few studies have assessed durability in routine clinical settings.MethodsAntiretroviral treatment-experienced patients initiating a RAL-containing salvage regimen were enrolled. Routine clinical and laboratory follow-up was performed at baseline, week 4, 12, and every 12 weeks thereafter. Data were censored at week 96.ResultsOut of 320 patients enrolled, 292 (91.25%) subjects maintained their initial regimen for 96 weeks; 28 discontinued prematurely for various reasons: death (11), viral failure (8), adverse events (5), loss to follow-up (3), consent withdrawal (1). Eight among these 28 subjects maintained RAL but changed the accompanying drugs. The mean CD4+ T-cell increase at week 96 was 227/mm(3); 273 out of 300 patients (91%), who were still receiving RAL at week 96, achieved viral suppression (HIV-1 RNA 4 (n = 40), CD4+ T-cell gain was similar across strata: +270, +214, +216, and +240 cells/mm(3), respectively, as was the proportion of subjects with undetectable viral load. Laboratory abnormalities (elevation of liver enzymes, total cholesterol and triglycerides) were rare, ranging from 0.9 to 3.1%. The mean 96-week total cholesterol increase was 23.6 mg/dL.ConclusionsIn a routine clinical setting, a RAL-based regimen allowed most patients in salvage therapy to achieve optimal viral suppression for at least 96 weeks, with relevant immunologic gain and very few adverse events.

Published
2012
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16. Neurocognitive Impairment in HIV-Infected Naïve Patients with Advanced Disease: The Role of Virus and Intrathecal Immune Activation

Author

Monica Airoldi, Alessandra Bandera, Daria Trabattoni, Benedetta Tagliabue, Beatrice Arosio, Alessandro Soria, Veronica Rainone, Giuseppe Lapadula, Giorgio Annoni, Mario Clerici, and Andrea Gori

Subjects
Immunologic diseases. Allergy, RC581-607
Abstract

Objective. To investigate intrathecal immune activation parameters and HIV-RNA in HIV-associated neurocognitive disorders (HAND) of advanced naïve HIV-infected patients and to evaluate their dynamics before and after initiation of antiretroviral therapy (ART). Methods. Cross-sectional and longitudinal analysis of HIV RNA, proinflammatory cytokines (IL-6, IL-10, INF-γ, TNF-α, TGF-β1, and TGF-β2) and chemokines (MIP-1α, MIP-1β, and MCP-1) in plasma and cerebrospinal fluid (CSF) of HIV-infected patients with CD4

Published
2012
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17. KIR-HLA genotypes in HIV-infected patients lacking immunological recovery despite effective antiretroviral therapy.

Author

Alessandro Soria, Franca Rosa Guerini, Alessandra Bandera, Elisabetta Bolognesi, Alessia Uglietti, Caterina Fusco, Patrizia Zucchi, Renato Maserati, Giuliano Rizzardini, Mario Clerici, and Andrea Gori

Subjects
Medicine, Science
Abstract

BACKGROUND: In HIV-infected individuals, mechanisms underlying unsatisfactory immune recovery during effective combination antiretroviral therapy (cART) have yet to be fully understood. We investigated whether polymorphism of genes encoding immune-regulating molecules, such as killer immunoglobulin-like receptors (KIR) and their ligands class I human leukocyte antigen (HLA), could influence immunological response to cART. METHODS: KIR and HLA frequencies were analyzed in 154 HIV-infected and cART-treated patients with undetectable viral load divided into two groups: 'immunological non responders' (INR, N = 50, CD4(+) T-cell count 350/mm(3)). Molecular KIR were typed using polymerase chain reaction-based genotyping. Comparisons were adjusted for baseline patient characteristics. RESULTS: The frequency of KIR2DL3 allele was significantly higher in FR than in INR (83.7% vs. 62%, P = 0.005). The functional compound genotype HLA-C1(+)/KIR2DL3(+), even at multivariable analysis, when adjusted for nadir CD4(+) T-cell count, was associated with reduced risk of INR status: odds ratio (95% Confidence Intervals) 0.34 (0.13-0.88), P = 0.03. CONCLUSIONS: Reduced presence of the inhibitory KIR2DL3 genotype detected in INR might provoke an imbalance in NK function, possibly leading to increased immune activation, impaired killing of latently infected cells, and higher proviral burden. These factors would hinder full immune recovery during therapy.

Published
2011
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18. CD4+ T cell depletion, immune activation and increased production of regulatory T cells in the thymus of HIV-infected individuals.

Author

Alessandra Bandera, Giulio Ferrario, Marina Saresella, Ivana Marventano, Alessandro Soria, Fabio Zanini, Francesca Sabbatini, Monica Airoldi, Giulia Marchetti, Fabio Franzetti, Daria Trabattoni, Mario Clerici, and Andrea Gori

Subjects
Medicine, Science
Abstract

Mechanisms by which HIV affects the thymus are multiple and only partially known, and the role of thymic dysfunction in HIV/AIDS immunopathogenesis remains poorly understood. To evaluate the effects of HIV infection on intra-thymic precursors of T cells in HIV-infected adults, we conducted a detailed immunophenotypic study of thymic tissue isolated from 7 HIV-infected and 10 HIV-negative adults who were to undergo heart surgery. We found that thymuses of HIV-infected individuals were characterized by a relative depletion of CD4+ single positive T cells and a corresponding enrichment of CD8+ single positive T cells. In addition, thymocytes derived from HIV-infected subjects showed increased levels of activated and proliferating cells. Our analysis also revealed a decreased expression of interleukin-7 receptor in early thymocytes from HIV-infected individuals, along with an increase in this same expression in mature double- and single-positive cells. Frequency of regulatory T cells (CD25+FoxP3+) was significantly increased in HIV-infected thymuses, particularly in priorly-committed CD4 single positive cells. Our data suggest that HIV infection is associated with a complex set of changes in the immunophenotype of thymocytes, including a reduction of intrathymic CD4+ T cell precursors, increased expression of activation markers, changes in the expression pattern of IL-7R and enrichment of T regulatory cells generation.

Published
2010
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19. HPV 16 and 18 contribute to development of anal dysplasia in HIV infection irrespective of gender and sexual orientation

Author

Paolo Bonfanti, Francesca Sabbatini, Alessandro Soria, Nicola Squillace, Elisa Colella, Andrea Marco Tamburini, Adriana Di Lucia, Marco Braga, Giuseppe Lapadula, Davide Paolo Bernasconi, Biagio Eugenio Leone, Marianna Rossi, Annalisa Cavallero, Sergio Malandrin, Ambrogio Brenna, Squillace, N, Bernasconi, D, Lapadula, G, Soria, A, Sabbatini, F, Colella, E, Rossi, M, Tamburini, A, Leone, B, Brenna, A, Malandrin, S, Cavallero, A, Di Lucia, A, Braga, M, and Bonfanti, P

Subjects
Male, HPV, medicine.medical_specialty, Genotype, Sexual Behavior, Anal Canal, HIV Infections, Lower risk, Logistic regression, anal cytologic abnormalitie, Men who have sex with men, Sexual and Gender Minorities, Risk Factors, Interquartile range, Internal medicine, Prevalence, medicine, Humans, Pharmacology (medical), Homosexuality, Male, Papillomaviridae, Human papillomavirus 16, business.industry, Health Policy, Papillomavirus Infections, HPV infection, HIV, virus diseases, Anal dysplasia, Odds ratio, medicine.disease, Confidence interval, HPV 16 and 18, Infectious Diseases, Female, business
Abstract

Objectives: The aim of the present study was too investigate prevalence and persistence of human papilloma virus (HPV) and cytological abnormalities (CAs) in the anal swabs of people living with HIV (PLWH): men who have sex with men (MSM), men who have sex with women (MSW) and women (W). Methods: Between March 2010 and January 2019, an anal swab for cytological and HPV genotyping tests was offered to all PLWH attending our clinic. Logistic regression analysis was conducted to identify predictors of infection. Results: In all, 354 PLWH were screened: 174 MSM, 90 MSW and 61 W. Prevalence of at least one high-risk (HR) HPV was higher in MSM (91%) and W (85%) than in MSW (77%) (P < 0.05). Cytological abnormalities were found in 21.1% of the entire population. At multivariable regression analysis a lower risk for HPV infection was found for W than for MSM [odds ratio = 0.24 (95% confidence interval: 0.115–0.513)] and for MSW than for MSM [0.37 (0.180–0.773)] and there was a significantly higher risk of CAs in PLWH with HPV 16 and 18 [3.3 (1.04–10.49)]. A total of 175 PLWH (103 MSM, 33 MSW and 26 W) had at least one follow-up visit (T1) after a median (interquartile range) follow-up of 3.6 (2.1–5.7) years. The acquisition rate of HR-HPV was high, with 66.7% of PLWH negative for HR-HPV at T0 who became positive at T1 (P < 0.001). The prevalence of CAs was stable (20.6%). A significant association between CAs at T1 and persistence of HPV-16 and/or 18 was found (P < 0.05). Conclusions: HPV 16 and 18 are associated with the presence and development of CAs irrespective of sexual orientation.

Published
2021

20. Dysmetabolism, Diabetes and Clinical Outcomes in Patients Cured of Chronic Hepatitis C: A Real-Life Cohort Study

Author

Gianpaolo Lorini, Roberta D'Ambrosio, Monia Mendeni, Angelo Pan, Valentina Zuccaro, Canio Carriero, Massimo Colombo, Gianpiero Aimo, Natalia Terreni, Barbara Menzaghi, Massimo Memoli, Alessandro Soria, Aldo Autolitano, Elisabetta Degasperi, Serena Pelusi, M. Puoti, Luca Valenti, Cristiana Bianco, Ombretta Spinelli, Elisabetta Buscarini, Antonella d'Arminio Monforte, Sara Gritti, Paolo Del Poggio, Alessia Giorgini, Tiziana Quirino, T. Re, Marie Graciella Pigozzi, Maria Grazia Rumi, Maria Chiara Colombo, Giuliana Cologni, Daniele Prati, Angiola Spinetti, Stefano Fagiuoli, Mauro Viganò, Isabella Carderi, Luisa Pasulo, Pietro Lampertico, Alessio Aghemo, Paolo Bonfanti, C. Iegri, Valenti, L, Pelusi, S, Aghemo, A, Gritti, S, Pasulo, L, Bianco, C, Iegri, C, Cologni, G, Degasperi, E, D'Ambrosio, R, del Poggio, P, Soria, A, Puoti, M, Carderi, I, Pigozzi, M, Carriero, C, Spinetti, A, Zuccaro, V, Memoli, M, Giorgini, A, Vigano, M, Rumi, M, Re, T, Spinelli, O, Colombo, M, Quirino, T, Menzaghi, B, Lorini, G, Pan, A, D'Arminio Monforte, A, Buscarini, E, Autolitano, A, Bonfanti, P, Terreni, N, Aimo, G, Mendeni, M, Prati, D, Lampertico, P, and Fagiuoli, S

Subjects
Liver Cirrhosis, medicine.medical_specialty, Carcinoma, Hepatocellular, Sustained Virologic Response, Chronic liver disease, Gastroenterology, Antiviral Agents, Cohort Studies, 03 medical and health sciences, Liver disease, 0302 clinical medicine, Internal medicine, Diabetes mellitus, Diabetes Mellitus, Medicine, Humans, 2. Zero hunger, Hepatology, business.industry, Hazard ratio, Liver Neoplasms, Odds ratio, Hepatitis C, Chronic, medicine.disease, 3. Good health, Metformin, Cardiovascular Diseases, 030220 oncology & carcinogenesis, Hepatocellular carcinoma, HCV, 030211 gastroenterology & hepatology, business, Body mass index, medicine.drug
Abstract

The aim of this study was to examine the impact of features of dysmetabolism on liver disease severity, evolution, and clinical outcomes in a real-life cohort of patients treated with direct acting antivirals for chronic hepatitis C virus (HCV) infection. To this end, we considered 7,007 patients treated between 2014 and 2018, 65.3% with advanced fibrosis, of whom 97.7% achieved viral eradication (NAVIGATORE-Lombardia registry). In a subset (n=748), liver stiffness measurement (LSM) was available at baseline and follow-up. Higher body mass index (BMI; odds ratio [OR] 1.06 per kg/m2, 1.03-1.09) and diabetes (OR 2.01 [1.65-2.46]) were independently associated with advanced fibrosis at baseline, whereas statin use was protective (OR 0.46 [0.35-0.60]; P&nbsp

Published
2021

21. Behavioural survey and street-based HIV and HCV rapid testing programme among transgender sex workers

Author

Giuseppe Lapadula, Alessandro Soria, Massimo Modesti, Arianna Vecchi, Francesca Sabbatini, Antonia Monopoli, Nicola Squillace, Eugenia Lungu, Jessenia Coloma, Paola Columpsi, Vincenzo Cristiano, Paolo Bonfanti, Lapadula, G, Soria, A, Modesti, M, Vecchi, A, Sabbatini, F, Monopoli, A, Squillace, N, Lungu, E, Coloma, J, Columpsi, P, Cristiano, V, and Bonfanti, P

Subjects
Infectious Diseases, sexual behavior, virus diseases, sex work, transgender person, Dermatology, HIV seroprevalence
Abstract

BackgroundTransgender women sex workers (TGW-SW) are disproportionally affected by HIV and have reduced access to testing. Moreover, information regarding their behaviours and health needs is scarce.MethodsA behavioural survey and a targeted testing programme in prostitution sites were conducted in Milan and Monza areas. The non-profit organisation ‘ALA Milano Onlus’ and ‘San Gerardo’ Hospital (Monza) implemented a mobile HIV testing unit involving a TGW peer educator, four physicians, a counsellor, a psychologist and a cultural mediator. All TGW-SW were offered anonymous HIV and hepatitis C virus (HCV) oral testing and asked to fill a questionnaire on sexual habits, drug abuse, and knowledge and attitudes towards HIV and STDs.ResultsBetween May and July 2017, 130 TGW-SW, predominantly migrants, were contacted during 15 street visits; among them, 78 (60%) were interviewed. HIV and HCV testing were accepted by 53 (42%) and 67 (52%) TGW-SW, respectively. Twenty-five (19.8%) subjects who reported already established HIV infection were not retested. Seven patients received a new diagnosis of HIV, while nobody tested positive for HCV. Overall, HIV prevalence was 13.2% (25% including those with already known HIV infection). Recent arrival in Italy and young age were associated with risk of undiagnosed HIV infection. Inconsistent condom use was commonly reported during commercial sex (27%) and with non-commercial partners (64%). Alcohol and cocaine abuse were common problems which facilitated risky behaviours.ConclusionsOral rapid HIV and HCV testing for TGW-SW in outreach settings were feasible and acceptable and led to a considerable number of new diagnoses. Interventions tailored to TGW-SW, focused on HIV prevention, testing and engagement in care, are fundamental.

