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1. Efficacy and durability of two‐ vs . three‐drug integrase inhibitor‐based regimens in virologically suppressed HIV‐infected patients: Data from real‐life ODOACRE cohort

Author

Fabbiani, M., Rossetti, B., Ciccullo, A., Oreni, L., Lagi, F., Celani, L., Colafigli, M., De Vito, A., Mazzitelli, M., Dusina, A., Durante, M., Montagnani, F., Rusconi, S., Capetti, A., Sterrantino, G., D'Ettorre, G., Di Giambenedetto, S., Zanelli, G., Baldin, G., Borghetti, A., Latini, A., Mastroianni, C., Borghi, V., Mussini, C., Cossu, M. V., Giacomelli, A., Formenti, T., Trecarichi, E. M., Torti, C., Madeddu, G., Vecchiet, J., Vignale, F., and Giacometti, A.

Subjects
Adult, medicine.medical_specialty, antiretroviral therapy, Integrase inhibitor, HIV Infections, Settore MED/17 - MALATTIE INFETTIVE, 3-Ring, Gastroenterology, Cohort Studies, chemistry.chemical_compound, Heterocyclic Compounds, Interquartile range, Raltegravir Potassium, Internal medicine, Oxazines, Humans, Medicine, Pharmacology (medical), HIV Integrase Inhibitors, InSTI, dual therapy, treatment discontinuation, virological failure, Heterocyclic Compounds, 3-Ring, Lamivudine, Viral Load, business.industry, Elvitegravir, Health Policy, Raltegravir, Discontinuation, Regimen, Infectious Diseases, Tolerability, chemistry, Dolutegravir, business, medicine.drug
Abstract

The aim of the present study was to compare the efficacy and durability of treatment switch to two-drug (2DR) vs. three-drug (3DR) integrase inhibitor (InSTI)-based regimens in a real-life setting.Within the ODOACRE cohort, we selected adult patients with HIV RNA 50 copies/mL switching to an InSTI-based 2DR or 3DR. Survival analyses were performed to estimate the probability of virological failure (VF, defined as one HIV RNA 1000 copies/mL or two consecutive HIV RNA 50 copies/mL) and treatment discontinuation (TD, defined as any modification, intensification or interruption of the regimen), and to evaluate their predictors.Overall, 1666 patients were included, of whom 1334 (80%) were treated with a 3DR (19.9%, 25.0% and 55.1% elvitegravir-, raltegravir- and dolutegravir-based, respectively) and 332 (20%) with a 2DR (79.2% dolutegravir + lamivudine and 20.8% dolutegravir + rilpivirine). Over a median (interquartile range) follow-up of 100 (52-150) weeks, 52 (3.1%) patients experienced VF with an incidence of 1.5/100 person-year of follow-up (PYFU). The estimated 96-week probability of VF was similar for the 2DR and 3DR groups (2.3% vs. 2.8%, P = 0.53), but it was higher for elvitegravir (4.9%) and raltegravir (5.0%) than for dolutegravir (1.5%) (P = 0.04). Four hundred (24%) patients discontinued their InSTI-based regimen, with an incidence of 11.3/100 PYFU. At 96 weeks, 3DRs showed a higher probability of TD for any reason (20.6% vs. 11.2%, P 0.001) and TD for toxicity (9.0% vs. 6.6%, P = 0.02) when compared with 2DRs. A higher risk of TD for central nervous system toxicity was observed for dolutegravir than for elvitegravir and raltegravir (4.0% vs. 2.5% vs. 0.6%, P = 0.005).In virologically suppressed HIV-infected patients, 2DRs showed an efficacy similar to 3DRs but with better tolerability.

Published
2021

2. The Effect of Switching to Maraviroc + Darunavir/Ritonavir Dual Therapy in Virologically Suppressed Patients on the Progression of Liver Fibrosis: Findings From a Randomized Study

Author

Rossetti, B., Gagliardini, R., Sterrantino, G., Colangeli, V., Latini, A., Colafigli, M., Vignale, F., Rusconi, S., Di Biagio, A., Orofino, G., Mezzaroma, I., Vullo, V., Francisci, D., Mastroianni, C., Trezzi, M., Canovari, B., Lamonica, S., Ciccullo, A., Borghetti, A., D'Arminio Monforte, A., Di Giambenedetto, S., De Luca, A., and GUSTA trial study group

Subjects
Oncology, Liver Cirrhosis, Male, medicine.medical_specialty, Darunavir+Ritonavir, Anti-HIV Agents, Liver fibrosis, Antiretroviral Therapy, HIV Infections, Darunavir, Disease Progression, Drug Substitution, Female, HIV-1, Humans, Maraviroc, Middle Aged, Ritonavir, Antiretroviral Therapy, Highly Active, Settore MED/17 - MALATTIE INFETTIVE, law.invention, chemistry.chemical_compound, Randomized controlled trial, law, Internal medicine, medicine, Pharmacology (medical), Highly Active, Dual therapy, Letters to the Editor, business.industry, fibrosis, Disease progression, HIV, Antiretroviral therapy, Infectious Diseases, chemistry, business
Published
2019

3. Treatment simplification to atazanavir/ritonavir+lamivudine versus maintenance of atazanavir/ritonavir+two NRTIs in virologically suppressed HIV-1-infected patients: 48 week results from a randomized trial (ATLAS-M)

Author

Di Giambenedetto, S., Fabbiani, M., Quiros Roldan, E., Latini, A., D'Ettorre, G., Antinori, A., Castagna, A., Orofino, G., Francisci, D., Chinello, P., Madeddu, G., Grima, P., Rusconi, S., Di Pietro, M., Mondi, A., Ciccarelli, N., Borghetti, A., Focà, E., Colafigli, M., De Luca, A., Cauda, R., Baldonero, E., Belmonti, S., D'Avino, A., Gagliardini, R., Lamonica, S., Lombardi, F., Sidella, L., Tamburrini, E., Visconti, E., Giacometti, A., Barchiesi, F., Castelli, P., Cirioni, O., Mazzocato, S., Blanc, P., Degli Esposti, A., Del Pin, B., Mariabelli, E., Marini, S., Poggi, A., Amadasi, S., Apostoli, A., Biasi, L., Bonito, A., Brianese, N., Compostella, S., Ferraresi, A., Motta, D., Mughini, M. T., Celesia, B. M., Gussio, M., Sofia, S., Tana, M., Tundo, P., Viscoli, C., De Hoffer, L., Di Biagio, A., Grignolo, S., Parisini, A., Schenone, E., Taramasso, L., Manconi, P. E., Boccone, A., Ortu, F., Piano, P., Serusi, L., Puoti, M., Moioli, M. C., Rossotti, R., Travi, G., Ventura, F., Galli, M., Di Nardo Stuppino, S., Di Cristo, V., Giacomelli, A., Vimercati, V., Viale, P., Gori, A., Rizzardini, G., Capetti, A., Carenzi, L., Mazza, F., Meraviglia, P., Rosa, S., Zucchi, P., Mineo, M., Giuliani, M., Pacifici, A., Pimpinelli, F., Solivetti, F., Stivali, F., Angelici, F., Bellagamba, R., Delle Rose, D., Fezza, R., Libertone, R., Mosti, S., Narciso, P., Nicastri, E., Ottou, S., Tomassi, C., Vlassi, C., Zaccarelli, M., Zoppè, F., Vullo, V., Altavilla, F., Ceccarelli, G., Fantauzzi, A., Gebremeskel, S., Lo Menzo, S., Mezzaroma, I., Tierno, F., Petrosillo, N., Boumis, E., Cicalini, S., Grilli, E., Musso, M., Stella, C., Mura, M. S., Bagella, P., Mannazzu, M., Soddu, V., Caramello, P., Carcieri, C., Carosella, S., Farenga, M., Scotton, P. G., Rossi, M. C., Concia, E., Corsini, F., Gricolo, C., Lanzafame, M., Lattuada, E., Leonardi, S., Rigo, F., Lazzarin, A., Bigoloni, A., Carini, E., Nozza, S., Spagnuolo, V., Belfiori, B., Malincarne, L., Schiaroli, E., Sfara, C., Tosti, A., Sacchini, D., Ruggieri, A., Valdatta, C., Di Giambenedetto, S, Fabbiani, M, Quiros Roldan, E, Latini, A, D'Ettorre, G, Antinori, A, Castagna, A, Orofino, G, Francisci, D, Chinello, P, Madeddu, G, Grima, P, Rusconi, S, Di Pietro, M, Mondi, A, Ciccarelli, N, Borghetti, A, Foca, E, Colafigli, M, De Luca, A, Cauda, R, Baldonero, E, Belmonti, S, D'Avino, A, Gagliardini, R, Lamonica, S, Lombardi, F, Sidella, L, Tamburrini, E, Visconti, E, Giacometti, A, Barchiesi, F, Castelli, P, Cirioni, O, Mazzocato, S, Blanc, P, Degli Esposti, A, Del Pin, B, Mariabelli, E, Marini, S, Poggi, A, Amadasi, S, Apostoli, A, Biasi, L, Bonito, A, Brianese, N, Compostella, S, Ferraresi, A, Motta, D, Mughini, M, Celesia, B, Gussio, M, Sofia, S, Tana, M, Tundo, P, Viscoli, C, De Hoffer, L, Di Biagio, A, Grignolo, S, Parisini, A, Schenone, E, Taramasso, L, Manconi, P, Boccone, A, Ortu, F, Piano, P, Serusi, L, Puoti, M, Moioli, M, Rossotti, R, Travi, G, Ventura, F, Galli, M, Di Nardo Stuppino, S, Di Cristo, V, Giacomelli, A, Vimercati, V, Viale, P, Gori, A, Rizzardini, G, Capetti, A, Carenzi, L, Mazza, F, Meraviglia, P, Rosa, S, Zucchi, P, Mineo, M, Giuliani, M, Pacifici, A, Pimpinelli, F, Solivetti, F, Stivali, F, Angelici, F, Bellagamba, R, Delle Rose, D, Fezza, R, Libertone, R, Mosti, S, Narciso, P, Nicastri, E, Ottou, S, Tomassi, C, Vlassi, C, Zaccarelli, M, Zoppe, F, Vullo, V, Altavilla, F, Ceccarelli, G, Fantauzzi, A, Gebremeskel, S, Lo Menzo, S, Mezzaroma, I, Tierno, F, Petrosillo, N, Boumis, E, Cicalini, S, Grilli, E, Musso, M, Stella, C, Mura, M, Bagella, P, Mannazzu, M, Soddu, V, Caramello, P, Carcieri, C, Carosella, S, Farenga, M, Scotton, P, Rossi, M, Concia, E, Corsini, F, Gricolo, C, Lanzafame, M, Lattuada, E, Leonardi, S, Rigo, F, Lazzarin, A, Bigoloni, A, Carini, E, Nozza, S, Spagnuolo, V, Belfiori, B, Malincarne, L, Schiaroli, E, Sfara, C, Tosti, A, Sacchini, D, Ruggieri, A, Valdatta, C, Roldan, Eq, Focà, E, and on behalf of the Atlas-M Study, Group

