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1. People with HIV pioneers of injectable cabotegravir and rilpivirine long acting in Italy: who are they?

Author

Bartalucci, C, Baldi, F, Ricci, E, Orofino, G, Menzaghi, B, Ferrara, S, Pellicano', G, Squillace, N, Sarchi, E, Pontali, E, Cenderello, G, Bargiacchi, O, Piccica, M, Carleo, M, Cascio, A, De Socio, G, Bonfanti, P, Di Biagio, A, Bartalucci C., Baldi F., Ricci E., Orofino G., Menzaghi B., Ferrara S., Pellicano' G. F., Squillace N., Sarchi E., Pontali E., Cenderello G., Bargiacchi O., Piccica M., Carleo M. A., Cascio A., De Socio G. V., Bonfanti P., Di Biagio A., Bartalucci, C, Baldi, F, Ricci, E, Orofino, G, Menzaghi, B, Ferrara, S, Pellicano', G, Squillace, N, Sarchi, E, Pontali, E, Cenderello, G, Bargiacchi, O, Piccica, M, Carleo, M, Cascio, A, De Socio, G, Bonfanti, P, Di Biagio, A, Bartalucci C., Baldi F., Ricci E., Orofino G., Menzaghi B., Ferrara S., Pellicano' G. F., Squillace N., Sarchi E., Pontali E., Cenderello G., Bargiacchi O., Piccica M., Carleo M. A., Cascio A., De Socio G. V., Bonfanti P., and Di Biagio A.

Abstract

Injectable cabotegravir and rilpivirine long-acting therapy is a revolutionary new antiretroviral treatment (ART) option for HIV infection in virologically suppressed adults on a stable ART. The aim of this study from SCOLTA multicenter observational prospective database is to describe the first people living with HIV (PWH) who started this regimen in Italy, assessing adherence to eligibility criteria, describing clinical-epidemiological characteristics compared to registration trials-population and describe early treatment-discontinuations.

Published
2024

2. TD-1 Efficacy, safety and metabolic changes at 6-months after switch to long-acting injectable CAB/RPV: results from an observational prospective multicenter study

Author

Bartalucci, C, Taramasso, L, Ricci, E, De Vito, A, Squillace, N, Ferrara, S, Pontali, E, Cenderello, G, Pellicanò, G, Sarchi, E, Lagi, F, Salomoni, E, Carleo, M, Bargiacchi, O, Madeddu, G, Cascio, A, Menzaghi, B, De Socio, G, Falasca, K, Bonfanti, P, Di Biagio, A, Pellicanò, GF, Carleo, MA, De Socio, GV, Bartalucci, C, Taramasso, L, Ricci, E, De Vito, A, Squillace, N, Ferrara, S, Pontali, E, Cenderello, G, Pellicanò, G, Sarchi, E, Lagi, F, Salomoni, E, Carleo, M, Bargiacchi, O, Madeddu, G, Cascio, A, Menzaghi, B, De Socio, G, Falasca, K, Bonfanti, P, Di Biagio, A, Pellicanò, GF, Carleo, MA, and De Socio, GV

Published
2024

3. Low level viremia at the beginning and in course of long-acting treatment with injectable cabotegravir and rilpivirine

Author

Taramasso, L, Ricci, E, De Vito, A, Squillace, N, Ferrara, S, Pontali, E, Cenderello, G, Pellicanò, G, Sarchi, E, Lagi, F, Salomoni, E, Carleo, M, Bargiacchi, O, Madeddu, G, Cascio, A, Menzaghi, B, De Socio, G, Falasca, K, Bonfanti, P, Di Biagio, A, Null, N, Pellicanò, GF, Carleo, MA, De Socio, GV, null, null, Taramasso, L, Ricci, E, De Vito, A, Squillace, N, Ferrara, S, Pontali, E, Cenderello, G, Pellicanò, G, Sarchi, E, Lagi, F, Salomoni, E, Carleo, M, Bargiacchi, O, Madeddu, G, Cascio, A, Menzaghi, B, De Socio, G, Falasca, K, Bonfanti, P, Di Biagio, A, Null, N, Pellicanò, GF, Carleo, MA, De Socio, GV, and null, null

Published
2024

4. Central nervous system and neuropsychiatric adverse events in Women living with HIV treated with INSTI-based regimens

Author

De Vito, A, Bonfanti, P, Ricci, E, Menzaghi, B, Orofino, G, Squillace, N, Maggi, P, Molteni, C, Sarchi, E, De Socio, G, Celesia, B, Pellicanò, F, Lagi, F, Gulminetti, R, Taramasso, L, Albini, L, Di Biagio, A, Madeddu, G, De Socio, GV, Celesia, BM, Pellicanò, FG, De Vito, A, Bonfanti, P, Ricci, E, Menzaghi, B, Orofino, G, Squillace, N, Maggi, P, Molteni, C, Sarchi, E, De Socio, G, Celesia, B, Pellicanò, F, Lagi, F, Gulminetti, R, Taramasso, L, Albini, L, Di Biagio, A, Madeddu, G, De Socio, GV, Celesia, BM, and Pellicanò, FG

Published
2024

5. Lipids, weight gain and body mass index in ARV experienced PLWH treated with doravirine-based treatments: a comparison between dual or triple regimens vs bictegravir based triple regimen

Author

Masiello, A, Iodice, V, Menzaghi, B, Taramasso, L, Bellagamba, R, Molteni, C, Pellicanò, G, Squillace, N, Sarchi, E, Lagi, F, Cascio, A, Carleo, M, Celesia, B, Salomoni, E, Ferrara, S, Pontali, E, De Socio, G, Madeddu, G, Franzetti, M, Martini, S, Falasca, K, Orofino, G, Bargiacchi, O, Fiordelisi, D, Angioni, G, Cenderello, G, Calza, L, Di Biagio, A, Bonfanti, P, Maggi, P, Null, N, Pellicanò, GF, Carleo, MA, Celesia, BM, De Socio, GV, null, null, Masiello, A, Iodice, V, Menzaghi, B, Taramasso, L, Bellagamba, R, Molteni, C, Pellicanò, G, Squillace, N, Sarchi, E, Lagi, F, Cascio, A, Carleo, M, Celesia, B, Salomoni, E, Ferrara, S, Pontali, E, De Socio, G, Madeddu, G, Franzetti, M, Martini, S, Falasca, K, Orofino, G, Bargiacchi, O, Fiordelisi, D, Angioni, G, Cenderello, G, Calza, L, Di Biagio, A, Bonfanti, P, Maggi, P, Null, N, Pellicanò, GF, Carleo, MA, Celesia, BM, De Socio, GV, and null, null

Published
2024

6. Changes in body mass index and lipid profile in PWH switching to a regimen without TAF vs PWH continuing TAF. Data from a real-life setting

Author

Squillace, N, Taramasso, L, Ricci, E, Menzaghi, B, De Socio, G, Orofino, G, Celesia, B, Sarchi, E, Piconi, S, Pellicano', G, Attala, L, Di Biagio, A, Bonfanti, P, Celesia, BM, Squillace, N, Taramasso, L, Ricci, E, Menzaghi, B, De Socio, G, Orofino, G, Celesia, B, Sarchi, E, Piconi, S, Pellicano', G, Attala, L, Di Biagio, A, Bonfanti, P, and Celesia, BM

Published
2024

7. Risk of Cardiovascular Events in People with HIV (PWH) Treated with Integrase Strand-Transfer Inhibitors: The Debate Is Not Over; Results of the SCOLTA Study

Author

Corti, N, Menzaghi, B, Orofino, G, Guastavigna, M, Lagi, F, Di Biagio, A, Taramasso, L, De Socio, G, Molteni, C, Madeddu, G, Salomoni, E, Pellicanò, G, Pontali, E, Bellagamba, R, Celesia, B, Cascio, A, Sarchi, E, Gulminetti, R, Calza, L, Maggi, P, Cenderello, G, Bandera, A, Carleo, M, Falasca, K, Ferrara, S, Martini, S, Guadagnino, G, Angioni, G, Bargiacchi, O, Ricci, E, Squillace, N, Bonfanti, P, Corti, Nicolò, Menzaghi, Barbara, Orofino, Giancarlo, Guastavigna, Marta, Lagi, Filippo, Di Biagio, Antonio, Taramasso, Lucia, De Socio, Giuseppe Vittorio, Molteni, Chiara, Madeddu, Giordano, Salomoni, Elena, Pellicanò, Giovanni Francesco, Pontali, Emanuele, Bellagamba, Rita, Celesia, Benedetto Maurizio, Cascio, Antonio, Sarchi, Eleonora, Gulminetti, Roberto, Calza, Leonardo, Maggi, Paolo, Cenderello, Giovanni, Bandera, Alessandra, Carleo, Maria Aurora, Falasca, Katia, Ferrara, Sergio, Martini, Salvatore, Guadagnino, Giuliana, Angioni, Goffredo, Bargiacchi, Olivia, Ricci, Elena Delfina, Squillace, Nicola, Bonfanti, Paolo, Corti, N, Menzaghi, B, Orofino, G, Guastavigna, M, Lagi, F, Di Biagio, A, Taramasso, L, De Socio, G, Molteni, C, Madeddu, G, Salomoni, E, Pellicanò, G, Pontali, E, Bellagamba, R, Celesia, B, Cascio, A, Sarchi, E, Gulminetti, R, Calza, L, Maggi, P, Cenderello, G, Bandera, A, Carleo, M, Falasca, K, Ferrara, S, Martini, S, Guadagnino, G, Angioni, G, Bargiacchi, O, Ricci, E, Squillace, N, Bonfanti, P, Corti, Nicolò, Menzaghi, Barbara, Orofino, Giancarlo, Guastavigna, Marta, Lagi, Filippo, Di Biagio, Antonio, Taramasso, Lucia, De Socio, Giuseppe Vittorio, Molteni, Chiara, Madeddu, Giordano, Salomoni, Elena, Pellicanò, Giovanni Francesco, Pontali, Emanuele, Bellagamba, Rita, Celesia, Benedetto Maurizio, Cascio, Antonio, Sarchi, Eleonora, Gulminetti, Roberto, Calza, Leonardo, Maggi, Paolo, Cenderello, Giovanni, Bandera, Alessandra, Carleo, Maria Aurora, Falasca, Katia, Ferrara, Sergio, Martini, Salvatore, Guadagnino, Giuliana, Angioni, Goffredo, Bargiacchi, Olivia, Ricci, Elena Delfina, Squillace, Nicola, and Bonfanti, Paolo

Abstract

Cardiovascular disease (CVD) is common in people with HIV (PWH), and has great impact in terms of morbidity and mortality. Several intertwined mechanisms are believed to play a role in determining the increased risk of CVD, including the effect of certain antiretrovirals; among these, the role of integrase strand-transfer inhibitors (INSTIs) is yet to be fully elucidated. We conducted a multicenter, observational study comprising 4984 PWH evaluating the antiretroviral therapy (ART)-related nature of CVD in real life settings, both in naïve vs. treatment-experienced people. A comparison was conducted between INSTIs vs. either protease inhibitors (PIs) or non-nucleoside reverse transcriptase inhibitors (NNRTIs) considering demographic, baseline clinical characteristics, incidence of CVD in both 2-year and complete follow-up periods. Among 2357 PWH exposed to INSTIs, 24 people experienced CVD; the corresponding figure was 12 cases out of 2599 PWH exposed to other ART classes. At univariate and multivariate analysis, a tendency towards an increased risk of CVD was observed in the 2-year follow-up period in PWH exposed to INSTIs in the absence, however, of statistical significance. These findings leave open the hypothesis that INSTIs may play a role, albeit minimal, in determining an increased risk of CVD in PWH.

Published
2024

8. Lipids and Transaminase in Antiretroviral-Treatment-Experienced People Living with HIV, Switching to a Doravirine-Based vs. a Rilpivirine-Based Regimen: Data from a Real-Life Setting

Author

Maggi, P, Ricci, E, Martinelli, C, De Socio, G, Squillace, N, Molteni, C, Masiello, A, Orofino, G, Menzaghi, B, Bellagamba, R, Vichi, F, Celesia, B, Madeddu, G, Pellicanò, G, Carleo, M, Cascio, A, Parisini, A, Taramasso, L, Valsecchi, L, Calza, L, Rusconi, S, Sarchi, E, Martini, S, Bargiacchi, O, Falasca, K, Cenderello, G, Ferrara, S, Di Biagio, A, Bonfanti, P, Maggi, Paolo, Ricci, Elena Delfina, Martinelli, Canio Vito, De Socio, Giuseppe Vittorio, Squillace, Nicola, Molteni, Chiara, Masiello, Addolorata, Orofino, Giancarlo, Menzaghi, Barbara, Bellagamba, Rita, Vichi, Francesca, Celesia, Benedetto Maurizio, Madeddu, Giordano, Pellicanò, Giovanni Francesco, Carleo, Maria Aurora, Cascio, Antonio, Parisini, Andrea, Taramasso, Lucia, Valsecchi, Laura, Calza, Leonardo, Rusconi, Stefano, Sarchi, Eleonora, Martini, Salvatore, Bargiacchi, Olivia, Falasca, Katia, Cenderello, Giovanni, Ferrara, Sergio, Di Biagio, Antonio, Bonfanti, Paolo, Maggi, P, Ricci, E, Martinelli, C, De Socio, G, Squillace, N, Molteni, C, Masiello, A, Orofino, G, Menzaghi, B, Bellagamba, R, Vichi, F, Celesia, B, Madeddu, G, Pellicanò, G, Carleo, M, Cascio, A, Parisini, A, Taramasso, L, Valsecchi, L, Calza, L, Rusconi, S, Sarchi, E, Martini, S, Bargiacchi, O, Falasca, K, Cenderello, G, Ferrara, S, Di Biagio, A, Bonfanti, P, Maggi, Paolo, Ricci, Elena Delfina, Martinelli, Canio Vito, De Socio, Giuseppe Vittorio, Squillace, Nicola, Molteni, Chiara, Masiello, Addolorata, Orofino, Giancarlo, Menzaghi, Barbara, Bellagamba, Rita, Vichi, Francesca, Celesia, Benedetto Maurizio, Madeddu, Giordano, Pellicanò, Giovanni Francesco, Carleo, Maria Aurora, Cascio, Antonio, Parisini, Andrea, Taramasso, Lucia, Valsecchi, Laura, Calza, Leonardo, Rusconi, Stefano, Sarchi, Eleonora, Martini, Salvatore, Bargiacchi, Olivia, Falasca, Katia, Cenderello, Giovanni, Ferrara, Sergio, Di Biagio, Antonio, and Bonfanti, Paolo

Abstract

Doravirine (DOR) is a newly approved non-nucleoside reverse transcriptase inhibitor (NNRTI). We aimed to investigate, in a real-life setting, how switching to a DOR-based regimen rather than a rilpivirine (RPV)-based regimen impacted metabolic and hepatic safety. The analysis included 551 antiretroviral treatment (ART)-experienced people living with HIV (PLWH), starting RPV-based or DOR-based regimens with viral load < 200 copies/mL, baseline (T0), and at least one control visit (6-month visit, T1). We enrolled 295 PLWH in the RPV and 256 in the DOR cohort. At T1, total cholesterol (TC), low-density lipoprotein-C (LDL-C), and triglycerides significantly decreased in both DOR and RPV cohorts, while high-density lipoprotein-C (HDL-C) only decreased in RPV-treated people. Consistently, the TC/HDL-C ratio declined more markedly in the DOR (−0.36, p < 0.0001) than in the RPV cohort (−0.08, p = 0.25) (comparison p = 0.39). Similar trends were observed when excluding the PLWH on lipid-lowering treatment from the analysis. People with normal alanine aminotransferase (ALT) levels showed a slight ALT increase in both cohorts, and those with baseline ALT > 40 IU/L experienced a significant decline (−14 IU/L, p = 0.008) only in the DOR cohort. Lipid profile improved in both cohorts, and there was a significant reduction in ALT in PLWH with higher-than-normal baseline levels on DOR-based ART.