Published
2021

22. Nonalcoholic fatty liver disease and steatohepatitis in people living with HIV

Author

Giorgio Bozzi, Alessandro Soria, Andrea Gori, Nicola Squillace, and Alessandra Bandera

Subjects
Nonalcoholic steatohepatitis, medicine.medical_specialty, Cirrhosis, Anti-HIV Agents, Population, Human immunodeficiency virus (HIV), HIV Infections, medicine.disease_cause, digestive system, 03 medical and health sciences, 0302 clinical medicine, Liver steatosis, Non-alcoholic Fatty Liver Disease, Risk Factors, Nonalcoholic fatty liver disease, Prevalence, medicine, Humans, Intensive care medicine, education, education.field_of_study, Hepatology, business.industry, Gastroenterology, nutritional and metabolic diseases, medicine.disease, digestive system diseases, Fatty Liver, 030220 oncology & carcinogenesis, Disease Progression, 030211 gastroenterology & hepatology, Steatohepatitis, business, Liver cancer
Abstract

Introduction: The burden of nonalcoholic fatty liver disease (NAFLD) and nonalcoholic steatohepatitis (NASH) is increasing worldwide. This phenomenon poses a potentially dangerous risk of rise in mortalities caused by cirrhosis and liver cancer. Owing to a complex combination of factors, NAFLD and NASH arise in a majority of people living with HIV (PLWH), but accurate estimates of prevalence differ, depending on sample selection, type of analysis, and data interpretation. The wide range of diagnostic tools used to assess liver steatosis and lack of control groups in many studies further contributes to current difficulties in properly assessing prevalence of these conditions. Areas covered: Thoroughly scrutinizing the current literature, we compared the prevalence of NAFLD and NASH in PLWH to rates found in the general population. We highlighted strengths and limitations of the studies, in order to determine the effective impact of these medical conditions in PLWH. Expert opinion: The prevalence and progression of NAFLD in human immunodeficiency virus (HIV) infection are reported to be widely variable. HIV infection itself and antiretroviral treatment have been demonstrated to play a role in the development of NAFLD. Larger and more effective studies are needed to evaluate the effects of NASH in PLWH and its progression.

Published
2019

23. Helmet CPAP to treat hypoxic pneumonia outside the ICU: an observational study during the COVID-19 outbreak

Author

Annalisa Benini, Marco Carbone, Alberto Pesci, Giacomo Mulinacci, Davide Gaudesi, Beatrice Noè, Giuseppe Foti, Paolo Mazzola, Robert Fruscio, Giacomo Bellani, Andrea Coppadoro, Luisa Verga, Giuseppe Bellelli, Eduardo Beck, Riccardo Di Sciacca, Maria Grazia Valsecchi, Giuseppe Citerio, Davide Ippolito, Andrea Biondi, Alessandro Soria, Paolo Bonfanti, Coppadoro, A, Benini, A, Fruscio, R, Verga, L, Mazzola, P, Bellelli, G, Carbone, M, Mulinacci, G, Soria, A, Noè, B, Beck, E, Di Sciacca, R, Ippolito, D, Citerio, G, Valsecchi, M, Biondi, A, Pesci, A, Bonfanti, P, Gaudesi, D, Bellani, G, and Foti, G

Subjects
Male, Coronavirus pneumonia, medicine.medical_specialty, Respiratory rate, medicine.medical_treatment, Pneumonia, Viral, Oxygen mask, Helmet continuous positive airways pressure CPAP, Critical Care and Intensive Care Medicine, law.invention, Disease Outbreaks, 03 medical and health sciences, 0302 clinical medicine, law, Oxygen therapy, medicine, Intubation, Humans, 030212 general & internal medicine, Continuous positive airway pressure, Positive end expiratory pressure PEEP, Hypoxia, Aged, Continuous Positive Airway Pressure, business.industry, Research, lcsh:Medical emergencies. Critical care. Intensive care. First aid, lcsh:RC86-88.9, Middle Aged, medicine.disease, Intensive care unit, respiratory tract diseases, Pneumonia, Intensive Care Units, Treatment Outcome, 030228 respiratory system, Respiratory failure, Emergency medicine, Feasibility Studies, Female, business, Covid-19, Noninvasive ventilation, circulatory and respiratory physiology
Abstract

Background Respiratory failure due to COVID-19 pneumonia is associated with high mortality and may overwhelm health care systems, due to the surge of patients requiring advanced respiratory support. Shortage of intensive care unit (ICU) beds required many patients to be treated outside the ICU despite severe gas exchange impairment. Helmet is an effective interface to provide continuous positive airway pressure (CPAP) noninvasively. We report data about the usefulness of helmet CPAP during pandemic, either as treatment, a bridge to intubation or a rescue therapy for patients with care limitations (DNI). Methods In this observational study we collected data regarding patients failing standard oxygen therapy (i.e., non-rebreathing mask) due to COVID-19 pneumonia treated with a free flow helmet CPAP system. Patients’ data were recorded before, at initiation of CPAP treatment and once a day, thereafter. CPAP failure was defined as a composite outcome of intubation or death. Results A total of 306 patients were included; 42% were deemed as DNI. Helmet CPAP treatment was successful in 69% of the full treatment and 28% of the DNI patients (P 2/FiO2 ratio doubled from about 100 to 200 mmHg (P P 2/FiO2 during CPAP, number of comorbidities were independently associated with CPAP failure. Helmet CPAP was maintained for 6 [3–9] days, almost continuously during the first two days. None of the full treatment patients died before intubation in the wards. Conclusions Helmet CPAP treatment is feasible for several days outside the ICU, despite persistent impairment in gas exchange. It was used, without escalating to intubation, in the majority of full treatment patients after standard oxygen therapy failed. DNI patients could benefit from helmet CPAP as rescue therapy to improve survival. Trial Registration: NCT04424992

Published
2021

24. Clinical features and comorbidity pattern of HCV infected migrants compared to native patients in care in Italy: A real-life evaluation of the PITER cohort

Author

Maria Giovanna Quaranta, Luigina Ferrigno, Xhimi Tata, Franca D'Angelo, Marco Massari, Carmine Coppola, Elisa Biliotti, Alessia Giorgini, Diletta Laccabue, Alessia Ciancio, Pier Luigi Blanc, Marzia Margotti, Donatella Ieluzzi, Maurizia Rossana Brunetto, Francesco Barbaro, Francesco Paolo Russo, Ilaria Beretta, Giulia Morsica, Gabriella Verucchi, Annalisa Saracino, Massimo Galli, Loeta A. Kondili, Cesare Mazzaro, Manuela Bertola, Ornella Schioppa, Antonio Benedetti, Laura Schiadà, Monica Cucco, Andrea Giacometti, Laura Brescini, Sefora Castelletti, Alessandro Fiorentini, Gioacchino Angarano, Michele Milella, Alfredo Di Leo, Maria Rendina, Fulvio Salvatore D'abramo, Chiara Lillo, Andrea Iannone, Mariano Piazzolla, Lorenzo Badia, Fabio Piscaglia, Francesca Benevento, Ilaria Serio, Francesco Castelli, Serena Zaltron, Angiola Spinetti, Silvia Odolini, Raffaele Bruno, Mario Mondelli, Luchino Chessa, Martina Loi, Carlo Torti, Chiara Costa, Maria Mazzitelli, Vincenzo Pisani, Vincenzo Scaglione, Enrico Maria Trecarichi, Anna Linda Zignego, Monica Monti, Francesco Madia, Letizia Attala, Piera Pierotti, Elena Salomoni, Elisa Mariabelli, Teresa Antonia Santantonio, Serena Rita Bruno, Ester Marina Cela, Matteo Bassetti, Giovanni Mazzarello, Anna Ida Alessandrini, Antonio Di Biagio, Laura Ambra Nicolini, Giovanni Raimondo, Roberto Filomia, Alessio Aghemo, Rossella Meli, Adriano Lazzarin, Stefania Salpietro, Anna Ludovica Fracanzani, Erika Fatta, Rosa Lombardi, Pietro Lampertico, Marta Borghi, Roberta D'ambrosio, Elisabetta Degasperi, Massimo Puoti, Chiara Baiguera, Federico D'amico, Maria Vinci, Maria Grazia Rumi, Massimo Zuin, Paola Zermiani, Pietro Andreone, Paolo Caraceni, Valeria Guarneri, Erica Villa, Veronica Bernabucci, Laura Bristot, Maria Luisa Paradiso, Guglielmo Migliorino, Alessandra Gambaro, Giuseppe Lapadula, Anna Spolti, Alessandro Soria, Pietro Invernizzi, Antonio Ciaccio, Martina LucÀ, Federica Malinverno, Laura Ratti, Daniela Caterina Amoruso, Federica Pisano, Ferdinando Scarano, Laura Staiano, Filomena Morisco, Valentina Cossiga, Ivan Gentile, Antonio Riccardo Buonomo, Maria Foggia, Emanuela Zappulo, Alessandro Federico, Marcello Dallio, Nicola Coppola, Caterina Sagnelli, Salvatore Martini, Caterina Monari, Gerardo Nardone, Costantino Sgamato, Liliana Chemello, Luisa Cavalletto, Daniela Sterrantino, Alberto Zanetto, Paola Zanaga, Giuseppina Brancaccio, Antonio Craxì, Salvatore Petta, Vincenza Calvaruso, Luciano Crapanzano, Salvatore Madonia, Marco Cannizzaro, Erica Maria Bruno, Anna Licata, Simona Amodeo, Adele Rosaria Capitano, Carlo Ferrari, Elisa Negri, Alessandra Orlandini, Marco Pesci, Roberto Gulminetti, Layla Pagnucco, Giustino Parruti, Paola Di Stefano, Barbara Coco, Romina Corsini, Elisa Garlassi, Massimo Andreoni, Elisabetta Teti, Carlotta Cerva, Lorenzo Baiocchi, Giuseppe Grassi, Antonio Gasbarrini, Maurizio Pompili, Martina De Siena, Gloria Taliani, Martina Spaziante, Marcello Persico, Mario Masarone, Andrea Aglitti, Gemma Calvanese, Marco Anselmo, Pasqualina De Leo, Monica Marturano, Giorgio Maria Saracco, Quaranta M.G., Ferrigno L., Tata X., D'Angelo F., Massari M., Coppola C., Biliotti E., Giorgini A., Laccabue D., Ciancio A., Blanc P.L., Margotti M., Ieluzzi D., Brunetto M.R., Barbaro F., Russo F.P., Beretta I., Morsica G., Verucchi G., Saracino A., Galli M., Kondili L.A., Mazzaro C., Bertola M., Benedetti A., Schiada L., Cucco M., Giacometti A., Brescini L., Castelletti S., Fiorentini A., Angarano G., Milella M., Leo A.D., Rendina M., Salvatore D'ABRAMO F., Lillo C., Iannone A., Piazzolla M., Badia L., Piscaglia F., Benevento F., Serio I., Castelli F., Zaltron S., Spinetti A., Odolini S., Bruno R., Mondelli M., Chessa L., Loi M., Torti C., Costa C., Mazzitelli M., Pisani V., Scaglione V., Trecarichi E.M., Zignego A.L., Monti M., Madia F., Attala L., Pierotti P., Salomoni E., Mariabelli E., Santantonio T.A., Bruno S.R., Cela E.M., Bassetti M., Mazzarello G., Alessandrini A.I., Biagio A.D., Nicolini L.A., Raimondo G., Filomia R., Aghemo A., Meli R., Lazzarin A., Salpietro S., Fracanzani A.L., Fatta E., Lombardi R., Lampertico P., Borghi M., D'ambrosio R., Degasperi E., Puoti M., Baiguera C., D'AMICO F., Vinci M., Rumi M.G., Zuin M., Zermiani P., Andreone P., Caraceni P., Guarneri V., Villa E., Bernabucci V., Bristot L., Paradiso M.L., Migliorino G., Gambaro A., Lapadula G., Spolti A., Soria A., Invernizzi P., Ciaccio A., LucA M., Malinverno F., Ratti L., Amoruso D.C., Pisano F., Scarano F., Staiano L., Morisco F., Cossiga V., Gentile I., Buonomo A.R., Foggia M., Zappulo E., Federico A., Dallio M., Coppola N., Sagnelli C., Martini S., Monari C., Nardone G., Sgamato C., Chemello L., Cavalletto L., Sterrantino D., Zanetto A., Zanaga P., Brancaccio G., Craxi A., Petta S., Calvaruso V., Crapanzano L., Madonia S., Cannizzaro M., Bruno E.M., Licata A., Amodeo S., Capitano A.R., Ferrari C., Negri E., Orlandini A., Pesci M., Gulminetti R., Pagnucco L., Parruti G., Stefano P.D., Coco B., Corsini R., Garlassi E., Andreoni M., Teti E., Cerva C., Baiocchi L., Grassi G., Gasbarrini A., Pompili M., Siena M.D., Taliani G., Spaziante M., Persico M., Masarone M., Aglitti A., Calvanese G., Anselmo M., Leo P.D., Marturano M., Saracco G.M., Quaranta, M, Ferrigno, L, Tata, X, D'Angelo, F, Massari, M, Coppola, C, Biliotti, E, Giorgini, A, Laccabue, D, Ciancio, A, Blanc, P, Margotti, M, Ieluzzi, D, Brunetto, M, Barbaro, F, Russo, F, Beretta, I, Morsica, G, Verucchi, G, Saracino, A, Galli, M, Kondili, L, Mazzaro, C, Bertola, M, Benedetti, A, Schiada, L, Cucco, M, Giacometti, A, Brescini, L, Castelletti, S, Fiorentini, A, Angarano, G, Milella, M, Leo, A, Rendina, M, Salvatore D'ABRAMO, F, Lillo, C, Iannone, A, Piazzolla, M, Badia, L, Piscaglia, F, Benevento, F, Serio, I, Castelli, F, Zaltron, S, Spinetti, A, Odolini, S, Bruno, R, Mondelli, M, Chessa, L, Loi, M, Torti, C, Costa, C, Mazzitelli, M, Pisani, V, Scaglione, V, Trecarichi, E, Zignego, A, Monti, M, Madia, F, Attala, L, Pierotti, P, Salomoni, E, Mariabelli, E, Santantonio, T, Bruno, S, Cela, E, Bassetti, M, Mazzarello, G, Alessandrini, A, Biagio, A, Nicolini, L, Raimondo, G, Filomia, R, Aghemo, A, Meli, R, Lazzarin, A, Salpietro, S, Fracanzani, A, Fatta, E, Lombardi, R, Lampertico, P, Borghi, M, D'Ambrosio, R, Degasperi, E, Puoti, M, Baiguera, C, D'Amico, F, Vinci, M, Rumi, M, Zuin, M, Zermiani, P, Andreone, P, Caraceni, P, Guarneri, V, Villa, E, Bernabucci, V, Bristot, L, Paradiso, M, Migliorino, G, Gambaro, A, Lapadula, G, Spolti, A, Soria, A, Invernizzi, P, Ciaccio, A, Luca, M, Malinverno, F, Ratti, L, Amoruso, D, Pisano, F, Scarano, F, Staiano, L, Morisco, F, Cossiga, V, Gentile, I, Buonomo, A, Foggia, M, Zappulo, E, Federico, A, Dallio, M, Coppola, N, Sagnelli, C, Martini, S, Monari, C, Nardone, G, Sgamato, C, Chemello, L, Cavalletto, L, Sterrantino, D, Zanetto, A, Zanaga, P, Brancaccio, G, Craxi, A, Petta, S, Calvaruso, V, Crapanzano, L, Madonia, S, Cannizzaro, M, Bruno, E, Licata, A, Amodeo, S, Capitano, A, Ferrari, C, Negri, E, Orlandini, A, Pesci, M, Gulminetti, R, Pagnucco, L, Parruti, G, Stefano, P, Coco, B, Corsini, R, Garlassi, E, Andreoni, M, Teti, E, Cerva, C, Baiocchi, L, Grassi, G, Gasbarrini, A, Pompili, M, Siena, M, Taliani, G, Spaziante, M, Persico, M, Masarone, M, Aglitti, A, Calvanese, G, Anselmo, M, Leo, P, Marturano, M, Saracco, G, Quaranta, M. G., Ferrigno, L., Tata, X., D'Angelo, F., Massari, M., Coppola, C., Biliotti, E., Giorgini, A., Laccabue, D., Ciancio, A., Blanc, P. L., Margotti, M., Ieluzzi, D., Brunetto, M. R., Barbaro, F., Russo, F. P., Beretta, I., Morsica, G., Verucchi, G., Saracino, A., Galli, M., Kondili, L. A., Mazzaro, C., Bertola, M., Benedetti, A., Schiada, L., Cucco, M., Giacometti, A., Brescini, L., Castelletti, S., Fiorentini, A., Angarano, G., Milella, M., Leo, A. D., Rendina, M., Salvatore D'ABRAMO, F., Lillo, C., Iannone, A., Piazzolla, M., Badia, L., Piscaglia, F., Benevento, F., Serio, I., Castelli, F., Zaltron, S., Spinetti, A., Odolini, S., Bruno, R., Mondelli, M., Chessa, L., Loi, M., Torti, C., Costa, C., Mazzitelli, M., Pisani, V., Scaglione, V., Trecarichi, E. M., Zignego, A. L., Monti, M., Madia, F., Attala, L., Pierotti, P., Salomoni, E., Mariabelli, E., Santantonio, T. A., Bruno, S. R., Cela, E. M., Bassetti, M., Mazzarello, G., Alessandrini, A. I., Biagio, A. D., Nicolini, L. A., Raimondo, G., Filomia, R., Aghemo, A., Meli, R., Lazzarin, A., Salpietro, S., Fracanzani, A. L., Fatta, E., Lombardi, R., Lampertico, P., Borghi, M., D'Ambrosio, R., Degasperi, E., Puoti, M., Baiguera, C., D'Amico, F., Vinci, M., Rumi, M. G., Zuin, M., Zermiani, P., Andreone, P., Caraceni, P., Guarneri, V., Villa, E., Bernabucci, V., Bristot, L., Paradiso, M. L., Migliorino, G., Gambaro, A., Lapadula, G., Spolti, A., Soria, A., Invernizzi, P., Ciaccio, A., Luca, M., Malinverno, F., Ratti, L., Amoruso, D. C., Pisano, F., Scarano, F., Staiano, L., Morisco, F., Cossiga, V., Gentile, I., Buonomo, A. R., Foggia, M., Zappulo, E., Federico, A., Dallio, M., Coppola, N., Sagnelli, C., Martini, S., Monari, C., Nardone, G., Sgamato, C., Chemello, L., Cavalletto, L., Sterrantino, D., Zanetto, A., Zanaga, P., Brancaccio, G., Craxi, A., Petta, S., Calvaruso, V., Crapanzano, L., Madonia, S., Cannizzaro, M., Bruno, E. M., Licata, A., Amodeo, S., Capitano, A. R., Ferrari, C., Negri, E., Orlandini, A., Pesci, M., Gulminetti, R., Pagnucco, L., Parruti, G., Stefano, P. D., Coco, B., Corsini, R., Garlassi, E., Andreoni, M., Teti, E., Cerva, C., Baiocchi, L., Grassi, G., Gasbarrini, A., Pompili, M., Siena, M. D., Taliani, G., Spaziante, M., Persico, M., Masarone, M., Aglitti, A., Calvanese, G., Anselmo, M., Leo, P. D., Marturano, M., and Saracco, G. M.

