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1. 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

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

Abstract

Background: Prone positioning (PP) is routinely used among patients with COVID-19 requiring mechanical ventilation (MV). 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 PaO2/FiO2 ratio (P/F) was >200 mmHg and who did not require MV or Continuous Positive Airway Pressure (CPAP) at hospital admission. Patients were randomised 1:1 to PP on top of standard of care (intervention group) versus standard of care only (controls). The primary composite outcome included death, MV, CPAP and P/F <200 mmHg; secondary outcomes were oxygen weaning and hospital discharge. Results: Sixty-one subjects were enrolled, 29 adjudicated to PP and 32 to the control group. By day 28, 24/61 (39.3%) patients met the primary outcome: 16 because of P/F ratio <200 mmHg, 5 CPAP and 3 MV. Three patients died. Using an intention-to-treat approach, 15/29 patients in PP group versus 9/32 controls met the primary outcome, corresponding to a significantly higher risk of progression among those randomised to PP (HR 2.38 [95%CI 1.04-5.43]; p=0.040). Using an as-treated approach, which included in the intervention group only patients who maintained PP for ≥3 h·day-1, no significant differences were found between the two groups (HR 1.77; [95%CI 0.79-3.94]; p=0.165). Also, we did not find any statistically significant difference in terms of time to oxygen weaning or hospital discharge between study arms, in any of the analyses conducted. Conclusions: We observed no clinical benefit from PP among spontaneously breathing patients with COVID-19 pneumonia requiring conventional oxygen therapy.

Published
2023

2. Efficacy and Safety of Reparixin in Patients with Severe COVID-19 Pneumonia: A Phase 3, Randomized, Double-Blind Placebo-Controlled Study

Author

Piemonti, L, Landoni, G, Voza, A, Puoti, M, Gentile, I, Coppola, N, Nava, S, Mattei, A, Marinangeli, F, Marchetti, G, Bonfanti, P, Mastroianni, C, Bassetti, M, Crisafulli, E, Grossi, P, Zangrillo, A, Desai, A, Merli, M, Foggia, M, Carpano, M, Schiavoni, L, D'Arminio Monforte, A, Bisi, L, Russo, G, Busti, F, Rovelli, C, Perrotta, E, Goisis, G, Gavioli, E, Toya, S, De Pizzol, M, Mantelli, F, Allegretti, M, Minnella, E, Piemonti, Lorenzo, Landoni, Giovanni, Voza, Antonio, Puoti, Massimo, Gentile, Ivan, Coppola, Nicola, Nava, Stefano, Mattei, Alessia, Marinangeli, Franco, Marchetti, Giulia, Bonfanti, Paolo, Mastroianni, Claudio Maria, Bassetti, Matteo, Crisafulli, Ernesto, Grossi, Paolo Antonio, Zangrillo, Alberto, Desai, Antonio, Merli, Marco, Foggia, Maria, Carpano, Marco, Schiavoni, Lorenzo, D'Arminio Monforte, Antonella, Bisi, Luca, Russo, Gianluca, Busti, Fabiana, Rovelli, Cristina, Perrotta, Elisabetta, Goisis, Giovanni, Gavioli, Elizabeth M, Toya, Sophie, De Pizzol, Maria, Mantelli, Flavio, Allegretti, Marcello, Minnella, Enrico Maria, Piemonti, L, Landoni, G, Voza, A, Puoti, M, Gentile, I, Coppola, N, Nava, S, Mattei, A, Marinangeli, F, Marchetti, G, Bonfanti, P, Mastroianni, C, Bassetti, M, Crisafulli, E, Grossi, P, Zangrillo, A, Desai, A, Merli, M, Foggia, M, Carpano, M, Schiavoni, L, D'Arminio Monforte, A, Bisi, L, Russo, G, Busti, F, Rovelli, C, Perrotta, E, Goisis, G, Gavioli, E, Toya, S, De Pizzol, M, Mantelli, F, Allegretti, M, Minnella, E, Piemonti, Lorenzo, Landoni, Giovanni, Voza, Antonio, Puoti, Massimo, Gentile, Ivan, Coppola, Nicola, Nava, Stefano, Mattei, Alessia, Marinangeli, Franco, Marchetti, Giulia, Bonfanti, Paolo, Mastroianni, Claudio Maria, Bassetti, Matteo, Crisafulli, Ernesto, Grossi, Paolo Antonio, Zangrillo, Alberto, Desai, Antonio, Merli, Marco, Foggia, Maria, Carpano, Marco, Schiavoni, Lorenzo, D'Arminio Monforte, Antonella, Bisi, Luca, Russo, Gianluca, Busti, Fabiana, Rovelli, Cristina, Perrotta, Elisabetta, Goisis, Giovanni, Gavioli, Elizabeth M, Toya, Sophie, De Pizzol, Maria, Mantelli, Flavio, Allegretti, Marcello, and Minnella, Enrico Maria

Abstract

Introduction: Polymorphonuclear cell influx into the interstitial and bronchoalveolar spaces is a cardinal feature of severe coronavirus disease 2019 (COVID-19), principally mediated by interleukin-8 (IL-8). We sought to determine whether reparixin, a novel IL-8 pathway inhibitor, could reduce disease progression in patients hospitalized with severe COVID-19 pneumonia. Methods: In this Phase 3, randomized, double-blind, placebo-controlled, multicenter study, hospitalized adult patients with severe COVID-19 pneumonia were randomized 2:1 to receive oral reparixin 1200 mg three times daily or placebo for up to 21 days or until hospital discharge. The primary endpoint was the proportion of patients alive and free of respiratory failure at Day 28, with key secondary endpoints being the proportion of patients free of respiratory failure at Day 60, incidence of intensive care unit (ICU) admission by Day 28 and time to recovery by Day 28. Results: Of 279 patients randomized, 182 received at least one dose of reparixin and 88 received placebo. The proportion of patients alive and free of respiratory failure at Day 28 was similar in the two groups {83.5% versus 80.7%; odds ratio 1.63 [95% confidence interval (CI) 0.75, 3.51]; p = 0.216}. There were no statistically significant differences in the key secondary endpoints, but a numerically higher proportion of patients in the reparixin group were alive and free of respiratory failure at Day 60 (88.7% versus 84.6%; p = 0.195), fewer required ICU admissions by Day 28 (15.8% versus 21.7%; p = 0.168), and a higher proportion recovered by Day 28 compared with placebo (81.6% versus 74.9%; p = 0.167). Fewer patients experienced adverse events with reparixin than placebo (45.6% versus 54.5%), most mild or moderate intensity and not related to study treatment. Conclusions: This trial did not meet the primary efficacy endpoints, yet reparixin showed a trend toward limiting disease progression as an add-on therapy in COVID-19 severe pneum