Subjects
Male, 0301 basic medicine, HIV Infections, ART HIV, Gastroenterology, law.invention, 0302 clinical medicine, Randomized controlled trial, immune system diseases, law, Antiretroviral Therapy, Highly Active, HIV Infection, Pharmacology (medical), Viral, 030212 general & internal medicine, Adult, Atazanavir Sulfate, Coinfection, Drug Therapy, Combination, Female, HIV-1, Humans, Lamivudine, Middle Aged, RNA, Viral, Ritonavir, Viral Load, Young Adult, Pharmacology, Infectious Diseases, virus diseases, dual therapy, Combination, Viral load, Human, medicine.drug, Microbiology (medical), medicine.medical_specialty, 030106 microbiology, Antiretroviral Therapy, Settore MED/17 - MALATTIE INFETTIVE, 03 medical and health sciences, Drug Therapy, Internal medicine, medicine, Highly Active, Adverse effect, business.industry, Surgery, Atazanavir, Regimen, RNA, business
Abstract

Background: Combination ART (cART)-related toxicities and costs have prompted the need for treatment simplification. The ATLAS-M trial explored 48 week non-inferior efficacy of simplification to atazanavir/ritonavir + lamivudine versus maintaining three-drug atazanavir/ritonavir-based cART in virologically suppressed patients. Methods: We performed an open-label, multicentre, randomized, non-inferiority study, enrolling HIV-infected adults on atazanavir/ritonavir+two NRTIs, with stable HIV-RNA 200 cells/mm3. Main exclusion criteria were hepatitis B virus coinfection, past virological failure on or resistance to study drugs, recent AIDS and pregnancy. Patients were randomly assigned 1:1 to either switch to 300mg of atazanavir/ 100mg of ritonavir once daily and 300mg of lamivudine once daily (atazanavir/ritonavir+lamivudine arm) or to continue the previous regimen (atazanavir/ritonavir+two NRTIs arm). The primary study outcome was the maintenance of HIV-RNA

Published
2017

4. Risk of Severe Non AIDS Events Is Increased among Patients Unable to Increase their CD4+ T-Cell Counts >200+/μl Despite Effective HAART

Author

LAPADULA, GIUSEPPE, GORI, ANDREA, Chatenoud, L, Castelli, F, Di Giambenedetto, S, Fabbiani, M, Maggiolo, F, Focà, E, Ladisa, N, Sighinolfi, L, Di Pietro, M, Pan, A, Torti, C, Carosi, G, Quiros, E, Nasta, P, Paraninfo, G, Cauda, R, Colafigli, M, Scalzini, A, Castelnuovo, F, El Hamad, I, Mazzotta, F, Locaputo, S, Pierotti, P, Marino, N, Blè, C, Vichi, F, Angarano, G, Monno, L, Maggi, P, Costarelli, S, Puoti, M, Viale, P, Colangeli, V, Borderi, M., Lapadula, G, Chatenoud, L, Gori, A, Castelli, F, Di Giambenedetto, S, Fabbiani, M, Maggiolo, F, Focà, E, Ladisa, N, Sighinolfi, L, Di Pietro, M, Pan, A, Torti, C, Carosi, G, Quiros, E, Nasta, P, Paraninfo, G, Cauda, R, Colafigli, M, Scalzini, A, Castelnuovo, F, El Hamad, I, Mazzotta, F, Locaputo, S, Pierotti, P, Marino, N, Blè, C, Vichi, F, Angarano, G, Monno, L, Maggi, P, Costarelli, S, Puoti, M, Viale, P, Colangeli, V, Borderi, M, Lapadula, G., Chatenoud, L., Gori, A., Castelli, F., Di Giambenedetto, S., Fabbiani, M., Maggiolo, F., Foca, E., Ladisa, N., Sighinolfi, L., Di Pietro, M., Pan, A., Torti, C., Carosi, G., Quiros, E., Nasta, P., Paraninfo, G., Cauda, R., Colafigli, M., Scalzini, A., Castelnuovo, F., El Hamad, I., Mazzotta, F., Locaputo, S., Pierotti, P., Marino, N., Ble, C., Vichi, F., Angarano, G., Monno, L., Maggi, P., Costarelli, S., Puoti, M., Viale, P., Colangeli, V., and Borderi, M.

Subjects
Male, Comorbidity, medicine.disease_cause, Risk Factors, Neoplasms, Antiretroviral Therapy, Highly Active, Cardiovascular Disease, education.field_of_study, Multidisciplinary, Coinfection, Incidence (epidemiology), Liver Diseases, Liver Disease, Medicine (all), Hepatitis C, Middle Aged, Viral Load, Cardiovascular Diseases, Disease Progression, Medicine, Female, Viral load, Research Article, Human, Adult, medicine.medical_specialty, Science, Hepatitis C virus, Population, Antiretroviral Therapy, Settore MED/17 - MALATTIE INFETTIVE, Acquired immunodeficiency syndrome (AIDS), Internal medicine, medicine, Humans, Highly Active, education, Acquired Immunodeficiency Syndrome, Biochemistry, Genetics and Molecular Biology (all), business.industry, Risk Factor, medicine.disease, CD4 Lymphocyte Count, cd4, Agricultural and Biological Sciences (all), Immunology, Neoplasm, business
Abstract

Background: Immunological non-response (INR) despite virological suppression is associated with AIDS-defining events/death (ADE). Little is known about its association with serious non-AIDS-defining events (nADE). Methods Patients highly-active antiretroviral therapy (HAART) with 50. Results: 1221 patients were observed for a median of 3 (IQR: 1.3-6.1) years. Pre-HAART CD4+were 77/μl (IQR: 28-142) and 56% of patients had experienced an ADE. After 1 year, CD4+ increased to 286 (IQR: 197-387), but 26.1% of patients were INR. Thereafter, 86 nADE (30.2% malignancies, 27.9%infectious, 17.4%renal, 17.4Êrdiovascular, 7% hepatic) were observed, accounting for an incidence of 1.83 events (95%CI: 1.73-2.61) per 100 PYFU. After adjusting for measurable confounders, INR had a significantly greater risk of nADE (HR 1.65; 95%CI: 1.06-2.56). Older age (per year, HR 1.03; 95%CI: 1.01-1.05), hepatitis C co-infection (HR 2.09; 95%CI: 1.19-3.7), a history of previous nADE (HR 2.16; 95% CI: 1.06-4.4) and the occurrence of ADE during the follow-up (HR 2.2; 95%CI: 1.15-4.21) were other independent predictors of newly diagnosed nADE. Conclusions: Patients failing to restore CD4+ to >200 cells/μl run a greater risk of serious nADE, which is intertwined or predicted by AIDS progression. Improved management of this fragile population and innovative therapy able to induce immune-reconstitution are urgently needed. Also, our results strengthen the importance of earlier diagnosis and HAART introduction.