Published
2023

9. Real-life safety of Emtricitabine/Tenofovir Alafenamide/Bictegravir

Author

Squillace, N, Ricci, E, Maggi, P, Taramasso, L, Menzaghi, B, De Socio, G, Piconi, S, Maurizio Celesia, B, Orofino, G, Sarchi, E, Pellicanò, G, Simeone, F, Valsecchi, L, Bandera, A, Cenderello, G, Attala, L, Angioni, G, Falasca, K, Cascio, A, Bargiacchi, O, Di Biagio, A, Bonfanti, P, Squillace, Nicola, Ricci, Elena, Maggi, Paolo, Taramasso, Lucia, Menzaghi, Barbara, De Socio, Giuseppe Vittorio, Piconi, Stefania, Maurizio Celesia, Benedetto, Orofino, Giancarlo, Sarchi, Eleonora, Pellicanò, Giovanni Francesco, Simeone, Filomena, Valsecchi, Laura, Bandera, Alessandra, Cenderello, Giovanni, Attala, Letizia, Angioni, Goffredo, Falasca, Katia, Cascio, Antonio, Bargiacchi, Olivia, Di Biagio, Antonio, Bonfanti, Paolo, Squillace, N, Ricci, E, Maggi, P, Taramasso, L, Menzaghi, B, De Socio, G, Piconi, S, Maurizio Celesia, B, Orofino, G, Sarchi, E, Pellicanò, G, Simeone, F, Valsecchi, L, Bandera, A, Cenderello, G, Attala, L, Angioni, G, Falasca, K, Cascio, A, Bargiacchi, O, Di Biagio, A, Bonfanti, P, Squillace, Nicola, Ricci, Elena, Maggi, Paolo, Taramasso, Lucia, Menzaghi, Barbara, De Socio, Giuseppe Vittorio, Piconi, Stefania, Maurizio Celesia, Benedetto, Orofino, Giancarlo, Sarchi, Eleonora, Pellicanò, Giovanni Francesco, Simeone, Filomena, Valsecchi, Laura, Bandera, Alessandra, Cenderello, Giovanni, Attala, Letizia, Angioni, Goffredo, Falasca, Katia, Cascio, Antonio, Bargiacchi, Olivia, Di Biagio, Antonio, and Bonfanti, Paolo

Abstract

Introduction Integrase strand transfer inhibitors (INSTI) are one of the most prescribed drug classes for the treatment of HIV infection worldwide. Emtricitabine/Tenofovir Alafenamide/ Bictegravir (FTC/TAF/BIC) has been evaluated in randomized clinical trials; few studies have verified tolerability and safety in clinical practice. Our aim was to investigate the metabolic and hepatic safety in a real-life setting of FTC/TAF/BIC. Materials and methods Consecutive people living with HIV infection (PLWH) enrolled in the SCOLTA project, switching to or initiating their first antiretroviral treatment with FTC/TAF/BIC were included. PLWH with HBV co-infection were excluded. Metabolic and hepatic variables were collected at T0 and T1, were defined as baseline and 6-month follow-up respectively, and their modifications were analysed using the paired t-test and the analysis of variance. Results Five hundred and thirty-nine PLWH with at least one follow-up visit were included in the analysis. Mean age was 48 years (±12.1), 74% were male, 16.1% were naïve to antiretrovirals (ART). At T1, ART-experienced PLWH showed a significant reduction of total cholesterol (TC) and triglycerides, and a slight increase in blood glucose (BG) and ALT. On the contrary, in ART-naïve PLWH blood lipids significantly increased, although with an unaffected TC/high density lipoprotein (HDL)-c ratio, while alanine aminotransferase (ALT) decreased significantly, mainly in those with altered baseline level. The treatment interruptions were 45 (8.4%) over the whole observation period, 13 (2.4%) due to AEs. The most frequent AEs were related to the central nervous system (6 events of depression, insomnia, headache, agitation) and 3 PLWH discontinued the regimen because of grade 1-2 weight gain. Conclusions In ART-experienced PLWH switching to FTC/TAF/BIC a significant improvement of lipid profile occurred but with significant BG and ALT variation without clinical relevance. In ARTnaïve PLWH, blood lipid

Published
2023

10. Incident diabetes in course of antiretroviral therapy

Author

Taramasso, L, Squillace, N, Ricci, E, Menzaghi, B, Orofino, G, Socio, G, Molteni, C, Martinelli, C, Madeddu, G, Vichi, F, Valsecchi, L, Celesia, B, Maggi, P, Rusconi, S, Pellicanò, G, Cascio, A, Sarchi, E, Gulminetti, R, Falasca, K, Di Biagio, A, Bonfanti, P, Taramasso, Lucia, Squillace, Nicola, Ricci, Elena, Menzaghi, Barbara, Orofino, Giancarlo, Socio, Giuseppe Vittorio De, Molteni, Chiara, Martinelli, Canio Vito, Madeddu, Giordano, Vichi, Francesca, Valsecchi, Laura, Celesia, Benedetto Maurizio, Maggi, Paolo, Rusconi, Stefano, Pellicanò, Giovanni Francesco, Cascio, Antonio, Sarchi, Eleonora, Gulminetti, Roberto, Falasca, Katia, Di Biagio, Antonio, Bonfanti, Paolo, Taramasso, L, Squillace, N, Ricci, E, Menzaghi, B, Orofino, G, Socio, G, Molteni, C, Martinelli, C, Madeddu, G, Vichi, F, Valsecchi, L, Celesia, B, Maggi, P, Rusconi, S, Pellicanò, G, Cascio, A, Sarchi, E, Gulminetti, R, Falasca, K, Di Biagio, A, Bonfanti, P, Taramasso, Lucia, Squillace, Nicola, Ricci, Elena, Menzaghi, Barbara, Orofino, Giancarlo, Socio, Giuseppe Vittorio De, Molteni, Chiara, Martinelli, Canio Vito, Madeddu, Giordano, Vichi, Francesca, Valsecchi, Laura, Celesia, Benedetto Maurizio, Maggi, Paolo, Rusconi, Stefano, Pellicanò, Giovanni Francesco, Cascio, Antonio, Sarchi, Eleonora, Gulminetti, Roberto, Falasca, Katia, Di Biagio, Antonio, and Bonfanti, Paolo

Abstract

Objective:Recent reports of excessive weight gain in people with HIV (PWH) have raised increasing concerns on the possible increase of diabetes mellitus (DM) risk in course of integrase inhibitors (INSTIs) treatment. In this study, we aimed at describing DM incidence in course of antiretroviral therapy (ART) and identifying the factors associated with new DM onset.Design:Observational prospective SCOLTA (Surveillance Cohort Long-Term Toxicity Antiretrovirals) cohort.Methods:All people enrolled in SCOLTA between January 2003 and November 2021 were included. Multivariable Cox regression yielded adjusted hazard ratios (aHRs) and 95% confidence intervals (CIs) for incident DM.Results:4366 PWH were included, 72.6% male, with mean age 45.6 years, and median CD4+ 460 [interquartile range (IQR) 256-710] cells/mm3cells/mm3. During the follow up, 120 incident cases of DM occurred (1.26 cases/100 person year-follow up, 95% CI 1.05-1.50).Baseline weight, but not the amount of weight gain, resulted significantly correlated to diabetes incidence (aHR by 1 kg 1.03; 95% CI 1.01-1.04), as well as older age (aHR 1.03 by 1 year; 95% CI 1.01-1.06), being ART-experienced with detectable HIV RNA at study entry (aHR 2.27, 95% CI 1.48-3.49), having untreated high blood pressure (aHR 2.90; 95% CI 1.30-6.45) and baseline blood glucose >100 mg/dl (aHR 5.47; 95% CI 3.82-7.85). Neither the INSTI class nor individual antiretrovirals were associated with an increased risk of DM.Conclusions:Baseline weight, but not weight gain or the ART class, was associated with incident DM in this observational cohort.

Published
2023

11. Lipids and transaminase elevations in ARV-experienced PLWH switching to a doravirine-based regimen from rilpivirine or other regimens

Author

Maggi, P, Ricci, E, Cicalini, S, Pellicanò, G, Celesia, B, Vichi, F, Cascio, A, Sarchi, E, Orofino, G, Squillace, N, Madeddu, G, De Socio, G, Bargiacchi, O, Molteni, C, Masiello, A, Saracino, A, Menzaghi, B, Falasca, K, Taramasso, L, Di Biagio, A, Bonfanti, P, Maggi, Paolo, Ricci, Elena Delfina, Cicalini, Stefania, Pellicanò, Giovanni Francesco, Celesia, Benedetto Maurizio, Vichi, Francesca, Cascio, Antonio, Sarchi, Eleonora, Orofino, Giancarlo, Squillace, Nicola, Madeddu, Giordano, De Socio, Giuseppe Vittorio, Bargiacchi, Olivia, Molteni, Chiara, Masiello, Addolorata, Saracino, Annalisa, Menzaghi, Barbara, Falasca, Katia, Taramasso, Lucia, Di Biagio, Antonio, Bonfanti, Paolo, Maggi, P, Ricci, E, Cicalini, S, Pellicanò, G, Celesia, B, Vichi, F, Cascio, A, Sarchi, E, Orofino, G, Squillace, N, Madeddu, G, De Socio, G, Bargiacchi, O, Molteni, C, Masiello, A, Saracino, A, Menzaghi, B, Falasca, K, Taramasso, L, Di Biagio, A, Bonfanti, P, Maggi, Paolo, Ricci, Elena Delfina, Cicalini, Stefania, Pellicanò, Giovanni Francesco, Celesia, Benedetto Maurizio, Vichi, Francesca, Cascio, Antonio, Sarchi, Eleonora, Orofino, Giancarlo, Squillace, Nicola, Madeddu, Giordano, De Socio, Giuseppe Vittorio, Bargiacchi, Olivia, Molteni, Chiara, Masiello, Addolorata, Saracino, Annalisa, Menzaghi, Barbara, Falasca, Katia, Taramasso, Lucia, Di Biagio, Antonio, and Bonfanti, Paolo

Abstract

Background: Doravirine (DOR) is a newly approved antiretroviral belonging to the class of non-nucleoside reverse transcriptase inhibitors (NNRTI), well tolerated and leading to an improved lipid profile in antiretroviral experienced people living with HIV (PLWH). We aimed at evaluating if the lipid-lowering effect is linked to the drug class, using real-life data from the SCOLTA cohort. Methods: We compared the lipid profile modifications in experienced PLWH switching to a DOR-based regimen from rilpivirine or another NNRTI-based regimen or from an integrase strand transferase (INSTI)-based regimen. T0 and T1 were defined as the baseline and 6-month follow-up respectively. Data were collected at baseline and prospectively every six months and changes from baseline were compared using a multivariable linear model. Results: In 107 PLWH, enrolled in the SCOLTA DOR cohort, with undetectable HIV-RNA at baseline, 32.7% switched from RPV-based regimens (DOR1), 29.9% from other NNRTI-including regimens (DOR2) and 37.4% switched from INSTI-including regimens (DOR3). At T1, TC significantly decreased in DOR2 (-15 mg/dL) and DOR3 (-23 mg/dL), and significantly more in DOR3 than in DOR1 (-6 mg/dL) (p = 0.016). HDL-C declined in DOR2 (-2 mg/dL) whereas it increased in DOR1 (+ 3 mg/dL) (p = 0.042) and remained stable in DOR3. LDL-C significantly decreased from baseline in DOR2 (-12 mg/dL) and DOR3 (-22 mg/dL) and was different between DOR1 (-8 mg/dL) and DOR3 (p = 0.022). TC/HDL ratio showed a significant decline in the DOR3 group (-0.45), although similar to DOR1 (-0.23, p = 0.315) and DOR2 (-0.19, p = 0.254). Triglycerides did not noticeably change. ALT significantly decreased in PLWH with a baseline level > 40 UI/mL. Conclusions: PLWH on doravirine treatment showed different trends in blood lipids according to their previous regimen. In PLWH switching from RPV, minimal modifications were seen, whereas in those switching from other NNRTIs and from INSTI-including regimens, w

Published
2023

12. Causes of HIV Treatment Interruption during the Last 20 Years: A Multi-Cohort Real-Life Study

Author

De Vito, A, Ricci, E, Menzaghi, B, Orofino, G, Martinelli, C, Squillace, N, Taramasso, L, De Socio, G, Molteni, C, Valsecchi, L, Costa, C, Celesia, B, Parruti, G, Pellicanò, G, Sarchi, E, Cascio, A, Cenderello, G, Falasca, K, Di Biagio, A, Bonfanti, P, Madeddu, G, De Vito, Andrea, Ricci, Elena, Menzaghi, Barbara, Orofino, Giancarlo, Martinelli, Canio Vito, Squillace, Nicola, Taramasso, Lucia, De Socio, Giuseppe Vittorio, Molteni, Chiara, Valsecchi, Laura, Costa, Cecilia, Celesia, Benedetto Maurizio, Parruti, Giustino, Pellicanò, Giovanni Francesco, Sarchi, Eleonora, Cascio, Antonio, Cenderello, Giovanni, Falasca, Katia, Di Biagio, Antonio, Bonfanti, Paolo, Madeddu, Giordano, De Vito, A, Ricci, E, Menzaghi, B, Orofino, G, Martinelli, C, Squillace, N, Taramasso, L, De Socio, G, Molteni, C, Valsecchi, L, Costa, C, Celesia, B, Parruti, G, Pellicanò, G, Sarchi, E, Cascio, A, Cenderello, G, Falasca, K, Di Biagio, A, Bonfanti, P, Madeddu, G, De Vito, Andrea, Ricci, Elena, Menzaghi, Barbara, Orofino, Giancarlo, Martinelli, Canio Vito, Squillace, Nicola, Taramasso, Lucia, De Socio, Giuseppe Vittorio, Molteni, Chiara, Valsecchi, Laura, Costa, Cecilia, Celesia, Benedetto Maurizio, Parruti, Giustino, Pellicanò, Giovanni Francesco, Sarchi, Eleonora, Cascio, Antonio, Cenderello, Giovanni, Falasca, Katia, Di Biagio, Antonio, Bonfanti, Paolo, and Madeddu, Giordano

Abstract

In the last years, many antiretroviral drugs (ART) have been developed with increased efficacy. Nowadays, the main reasons for treatment switches are adverse events, proactive strategy or simplification. We conducted a retrospective cohort study to investigate the reason for treatment interruption in the last 20 years. We merged data of eight cohorts of the SCOLTA project: lopinavir/r (LPV), atazanavir/r (ATV), darunavir/r or /c (DRV), rilpivirine (RPV), raltegravir (RAL), elvitegravir/c (EVG), dolutegravir (DTG) and bictegravir (BIC). We included 4405 people with HIV (PWH). Overall, 664 (15.1%), 489 (11.1%), and 271 (6.2%) PWH interrupted the treatment in the first, second, and third years after starting a new ART. Looking at the interruption in the first year, the most frequent causes were adverse events (3.8%), loss to follow-up (3.7%), patients’ decisions (2.6%), treatment failure (1.7%), and simplification (1.3%). In the multivariate analysis regarding experienced patients, treatment with LPV, ATV, RPV or EVG/c, having less than 250 CD4 cells/mL, history of intravenous drug use, and HCV positivity were associated with an increased risk of interruption. In naive people, only LPV/r was associated with an increased risk of interruption, while RPV was associated with a lower risk. In conclusion, our data on more than 4400 PWH show that adverse events have represented the most frequent cause of treatment interruptions in the first year of ART (3.84%). Treatment discontinuations were more frequent during the first year of follow-up and decreased thereafter. First-generation PI in both naïve and experienced PWH, and EVG/c, in experienced PWH, were associated with a higher risk of treatment interruptions.