Subjects
Male, HCV genotypes, Ethnic group, Linked-to-care patient, Comorbidity, Hepacivirus, Logistic regression, medicine.disease_cause, Comorbidities, Direct acting antivirals, HCV Cohort, Linked-to-care patients, Aged, Antiviral Agents, Coinfection, Female, Hepatitis C, Chronic, Humans, Italy, Middle Aged, Transients and Migrants, 0302 clinical medicine, Medicine, Chronic, Gastroenterology, virus diseases, Hepatitis C, Life evaluation, 030220 oncology & carcinogenesis, Cohort, 030211 gastroenterology & hepatology, Comorbiditie, Human, Hepatitis C virus, Settore MED/12 - GASTROENTEROLOGIA, 03 medical and health sciences, Disease severity, Antiviral Agent, Hepaciviru, Hepatology, business.industry, Settore MED/09 - MEDICINA INTERNA, medicine.disease, digestive system diseases, Direct acting antiviral, business, Demography
Abstract

Background: Direct-acting antivirals are highly effective for the treatment of hepatitis C virus (HCV) infection, regardless race/ethnicity. We aimed to evaluate demographic, virological and clinical data of HCV-infected migrants vs. natives consecutively enrolled in the PITER cohort. Methods: Migrants were defined by country of birth and nationality that was different from Italy. Mann-Whitney U test, Chi-squared test and multiple logistic regression were used. Results: Of 10,669 enrolled patients, 301 (2.8%) were migrants: median age 47 vs. 62 years, (p < 0.001), females 56.5% vs. 45.3%, (p < 0.001), HBsAg positivity 3.8% vs. 1.4%, (p < 0.05). Genotype 1b was prevalent in both groups, whereas genotype 4 was more prevalent in migrants (p < 0.05). Liver disease severity and sustained virologic response (SVR) were similar. A higher prevalence of comorbidities was reported for natives compared to migrants (p < 0.05). Liver disease progression cofactors (HBsAg, HIV coinfection, alcohol abuse, potential metabolic syndrome) were present in 39.1% and 47.1% (p > 0.05) of migrants and natives who eradicated HCV, respectively. Conclusion: Compared to natives, HCV-infected migrants in care have different demographics, HCV genotypes, viral coinfections and comorbidities and similar disease severity, SVR and cofactors for disease progression after HCV eradication. A periodic clinical assessment after HCV eradication in Italians and migrants with cofactors for disease progression is warranted.

Published
2021

25. Beware of biases in observational studies on anti-spike monoclonal antibodies

Author

Alessandro Soria, Davide Paolo Bernasconi, Maria Grazia Valsecchi, Giuseppe Lapadula, Paolo Bonfanti, Lapadula, G, Bernasconi, D, Soria, A, Valsecchi, M, and Bonfanti, P

Subjects
Microbiology (medical), Infectious Diseases, Coronavirus disease 2019 (COVID-19), business.industry, medicine.drug_class, Immunology, MEDLINE, Medicine, COVID-19, Spike (software development), Observational study, business, Monoclonal antibody
Published
2021

26. The high volume of patients admitted during the SARS-CoV-2 pandemic has an independent harmful impact on in-hospital mortality from COVID-19

Author

Agata Ardini, Paolo Bonfanti, F Visco, Alessandro Soria, Giuseppe Lapadula, Maria Grazia Valsecchi, Stefania Galimberti, Soria, A, Galimberti, S, Lapadula, G, Visco, F, Ardini, A, Valsecchi, M, and Bonfanti, P

Subjects
Male, Viral Diseases, Epidemiology, Medical Conditions, Interquartile range, Risk Factors, Medicine and Health Sciences, Cumulative incidence, Hospital Mortality, Multidisciplinary, Mortality rate, Hazard ratio, Middle Aged, Hospitals, Hospitalization, Intensive Care Units, Infectious Diseases, Italy, Research Design, Medicine, Female, Research Article, Adult, medicine.medical_specialty, Census, Death Rates, Science, Research and Analysis Methods, Age Distribution, Population Metrics, medicine, Humans, Pandemics, Aged, Proportional Hazards Models, Retrospective Studies, Survey Research, Population Biology, Proportional hazards model, business.industry, SARS-CoV-2, Biology and Life Sciences, COVID-19, Retrospective cohort study, Covid 19, Confidence interval, Health Care, Health Care Facilities, Medical Risk Factors, Emergency medicine, business
Abstract

Background During the Coronavirus disease 2019 (COVID-19) pandemic, advanced health systems have come under pressure by the unprecedented high volume of patients needing urgent care. The impact on mortality of this “patients’ burden” has not been determined. Methods and findings Through retrieval of administrative data from a large referral hospital of Northern Italy, we determined Aalen-Johansen cumulative incidence curves to describe the in-hospital mortality, stratified by fixed covariates. Age- and sex-adjusted Cox models were used to quantify the effect on mortality of variables deemed to reflect the stress on the hospital system, namely the time-dependent number of daily admissions and of total hospitalized patients, and the calendar period. Of the 1225 subjects hospitalized for COVID-19 between February 20 and May 13, 283 died (30-day mortality rate 24%) after a median follow-up of 14 days (interquartile range 5–19). Hospitalizations increased progressively until a peak of 465 subjects on March 26, then declined. The risk of death, adjusted for age and sex, increased for a higher number of daily admissions (adjusted hazard ratio [AHR] per an incremental daily admission of 10 patients: 1.13, 95% Confidence Intervals [CI] 1.05–1.22, p = 0.0014), and for a higher total number of hospitalized patients (AHR per an increase of 50 patients in the total number of hospitalized subjects: 1.11, 95%CI 1.04–1.17, p = 0.0004), while was lower for the calendar period after the peak (AHR 0.56, 95%CI 0.43–0.72, p Conclusions The pressure of a high volume of severely ill patients suffering from COVID-19 has a measurable independent impact on in-hospital mortality.

Published
2021

27. COVID-19 Mortality and Stress to the Hospital System From High Patient Load

Author

Paolo Bonfanti, Alessandro Soria, Giuseppe Lapadula, Soria, A, Lapadula, G, and Bonfanti, P

Subjects
2019-20 coronavirus outbreak, medicine.medical_specialty, Coronavirus disease 2019 (COVID-19), SARS-CoV-2, business.industry, Severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2), MEDLINE, COVID-19, Hospitals, Hospitalization, Hospital system, Patient Load, Emergency medicine, Internal Medicine, Humans, Medicine, business
Published
2021

28. Malassorbimento intestinale della terapia antiretrovirale in un paziente affetto da AIDS e micobatteriosi atipica disseminata

Author

Lucia Borghesi, M, Soria, A, Sabbatini, F, Rossi, M, Pollastri, E, Limonta, S, Iannuzzi, F, Migliorino, G, Lapadula, G, Bonfanti, P, Maria Lucia Borghesi, Alessandro Soria, Francesca Sabbatini, Marianna Rossi, Ester Pollastri, Silvia Limonta, Francesca Iannuzzi, Guglielmo Marco Migliorino, Giuseppe Lapadula, Paolo Bonfanti, Lucia Borghesi, M, Soria, A, Sabbatini, F, Rossi, M, Pollastri, E, Limonta, S, Iannuzzi, F, Migliorino, G, Lapadula, G, Bonfanti, P, Maria Lucia Borghesi, Alessandro Soria, Francesca Sabbatini, Marianna Rossi, Ester Pollastri, Silvia Limonta, Francesca Iannuzzi, Guglielmo Marco Migliorino, Giuseppe Lapadula, and Paolo Bonfanti

Abstract

Nontuberculous mycobacteria infection is one of the most serious and difficult-to-treat complications in AIDS patients. Difficult microbiological diagnosis together with variable compliance to treatment, pharmacological interactions and intestinal malabsorption are the most frequent problems that can cause treatment failure. We report a case of a young HIV-infected man, AIDS presenter with disseminated non-tuberculous mycobacteria infection and immune reconstitution inflammatory syndrome, who failed antimycobacterial and antiretroviral treatment because of intestinal malabsorption. Clinical improvement was seen after intravenous administration of antimycobacterial drugs and following an adjustment of antiretroviral treatment due to virological failure. Intestinal malabsorption must be accounted for in cases of oral treatment failure in mycobacterial infections.