Published
2023

3. Infezione disseminata da Mycobacterium avium complex con batteriemia persistente in un paziente AIDS-presenter [Disseminated Mycobacterium avium complex infection with persistent bacteremia in an AIDS-presenter patient]

Author

Mezzadri, L, Borghesi Maria, L, Caramma Ilaria, C, Bisi, L, Rossi, M, Lapadula, G, Migliorino Guglielmo, M, Carbone, M, Bonfanti, P, Mezzadri Luca, Borghesi Maria Lucia, Caramma Ilaria Chiara, Bisi Luca, Rossi Marianna, Lapadula Giuseppe, Migliorino Guglielmo Marco, Carbone Maurizio, Bonfanti Paolo, Mezzadri, L, Borghesi Maria, L, Caramma Ilaria, C, Bisi, L, Rossi, M, Lapadula, G, Migliorino Guglielmo, M, Carbone, M, Bonfanti, P, Mezzadri Luca, Borghesi Maria Lucia, Caramma Ilaria Chiara, Bisi Luca, Rossi Marianna, Lapadula Giuseppe, Migliorino Guglielmo Marco, Carbone Maurizio, and Bonfanti Paolo

Abstract

Negli ultimi decenni, l’incidenza di casi AIDS-presenter è calata drasticamente grazie alla diffusione della terapia antiretrovirale e al suo utilizzo sempre più precoce. Fra le patologie opportunistiche associate all’AIDS, l’infezione disseminata da micobatteri non tubercolari rappresenta una grave complicanza. La presentazione clinica aspecifica, così come il difficile work-up diagnostico, possono ritardarne il riconoscimento e il successivo avvio della terapia. Ad oggi, nonostante efficaci terapie anti-micobatteriche, il fattore determinante per il successo della terapia è rappresentato dall’immuno-ricostituzione conseguente alla introduzione di una terapia antiretrovirale efficace. Il caso qui descritto rappresenta un esempio di infezione di difficile trattamento con coinvolgimento midollare, esordito come sospetta patologica ematologica., In recent decades, the incidence of AIDS-presenter cases has drastically decreased thanks to the availability of highly active antiretroviral therapy (HAART) and its early use. Among the AIDS-associated opportunistic diseases, non-tuberculous mycobacteria (NTM) disseminated infection represents a serious complication. The nonspecific clinical presentation, as well as the difficult diagnostic work-up, can delay the recognition and the subsequent initiation of therapy. To date, despite effective antimycobacterial drugs, the determining factor for treatment outcome is immune reconstitution resulting from HAART introduction. The case described here represents an example of a difficult-to-treat infection with bone marrow invasion, which began as a suspected hematological disease.

Published
2023

6. Gestione clinica della malaria nel paziente HIV positivo

Author

Iannuzzi, F, Bisi, L, Bonfanti, P, Iannuzzi Francesca, Bisi Luca, Bonfanti Paolo, Iannuzzi, F, Bisi, L, Bonfanti, P, Iannuzzi Francesca, Bisi Luca, and Bonfanti Paolo

Abstract

Vi è un’estesa sovrapposizione geografica tra malaria e infezione da HIV nell’Africa Sub-Sahariana e, in minor misura, nel Sud-Est Asiatico. In Europa e Nord America i casi di malaria nei pazienti HIV positivi sono limitati ai viaggiatori in aree malariche senza idonea profilassi. La co-infezione malaria-HIV (CMH) comporta un aumento della viremia e una riduzione del numero dei linfociti CD4+, l’incremento della parassitemia e della frequenza di gametocitemia persistente, più frequenti complicanze da malaria grave e mortalità più elevata. La CMH in gravidanza aumenta il rischio di complicanze perinatali (parto pre-termine, aumentata mortalità neonatale, anemia grave). Nella scelta del trattamento antimalarico è necessario tenere in considerazione le numerose interazioni farmacologiche con la terapia antiretrovirale. In generale gli inibitori delle proteasi e gli NNRTI sono i farmaci con il maggior numero di interazioni farmacologiche con le terapie di combinazione a base di derivati dell’artemisinina. L’allungamento del tratto QT è l’evento avverso più frequente e che richiede un monitoraggio ECG più attento nei pazienti in trattamento antiretrovirale. Il paziente con infezione da HIV necessita pertanto un attento monitoraggio degli effetti collaterali in corso di terapia e rivalutazione nelle settimane successive per assicurarsi l’efficacia del trattamento antimalarico., There is extensive geographical overlap between malaria and HIV infection in Sub-Saharan Africa and, to a lesser extent, Southeast Asia. In Europe and North America, malaria cases in HIV-positive patients are limited to travellers in malarial areas without appropriate prophylaxis. Malaria-HIV co-infection (MHC) results in increased viremia and reduced CD4+ counts, increased parasitaemia and frequency of persistent gametocytaemia, more frequent severe malaria complications and higher mortality. MHC in pregnancy increases the risk of perinatal complications (pre-term delivery, increased neonatal mortality, severe anaemia). Numerous drug interactions with antiretroviral therapy must be considered when choosing antimalarial treatment. In general, protease inhibitors and NNRTIs are the antiretrovirals with the highest number of drug interactions with artemisinin-based combination therapies. QT prolongation is the most frequent adverse event, requiring closer ECG monitoring in patients on antiretroviral therapy. MHC patients therefore need careful monitoring of side effects during therapy and closer follow-up to ensure successful antimalarial treatment.

Published
2021

7. Control Frequency Adaptation via Action Persistence in Batch Reinforcement Learning

Author

Alberto Maria Metelli, Mazzolini, F., Bisi, L., Sabbioni, L., and Restelli, M.