Published
2023

13. Metabolic syndrome and body weight in people living with HIV infection: analysis of differences observed in three different cohort studies over a decade

Author

Taramasso L., Bonfanti P., Ricci E., Maggi P., Orofino G., Squillace N., Menzaghi B., Madeddu G., Molteni C., Vichi F., Riguccini E., Saracino A., Santoro C., Guastavigna M., Francisci D., Di Biagio A., De Socio G. V., Sarchi E., Chichino G., Bolla C., Bellacosa C., Angarano G., Calza L., Farinazzo M., Angioni G., Gussio M., Celesia B. M., Falasca K., Mastroianni A., Guadagnino G., Salomoni E., Martinelli C., Dentone C., Bassetti M., Cenderello G., Pellicano G. F., Nunnari G., Valsecchi L., Cordier L., Parisini S., Rizzardini G., Rusconi S., Conti F., Bandera A., Gori A., Motta D., Puoti M., Migliorino G. M., Martini S., Cascio A., Trizzino M., Gulminetti R., Nofri M., Cibelli D., Parruti G., Mameli M. S., Taramasso L., Bonfanti P., Ricci E., Maggi P., Orofino G., Squillace N., Menzaghi B., Madeddu G., Molteni C., Vichi F., Riguccini E., Saracino A., Santoro C., Guastavigna M., Francisci D., Di Biagio A., De Socio G.V., Sarchi E., Chichino G., Bolla C., Bellacosa C., Angarano G., Calza L., Farinazzo M., Angioni G., Gussio M., Celesia B.M., Falasca K., Mastroianni A., Guadagnino G., Salomoni E., Martinelli C., Dentone C., Bassetti M., Cenderello G., Pellicano G.F., Nunnari G., Valsecchi L., Cordier L., Parisini S., Rizzardini G., Rusconi S., Conti F., Bandera A., Gori A., Motta D., Puoti M., Migliorino G.M., Martini S., Cascio A., Trizzino M., Gulminetti R., Nofri M., Cibelli D., Parruti G., Mameli M.S., Taramasso, L, Bonfanti, P, Ricci, E, Maggi, P, Orofino, G, Squillace, N, Menzaghi, B, Madeddu, G, Molteni, C, Vichi, F, Riguccini, E, Saracino, A, Santoro, C, Guastavigna, M, Francisci, D, Di Biagio, A, De Socio, G, Taramasso, Lucia, Bonfanti, Paolo, Ricci, Elena, Maggi, Paolo, Orofino, Giancarlo, Squillace, Nicola, Menzaghi, Barbara, Madeddu, Giordano, Molteni, Chiara, Vichi, Francesca, Riguccini, Erika, Saracino, Annalisa, Santoro, Carmen, Guastavigna, Marta, Francisci, Daniela, Di Biagio, Antonio, and De Socio, Giuseppe Vittorio

Subjects
Adult, Male, dyslipidaemia, antiretroviral therapy, HIV Infections, Overweight, Logistic regression, Body Mass Index, Cohort Studies, Prevalence, medicine, overweight, Humans, Pharmacology (medical), Metabolic Syndrome, business.industry, Health Policy, Incidence (epidemiology), Body Weight, HIV, weight gain, Odds ratio, Middle Aged, medicine.disease, Confidence interval, metabolic syndrome, Cross-Sectional Studies, Infectious Diseases, Metabolic syndrome, medicine.symptom, business, Weight gain, Demography, Cohort study
Abstract

Objectives: The aim of this study was to assess the incidence of being overweight and metabolic syndrome (MS) among people living with HIV (PHIV) in three different cross-sectional studies conducted over three different periods: 2005, 2011 and 2015. Methods: This was a multi-centre, nationwide study. Data were collected in three studies from the CISAI group - SIMOne, HIV-HY and STOPSHIV - and included a total of 3014 PHIV. Logistic regression [odds ratio (OR), 95% confidence interval (CI)] was used to account for age and gender difference among three groups when comparing MS prevalence and being overweight; potential confounders were accounted for by including them in the regression equation. Results: Overall, the mean age was 46.9±10.2years, and men comprised 73.3% of participants. Comparing 2005, 2011 and 2015, MS was present in 34.5%, 33.0% and 29.3% of PHIV, respectively. Adjusted OR for MS was 0.64 (95% CI: 0.52-0.78) in 2011 and 0.56 (95% CI: 0.46-0.69) in 2015 compared with 2005, while BMI (kg/m2 ) increased from 23.6 in 2005, 24.5 in 2011 and 24.5 in 2015, with a concomitant increase of being overweight from 29.4% to 39.5% to 39.6% (p&nbsp

Published
2021
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14. Reversibility of Central Nervous System Adverse Events in Course of Art

Author

Taramasso, L, Orofino, G, Ricci, E, Menzaghi, B, De Socio, G, Squillace, N, Madeddu, G, Vichi, F, Celesia, B, Molteni, C, Conti, F, Del Puente, F, Sarchi, E, Angioni, G, Cascio, A, Grosso, C, Parruti, G, Di Biagio, A, Bonfanti, P, Taramasso, Lucia, Orofino, Giancarlo, Ricci, Elena, Menzaghi, Barbara, De Socio, Giuseppe Vittorio, Squillace, Nicola, Madeddu, Giordano, Vichi, Francesca, Celesia, Benedetto Maurizio, Molteni, Chiara, Conti, Federico, Del Puente, Filippo, Sarchi, Eleonora, Angioni, Goffredo, Cascio, Antonio, Grosso, Carmela, Parruti, Giustino, Di Biagio, Antonio, Bonfanti, Paolo, Taramasso, L, Orofino, G, Ricci, E, Menzaghi, B, De Socio, G, Squillace, N, Madeddu, G, Vichi, F, Celesia, B, Molteni, C, Conti, F, Del Puente, F, Sarchi, E, Angioni, G, Cascio, A, Grosso, C, Parruti, G, Di Biagio, A, Bonfanti, P, Taramasso, Lucia, Orofino, Giancarlo, Ricci, Elena, Menzaghi, Barbara, De Socio, Giuseppe Vittorio, Squillace, Nicola, Madeddu, Giordano, Vichi, Francesca, Celesia, Benedetto Maurizio, Molteni, Chiara, Conti, Federico, Del Puente, Filippo, Sarchi, Eleonora, Angioni, Goffredo, Cascio, Antonio, Grosso, Carmela, Parruti, Giustino, Di Biagio, Antonio, and Bonfanti, Paolo

Abstract

The purpose of this study is to evaluate the frequency of central nervous system adverse events (CNS-AE) on dolutegravir (DTG) and non-DTG containing ART, and their reversibility, in the observational prospective SCOLTA cohort. Factors associated with CNS-AE were estimated using a Cox proportional-hazards model. 4939 people living with HIV (PLWH) were enrolled in DTG (n = 1179) and non-DTG (n = 3760) cohorts. Sixty-six SNC-AE leading to ART discontinuation were reported, 39/1179 (3.3%) in DTG and 27/3760 (0.7%) in non-DTG cohort. PLWH naïve to ART, with higher CD4 + T count and with psychiatric disorders were more likely to develop a CNS-AE. The risk was lower in non-DTG than DTG-cohort (aHR 0.33, 95% CI 0.19–0.55, p < 0.0001). One-year follow-up was available for 63/66 PLWH with CNS-AE. AE resolution was reported in 35/39 and 23/24 cases in DTG and non-DTG cohorts, respectively. The probability of AE reversibility was not different based on ART class, sex, ethnicity, CDC stage, or baseline psychiatric disorder. At the same time, a lower rate of event resolution was found in PLWH older than 50 years (p = 0.017). In conclusion, CNS-AE leading to ART discontinuation was more frequent in DTG than non-DTG treated PLWH. Most CNS-AE resolved after ART switch, similarly in both DTG and non-DTG cohorts.

Published
2022

15. Growing old with antiretroviral therapy or elderly people in antiretroviral therapy: two different profiles of comorbidity?

Author

Maggi, P, De Socio, G, Menzaghi, B, Molteni, C, Squillace, N, Taramasso, L, Guastavigna, M, Gamboni, G, Madeddu, G, Vichi, F, Cascio, A, Sarchi, E, Pellicanò, G, Martinelli, C, Celesia, B, Valsecchi, L, Gulminetti, R, Cenderello, G, Parisini, A, Calza, L, Falasca, K, Orofino, G, Ricci, E, Di Biagio, A, Bonfanti, P, Maggi, Paolo, De Socio, Giuseppe Vittorio, Menzaghi, Barbara, Molteni, Chiara, Squillace, Nicola, Taramasso, Lucia, Guastavigna, Marta, Gamboni, Giulia, Madeddu, Giordano, Vichi, Francesca, Cascio, Antonio, Sarchi, Eleonora, Pellicanò, Giovanni, Martinelli, Canio Vito, Celesia, Benedetto Maurizio, Valsecchi, Laura, Gulminetti, Roberto, Cenderello, Giovanni, Parisini, Andrea, Calza, Leonardo, Falasca, Katia, Orofino, Giancarlo, Ricci, Elena, Di Biagio, Antonio, Bonfanti, Paolo, Maggi, P, De Socio, G, Menzaghi, B, Molteni, C, Squillace, N, Taramasso, L, Guastavigna, M, Gamboni, G, Madeddu, G, Vichi, F, Cascio, A, Sarchi, E, Pellicanò, G, Martinelli, C, Celesia, B, Valsecchi, L, Gulminetti, R, Cenderello, G, Parisini, A, Calza, L, Falasca, K, Orofino, G, Ricci, E, Di Biagio, A, Bonfanti, P, Maggi, Paolo, De Socio, Giuseppe Vittorio, Menzaghi, Barbara, Molteni, Chiara, Squillace, Nicola, Taramasso, Lucia, Guastavigna, Marta, Gamboni, Giulia, Madeddu, Giordano, Vichi, Francesca, Cascio, Antonio, Sarchi, Eleonora, Pellicanò, Giovanni, Martinelli, Canio Vito, Celesia, Benedetto Maurizio, Valsecchi, Laura, Gulminetti, Roberto, Cenderello, Giovanni, Parisini, Andrea, Calza, Leonardo, Falasca, Katia, Orofino, Giancarlo, Ricci, Elena, Di Biagio, Antonio, and Bonfanti, Paolo

Abstract

Background In persons living with HIV (PLWH), the burden of non-communicable chronic diseases increased over time, because of aging associated with chronic inflammation, systemic immune activation, and long-term exposure to the combination antiretroviral therapy (ART).Methods To explore the association of chronological age, age at first ART, and exposure to ART with non-communicable chronic diseases, we performed a cross-sectional analysis to evaluate the prevalence of comorbidities in patients enrolled in the SCOLTA Project, stratified by groups of chronological age (50–59 and 60–69 years) and by years of antiretroviral treatment (ART, ≤ 3 or > 3 years).Results In 1394 subjects (23.8% women), mean age at enrollment was 57.4 (SD 6.5) years, and at first ART 45.3 (SD 10.7). Men were older than women both at enrollment (57.6 vs 56.8, p = 0.06) and at first ART (45.8 vs 43.6, p = 0.0009). ART duration was longer in women (13.1 vs 11.7 years, p = 0.01). The age- and sex-adjusted rate ratios (aRRs, and 95% confidence interval, CI) showed that longer ART exposure was associated with dyslipidemia (aRR 1.35, 95% CI 1.20–1.52), hypertension (aRR 1.52, 95% CI 1.22–1.89), liver disease (aRR 1.78, 95% CI 1.32–2.41), osteopenia/osteoporosis (aRR 2.88, 95% CI 1.65–5.03) and multimorbidity (aRR 1.36, 95% CI 1.21–1.54). These findings were confirmed in strata of age, adjusting for sex.Conclusions Our data suggest that longer ART exposure was associated with increased risk of dyslipidemia, hypertension, and osteopenia/osteoporosis, hence the presence of multimorbidity, possibly due to the exposition to more toxic antiretrovirals. We observed different comorbidities, according to ART exposure and age.

Published
2022

16. Invecchiare con la terapia antiretrovirale o essere anziani in terapia antiretrovirale: due profili di comorbidità differenti?

Author

Zollo, V, Menzaghi, B, Molteni, C, Squillace, N, Taramasso, L, De Luca, I, Gamboni, G, Altobelli, D, Guastavigna, M, Madeddu, G, Vichi9 Antonio Cascio, F, Sarchi, E, Pellicanò, G, Martinelli, C, Maurizio Celesia, B, Valsecchi, L, Gulminetti, R, Cenderello, G, Parisini, A, Calza, L, Falasca, K, Di Biagio, A, Bonfanti, P, Orofino, G, Maggi., P, Verdiana Zollo, Barbara Menzaghi, Chiara Molteni, Nicola Squillace, Lucia Taramasso, Ilaria De Luca, Giulia Gamboni, Debora Altobelli, Marta Guastavigna, Giordano Madeddu, Francesca Vichi9 Antonio Cascio, Eleonora Sarchi, Giovanni Pellicanò, Canio Martinelli, Benedetto Maurizio Celesia, Laura Valsecchi, Roberto Gulminetti, Giovanni Cenderello, Andrea Parisini, Leonardo Calza, Katia Falasca, Antonio Di Biagio, Paolo Bonfanti, Giancarlo Orofino, Paolo Maggi., Zollo, V, Menzaghi, B, Molteni, C, Squillace, N, Taramasso, L, De Luca, I, Gamboni, G, Altobelli, D, Guastavigna, M, Madeddu, G, Vichi9 Antonio Cascio, F, Sarchi, E, Pellicanò, G, Martinelli, C, Maurizio Celesia, B, Valsecchi, L, Gulminetti, R, Cenderello, G, Parisini, A, Calza, L, Falasca, K, Di Biagio, A, Bonfanti, P, Orofino, G, Maggi., P, Verdiana Zollo, Barbara Menzaghi, Chiara Molteni, Nicola Squillace, Lucia Taramasso, Ilaria De Luca, Giulia Gamboni, Debora Altobelli, Marta Guastavigna, Giordano Madeddu, Francesca Vichi9 Antonio Cascio, Eleonora Sarchi, Giovanni Pellicanò, Canio Martinelli, Benedetto Maurizio Celesia, Laura Valsecchi, Roberto Gulminetti, Giovanni Cenderello, Andrea Parisini, Leonardo Calza, Katia Falasca, Antonio Di Biagio, Paolo Bonfanti, Giancarlo Orofino, and Paolo Maggi.