Published
2021

29. COVID-19 Infection Among Incarcerated Individuals and Prison Staff in Lombardy, Italy, March 2020 to February 2021

Author

Sara Mazzilli, Lara Tavoschi, Alessandro Soria, Marco Fornili, Giorgia Cocca, Teresa Sebastiani, Giuditta Scardina, Cristina Cairone, Guglielmo Arzilli, Giuseppe Lapadula, Luca Ceccarelli, Nicola Cocco, Raffaella Bartolotti, Stefano De Vecchi, Giacomo Placidi, Leonardo Rezzonico, Laura Baglietto, Ruggero Giuliani, Roberto Ranieri, Mazzilli, S, Tavoschi, L, Soria, A, Fornili, M, Cocca, G, Sebastiani, T, Scardina, G, Cairone, C, Arzilli, G, Lapadula, G, Ceccarelli, L, Cocco, N, Bartolotti, R, De Vecchi, S, Placidi, G, Rezzonico, L, Baglietto, L, Giuliani, R, and Ranieri, R

Subjects
Cross-Sectional Studie, Adult, Pandemic, SARS-CoV-2, Prisoners, Prison, COVID-19, General Medicine, Cross-Sectional Studies, Female, Humans, Italy, Pandemics, Prisons, Human
Abstract

Importance: Owing to infrastructural and population characteristics, the prison setting is at increased risk for transmission of SARS-CoV-2 and for severe clinical outcomes. Because of structural and operational reasons, research in prison settings is challenging and available studies are often monocentric and have limited temporal coverage; broader-based research is necessary. Objectives: To assess the extent and dynamics of the COVID-19 pandemic within the prison system of a large Italian region, Lombardy, and report the infection prevention and control measures implemented. Design, Setting, and Participants: This repeated cross-sectional study was carried out from March 1, 2020, through February 28, 2021 (first wave, March-June 2020; second wave, October 2020-February 2021) in the prison system of Lombardy, which includes 18 detention facilities for adults. All incarcerated persons and the prison staff of the penitentiary system of the Lombardy region participated in the study. Exposures: The main exposures of interest were the weekly average number of incarcerated individuals placed in quarantine in single or shared isolation rooms, the rate of sick leave by symptomatic and asymptomatic prison staff reported to the prison occupational medicine department on a weekly basis, and the level of overcrowding. Main Outcomes and Measures: The primary outcome measures were weekly COVID-19 crude case rates, weekly test positivity rate, and the relative risk of acquiring the infection for prison staff, incarcerated persons, and the general population. Results: The study population comprised a mean of 7599 incarcerated individuals and 4591 prison staff. Approximately 5.1% of the prison population were women; demographic characteristics of the prison staff were not available. During the study, COVID-19 occurred in 1564 incarcerated individuals and 661 prison staff. Most of these cases were reported during the second wave (1474 in incarcerated individuals, 529 in prison staff), when stringent measures previously enforced were relaxed. During both epidemic waves, incarcerated individuals and prison staff had a higher relative risk for COVID-19 infection than the general population during both the first wave (incarcerated individuals: 1.30; 95% CI, 1.06-1.58; prison staff: 3.23; 95% CI, 2.74-3.84) and the second wave (incarcerated individuals: 3.91; 95% CI, 3.73-4.09; prison staff: 2.61; 95% CI, 2.41-2.82). Conclusions and Relevance: The findings of this study suggest that the prison setting was an element of fragility during COVID-19 pandemic, with a high burden of COVID-19 cases among both the incarcerated individuals and prison staff. The prison setting and prison population need to be included and possibly prioritized in the response during epidemic events.

Published
2022

30. Helmet CPAP to Treat Hypoxic Pneumonia Outside the ICU: An Observational Study During the COVID-19 Outbreak

Author

Andrea Coppadoro, Annalisa Benini, Robert Fruscio, Luisa Verga, Paolo Mazzola, Marco Carbone, Giacomo Mulinacci, Alessandro Soria, Beatrice Noe', Eduardo Beck, Riccardo Di Sciacca, Davide Ippolito, Giuseppe Citerio, Grazia Valsecchi, Andrea Biondi, Alberto Pesci, Paolo Bonfanti, Davide Gaudesi, Giacomo Bellani, and Giuseppe Foti

Subjects
respiratory tract diseases
Abstract

Background: Respiratory failure due to COVID-19 pneumonia is associated with high mortality and may threaten healthcare systems hold, due to the surge patients requiring advanced respiratory support. Shortage of intensive care unit (ICU) beds required many patients to be treated outside the ICU despite severe hypoxia. Helmet is as effective interface to provide Continuous Positive Airway Pressure (CPAP) non-invasively. We report data about the usefulness of helmet CPAP during pandemic, either as an effective treatment, a bridge to intubation or a rescue therapy for patients with care limitations (DNI).Methods: In this observational study we collected data regarding patients failing standard oxygen therapy (i.e. non-rebreathing mask) due to COVID-19 pneumonia treated with a free flow helmet CPAP system. Patients’ data were recorded before, at initiation of CPAP treatment and once a day, since. CPAP failure was defined as a composite outcome of intubation or death.Results: A total of 306 patients were included; 42% were deemed as DNI. Helmet CPAP treatment was successful in 69% of the full-treatment and 29% of the DNI patients (P<0.001). With helmet CPAP, PaO2/FiO2 ratio doubled from about 100 to 200 mmHg (P<0.001); respiratory rate decreased from 28 [22-32] to 24 [20-29] breaths per minute, P2/FiO2 during CPAP, number of comorbidities. Helmet CPAP was maintained for 6 [3-9] days, almost continuously during the first two days. None of the full treatment patients died before intubation in the wardsConclusions: Helmet CPAP treatment is feasible for several days outside the ICU, despite persisting hypoxia. It is effective, avoiding intubation in the majority of full treatment patients when standard oxygen therapy fails. DNI patients could benefit from helmet CPAP as rescue therapy to improve survival.Trial Registration: NCT04424992

Published
2020

31. High rates of 30-day mortality in patients with cirrhosis and COVID-19

Author

Stefano Fagiuoli, Michela Triolo, Massimo Iavarone, Paolo Bonfanti, Alessandro Soria, Sara Massironi, Roberta D'Ambrosio, Nicola Pugliese, Martina Lucà, Elisabetta Buscarini, Canio Carriero, Giovanni Perricone, Maria Grazia Rumi, Paolo Poggio, Pietro Invernizzi, Angiola Spinetti, Alessandro Rimondi, Luca S. Belli, Marianna Pedaci, Mauro Viganò, Pietro Lampertico, Alessio Aghemo, Iavarone, M, D'Ambrosio, R, Soria, A, Triolo, M, Pugliese, N, Del Poggio, P, Perricone, G, Massironi, S, Spinetti, A, Buscarini, E, Viganò, M, Carriero, C, Fagiuoli, S, Aghemo, A, Belli, L, Lucà, M, Pedaci, M, Rimondi, A, Rumi, M, Invernizzi, P, Bonfanti, P, and Lampertico, P

Subjects
Liver Cirrhosis, Male, 0301 basic medicine, Cirrhosis, medicine.medical_treatment, Comorbidity, Liver transplantation, Liver disease, COVID-19 Testing, 0302 clinical medicine, Liver Function Tests, Risk Factors, HBV, hepatitis, COVID-19, coronavirus disease-2019, medicine.diagnostic_test, liver transplantation, Mortality rate, hepatocellular carcinoma, EPV, events per predictor variable, Italy, SARS-CoV-2, severe acute respiratory syndrome-associated coronavirus 2, Ang, angiotensin, HCV, Female, 030211 gastroenterology & hepatology, INR, International normalized ratio, Coronavirus Infections, medicine.medical_specialty, Pneumonia, Viral, Hepatiti, Antiviral Agents, Article, Betacoronavirus, 03 medical and health sciences, ACE2, Angiotensin-converting enzyme 2, PT, prothrombin time, Internal medicine, medicine, Humans, Mortality, Risk factor, Pandemics, Aged, Retrospective Studies, Hepatitis, Hepatology, Clinical Laboratory Techniques, business.industry, SARS-CoV-2, COVID-19, medicine.disease, 030104 developmental biology, Liver function, business, Liver function tests
Abstract

Background and aims Coronavirus disease (COVID-19) is a major worldwide threat for healthy individuals as well as for patients with comorbidities, but its impact on patients with cirrhosis is currently unknown. This study aimed at evaluating the impact of COVID-19 on the clinical outcome of these patients. Methods In this multicenter retrospective study, cirrhotic patients with confirmed Severe Acute Respiratory Syndrome Coronavirus-2 (SARS-CoV-2) infection were enrolled between 1st and 31th March 2020. Clinical and biochemical data at COVID-19 and at the last outpatient visit were obtained through review of medical records. Results Fifty cirrhotic patients with confirmed SARS-CoV-2 infection were enrolled (age 67 years, 70% men, 38% virus-related, 52% previously compensated cirrhosis). At diagnosis, 64% of patients presented fever, 42% shortness of breath/polypnea, 22% encephalopathy, 96% needed hospitalization or prolonged an ongoing one. Respiratory-support was necessary in 71%, 52% received antivirals, 80% heparin. Serum albumin significantly decreased, while bilirubin, creatinine and prothrombin time significantly increased at COVID-19 diagnosis compared to last available data. The proportion of patients with MELD≥15 increased from 13% to 26% (p=0.037), acute-on-chronic liver failure and and de novo acute liver injury occurred in 14 (28%) and 10 patients, respectively. Seventeen patients died after a median of 10 (4-13) days from COVID-19 diagnosis, with a 30-day-mortality rate of 34%. Severity of lung and liver (according to CLIF-C, CLIF-OF and MELD scores) diseases independently predicted mortality. Mortality was significantly higher in hospitalized cirrhotics with COVID-19 than in those hospitalized for bacterial infections. Conclusion COVID-19 is associated with liver function deterioration and elevated mortality in cirrhotic patients., Graphical abstract, Highlights − Fifty cirrhotic patients with SARS-CoV-2 infection were studied: 64% presented with fever, 42% shortness of breath/polypnea, 22% encephalopathy; respiratory-support was necessary in 71%. − The 30-day mortality was 34% (95% CI 23-49), higher in those patients with moderate/severe respiratory failure and in those who had a more deteriorated liver function, as indicated by the increased MELD and CLIF-OF scores at COVID-19 diagnosis. − The 30-days mortality rate was higher in cirrhotics with COVID-19 than in cirrhotics with bacterial infection and in COVID-19 patients without cirrhosis − No major adverse events related to the thromboprophylaxis with heparin given to 80% of patients and treatments used to tackle the coronavirus infection.

Published
2020

32. Feasibility and physiological effects of prone positioning in non-intubated patients with acute respiratory failure due to COVID-19 (PRON-COVID): a prospective cohort study

Author

Michela Di Pierro, Paola Faverio, Giacomo Bellani, Alessandro Soria, Dario Winterton, Maria Grazia Valsecchi, Annalisa Benini, Laura Antolini, Grazia Messinesi, Giuseppe Foti, S. Mori, Ernesto Contro, Matteo Cairo, Paolo Bonfanti, Anna Coppo, Coppo, A, Bellani, G, Winterton, D, Di Pierro, M, Soria, A, Faverio, P, Cairo, M, Mori, S, Messinesi, G, Contro, E, Bonfanti, P, Benini, A, Valsecchi, M, Antolini, L, and Foti, G

Subjects
Pulmonary and Respiratory Medicine, Supine position, medicine.medical_treatment, Pneumonia, Viral, Article, 03 medical and health sciences, Betacoronavirus, 0302 clinical medicine, Intensive care, Prone Position, Medicine, Intubation, Humans, 030212 general & internal medicine, Continuous positive airway pressure, Prospective Studies, Prospective cohort study, Pandemics, Respiratory Distress Syndrome, acute respiratory failure, business.industry, SARS-CoV-2, COVID-19, prone positioning, Prone position, 030228 respiratory system, Respiratory failure, Anesthesia, Feasibility Studies, business, Coronavirus Infections, Respiratory Insufficiency, Cohort study
Abstract

Background: The COVID-19 pandemic is challenging advanced health systems, which are dealing with an overwhelming number of patients in need of intensive care for respiratory failure, often requiring intubation. Prone positioning in intubated patients is known to reduce mortality in moderate-to-severe acute respiratory distress syndrome. We aimed to investigate feasibility and effect on gas exchange of prone positioning in awake, non-intubated patients with COVID-19-related pneumonia. Methods: In this prospective, feasibility, cohort study, patients aged 18–75 years with a confirmed diagnosis of COVID-19-related pneumonia receiving supplemental oxygen or non-invasive continuous positive airway pressure were recruited from San Gerardo Hospital, Monza, Italy. We collected baseline data on demographics, anthropometrics, arterial blood gas, and ventilation parameters. After baseline data collection, patients were helped into the prone position, which was maintained for a minimum duration of 3 h. Clinical data were re-collected 10 min after prone positioning and 1 h after returning to the supine position. The main study outcome was the variation in oxygenation (partial pressure of oxygen [PaO2]/fractional concentration of oxygen in inspired air [FiO2]) between baseline and resupination, as an index of pulmonary recruitment. This study is registered on ClinicalTrials.gov, NCT04365959, and is now complete. Findings: Between March 20 and April 9, 2020, we enrolled 56 patients, of whom 44 (79%) were male; the mean age was 57·4 years (SD 7·4) and the mean BMI was 27·5 kg/m2 (3·7). Prone positioning was feasible (ie, maintained for at least 3 h) in 47 patients (83·9% [95% CI 71·7 to 92·4]). Oxygenation substantially improved from supine to prone positioning (PaO2/FiO2 ratio 180·5 mm Hg [SD 76·6] in supine position vs 285·5 mm Hg [112·9] in prone position; p

Published
2020

33. Comparison of three therapeutic regimens for genotype-3 hepatitis C virus infection in a large real-life multicentre cohort

Author

Sergio Lazzaroni, Paolo Grossi, Chiara Molteni, Maria Grazia Valsecchi, Pietro Lampertico, Luca Valenti, Alessio Aghemo, Alessia Giorgini, Antonella d'Arminio Monforte, Roberta D'Ambrosio, Federico Gatti, Omar Giglio, Daniele Bella, Davide Paolo Bernasconi, Giuseppe Lapadula, Sherrie Bhoori, Hamid Hasson, Monica Schiavini, Elisa Colella, Roberto Boldizzoni, A. Ciaccio, Simona Landonio, Andrea Capretti, Maria Cristina Vinci, Giuliano Rizzardini, Barbara Menzaghi, Elisabetta Degasperi, Caterina Uberti-Foppa, Chiara Baiguera, Andrea Lombardi, Gianpiero Aimo, Layla Pagnucco, Paolo Perini, Giuliana Cologni, Natalia Terreni, Paolo Bonfanti, Mauro Viganò, Paolo Viganò, Alessandro Soria, Roberto Rossotti, Massimo Puoti, Ombretta Spinelli, Canio Carriero, Silvia Polo, Guglielmo Marco Migliorino, Silvia Colombo, Riccardo Centenaro, Luisa Pasulo, Anna De Bona, E. Dionigi, Paolo Poggio, Franco Noventa, Isabella Carderi, Angelo Pan, Angiola Spinetti, Mariella Di Marco, Cecilia Liani, Stefano Fagiuoli, Marie Graciella Pigozzi, Marco Fava, Massimo Graffeo, Maria Grazia Rumi, Alberto Colombo, Soria, A., Fava, M., Bernasconi, D. P., Lapadula, G., Colella, E., Valsecchi, M. G., Migliorino, G. M., D'Ambrosio, R., Landonio, S., Schiavini, M., Spinetti, A., Carriero, C., Degasperi, E., Cologni, G., Gatti, F., Vigano, P., Hasson, H., Uberti-Foppa, C., Pasulo, L., Baiguera, C., Rossotti, R., Vinci, M., Puoti, M., Giorgini, A., Menzaghi, B., Lombardi, A., Pan, A., Aghemo, A., Grossi, P. A., Boldizzoni, R., Colombo, S., Vigano, M., Rumi, M. G., Del Poggio, P., Valenti, L., Giglio, O., De Bona, A., d'Arminio Monforte, A., Colombo, A., Spinelli, O., Pigozzi, M. G., Molteni, C., Bonfanti, P., Terreni, N., Perini, P., Capretti, A., Bella, D., Liani, C., Polo, S., Aimo, G., Pagnucco, L., Bhoori, S., Centenaro, R., Graffeo, M., Ciaccio, A., Dionigi, E., Lazzaroni, S., Carderi, I., Di Marco, M., Rizzardini, G., Noventa, F., Lampertico, P., Fagiuoli, S., Soria, A, Fava, M, Bernasconi, D, Lapadula, G, Colella, E, Valsecchi, M, Migliorino, G, D'Ambrosio, R, Landonio, S, Schiavini, M, Spinetti, A, Carriero, C, Degasperi, E, Cologni, G, Gatti, F, Vigano, P, Hasson, H, Uberti-Foppa, C, Pasulo, L, Baiguera, C, Rossotti, R, Vinci, M, Puoti, M, Giorgini, A, Menzaghi, B, Lombardi, A, Pan, A, Aghemo, A, Grossi, P, Boldizzoni, R, Colombo, S, Vigano, M, Rumi, M, Del Poggio, P, Valenti, L, Giglio, O, De Bona, A, d'Arminio Monforte, A, Colombo, A, Spinelli, O, Pigozzi, M, Molteni, C, Bonfanti, P, Terreni, N, Perini, P, Capretti, A, Bella, D, Liani, C, Polo, S, Aimo, G, Pagnucco, L, Bhoori, S, Centenaro, R, Graffeo, M, Ciaccio, A, Dionigi, E, Lazzaroni, S, Carderi, I, Di Marco, M, Rizzardini, G, Noventa, F, Lampertico, P, and Fagiuoli, S