Subjects
FOS: Computer and information sciences, Computer Science - Machine Learning, Statistics - Machine Learning, Machine Learning (stat.ML), Machine Learning (cs.LG)
Abstract

The choice of the control frequency of a system has a relevant impact on the ability of reinforcement learning algorithms to learn a highly performing policy. In this paper, we introduce the notion of action persistence that consists in the repetition of an action for a fixed number of decision steps, having the effect of modifying the control frequency. We start analyzing how action persistence affects the performance of the optimal policy, and then we present a novel algorithm, Persistent Fitted Q-Iteration (PFQI), that extends FQI, with the goal of learning the optimal value function at a given persistence. After having provided a theoretical study of PFQI and a heuristic approach to identify the optimal persistence, we present an experimental campaign on benchmark domains to show the advantages of action persistence and proving the effectiveness of our persistence selection method.

Published
2020
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11. Tigecycline Lock Therapy for Catheter-Related Bloodstream Infection Caused by KPC-Producing Klebsiella pneumoniae in Two Pediatric Hematological Patients

Author

Foresti, S, Di Bella, S, Rovelli, A, Sala, A, Verna, M, Bisi, L, Nisii, C, Gori, A, GORI, ANDREA, Foresti, S, Di Bella, S, Rovelli, A, Sala, A, Verna, M, Bisi, L, Nisii, C, Gori, A, and GORI, ANDREA

Abstract

Catheter-related bacteremias carry high mortality rates in hematological patients. When a multidrug-resistant microorganism is involved, the catheter should ideally be removed; however, this approach is not always possible. Tigecycline lock therapy was used in two pediatric oncohematological patients with intravascular catheter-related infection due to KPC-producing Klebsiella pneumoniae. The catheter was salvaged in both cases, and the patients were later discharged. Our experience suggests the usefulness of this approach in treating this type of infection.

Published
2015

13. A case of cerebrospinal fluid viral escape on a dual antiretroviral regimen: Worth the risk?

Author

Mangioni, D, Muscatello, A, Sabbatini, F, Soria, A, Rossi, M, Bisi, L, Squillace, N, De Grandi, C, Gori, A, Bandera, A, MUSCATELLO, ANTONIO, SORIA, ALESSANDRO, ROSSI, MARIANNA, SQUILLACE, NICOLA, GORI, ANDREA, BANDERA, ALESSANDRA, Mangioni, D, Muscatello, A, Sabbatini, F, Soria, A, Rossi, M, Bisi, L, Squillace, N, De Grandi, C, Gori, A, Bandera, A, MUSCATELLO, ANTONIO, SORIA, ALESSANDRO, ROSSI, MARIANNA, SQUILLACE, NICOLA, GORI, ANDREA, and BANDERA, ALESSANDRA

Published
2014

20. 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

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

Subjects
COVID-19
Abstract

Background: Prone positioning (PP) is routinely used among patients with COVID-19 requiring mechanical ventilation (MV). 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 PaO2/FiO2 ratio (P/F) was >200 mmHg and who did not require MV or Continuous Positive Airway Pressure (CPAP) at hospital admission. Patients were randomised 1:1 to PP on top of standard of care (intervention group) versus standard of care only (controls). The primary composite outcome included death, MV, CPAP and P/F

Published
2023

21. Infezione disseminata da Mycobacterium avium complex con batteriemia persistente in un paziente AIDS-presenter [Disseminated Mycobacterium avium complex infection with persistent bacteremia in an AIDS-presenter patient]

Author

Mezzadri Luca, Borghesi Maria Lucia, Caramma Ilaria Chiara, Bisi Luca, Rossi Marianna, Lapadula Giuseppe, Migliorino Guglielmo Marco, Carbone Maurizio, Bonfanti Paolo, Mezzadri, L, Borghesi Maria, L, Caramma Ilaria, C, Bisi, L, Rossi, M, Lapadula, G, Migliorino Guglielmo, M, Carbone, M, and Bonfanti, P

Subjects
Non-tuberculous Mycobacteria, HIV, AIDS, Immunodepression, Therapeutic Drug Monitoring (TDM)
Abstract

Negli ultimi decenni, l’incidenza di casi AIDS-presenter è calata drasticamente grazie alla diffusione della terapia antiretrovirale e al suo utilizzo sempre più precoce. Fra le patologie opportunistiche associate all’AIDS, l’infezione disseminata da micobatteri non tubercolari rappresenta una grave complicanza. La presentazione clinica aspecifica, così come il difficile work-up diagnostico, possono ritardarne il riconoscimento e il successivo avvio della terapia. Ad oggi, nonostante efficaci terapie anti-micobatteriche, il fattore determinante per il successo della terapia è rappresentato dall’immuno-ricostituzione conseguente alla introduzione di una terapia antiretrovirale efficace. Il caso qui descritto rappresenta un esempio di infezione di difficile trattamento con coinvolgimento midollare, esordito come sospetta patologica ematologica. In recent decades, the incidence of AIDS-presenter cases has drastically decreased thanks to the availability of highly active antiretroviral therapy (HAART) and its early use. Among the AIDS-associated opportunistic diseases, non-tuberculous mycobacteria (NTM) disseminated infection represents a serious complication. The nonspecific clinical presentation, as well as the difficult diagnostic work-up, can delay the recognition and the subsequent initiation of therapy. To date, despite effective antimycobacterial drugs, the determining factor for treatment outcome is immune reconstitution resulting from HAART introduction. The case described here represents an example of a difficult-to-treat infection with bone marrow invasion, which began as a suspected hematological disease.

Published
2023

22. Gestione clinica della malaria nel paziente HIV positivo

Author

Iannuzzi Francesca, Bisi Luca, Bonfanti Paolo, Iannuzzi, F, Bisi, L, and Bonfanti, P