Published
2015

5. Evolution of transmitted HIV-1 drug resistance in HIV-1-infected patients in Italy from 2000 to 2010

Author

Colafigli, M, Torti, C, Trecarichi, Em, Albini, L, Rosi, A, Micheli, V, Manca, N, Penco, G, Bruzzone, B, Punzi, G, Corsi, P, Parruti, G, Bagnarelli, P, Monno, L, Gonnelli, A, Cauda, R, Di Giambenedetto, S, Arca, Ucsc, Brescia HIV resistance study groups, Francisci, Daniela, Colafigli, M, Torti, C, Trecarichi, E, Albini, L, Rosi, A, Micheli, V, Manca, N, Penco, G, Bruzzone, B, Punzi, G, Corsi, P, Parruti, G, Bagnarelli, P, Monno, L, Gonnelli, A, Cauda, R, Di Giambenedetto, S, and Mancuso, S

Subjects
Adult, Male, Microbiology (medical), Cart, Drug, medicine.medical_specialty, Genotype, Anti-HIV Agents, media_common.quotation_subject, Human immunodeficiency virus (HIV), HIV Infections, Drug resistance, medicine.disease_cause, Article, Evolution, Molecular, 03 medical and health sciences, recent HIV infection, 0302 clinical medicine, Internal medicine, Drug Resistance, Viral, Prevalence, medicine, Humans, HIV Infection, 030212 general & internal medicine, media_common, 0303 health sciences, chronic HIV infection, 030306 microbiology, business.industry, Antiretroviral therapy, Chronic HIV infection, Recent HIV infection, Resistance epidemiology, Transmitted resistance, Infectious Diseases, Anti-HIV Agent, General Medicine, Middle Aged, transmitted resistance, Virology, 3. Good health, Italy, HIV-1, Genotypic resistance, Female, business, Human, resistance epidemiology
Abstract

Prevalence and predictors of transmitted drug resistance (TDR), defined as the presence of at least one WHO surveillance drug resistance mutation (SDRM), were investigated in antiretroviral-naïve HIV-1-infected patients, with a genotypic resistance test (GRT) performed ≤6months before starting cART between 2000 and 2010. 3163 HIV-1 sequences were selected (69% subtype B). Overall, the prevalence of TDR was 12% (13.2% subtype B, 9% non-B). TDR significantly declined overall and for the single drug classes. Older age independently predicted increased odds of TDR, whereas a more recent GRT, a higher HIV-RNA and C vs. B subtype predicted lower odds of TDR. © 2012 The Authors. Clinical Microbiology and Infection © 2012 European Society of Clinical Microbiology and Infectious Diseases.

Published
2012
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6. Exposure to abacavir and biomarkers of cardiovascular disease in HIV-1-infected patients on suppressive antiretroviral therapy: a longitudinal study

Author

De Luca A, de Gaetano Donati K, Cozzi Lepri A, Colafigli M, De Curtis A, Capobianchi MR, Antinori A, Giacometti A, Magnani G, Vullo V, Cauda R, Iacoviello L, d'Arminio Monforte A, ICoNA Foundation Study Group, VIALE, PIERLUIGI, BORDERI, MARCO, VERUCCHI, GABRIELLA, De Luca A, de Gaetano Donati K, Cozzi-Lepri A, Colafigli M, De Curtis A, Capobianchi MR, Antinori A, Giacometti A, Magnani G, Vullo V, Cauda R, Iacoviello L, d'Arminio Monforte A, Viale PL, Borderi M, Verucchi G, ICoNA Foundation Study Group., De Luca, Andrea, De Gaetano Donati, Katleen, Cozzi lepri, Alessandro, Colafigli, Manuela, De Curtis, Amalia, Capobianchi, Maria Rosaria, Antinori, Andrea, Giacometti, Andrea, Magnani, Giacomo, Vullo, Vincenzo, Cauda, Roberto, Iacoviello, Licia, Monforte, Antonella D'arminio, Icona Foundation Study, Group, Castagna, Antonella, De Luca, A, De Gaetano Donati, K, Cozzi Lepri, A, Colafigli, M, De Curtis, A, Capobianchi, M, Antinori, A, Giacometti, A, Magnani, G, Vullo, V, Cauda, R, Iacoviello, L, Monforte, A, and Gori, A

Subjects
Longitudinal study, Time Factors, HAART, Human immunodeficiency virus (HIV), Longitudinal Studie, HIV Infections, Disease, medicine.disease_cause, Risk Factors, Abacavir, Cardiovascular Disease, ABACAVIR, HIV Infection, Pharmacology (medical), Longitudinal Studies, biology, Dideoxynucleosides, Dideoxynucleoside, C-Reactive Protein, Infectious Diseases, Cardiovascular Diseases, HEART, Human, medicine.drug, Time Factor, Anti-HIV Agents, Vascular Cell Adhesion Molecule-1, CARDIOVASCULAR DISEASE, Infectious Disease, NO, Fibrin Fibrinogen Degradation Products, medicine, Humans, Interleukin 6, Interleukin-6, business.industry, Risk Factor, C-reactive protein, Anti-HIV Agent, HIV, Biomarker, Antiretroviral therapy, Virology, Biological Marker, Immunology, HIV-1, biology.protein, business, Biomarkers, Fibrin Fibrinogen Degradation Product
Abstract

A large observational study found an association between the use of the nucleoside reverse transcriptase inhibitor abacavir and an increase of cardiovascular risk in HIV-1–infected patients.1–3 Since then, different studies have reported controversial results: some cohort studies seemed to confirm the observation,4,5 whereas other more recent analyses and a meta-analysis seem to6–9 contradict this hypothesis. Currently, the major treatment guidelines warrant caution in the prescription of this drug in patients already showing a high cardiovascular risk based on traditional parameters.Nonetheless, a biological mechanism explaining the reasons for this finding has never been elucidated. Despite an initial observation of higher levels of inflammatory markers in a cross-sectional analysis of samples from 2 observational cohorts,4 subsequent longitudinal studies failed to detect significant associations between the use of abacavir and changes in the levels of cardiovascular risk biomarkers.

Published
2012

7. Survival in HIV-infected patients after a cancer diagnosis in the cART Era: results of an italian multicenter study

Author

Gotti D., Raffetti E., Albini L., Sighinolfi L., Maggiolo F., Di Filippo E., Ladisa N., Angarano G., Lapadula G., Pan A., Esposti A. D., Fabbiani M., Foca E., Scalzini A., Donato F., Quiros-Roldan E., Castelli F., Torti C., Casari S., Nasta P., Castelnuovo F., El Hamad I., Saracino A. L., Monno L., Cauda R., Di Giambenedetto S., Colafigli M., Mazzotta F., Lo Caputo S., Pierotti P., Di Pietro M., Ble C., Carnevale G., Gori A., Costarelli S., Gotti, D, Raffetti, E, Albini, L, Sighinolfi, L, Maggiolo, F, Di Filippo, E, Ladisa, N, Angarano, G, Lapadula, G, Pan, A, Esposti, A, Fabbiani, M, Foca, E, Scalzini, A, Donato, F, Quiros-Roldan, E, Castelli, F, Torti, C, Casari, S, Nasta, P, Castelnuovo, F, El Hamad, I, Saracino, A, Monno, L, Cauda, R, Di Giambenedetto, S, Colafigli, M, Mazzotta, F, Lo Caputo, S, Pierotti, P, Di Pietro, M, Ble, C, Carnevale, G, Gori, A, and Costarelli, S

Subjects
Oncology, Viral Diseases, Epidemiology, lcsh:Medicine, HIV Infections, Kaplan-Meier Estimate, Cohort Studies, Immunodeficiency Viruses, Neoplasms, HIV Infection, lcsh:Science, Cancers and neoplasms, Cervical cancer, Univariate analysis, Multidisciplinary, Cancer Risk Factors, Prognosis, Infectious Diseases, Medical Microbiology, HIV epidemiology, Research Design, Viral Pathogens, Observational Studies, Liver cancer, Research Article, Human, medicine.medical_specialty, Clinical Research Design, Prognosi, Research and Analysis Methods, Settore MED/17 - MALATTIE INFETTIVE, Microbiology, Breast cancer, Internal medicine, Cancer Detection and Diagnosis, medicine, Humans, Lung cancer, Microbial Pathogens, Proportional Hazards Models, Retrospective Studies, Medicine and health sciences, AIDS-related cancers, business.industry, Proportional hazards model, Clinical epidemiology, lcsh:R, Biology and Life Sciences, HIV, Cancer, Retrospective cohort study, medicine.disease, Surgery, body regions, Proportional Hazards Model, Neoplasm, lcsh:Q, business
Abstract

Objectives: We studied survival and associated risk factors in an Italian nationwide cohort of HIV-infected individuals after an AIDS-defining cancer (ADC) or non-AIDS-defining cancer (NADC) diagnosis in the modern cART era. Methods: Multi-center, retrospective, observational study of HIV patients included in the MASTER Italian Cohort with a cancer diagnosis from January 1998 to September 2012. Malignancies were divided into ADC or NADC on the basis of the Centre for Disease Control-1993 classification. Recurrence of cancer and metastases were excluded. Survivals were estimated according to the Kaplan-Meier method and compared according to the log-rank test. Statistically significant variables at univariate analysis were entered in a multivariate Cox regression model. Results: Eight hundred and sixty-six cancer diagnoses were recorded among 13,388 subjects in the MASTER Database after 1998: 435 (51%) were ADCs and 431 (49%) were NADCs. Survival was more favorable after an ADC diagnosis than a NADC diagnosis (10-year survival: 62.7%±2.9% vs. 46%±4.2%; p = 0.017). Non-Hodgkin lymphoma had lower survival rates than patients with Kaposi sarcoma or cervical cancer (10-year survival: 48.2%±4.3% vs. 72.8%±4.0% vs. 78.5%±9.9%; p

Published
2014

8. Genotypic resistance profiles associated with virological failure to darunavir-containing regimens: a cross-sectional analysis