Subjects
Male, medicine.medical_specialty, Daclatasvir, Genotype, Sofosbuvir, ribavirin, pibrentasvir, daclatasvir, genotype 3, glecaprevir, Hepatitis C, sofosbuvir, sustained virological response, velpatasvir, Hepacivirus, Antiviral Agents, Gastroenterology, 03 medical and health sciences, chemistry.chemical_compound, 0302 clinical medicine, Internal medicine, Ribavirin, medicine, Humans, Univariate analysis, Hepatology, business.industry, Glecaprevir, Hepatitis C, Chronic, medicine.disease, Pibrentasvir, Regimen, Treatment Outcome, chemistry, 030220 oncology & carcinogenesis, Drug Therapy, Combination, Female, 030211 gastroenterology & hepatology, business, medicine.drug
Abstract

Background & Aims: In the direct-acting antiviral era, treatment of genotype-3 HCV (HCV-GT3) is still challenging. Real-life comparisons between recommended regimens, sofosbuvir (SOF)+daclatasvir (DAC), SOF/velpatasvir (VEL), glecaprevir/pibrentasvir (GLE/PIB), are scarce. We aimed at filling this data gap. Methods: Sustained virological response 12weeks after treatment completion (SVR12) was assessed for all HCV-GT3 patients consecutively treated within the Lombardia web-based Navigatore HCV-Network; differences in SVR12 across regimens were evaluated by logistic regression. Results: Of the 2082 subjects with HCV-GT3, 1544 were evaluable for comparisons between regimens: SOF+DAC (1023, 66.2%), SOF/VEL (369, 23.9%), GLE/PIB (152, 9.8%). Patients treated with former regimens were more frequently male, cirrhotic, HIV-positive, pretreated, used ribavirin in their regimen, and had lower baseline HCV-RNA. SVR12 was similar across groups: 94.8% in SOF+DAC, 97.6% in SOF/VEL, 96.7% in GLE/PIB (P=.065). At univariate analysis, SVR12 was associated with female gender (97.9% vs 94.8%, P=.007) and lower median pretreatment Log10HCV-RNA (5.87 vs 6.20, P=.001). At multivariate logistic regression analysis, treatment with SOF/VEL was associated with a higher likelihood of SVR12 than SOF+DAC, but only in the absence of ribavirin (98% vs 90.3%). Female gender and lower pretreatment HCV-RNA were independently associated with SVR12. Conclusions: In a large real-life setting of HCV-GT3-infected patients with a high proportion of cirrhosis, the success rate was remarkable. The slight advantage of SOF/VEL on SOF+DAC was significant only without ribavirin. The current prescription shift towards novel regimens (ie SOF/VEL and GLE/PIB) in easier-to-treat patients allows ribavirin-free and shorter schedules without mining SVR12 in this <> genotype.

Published
2020

34. Durability of dolutegravir plus boosted darunavir as salvage or simplification of salvage regimens in HIV-1 infected, highly treatment-experienced subjects

Author

Niccolò Riccardi, Fosca Niero, Maria Vittoria Cossu, Anna Maria Cattelan, Giuseppe Vittorio De Socio, Giorgio Barbarini, Stefano Rusconi, Amedeo Capetti, Giuliano Rizzardini, Gaetana Sterrantino, Benedetto Maurizio Celesia, Gian M Baldin, Giovanni Cenderello, and Alessandro Soria

Subjects
Adult, Male, 0301 basic medicine, Oncology, endocrine system, medicine.medical_specialty, Pyridones, 030106 microbiology, Human immunodeficiency virus (HIV), Salvage therapy, HIV Infections, medicine.disease_cause, Piperazines, Treatment experienced, Cohort Studies, 03 medical and health sciences, chemistry.chemical_compound, 0302 clinical medicine, Internal medicine, Oxazines, Salvage regimen, medicine, Humans, Pharmacology (medical), HIV Integrase Inhibitors, 030212 general & internal medicine, Darunavir, Aged, Salvage Therapy, business.industry, Reproducibility of Results, HIV Protease Inhibitors, Middle Aged, Infectious Diseases, Italy, chemistry, Dolutegravir, HIV-1, Female, business, Heterocyclic Compounds, 3-Ring, medicine.drug
Abstract

Dolutegravir (DTG) plus boosted darunavir (bDRV) is a compact, adherence-friendly salvage regimen with the highest genetic barrier to HIV-1 resistance.Aim of the present study is to assess the long term (96-week) safety and efficacy of DTG + bDRV in a of multidrug-experienced HIV-1 infected patients, simplifying or building rescue regimens.All HIV-1-infected subjects from eleven Italian centers switched to DTG + bDRV between March 2014 and September 2015 were included and followed for minimum 96 weeks.The cohort comprises 130 subjects, switched from 42 different, complex or at least twice-daily regimens, mainly for simplification (44.6%), viral failure (30.0%) or toxicity (16.6%). At baseline 118 had documented resistance to 1-5 antiretroviral classes and 12 lacked genotypic results either for historical reasons or for problems with primer annealing; 52 (40%) had uncontrolled viral replication, three above 500.000 copies/mL. At week 96 two showed ≥50 HIV-1 RNA copies/mL, 23 had 1-49 copies/mL and 101 had no virus detected. The proportion of subjects presenting abnormal values at baseline significantly decreased for serum glucose, creatinine, AST, total cholesterol and triglycerides.These long-term data confirm the reliability of the two-drug regimen consisting of bDRV plus DTG in salvage settings in HIV-1 infection.

Published
2018

35. Safety and efficacy of daclatasvir at doses other than 60 mg daily in HIV/HCV co-infected subjects: Data from the ICONA/HepaICONA foundation cohorts

Author

Rossotti, R, Tavelli, A, Bonora, S, Cingolani, A, Lo Caputo, S, Saracino, A, Soria, A, Marinaro, L, Uberti-Foppa, C, Mussini, C, Puoti, M, d'Arminio Monforte, A, Roberto Rossotti, Alessandro Tavelli, Stefano Bonora, Antonella Cingolani, Sergio Lo Caputo, Annalisa Saracino, Alessandro Soria, Letizia Marinaro, Caterina Uberti-Foppa, Cristina Mussini, Massimo Puoti, Antonella d'Arminio Monforte, Rossotti, R, Tavelli, A, Bonora, S, Cingolani, A, Lo Caputo, S, Saracino, A, Soria, A, Marinaro, L, Uberti-Foppa, C, Mussini, C, Puoti, M, d'Arminio Monforte, A, Roberto Rossotti, Alessandro Tavelli, Stefano Bonora, Antonella Cingolani, Sergio Lo Caputo, Annalisa Saracino, Alessandro Soria, Letizia Marinaro, Caterina Uberti-Foppa, Cristina Mussini, Massimo Puoti, and Antonella d'Arminio Monforte

Abstract

Background: Daclatasvir (DCV) is a HCV NS5A inhibitor whose plasma exposure may be influenced by co-administration with inducers or inhibitors of CYP3A4 such as many antiretrovirals. Aims: Describe the use of different DCV dosages; assess if dose prescription complies with Summaries of Product Characteristics (SmPC); evaluate safety and efficacy of 60 versus 30/90 mg and adequate (i.e. concordant with SmPC) versus incorrect prescriptions. Methods: Retrospective analysis of patients included in ICONA/HepaICONA starting a DCV-including treatment. Incidence rates of liver adverse events (LAE) were calculated; Poisson regression model was used to identify factors associated with LAE. Results: 311 patients were included: 250 (80.4%) received DCV at a dosage of 60 mg, 52 (16.7%) 30 mg and 9 (2.9%) 90 mg. An inadequate dosage was used in 18 individuals (5.8%). No difference in SVR was observed (93.8% with 60 mg and 94.2% with 30/90 mg, p = 0.910; 93.5% with adequate and 100% with incorrect dosage, p = 0.277). There were 36 LAE with no differences in the two-paired groups. Decompensated liver disease was a risk factor for LAE (aRR = 2.37; p = 0.034), while HIV RNA < 50 copies/ml resulted protective (aRR = 0.22; p = 0.003). Conclusions: DCV use resulted in high SVR rate regardless of dosage and correctness of prescription.

Published
2020

36. Evaluation of adhesion molecules and immune parameters in HIV-infected patients treated with an atazanavir/ritonavir- compared with a lopinavir/ritonavir-based regimen

Author

Nicola Squillace, Claudio Fenizia, Cristina Giannattasio, Francesca Sabbatini, Alessandro Maloberti, Mario Clerici, Michela Masetti, Andrea Gori, Antonio Muscatello, Alessandra Bandera, Daria Trabattoni, Alessandro Soria, Squillace, N, Trabattoni, D, Muscatello, A, Sabbatini, F, Maloberti, A, Giannattasio, C, Masetti, M, Fenizia, C, Soria, A, Clerici, M, Gori, A, and Bandera, A

Subjects
CD4-Positive T-Lymphocytes, Male, Microbiology (medical), medicine.medical_specialty, Anti-HIV Agents, T cell, Atazanavir Sulfate, Lopinavir/ritonavir, HIV Infections, CD8-Positive T-Lymphocytes, Pulse Wave Analysis, 030204 cardiovascular system & hematology, Lymphocyte Activation, Carotid Intima-Media Thickness, Gastroenterology, Lopinavir, Random Allocation, 03 medical and health sciences, 0302 clinical medicine, immune system diseases, Antiretroviral Therapy, Highly Active, Internal medicine, medicine, Humans, Pharmacology (medical), Prospective Studies, 030212 general & internal medicine, IL-2 receptor, HIV, adhesion molecule, Prospective cohort study, Pharmacology, Ritonavir, business.industry, Endothelial Cells, virus diseases, Atherosclerosis, Atazanavir, Regimen, Infectious Diseases, medicine.anatomical_structure, Female, business, Cell Adhesion Molecules, Biomarkers, Follow-Up Studies, medicine.drug
Abstract

Objectives To evaluate changes in pro-atherosclerotic biomarkers and endothelial function in patients initiating two different PI-based regimens as part of ART. Design Prospective randomized 24 week study. Treatment-naive HIV-infected patients with CD4+ T cell count >250 cells/mm3 started PI-based regimens including atazanavir/ritonavir (Group A) or lopinavir/ritonavir (Group B) and were followed up in an observational follow-up study until week 96. Methods The expression of immune activation and adhesion molecules on CD4+ and CD8+ cells and plasma cytokine levels were assessed at weeks 0, 4, 12, 24, 48, 72 and 96. Flow-mediated dilation (FMD), pulse-wave velocity (PWV) and intima-media thickness (IMT) were measured at weeks 0 and 24. Median changes within (signed rank test) and between (Wilcoxon test) arms were calculated. Results Twenty-seven patients were enrolled, of whom 15 were treated with atazanavir/ritonavir and 12 with lopinavir/ritonavir. After 96 weeks of ART, CD25+/CD8+ T cells and plasma concentration of MCP-1/CCL-2 rose whereas CD44+/CD8+ T cells decreased significantly in both groups. Differences between treatments were noted for HLA-DRII+/CD8+, CD44+/CD4+ and CD11a+/CD4+, with significant increases in Group B versus Group A. No differences between groups regarding IMT, PWV and FMD were found at baseline and week 24. Conclusions ART initiation with PI-based regimens led to a decrease in pro-atherosclerotic biomarkers at week 24, which then rebounded at week 96. Lopinavir/ritonavir treatment resulted in an unfavourable modulation of such markers compared with atazanavir/ritonavir treatment.