Subjects
HIV, Interazioni farmacologiche, Malaria
Abstract

Vi è un’estesa sovrapposizione geografica tra malaria e infezione da HIV nell’Africa Sub-Sahariana e, in minor misura, nel Sud-Est Asiatico. In Europa e Nord America i casi di malaria nei pazienti HIV positivi sono limitati ai viaggiatori in aree malariche senza idonea profilassi. La co-infezione malaria-HIV (CMH) comporta un aumento della viremia e una riduzione del numero dei linfociti CD4+, l’incremento della parassitemia e della frequenza di gametocitemia persistente, più frequenti complicanze da malaria grave e mortalità più elevata. La CMH in gravidanza aumenta il rischio di complicanze perinatali (parto pre-termine, aumentata mortalità neonatale, anemia grave). Nella scelta del trattamento antimalarico è necessario tenere in considerazione le numerose interazioni farmacologiche con la terapia antiretrovirale. In generale gli inibitori delle proteasi e gli NNRTI sono i farmaci con il maggior numero di interazioni farmacologiche con le terapie di combinazione a base di derivati dell’artemisinina. L’allungamento del tratto QT è l’evento avverso più frequente e che richiede un monitoraggio ECG più attento nei pazienti in trattamento antiretrovirale. Il paziente con infezione da HIV necessita pertanto un attento monitoraggio degli effetti collaterali in corso di terapia e rivalutazione nelle settimane successive per assicurarsi l’efficacia del trattamento antimalarico. There is extensive geographical overlap between malaria and HIV infection in Sub-Saharan Africa and, to a lesser extent, Southeast Asia. In Europe and North America, malaria cases in HIV-positive patients are limited to travellers in malarial areas without appropriate prophylaxis. Malaria-HIV co-infection (MHC) results in increased viremia and reduced CD4+ counts, increased parasitaemia and frequency of persistent gametocytaemia, more frequent severe malaria complications and higher mortality. MHC in pregnancy increases the risk of perinatal complications (pre-term delivery, increased neonatal mortality, severe anaemia). Numerous drug interactions with antiretroviral therapy must be considered when choosing antimalarial treatment. In general, protease inhibitors and NNRTIs are the antiretrovirals with the highest number of drug interactions with artemisinin-based combination therapies. QT prolongation is the most frequent adverse event, requiring closer ECG monitoring in patients on antiretroviral therapy. MHC patients therefore need careful monitoring of side effects during therapy and closer follow-up to ensure successful antimalarial treatment.

Published
2021
Full Text
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23. Nosocomial infections during extracorporeal membrane oxygenation: Incidence, etiology, and impact on patients' outcome

Author

Antonio Pesenti, Andrea Gori, Stefano Biffi, Michela Bombino, Luca Bisi, Vittorio Scaravilli, Nicolò Patroniti, Stefano Di Bella, Giacomo Grasselli, Laura Alagna, Anna Maria Peri, Grasselli, G., Scaravilli, V., Di Bella, S., Biffi, S., Bombino, M., Patroniti, N., Bisi, L., Peri, A. M., Pesenti, A., Gori, A., and Alagna, L.

Subjects
Male, medicine.medical_treatment, retrospective study, Drug Resistance, Bacteremia, 030204 cardiovascular system & hematology, Critical Care and Intensive Care Medicine, intensive care unit, law.invention, 0302 clinical medicine, Retrospective Studie, law, Risk Factors, Drug Resistance, Multiple, Bacterial, Age Factor, health care-associated infection, Child, Cross Infection, Incidence (epidemiology), Incidence, Age Factors, Bacterial, Pneumonia, Ventilator-Associated, Middle Aged, Intensive care unit, Intensive Care Units, Ventilator-Associated, Italy, extracorporeal membrane oxygenation, multidrug resistance, Adolescent, Adult, Catheter-Related Infections, Child, Preschool, Extracorporeal Membrane Oxygenation, Female, Humans, Length of Stay, Retrospective Studies, Urinary Tract Infections, Young Adult, Multiple, Human, medicine.medical_specialty, Intensive Care Unit, Extracorporeal, 03 medical and health sciences, medicine, Extracorporeal membrane oxygenation, Intensive care medicine, Preschool, Catheter-Related Infection, business.industry, Risk Factor, 030208 emergency & critical care medicine, Retrospective cohort study, Pneumonia, medicine.disease, Urinary Tract Infection, Emergency medicine, Etiology, business
Abstract

OBJECTIVE: To study incidence, type, etiology, risk factors, and impact on outcome of nosocomial infections during extracorporeal membrane oxygenation. DESIGN: Retrospective analysis of prospectively collected data. SETTING: Italian tertiary referral center medical-surgical ICU. PATIENTS: One hundred five consecutive patients who were treated with extracorporeal membrane oxygenation from January 2010 to November 2015. INTERVENTIONS: None. MEASUREMENTS AND MAIN RESULTS: Ninety-two patients were included in the analysis (48.5 [37-56] years old, simplified acute physiology score II 37 [32-47]) who underwent peripheral extracorporeal membrane oxygenation (87% veno-venous) for medical indications (78% acute respiratory distress syndrome). Fifty-two patients (55%) were infected (50.4 infections/1,000 person-days of extracorporeal membrane oxygenation). We identified 32 ventilator-associated pneumonia, eight urinary tract infections, five blood stream infections, three catheter-related blood stream infections, two colitis, one extracorporeal membrane oxygenation cannula infection, and one pulmonary-catheter infection. G+ infections (35%) occurred earlier compared with G- (48%) (4 [2-10] vs. 13 [7-23] days from extracorporeal membrane oxygenation initiation; p < 0.001). Multidrug-resistant organisms caused 56% of bacterial infections. Younger age (2-35 years old) was independently associated with higher risk for nosocomial infections. Twenty-nine patients (31.5%) died (13.0 deaths/1,000 person-days of extracorporeal membrane oxygenation). Infected patients had higher risk for death (18 vs. 8 deaths/1,000 person-days of extracorporeal membrane oxygenation; p = 0.037) and longer ICU stay (32.5 [19.5-78] vs. 19 [10.5-27.5] days; p = 0.003), mechanical ventilation (36.5 [20-80.5] vs. 16.5 [9-25.5] days; p < 0.001), and extracorporeal membrane oxygenation (25.5 [10.75-54] vs. 10 [5-13] days; p < 0.001). Older age (> 50 years old), reason for connection different from acute respiratory distress syndrome, higher simplified acute physiology score II, diagnosis of ventilator-associated pneumonia, and infection by multidrug-resistant bacteria were independently associated to increased death rate. CONCLUSIONS: Infections (especially ventilator-associated pneumonia) during extracorporeal membrane oxygenation therapy are common and frequently involve multidrug-resistant organisms. In addition, they have a negative impact on patients' outcomes.