Author

Sterrantino, G, Zaccarelli, M, Colao, G, Baldanti, F, Di Giambenedetto, S, Carli, T, Maggiolo, F, Zazzi, M, Giacometti, A, Butini, L, Del Gobbo, R, Bagnarelli, P, Tacconi, D, Corbelli, G, Zanussi, S, Monno, L, Punzi, G, Callegaro, A, Calza, L, Re, MC, Pristera, R, Turconi, P, Mandas, A, Tini, S, Zoncada, A, Paolini, E, Amadio, G, Sighinolfi, L, Zuccati, G, Morfini, M, Manetti, R, Corsi, P, Galli, L, Di Pietro, M, Bartalesi, F, Tosti, A, Di Biagio, A, Setti, M, Bruzzone, B, di Biagio, A, Penco, G, Trezzi, M, Orani, A, Pardelli, R, Arcidiacono, I, Degiuli, A, de Gennaro, M, Chiodera, A, Scalzini, A, Palvarini, L, Almi, P, Todaro, G, Cicconi, P, Rusconi, S, Gismondo, MR, Micheli, V, Biondi ML, Gianotti, N, Capetti, A, Meraviglia, P, Boeri, E, Mussini, C, Pecorari, M, Soria, A, Vecchi, L, Gerardo, AO, Santirocchi, M, Brustia, D, Maggiore, AO, Ravanini, P, Bello, FD, Romano, N, MANCUSO, Salvatrice, Calzetti, C, Maserati, R, Filice, G, Francisci, D, Parruti, G, Polilli, E, Sacchini, D, Martinelli, C, Consolini, R, Vatteroni, L, Vivarelli, A, Nerli, A, Lenzi, L, Magnani, G, Ortolani, P, Andreoni, M, Palamara, G, Fimiani, C, Palmisano, L, di Giambenedetto, S, Colafigli, M, Vullo, V, Turriziani, O, Montano, M, Antinori, A, Dentone, C, Gonnelli, A, de Luca, A, Palumbo, M, Ghisetti, V, Bonora, S, Foglie, PD, Rossi, C, Mondino, V, Malena, M, Grossi, P, Seminari, E, Poletti, F., Sterrantino, G, Zaccarelli, M, Colao, G, Baldanti, F, Di Giambenedetto, S, Carli, T, Maggiolo, F, Zazzi, M, Giacometti, A, Butini, L, Del Gobbo, R, Bagnarelli, P, Tacconi, D, Corbelli, G, Zanussi, S, Monno, L, Punzi, G, Callegaro, A, Calza, L, Re, MC, Pristera, R, Turconi, P, Mandas, A, Tini, S, Zoncada, A, Paolini, E, Amadio, G, Sighinolfi, L, Zuccati, G, Morfini, M, Manetti, R, Corsi, P, Galli, L, Di Pietro, M, Bartalesi, F, Tosti, A, Di Biagio, A, Setti, M, Bruzzone, B, di Biagio, A, Penco, G, Trezzi, M, Orani, A, Pardelli, R, Arcidiacono, I, Degiuli, A, de Gennaro, M, Chiodera, A, Scalzini, A, Palvarini, L, Almi, P, Todaro, G, Cicconi, P, Rusconi, S, Gismondo, MR, Micheli, V, Biondi ML, Gianotti, N, Capetti, A, Meraviglia, P, Boeri, E, Mussini, C, Pecorari, M, Soria, A, Vecchi, L, Gerardo, AO, Santirocchi, M, Brustia, D, Maggiore, AO, Ravanini, P, Bello, FD, Romano, N, Mancuso, S, Calzetti, C, Maserati, R, Filice, G, Francisci, D, Parruti, G, Polilli, E, Sacchini, D, Martinelli, C, Consolini, R, Vatteroni, L, Vivarelli, A, Nerli, A, Lenzi, L, Magnani, G, Ortolani, P, Andreoni, M, Palamara, G, Fimiani, C, Palmisano, L, di Giambenedetto, S, Colafigli, M, Vullo, V, Turriziani, O, Montano, M, Antinori, A, Dentone, C, Gonnelli, A, de Luca, A, Palumbo, M, Ghisetti, V, Bonora, S, Foglie, PD, Rossi, C, Mondino, V, Malena, M, Grossi, P, Seminari, E, and Poletti, F

Subjects
Male, Time Factors, Cross-sectional study, Human immunodeficiency virus (HIV), Drug Resistance, HIV Infections, Drug resistance, medicine.disease_cause, Cohort Studies, Antiretroviral Therapy, Highly Active, Ritonavir-boosted darunavir, Genotype, HIV Infection, Treatment Failure, Viral, Genotypic resistance, Darunavir, Sulfonamides, General Medicine, Middle Aged, Virological failure, Infectious Diseases, Female, Human, medicine.drug, Adult, Microbiology (medical), Logistic Model, Time Factor, Antiretroviral Therapy, Settore MED/17 - MALATTIE INFETTIVE, Sulfonamide, Drug Resistance, Viral, medicine, Humans, Highly Active, Protease inhibitors, Cross-Sectional Studies, HIV Protease Inhibitors, HIV-1, Logistic Models, Mutation, HIV Protease Inhibitor, Cross-Sectional Studie, business.industry, Antiretroviral therapy, Virology, Protease inhibitor, Cohort Studie, business
Abstract

Introduction: This study aimed at defining protease (PR) resistance mutations associated with darunavir (DRV) failure and PR resistance evolution at DRV failure in a large database of treatment-experienced human immunodeficiency virus (HIV) patients. Results: Overall, 1,104 patients were included: 118 (10.7%) failed at a median observation time of 16 months. The mean number of PR mutations at baseline was 2.7, but it was higher in patients who subsequently failed DRV. In addition, the number of PR mutations increased at failure. The increase in the mean number of mutations was completely related to mutations considered to be associated with DRV resistance following the indications of the main DRV clinical trials. Discussion The higher statistical difference at baseline between failing versus non-failing patients was observed for the V32I and I84V mutations. At DRV failure, the major increase was still observed for V32I; I54L, V11I, T74P and I50V also increased. Despite the increment in the mean number of mutations per patient between baseline and failure, in 21 patients (17.8%) at baseline and 36 (30.5%) at failure, no PR mutation was detected. Conclusion: The HIV-DB interpretation algorithm identified few patients with full DRV resistance at baseline and few patients developed full resistance at DRV failure, indicating that complete resistance to DRV is uncommon. © Springer-Verlag 2011.

Published
2012

9. Use of efavirenz or atazanavir/ritonavir is associated with better clinical outcomes of HAART compared to other protease inhibitors: routine evidence from the Italian MASTER Cohort

Author

Postorino, M. C, Prosperi, M., QUIROS ROLDAN, Maria Eugenia, Maggiolo, F., Di Giambenedetto, S., Saracino, A., Costarelli, S., Lorenzotti, S., Sighinolfi, L., Di Pietro, M., Torti, Carlo, Castelli, Francesco, Carosi, Giampiero, Nasta, Paola, Paraninfo, G., Foca', Emanuele, Torti, C., Cauda, R., Fabbiani, M., Colafigli, M., Scalzini, Alfredo, Castelnuovo, F., Mazzotta, F., Locaputo, S., Marino, N., Pierotti, P., Ble, C., Vichi, F., Angarano, G., Ladisa, N., Monno, L., Maggi, Paolo, Pan, A., Gori, A., Lapadula, G., Ospedale, S., Puoti, M., Viale, P., Colangeli, V., Borderi, M., Policlinico, S., Postorino, M. C., Prosperi, M., Quiros-Roldan, E., Maggiolo, F., Di Giambenedetto, S., Saracino, A., Costarelli, S., Lorenzotti, S., Sighinolfi, L., Di Pietro, M., Torti, C., Castelli, F., Carosi, G., Nasta, P., Paraninfo, G., Foca, E., Cauda, R., Fabbiani, M., Colafigli, M., Scalzini, A., Castelnuovo, F., Mazzotta, F., Locaputo, S., Marino, N., Pierotti, P., Ble, C., Vichi, F., Angarano, G., Ladisa, N., Monno, L., Maggi, P., Pan, A., Gori, A., Lapadula, G., Ospedale, S., Puoti, M., Viale, P., Colangeli, V., Borderi, M., and Policlinico, S.