Abstract

In Persons Living With HIV (PLWH), the burden of non-communicable chronic diseases increased over time, because of aging linked to prolonged survival, chronic inflammation, systemic immune activation, and long-term exposure to the combination antiretroviral therapy (ART). Chronological age, age at HIV diagnosis, and exposure to ART may exert an effect on qualitative and quantitative differences. To explore this hypothesis, we evaluated the prevalence of some selected comorbidities in patients enrolled in the SCOLTA Project, by groups of chronological age (50- 59 and ≥60 years old) and ART duration. In 1336 subjects (23.9% women), ART duration was similar between age groups, both when considered in continuous (p=0.85) and in categories (p=0.88). As expected, comorbidities and multimorbidity were less frequent in the 50-59 than in the ≥60 years class. The age- and sex-adjusted odds ratios (ORs) showed that, in the 50-59 years group, a consistent and significant risk increase was observed through ART duration categories for CVD (ORs from 1.68 to 2.18), dyslipidemia (ORs from 3.61 to 9.08) and osteopenia/osteoporosis (ORs from 3.74 to 6.23). Consequently, the risk of multimorbidity also increased across ART duration categories (ORs from 2.04 to 4.40). In the ≥60 years group, the CVD risk was significantly increased only in those patients with ART duration ≥20 years (OR 2.61, 95% CI 1.22-5.58, reference category ≤6 months). Dyslipidemia and multimorbidity increase were consistently associated with longer ART duration. In conclusion, age, age at HIV infection diagnosis, and ART exposure were associated to multimorbidity in PLWH.&nbsp

Published
2022

17. Trajectories of CD4+/CD8+ T-Cells Ratio 96 Weeks after Switching to Dolutegravir-Based Two-Drug Regimens: Results from a Multicenter Prospective Cohort Study

Author

Taramasso, L, Falletta, A, Ricci, E, Orofino, G, Squillace, N, Menzaghi, B, De Socio, G, Molteni, C, Pellicanò, G, Gulminetti, R, Madeddu, G, Sarchi, E, Vichi, F, Celesia, B, Bonfanti, P, Di Biagio, A, Taramasso, Lucia, Falletta, Antonio, Ricci, Elena, Orofino, Giancarlo, Squillace, Nicola, Menzaghi, Barbara, De Socio, Giuseppe Vittorio, Molteni, Chiara, Pellicanò, Giovanni Francesco, Gulminetti, Roberto, Madeddu, Giordano, Sarchi, Eleonora, Vichi, Francesca, Celesia, Benedetto Maurizio, Bonfanti, Paolo, Di Biagio, Antonio, Taramasso, L, Falletta, A, Ricci, E, Orofino, G, Squillace, N, Menzaghi, B, De Socio, G, Molteni, C, Pellicanò, G, Gulminetti, R, Madeddu, G, Sarchi, E, Vichi, F, Celesia, B, Bonfanti, P, Di Biagio, A, Taramasso, Lucia, Falletta, Antonio, Ricci, Elena, Orofino, Giancarlo, Squillace, Nicola, Menzaghi, Barbara, De Socio, Giuseppe Vittorio, Molteni, Chiara, Pellicanò, Giovanni Francesco, Gulminetti, Roberto, Madeddu, Giordano, Sarchi, Eleonora, Vichi, Francesca, Celesia, Benedetto Maurizio, Bonfanti, Paolo, and Di Biagio, Antonio

Abstract

The aim of the present study was to evaluate CD4/CD8 dynamics in patients on dolutegravir (DTG)-based two-drug regimens (2DRs) and compare them with DTG-containing triple-drug regimens (3DRs). A prospective observational study was performed in the context of the SCOLTA cohort. Experienced PWH with HIV-RNA < 50 copies/mL were included if they were on the DTG-2DR, the DTG + tenofovir/emtricitabine (TDF/FTC) regimen, the DTG + tenofovir alafenamide (TAF)/FTC regimen, or the DTG + abacavir/lamivudine (ABC/3TC) regimen; they were followed-up for at least one year. A total of 533 PWH were enrolled, 120 in the DTG + 3TC group, 38 in the DTG + protease inhibitors (PI) group, 67 in the DTG + rilpivirine (RPV) group, 49 in the DTG + TDF/FTC group, 27 in the DTG + TAF/FTC group, and 232 in the DTG + ABC/3TC group. After one year, the CD4/CD8 ratio significantly increased in the PWH treated with DTG + 3TC (+0.08 ± 0.26), DTG + TDF/FTC (+0.1 ± 0.19), and DTG + ABC/3TC (+0.08 ± 0.25). At two years, the CD4/CD8 increase was confirmed for PWH on DTG + TDF/FTC (+0.16 ± 0.28) and DTG + ABC/3TC (+0.1 ± 0.3). In the SCOLTA cohort, PWH on 2DRs experienced a CD4/CD8 increase only in the DTG + 3TC group. Controlled studies with longer follow-up will clarify the long-term immunological and clinical impacts of DTG-2DR.

Published
2022

19. Positioning of darunavir/cobicistat-containing antiretroviral regimens in real life: Results from a large multicentre observational prospective cohort (SCOLTA)

Author

Taramasso, L, Ricci, E, Cascio, A, Valsecchi, L, Menzaghi, B, Squillace, N, Maggi, P, De Socio, G, Dentone, C, Madeddu, G, Pellicano, G, Calza, L, Angioni, G, Bonfanti, P, Di Biagio, A, Sarchi, E, Chichino, G, Bellacosa, C, Angarano, G, Farinazzo, M, Gussio, M, Celesia, B, Falasca, K, Mastroianni, A, Guadagnino, G, Vichi, F, Salomoni, E, Martinelli, C, Nicolini, L, Cenderello, G, Molteni, C, Nunnari, G, Cordier, L, Parisini, A, Rizzardini, G, Rusconi, S, Conti, F, Bandera, A, Gori, A, Motta, D, Puoti, M, Migliorino, G, Martini, S, Trizzino, M, Gulminetti, R, Cibelli, D, Parruti, G, Mameli, M, Orofino, G, Guastavigna, M, Taramasso L., Ricci E., Cascio A., Valsecchi L., Menzaghi B., Squillace N., Maggi P., De Socio G. V., Dentone C., Madeddu G., Pellicano G. F., Calza L., Angioni G., Bonfanti P., Di Biagio A., Sarchi E., Chichino G., Bellacosa C., Angarano G., Farinazzo M., Gussio M., Celesia B. M., Falasca K., Mastroianni A., Guadagnino G., Vichi F., Salomoni E., Martinelli C., Nicolini L., Cenderello G., Molteni C., Nunnari G., Cordier L., Parisini A., Rizzardini G., Rusconi S., Conti F., Bandera A., Gori A., Motta D., Puoti M., Migliorino G. M., Martini S., Trizzino M., Gulminetti R., Cibelli D., Parruti G., Mameli M. S., Orofino G., Guastavigna M., Taramasso, L, Ricci, E, Cascio, A, Valsecchi, L, Menzaghi, B, Squillace, N, Maggi, P, De Socio, G, Dentone, C, Madeddu, G, Pellicano, G, Calza, L, Angioni, G, Bonfanti, P, Di Biagio, A, Sarchi, E, Chichino, G, Bellacosa, C, Angarano, G, Farinazzo, M, Gussio, M, Celesia, B, Falasca, K, Mastroianni, A, Guadagnino, G, Vichi, F, Salomoni, E, Martinelli, C, Nicolini, L, Cenderello, G, Molteni, C, Nunnari, G, Cordier, L, Parisini, A, Rizzardini, G, Rusconi, S, Conti, F, Bandera, A, Gori, A, Motta, D, Puoti, M, Migliorino, G, Martini, S, Trizzino, M, Gulminetti, R, Cibelli, D, Parruti, G, Mameli, M, Orofino, G, Guastavigna, M, Taramasso L., Ricci E., Cascio A., Valsecchi L., Menzaghi B., Squillace N., Maggi P., De Socio G. V., Dentone C., Madeddu G., Pellicano G. F., Calza L., Angioni G., Bonfanti P., Di Biagio A., Sarchi E., Chichino G., Bellacosa C., Angarano G., Farinazzo M., Gussio M., Celesia B. M., Falasca K., Mastroianni A., Guadagnino G., Vichi F., Salomoni E., Martinelli C., Nicolini L., Cenderello G., Molteni C., Nunnari G., Cordier L., Parisini A., Rizzardini G., Rusconi S., Conti F., Bandera A., Gori A., Motta D., Puoti M., Migliorino G. M., Martini S., Trizzino M., Gulminetti R., Cibelli D., Parruti G., Mameli M. S., Orofino G., and Guastavigna M.

Abstract

Background: Study aim was to evaluate the safety and durability of darunavir/cobicistat (DRV/c) in a real life setting. Methods: Multicentre prospective cohort study performed in the context of SCOLTA (Surveillance Cohort Long-Term Toxicity Antiretrovirals). Patients were evaluated at baseline, week 24 and 48. Changes were evaluated using the paired t test or signed rank test. The multivariable analysis was performed using a general linear model, after ranking of not normally distributed variables. Results: A total of 249 patients were included, 72 (29%) were in DRV/c-based dual therapies (DT). Hypercholesterolemia, HC, (total cholesterol (TC) ≥ 200 mg/dL or low density-C (LDL-C) ≥ 130 or statin use) was present in 121 (48.6%) and hypertriglyceridemia, (triglycerides (TG) ≥ 200 mg/dl or fibrate use) in 41 (16.5%) patients. Blood lipid profile did not change significantly in either the global population or patients with HC. After a median observation of 17 months (IQR 13-20), 59 (25.3%) patients discontinued DRV/c, of which 13 were in DT. The durability DT resulted higher than that of triple therapy (log-rank test p = 0.01). Main reasons for stopping DRV/c were simplification (15 patients), adverse events (13 patients), planned discontinuation for treatment initiation with DAA (4 patients), treatment failure (2 patients); death (2 patients), other causes (10 patients). Twenty-six were lost to follow-up. Conclusions: DRV/c was safe and well tolerated. Dual therapies showed a better profile of tolerability and a longer durability compared to triple therapies.

Published
2019

20. Positioning of darunavir/cobicistat-containing antiretroviral regimens in real life: results from a large multicentre observational prospective cohort (SCOLTA)

Author

Taramasso L., Ricci E., Cascio A., Valsecchi L., Menzaghi B., Squillace N., Maggi P., De Socio G. V., Dentone C., Madeddu G., Pellicano G. F., Calza L., Angioni G., Bonfanti P., Di Biagio A., Sarchi E., Chichino G., Bellacosa C., Angarano G., Farinazzo M., Gussio M., Celesia B. M., Falasca K., Mastroianni A., Guadagnino G., Vichi F., Salomoni E., Martinelli C., Nicolini L., Cenderello G., Molteni C., Nunnari G., Cordier L., Parisini A., Rizzardini G., Rusconi S., Conti F., Bandera A., Gori A., Motta D., Puoti M., Migliorino G. M., Martini S., Trizzino M., Gulminetti R., Cibelli D., Parruti G., Mameli M. S., Orofino G., Guastavigna M., Lucia Taramasso, Elena Ricci, Antonio Cascio, Laura Valsecchi, Barbara Menzaghi, Nicola Squillace, Paolo Maggi, Giuseppe Vittorio De Socio, Chiara Dentone, Giordano Madeddu, Giovanni F. Pellicanò, Leonardo Calza, Goffredo Angioni, Paolo Bonfanti, Antonio Di Biagio, CISAI Study Group, Taramasso, L, Ricci, E, Cascio, A, Valsecchi, L, Menzaghi, B, Squillace, N, Maggi, P, De Socio, Gv, Dentone, C, Madeddu, G, Pellicanò, Gf, Calza, L, Angioni, G, Bonfanti, P, Di Biagio, A, Sarchi, E, Chichino, G, Bellacosa, C, Angarano, G, Farinazzo, M, Gussio, M, Celesia, B, Falasca, K, Mastroianni, A, Guadagnino, G, Vichi, F, Salomoni, E, Martinelli, C, Nicolini, L, Cenderello, G, Molteni, C, Pellicanò, G, Nunnari, G, Cordier, L, Parisini, A, Rizzardini, G, Rusconi, S, Conti, F, Bandiera, A, Gori, A, Motta, D, Puoti, M, Migliorino, G, Martini, S, Trizzino, M, Gulminetti, R, De Socio, G, Cibelli, D, Parruti, G, Mameli, M, Orofino, G, Guastavigna, M, Pellicano, G, Bandera, A, Taramasso L., Ricci E., Cascio A., Valsecchi L., Menzaghi B., Squillace N., Maggi P., De Socio G.V., Dentone C., Madeddu G., Pellicano G.F., Calza L., Angioni G., Bonfanti P., Di Biagio A., Sarchi E., Chichino G., Bellacosa C., Angarano G., Farinazzo M., Gussio M., Celesia B.M., Falasca K., Mastroianni A., Guadagnino G., Vichi F., Salomoni E., Martinelli C., Nicolini L., Cenderello G., Molteni C., Nunnari G., Cordier L., Parisini A., Rizzardini G., Rusconi S., Conti F., Bandera A., Gori A., Motta D., Puoti M., Migliorino G.M., Martini S., Trizzino M., Gulminetti R., Cibelli D., Parruti G., Mameli M.S., Orofino G., and Guastavigna M.

Subjects
0301 basic medicine, Male, HIV Infections, 0302 clinical medicine, Dual, Medicine, HIV Infection, Pharmacology (medical), 030212 general & internal medicine, Prospective Studies, Prospective cohort study, Darunavir, Cobicistat, Middle Aged, Viral Load, Tolerability, Anti-Retroviral Agents, Cohort, Molecular Medicine, Drug Therapy, Combination, Female, Darunavir/cobicistat, Human, medicine.drug, Adverse event, Adult, lcsh:Immunologic diseases. Allergy, medicine.medical_specialty, 030106 microbiology, Context (language use), Durability, 03 medical and health sciences, Darunavir/cobicistat, Dual, Durability, Tolerability, CISAI, Adverse events, Virology, Internal medicine, Humans, business.industry, Research, Hypertriglyceridemia, medicine.disease, CISAI, Discontinuation, Prospective Studie, Adverse events, HIV-1, Anti-Retroviral Agent, business, lcsh:RC581-607
Abstract

Background Study aim was to evaluate the safety and durability of darunavir/cobicistat (DRV/c) in a real life setting. Methods Multicentre prospective cohort study performed in the context of SCOLTA (Surveillance Cohort Long-Term Toxicity Antiretrovirals). Patients were evaluated at baseline, week 24 and 48. Changes were evaluated using the paired t test or signed rank test. The multivariable analysis was performed using a general linear model, after ranking of not normally distributed variables. Results A total of 249 patients were included, 72 (29%) were in DRV/c-based dual therapies (DT). Hypercholesterolemia, HC, (total cholesterol (TC) ≥ 200 mg/dL or low density-C (LDL-C) ≥ 130 or statin use) was present in 121 (48.6%) and hypertriglyceridemia, (triglycerides (TG) ≥ 200 mg/dl or fibrate use) in 41 (16.5%) patients. Blood lipid profile did not change significantly in either the global population or patients with HC. After a median observation of 17 months (IQR 13–20), 59 (25.3%) patients discontinued DRV/c, of which 13 were in DT. The durability DT resulted higher than that of triple therapy (log-rank test p = 0.01). Main reasons for stopping DRV/c were simplification (15 patients), adverse events (13 patients), planned discontinuation for treatment initiation with DAA (4 patients), treatment failure (2 patients); death (2 patients), other causes (10 patients). Twenty-six were lost to follow-up. Conclusions DRV/c was safe and well tolerated. Dual therapies showed a better profile of tolerability and a longer durability compared to triple therapies.