Published
2017

24. Tigecycline Lock Therapy for Catheter-Related Bloodstream Infection Caused by KPC-Producing Klebsiella pneumoniae in Two Pediatric Hematological Patients

Author

Sergio Foresti, Attilio Rovelli, Carla Nisii, Marta Verna, Andrea Gori, Alessandra Sala, Luca Bisi, Stefano Di Bella, Foresti, S, Di Bella, S, Rovelli, A, Sala, A, Verna, M, Bisi, L, Nisii, C, and Gori, A

Subjects
medicine.medical_specialty, Adolescent, Klebsiella pneumoniae, Anemia, Antineoplastic Agents, Bacteremia, Minocycline, Tigecycline, Clinical Therapeutics, Drug Administration Schedule, Bloodstream infection, Medicine, Central Venous Catheters, Humans, Pharmacology (medical), lock therapy, Pharmacology, biology, business.industry, High mortality, Anemia, Aplastic, Infant, biology.organism_classification, medicine.disease, Surgery, Anti-Bacterial Agents, Klebsiella Infections, tigecycline, Catheter, KPC, Infectious Diseases, Treatment Outcome, Catheter-Related Infections, Female, business, Immunosuppressive Agents, medicine.drug
Abstract

Catheter-related bacteremias carry high mortality rates in hematological patients. When a multidrug-resistant microorganism is involved, the catheter should ideally be removed; however, this approach is not always possible. Tigecycline lock therapy was used in two pediatric oncohematological patients with intravascular catheter-related infection due to KPC-producing Klebsiella pneumoniae . The catheter was salvaged in both cases, and the patients were later discharged. Our experience suggests the usefulness of this approach in treating this type of infection.

Published
2015

25. Comment on 'Management of infections in cirrhotic patients: report of a consensus conference' S Fagiuoli et al. [Dig liver dis 2014;46:204-212]

Author

Marianna Rossi, Luca Bisi, Sebastiano Leone, Andrea Gori, Leone, S, Bisi, L, Rossi, M, and Gori, A

Subjects
Liver Cirrhosis, medicine.medical_specialty, Anti-Bacterial Agents, Antifungal Agents, Bacterial Infections, Humans, Mycoses, Liver Cirrhosi, Mycose, Bacterial Infection, Gastroenterology, Dig, Internal medicine, Anti-Bacterial Agent, Antifungal Agent, Medicine, Hepatology, business.industry, Medicine (all), General surgery, Consensus conference, business, Human
Published
2013

26. Antibiotic dose adjustment in patients with advanced liver disease

Author

Marianna Rossi, Silvano Esposito, Andrea Gori, Sebastiano Leone, Luca Bisi, Leone, S, Rossi, M, Bisi, L, Gori, A, and Esposito, S

Subjects
Liver Cirrhosis, medicine.medical_specialty, Hepatology, medicine.drug_class, business.industry, Pharmaceutical Preparation, Liver Cirrhosi, Antibiotics, Gastroenterology, medicine.disease, Liver disease, Pharmaceutical Preparations, Dose adjustment, Internal medicine, Practice Guidelines as Topic, medicine, Humans, In patient, Pharmacology (medical), business, Human
Published
2013

27. Antimicrobial therapy duration: a major matter in the management of severe infections

Author

Marianna Rossi, Silvano Esposito, Sebastiano Leone, Andrea Gori, Luca Bisi, Leone, S, Rossi, M, Bisi, L, Gori, A, and Esposito, S

Subjects
Microbiology (medical), medicine.medical_specialty, business.industry, Bacteremia, Infectious Disease, General Medicine, Antimicrobial, medicine.disease, Anti-Bacterial Agents, Infectious Diseases, Internal medicine, Immunology, Anti-Bacterial Agent, medicine, Humans, Pharmacology (medical), Duration (project management), business, Human
Published
2013

28. A Case of Cerebrospinal Fluid Viral Escape on a Dual Antiretroviral Regimen: Worth the Risk?

Author

Marianna Rossi, Carlo De Grandi, Luca Bisi, Antonio Muscatello, Alessandra Bandera, Davide Mangioni, Andrea Gori, Francesca Sabbatini, Alessandro Soria, Nicola Squillace, Mangioni, D, Muscatello, A, Sabbatini, F, Soria, A, Rossi, M, Bisi, L, Squillace, N, De Grandi, C, Gori, A, and Bandera, A

Subjects
Microbiology (medical), Anti-Retroviral Agents, business.industry, Brain, Infectious Disease, Middle Aged, Viral Load, DUAL (cognitive architecture), Magnetic Resonance Imaging, Virology, Regimen, Infectious Diseases, Cerebrospinal fluid, Immunology, RNA, Viral, Medicine, Anti-Retroviral Agent, Female, HIV Infection, business, Viral load, Human
Published
2014
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29. Efficacy and Safety of Reparixin in Patients with Severe COVID-19 Pneumonia: A Phase 3, Randomized, Double-Blind Placebo-Controlled Study.

Author

Piemonti L, Landoni G, Voza A, Puoti M, Gentile I, Coppola N, Nava S, Mattei A, Marinangeli F, Marchetti G, Bonfanti P, Mastroianni CM, Bassetti M, Crisafulli E, Grossi PA, Zangrillo A, Desai A, Merli M, Foggia M, Carpano M, Schiavoni L, D'Arminio Monforte A, Bisi L, Russo G, Busti F, Rovelli C, Perrotta E, Goisis G, Gavioli EM, Toya S, De Pizzol M, Mantelli F, Allegretti M, and Minnella EM

Abstract

Introduction: Polymorphonuclear cell influx into the interstitial and bronchoalveolar spaces is a cardinal feature of severe coronavirus disease 2019 (COVID-19), principally mediated by interleukin-8 (IL-8). We sought to determine whether reparixin, a novel IL-8 pathway inhibitor, could reduce disease progression in patients hospitalized with severe COVID-19 pneumonia., Methods: In this Phase 3, randomized, double-blind, placebo-controlled, multicenter study, hospitalized adult patients with severe COVID-19 pneumonia were randomized 2:1 to receive oral reparixin 1200 mg three times daily or placebo for up to 21 days or until hospital discharge. The primary endpoint was the proportion of patients alive and free of respiratory failure at Day 28, with key secondary endpoints being the proportion of patients free of respiratory failure at Day 60, incidence of intensive care unit (ICU) admission by Day 28 and time to recovery by Day 28., Results: Of 279 patients randomized, 182 received at least one dose of reparixin and 88 received placebo. The proportion of patients alive and free of respiratory failure at Day 28 was similar in the two groups {83.5% versus 80.7%; odds ratio 1.63 [95% confidence interval (CI) 0.75, 3.51]; p = 0.216}. There were no statistically significant differences in the key secondary endpoints, but a numerically higher proportion of patients in the reparixin group were alive and free of respiratory failure at Day 60 (88.7% versus 84.6%; p = 0.195), fewer required ICU admissions by Day 28 (15.8% versus 21.7%; p = 0.168), and a higher proportion recovered by Day 28 compared with placebo (81.6% versus 74.9%; p = 0.167). Fewer patients experienced adverse events with reparixin than placebo (45.6% versus 54.5%), most mild or moderate intensity and not related to study treatment., Conclusions: This trial did not meet the primary efficacy endpoints, yet reparixin showed a trend toward limiting disease progression as an add-on therapy in COVID-19 severe pneumonia and was well tolerated., Trial Registration: ClinicalTrials.gov: NCT04878055, EudraCT: 2020-005919-51., (© 2023. The Author(s).)