Subjects
Cyclopropanes, Male, AIDS event, HIV Infections, Cohort Studies, chemistry.chemical_compound, Antiretroviral Therapy, Highly Active, HIV Infection, Viral, immunological response, ritonavir-boosted protease inhibitors, composite outcome, virus diseases, Lopinavir, General Medicine, Hepatitis C, Middle Aged, Viral Load, non-nucleoside reverse transcriptase inhibitors, Death, Ritonavir-boosted protease inhibitor, Treatment Outcome, Infectious Diseases, Anti-Retroviral Agents, Italy, Alkynes, Cohort, RNA, Viral, Female, Viral load, Human, medicine.drug, Cohort study, Benzoxazine, Adult, Microbiology (medical), medicine.medical_specialty, Efavirenz, Atazanavir Sulfate, virological response, Antiretroviral Therapy, Non-nucleoside reverse transcriptase inhibitor, AIDS events, Composite outcome, Deaths, First-line therapy, Immunological response, Non-nucleoside reverse transcriptase inhibitors, Ritonavir-boosted protease inhibitors, Virological response, Benzoxazines, CD4 Lymphocyte Count, Humans, Ritonavir, Settore MED/17 - MALATTIE INFETTIVE, first-line therapy, Internal medicine, medicine, Highly Active, business.industry, Odds ratio, medicine.disease, deaths, chemistry, Immunology, RNA, Anti-Retroviral Agent, Cohort Studie, business
Abstract

Randomized trials and observational cohorts reported higher rates of virological suppression after highly active antiretroviral therapy (HAART) including efavirenz (EFV), compared with boosted protease inhibitors (PIs). Correlations with immunological and clinical outcomes are unclear. Patients of the Italian MASTER cohort who started HAART from 2000 to 2010 were selected. Outstanding outcome (composite outcome for success (COS)) was introduced. We evaluated predictors of COS (no AIDS plus CD4+ count >500/mm3 plus HIV-RNA

Published
2015

10. Naïve/Effector CD4 T cell ratio as a useful predictive marker of immune reconstitution in late presenter HIV patients: A multicenter study

Author

Elisabetta Trento, Arianna Gatti, Laura Del Pup, Alessandra Sacchi, Alessandra Latini, Chiara Agrati, Sara Carputo, Gabriella De Carli, Veronica Bordoni, Francesco Ortu, Pierluca Piselli, Paola Selva, Manuela Colafigli, Marina Potestà, Nicoletta Orchi, Olindo Forini, Bruno Brando, Giusy Capuano, Sandro Grelli, Andrea Antinori, Carlotta Cerva, Massimo Andreoni, Federica Garziano, Antonella Minutolo, Federico Enrico Perna, Maria Luisa Martino, Umberto Atripaldi, Patrizia Lorenzini, Giovanna D'Agosto, Antonio Cristaudo, Irene Guarnori, Bordoni, V., Brando, B., Piselli, P., Forini, O., Perna, F. E., Atripaldi, U., Carputo, S., Garziano, F., Trento, E., D'Agosto, G., Latini, A., Colafigli, M., Cristaudo, A., Sacchi, A., Andreoni, M., de Carli, G., Orchi, N., Grelli, S., Gatti, A., Cerva, C., Minutolo, A., Potesta, M., Di Martino, M. L., Ortu, F., Selva, P., Pup, L. D., Guarnori, I., Lorenzini, P., Capuano, G., Antinori, A., and Agrati, C.

Subjects
CD4-Positive T-Lymphocytes, Male, RNA viruses, 0301 basic medicine, HIV Infections, CD38, Pathology and Laboratory Medicine, White Blood Cells, Immune Reconstitution, 0302 clinical medicine, Immunodeficiency Viruses, Animal Cells, Antiretroviral Therapy, Highly Active, Medicine and Health Sciences, Cytotoxic T cell, Prospective Studies, 030212 general & internal medicine, Immune Response, Multidisciplinary, Predictive marker, T Cells, HIV diagnosis and management, Middle Aged, Treatment Outcome, medicine.anatomical_structure, Medical Microbiology, Viral Pathogens, Viruses, Infectious diseases, Medicine, Female, Cellular Types, Pathogens, Research Article, Adult, Cart, Settore MED/17 - Malattie Infettive, Naive T cell, Anti-HIV Agents, Immune Cells, T cell, Science, Immunology, Cell Enumeration Techniques, Cytotoxic T cells, Viral diseases, Research and Analysis Methods, Microbiology, 03 medical and health sciences, Immune system, Retroviruses, medicine, Humans, T Helper Cells, Microbial Pathogens, Blood Cells, business.industry, Lentivirus, Organisms, Biology and Life Sciences, HIV, Cell Biology, Diagnostic medicine, CD4 Lymphocyte Count, 030104 developmental biology, business, CD8
Abstract

A significant proportion of HIV-infected patients experiencing a late diagnosis highlights the need to define immunological protocols able to help the clinicians in identifying patients at higher risk for immunological failure. The aim of the study was to evaluate the feasibility of easy cytometric tests in defining the effect of antiretroviral treatment (cART) on immunological homeostasis and in identifying predictive markers of early immune recovery. Chronic HIV infected patients (n = 202) were enrolled in a prospective multicentric study, and their immunological profile was studied before (w0) and after 24 weeks (w24) of antiretroviral treatment (cART) using a standardized flow cytometric panel. Based on CD4 T cell count before treatment, patients were divided in late (LP: CD4 500/mmc) presenters. In all groups, cART introduction increased CD4 and CD4/CD8 T cell ratio, naïve T cell (CD4 and CD8) and CD127-expressing CD4 T cells. In parallel, cART significantly reduced effector memory T cells (CD4 and CD8) and T cell activation (CD38+CD8 and CD95+CD4 T cells). Moreover, the frequency of Naïve and Effector CD4 T cells before treatment correlated with several immune parameters key associated with the pathogenesis of HIV, thus mirroring the health of immune system. Interestingly, we identified the Naïve/Effector CD4 T cell ratio (N/EM) at w0 as a marker able to predict early immune recovery. Specifically, in LP, N/EM ratio was significantly higher in immunological responder patients (CD4>500/mmc at w24) when compared to immunological non responder (CD4 T cells

Published
2019

11. Evolution of transmitted HIV-1 drug resistance and viral subtypes circulation in Italy from 2006 to 2016

Author

Rossetti, B., Giambenedetto, Di, Torti, S, Postorino, C. c., Punzi, M. C., Saladini, G., Gennari, F., Borghi, W. f., Monno, V., Pignataro, L., Polilli, A. R., Colafigli, E., Poggi, M., Tini, A., Zazzi, S., Luca, De, Mellace, A., Capetti, V., Gismondo, A., Biondi, M. R., Mussini, M. L., Pecorari, C., Gianotti, M., Sacchini, N., Parruti, D., Baldelli, F., Zanussi, S., Nerli, A., Lenzi, L., Calzetti, C., Vivarelli, A., Maserati, R., Baldanti, F., Poletti, F., Mondino, V., Malena, M., Cascio, A., Filice, G., Magnani, G., Zerbini, A., Lombardi, F., Gaimbenedetto, Di, Andreoni, S., Montano, M., Vullo, M., Turriziani, V., Gonnelli, O., Boeri, A., Bonora, E., Ghisetti, S., Francisci, D., Grossi, P., Bagnarelli, P., Butini, L., Del, Gobbo, Giacometti, R., Tacconi, A., Callegaro, D., Maggiolo, A., Zoncada, F., Paolini, A., Sighinolfi, E., Colao, L., Corsi, G., Blanc, P., Galli, P., Meraviglia, L., Tosti, P., Bruzzone, A., Setti, B., Penco, M., Biagio, Di, Nencioni, A., Pardelli, C., Arcidiacono, R., Degiuli, I., Gennaro, De, Soria, M., Foc, A., Latella, A., Cosco, S., Malandrin, L., Milini, S., Cicconi, P., Rusconi, P., Micheli, S., the Antiviral Response Cohort Analysis (ARCA) Collaborative Group, Rossetti B., Di Giambenedetto S., Torti C., Postorino M.C., Punzi G., Saladini F., Gennari W., Borghi V., Monno L., Pignataro A.R., Polilli E., Colafigli M., Poggi A., Tini S., Zazzi M., De Luca A., Mellace V., Capetti A., Gismondo M.R., Biondi M.L., Mussini C., Pecorari M., Gianotti N., Sacchini D., Parruti G., Baldelli F., Zanussi S., Nerli A., Lenzi L., Calzetti C., Vivarelli A., Maserati R., Baldanti F., Poletti F., Mondino V., Malena M., Cascio A., Filice G., Magnani G., Zerbini A., Lombardi F., Di Gaimbenedetto S., Andreoni M., Montano M., Vullo V., Turriziani O., Gonnelli A., Boeri E., Bonora S., Ghisetti V., Francisci D., Grossi P., Bagnarelli P., Butini L., del Gobbo R., Giacometti A., Tacconi D., Callegaro A., Maggiolo F., Zoncada A., Paolini E., Sighinolfi L., Colao G., Corsi P., Blanc P., Galli L., Meraviglia P., Tosti A., Bruzzone B., Setti M., Penco G., Di Biagio A., Nencioni C., Pardelli R., Arcidiacono I., Degiuli A., De Gennaro M., Soria A., Foc A., Latella S., Cosco L., Malandrin S., Milini P., Cicconi P., Rusconi S., and Micheli V.