Published
2019

21. Simple parameters from complete blood count predict in-hospital mortality in covid-19

Author

Bellan, M., Azzolina, D., Hayden, E., Gaidano, G., Pirisi, M., Acquaviva, A., Aimaretti, G., Valletti, P. A., Angilletta, R., Arioli, R., Avanzi, G. C., Avino, G., Balbo, P. E., Baldon, G., Baorda, F., Barbero, E., Baricich, A., Barini, M., Barone-Adesi, F., Battistini, S., Beltrame, M., Bertoli, M., Bertolin, S., Bertolotti, M., Betti, M., Bobbio, F., Boffano, P., Boglione, L., Borre, S., Brucoli, M., Calzaducca, E., Cammarata, E., Cantaluppi, V., Cantello, R., Capponi, A., Carriero, A., Casciaro, G. F., Castello, L. M., Ceruti, F., Chichino, G., Chirico, E., Cisari, C., Cittone, M. G., Colombo, C., Comi, C., Croce, E., Daffara, T., Danna, P., Corte, F. D., de Vecchi, S., Dianzani, U., Benedetto, D. D., Esposto, E., Faggiano, F., Falaschi, Z., Ferrante, D., Ferrero, A., Gagliardi, I., Galbiati, A., Gallo, S., Garavelli, P. L., Gardino, C. A., Garzaro, M., Gastaldello, M. L., Gavelli, F., Gennari, A., Giacomini, G. M., Giacone, I., Via, V. G., Giolitti, F., Gironi, L. C., Gramaglia, C., Grisafi, L., Inserra, I., Invernizzi, M., Krengli, M., Labella, E., Landi, I. C., Landi, R., Leone, I., Lio, V., Lorenzini, L., Maconi, A., Malerba, M., Manfredi, G. F., Martelli, M., Marzari, L., Marzullo, P., Mennuni, M., Montabone, C., Morosini, U., Mussa, M., Nerici, I., Nuzzo, A., Olivieri, C., Padelli, S. A., Panella, M., Parisini, A., Pasche, A., Patrucco, F., Patti, G., Pau, A., Pedrinelli, A. R., Percivale, I., Ragazzoni, L., Re, R., Rigamonti, C., Rizzi, E., Rognoni, A., Roveta, A., Salamina, L., Santagostino, M., Saraceno, M., Savoia, P., Sciarra, M., Schimmenti, A., Scotti, L., Spinoni, E., Smirne, C., Tarantino, V., Tillio, P. A., Tonello, S., Vaschetto, R., Vassia, V., Zagaria, D., Zavattaro, E., Zeppegno, P., Zottarelli, F., Sainaghi, P. P., Aiosa, G., Airoldi, A., Barco, A., Bargiacchi, O., Bazzano, S., Berni, P., Bianchi, B., Bianco, S., Biffi, S., Binda, V., Bolgeo, T., Bolla, C., Bonato, V., Bonizzoni, G., Bragantini, A., Brustia, D., Bullara, V., Burlone, M., Brustia, F., Caccia, S., Calareso, A., Cammarota, G., Cancelliere, L., Carbone, R., Cassinari, A., Ceriani, E., Cena, T., Clivati, E., Collimedaglia, L., Colombatto, A., Cornella, C., Costanzo, M., Croce, A., de Benedittis, C., Delorenzi, S., Dionisio, R., Donato, P., Esposito, M., Fangazio, S., Feggi, A., Ferrillo, S., Foci, V., Fra, G. P., Gaggino, C., Gambaro, E., Gattoni, E., Gattoni, L., Giacchero, F., Gianfreda, R., Giubertoni, A., Grecu, L., Grossi, F., Guglielmetti, G., Guido, S., Iannantuoni, G., Ingrao, S., Jona, A., Lazzarich, E., Lissandrin, R., Maduli, E., Magne, F., Mantia, E., Marangon, D., Massara, M., Matino, E., Mauri, M. G., Menegatti, M., Moglia, R., Molinari, R., Morelli, S., Morlino, P., Naldi, P., Nebbiolo, C., Omodeo, P., Palmieri, D., Panero, A., Parodi, M., Pedrazzoli, R., Pelazza, C., Penpa, S., Perucca, R., Pirovano, A., Pittau, S., Pochetti, P., Poletti, F., Polla, B., Prandi, P., Prodam, F., Prosperini, P., Puma, A., Quaglia, M., Raie, A., Rapetti, R., Ravera, S., Re, A., Reale, M., Rossati, A., Rossi, M., Rossi, P., Rostagno, R., Salomoni, G., Sama, M. T., Sarchi, E., Sarcoli, M., Sarda, C., Sguazzotti, I., Soddu, D., Sola, D., Stobbione, P., Todoerti, M., Vallese, G. C., Varrasi, C., Veia, A., Vignazia, G. L., Zanotti, I., Zecca, E., Zichittella, D., Zisa, G., and Zoppis, E.

Subjects
Adult, Male, medicine.medical_specialty, Medicine (General), Multivariate analysis, Article Subject, Clinical Decision Rules, COVID-19, Prognosis, Blood Cell Count, Hospital Mortality, Severity of Illness Index, Clinical Biochemistry, Asymptomatic, Severity of Illness Index, NO, R5-920, Internal medicine, Clinical Decision Rules, Severity of illness, Genetics, 80 and over, Medicine, Humans, Hospital Mortality, Molecular Biology, Aged, Retrospective Studies, Aged, 80 and over, medicine.diagnostic_test, business.industry, Biochemistry (medical), Complete blood count, COVID-19, Retrospective cohort study, Red blood cell distribution width, General Medicine, Odds ratio, Middle Aged, Prognosis, Female, Italy, Multivariate Analysis, Blood Cell Count, Cohort, medicine.symptom, business, Research Article
Abstract

Introduction. The clinical course of Coronavirus Disease 2019 (COVID-19) is highly heterogenous, ranging from asymptomatic to fatal forms. The identification of clinical and laboratory predictors of poor prognosis may assist clinicians in monitoring strategies and therapeutic decisions. Materials and Methods. In this study, we retrospectively assessed the prognostic value of a simple tool, the complete blood count, on a cohort of 664 patients ( F 260; 39%, median age 70 (56-81) years) hospitalized for COVID-19 in Northern Italy. We collected demographic data along with complete blood cell count; moreover, the outcome of the hospital in-stay was recorded. Results. At data cut-off, 221/664 patients (33.3%) had died and 453/664 (66.7%) had been discharged. Red cell distribution width (RDW) ( χ 2 10.4; p < 0.001 ), neutrophil-to-lymphocyte (NL) ratio ( χ 2 7.6; p = 0.006 ), and platelet count ( χ 2 5.39; p = 0.02 ), along with age ( χ 2 87.6; p < 0.001 ) and gender ( χ 2 17.3; p < 0.001 ), accurately predicted in-hospital mortality. Hemoglobin levels were not associated with mortality. We also identified the best cut-off for mortality prediction: a NL ratio > 4.68 was characterized by an odds ratio for in-hospital mortality OR = 3.40 (2.40-4.82), while the OR for a RDW > 13.7 % was 4.09 (2.87-5.83); a platelet count > 166,000 /μL was, conversely, protective (OR: 0.45 (0.32-0.63)). Conclusion. Our findings arise the opportunity of stratifying COVID-19 severity according to simple lab parameters, which may drive clinical decisions about monitoring and treatment.

Published
2021

22. Durability of Dolutegravir-Based Regimens: A 5-Year Prospective Observational Study

Author

Taramasso, L, De Vito, A, Ricci, E, Orofino, G, Squillace, N, Menzaghi, B, Molteni, C, Gulminetti, R, De Socio, G, Pellicanò, G, Sarchi, E, Celesia, B, Calza, L, Rusconi, S, Valsecchi, L, Martinelli, C, Cascio, A, Maggi, P, Vichi, F, Angioni, G, Guadagnino, G, Cenderello, G, Dentone, C, Bandera, A, Falasca, K, Bonfanti, P, Di Biagio, A, Madeddu, G, Taramasso, Lucia, De Vito, Andrea, Ricci, Elena Delfina, Orofino, Giancarlo, Squillace, Nicola, Menzaghi, Barbara, Molteni, Chiara, Gulminetti, Roberto, De Socio, Giuseppe Vittorio, Pellicanò, Giovanni Francesco, Sarchi, Eleonora, Celesia, Benedetto Maurizio, Calza, Leonardo, Rusconi, Stefano, Valsecchi, Laura, Martinelli, Canio Vito, Cascio, Antonio, Maggi, Paolo, Vichi, Francesca, Angioni, Goffredo, Guadagnino, Giuliana, Cenderello, Giovanni, Dentone, Chiara, Bandera, Alessandra, Falasca, Katia, Bonfanti, Paolo, Di Biagio, Antonio, Madeddu, Giordano, Taramasso, L, De Vito, A, Ricci, E, Orofino, G, Squillace, N, Menzaghi, B, Molteni, C, Gulminetti, R, De Socio, G, Pellicanò, G, Sarchi, E, Celesia, B, Calza, L, Rusconi, S, Valsecchi, L, Martinelli, C, Cascio, A, Maggi, P, Vichi, F, Angioni, G, Guadagnino, G, Cenderello, G, Dentone, C, Bandera, A, Falasca, K, Bonfanti, P, Di Biagio, A, Madeddu, G, Taramasso, Lucia, De Vito, Andrea, Ricci, Elena Delfina, Orofino, Giancarlo, Squillace, Nicola, Menzaghi, Barbara, Molteni, Chiara, Gulminetti, Roberto, De Socio, Giuseppe Vittorio, Pellicanò, Giovanni Francesco, Sarchi, Eleonora, Celesia, Benedetto Maurizio, Calza, Leonardo, Rusconi, Stefano, Valsecchi, Laura, Martinelli, Canio Vito, Cascio, Antonio, Maggi, Paolo, Vichi, Francesca, Angioni, Goffredo, Guadagnino, Giuliana, Cenderello, Giovanni, Dentone, Chiara, Bandera, Alessandra, Falasca, Katia, Bonfanti, Paolo, Di Biagio, Antonio, and Madeddu, Giordano

Abstract

This study evaluates the frequency and causes of dolutegravir (DTG) discontinuation along 5 years of follow-up, in both antiretroviral treatment (ART)-naive and experienced people living with HIV (PLWH). This is a prospective multi-center cohort study enrolling PLWH on DTG from July 2014 until November 2020. DTG-durability was investigated using the Kaplan-Meier survival curve. The Cox proportional-hazards model was used for estimating the hazard ratio (HR) of DTG discontinuation for any cause, and for adverse events (AEs). Nine hundred sixty-three PLWH were included, 25.3% were women and 28.0% were ART-naive. Discontinuations for any causes were 10.1 [95% confidence interval (95% CI) 8.9-11.5] per 100 person-years, similar in most regimens, with the apparent exception of tenofovir alafenamide/emtricitabine+DTG (p < 0.0001). In the multivariable Cox regression model, non-Caucasian ethnicity, age ≥50 years, and lower estimated glomerular filtration rate (eGFR) were associated with a higher probability of DTG interruption. The incidence rate of virological failure was 0.4 (95% CI 0.2-0.7) per 100 person-years, while the estimated discontinuation rate for AEs was 4.0 (3.2-4.9) per 100 person-years. Thirty-four DTG interruptions were due to grade ≥3 events (10 central nervous system, 6 hypersensitivity, 3 renal, 3 myalgia/asthenia, 3 abdominal pain, 2 gastrointestinal, and 7 other events). People with lower body mass index, age ≥50 years, and lower eGFR were at higher risk of AEs, while dual combinations were protective (HR 0.41 compared with abacavir/lamivudine/DTG, 95% CI 0.22-0.77). In this prospective observational study, we found high DTG durability and a low rate of virological failures. Dual therapies seemed protective toward AEs and might be considered, when feasible, a suitable option to minimize drug interactions and improve tolerability.

Published
2021

23. Metabolic syndrome and body weight in people living with HIV infection: analysis of differences observed in three different cohort studies over a decade.

Author

Taramasso, Lucia, Bonfanti, Paolo, Ricci, Elena, Maggi, Paolo, Orofino, Giancarlo, Squillace, Nicola, Menzaghi, Barbara, Madeddu, Giordano, Molteni, Chiara, Vichi, Francesca, Riguccini, Erika, Saracino, Annalisa, Santoro, Carmen, Guastavigna, Marta, Francisci, Daniela, Di Biagio, Antonio, De Socio, Giuseppe Vittorio, Sarchi, E., Chichino, G., and Bolla, C.

Subjects
HIV infections, OBESITY, RESEARCH, HIV-positive persons, CONFIDENCE intervals, MEDICAL cooperation, METABOLIC syndrome, DESCRIPTIVE statistics, LOGISTIC regression analysis, ODDS ratio, BODY mass index
Abstract

Objectives: The aim of this study was to assess the incidence of being overweight and metabolic syndrome (MS) among people living with HIV (PHIV) in three different cross‐sectional studies conducted over three different periods: 2005, 2011 and 2015. Methods: This was a multi‐centre, nationwide study. Data were collected in three studies from the CISAI group – SIMOne, HIV‐HY and STOPSHIV – and included a total of 3014 PHIV. Logistic regression [odds ratio (OR), 95% confidence interval (CI)] was used to account for age and gender difference among three groups when comparing MS prevalence and being overweight; potential confounders were accounted for by including them in the regression equation. Results: Overall, the mean age was 46.9 ± 10.2 years, and men comprised 73.3% of participants. Comparing 2005, 2011 and 2015, MS was present in 34.5%, 33.0% and 29.3% of PHIV, respectively. Adjusted OR for MS was 0.64 (95% CI: 0.52–0.78) in 2011 and 0.56 (95% CI: 0.46–0.69) in 2015 compared with 2005, while BMI (kg/m2) increased from 23.6 in 2005, 24.5 in 2011 and 24.5 in 2015, with a concomitant increase of being overweight from 29.4% to 39.5% to 39.6% (p < 0.0001). Conclusions: In recent years, PHIV have had a significantly improved metabolic profile compared with previously, despite increasing weight and BMI. [ABSTRACT FROM AUTHOR]

Published
2022
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28. Growing old with antiretroviral therapy or elderly people in antiretroviral therapy: two different profiles of comorbidity?

Author

Paolo Maggi, Giuseppe Vittorio De Socio, Barbara Menzaghi, Chiara Molteni, Nicola Squillace, Lucia Taramasso, Marta Guastavigna, Giulia Gamboni, Giordano Madeddu, Francesca Vichi, Antonio Cascio, Eleonora Sarchi, Giovanni Pellicanò, Canio Vito Martinelli, Benedetto Maurizio Celesia, Laura Valsecchi, Roberto Gulminetti, Giovanni Cenderello, Andrea Parisini, Leonardo Calza, Katia Falasca, Giancarlo Orofino, Elena Ricci, Antonio Di Biagio, Paolo Bonfanti, Maggi, Paolo, De Socio, Giuseppe Vittorio, Menzaghi, Barbara, Molteni, Chiara, Squillace, Nicola, Taramasso, Lucia, Guastavigna, Marta, Gamboni, Giulia, Madeddu, Giordano, Vichi, Francesca, Cascio, Antonio, Sarchi, Eleonora, Pellicanò, Giovanni, Martinelli, Canio Vito, Celesia, Benedetto Maurizio, Valsecchi, Laura, Gulminetti, Roberto, Cenderello, Giovanni, Parisini, Andrea, Calza, Leonardo, Falasca, Katia, Orofino, Giancarlo, Ricci, Elena, Di Biagio, Antonio, Bonfanti, Paolo, Maggi, P, De Socio, G, Menzaghi, B, Molteni, C, Squillace, N, Taramasso, L, Guastavigna, M, Gamboni, G, Madeddu, G, Vichi, F, Cascio, A, Sarchi, E, Pellicanò, G, Martinelli, C, Celesia, B, Valsecchi, L, Gulminetti, R, Cenderello, G, Parisini, A, Calza, L, Falasca, K, Orofino, G, Ricci, E, Di Biagio, A, Bonfanti, P, and Maggi P, De Socio GV, Menzaghi B, Molteni C, Squillace N, Taramasso L, Guastavigna M, Gamboni G, Madeddu G, Vichi F, Cascio A, Sarchi E, Pellicanò G, Martinelli CV, Celesia BM, Valsecchi L, Gulminetti R, Cenderello G, Parisini A, Calza L, Falasca K, Orofino G, Ricci E, Di Biagio A, Bonfanti P.