Published
2023
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30. 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

Fezzi M, Antolini L, Soria A, Bisi L, Iannuzzi F, Sabbatini F, Rossi M, Limonta S, Rugova A, Columpsi P, Squillace N, Foresti S, Pollastri E, Valsecchi MG, Migliorino GM, Bonfanti P, and Lapadula G

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 ( P aO 2 / F IO 2 ) 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 P aO 2 / F IO 2 <200 mmHg; secondary outcomes were oxygen weaning and hospital discharge., Results: A total of 61 subjects were enrolled, 29 adjudicated to prone positioning and 32 to the control group. By day 28, 24 out of 61 patients (39.3%) met the primary outcome: 16 because of a P aO 2 / F IO 2 ratio <200 mmHg, five because of the need for continuous positive airway pressure and three because of the need for mechanical ventilation. Three patients died. Using an intention-to-treat approach, 15 out of 29 patients in the prone positioning group versus nine out of 32 controls met the primary outcome, corresponding to a significantly higher risk of progression among those randomised to prone positioning (HR 2.38, 95% CI 1.04-5.43; p=0.040). Using an as-treated approach, which included in the intervention group only patients who maintained prone positioning for ≥3 h·day -1 , no significant differences were found between the two groups (HR 1.77, 95% CI 0.79-3.94; p=0.165). Also, we did not find any statistically significant difference in terms of time to oxygen weaning or hospital discharge between study arms in any of the analyses conducted., Conclusions: We observed no clinical benefit from prone positioning among spontaneously breathing patients with COVID-19 pneumonia requiring conventional oxygen therapy., Competing Interests: Conflict of interest: The authors declare that they have no conflicts of interest for the present study., (Copyright ©The authors 2023.)

Published
2023
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31. Recurrent posterior reversible encephalopathy syndrome in an HIV-HCV coinfected liver transplant recipient.

Author

Cappelletti A, Peri AM, Bisi L, Sabbatini F, Rossi M, Migliorino GM, Foresti S, Bandera A, and Gori A

Subjects
Brain diagnostic imaging, Brain pathology, Humans, Magnetic Resonance Imaging, Male, Middle Aged, Coinfection complications, HIV Infections complications, Hepatitis C, Chronic complications, Liver Transplantation, Posterior Leukoencephalopathy Syndrome diagnosis, Posterior Leukoencephalopathy Syndrome pathology, Transplant Recipients
Published
2019
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32. Nosocomial Infections During Extracorporeal Membrane Oxygenation: Incidence, Etiology, and Impact on Patients' Outcome.

Author

Grasselli G, Scaravilli V, Di Bella S, Biffi S, Bombino M, Patroniti N, Bisi L, Peri AM, Pesenti A, Gori A, and Alagna L

Subjects
Adolescent, Adult, Age Factors, Bacteremia epidemiology, Bacteremia microbiology, Catheter-Related Infections epidemiology, Child, Child, Preschool, Cross Infection microbiology, Drug Resistance, Multiple, Bacterial, Female, Humans, Incidence, Intensive Care Units, Italy epidemiology, Length of Stay statistics & numerical data, Male, Middle Aged, Pneumonia, Ventilator-Associated epidemiology, Pneumonia, Ventilator-Associated microbiology, Retrospective Studies, Risk Factors, Urinary Tract Infections epidemiology, Urinary Tract Infections microbiology, Young Adult, Cross Infection epidemiology, Extracorporeal Membrane Oxygenation adverse effects
Abstract

Objective: To study incidence, type, etiology, risk factors, and impact on outcome of nosocomial infections during extracorporeal membrane oxygenation., Design: Retrospective analysis of prospectively collected data., Setting: Italian tertiary referral center medical-surgical ICU., Patients: One hundred five consecutive patients who were treated with extracorporeal membrane oxygenation from January 2010 to November 2015., Interventions: None., Measurements and Main Results: Ninety-two patients were included in the analysis (48.5 [37-56] years old, simplified acute physiology score II 37 [32-47]) who underwent peripheral extracorporeal membrane oxygenation (87% veno-venous) for medical indications (78% acute respiratory distress syndrome). Fifty-two patients (55%) were infected (50.4 infections/1,000 person-days of extracorporeal membrane oxygenation). We identified 32 ventilator-associated pneumonia, eight urinary tract infections, five blood stream infections, three catheter-related blood stream infections, two colitis, one extracorporeal membrane oxygenation cannula infection, and one pulmonary-catheter infection. G+ infections (35%) occurred earlier compared with G- (48%) (4 [2-10] vs. 13 [7-23] days from extracorporeal membrane oxygenation initiation; p < 0.001). Multidrug-resistant organisms caused 56% of bacterial infections. Younger age (2-35 years old) was independently associated with higher risk for nosocomial infections. Twenty-nine patients (31.5%) died (13.0 deaths/1,000 person-days of extracorporeal membrane oxygenation). Infected patients had higher risk for death (18 vs. 8 deaths/1,000 person-days of extracorporeal membrane oxygenation; p = 0.037) and longer ICU stay (32.5 [19.5-78] vs. 19 [10.5-27.5] days; p = 0.003), mechanical ventilation (36.5 [20-80.5] vs. 16.5 [9-25.5] days; p < 0.001), and extracorporeal membrane oxygenation (25.5 [10.75-54] vs. 10 [5-13] days; p < 0.001). Older age (> 50 years old), reason for connection different from acute respiratory distress syndrome, higher simplified acute physiology score II, diagnosis of ventilator-associated pneumonia, and infection by multidrug-resistant bacteria were independently associated to increased death rate., Conclusions: Infections (especially ventilator-associated pneumonia) during extracorporeal membrane oxygenation therapy are common and frequently involve multidrug-resistant organisms. In addition, they have a negative impact on patients' outcomes.