Published
2018

37. Maraviroc in addition to cART during primary HIV infection: Results from MAIN randomized clinical trial and 96-weeks follow-up

Author

Stefania Chiappetta, Cristina Rovelli, Marco Ripa, Manuela Pogliaghi, Silvia Nozza, Alessandro Soria, Giacomo Coppalini, Giuseppe Tambussi, Ripa, Marco, Pogliaghi, Manuela, Chiappetta, Stefania, Nozza, Silvia, Soria, Alessandro, Coppalini, Giacomo, Rovelli, Cristina, and Tambussi, Giuseppe

Subjects
Male, 0301 basic medicine, Human immunodeficiency virus (HIV), Acute infection, HIV Infections, medicine.disease_cause, Primary HIV infection, law.invention, Maraviroc, chemistry.chemical_compound, 0302 clinical medicine, Randomized controlled trial, law, Antiretroviral Therapy, Highly Active, HIV Infection, 030212 general & internal medicine, virus diseases, Middle Aged, Viral Load, musculoskeletal system, Treatment Outcome, Infectious Diseases, Anti-Retroviral Agents, CCR5 Receptor Antagonists, RNA, Viral, Female, Human, Adult, Cart, medicine.medical_specialty, 030106 microbiology, CCR5 Receptor Antagonist, Nerve Tissue Proteins, Follow-Up Studie, 03 medical and health sciences, Cyclohexane, Cyclohexanes, Virology, Internal medicine, medicine, Humans, business.industry, HIV, Triazoles, CD4, CD4 Lymphocyte Count, Surgery, Discontinuation, body regions, Clinical trial, chemistry, Nerve Tissue Protein, Anti-Retroviral Agent, Triazole, business, human activities, Follow-Up Studies
Abstract

Background Multi-targeted treatment strategies including maraviroc (MVC) during Primary HIV Infection (PHI) may benefit from the immune-modulatory properties of this CCR5-inhibitor. Objectives We conducted a proof-of-concept clinical trial aimed at assessing whether maraviroc in addition of a combination antiretroviral therapy (cART) initiated during PHI would improve immunological and virological parameters. Study design The MAIN (Maraviroc in HIV Acute INfection) study was a randomized open-label clinical trial (EUDRACT number: 2008-007004-29) which enrolled 29 patients with PHI. Subjects were randomly assigned to receive cART-only (cART), cART + 8 weeks of MVC (ST-MVC) or cART + 48 weeks of MVC (LT-MVC), regardless of predicted co-receptor usage. After 48 weeks patients in ST-MVC and LT-MVC groups discontinued MVC. Patients were evaluated at week 48 and at week 96 of follow-up to assess differences in CD4 T-cell gain and plasma HIV-RNA. Results Twenty-nine patients were enrolled. Seven patients (24%) had a predicted CXCR4 co-receptor usage. At week 48, 27 patients (93.1%) reached HIV-RNA

Published
2016

38. Real-life effectiveness and safety of sofosbuvir/velpatasvir/voxilaprevir in hepatitis C patients with previous DAA failure

Author

Elisabetta, Degasperi, Angiola, Spinetti, Andrea, Lombardi, Simona, Landonio, Maria Cristina, Rossi, Luisa, Pasulo, Pietro, Pozzoni, Alessia, Giorgini, Paolo, Fabris, Antonietta, Romano, Lorenzo, Lomonaco, Massimo, Puoti, Maria, Vinci, Federico, Gatti, Giada, Carolo, Alessia, Zoncada, Paolo, Bonfanti, Russo, FRANCESCO PAOLO, Alessio, Aghemo, Alessandro, Soria, Riccardo, Centenaro, Franco, Maggiolo, Pierangelo, Rovere, Francesca, Pasin, Veronica, Paon, Giovanni, Faggiano, Alessandro, Vario, Glenda, Grossi, Roberta, Soffredini, Canio, Carriero, Stefania, Paolucci, Franco, Noventa, Alfredo, Alberti, Pietro, Lampertico, Stefano, Fagiuoli, NAVIGATORE-Lombardia and Veneto Study Groups, Degasperi, E, Spinetti, A, Lombardi, A, Landonio, S, Rossi, M, Pasulo, L, Pozzoni, P, Giorgini, A, Fabris, P, Romano, A, Lomonaco, L, Puoti, M, Vinci, M, Gatti, F, Carolo, G, Zoncada, A, Bonfanti, P, Russo, F, Aghemo, A, Soria, A, Centenaro, R, Maggiolo, F, Rovere, P, Pasin, F, Paon, V, Faggiano, G, Vario, A, Grossi, G, Soffredini, R, Carriero, C, Paolucci, S, Noventa, F, Alberti, A, Lampertico, P, and Fagiuoli, S

Subjects
0301 basic medicine, Liver Cirrhosis, Male, Sofosbuvir, Sustained Virologic Response, Resistance, Hepacivirus, Viral Nonstructural Proteins, medicine.disease_cause, Direct-acting antiviral, Direct-acting antivirals, Gastroenterology, chemistry.chemical_compound, 0302 clinical medicine, Risk Factors, Sulfonamides, Liver Neoplasms, Hepatitis C, Middle Aged, Drug Combinations, Treatment Outcome, Italy, Hepatocellular carcinoma, HCV, RAS, Retreatment, RNA, Viral, 030211 gastroenterology & hepatology, Female, medicine.drug, medicine.medical_specialty, Carcinoma, Hepatocellular, Macrocyclic Compounds, Anemia, Voxilaprevir, Hepatitis C virus, Antiviral Agents, Heterocyclic Compounds, 4 or More Rings, 03 medical and health sciences, Internal medicine, Drug Resistance, Viral, medicine, Humans, Intention-to-treat analysis, Hepatology, business.industry, Ribavirin, Hepatitis C, Chronic, medicine.disease, 030104 developmental biology, chemistry, Carbamates, business
Abstract

Background & Aims Sofosbuvir/velpatasivr/voxilaprevir (SOF/VEL/VOX) is approved for retreatment of patients with HCV and a previous failure on direct-acting antivirals (DAAs), however real-life data are limited. The aim of this study was to assess the effectiveness and safety of SOF/VEL/VOX in a real-life setting. Methods All consecutive patients with HCV receiving SOF/VEL/VOX between May-October 2018 in 27 centers in Northern Italy were enrolled. Bridging fibrosis (F3) and cirrhosis (F4) were diagnosed by liver stiffness measurement: >10 and >13 kPa respectively. Sustained virological response (SVR) was defined as undetectable HCV-RNA 4 (SVR4) or 12 (SVR12) weeks after the end-of-treatment. Results A total of 179 patients were included: median age 57 (18–88) years, 74% males, median HCV-RNA 1,081,817 (482–25,590,000) IU/ml. Fibrosis stage was F0-F2 in 32%, F3 in 21%, F4 in 44%. HCV genotype was 1 in 58% (1b 33%, 1a 24%, 1nc 1%), 2 in 10%, 3 in 23% and 4 in 9%; 82% of patients carried resistance-associated substitutions in the NS3, NS5A or NS5B regions. Patients received SOF/VEL/VOX for 12 weeks, ribavirin was added in 22% of treatment schedules. Undetectable HCV-RNA was achieved by 74% of patients at week 4 and by 99% at week 12. Overall, 162/179 (91%) patients by intention to treat analysis and 162/169 (96%) by per protocol analysis achieved SVR12, respectively; treatment failures included 6 relapsers and 1 virological non-responder. Cirrhosis (p = 0.005) and hepatocellular carcinoma (p = 0.02) were the only predictors of treatment failure. Most frequent adverse events included fatigue (6%), hyperbilirubinemia (6%) and anemia (4%). Conclusions SOF/VEL/VOX is an effective and safe retreatment for patients with HCV who have failed on a previous DAA course in a real-life setting. Lay summary This is the largest European real-life study evaluating effectiveness and safety of sofosbuvir/velpatasvir/voxilaprevir (SOF/VEL/VOX) in a large cohort of consecutive patients with hepatitis C virus infection and a prior direct-acting antiviral failure, who were treated within the NAVIGATORE Lombardia and Veneto Networks, in Italy. This study demonstrated excellent effectiveness (98% and 96% sustained virological response rates at week 4 and 12, respectively) and an optimal safety profile of SOF/VEL/VOX. Cirrhosis and hepatocellular carcinoma onset were the only features associated with treatment failure.

Published
2019

39. Hepatitis C virus-related factors associated WITH cognitive performance in HIV-HCV-coinfected patients

Author

Davide Moschese, Manuela Valsecchi, Arianna Emiliozzi, Simona Di Giambenedetto, Andrea De Luca, Alessandra Bandera, Alessandro Soria, Andrea Gori, Massimiliano Fabbiani, Alberto Borghetti, Nicoletta Ciccarelli, Valeria Castelli, and Elisa Colella

Subjects
0301 basic medicine, Adult, Male, medicine.medical_specialty, Neurology, Settore M-PSI/02 - PSICOBIOLOGIA E PSICOLOGIA FISIOLOGICA, Hepatitis C virus, Integrase inhibitor, HIV Infections, Hepacivirus, Logistic regression, medicine.disease_cause, Cognitive impairment, Liver fibrosis, HIV, AIDS, HCV, 03 medical and health sciences, Cellular and Molecular Neuroscience, 0302 clinical medicine, Acquired immunodeficiency syndrome (AIDS), Virology, Internal medicine, medicine, Humans, Cognitive Dysfunction, Effects of sleep deprivation on cognitive performance, HIV Integrase Inhibitors, Pathological, business.industry, Coinfection, virus diseases, Cognition, Middle Aged, medicine.disease, Hepatitis C, 030104 developmental biology, Cross-Sectional Studies, Female, Neurology (clinical), business, 030217 neurology & neurosurgery
Abstract

The contribution of HCV-related variables to cognitive impairment in HIV-HCV-coinfected patients has been poorly investigated. We selected HIV-HCV-coinfected patients undergoing cognitive examination (exploring memory, language, speed of mental processing and fine motor function) at three clinical centres. Cognitive performance was evaluated using Z-transformed scores. Logistic regression analysis was used to investigate variables associated to cognitive impairment (defined as a composite Z-score ≤ − 1). Overall, 146 HIV-HCV-coinfected patients were enrolled. Median HCV-RNA was 6.2logU/mL. HCV genotype 1a/b was the most represented (53.4%). Liver fibrosis was mild (Fib4 ≤ 1.45) in the majority of patients (44.5%). Global cognitive impairment was diagnosed in 35 (24%) subjects. Exploring each domain, a higher proportion of impairment was observed for memory (37%) followed by speed of mental processing (32.2%), fine motor functioning (24%) and language (18.5%). Among HCV-related variables, the duration of HCV infection was independently associated with global cognitive impairment (aOR 1.13 per +1 year, p = 0.016) and abnormal speed of mental processing (aOR 1.16 per +1 year, p = 0.001), while higher HCV-RNA was independently associated to fine motor functioning impairment (aOR 1.98 per +1log, p = 0.037). HCV genotype, fibrosis stage, transaminases or bilirubin levels were not related to cognitive performance. Of note, integrase inhibitor (InSTI) use was independently associated to a pathological performance in fine motor functioning (aOR 3.34, p = 0.035) and memory (aOR 3.70, p = 0.014). In conclusion, the duration of HCV infection and HCV-RNA load showed an association with cognitive impairment, suggesting a role of hepatitis-related factors in the development of cognitive disorders in HIV-HCV-coinfected patients. The association between InSTI use and altered cognitive performance should prompt investigations about potential neurotoxicity of these drugs.

Published
2019

40. Impact of the M184V Resistance Mutation on Virological Efficacy and Durability of Lamivudine-Based Dual Antiretroviral Regimens as Maintenance Therapy in Individuals With Suppressed HIV-1 RNA: A Cohort Study

Author

Roberta, Gagliardini, Arturo, Ciccullo, Alberto, Borghetti, Franco, Maggiolo, Dario BartolozziVincenzo Mellace, Amedeo, Capetti, Maria Rita Gismondo, Maria Luisa Biondi, Cristina, Mussini, Monica, Pecorari, Nicola, Gianotti, Daria, Sacchini, Giustino, Parruti, Ennio, Polilli, Franco, Baldelli, Stefania, Zanussi, Alessandro, Nerli, Lucia, Lenzi, Carlo, Calzetti, Angela, Vivarelli, Renato, Maserati, Fausto, Baldanti, Federica, Poletti, Vincenzo, Mondino, Marina, Malena, Antonio, Cascio, Gaetano, Filice, Giacomo, Magnani, Alessandro, Zerbini, Francesca, Lombardi, Simona Di Giambenedetto, Massimo, Andreoni, Marco, Montano, Vullo, Vincenzo, Turriziani, Ombretta, Maurizio, Zazzi, Angela, Gonnelli, Andrea De Luca, Enzo, Boeri, Stefano, Bonora, Valeria, Ghisetti, Daniela, Francisci, Paolo, Grossi, Patrizia, Bagnarelli, Luca, Butini, Romana del Gobbo, Andrea, Giacometti, Danilo, Tacconi, Laura, Monno, Grazia, Punzi, Annapaola, Callegaro, Alessia, Zoncada, Elisabetta, Paolini, Laura, Sighinolfi, Grazia, Colao, Paola, Corsi, Pierluigi, Blanc, Luisa, Galli, Paola, Meraviglia, Andrea, Tosti, Bianca, Bruzzone, Maurizio, Setti, Giovanni, Penco, Antonio Di Biagio, Cesira, Nencioni, Riccardo, Pardelli, Irene, Arcidiacono, Alberto, Degiuli, Michele De Gennaro, Alessandro, Soria, Alfredo, Focà, Latella, Surace, Lucio, Cosco, Sergio, Malandrin, Paola, Milini, Paola, Cicconi, Stefano, Rusconi, and Valeria Micheli, Vanni, Borghi, Anna Paola Callegaro, Francesco, Saladini, and Stefania, Paolucci

Subjects
0301 basic medicine, Oncology, medicine.medical_specialty, 030106 microbiology, Integrase inhibitor, NRTI mutations, Hiv 1 rna, 03 medical and health sciences, Dual therapy, Integrase inhibitors, Lamivudine, M184V, 0302 clinical medicine, Maintenance therapy, Internal medicine, medicine, Major Article, dual therapy, integrase inhibitors, lamivudine, In patient, 030212 general & internal medicine, Dual therapy, Integrase inhibitors, Lamivudine, M184V, NRTI mutations, business.industry, virus diseases, Resistance mutation, Editor's Choice, Infectious Diseases, Neurology (clinical), business, Cohort study, medicine.drug
Abstract

Background Dual therapy (DT) with boosted protease inhibitors (bPIs) plus lamivudine has been shown to be superior to bPI monotherapy in virologically suppressed patients despite previous selection of the lamivudine resistance M184V mutation. We compared the virological efficacy of lamivudine-based DT in patients with and without a history of M184V detection. Methods We retrospectively analyzed patients with HIV-RNA ≤50 copies/mL switching to DT with at least 1 previous resistance genotype in the ARCA database. Time to virological failure (VF; HIV-RNA ≥200 copies/mL or 2 consecutive HIV-RNA >50 copies/mL) and to treatment discontinuation (TD) was analyzed by survival analysis. Results Four hundred thirty-six patients switching to lamivudine plus bPIs (70%) or integrase inhibitors (30%) were included. Patients with M184V (n = 87) were older, had lower nadir CD4+ cell count, longer duration of antiretroviral therapy and of virologic suppression, and higher rate of hepatitis C virus infection compared with patients without M184V. The 3-year probability of remaining free from VF was 91.9% (95% confidence interval [CI], 86.6–97.2) without M184V and 87.8% (95% CI, 78.4–97.2) with M184V (P = .323). The time to TD did not differ between groups. Multivariate analysis adjusting for baseline variables differing between groups also did not detect M184V as being associated with VF or TD; however, the 3-year probability of remaining free of viral blips (isolated HIV-RNA 51–199 copies/mL) was 79.8% (95% CI, 67.8%–91.8%) with M184V vs 90.1% (95% CI, 84.0%–96.2%) without M184V (P = .016). Conclusions Previous selection of M184V did not increase the risk of VF or TD with lamivudine-based DT but was associated with a higher probability of viral blips.

