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1. Analysis of Patients’ Characteristics and Treatment Profile of People Who Use Drugs (PWUDs) with and without a Co-Diagnosis of Viral Hepatitis C: A Real-World Retrospective Italian Analysis

Author

Nava FA, Mangia A, Riglietta M, Somaini L, Foschi FG, Claar E, Maida I, Ucciferri C, Frigerio F, Hernandez C, Dovizio M, Perrone V, Degli Esposti L, and Puoti M

Subjects
drug abuse, hepatitis c virus, alcohol dependency, real-world evidence, Therapeutics. Pharmacology, RM1-950
Abstract

Felice Alfonso Nava,1 Alessandra Mangia,2 Marco Riglietta,3 Lorenzo Somaini,4 Francesco Giuseppe Foschi,5 Ernesto Claar,6 Ivana Maida,7 Claudio Ucciferri,8 Francesca Frigerio,9 Candido Hernandez,10 Melania Dovizio,11 Valentina Perrone,11 Luca Degli Esposti,11 Massimo Puoti12 1U.O. Sanità Penitenziaria e Area Dipendenze, Azienda ULSS 6 Euganea, Padova, Italy; 2UOS Epatologia, Istituto di Ricovero e Cura “Casa Sollievo della Sofferenza”, S. Giovanni Rotondo, Italy; 3UOC Dipendenze, ASST Papa Giovanni XXIII, Bergamo, Italy; 4Servizio per le Dipendenze, SERT di Cossato, Biella, Italy; 5UOC Medicina Interna, Ospedale di Faenza, Faenza, Italy; 6UOC Medicina Interna, Ospedale Evangelico “Villa Betania”, Napoli, Italy; 7UOC Malattie Infettive e Parassitarie, Azienda Ospedaliero Universitaria di Sassari, Sassari, Italy; 8Clinica di Malattie Infettive Ospedale “SS Annunziata”, Chieti, Italy; 9Gilead Sciences, Milano, Italy; 10Gilead Sciences, Global Medical Affairs, Stockley Park, London, UB11 1BD, UK; 11CliCon S.R.L. Società Benefit, Health Economics and Outcomes Research, Bologna, Italy; 12SC Malattie Infettive, ASST Grande Ospedale Metropolitano Niguarda, Milano, ItalyCorrespondence: Luca Degli Esposti, CliCon S.r.l. Società Benefit, Health, Economics & Outcomes Research, Via Murri, 9, Bologna, 40137, Italy, Tel +39 544 38393, Fax +39 544 212699, Email luca.degliesposti@clicon.itPurpose: Hepatitis C virus (HCV) spreads from contact with blood of an infected person. HCV infections are common among people who use drugs (PWUDs), when sharing needles, syringes, or other equipment for injected drugs. The advent of pangenotypic direct-antiviral agents (DAA) in 2017 transformed the treatment landscape for HCV, but PWUDs remain a complex and hard-to-treat population with high risk of HCV reinfection. The aim of this real-world analysis was to characterize the demographic and clinical features of PWUDs in Italy, also focusing on comorbidity profile, treatment with DAAs, resource consumptions for the National Health System (NHS).Patients and Methods: During 01/2011– 06/2020, administrative databases of Italian healthcare entities, covering 3,900,000 individuals, were browsed to identify PWUDs with or without HCV infection. Among HCV+ patients, a further stratification was made into treated and untreated with DAAs. The date of PWUD or HCV first diagnosis or DAA first prescription was considered as index-date. Patients were then followed-up for one year. Alcohol-dependency was also investigated.Results: Total 3690 PWUDs were included, of whom 1141 (30.9%) PWUD-HCV+ and 2549 (69.1%) PWUD-HCV-. HCV-positive were significantly older (43.6 vs 38.5 years, p < 0.001), had a worse comorbidity profile (Charlson-index: 0.8 vs 0.4, p < 0.001), and high rates of psychiatric, respiratory, dermatological, musculoskeletal diseases and genitourinary (sexually transmitted) infections. Moreover, they received more drug prescriptions (other than DAAs, like anti-acids, antiepileptics, psycholeptics) and had undergone more frequent hospitalization, predominantly for hepatobiliary, respiratory system and mental disorders. DDA-untreated had significantly higher Charlson-index than DAA-treated (0.9 vs 0.6, p = 0.003). Alcoholism was found in 436 (11.8%) cases.Conclusion: This Italian real-world analysis suggests that PWUDs with HCV infection, especially those untreated with DAAs, show an elevated drug consumption due to their complex clinical profile. These findings could help to ameliorate the healthcare interventions on PWUDs with HCV infection.Keywords: drug abuse, hepatitis C virus, alcohol dependency, real-world evidence

Published
2023

2. Analysis of Patients’ Characteristics and Treatment Profile of People Who Use Drugs (PWUDs) with and without a Co-Diagnosis of Viral Hepatitis C: A Real-World Retrospective Italian Analysis