Subjects
Cross-Sectional Studie, Male, ART exposure, HIV, Multimorbidity, HIV Infections, Comorbidity, Osteoporosis, Noncommunicable Disease, Bone Diseases, Metabolic, Cross-Sectional Studies, Infectious Diseases, Age, Anti-Retroviral Agents, Hypertension, Humans, Anti-Retroviral Agent, Female, HIV Infection, Noncommunicable Diseases, Aged, Human
Abstract

Background In persons living with HIV (PLWH), the burden of non-communicable chronic diseases increased over time, because of aging associated with chronic inflammation, systemic immune activation, and long-term exposure to the combination antiretroviral therapy (ART). Methods To explore the association of chronological age, age at first ART, and exposure to ART with non-communicable chronic diseases, we performed a cross-sectional analysis to evaluate the prevalence of comorbidities in patients enrolled in the SCOLTA Project, stratified by groups of chronological age (50–59 and 60–69 years) and by years of antiretroviral treatment (ART, ≤ 3 or > 3 years). Results In 1394 subjects (23.8% women), mean age at enrollment was 57.4 (SD 6.5) years, and at first ART 45.3 (SD 10.7). Men were older than women both at enrollment (57.6 vs 56.8, p = 0.06) and at first ART (45.8 vs 43.6, p = 0.0009). ART duration was longer in women (13.1 vs 11.7 years, p = 0.01). The age- and sex-adjusted rate ratios (aRRs, and 95% confidence interval, CI) showed that longer ART exposure was associated with dyslipidemia (aRR 1.35, 95% CI 1.20–1.52), hypertension (aRR 1.52, 95% CI 1.22–1.89), liver disease (aRR 1.78, 95% CI 1.32–2.41), osteopenia/osteoporosis (aRR 2.88, 95% CI 1.65–5.03) and multimorbidity (aRR 1.36, 95% CI 1.21–1.54). These findings were confirmed in strata of age, adjusting for sex. Conclusions Our data suggest that longer ART exposure was associated with increased risk of dyslipidemia, hypertension, and osteopenia/osteoporosis, hence the presence of multimorbidity, possibly due to the exposition to more toxic antiretrovirals. We observed different comorbidities, according to ART exposure and age.

Published
2022

29. Durability of Dolutegravir-Based Regimens: A 5-Year Prospective Observational Study

Author

Lucia, Taramasso, Andrea, De Vito, Elena Delfina, Ricci, Giancarlo, Orofino, Nicola, Squillace, Barbara, Menzaghi, Chiara, Molteni, Roberto, Gulminetti, Giuseppe Vittorio, De Socio, Giovanni Francesco, Pellicanò, Eleonora, Sarchi, Benedetto Maurizio, Celesia, Leonardo, Calza, Stefano, Rusconi, Laura, Valsecchi, Canio Vito, Martinelli, Antonio, Cascio, Paolo, Maggi, Francesca, Vichi, Goffredo, Angioni, Giuliana, Guadagnino, Giovanni, Cenderello, Chiara, Dentone, Alessandra, Bandera, Katia, Falasca, Paolo, Bonfanti, Antonio, Di Biagio, Giordano, Madeddu, M, Guastavigna, Taramasso, L., De Vito, A., Ricci, E. D., Orofino, G., Squillace, N., Menzaghi, B., Molteni, C., Gulminetti, R., De Socio, G. V., Pellicano, G. F., Sarchi, E., Celesia, B. M., Calza, L., Rusconi, S., Valsecchi, L., Martinelli, C. V., Cascio, A., Maggi, P., Vichi, F., Angioni, G., Guadagnino, G., Cenderello, G., Dentone, C., Bandera, A., Falasca, K., Bonfanti, P., Di Biagio, A., Madeddu, G., Taramasso L, De Vito A, Ricci ED, Orofino G, Squillace N, Menzaghi B, Molteni C, Gulminetti R, De Socio GV, Pellicanò GF, Sarchi E, Celesia BM, Calza L, Rusconi S, Valsecchi L, Martinelli CV, Cascio A, Maggi P, Vichi F, Angioni G, Guadagnino G, Cenderello G, Dentone C, Bandera A, Falasca K, Bonfanti P, Di Biagio A, Madeddu G, Taramasso L., De Vito A., Ricci E.D., Orofino G., Squillace N., Menzaghi B., Molteni C., Gulminetti R., De Socio G.V., Pellicano G.F., Sarchi E., Celesia B.M., Calza L., Rusconi S., Valsecchi L., Martinelli C.V., Cascio A., Maggi P., Vichi F., Angioni G., Guadagnino G., Cenderello G., Dentone C., Bandera A., Falasca K., Bonfanti P., Di Biagio A., Madeddu G., Taramasso, L, De Vito, A, Ricci, E, Orofino, G, Squillace, N, Menzaghi, B, Molteni, C, Gulminetti, R, De Socio, G, Pellicanò, G, Sarchi, E, Celesia, B, Calza, L, Rusconi, S, Valsecchi, L, Martinelli, C, Cascio, A, Maggi, P, Vichi, F, Angioni, G, Guadagnino, G, Cenderello, G, Dentone, C, Bandera, A, Falasca, K, Bonfanti, P, Di Biagio, A, and Madeddu, G

Subjects
adverse events, dolutegravir, durability, HIV, safety, toxicity, virolgical failure, Cohort Studies, Female, Heterocyclic Compounds, 3-Ring, Humans, Middle Aged, Oxazines, Piperazines, Prospective Studies, Pyridones, Anti-HIV Agents, HIV Infections, Pediatrics, medicine.medical_specialty, Settore MED/17 - Malattie Infettive, Oxazine, Human immunodeficiency virus (HIV), adverse event, Pyridone, medicine.disease_cause, 3-Ring, chemistry.chemical_compound, Heterocyclic Compounds, Antiretroviral treatment, Medicine, Adverse effect, Piperazine, business.industry, Public Health, Environmental and Occupational Health, Anti-HIV Agent, Discontinuation, Prospective Studie, Infectious Diseases, chemistry, Dolutegravir, Observational study, Cohort Studie, business, Human
Abstract

This study evaluates the frequency and causes of dolutegravir (DTG) discontinuation along 5 years of follow-up, in both antiretroviral treatment (ART)-naive and experienced people living with HIV (PLWH). This is a prospective multi-center cohort study enrolling PLWH on DTG from July 2014 until November 2020. DTG-durability was investigated using the Kaplan-Meier survival curve. The Cox proportional-hazards model was used for estimating the hazard ratio (HR) of DTG discontinuation for any cause, and for adverse events (AEs). Nine hundred sixty-three PLWH were included, 25.3% were women and 28.0% were ART-naive. Discontinuations for any causes were 10.1 [95% confidence interval (95% CI) 8.9-11.5] per 100 person-years, similar in most regimens, with the apparent exception of tenofovir alafenamide/emtricitabine+DTG (p

Published
2021

30. Incident diabetes in course of antiretroviral therapy

Author

Taramasso, Lucia, Squillace, Nicola, Ricci, Elena, Menzaghi, Barbara, Orofino, Giancarlo, Socio, Giuseppe Vittorio De, Molteni, Chiara, Martinelli, Canio Vito, Madeddu, Giordano, Vichi, Francesca, Valsecchi, Laura, Celesia, Benedetto Maurizio, Maggi, Paolo, Rusconi, Stefano, Pellicanò, Giovanni Francesco, Cascio, Antonio, Sarchi, Eleonora, Gulminetti, Roberto, Falasca, Katia, Di Biagio, Antonio, Bonfanti, Paolo, Taramasso, L, Squillace, N, Ricci, E, Menzaghi, B, Orofino, G, Socio, G, Molteni, C, Martinelli, C, Madeddu, G, Vichi, F, Valsecchi, L, Celesia, B, Maggi, P, Rusconi, S, Pellicanò, G, Cascio, A, Sarchi, E, Gulminetti, R, Falasca, K, Di Biagio, A, Bonfanti, P, Taramasso, Lucia, Squillace, Nicola, Ricci, Elena, Menzaghi, Barbara, Orofino, Giancarlo, Socio, Giuseppe Vittorio De, Molteni, Chiara, Martinelli, Canio Vito, Madeddu, Giordano, Vichi, Francesca, Valsecchi, Laura, Celesia, Benedetto Maurizio, Maggi, Paolo, Rusconi, Stefano, Pellicanò, Giovanni Francesco, Cascio, Antonio, Sarchi, Eleonora, Gulminetti, Roberto, Falasca, Katia, Di Biagio, Antonio, and Bonfanti, Paolo

Subjects
protease inhibitor, metabolic health, obesity, Infectious Diseases, diabete, insulin resistance, Immunology, Immunology and Allergy, integrase inhibitor, weight gain
Abstract

Objective:Recent reports of excessive weight gain in people with HIV (PWH) have raised increasing concerns on the possible increase of diabetes mellitus (DM) risk in course of integrase inhibitors (INSTIs) treatment. In this study, we aimed at describing DM incidence in course of antiretroviral therapy (ART) and identifying the factors associated with new DM onset.Design:Observational prospective SCOLTA (Surveillance Cohort Long-Term Toxicity Antiretrovirals) cohort.Methods:All people enrolled in SCOLTA between January 2003 and November 2021 were included. Multivariable Cox regression yielded adjusted hazard ratios (aHRs) and 95% confidence intervals (CIs) for incident DM.Results:4366 PWH were included, 72.6% male, with mean age 45.6 years, and median CD4+ 460 [interquartile range (IQR) 256-710] cells/mm3cells/mm3. During the follow up, 120 incident cases of DM occurred (1.26 cases/100 person year-follow up, 95% CI 1.05-1.50).Baseline weight, but not the amount of weight gain, resulted significantly correlated to diabetes incidence (aHR by 1 kg 1.03; 95% CI 1.01-1.04), as well as older age (aHR 1.03 by 1 year; 95% CI 1.01-1.06), being ART-experienced with detectable HIV RNA at study entry (aHR 2.27, 95% CI 1.48-3.49), having untreated high blood pressure (aHR 2.90; 95% CI 1.30-6.45) and baseline blood glucose >100 mg/dl (aHR 5.47; 95% CI 3.82-7.85). Neither the INSTI class nor individual antiretrovirals were associated with an increased risk of DM.Conclusions:Baseline weight, but not weight gain or the ART class, was associated with incident DM in this observational cohort.

Published
2023

31. Lipids and transaminase elevations in ARV-experienced PLWH switching to a doravirine-based regimen from rilpivirine or other regimens

Author

Maggi, Paolo, Ricci, Elena Delfina, Cicalini, Stefania, Pellicanò, Giovanni Francesco, Celesia, Benedetto Maurizio, Vichi, Francesca, Cascio, Antonio, Sarchi, Eleonora, Orofino, Giancarlo, Squillace, Nicola, Madeddu, Giordano, De Socio, Giuseppe Vittorio, Bargiacchi, Olivia, Molteni, Chiara, Masiello, Addolorata, Saracino, Annalisa, Menzaghi, Barbara, Falasca, Katia, Taramasso, Lucia, Di Biagio, Antonio, Bonfanti, Paolo, Maggi, Paolo, Ricci, Elena Delfina, Cicalini, Stefania, Pellicanò, Giovanni Francesco, Celesia, Benedetto Maurizio, Vichi, Francesca, Cascio, Antonio, Sarchi, Eleonora, Orofino, Giancarlo, Squillace, Nicola, Madeddu, Giordano, De Socio, Giuseppe Vittorio, Bargiacchi, Olivia, Molteni, Chiara, Masiello, Addolorata, Saracino, Annalisa, Menzaghi, Barbara, Falasca, Katia, Taramasso, Lucia, Di Biagio, Antonio, Bonfanti, Paolo, Maggi, P, Ricci, E, Cicalini, S, Pellicanò, G, Celesia, B, Vichi, F, Cascio, A, Sarchi, E, Orofino, G, Squillace, N, Madeddu, G, De Socio, G, Bargiacchi, O, Molteni, C, Masiello, A, Saracino, A, Menzaghi, B, Falasca, K, Taramasso, L, Di Biagio, A, and Bonfanti, P

Subjects
Adverse event, Doravirine, Infectious Diseases, Metabolic safety, Hepatic safety, Rilpivirine, ART-experienced, HIV infection
Abstract

Background Doravirine (DOR) is a newly approved antiretroviral belonging to the class of non-nucleoside reverse transcriptase inhibitors (NNRTI), well tolerated and leading to an improved lipid profile in antiretroviral experienced people living with HIV (PLWH). We aimed at evaluating if the lipid-lowering effect is linked to the drug class, using real-life data from the SCOLTA cohort. Methods We compared the lipid profile modifications in experienced PLWH switching to a DOR-based regimen from rilpivirine or another NNRTI-based regimen or from an integrase strand transferase (INSTI)-based regimen. T0 and T1 were defined as the baseline and 6-month follow-up respectively. Data were collected at baseline and prospectively every six months and changes from baseline were compared using a multivariable linear model. Results In 107 PLWH, enrolled in the SCOLTA DOR cohort, with undetectable HIV-RNA at baseline, 32.7% switched from RPV-based regimens (DOR1), 29.9% from other NNRTI-including regimens (DOR2) and 37.4% switched from INSTI-including regimens (DOR3). At T1, TC significantly decreased in DOR2 (-15 mg/dL) and DOR3 (-23 mg/dL), and significantly more in DOR3 than in DOR1 (-6 mg/dL) (p = 0.016). HDL-C declined in DOR2 (-2 mg/dL) whereas it increased in DOR1 (+ 3 mg/dL) (p = 0.042) and remained stable in DOR3. LDL-C significantly decreased from baseline in DOR2 (-12 mg/dL) and DOR3 (-22 mg/dL) and was different between DOR1 (-8 mg/dL) and DOR3 (p = 0.022). TC/HDL ratio showed a significant decline in the DOR3 group (-0.45), although similar to DOR1 (-0.23, p = 0.315) and DOR2 (-0.19, p = 0.254). Triglycerides did not noticeably change. ALT significantly decreased in PLWH with a baseline level > 40 UI/mL. Conclusions PLWH on doravirine treatment showed different trends in blood lipids according to their previous regimen. In PLWH switching from RPV, minimal modifications were seen, whereas in those switching from other NNRTIs and from INSTI-including regimens, we observed an overall improvement in lipid profile, seemingly independent of the “statin effect” of TDF.