Published
2017
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33. Clinical Usefulness of Klebsiella Pneumoniae Carbapenemase-Producing K. Pneumoniae Genotyping: The Experience of a Single-Center Epidemic.

Author

Rossi M, Chatenoud L, Viganò EF, Peri AM, Alagna L, Bramati S, Manenti M, Raggi M, Cavallero A, Bisi L, Leone S, Migliorino GM, Bandera A, and Gori A

Abstract

Background: During the last decade, the spread of Klebsiella pneumoniae -carbapenemase-producing Klebsiella pneumoniae (KPC- Kp ) has increased dramatically worldwide. In this scenario, growing interest has been addressed to genotyping of KPC- Kp strains, which emerged as an important tool for a better understanding of the epidemiological and clinical characteristics of the outbreaks., Methods: We performed a retrospective cohort study on patients infected with KPC- Kp during a 28-month outbreak period (January 2010-April 2012) at San Gerardo Hospital (Monza, Italy), investigating KPC- Kp genotypes by means of repetitive element sequence-based polymerase chain reaction (Rep-PCR)., Results: We enrolled 97 patients infected with KPC- Kp . Rep-PCR analysis identified 5 distinct clone types, with different distribution over time. During the first 12 months of the outbreak period, only 1 clone was detected (clone A, in 47 patients), while the 4 other clones were identified over the remaining 16 months (clones C, E, and F/L in 23, 24, and 3 patients respectively). Mechanical ventilation was less frequent in patients infected with clones C/E/F/L (OR = 0.14; 95% CI: 0.05-0.37) compared to clone A, and the Charlson comorbidity index (CI) was more likely to have a score >5 in patients infected with clones C/E/F/L (OR = 7.21; 95% CI: 2.24-23.14) compared to clone A.Overall mortality was higher in patients infected with clones C/E/F/L (13/20 patients, 65%) compared to those infected with clone A (7/20, 35%). Mortality in patients infected with clones C/E/F/L remained significantly higher even after adjusting for the potential confounding effect of comorbidities (ie, CI), with a hazard ratio (HR) of 4.65 (95% CI: 1.83-11.89)., Conclusions: Our results suggested a close relationship between strain genotype and clinical outcome., Competing Interests: All authors: No reported conflicts. Conflicts that the editors consider relevant to the content of the manuscript have been disclosed.

Published
2017
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34. Tigecycline Lock Therapy for Catheter-Related Bloodstream Infection Caused by KPC-Producing Klebsiella pneumoniae in Two Pediatric Hematological Patients.

Author

Foresti S, Di Bella S, Rovelli A, Sala A, Verna M, Bisi L, Nisii C, and Gori A

Subjects
Adolescent, Anemia, Aplastic complications, Anemia, Aplastic drug therapy, Anemia, Aplastic immunology, Anemia, Aplastic pathology, Antineoplastic Agents therapeutic use, Bacteremia complications, Bacteremia immunology, Bacteremia pathology, Catheter-Related Infections complications, Catheter-Related Infections immunology, Catheter-Related Infections pathology, Central Venous Catheters, Drug Administration Schedule, Female, Humans, Immunosuppressive Agents therapeutic use, Infant, Klebsiella Infections complications, Klebsiella Infections immunology, Klebsiella Infections pathology, Klebsiella pneumoniae drug effects, Klebsiella pneumoniae growth & development, Klebsiella pneumoniae pathogenicity, Minocycline therapeutic use, Tigecycline, Treatment Outcome, Anti-Bacterial Agents therapeutic use, Bacteremia drug therapy, Catheter-Related Infections drug therapy, Klebsiella Infections drug therapy, Minocycline analogs & derivatives
Abstract

Catheter-related bacteremias carry high mortality rates in hematological patients. When a multidrug-resistant microorganism is involved, the catheter should ideally be removed; however, this approach is not always possible. Tigecycline lock therapy was used in two pediatric oncohematological patients with intravascular catheter-related infection due to KPC-producing Klebsiella pneumoniae. The catheter was salvaged in both cases, and the patients were later discharged. Our experience suggests the usefulness of this approach in treating this type of infection., (Copyright © 2015, American Society for Microbiology. All Rights Reserved.)

Published
2015
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35. A case of cerebrospinal fluid viral escape on a dual antiretroviral regimen: worth the risk?

Author

Mangioni D, Muscatello A, Sabbatini F, Soria A, Rossi M, Bisi L, Squillace N, De Grandi C, Gori A, and Bandera A

Subjects
Anti-Retroviral Agents adverse effects, Brain pathology, Female, HIV Infections drug therapy, HIV Infections virology, Humans, Magnetic Resonance Imaging, Middle Aged, RNA, Viral cerebrospinal fluid, Viral Load, Anti-Retroviral Agents administration & dosage, HIV Infections cerebrospinal fluid
Published
2014
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38. Increased plasma levels of extracellular mitochondrial DNA during HIV infection: a new role for mitochondrial damage-associated molecular patterns during inflammation.

Author

Cossarizza A, Pinti M, Nasi M, Gibellini L, Manzini S, Roat E, De Biasi S, Bertoncelli L, Montagna JP, Bisi L, Manzini L, Trenti T, Borghi V, and Mussini C

Subjects
Adult, Aged, Anti-HIV Agents therapeutic use, Antiretroviral Therapy, Highly Active, CD4 Lymphocyte Count, CD8-Positive T-Lymphocytes pathology, Female, HIV Infections drug therapy, HIV Infections immunology, HIV Infections pathology, Humans, Inflammation metabolism, Lipopolysaccharide Receptors blood, Male, Middle Aged, Viral Load, Young Adult, DNA, Mitochondrial blood, HIV Infections blood, HIV-1 physiology
Abstract

HIV infection is characterized by a chronic inflammatory state. Recently, it has been shown that mitochondrial DNA (mtDNA) released from damaged or dead cells can bind Toll like receptor-9 (TLR9), an intracellular receptor that responds to bacterial or viral DNA molecules. The activation of TLR9 present within monocytes or neutrophils results in a potent inflammatory reaction, with the production of proinflammatory cytokines. We measured plasma levels of mtDNA in different groups of HIV(+) patients, i.e., those experiencing an acute HIV infection (AHI), long term non progressors (LTNP), late presenters (LP) taking antiretroviral therapy for the first time, and healthy controls. We found that in AHI and LP mtDNA plasma levels were significantly higher than in healthy individuals or in LTNP. Plasma mtDNA levels were not correlated to peripheral blood CD4(+) T cell count, nor to markers of immune activation, but had a significant correlation with plasma viral load, revealing a possible role for mtDNA in inflammation, or as a biomarker of virus-induced damage., (Copyright © 2011 © Elsevier B.V. and Mitochondria Research Society. All rights reserved. Published by Elsevier B.V. All rights reserved.)