Author

Nava, F, Mangia, A, Riglietta, M, Somaini, L, Foschi, F, Claar, E, Maida, I, Ucciferri, C, Frigerio, F, Hernandez, C, Dovizio, M, Perrone, V, Degli Esposti, L, Puoti, M, Nava F. A., Mangia A., Riglietta M., Somaini L., Foschi F. G., Claar E., Maida I., Ucciferri C., Frigerio F., Hernandez C., Dovizio M., Perrone V., Degli Esposti L., Puoti M., Nava, F, Mangia, A, Riglietta, M, Somaini, L, Foschi, F, Claar, E, Maida, I, Ucciferri, C, Frigerio, F, Hernandez, C, Dovizio, M, Perrone, V, Degli Esposti, L, Puoti, M, Nava F. A., Mangia A., Riglietta M., Somaini L., Foschi F. G., Claar E., Maida I., Ucciferri C., Frigerio F., Hernandez C., Dovizio M., Perrone V., Degli Esposti L., and Puoti M.

Abstract

Purpose: Hepatitis C virus (HCV) spreads from contact with blood of an infected person. HCV infections are common among people who use drugs (PWUDs), when sharing needles, syringes, or other equipment for injected drugs. The advent of pangenotypic direct-antiviral agents (DAA) in 2017 transformed the treatment landscape for HCV, but PWUDs remain a complex and hard-to-treat population with high risk of HCV reinfection. The aim of this real-world analysis was to characterize the demographic and clinical features of PWUDs in Italy, also focusing on comorbidity profile, treatment with DAAs, resource consumptions for the National Health System (NHS). Patients and Methods: During 01/2011–06/2020, administrative databases of Italian healthcare entities, covering 3,900,000 individuals, were browsed to identify PWUDs with or without HCV infection. Among HCV+ patients, a further stratification was made into treated and untreated with DAAs. The date of PWUD or HCV first diagnosis or DAA first prescription was considered as index-date. Patients were then followed-up for one year. Alcohol-dependency was also investigated. Results: Total 3690 PWUDs were included, of whom 1141 (30.9%) PWUD-HCV+ and 2549 (69.1%) PWUD-HCV-. HCV-positive were significantly older (43.6 vs 38.5 years, p < 0.001), had a worse comorbidity profile (Charlson-index: 0.8 vs 0.4, p < 0.001), and high rates of psychiatric, respiratory, dermatological, musculoskeletal diseases and genitourinary (sexually transmitted) infections. Moreover, they received more drug prescriptions (other than DAAs, like anti-acids, antiepileptics, psycholeptics) and had undergone more frequent hospitalization, predominantly for hepatobiliary, respiratory system and mental disorders. DDA-untreated had significantly higher Charlson-index than DAA-treated (0.9 vs 0.6, p = 0.003). Alcoholism was found in 436 (11.8%) cases. Conclusion: This Italian real-world analysis suggests that PWUDs with HCV infection, especially those untreat

Published
2023

4. Francesco Somaini. Alle origini del sacro

Author

Somaini, L., Tedeschi, F., Tedeschi, Francesco, Tedeschi Francesco (ORCID:0000-0002-8007-4258), Somaini, L., Tedeschi, F., Tedeschi, Francesco, and Tedeschi Francesco (ORCID:0000-0002-8007-4258)

Abstract

The text regards the way into which the Italian artist Francesco Somaini has confronted with the themes of sacred art, with particular attention to the works he realized at the end of the Sixties for a project about the relation to life, death and regeneration in his way of creating plastic forms for a "retablo" that he exhibited during a show in Palazzo Te in Mantova. That project has been object of a reprise in his thinking about his work in a letter to the Italian critic Enrico Crispolti, very close to the artist. The opportunity to exhibit all the scultpures that were part of that project, with the documents and pictures concerning that moment, permitted to pursue the reflections about the terms into which Somaini related to the themes of "sacred" as part of his inspiration and his way of creating in his sculpture of different moments, starting with the "Crosses" he realized at the end of the Fifties.

Published
2023

14. Hepatitis C virus infection among drug addicts in Italy

Author

Stroffolini T, D'Egidio PF, Aceti A, Puoti M, Leonardi C, Almasio PL, Pieri MC, Balestra R, Lucchini A, Riglietta M, Marino V, Bignamini E, Somaini L, Lovaste, R., Nava, F., Fasciani P, Cesarini F, Meini M, Ruffa F, Pedetti M, D'Amore A, Nigro C, Buttazzo R, Taranto A, Magnelli F, Faillace G, Ferdico M, Montesano F. Hepatitis C. virus infection among drug addicts in Italy Journal of Medical Virology, p.p. 1608 1612, FILIPPINI, Pietro, Stroffolini, T, D'Egidio, Pf, Aceti, A, Filippini, Pietro, Puoti, M, Leonardi, C, Almasio, Pl, Pieri, Mc, Balestra, R, Lucchini, A, Riglietta, M, Marino, V, Bignamini, E, Somaini, L, Lovaste, R., Nava, F., Fasciani, P, Cesarini, F, Meini, M, Ruffa, F, Pedetti, M, D'Amore, A, Nigro, C, Buttazzo, R, Taranto, A, Magnelli, F, Faillace, G, Ferdico, M, Montesano F. Hepatitis C., virus infection among drug addicts in Italy Journal of Medical Virology, and 1608 1612, p. p.

