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2. 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

Kondili, Loreta A., GAETA, Giovanni Battista, Ieluzzi, Donatella, Zignego, Anna Linda, Monti, Monica, Gori, Andrea, Soria, Alessandro, Raimondo, Giovanni, Filomia, Roberto, Leo, Alfredo Di, Iannone, Andrea, Massari, Marco, Corsini, Romina, Gulminetti, Roberto, Comini, Alberto Gatti, Toniutto, Pierluigi, Dissegna, Denis, Russo, Francesco Paolo, Zanetto, Alberto, Rumi, Maria Grazia, Brancaccio, Giuseppina, Danieli, Elena, Brunetto, Maurizia Rossana, Weimer, Liliana Elena, Quaranta, Maria Giovanna, Vella, Stefano, Puoti, Massimo, PITER Cohort Study, FEDERICO, Alessandro, Dallio, M, LOGUERCIO, Carmelina, Kondili, L, Gaeta, G, Ieluzzi, D, Zignego, A, Monti, M, Gori, A, Soria, A, Raimondo, G, Filomia, R, Leo, A, Iannone, A, Massari, M, Corsini, R, Gulminetti, R, Comini, A, Toniutto, P, Dissegna, D, Russo, F, Zanetto, A, Rumi, M, Brancaccio, G, Danieli, E, Brunetto, M, Weimer, L, Quaranta, M, Vella, S, Puoti, M, Kondili, Loreta A., Gaeta, Giovanni Battista, Ieluzzi, Donatella, Zignego, Anna Linda, Monti, Monica, Gori, Andrea, Soria, Alessandro, Raimondo, Giovanni, Filomia, Roberto, Leo, Alfredo Di, Iannone, Andrea, Massari, Marco, Corsini, Romina, Gulminetti, Roberto, Comini, Alberto Gatti, Toniutto, Pierluigi, Dissegna, Deni, Russo, Francesco Paolo, Zanetto, Alberto, Rumi, Maria Grazia, Brancaccio, Giuseppina, Danieli, Elena, Brunetto, Maurizia Rossana, Weimer, Liliana Elena, Quaranta, Maria Giovanna, Vella, Stefano, Puoti, Massimo, PITER Cohort, Study, Federico, Alessandro, Dallio, M, and Loguercio, Carmelina

Subjects
Genetics and Molecular Biology (all), Male, Cirrhosis, Disease, Hepacivirus, Toxicology, Biochemistry, Viral infection, 0302 clinical medicine, 80 and over, Medicine, Prospective Studies, Chronic, lcsh:Science, media_common, Aged, 80 and over, Liver Diseases, Drug Interaction, Italy, Adult, Aged, Antiviral Agents, Drug Administration Schedule, Drug Therapy, Combination, Female, Hepatitis C, Chronic, Humans, Interferons, Liver Cirrhosis, Middle Aged, Risk, Drug Interactions, Medicine (all), Biochemistry, Genetics and Molecular Biology (all), Agricultural and Biological Sciences (all), 030220 oncology & carcinogenesis, Interferon, 030211 gastroenterology & hepatology, Human, Cohort study, Drug, medicine.medical_specialty, media_common.quotation_subject, Drug-Drug Interactions, Gastroenterology and Hepatology, Microbiology, 03 medical and health sciences, Drug Therapy, Pharmacology, Hepaciviru, Flaviviruses, lcsh:R, Organisms, Correction, medicine.disease, Prospective Studie, Regimen, Immunology, lcsh:Q, RNA viruses, lcsh:Medicine, 030204 cardiovascular system & hematology, medicine.disease_cause, Cohort Studies, Liver disease, Drug Metabolism, Medicine and Health Sciences, 030212 general & internal medicine, Prospective cohort study, Pathology and laboratory medicine, Multidisciplinary, HCV DAA, Hepatitis C virus, Antiviral therapy, Medical microbiology, Hepatitis C, Real life data, Research Design, Combination, Viruses, Pathogens, Research Article, Liver Cirrhosi, Biology, Research and Analysis Methods, Chronic hepatitis, Internal medicine, Pharmacokinetics, In patient, Antiviral Agent, Biology and life sciences, Toxicity, business.industry, Interferon free, Viral pathogens, Hepatitis viruses, Microbial pathogens, business
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
2018
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3. 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

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

Published
2018
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4. 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

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

Published
2017
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6. Maraviroc as Intensification Strategy in HIV-1 Positive Patients with Deficient Immunological Response: an Italian Randomized Clinical Trial

Author

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

Published
2013
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7. Risk of Chronic Kidney Disease among Patients Developing Mild Renal Impairment during Tenofovir-Containing Antiretroviral Treatment.

Author

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

Subjects
CHRONIC kidney failure, TENOFOVIR, ANTIRETROVIRAL agents, GLOMERULAR filtration rate, KIDNEY tubules, DISEASES, THERAPEUTICS, DISEASE risk factors
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 eGFR<60 ml/min 3 to 6 months apart. Multivariable Poisson regression analysis was used to investigate whether outcome was associated with current and cumulative use of TDF (modeled as time-varying covariates). Results: 2023 (29%) out of 6984 patients developed mild renal impairment on TDF. Among them, 191 progressed to CKD. The incidence of CKD did not significantly differ during TDF treatment (2.6 per 100 PYFU; 95%CI 2.2–3.2) or after its discontinuation (2.2 per 100 PYFU; 95%CI 1.8–2.6). However, the rate of CKD was significantly higher among patients continuing with TDF treatment compared to those who had discontinued it within 6 months of occurrence of mild renal impairment (aIRR 4, 95%CI 2.4–6.8). In contrast, among patients who had maintained TDF >6 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. [ABSTRACT FROM AUTHOR]

Published
2016
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8. 96 Week Follow-Up of HIV-Infected Patients in Rescue with Raltegravir Plus Optimized Backbone Regimens: A Multicentre Italian Experience

Author

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

Published
2012
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9. KIR-HLA Genotypes in HIV-Infected Patients Lacking Immunological Recovery despite Effective Antiretroviral Therapy

Author

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

Published
2011
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10. CD4+ T Cell Depletion, Immune Activation and Increased Production of Regulatory T Cells in the Thymus of HIV-Infected Individuals

Author

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

Published
2010
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11. 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

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

Subjects
*ANTIRETROVIRAL agents, *HIV infections, *CD4 antigen, *T cells, *CLINICAL trials, *LONGITUDINAL method
Abstract

Background: 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. Methods: 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. Results: 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. Conclusions: 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. Trial Registration: EU Clinical Trial Register EUDRACT number 2008-006188-35 [ABSTRACT FROM AUTHOR]

Published
2015
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