Published
2023

32. Reversibility of Central Nervous System Adverse Events in Course of Art

Author

Lucia Taramasso, Giancarlo Orofino, Elena Ricci, Barbara Menzaghi, Giuseppe Vittorio De Socio, Nicola Squillace, Giordano Madeddu, Francesca Vichi, Benedetto Maurizio Celesia, Chiara Molteni, Federico Conti, Filippo Del Puente, Eleonora Sarchi, Goffredo Angioni, Antonio Cascio, Carmela Grosso, Giustino Parruti, Antonio Di Biagio, Paolo Bonfanti, Taramasso, Lucia, Orofino, Giancarlo, Ricci, Elena, Menzaghi, Barbara, De Socio, Giuseppe Vittorio, Squillace, Nicola, Madeddu, Giordano, Vichi, Francesca, Celesia, Benedetto Maurizio, Molteni, Chiara, Conti, Federico, Del Puente, Filippo, Sarchi, Eleonora, Angioni, Goffredo, Cascio, Antonio, Grosso, Carmela, Parruti, Giustino, Di Biagio, Antonio, Bonfanti, Paolo, Taramasso, L, Orofino, G, Ricci, E, Menzaghi, B, De Socio, G, Squillace, N, Madeddu, G, Vichi, F, Celesia, B, Molteni, C, Conti, F, Del Puente, F, Sarchi, E, Angioni, G, Cascio, A, Grosso, C, Parruti, G, Di Biagio, A, and Bonfanti, P

Subjects
Central Nervous System, Anti-HIV Agents, adverse event, HIV, Anti-HIV Agent, HIV Infections, dolutegravir, CD4 Lymphocyte Count, Prospective Studie, Infectious Diseases, psychiatric, reversibility, Virology, neurocognitive, Humans, Prospective Studies, CNS, adverse events, Human
Abstract

The purpose of this study is to evaluate the frequency of central nervous system adverse events (CNS-AE) on dolutegravir (DTG) and non-DTG containing ART, and their reversibility, in the observational prospective SCOLTA cohort. Factors associated with CNS-AE were estimated using a Cox proportional-hazards model. 4939 people living with HIV (PLWH) were enrolled in DTG (n = 1179) and non-DTG (n = 3760) cohorts. Sixty-six SNC-AE leading to ART discontinuation were reported, 39/1179 (3.3%) in DTG and 27/3760 (0.7%) in non-DTG cohort. PLWH naïve to ART, with higher CD4 + T count and with psychiatric disorders were more likely to develop a CNS-AE. The risk was lower in non-DTG than DTG-cohort (aHR 0.33, 95% CI 0.19–0.55, p < 0.0001). One-year follow-up was available for 63/66 PLWH with CNS-AE. AE resolution was reported in 35/39 and 23/24 cases in DTG and non-DTG cohorts, respectively. The probability of AE reversibility was not different based on ART class, sex, ethnicity, CDC stage, or baseline psychiatric disorder. At the same time, a lower rate of event resolution was found in PLWH older than 50 years (p = 0.017). In conclusion, CNS-AE leading to ART discontinuation was more frequent in DTG than non-DTG treated PLWH. Most CNS-AE resolved after ART switch, similarly in both DTG and non-DTG cohorts.

Published
2022
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33. Trajectories of CD4+/CD8+ T-Cells Ratio 96 Weeks after Switching to Dolutegravir-Based Two-Drug Regimens: Results from a Multicenter Prospective Cohort Study

Author

Lucia Taramasso, Antonio Falletta, Elena Ricci, Giancarlo Orofino, Nicola Squillace, Barbara Menzaghi, Giuseppe Vittorio De Socio, Chiara Molteni, Giovanni Francesco Pellicanò, Roberto Gulminetti, Giordano Madeddu, Eleonora Sarchi, Francesca Vichi, Benedetto Maurizio Celesia, Paolo Bonfanti, Antonio Di Biagio, Taramasso, L, Falletta, A, Ricci, E, Orofino, G, Squillace, N, Menzaghi, B, De Socio, G, Molteni, C, Pellicanò, G, Gulminetti, R, Madeddu, G, Sarchi, E, Vichi, F, Celesia, B, Bonfanti, P, and Di Biagio, A

Subjects
dolutegravir, two-drug regimen, three-drug regimen, ART, immune recovery, CD4/CD8 ratio, Infectious Diseases, Virology
Abstract

The aim of the present study was to evaluate CD4/CD8 dynamics in patients on dolutegravir (DTG)-based two-drug regimens (2DRs) and compare them with DTG-containing triple-drug regimens (3DRs). A prospective observational study was performed in the context of the SCOLTA cohort. Experienced PWH with HIV-RNA < 50 copies/mL were included if they were on the DTG-2DR, the DTG + tenofovir/emtricitabine (TDF/FTC) regimen, the DTG + tenofovir alafenamide (TAF)/FTC regimen, or the DTG + abacavir/lamivudine (ABC/3TC) regimen; they were followed-up for at least one year. A total of 533 PWH were enrolled, 120 in the DTG + 3TC group, 38 in the DTG + protease inhibitors (PI) group, 67 in the DTG + rilpivirine (RPV) group, 49 in the DTG + TDF/FTC group, 27 in the DTG + TAF/FTC group, and 232 in the DTG + ABC/3TC group. After one year, the CD4/CD8 ratio significantly increased in the PWH treated with DTG + 3TC (+0.08 ± 0.26), DTG + TDF/FTC (+0.1 ± 0.19), and DTG + ABC/3TC (+0.08 ± 0.25). At two years, the CD4/CD8 increase was confirmed for PWH on DTG + TDF/FTC (+0.16 ± 0.28) and DTG + ABC/3TC (+0.1 ± 0.3). In the SCOLTA cohort, PWH on 2DRs experienced a CD4/CD8 increase only in the DTG + 3TC group. Controlled studies with longer follow-up will clarify the long-term immunological and clinical impacts of DTG-2DR.

Published
2022

34. Invecchiare con la terapia antiretrovirale o essere anziani in terapia antiretrovirale: due profili di comorbidità differenti?

Author

Verdiana Zollo, Barbara Menzaghi, Chiara Molteni, Nicola Squillace, Lucia Taramasso, Ilaria De Luca, Giulia Gamboni, Debora Altobelli, Marta Guastavigna, Giordano Madeddu, Francesca Vichi9 Antonio Cascio, Eleonora Sarchi, Giovanni Pellicanò, Canio Martinelli, Benedetto Maurizio Celesia, Laura Valsecchi, Roberto Gulminetti, Giovanni Cenderello, Andrea Parisini, Leonardo Calza, Katia Falasca, Antonio Di Biagio, Paolo Bonfanti, Giancarlo Orofino, Paolo Maggi., Zollo, V, Menzaghi, B, Molteni, C, Squillace, N, Taramasso, L, De Luca, I, Gamboni, G, Altobelli, D, Guastavigna, M, Madeddu, G, Vichi9 Antonio Cascio, F, Sarchi, E, Pellicanò, G, Martinelli, C, Maurizio Celesia, B, Valsecchi, L, Gulminetti, R, Cenderello, G, Parisini, A, Calza, L, Falasca, K, Di Biagio, A, Bonfanti, P, Orofino, G, and Maggi., P

Subjects
ART duration, multimorbidity, age, HIV
Abstract

Nelle persone che vivono con HIV (PLWH), il peso delle patologie corniche non trasmissibili è aumentato nel tempo, a causa dell’invecchiamento legato a una maggiore sopravvivenza, all’infiammazione cronica, all’attivazione del sistema immunitario, e all’esposizione a lungo termine alla terapia antiretrovirale (ART). L’età anagrafica, quella alla diagnosi di infezione da HIV, e l’esposizione alla ART sono fattori che possono esercitare un effetto sulle differenze sia qualitative che quantitative tra le comorbidità.Per esplorare questa ipotesi, abbiamo valutato la prevalenza di alcune patologie selezionate nei pazienti arruolati nel progetto SCOLTA, per gruppi di età (50-59 e ≥60 anni) e durata della ART. In 1336 soggetti (23.9% donne), la durata della ART era simile tra gruppi di età, sia considerata in continuo (p=0.85) che in categorie (p=0.88). Come atteso, le comorbidità e la multimorbidità erano meno frequenti nel gruppo 50-59 che in quello ≥60 anni. Gli odds ratios (ORs) aggiustati per sesso ed età hanno mostrato che, nella categoria 50-59, si rilevava un aumento di rischio significativo e coerente in categorie di durata della ART, per le malattie cardiovascolari (CVD) (ORs da 1.68 a 2.18), dislipidemia (ORs da 3.61 a 9.08) e osteopenia/osteoporosi (ORs da 3.74 a 6.23). Di conseguenza, anche il rischio di multimorbidità aumentava attraverso le classi di durata della ART (ORs da 2.04 a 4.40). Nel gruppo ≥60 anni, il rischio CVD era significativamente più elevato solo nei pazienti con durata della ART ≥20 anni (OR 2.61, 95% intervallo di confidenza al 95% 1.22-5.58, categoria di riferimento ≤6 mesi). L’aumento di dislipidemia e multimorbidità era coerentemente associato con una maggiore durata della ART.In conclusione, l’età anagrafica, quella alla diagnosi di infezione da HIV, e l’esposizione alla ART sono associate alla multi-morbidità nelle PLWH.

Published
2022

35. Risk of Cardiovascular Events in People with HIV (PWH) Treated with Integrase Strand-Transfer Inhibitors: The Debate Is Not Over; Results of the SCOLTA Study.

Author

Corti N, Menzaghi B, Orofino G, Guastavigna M, Lagi F, Di Biagio A, Taramasso L, De Socio GV, Molteni C, Madeddu G, Salomoni E, Pellicanò GF, Pontali E, Bellagamba R, Celesia BM, Cascio A, Sarchi E, Gulminetti R, Calza L, Maggi P, Cenderello G, Bandera A, Carleo MA, Falasca K, Ferrara S, Martini S, Guadagnino G, Angioni G, Bargiacchi O, Ricci ED, Squillace N, and Bonfanti P

Subjects
Humans, Male, Female, Middle Aged, Adult, Risk Factors, Incidence, Reverse Transcriptase Inhibitors therapeutic use, Reverse Transcriptase Inhibitors adverse effects, Anti-HIV Agents therapeutic use, Anti-HIV Agents adverse effects, Cardiovascular Diseases, HIV Infections drug therapy, HIV Infections complications, HIV Integrase Inhibitors therapeutic use, HIV Integrase Inhibitors adverse effects
Abstract

Cardiovascular disease (CVD) is common in people with HIV (PWH), and has great impact in terms of morbidity and mortality. Several intertwined mechanisms are believed to play a role in determining the increased risk of CVD, including the effect of certain antiretrovirals; among these, the role of integrase strand-transfer inhibitors (INSTIs) is yet to be fully elucidated. We conducted a multicenter, observational study comprising 4984 PWH evaluating the antiretroviral therapy (ART)-related nature of CVD in real life settings, both in naïve vs. treatment-experienced people. A comparison was conducted between INSTIs vs. either protease inhibitors (PIs) or non-nucleoside reverse transcriptase inhibitors (NNRTIs) considering demographic, baseline clinical characteristics, incidence of CVD in both 2-year and complete follow-up periods. Among 2357 PWH exposed to INSTIs, 24 people experienced CVD; the corresponding figure was 12 cases out of 2599 PWH exposed to other ART classes. At univariate and multivariate analysis, a tendency towards an increased risk of CVD was observed in the 2-year follow-up period in PWH exposed to INSTIs in the absence, however, of statistical significance. These findings leave open the hypothesis that INSTIs may play a role, albeit minimal, in determining an increased risk of CVD in PWH.

Published
2024
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36. People with HIV pioneers of injectable cabotegravir and rilpivirine long acting in Italy: who are they?

Author

Bartalucci C, Baldi F, Ricci E, Orofino G, Menzaghi B, Ferrara S, Pellicano' GF, Squillace N, Sarchi E, Pontali E, Cenderello G, Bargiacchi O, Piccica M, Carleo MA, Cascio A, De Socio GV, Bonfanti P, and Di Biagio A

Subjects
Adult, Humans, Anti-Retroviral Agents, Italy, Rilpivirine, HIV Infections drug therapy, Pyridones, Diketopiperazines
Abstract

Injectable cabotegravir and rilpivirine long-acting therapy is a revolutionary new antiretroviral treatment (ART) option for HIV infection in virologically suppressed adults on a stable ART. The aim of this study from SCOLTA multicenter observational prospective database is to describe the first people living with HIV (PWH) who started this regimen in Italy, assessing adherence to eligibility criteria, describing clinical-epidemiological characteristics compared to registration trials-population and describe early treatment-discontinuations., (Copyright © 2024 Wolters Kluwer Health, Inc. All rights reserved.)

Published
2024
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37. Real-life safety of Emtricitabine/Tenofovir Alafenamide/Bictegravir.

Author

Squillace N, Ricci E, Maggi P, Taramasso L, Menzaghi B, De Socio GV, Piconi S, Maurizio Celesia B, Orofino G, Sarchi E, Pellicanò GF, Simeone F, Valsecchi L, Bandera A, Cenderello G, Attala L, Angioni G, Falasca K, Cascio A, Bargiacchi O, Di Biagio A, and Bonfanti P

Subjects
Male, Humans, Middle Aged, Female, Emtricitabine adverse effects, Alanine therapeutic use, Heterocyclic Compounds, 3-Ring therapeutic use, Pyridones therapeutic use, Anti-Retroviral Agents therapeutic use, Lipoproteins, HDL, HIV Infections drug therapy, Anti-HIV Agents adverse effects
Abstract

Introduction: Integrase strand transfer inhibitors (INSTI) are one of the most prescribed drug classes for the treatment of HIV infection worldwide. Emtricitabine/Tenofovir Alafenamide/ Bictegravir (FTC/TAF/BIC) has been evaluated in randomized clinical trials; few studies have verified tolerability and safety in clinical practice. Our aim was to investigate the metabolic and hepatic safety in a real-life setting of FTC/TAF/BIC., Materials and Methods: Consecutive people living with HIV infection (PLWH) enrolled in the SCOLTA project, switching to or initiating their first antiretroviral treatment with FTC/TAF/BIC were included. PLWH with HBV co-infection were excluded. Metabolic and hepatic variables were collected at T0 and T1, were defined as baseline and 6-month follow-up respectively, and their modifications were analysed using the paired t-test and the analysis of variance., Results: Five hundred and thirty-nine PLWH with at least one follow-up visit were included in the analysis. Mean age was 48 years (±12.1), 74% were male, 16.1% were naïve to antiretrovirals (ART). At T1, ART-experienced PLWH showed a significant reduction of total cholesterol (TC) and triglycerides, and a slight increase in blood glucose (BG) and ALT. On the contrary, in ART-naïve PLWH blood lipids significantly increased, although with an unaffected TC/high density lipoprotein (HDL)-c ratio, while alanine aminotransferase (ALT) decreased significantly, mainly in those with altered baseline level. The treatment interruptions were 45 (8.4%) over the whole observation period, 13 (2.4%) due to AEs. The most frequent AEs were related to the central nervous system (6 events of depression, insomnia, headache, agitation) and 3 PLWH discontinued the regimen because of grade 1-2 weight gain., Conclusions: In ART-experienced PLWH switching to FTC/TAF/BIC a significant improvement of lipid profile occurred but with significant BG and ALT variation without clinical relevance. In ART-naïve PLWH, blood lipids increased even though lipid profile did not worsen, and a trend towards normalization of liver enzymes was suggested. FTC/TAF/BIC is well tolerated in the real life setting., Competing Interests: “The following authors served as consultant or advisory board and/or received speaker’s fees and/or received research grants for their institutions, outside the present work: PM and GFP from Gilead Science, ViiV Healthcare, Janssen and Merck Sharp & Dohme, PB from Gilead Science, ViiV Healthcare, Janssen, Merck Sharp & Dohme and Pfizer. ADB from Gilead Science, ViiV Healthcare and Janssen. RB from Gilead Science, ViiV Healthcare, and Merck Sharp & Dohme. AC from Gilead Science, Janssen, Merck Sharp & Dohme; NS from ViiV Healthcare, Janssen and Gilead Sciences; LT from ViiV Healthcare and Gilead Science; GVDS from ViiV Healthcare. All remaining authors have no potential conflicts of interest. This does not alter our adherence to PLOS ONE policies on sharing data and materials.”, (Copyright: © 2023 Squillace et al. This is an open access article distributed under the terms of the Creative Commons Attribution License, which permits unrestricted use, distribution, and reproduction in any medium, provided the original author and source are credited.)