Published
2012

18. Global impact of prescription opioid misuse: Europe and U.S.

Author

Green, J.L., primary, Martinez, E.M., additional, Rosenblum, Andrew, additional, Cicero, Theodore, additional, Dart, Richard, additional, Walcher, S., additional, Somaini, L., additional, Deruvo, G., additional, Desel, H., additional, Milanesi, G., additional, Sesana, F., additional, Guareschi, M., additional, McBride, K., additional, Maremmani, I., additional, and Parrino, M., additional

Published
2015
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19. SY15-4 * PRESCRIPTION OPIOIDS IN SOUTHERN EUROPE: FRANCE

Author

Touzeau, D., primary, Green, J. L., additional, Maremmani, I., additional, Torrens, M., additional, Walcher, S., additional, Deruvo, G., additional, Somaini, L., additional, Martines, D., additional, Rossi, P., additional, Martinez-Riera, R., additional, and Fonseca, F., additional

Published
2014
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20. The Italian Manifesto for the treatment of heroin addiction. The mixed care model a proposed layout for a new healthcare system for citizens with heroin addiction

Author

Maremmani, I, Barra, M, Burton-Phillips, E, Cecchini, I, di Chiara, G, Gerra, G, Mantovani, L, Pani, P, Pitts, G, Rossi, A, Somaini, L, Starace, F, Mantovani LG, Pani, PP, Maremmani, I, Barra, M, Burton-Phillips, E, Cecchini, I, di Chiara, G, Gerra, G, Mantovani, L, Pani, P, Pitts, G, Rossi, A, Somaini, L, Starace, F, Mantovani LG, and Pani, PP

Published
2013

21. Model-based Heart rate prediction during Lokomat walking

Author

Koenig, A C, Somaini, L, Pulfer, M, Holenstein, T, Omlin, X, Wieser, M, Riener, R, Koenig, A C, Somaini, L, Pulfer, M, Holenstein, T, Omlin, X, Wieser, M, and Riener, R

Abstract

We implemented a model for prediction of heart rate during Lokomat walking. Using this model, we can predict potential overstressing of the patient and adapt the physical load accordingly. Current models for treadmill based heart rate control neglect the fact that the interaction torques between Lokomat and human can have a significant effect on heart rate. Tests with five healthy subjects lead to a model of sixth order with walking speed and power expenditure as inputs and heart rate prediction as output. Recordings with five different subjects were used for model validation. Future work includes model identification and predictive heart rate control with spinal cord injured and stroke patients.

Published
2009

49. Relevance of perceived childhood neglect, 5HTT gene variants and hypothalamus–pituitary–adrenal axis dysregulation to substance abuse susceptibilityThe views expressed herein are those of the authors and do not necessarily reflect the views of the United Nations.How to Cite this Article: Gerra G, Zaimovic A, Castaldini L, Garofano L, Manfredini M, Somaini L, Leonardi C, Gerra ML, Donnini C. 2010. Relevance of Perceived Childhood Neglect, 5HTT Gene Variants and Hypothalamus–Pituitary–Adrenal Axis Dysregulation to Substance Abuse Susceptibility. Am J Med Genet Part B 153B:715–722.

Author

Gerra, G., Zaimovic, A., Castaldini, L., Garofano, L., Manfredini, M., Somaini, L., Leonardi, C., Gerra, M.L., and Donnini, C.

Abstract

The hypotheses of 1 gene × environment interaction in the susceptibility to experiment with drugs and 2 hypothalamus–pituitary–adrenal HPA axis involvement in mediating the effects of early adverse experiences and gene variants affecting serotonin function on substance abuse vulnerability were tested by investigating in 187 healthy adolescents the possible relevance of 5HTT “S” polymorphism, childhood parental neglect reported retrospectively and HPA axis function to the susceptibility to experiment with illicit drugs. Higher frequency of the 5HTT SS genotype seems to be associated with an increased susceptibility to use illegal psychotropic drugs among the adolescents. At the same time, reduced maternal care perception was found to represent a key intermediate factor of the association between SS polymorphism and drug use, suggesting that genetic factors and parental behavior concur to drug use susceptibility. Our results also confirm the relationship between basal plasma levels of cortisol and adrenocorticotropic hormone ACTH on the one hand, and retrospective measures of neglect during childhood: the higher the mother and father neglect CECAQ scores, the higher the plasma levels of the two HPA hormones. Such positive relationship has been proved to be particularly effective and important when associated to the Sallele, both in homozygote and heterozygote individuals. However, when tested together with genotype and parental neglect, the effect of HPA hormones such as cortisol and ACTH was not found to improve significantly the explanatory power of the risk model. © 2009 WileyLiss, Inc.

Published
2010
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