Published
2018

41. Safety and efficacy of ombitasvir/paritaprevir/ritonavir/dasabuvir plus ribavirin in patients over 65 years with HCV genotype 1 cirrhosis

Author

Giada Carolo, Veronica Bernabucci, Luchino Chessa, Maria Luisa Russo, Giorgio Maria Saracco, Marzia Montalbano, Barbara Menzaghi, Giovanni Di Perri, Adriano Lazzarin, Silvia La Monica, Raffaele Bruno, Gian Ludovico Rapaccini, Mario U. Mondelli, Anna Maria Schimizzi, Caterina Pasquazzi, Maurizia Rossana Brunetto, Antonio Craxì, Filomena Morisco, Carmela Lo Guercio, Vania Giacomet, Alessia Giorgini, Mario Masarone, Francesca Paolo Russo, T. Zolfino, Vincenzo Sangiovanni, Alessia Ciancio, Antonella d'Arminio Monforte, Savino Bruno, E.M. Erne, Antonio Gasbarrini, Francesco Castelli, Sergio Novara, G. Nardone, Andrea De Luca, Claudio Maria Mastroianni, Gioacchino Angarano, Chiara Dentone, Renato Maserati, Anna Maria Piscaglia, Tiziana Quirino, Giuseppe Tarantino, M. Lichtner, Antonio Chirianni, Giuseppina Brancaccio, S. Paganin, Alfredo Alberti, Silvia Corradori, Edoardo G. Giannini, Carlo Torti, Chiara Boarini, Raffaele Cozzolongo, Marco Di Stefano, Alessandro Soria, Paolo Tundi, Giovanni Cassola, Debora Angrisani, Antonio Grieco, Cecilia Pravadelli, Giuliano Rizzardini, Roberto Gulminetti, Vincenzo Messina, Maria Rendina, Massimo Pirisi, Irene Cacciola, Roberto Ganga, Raffaella Lionetti, Paolo Calabrese, Laura Ponti, Filomena Simeone, Maurizio Russello, Monica Monti, Nicola Boffa, Pierluigi Tarquini, Franco Capra, Ivo Avancini, Domenico Sansonno, Stefano Fagiuoli, Michele Barone, Giacomo Vecchiet, Salvatore Rizzo, Carlo Federico Perno, Teresa Santantonio, Pierluigi Toniutto, Massimo Zuin, Nicola Caporaso, Alessandra Orlandini, Grazielle Marie Pigozzi, Martina Felder, Antonio Cristaudo, Roberto Cecere, Massimo Marignani, Vincenza Calvaruso, G. Abbati, Domenico Potenza, Maria Chiara Piras, Mario Rizzetto, Serena Cima, Marco delle Monache, Alessio Aghemo, D. Ieluzzi, Guglielmo Borgia, Giampaolo Corti, Paolo Poggio, Manuela Merli, Elena Danieli, Andrea Giacometti, Massimo Andreoni, Antonino Picciotto, Mario Angelico, Benedetta Canovari, Sara Piovesan, Anna Linda Zignego, Antonio Benedetti, Emanuele Durante, Erica Villa, Marcello Persico, Antonio Patrizio Termite, Barbara Coco, Maria Vinci, Lucio Boglione, Cristina Rossi, Paolo Angeli, Massimo Memoli, Maria Teresa Giordani, Massimo De Luca, Luisa Pasulo, Vincenzo Vullo, Mario Melazzini, Attilio Solinas, Pietro Gatti, Michele Guerra, Silvia Martini, Antonio Ascione, Massimo Puoti, Roberto Cauda, Giovanna Onnelli, Silvia Magnani, Salvatore Madonna, Giovanni Raimondo, Marco Tabone, Gloria Taliani, Dante Romagnoli, Aldo Marrone, Umberto Vespasiani Gentilucci, Luca Miele, Marcello Tavio, Andrea Antinori, Giampiero D'Offizi, Mirella Onofrio, Valentina Iodice, Lucio Cosco, Guido Piai, Luca Pani, Francesca Ceccherini Silberstein, Simona Montilla, Marco Lenzi, Luca Fontanella, Alessandro Federico, Carlo Ferrari, Giustino Parruti, Antonio Di Biagio, Gabriella Verucchi, Fabio Marsetti, Michele Milella, Maria Grazia Rumi, Antonio Izzi, Marco Marzioni, Francesca Donato, Vanni Borghi, Mariano Quartini, Massimo Colombo, Michele Imparato, Giovanni Battista Gaeta, P.L. Blanc, Alfredo Di Leo, Nicola Coppola, Alessandro Chiodera, Ivana Maida, Davide Campagnolo, Cinzia Antonini, Antonietta Romano, A. Gianstefani, Katia Falasca, Massimo Levrero, Gaetano Serviddio, Maria Paola Trotta, Olivia Morelli, Salvatore Petta, Elisabetta Teti, Maria Rita Parisi, Pietro Andreone, Ascione, Antonio, De Luca, Massimo, Melazzini, Mario, Montilla, Simona, Trotta, Maria Paola, Petta, Salvatore, Puoti, Massimo, Sangiovanni, Vincenzo, Messina, Vincenzo, Bruno, Savino, Izzi, Antonio, Villa, Erica, Aghemo, Alessio, Zignego, Anna Linda, Orlandini, Alessandra, Fontanella, Luca, Gasbarrini, Antonio, Marzioni, Marco, Giannini, Edoardo G., Craxì, Antonio, Abbati, Giuseppe, Alberti, Alfredo, Andreone, Pietro, Andreoni, Massimo, Angeli, Paolo, Angelico, Mario, Angarano, Gioacchino, Angrisani, Debora, Antinori, Andrea, Antonini, Cinzia, Avancini, Ivo, Barone, Michele, Bruno, Raffaele, Benedetti, Antonio, Bernabucci, Veronica, Blanc, Pier, Boarini, Chiara, Boffa, Nicola, Boglione, Lucio, Borghi, Vanni, Borgia, Guglielmo, Brancaccio, Giuseppina, Brunetto, Maurizia, Cacciola, Irene, Calabrese, Paolo, Calvaruso, Vincenza, Campagnolo, Davide, Canovari, Benedetta, Caporaso, Nicola, Capra, Franco, Carolo, Giada, Cassola, Giovanni, Castelli, Francesco, Cauda, Roberto, Silberstein, Francesca Ceccherini, Cecere, Roberto, Chessa, Luchino, Chiodera, Alessandro, Chirianni, Antonio, Ciancio, Alessia, Cima, Serena, Coco, Barbara, Colombo, Massimo, Coppola, Nicola, Corti, Giampaolo, Cosco, Lucio, Corradori, Silvia, Cozzolongo, Raffaele, Cristaudo, Antonio, Danieli, Elena, Monforte, Antonella D’Arminio, Monache, Marco delle, Del Poggio, Paolo, de Luca, Andrea, Dentone, Chiara, Di Biagio, Antonio, Di Leo, Alfredo, Di Perri, Giovanni, Di Stefano, Marco, D’Offizi, Giampiero, Donato, Francesca, Durante, Emanuele, Erne, Elke, Fagiuoli, Stefano, Falasca, Katia, Federico, Alessandro, Felder, Martina, Ferrari, Carlo, Gaeta, Giovanni Battista, Ganga, Roberto, Gatti, Pietro, Giacomet, Vania, Giacometti, Andrea, Gianstefani, Alice, Giordani, Maria, Giorgini, Alessia, Grieco, Antonio, Guerra, Michele, Gulminetti, Roberto, Ieluzzi, Donatella, Imparato, Michele, Iodice, Valentina, La Monica, Silvia, Lazzarin, Adriano, Lenzi, Marco, Levrero, Massimo, Lichtner, Myriam, Lionetti, Raffaella, Guercio, Carmela Lo, Madonna, Salvatore, Magnani, Silvia, Maida, Ivana, Marignani, Massimo, Marrone, Aldo, Marsetti, Fabio, Martini, Silvia, Masarone, Mario, Maserati, Renato, Mastroianni, Claudio Maria, Memoli, Massimo, Menzaghi, Barbara, Merli, Manuela, Miele, Luca, Milella, Michele, Mondelli, Mario, Montalbano, Marzia, Monti, Monica, Morelli, Olivia, Morisco, Filomena, Nardone, Gaetano, Novara, Sergio, Onnelli, Giovanna, Onofrio, Mirella, Paganin, Simona, Pani, Luca, Parisi, Maria Rita, Parruti, Giustino, Pasquazzi, Caterina, Pasulo, Luisa, Perno, Carlo Federico, Persico, Marcello, Piai, Guido, Picciotto, Antonino, Pigozzi, Grazielle Marie, Piovesan, Sara, Piras, Maria Chiara, Pirisi, Massimo, Piscaglia, Anna Maria, Ponti, Laura, Potenza, Domenico, Pravadelli, Cecilia, Quartini, Mariano, Quirino, Tiziana, Raimondo, Giovanni, Rapaccini, Gian Ludovico, Rendina, Maria, Rizzardini, Giuliano, Rizzetto, Mario, Rizzo, Salvatore, Romagnoli, Dante, Romano, Antonietta, Rossi, Cristina, Rumi, Maria Grazia, Russello, Maurizio, Russo, Francesca Paolo, Russo, Maria Luisa, Sansonno, Domenico Ettore, Santantonio, Teresa Antonia, Saracco, Giorgio, Schimizzi, Anna Maria, Serviddio, Gaetano, Simeone, Filomena, Solinas, Attilio, Soria, Alessandro, Tabone, Marco, Taliani, Gloria, Tarantino, Giuseppe, Tarquini, Pierluigi, Tavio, Marcello, Termite, Antonio, Teti, Elisabetta, Toniutto, Pierluigi, Torti, Carlo, Tundi, Paolo, Vecchiet, Giacomo, Verucchi, Gabriella, Gentilucci, Umberto Vespasiani, Vinci, Maria, Vullo, Vincenzo, Zolfino, Teresa, Zuin, Massimo, Ascione, A, De Luca, M, Melazzini, M, Montilla, S, Trotta, M, Petta, S, Puoti, M, Sangiovanni, V, Messina, V, Bruno, S, Izzi, A, Villa, E, Aghemo, A, Zignego, A, Orlandini, A, Fontanella, L, Gasbarrini, A, Marzioni, M, Giannini, E, Craxi, A, Abbati, G, Alberti, A, Andreone, P, Andreoni, M, Angeli, P, Angelico, M, Angarano, G, Angrisani, D, Antinori, A, Antonini, C, Avancini, I, Barone, M, Bruno, R, Benedetti, A, Bernabucci, V, Blanc, P, Boarini, C, Boffa, N, Boglione, L, Borghi, V, Borgia, G, Brancaccio, G, Brunetto, M, Cacciola, I, Calabrese, P, Calvaruso, V, Campagnolo, D, Canovari, B, Caporaso, N, Capra, F, Carolo, G, Cassola, G, Castelli, F, Cauda, R, Silberstein, F, Cecere, R, Chessa, L, Chiodera, A, Chirianni, A, Ciancio, A, Cima, S, Coco, B, Colombo, M, Coppola, N, Corti, G, Cosco, L, Corradori, S, Cozzolongo, R, Cristaudo, A, Danieli, E, Monforte, A, Monache, M, Del Poggio, P, de Luca, A, Dentone, C, Di Biagio, A, Di Leo, A, Di Perri, G, Di Stefano, M, D'Offizi, G, Donato, F, Durante, E, Erne, E, Fagiuoli, S, Falasca, K, Federico, A, Felder, M, Ferrari, C, Gaeta, G, Ganga, R, Gatti, P, Giacomet, V, Giacometti, A, Gianstefani, A, Giordani, M, Giorgini, A, Grieco, A, Guerra, M, Gulminetti, R, Ieluzzi, D, Imparato, M, Iodice, V, La Monica, S, Lazzarin, A, Lenzi, M, Levrero, M, Lichtner, M, Lionetti, R, Guercio, C, Madonna, S, Magnani, S, Maida, I, Marignani, M, Marrone, A, Marsetti, F, Martini, S, Masarone, M, Maserati, R, Mastroianni, C, Memoli, M, Menzaghi, B, Merli, M, Miele, L, Milella, M, Mondelli, M, Montalbano, M, Monti, M, Morelli, O, Morisco, F, Nardone, G, Novara, S, Onnelli, G, Onofrio, M, Paganin, S, Pani, L, Parisi, M, Parruti, G, Pasquazzi, C, Pasulo, L, Perno, C, Persico, M, Piai, G, Picciotto, A, Pigozzi, G, Piovesan, S, Piras, M, Pirisi, M, Piscaglia, A, Ponti, L, Potenza, D, Pravadelli, C, Quartini, M, Quirino, T, Raimondo, G, Rapaccini, G, Rendina, M, Rizzardini, G, Rizzetto, M, Rizzo, S, Romagnoli, D, Romano, A, Rossi, C, Rumi, M, Russello, M, Russo, F, Russo, M, Sansonno, D, Santantonio, T, Saracco, G, Schimizzi, A, Serviddio, G, Simeone, F, Solinas, A, Soria, A, Tabone, M, Taliani, G, Tarantino, G, Tarquini, P, Tavio, M, Termite, A, Teti, E, Toniutto, P, Torti, C, Tundi, P, Vecchiet, G, Verucchi, G, Gentilucci, U, Vinci, M, Vullo, V, Zolfino, T, and Zuin, M

Subjects
Cyclopropanes, Liver Cirrhosis, Male, Cirrhosis, Dasabuvir, Elderly, Ombitasvir, Paritaprevir, Aged, 80 and over, Anilides, Antiviral Agents, Biomarkers, Carbamates, Female, Hepacivirus, Hepatitis C, Chronic, Humans, Macrocyclic Compounds, Ribavirin, Ritonavir, Sulfonamides, Treatment Outcome, Uracil, Drug Therapy, Combination, Genotype, Cirrhosis, Dasabuvir, Elderly, Ombitasvir, Paritaprevir, Microbiology (medical), Infectious Diseases, Aged, 80 and over, Hepatitis C, Chronic, Drug Therapy, Combination, Microbiology (medical), Infectious Diseases, Gastroenterology, chemistry.chemical_compound, 0302 clinical medicine, 2-Naphthylamine, Medicine, 030212 general & internal medicine, Valine, General Medicine, 030211 gastroenterology & hepatology, Macrocyclic Compound, medicine.drug, Human, medicine.medical_specialty, Proline, Lactams, Macrocyclic, Settore MED/12 - GASTROENTEROLOGIA, Liver Cirrhosi, Sulfonamide, 03 medical and health sciences, Internal medicine, Decompensation, Hepatitis, Antiviral Agent, Cirrhosi, Hepaciviru, business.industry, Settore MED/09 - MEDICINA INTERNA, Anilide, Biomarker, medicine.disease, chemistry, Carbamate, business
Abstract

Purpose: To analyse safety and efficacy of treatment based on ombitasvir/paritaprevir/ritonavir/dasabuvir plus ribavirin in the sub-group of GT1 patients older than 65years. Methods: We collected data extracted from the ABACUS compassionate-use nationwide Italian programme, in patients with cirrhosis due to hepatitis C virus (HCV) Genotype-1 (GT1) or 4 and at high risk of decompensation. GT1-HCV-infected patients received once-daily ombitasvir/paritaprevir, with the pharmacokinetic enhancer ritonavir (25/150/100mg) and twice-daily dasabuvir (250mg) plus Ribavirin (RBV) (OBV/PTV/r + DSV + RBV) for 12 (GT1b) or 24 (GT1a) weeks. Endpoints were to evaluate safety and efficacy, the latter defined as HCV RNA negative 12weeks after the end of treatment (SVR12). Results: Patients who suffered any adverse event (AE) were 74/240 (30.8%); 13/240 (5.4%) discontinued the treatment. A multivariate analysis found albumin < 3.5g/dL (OR 2.04: 95% CI 1.0–4.2, p < 0.05) and hypertension (OR 4.6: 95% CI 2.3–9.2, p < 0.001) as variables independently associated with AE occurrence. The SVR12 was 95% (228/240). Multivariate analysis identified baseline bilirubin < 2mg/dL (OR 4.9: 95% CI 1.17–20.71, p = 0.029) as the only variable independently associated with SVR12. Conclusion: Our findings suggest that OBV/PTV/r + DSV + RBV is safe and effective in real-life use in patients with compensated cirrhosis, HCV-GT1 infection, and age over 65.