Published
2011
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39. Brucellosis in a patient with end-stage liver disease undergoing liver transplantation: successful treatment with tigecycline.

Author

Cocchi S, Bisi L, Codeluppi M, Venturelli C, Di Benedetto F, Ballarin R, Gerunda GE, Rumpianesi F, Esposito R, and Guaraldi G

Subjects
Adult, Brucella melitensis isolation & purification, Brucellosis complications, Brucellosis diagnosis, Carcinoma, Hepatocellular virology, Graft Rejection etiology, Graft Rejection surgery, Humans, Liver Failure virology, Liver Neoplasms virology, Male, Minocycline therapeutic use, Reoperation, Tigecycline, Treatment Outcome, Anti-Bacterial Agents therapeutic use, Brucellosis drug therapy, Carcinoma, Hepatocellular surgery, Hepatitis C complications, Liver Failure surgery, Liver Neoplasms surgery, Liver Transplantation adverse effects, Minocycline analogs & derivatives
Published
2010
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40. One-pill once-a-day HAART: a simplification strategy that improves adherence and quality of life of HIV-infected subjects.

Author

Airoldi M, Zaccarelli M, Bisi L, Bini T, Antinori A, Mussini C, Bai F, Orofino G, Sighinolfi L, Gori A, Suter F, and Maggiolo F

Abstract

Objective: The aim of the ADONE (ADherence to ONE pill) study was to verify the effect of a reduced number of pills on adherence and quality of life (QoL) in HIV-infected patients on highly active antiretroviral therapy (HAART)., Design: Prospective, multicenter, study., Methods: Patients chronically treated with emtricitabine (FTC) + tenofovir (TDF) + efavirenz (EFV) or lamivudine (3TC) +TDF +EFV and with a HIV-RNA < 50 copies/mL were switched to the single-pill fixed-dose regimen (FDR) of FTC +TDF +EFV. Data were collected with SF-36 using visual analog scales. Results of the final (6 months) primary as-treated analysis are reported., Results: 212 patients (77.4% males) of mean age 45.8 years were enrolled; 202 completed the study. One month post switch to FDR the adherence rate increased significantly to 96.1% from a baseline value of 93.8% (P < 0.01). The increase was steadily maintained throughout the study (96.2% at 6 months). QoL improved over time from 68.8% to 72.7% (P = 0.042) as well, and was significantly associated with the perception of health status, presence of adverse events (AEs) and number of reported AEs (P < 0.0001). QoL significantly influenced adherence (P < 0.0001). During FDR use the mean CD4 count increased from 556 to 605 cells/muL (P < 0.0001). At the end of follow-up 98% of patients maintained HIV-RNA level < 50 copies/mL and 100% <400 copies/mL. Four patients stopped therapy because they were lost to follow-up and 6 because of AEs (insomnia/nervousness 4, allergy 1, difficulties swallowing pills 1)., Conclusion: By substituting a one-pill once-a-day HAART, we observed an improvement of both adherence and QoL while maintaining high virologic and immunologic efficacy. HAART simplicity is an added value that favors adherence and may improve long-term success.

Published
2010
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41. Predictive value of intracellular HIV-1 DNA levels during CD4-guided treatment interruption in HIV+ patients.

Author

Nasi M, Pinti M, Manzini S, Gibellini L, Manzini L, Bisi L, De Biasi S, Del Giovane C, D'Amico R, Borghi V, Mussini C, and Cossarizza A

Subjects
Adult, CD4 Lymphocyte Count, DNA, Viral genetics, DNA, Viral isolation & purification, Drug Administration Schedule, Female, HIV Infections virology, HIV-1 genetics, Humans, Male, Middle Aged, Predictive Value of Tests, Treatment Outcome, Anti-HIV Agents administration & dosage, Anti-HIV Agents therapeutic use, CD4-Positive T-Lymphocytes virology, DNA, Viral blood, HIV Infections drug therapy, HIV Infections immunology, HIV-1 drug effects
Abstract

The amount of HIV-1 DNA within peripheral blood mononuclear cells is an important marker of viral activity. We studied intracellular HIV-1 DNA content in purified CD4(+) T cells from 28 chronically HIV-1-infected adults with sustained CD4(+) T cell counts (>500 cells/microl) and undetectable plasma viral load (<50 copies/ml), who underwent CD4-guided treatment interruption (TI). Patients were followed up for 18 months during TI, and for 6 months after treatment resumption (TR). Six naïve HIV(+) patients starting therapy were also enrolled and followed up for 6 months. All patients were studied every 2 months; HIV-1 DNA copy number was quantified with real-time PCR. Considering all patients remaining off-treatment, in the first 18 months of TI, intracellular HIV-1 DNA levels (expressed as Log(10) copies/million cells) remained stable (mean, 3.82 and 3.77 at time 0 and after 18 months, respectively). Similarly, HIV-1 DNA values, either in patients who restarted treatment after TI (time 0, 4.90) or in naïve patients who started treatment for the first time (time 0, 4.37), did not change significantly in the first 6 months of therapy (4.42 and 3.67, respectively). Evaluating HIV-1 DNA variations during the first 2 months of TI, we found that patients with a stable level had a lower risk to reach a CD4(+) T cell count <350 cells/microl, and thus to restart therapy, whereas this risk was significantly higher in those with a marked increase of HIV-1 DNA. In conclusion, intracellular HIV-1 DNA is a predictive marker for the length of CD4-guided TI.

Published
2010
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