Subjects
0301 basic medicine, Male, antiretroviral therapy, HIV, recent HIV infection, resistance epidemiology, transmitted HIV drug resistance, Adult, Anti-HIV Agents, CD4 Lymphocyte Count, Female, HIV Infections, HIV-1, Humans, Italy, Middle Aged, Mutation, Odds Ratio, Prevalence, Viral Proteins, Drug Resistance, Viral, Health Policy, Infectious Diseases, Pharmacology (medical), Drug Resistance, Drug resistance, Gastroenterology, Interquartile range, HIV Infection, Viral, biology, Integrase, Viral load, Human, medicine.medical_specialty, 030106 microbiology, Settore MED/17 - MALATTIE INFETTIVE, Virus, 03 medical and health sciences, Internal medicine, medicine, Viral Protein, business.industry, Anti-HIV Agent, Odds ratio, Reverse transcriptase, Confidence interval, biology.protein, business
Abstract

Objectives: The aim was to evaluate the evolution of transmitted HIV-1 drug resistance (TDR) prevalence in antiretroviral therapy (ART)-naïve patients from 2006 to 2016. Methods: HIV-1 sequences were retrieved from the Antiviral Response Cohort Analysis (ARCA) database and TDR was defined as detection of at least one mutation from the World Health Organization (WHO) surveillance list. Results: We included protease/reverse transcriptase sequences from 3573 patients; 455 had also integrase sequences. Overall, 68.1% of the patients were Italian, the median CD4 count was 348 cells/μL [interquartile range (IQR) 169–521 cells/μL], and the median viral load was 4.7 log 10 HIV-1 RNA copies/mL (IQR 4.1–5.3 log 10 copies/mL). TDR was detected in 10.3% of patients: 6% carried mutations to nucleos(t)ide reverse transcriptase inhibitors (NRTIs), 4.4% to nonnucleos(t)ide reverse transcriptase inhibitors (NNRTIs), 2.3% to protease inhibitors (PIs), 0.2% to integrase strand transfer inhibitors (INSTIs) and 2.1% to at least two drug classes. TDR declined from 14.5% in 2006 to 7.3% in 2016 (P=0.003): TDR to NRTIs from 9.9 to 2.9% (P=0.003) and TDR to NNRTIs from 5.1 to 3.7% (P=0.028); PI TDR remained stable. The proportion carrying subtype B virus declined from 76.5 to 50% (P&nbsp

Published
2018

12. Biochemical and inflammatory modifications after switching to dual antiretroviral therapy in HIV-infected patients in Italy: A multicenter retrospective cohort study from 2007 to 2015

Author

Quiros-Roldan, E., Magro, P., Raffetti, E., Izzo, I., Borghetti, Alberto, Lombardi, Francesca, Saracino, A., Maggiolo, F., Castelli, F., Carosi, Giulia, Paraninfo, G. E., Torti, Carlo, Cauda, Roberto, Di Giambenedetto, Simona, Fabbiani, M., Colafigli, Manuela, Scalzini, A., Castelnuovo, F., El Hamad, I., Mazzotta, F., Locaputo, S., Marino, N., Pierotti, P., Di Pietro, Maria Luisa, Ble, C., Vichi, F., Sighinolfi, L., Angarano, G., Ladisa, N., Monno, L., Maggi, P., Pan, A., Costarelli, S., Gori, A., Lapadula, G., Puoti, M., Viale, P., Colangeli, V., Borderi, M., Quiros-Roldan, E, Magro, P, Raffetti, E, Izzo, I, Borghetti, A, Lombardi, F, Saracino, A, Maggiolo, F, Castelli, F, Carosi, G, Paraninfo, G, Torti, C, Cauda, R, Di Giambenedetto, S, Fabbiani, M, Colafigli, M, Scalzini, A, Castelnuovo, F, El Hamad, I, Mazzotta, F, Locaputo, S, Marino, N, Pierotti, P, Di Pietro, M, Ble, C, Vichi, F, Sighinolfi, L, Angarano, G, Ladisa, N, Monno, L, Maggi, P, Pan, A, Costarelli, S, Gori, A, Lapadula, G, Puoti, M, Viale, P, Colangeli, V, Borderi, M, Blè, C, and Border, M

Subjects
0301 basic medicine, Male, HIV Infections, Gastroenterology, Cohort Studies, 0302 clinical medicine, Abacavir, Antiretroviral Therapy, Highly Active, 030212 general & internal medicine, Darunavir, virus diseases, Switch, Middle Aged, Antiretroviral therapy, Infectious Diseases, Treatment Outcome, Italy, Reverse Transcriptase Inhibitors, Female, medicine.symptom, medicine.drug, Research Article, Adult, medicine.medical_specialty, Anti-HIV Agents, Dual-therapy, HIV, Inflammation, Atazanavir Sulfate, CD4-CD8 Ratio, Renal function, Settore MED/17 - MALATTIE INFETTIVE, lcsh:Infectious and parasitic diseases, 03 medical and health sciences, Immune system, Internal medicine, medicine, Humans, lcsh:RC109-216, Tenofovir, Retrospective Studies, business.industry, Retrospective cohort study, Reverse transcriptase, Dideoxynucleosides, Regimen, 030104 developmental biology, business, CD8
Abstract

Background Triple-drug regimens are the gold standard for HIV therapy. Nucleos(t)ide reverse transcriptase inhibitors (NRTIs) reducing regimens are used to decrease drugs toxicity, exposure and costs. Aim of our study was to evaluate trends of biochemical and inflammatory indices in patients switching to dual therapy (DT). Methods We included patients that a) switched to a DT from 2007 to 2015 from a tenofovir/abacavir-based triple regimen b) previously maintained a triple and c) subsequently a dual regimen for 12 months with virological suppression. We retrieved data measured at 5 points (at the switch, 6 and 12 months before and after switch). We used platelet-to-lymphocyte ratio (PLR), neutrophil-to-lymphocyte ratio (NLR) and CD4/CD8 ratio as inflammatory indices. We assessed temporal trends of viro-immunological, biochemical and inflammatory parameters. Results Overall, 364 and 65 patients switched from a tenofovir- and an abacavir-triple regimen, respectively. In the tenofovir-reducing group, creatinine clearance and lipids raised after the switch. There was a significant increase in both CD4+ cells and CD4/CD8. CD8+ cells rose after the switch, while opposite trend was found for PLR. In the abacavir-reducing group total lipids showed a decrease during the first 6 months after the switch and then stabilized. An increase of CD4+ and a decrease of CD8+ cells was observed during the study period, although not statistically significant. While CD4/CD8 remained stable after simplification, PLR decreased significantly after 6 months, then returning to baseline. CD8+ cells increased in the tenofovir-reducing group despite a viro-immunological response. Intriguingly, PLR decreased, maintaining this trend for 12 and 6 months after tenofovir and abacavir interruption respectively. Conclusions Increased PLR has been linked to hypercholesterolemia and metabolic-syndrome, while high CD8+ cells count to increased risk of non-AIDS-related events regardless of CD4 T-cell recovery and to virological failure. Whether these findings may have clinical implications, and which role DT plays on the immune system and on inflammation should be further investigated.

Published
2018

13. Exploratory analysis for the evaluation of estimated glomerular filtration rate, cholesterol and triglycerides after switching from tenofovir/emtricitabine plus atazanavir/ritonavir (ATV/r) to abacavir/lamivudine plus ATV/r in patients with preserved renal function

Author

Postorino, Maria Concetta, Quiros Roldan, Eugenia, Maggiolo, Franco, Di Giambenedetto, Simona, Ladisa, Nicoletta, Lapadula, Giuseppe, Lorenzotti, Silvia, Sighinolfi, Laura, Castelnuovo, Filippo, di Pietro, Massimo, Gotti, Daria, Mazzini, Nicola, Torti, Carlo, Castelli, F., Carosi, G., Nasta, P., Paraninfo, G., Focà, E., di Giambenedetto, R. Cauda S., Fabbiani, Massimiliano, Colafigli, Manuela, Scalzini, A., El Hamad, I., Mazzotta, F., Locaputo, S., Marino, N., Pierotti, P., Ble, C., Vichi, F., Angarano, G., Monno, L., Maggi, P., Pan, A., Costarelli, S., Gori, A., Lapadula, G., Puoti, M., Viale, P., Colangeli, V., Borderi, M., Postorino, M, Quiros-Roldan, E, Maggiolo, F, di Giambenedetto, S, Ladisa, N, Lapadula, G, Lorenzotti, S, Sighinolfi, L, Castelnuovo, F, di Pietro, M, Gotti, D, Mazzini, N, Torti, C, Castelli, F, Carosi, G, Nasta, P, Paraninfo, G, Foca, E, Fabbiani, M, Colafigli, M, Scalzini, A, El Hamad, I, Mazzotta, F, Locaputo, S, Marino, N, Pierotti, P, Ble, C, Vichi, F, Angarano, G, Monno, L, Maggi, P, Pan, A, Costarelli, S, Gori, A, Puoti, M, Viale, P, Colangeli, V, and Borderi, M

Subjects
0301 basic medicine, Atazanavir, Cholesterol, eGFR, Highly active antiretroviral therapy, Nephrotoxicity, Tenofovir, Public Health, Environmental and Occupational Health, Infectious Diseases, Virology, medicine.medical_specialty, Urology, Renal function, Pharmacology, Emtricitabine, Settore MED/17 - MALATTIE INFETTIVE, Article, 03 medical and health sciences, chemistry.chemical_compound, Abacavir, medicine, Creatinine, business.industry, Highly Active Antiretroviral Therapy, Environmental and Occupational Health, Lamivudine, Abacavir/Lamivudine, 030112 virology, chemistry, Ritonavir, Public Health, business, medicine.drug
Abstract

Background and Objectives: Renal toxicity due to tenofovir (TDF) has been largely described in patients with HIV infection. However, other antiretroviral drugs (such as atazanavir [ATV], especially when boosted by ritonavir, ATV/r) could perpetuate some degrees of renal impairment with or without TDF co-administration. Also, possible benefits of stopping TDF in patients without renal diseases is not well known. This study aimed at exploring evolution of renal function and lipid profile after switching from tenofovir/emtricitabine (TDF/FTC) to abacavir/lamivudine (ABC/3TC), maintaining the ATV/r component of the regimen. Methods: Patients in the Italian MASTER Cohort, who switched from TDF/FTC plus ATV/r to ABC/3TC plus ATV/r were included, provided that major renal diseases were not diagnosed before switching (i.e., baseline). Serum creatinine, estimated glomerular filtration rate (eGFR), total cholesterol, HDL and triglycerides were evaluated at baseline and at month 18 after switching. Results: 126 patients were selected (80% males). Patients were mostly Italians (92%). 79% had undetectable HIV-RNA and 44% were coinfected by HBV and/or HCV. Median age at switch was 47 years (IQR 43-55). A small but significant decrease in serum creatinine [from 1.06 mg/dl (SD: 0.3) to 0.94 mg/dl (SD: 0.2); p