Published
2018

42. THU-141-Efficacy and safety of elbasvir/grazoprevir in a large real-life cohort of HCV-infected patients

Author

Alberto Colombo, Sandro Panese, Mauro Viganò, Simona Landonio, Agostino Colli, Barbara Menzaghi, Caterina Uberti-Foppa, Veronica Paon, Paolo Sacchi, Maria Cristina Rossi, Francesca Cattelan, Andrea Capretti, Maria Cristina Vinci, Luisa Pasulo, Valter Vincenzi, S. Lobello, Giada Carolo, Liliana Chemello, Ombretta Spinelli, Roberta D'Ambrosio, Monia Mendeni, Franco Capra, Alessandro Soria, Roberta Soffredini, Maurizio Carrara, M. Colpani, Massimo Puoti, Giancarlo Spinzi, Alfredo Alberti, Pietro Lampertico, Luisa Cavalletto, Angiola Spinetti, Elisabetta Degasperi, Massimo Zuin, Alessio Aghemo, Laura Comi, Giovanna Cardaci, Valentina Zuccaro, Massimo Memoli, Paolo Poggio, Angelo Pan, Vinicio Manfrin, Alessia Giorgini, Marie Graciella Pigozzi, Serena Zaltron, Francesco Castelli, Franco Noventa, Paolo Grossi, Monica Schiavini, Clara Dibenedetto, Antonella d'Arminio Monforte, Roberto Gulminetti, Elisabetta Buscarini, Piergiorgio Scotton, Stefano Fagiuoli, Martina Gambato, Francesco Russo, Andrea Gori, Paolo Fabris, Caterina Pozzan, and Maria Grazia Rumi

Subjects
medicine.medical_specialty, Hepatology, business.industry, Internal medicine, Cohort, medicine, Elbasvir, Grazoprevir, business
Published
2019

43. THU-166-Treatment of 320 genotype 3 cirrhotic patients with 12 weeks of sofosbuvir/velpatasvir with or without ribavirin: Real life experience from Italy

Author

Giancarlo Spinzi, Vito Di Marco, Giada Carolo, Caterina Pozzan, Barbara Menzaghi, Giuliana Cologni, Roberta Soffredini, Mauro Viganò, Colombatto Piero, Carlo Magni, Serena Zaltron, Francesco Castelli, Roberta D'Ambrosio, Monia Mendeni, Alfredo Alberti, Paolo Grossi, Massimo Zuin, Maria Grazia Rumi, Veronica Paon, Luisa Pasulo, Alberto Colombo, Pietro Lampertico, Paolo Sacchi, Monica Schiavini, Alessio Aghemo, Andrea Capretti, Maria Cristina Vinci, Valter Vincenzi, Andrea Lombardi, Alessia Giorgini, Lorenzo Difrancesco, Maria Antonietta Di Rosolini, Piergiorgio Scotton, Francesco Russo, Antonio Albanese, Sandro Panese, Andrea Gori, Franco Noventa, Stefano Fagiuoli, F. Cartabellotta, Agostino Colli, Martina Gambato, Caterina Uberti-Foppa, Angelo Pan, Luisa Cavalletto, Clara Dibenedetto, Antonio Di Giacomo, Franco Capra, Angiola Spinetti, S. Lobello, M. Colpani, Ombretta Spinelli, Vinicio Manfrin, Liliana Chemello, Roberto Gulminetti, Alessandro Soria, Irene Cacciola, Maurizia Rossana Brunetto, Vincenza Calvaruso, Antonella d'Arminio Monforte, Massimo Memoli, Elisabetta Buscarini, Alessia Ciancio, and Massimo Puoti

Subjects
medicine.medical_specialty, chemistry.chemical_compound, Hepatology, chemistry, business.industry, Internal medicine, Ribavirin, Genotype, medicine, business, Gastroenterology, Sofosbuvir/velpatasvir
Published
2019

44. Treatment of 320 genotype 3 cirrhotic patients with 12 weeks Sofosbuvir/Velpatasvir with or without ribavirin: real life experience from Italy

Author

Alessia Ciancio, Angelo Pan, Pietro Lampertico, F. Cartabellotta, Barbara Menzaghi, Alessio Aghemo, S. Lo Bello, Roberta Soffredini, Roberta D'Ambrosio, Monia Mendeni, Roberto Gulminetti, Caterina Pozzan, Piergiorgio Scotton, Mauro Viganò, Sandro Panese, Francesco Russo, Maurizio Carrara, Veronica Paon, Ombretta Spinelli, P. Colombatto, Maurizia Rossana Brunetto, Stefano Fagiuoli, F. Di Lorenzo, Valter Vincenzi, Agostino Colli, Andrea Gori, Martina Gambato, Franco Noventa, Serena Zaltron, Paolo Sacchi, Francesco Castelli, Massimo Zuin, Caterina Uberti-Foppa, Claudio Rossi, Luisa Pasulo, G. Cologni, A. Albanese, V. Di Marco, Andrea Capretti, Maria Cristina Vinci, Giada Carolo, Elisabetta Buscarini, Maria Grazia Rumi, Monica Schiavini, Alessia Giorgini, Alberto Colombo, Andrea Lombardi, P. Del Poggio, Franco Capra, M. Colpani, Liliana Chemello, Carlo Magni, M.A. Di Rosolini, Luisa Cavalletto, Vinicio Manfrin, Alfredo Alberti, A d'Arminio Monforte, A. Digiacomo, Paolo Grossi, Angiola Spinetti, Giancarlo Spinzi, Paolo Fabris, Clara Dibenedetto, Massimo Memoli, Alessandro Soria, Irene Cacciola, Massimo Puoti, Vincenza Calvaruso, and G. Cardaci

Subjects
chemistry.chemical_compound, medicine.medical_specialty, Hepatology, chemistry, business.industry, Ribavirin, Internal medicine, Genotype, Gastroenterology, medicine, business, Sofosbuvir/velpatasvir
Published
2019

45. Efficacy and safety of Elbasvir/Grazoprevir in a large real-life cohort of HCV-infected patients

Author

Paolo Grossi, Sandro Panese, G. Cardaci, Barbara Menzaghi, Piergiorgio Scotton, Simona Landonio, Agostino Colli, Massimo Zuin, Caterina Uberti-Foppa, Francesco Russo, M. Colpani, Mauro Viganò, Alessia Giorgini, Maria Cristina Rossi, Elisabetta Degasperi, Serena Zaltron, Francesco Castelli, Massimo Memoli, Andrea Gori, Roberta Soffredini, Franco Noventa, S. Lobello, Ombretta Spinelli, Alessandro Soria, A d'Arminio Monforte, Luisa Pasulo, Vinicio Manfrin, Elisabetta Buscarini, Angelo Pan, Monica Schiavini, Maria Grazia Rumi, P. Del Poggio, Alberto Colombo, Valter Vincenzi, Giancarlo Spinzi, Franco Capra, Massimo Puoti, Roberto Gulminetti, Valentina Zuccaro, Stefano Fagiuoli, Alfredo Alberti, Martina Gambato, Luisa Cavalletto, F. Cattelan, Pietro Lampertico, I. Franceschet, Alessio Aghemo, Marie Graciella Pigozzi, L. Comi, Giada Carolo, Liliana Chemello, Veronica Paon, Paolo Sacchi, Andrea Capretti, Maria Cristina Vinci, Roberta D'Ambrosio, Monia Mendeni, Maurizio Carrara, Paolo Fabris, Angiola Spinetti, and Clara Dibenedetto

Subjects
medicine.medical_specialty, Hepatology, business.industry, Internal medicine, Cohort, Gastroenterology, Medicine, Elbasvir, Grazoprevir, business
Published
2019

46. A dual regimen of ritonavir/darunavir plus dolutegravir for rescue or simplification of rescue therapy: 48 weeks' observational data

Author

Niccolò Riccardi, Giovanni Cenderello, Giuseppe Vittorio De Socio, Gaetana Sterrantino, Gianmaria Baldin, Maria Vittoria Cossu, Alessandro Soria, Giancarlo Orofino, Anna Maria Cattelan, Giorgio Barbarini, Giuliano Rizzardini, Fosca Niero, Stefano Rusconi, and Amedeo Capetti

Subjects
0301 basic medicine, Male, medicine.medical_specialty, Anti-HIV Agents, Pyridones, Salvage therapy, HIV Infections, Piperazines, Simplification, lcsh:Infectious and parasitic diseases, 03 medical and health sciences, chemistry.chemical_compound, 0302 clinical medicine, Internal medicine, Drug Resistance, Viral, Oxazines, medicine, Dual, Humans, lcsh:RC109-216, 030212 general & internal medicine, Darunavir, Creatinine, Ritonavir, business.industry, Switch, Middle Aged, Viral Load, 030112 virology, Surgery, Regimen, Infectious Diseases, Treatment Outcome, chemistry, Dolutegravir, Toxicity, HIV-1, Salvage, Drug Therapy, Combination, Female, Lost to Follow-Up, business, Viral load, Heterocyclic Compounds, 3-Ring, medicine.drug, Research Article
Abstract

Background Dolutegravir (DTG) plus darunavir/ritonavir (DRV/r) is a simple combination of drugs that has the best genetic barrier to HIV-1 resistance and may be fit for salvage therapy. Methods All HIV-1-infected subjects treated with DTG plus DRV/r between March 2014 and September 2015 in eight Italian centres were included in the analysis. The main metabolic data, efficacy parameters and safety data routinely collected were provided. This observational study is aimed to assess the efficacy of such approach. The primary end-point was the proportion of subjects achieving or maintaining virologic suppression

Published
2017

47. Unexpected viral relapses in hepatitis C virus-infected patients diagnosed with hepatocellular carcinoma during treatment with direct-acting antivirals

Author

Alessandro Soria, Andrea Gori, Massimiliano Fabbiani, Giuseppe Lapadula, Soria, A, Fabbiani, M, Lapadula, G, and Gori, A

Subjects
Male, Carcinoma, Hepatocellular, Hepatitis C virus, medicine.disease_cause, DIRECT ACTING ANTIVIRALS, Antiviral Agents, 03 medical and health sciences, 0302 clinical medicine, Recurrence, medicine, Humans, Aged, Antiviral Agent, Hepatology, business.industry, Liver Neoplasms, Hepatitis C, Chronic, Middle Aged, medicine.disease, Virology, Liver Neoplasm, 030220 oncology & carcinogenesis, Hepatocellular carcinoma, 030211 gastroenterology & hepatology, Female, business, Human
Published
2017

48. The role of baseline HIV-1 RNA, drug resistance, and regimen type as determinants of response to first-line antiretroviral therapy

Author

Maurizio Zazzi, PAOLO GROSSI, Fausto Baldanti, Alessandro SORIA, Nicola Gianotti, Manuela Colafigli, Valeria Ghisetti, Laura MONNO, STEFANIA ZANUSSI, Paolo Bonfanti, Irene Schiavetti, Andrea De Luca, Maria Rita Gismondo, Alessio Signori, Elena Seminari, Antonio Di Biagio, and Stefano Rusconi

Subjects
business.industry, Integrase inhibitor, Retrospective cohort study, Drug resistance, Virology, Regimen, Infectious Diseases, Cohort, Clinical endpoint, Medicine, business, Viral load, Cohort study
Abstract

The factors influencing virological response to first-line combined antiretroviral therapy (cART) in an Italian cohort of HIV-1-infected patients were examined. Eligible patients were those enrolled in a national prospective observational cohort (Antiretroviral Resistance Cohort Analysis), starting first-line cART between 2001 and 2011 and who had at least one follow-up of HIV-1 RNA. The primary endpoint was virological success, defined as the first viral load 100,000 copies/ml, virologic success was only associated with the use of integrase inhibitors in the first cART regimen. Independent predictors of immunological success were baseline CD4+ cell count and wGSS

Published
2014

49. Multifactor risk evaluation in patients who have eradicated HCV infection: an interim analysis in the PITER cohort

Author

Alessandra Orlandini, Vincenza Calvaruso, Valentina Cossiga, Monica Monti, D.C. Amoruso, Andrea Iannone, A.R. Buonomo, S. Labanca, Roberta D'Ambrosio, A. Ciaccio, Giuseppina Brancaccio, Mario Masarone, Elisa Biliotti, Alessandro Soria, Chiara Baiguera, Maria Elena Tosti, Roberto Filomia, Barbara Coco, Homie Razavi, F. Baragli, Michele Quaranta, Stefano Rosato, M. Cannizzaro, C. Eleonora, Chris Estes, Marcello Dallio, Luigina Ferrigno, Loreta A. Kondili, M. Loi, V. Guarnieri, A. Ciancio, Maria Cristina Vinci, Romina Corsini, Alberto Zanetto, M. Siciliano, D. Ieluzzi, Alessia Giorgini, Savino Bruno, and L. E. Weimer

Subjects
medicine.medical_specialty, Hepatology, business.industry, Internal medicine, Cohort, Medicine, In patient, Interim analysis, business, Risk evaluation
Published
2018

50. Reply

Author

Alessandro Soria, Giuseppe Lapadula, Massimiliano Fabbiani, and Andrea Gori

Subjects
Hepatology
Published
2018

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