Published
2016

14. Estimating minimum adult HIV prevalence: A cross-sectional study to assess the characteristics of people living with HIV in Italy

Author

Margherita Busso, Tullio Prestileo, Ermenegildo Francavilla, Marco Anselmo, Francesco Montella, Evangelista Sagnelli, Teresa Santantonio, Massimo Galli, Marcello Saitta, Giuseppe Foti, Cecilia Guariglia, Franco Baldelli, Simona Di Gianbenedetto, Pierluigi Viale, Francesco Castelli, Antonella d'Arminio Monforte, Angelo Pan, Gabriella D’Ettore, Maria Dorrucci, Salvatore Bruno, Tiziana Quirino, Mariangela Raimondo, Alessandro Bartoloni, Vinicio Manfrin, Giovanni Mazzarello, Eugenio Mantia, Raffaele Pempinello, Antonio Traverso, Barbara Suligoi, Fabio Bulla, Pietro Mesina, Alessia Zoncada, Gianfranco Orofino, Oliviero Bosco, Gianmichele Moise, Angelo Salomone Megna, Roberto Ferretto, Mauro Valle, Manuela Colafigli, Claudio Paternoster, S. Artioli, Giovanni Riccio, Stefania Bernardi, Paolo Grossi, Milena Zoppi, Sebastiano Maiuzzo, Giorgio Perboni, Sauro Tini, Giuseppe Ferrea, Nicoletta Ladisa, Enzo M. Farinella, Daniela Francisci, Dino Sgarabotto, Roberto Monarca, Enzo Petrelli, A. Franco, Izzo Cm, Pietro Bellissima, Francesco Ortu, Laura Sighinolfi, Antonio Chirianni, Filippo Bartalesi, Giulio De Stefano, Claudia Colomba, Laura Camoni, Salvatore Galvagna, Benedetto Maurizio Celesia, Andrea Petrucci, Camillo Baretti, Pierluigi Brugnaro, Federica Poletti, Maurilio Chimenti, Camilla Ajassa, Mario Falciano, Rosaria La Sala, Sauro Luchi, V. Portelli, Annamaria Degli Antoni, Francesco Mazzotta, Giuliano Zuccati, Vincenzo Colangeli, Ercole Concia, Giordano Madeddu, Maria Cristina Salfa, Francesca Cattelan, Nicola Acone, Vincenza Regine, Olivia Bargiacchi, Maurizio de Martino, F. Paoletti, Giovanni Cassola, Giuliano Schettino, Carlo De Stefano, Enza Anzalone, D. Aquilini, Giacomo Magnani, Vanni Borghi, Roberta Gastaldi, Alessandra Govoni, Cristina Rossi, Rita Consolini, Gioacchino Angarano, Gloria Taliani, Tommaso Fontana, Sergio Lo Caputo, Davide Vitullo, Pierpaolo Congedo, Emanuela Vaccher, Paolo Viganò, Maria Stella Mura, Claudio Cancellieri, Enrico Girardi, Francesca Savalli, Cecilia Fico, Anna Maria Cattelan, Alessandro Chiodera, Renzo Scaggiante, P. Osimani, Caterina Bramato, Nicola Pietrosillo, Giovanna D'Alessio, Salvatore Bonfante, Vincenzo Vullo, Andrea Gori, Margherita Dalessandro, Domenico Lucchino, Massimo Deseraca, Paolo Tundo, Alfredo Pennica, M. Paoloni, Antonella Castagna, Nicola Serrao, Paolo Costa, Franco Marranconi, Massimo Villa, Pietro Filippini, Maurizio Setti, Eligio Pizzigallo, Marco Tinelli, Mauro Marchili, Domenico Santoro, Cesira Nencioni, Piera Dones, Vincenzo Renda, Alberto Giannetti, Domenico La Rovere, Nicoletta Dorigoni, Guido Palamara, Angelo Iodice, Clara Gabiano, Peter Mian, Luigi Guarnieri, Andrea De Luca, Nicola Tripodi, Giovanni Cristina, Giustino Parruti, Maria Montroni, Loredana Palvarini, Marco Rizzi, Benvenuto Grisorio, Corrado Catalani, Paolo Emilio Manconi, Jacopo Vecchiett, Tiziana Carli, Riccardo Iapoce, Massimo Andreoni, Adriano Lazzarin, Giorgetta Casalino Finocchio, D Sacchini, Mario Gobber, Spartaco Sani, Marco Campus, Rosario La Rosa, Maurizio Mazzeo, Stefano Bonora, Michele Trezzi, Paolo Bassi, Angela La Gala, Alessandro Grimaldi, Dante Di Giammartino, Guido Leo, Gaetano Filice, Antonio Salvo, Paolo Bonfanti, Chiara Pasqualini, Marcello Tavio, Luca Butini, N. Abrescia, Angela Linzalone, Gianpaolo Natalini Ramponi, Pierangelo Rovere, Piero Cortese, Dario Bartolozzi, F. Resta, Miriam Lichtner, Loredana Sarmati, Francesco Cesario, Renato F. Frongillo, Ivano Mezzaroma, Carlo Ferrari, Lorenzo Minoli, Paola Di Stefano, Lucina Titone, Rosa Boncoraglio, Mariana Farenga, Giuliano Rizzardini, Stefano Aviani Barbacci, Andrea Giacometti, Andrea Antinori, Antonio Caterini, Consuelo Geraci, Piergiorgio Chiriacò, Lucio Cosco, Claudio Viscoli, Alfredo Scalzini, Sandro Piga, Massimo Arlotti, Cecilia Occhino, Roberto Luzzati, Paola Sabbatini, Guglielmo Borgia, Umberto Tirelli, Antonio Davi, Letizia Cristiano, Cristina Mussini, Roberto Cauda, Patrizio Vittucci, B. Salassa, Marco Libanore, Maria Pina Sciotti, Isa Picerno, Matteo Bassetti, Benedetto Caroleo, Oswald Moling, Danilo Tacconi, Massimo Puoti, Camoni, Laura, Raimondo, Mariangela, Dorrucci, Maria, Regine V, Salfa MC, CARPHA Study, Group, Lazzarin, Adriano, Castagna, Antonella, Camoni, L, Raimondo, M, Dorrucci, M, Regine, V, Salfa, M, Suligoi, B, Di Giammartino, D, Parruti, G, Di Stefano, P, Paoloni, M, D'Alessandro, M, Grimaldi, A, Sciotti, M, Pizzigallo, E, Vecchiett, J, De Stefano, C, La Gala, A, De Stefano, G, Linzalone, A, Cesario, F, Cosco, L, Caroleo, B, Foti, G, Serrao, N, Lucchino, D, Chirianni, A, Abrescia, N, Pempinello, R, Izzo, C, Borgia, G, Filippini, P, Sagnelli, E, Iodice, A, Megna, A, D'Alessio, G, Acone, N, Mazzeo, M, Sacchini, D, Ferrari, C, Degli Antoni, A, Magnani, G, Mussini, C, Borghi, V, Viale, P, Colangeli, V, Sighinolfi, L, Libanore, M, Govoni, A, Cancellieri, C, Bassi, P, Arlotti, M, Luzzati, R, Bassetti, M, Tirelli, U, Vaccher, E, Moise, G, Palamara, G, Bernardi, S, Falciano, M, Vullo, V, D'Ettore, G, Renda, V, Guariglia, C, Taliani, G, Mezzaroma, I, Paoletti, F, Ajassa, C, Gastaldi, R, Andreoni, M, Sarmati, L, Montella, F, Antinori, A, Giannetti, A, Pietrosillo, N, Girardi, E, Pennica, A, Cauda, R, Colafigli, M, Di Gianbenedetto, S, Caterini, A, Monarca, R, Barbacci, S, Ramponi, G, Marchili, M, Anzalone, E, Lichtner, M, Ferrea, G, Cassola, G, Viscoli, C, Mazzarello, G, Setti, M, Artioli, S, Riccio, G, Finocchio, G, Anselmo, M, Rizzi, M, Scalzini, A, Castelli, F, Quirino, T, Santoro, D, Pan, A, Zoncada, A, Bonfanti, P, Viganò, P, Villa, M, Tinelli, M, Perboni, G, Palvarini, L, Costa, P, Puoti, M, Galli, M, Rizzardini, G, Monforte, A, Lazzarin, A, Castagna, A, Gori, A, Minoli, L, Filice, G, Grossi, P, Giacometti, A, Tavio, M, Montroni, M, Butini, L, Osimani, P, Petrelli, E, Chiodera, A, Vittucci, P, Sabbatini, P, Pasqualini, C, Valle, M, Zoppi, M, Mantia, E, Schettino, G, Deseraca, M, Vitullo, D, Bargiacchi, O, Orofino, G, Bramato, C, Busso, M, Salassa, B, Farenga, M, Bonora, S, Leo, G, Poletti, F, Gobber, M, Cristina, G, Gabiano, C, Mian, P, Moling, O, Paternoster, C, Dorigoni, N, Fontana, T, Angarano, G, Ladisa, N, La Rovere, D, Fico, C, Bulla, F, Santantonio, T, Grisorio, B, Chiriacò, P, Congedo, P, Tundo, P, Resta, F, Cristiano, L, Mura, M, Madeddu, G, Mesina, P, Piga, S, Campus, M, Manconi, P, Ortu, F, Salvo, A, Baretti, C, La Sala, R, Bellissima, P, Bonfante, S, Galvagna, S, Celesia, B, La Rosa, R, Maiuzzo, S, Guarnieri, L, Bruno, S, Picerno, I, Tripodi, N, Farinella, E, Occhino, C, Titone, L, Colomba, C, Prestileo, T, Saitta, M, Dones, P, Boncoraglio, R, Davi, A, Franco, A, Portelli, V, Savalli, F, Geraci, C, Chimenti, M, Luchi, S, Catalani, C, Trezzi, M, Aquilini, D, Sani, S, Nencioni, C, Carli, T, Mazzotta, F, Lo Caputo, S, Zuccati, G, Iapoce, R, Consolini, R, Bartolozzi, D, Bartoloni, A, Bartalesi, F, DE LUCA, A, De Martino, M, Tacconi, D, Tini, S, Baldelli, F, Francisci, D, Frongillo, R, Traverso, A, Francavilla, E, Ferretto, R, Marranconi, F, Manfrin, V, Cortese, P, Rossi, C, Cattelan, F, Petrucci, A, Brugnaro, P, Sgarabotto, D, Scaggiante, R, Cattelan, A, Bosco, O, Concia, E, Rovere, P, Regine, Vincenza, Salfa, Maria Cristina, Suligoi, Barbara, and Luzzati, Roberto

Subjects
Adult, Male, Pediatrics, medicine.medical_specialty, Immunology, Infectious Diseases, Virology, Settore MED/17 - Malattie Infettive, Epidemiology, Cross-sectional study, Human immunodeficiency virus (HIV), MEDLINE, HIV Infections, medicine.disease_cause, Anti-Retroviral Agents, CD4 Lymphocyte Count, Cross-Sectional Studies, Female, Humans, Italy, Middle Aged, Prevalence, Retrospective Studies, medicine, HIV Infection, HIV, prevalence, Italy, Cross-Sectional Studie, business.industry, Transmission (medicine), HIV, Retrospective cohort study, Hiv prevalence, Northern italy, Anti-Retroviral Agent, business, Viral load, Human, Demography
Abstract

In 2012, we conducted a retrospective cross-sectional study to assess the number of people living with HIV linked to care and, among these, the number of people on antiretroviral therapy. The health authority in each of the 20 Italian Regions provided the list of Public Infectious Diseases Clinics providing antiretroviral therapy and monitoring people with HIV infection. We asked every Public Infectious Diseases Clinic to report the number of HIV-positive people diagnosed and linked to care and the number of those on antiretroviral therapy during 2012. In 2012, 94,146 people diagnosed with HIV and linked to care were reported. The majority were males (70.1%), Italians (84.4%), and aged between 25 and 49 years (63.4%); the probable route of transmission was heterosexual contact in 37.5% of cases, injecting drug use in 28.1%, and male-to-male contact in 27.9%. Among people in care, 20.1% had less than 350 CD4 cells/μl, 87.6% received antiretroviral therapy, and among these, 62.4% had a CD4 cell count higher than 350 cells/μl. The overall estimated prevalence of individuals diagnosed and linked to care in 2012 in Italy was 0.16 per 100 residents (all ages). Adding the estimated proportion of undiagnosed people, the estimated HIV prevalence would range between 0.19 and 0.26 per 100 residents. In Italy, the majority of people diagnosed and linked to care receive antiretroviral therapy. A higher prevalence of individuals diagnosed and linked to care was observed in Northern Italy and among males. More information for developing the HIV care continuum is necessary to improve the entire engagement in care, focusing on test-and-treat strategies to substantially reduce the proportion of people still undiagnosed or with a detectable viral load.

Published
2015

15. Genotypic resistance to lopinavir and fosamprenavir with or without ritonavir of clinical isolates from patients failing protease inhibitors-containing HAART regimens: prevalence and predictors

Author

Simona Di Giambenedetto, Mattia Prosperi, Roberto Cauda, Andrea De Luca, Giorgio Gatti, Manuela Colafigli, Carmen Pinnetti, Alessanra Bacarelli, DI GIANBENEDETTO, S., Bacarelli, A., Pinnetti, C., Colafigli, M., Prosperi, Mattia, Gatti, G., Cauda, R., and DE LUCA, Andrea

Subjects
Microbiology (medical), Adult, Male, HAART, Genotype, Fosamprenavir, HIV Infections, Pyrimidinones, Settore MED/17 - MALATTIE INFETTIVE, Lopinavir, Drug Resistance, Multiple, Viral, Indinavir, Antiretroviral Therapy, Highly Active, medicine, Prevalence, Humans, Protease inhibitor (pharmacology), SI, Sida, Furans, Retrospective Studies, Sulfonamides, Ritonavir, General Immunology and Microbiology, biology, business.industry, virus diseases, General Medicine, HIV Protease Inhibitors, biology.organism_classification, Virology, Organophosphates, Infectious Diseases, Nelfinavir, HIV-1, Female, Viral disease, Carbamates, business, Algorithms, medicine.drug
Abstract

The aim of this study was to establish the prevalence and predictors of genotypic resistance of HIV-1 to lopinavir and fosamprenavir from patients failing protease inhibitors (PI)-based regimens. We selected 643 HIV-1-infected patients with available treatment history who underwent genotypic resistance assays for virological failure from a clinical site and from the Stanford database. According to the genotypic resistance interpretation of the Stanford algorithm, proportions of viruses showing full susceptibility to fosamprenavir and lopinavir were 32% and 34%, respectively (p =ns). Proportions of viruses fully susceptible to lopinavir/r and fosamprenavir/r according to the Agence Nationale pour la Recherche sur le SIDA (ANRS) algorithm, were 81% and 81%, respectively. According to the Rega algorithm, proportions of viruses showing full susceptibility to fosamprenavir/r and lopinavir were 80% and 70%, respectively (p0.001). According to the ANRS and Rega interpretations, the time on therapy predicted susceptibility to lopinavir/r, while susceptibility to fosamprenavir/r according to ANRS was predicted by the number of prior PI regimens experienced. According to the Stanford interpretation, prior indinavir exposure predicted resistance to lopinavir/r and fosamprenavir/r while prior nelfinavir use predicted susceptibility to both drugs. After failing PI-based regimens, the majority of viruses retained a predicted susceptibility to fosamprenavir/r and lopinavir/r. In patients failing PIs, the interpretation of genotypic resistance to fosamprenavir may change considerably according to the different algorithms and in respect to the effect of pharmacokinetic boosting with ritonavir.

16. The association of high-sensitivity c-reactive protein and other biomarkers with cardiovascular disease in patients treated for HIV: a nested case–control study

Author

Licia Iacoviello, Andrea Gori, Katleen de Gaetano Donati, Amalia De Curtis, Andrea De Luca, Alessandro Cozzi-Lepri, Manuela Colafigli, Maria Rosaria Capobianchi, Alessandro D'Avino, Laura Sighinolfi, Antonella d'Arminio Monforte, Andrea Giacometti, Roberto Cauda, De Luca, A, de Gaetano Donati, K, Colafigli, M, Cozzi Lepri, A, De Curtis, A, Gori, A, Sighinolfi, L, Giacometti, A, Capobianchi, M, D'Avino, A, Iacoviello, L, Cauda, R, and D'Arminio Monforte, A

Subjects
Male, HIV Infections, hiv, Gastroenterology, Risk Factors, Retrospective Studie, cardiovascular disease, HIV Infection, education.field_of_study, Predictive marker, biology, Middle Aged, protein c, hsCRP, C-Reactive Protein, Infectious Diseases, Cardiovascular Diseases, Biomarker (medicine), Female, Case-Control Studie, Research Article, Human, Adult, medicine.medical_specialty, Anti-HIV Agents, Population, Settore MED/17 - MALATTIE INFETTIVE, biomarkers, Internal medicine, Diabetes mellitus, medicine, Humans, cardiovascular diseases, education, Retrospective Studies, Aged, business.industry, Interleukin-6, Risk Factor, C-reactive protein, Case-control study, Anti-HIV Agent, Odds ratio, Biomarker, medicine.disease, Case-Control Studies, Nested case-control study, Immunology, Biological Marker, biology.protein, business
Abstract

Background: Elevated high-sensitivity C-reactive protein (hsCRP) increases the risk of cardiovascular disease (CVD) in the general population, but its role as a predictive marker in HIV-positive patients remains unclear. Aim of the study was to evaluate whether hsCRP or other biomarkers are independent predictors of CVD risk in HIV-infected patients.Methods: Retrospective, nested case-control study. HIV-positive men and women (35-69 years of age) receiving combination antiretroviral therapy (cART) were included. Cases (n = 35) had a major CVD event. Controls (n = 74) free from CVD events for at least 5 years from starting ART were matched on diabetes and smoking. HsCRP, D-dimer, P-selectin, interleukin-6 (IL-6), tissue plasminogen activator, plasminogen activator inhibitor-1 levels were measured.Results: High hsCRP was associated with CVD risk, independently of traditional cardiovascular risk factors, HIV replication and the type of ART received at the time of sampling (adjusted odds ratio 8.00 [1.23-51.94] comparing >3.3 mg/L with

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