Published
2023
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38. Lipids and Transaminase in Antiretroviral-Treatment-Experienced People Living with HIV, Switching to a Doravirine-Based vs. a Rilpivirine-Based Regimen: Data from a Real-Life Setting.

Author

Maggi P, Ricci ED, Martinelli CV, De Socio GV, Squillace N, Molteni C, Masiello A, Orofino G, Menzaghi B, Bellagamba R, Vichi F, Celesia BM, Madeddu G, Pellicanò GF, Carleo MA, Cascio A, Parisini A, Taramasso L, Valsecchi L, Calza L, Rusconi S, Sarchi E, Martini S, Bargiacchi O, Falasca K, Cenderello G, Ferrara S, Di Biagio A, and Bonfanti P

Subjects
Humans, Rilpivirine therapeutic use, Rilpivirine pharmacology, Transaminases, Anti-Retroviral Agents therapeutic use, Lipoproteins, LDL, Viral Load, Anti-HIV Agents therapeutic use, HIV Infections drug therapy
Abstract

Doravirine (DOR) is a newly approved non-nucleoside reverse transcriptase inhibitor (NNRTI). We aimed to investigate, in a real-life setting, how switching to a DOR-based regimen rather than a rilpivirine (RPV)-based regimen impacted metabolic and hepatic safety. The analysis included 551 antiretroviral treatment (ART)-experienced people living with HIV (PLWH), starting RPV-based or DOR-based regimens with viral load < 200 copies/mL, baseline (T0), and at least one control visit (6-month visit, T1). We enrolled 295 PLWH in the RPV and 256 in the DOR cohort. At T1, total cholesterol (TC), low-density lipoprotein-C (LDL-C), and triglycerides significantly decreased in both DOR and RPV cohorts, while high-density lipoprotein-C (HDL-C) only decreased in RPV-treated people. Consistently, the TC/HDL-C ratio declined more markedly in the DOR (-0.36, p < 0.0001) than in the RPV cohort (-0.08, p = 0.25) (comparison p = 0.39). Similar trends were observed when excluding the PLWH on lipid-lowering treatment from the analysis. People with normal alanine aminotransferase (ALT) levels showed a slight ALT increase in both cohorts, and those with baseline ALT > 40 IU/L experienced a significant decline (-14 IU/L, p = 0.008) only in the DOR cohort. Lipid profile improved in both cohorts, and there was a significant reduction in ALT in PLWH with higher-than-normal baseline levels on DOR-based ART.

Published
2023
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39. Incident diabetes in course of antiretroviral therapy.

Author

Taramasso L, Squillace N, Ricci E, Menzaghi B, Orofino G, Socio GV, Molteni C, Martinelli CV, Madeddu G, Vichi F, Valsecchi L, Celesia BM, Maggi P, Rusconi S, Pellicanò GF, Cascio A, Sarchi E, Gulminetti R, Falasca K, Di Biagio A, and Bonfanti P

Subjects
Humans, Male, Middle Aged, Female, Prospective Studies, Weight Gain, Anti-Retroviral Agents adverse effects, HIV Infections complications, HIV Infections drug therapy, HIV Infections epidemiology, Diabetes Mellitus chemically induced, Diabetes Mellitus epidemiology, Anti-HIV Agents adverse effects
Abstract

Objective: Recent reports of excessive weight gain in people with HIV (PWH) have raised increasing concerns on the possible increase of diabetes mellitus (DM) risk in course of integrase inhibitors (INSTIs) treatment. In this study, we aimed at describing DM incidence in course of antiretroviral therapy (ART) and identifying the factors associated with new DM onset., Design: Observational prospective SCOLTA (Surveillance Cohort Long-Term Toxicity Antiretrovirals) cohort., Methods: All people enrolled in SCOLTA between January 2003 and November 2021 were included. Multivariable Cox regression yielded adjusted hazard ratios (aHRs) and 95% confidence intervals (CIs) for incident DM., Results: 4366 PWH were included, 72.6% male, with mean age 45.6 years, and median CD4 + 460 [interquartile range (IQR) 256-710] cells/mm 3 cells/mm 3 . During the follow up, 120 incident cases of DM occurred (1.26 cases/100 person year-follow up, 95% CI 1.05-1.50).Baseline weight, but not the amount of weight gain, resulted significantly correlated to diabetes incidence (aHR by 1 kg 1.03; 95% CI 1.01-1.04), as well as older age (aHR 1.03 by 1 year; 95% CI 1.01-1.06), being ART-experienced with detectable HIV RNA at study entry (aHR 2.27, 95% CI 1.48-3.49), having untreated high blood pressure (aHR 2.90; 95% CI 1.30-6.45) and baseline blood glucose >100 mg/dl (aHR 5.47; 95% CI 3.82-7.85). Neither the INSTI class nor individual antiretrovirals were associated with an increased risk of DM., Conclusions: Baseline weight, but not weight gain or the ART class, was associated with incident DM in this observational cohort., (Copyright © 2023 Wolters Kluwer Health, Inc. All rights reserved.)

Published
2023
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40. Lipids and transaminase elevations in ARV-experienced PLWH switching to a doravirine-based regimen from rilpivirine or other regimens.

Author

Maggi P, Ricci ED, Cicalini S, Pellicanò GF, Celesia BM, Vichi F, Cascio A, Sarchi E, Orofino G, Squillace N, Madeddu G, De Socio GV, Bargiacchi O, Molteni C, Masiello A, Saracino A, Menzaghi B, Falasca K, Taramasso L, Di Biagio A, and Bonfanti P

Subjects
Humans, Rilpivirine therapeutic use, Reverse Transcriptase Inhibitors therapeutic use, Lipids, Anti-HIV Agents therapeutic use, HIV Infections drug therapy
Abstract

Background: Doravirine (DOR) is a newly approved antiretroviral belonging to the class of non-nucleoside reverse transcriptase inhibitors (NNRTI), well tolerated and leading to an improved lipid profile in antiretroviral experienced people living with HIV (PLWH). We aimed at evaluating if the lipid-lowering effect is linked to the drug class, using real-life data from the SCOLTA cohort., Methods: We compared the lipid profile modifications in experienced PLWH switching to a DOR-based regimen from rilpivirine or another NNRTI-based regimen or from an integrase strand transferase (INSTI)-based regimen. T0 and T1 were defined as the baseline and 6-month follow-up respectively. Data were collected at baseline and prospectively every six months and changes from baseline were compared using a multivariable linear model., Results: In 107 PLWH, enrolled in the SCOLTA DOR cohort, with undetectable HIV-RNA at baseline, 32.7% switched from RPV-based regimens (DOR1), 29.9% from other NNRTI-including regimens (DOR2) and 37.4% switched from INSTI-including regimens (DOR3). At T1, TC significantly decreased in DOR2 (-15 mg/dL) and DOR3 (-23 mg/dL), and significantly more in DOR3 than in DOR1 (-6 mg/dL) (p = 0.016). HDL-C declined in DOR2 (-2 mg/dL) whereas it increased in DOR1 (+ 3 mg/dL) (p = 0.042) and remained stable in DOR3. LDL-C significantly decreased from baseline in DOR2 (-12 mg/dL) and DOR3 (-22 mg/dL) and was different between DOR1 (-8 mg/dL) and DOR3 (p = 0.022). TC/HDL ratio showed a significant decline in the DOR3 group (-0.45), although similar to DOR1 (-0.23, p = 0.315) and DOR2 (-0.19, p = 0.254). Triglycerides did not noticeably change. ALT significantly decreased in PLWH with a baseline level > 40 UI/mL., Conclusions: PLWH on doravirine treatment showed different trends in blood lipids according to their previous regimen. In PLWH switching from RPV, minimal modifications were seen, whereas in those switching from other NNRTIs and from INSTI-including regimens, we observed an overall improvement in lipid profile, seemingly independent of the "statin effect" of TDF., (© 2023. The Author(s).)

Published
2023
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41. Causes of HIV Treatment Interruption during the Last 20 Years: A Multi-Cohort Real-Life Study.

Author

De Vito A, Ricci E, Menzaghi B, Orofino G, Martinelli CV, Squillace N, Taramasso L, De Socio GV, Molteni C, Valsecchi L, Costa C, Celesia BM, Parruti G, Pellicanò GF, Sarchi E, Cascio A, Cenderello G, Falasca K, Di Biagio A, Bonfanti P, and Madeddu G

Subjects
Humans, Retrospective Studies, Lopinavir therapeutic use, Rilpivirine therapeutic use, Cohort Studies, Anti-HIV Agents, HIV Infections drug therapy
Abstract

In the last years, many antiretroviral drugs (ART) have been developed with increased efficacy. Nowadays, the main reasons for treatment switches are adverse events, proactive strategy or simplification. We conducted a retrospective cohort study to investigate the reason for treatment interruption in the last 20 years. We merged data of eight cohorts of the SCOLTA project: lopinavir/r (LPV), atazanavir/r (ATV), darunavir/r or /c (DRV), rilpivirine (RPV), raltegravir (RAL), elvitegravir/c (EVG), dolutegravir (DTG) and bictegravir (BIC). We included 4405 people with HIV (PWH). Overall, 664 (15.1%), 489 (11.1%), and 271 (6.2%) PWH interrupted the treatment in the first, second, and third years after starting a new ART. Looking at the interruption in the first year, the most frequent causes were adverse events (3.8%), loss to follow-up (3.7%), patients' decisions (2.6%), treatment failure (1.7%), and simplification (1.3%). In the multivariate analysis regarding experienced patients, treatment with LPV, ATV, RPV or EVG/c, having less than 250 CD4 cells/mL, history of intravenous drug use, and HCV positivity were associated with an increased risk of interruption. In naive people, only LPV/r was associated with an increased risk of interruption, while RPV was associated with a lower risk. In conclusion, our data on more than 4400 PWH show that adverse events have represented the most frequent cause of treatment interruptions in the first year of ART (3.84%). Treatment discontinuations were more frequent during the first year of follow-up and decreased thereafter. First-generation PI in both naïve and experienced PWH, and EVG/c, in experienced PWH, were associated with a higher risk of treatment interruptions.

Published
2023
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42. Trajectories of CD4 + /CD8 + T-Cells Ratio 96 Weeks after Switching to Dolutegravir-Based Two-Drug Regimens: Results from a Multicenter Prospective Cohort Study.

Author

Taramasso L, Falletta A, Ricci E, Orofino G, Squillace N, Menzaghi B, De Socio GV, Molteni C, Pellicanò GF, Gulminetti R, Madeddu G, Sarchi E, Vichi F, Celesia BM, Bonfanti P, and Di Biagio A

Subjects
Humans, Lamivudine therapeutic use, CD8-Positive T-Lymphocytes, Prospective Studies, Heterocyclic Compounds, 3-Ring therapeutic use, Emtricitabine therapeutic use, CD4-Positive T-Lymphocytes, HIV Infections drug therapy, Anti-HIV Agents therapeutic use
Abstract

The aim of the present study was to evaluate CD4/CD8 dynamics in patients on dolutegravir (DTG)-based two-drug regimens (2DRs) and compare them with DTG-containing triple-drug regimens (3DRs). A prospective observational study was performed in the context of the SCOLTA cohort. Experienced PWH with HIV-RNA < 50 copies/mL were included if they were on the DTG-2DR, the DTG + tenofovir/emtricitabine (TDF/FTC) regimen, the DTG + tenofovir alafenamide (TAF)/FTC regimen, or the DTG + abacavir/lamivudine (ABC/3TC) regimen; they were followed-up for at least one year. A total of 533 PWH were enrolled, 120 in the DTG + 3TC group, 38 in the DTG + protease inhibitors (PI) group, 67 in the DTG + rilpivirine (RPV) group, 49 in the DTG + TDF/FTC group, 27 in the DTG + TAF/FTC group, and 232 in the DTG + ABC/3TC group. After one year, the CD4/CD8 ratio significantly increased in the PWH treated with DTG + 3TC (+0.08 ± 0.26), DTG + TDF/FTC (+0.1 ± 0.19), and DTG + ABC/3TC (+0.08 ± 0.25). At two years, the CD4/CD8 increase was confirmed for PWH on DTG + TDF/FTC (+0.16 ± 0.28) and DTG + ABC/3TC (+0.1 ± 0.3). In the SCOLTA cohort, PWH on 2DRs experienced a CD4/CD8 increase only in the DTG + 3TC group. Controlled studies with longer follow-up will clarify the long-term immunological and clinical impacts of DTG-2DR.

Published
2022
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43. Growing old with antiretroviral therapy or elderly people in antiretroviral therapy: two different profiles of comorbidity?

Author

Maggi P, De Socio GV, Menzaghi B, Molteni C, Squillace N, Taramasso L, Guastavigna M, Gamboni G, Madeddu G, Vichi F, Cascio A, Sarchi E, Pellicanò G, Martinelli CV, Celesia BM, Valsecchi L, Gulminetti R, Cenderello G, Parisini A, Calza L, Falasca K, Orofino G, Ricci E, Di Biagio A, and Bonfanti P

Subjects
Aged, Anti-Retroviral Agents adverse effects, Comorbidity, Cross-Sectional Studies, Female, Humans, Male, Bone Diseases, Metabolic complications, HIV Infections complications, HIV Infections drug therapy, HIV Infections epidemiology, Hypertension complications, Noncommunicable Diseases epidemiology, Osteoporosis complications, Osteoporosis epidemiology
Abstract

Background: In persons living with HIV (PLWH), the burden of non-communicable chronic diseases increased over time, because of aging associated with chronic inflammation, systemic immune activation, and long-term exposure to the combination antiretroviral therapy (ART)., Methods: To explore the association of chronological age, age at first ART, and exposure to ART with non-communicable chronic diseases, we performed a cross-sectional analysis to evaluate the prevalence of comorbidities in patients enrolled in the SCOLTA Project, stratified by groups of chronological age (50-59 and 60-69 years) and by years of antiretroviral treatment (ART, ≤ 3 or > 3 years)., Results: In 1394 subjects (23.8% women), mean age at enrollment was 57.4 (SD 6.5) years, and at first ART 45.3 (SD 10.7). Men were older than women both at enrollment (57.6 vs 56.8, p = 0.06) and at first ART (45.8 vs 43.6, p = 0.0009). ART duration was longer in women (13.1 vs 11.7 years, p = 0.01). The age- and sex-adjusted rate ratios (aRRs, and 95% confidence interval, CI) showed that longer ART exposure was associated with dyslipidemia (aRR 1.35, 95% CI 1.20-1.52), hypertension (aRR 1.52, 95% CI 1.22-1.89), liver disease (aRR 1.78, 95% CI 1.32-2.41), osteopenia/osteoporosis (aRR 2.88, 95% CI 1.65-5.03) and multimorbidity (aRR 1.36, 95% CI 1.21-1.54). These findings were confirmed in strata of age, adjusting for sex., Conclusions: Our data suggest that longer ART exposure was associated with increased risk of dyslipidemia, hypertension, and osteopenia/osteoporosis, hence the presence of multimorbidity, possibly due to the exposition to more toxic antiretrovirals. We observed different comorbidities, according to ART exposure and age., (© 2022. The Author(s).)

Published
2022
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44. Reversibility of Central Nervous System Adverse Events in Course of Art.

Author

Taramasso L, Orofino G, Ricci E, Menzaghi B, De Socio GV, Squillace N, Madeddu G, Vichi F, Celesia BM, Molteni C, Conti F, Del Puente F, Sarchi E, Angioni G, Cascio A, Grosso C, Parruti G, Di Biagio A, and Bonfanti P

Subjects
CD4 Lymphocyte Count, Central Nervous System, Humans, Prospective Studies, Anti-HIV Agents adverse effects, HIV Infections complications, HIV Infections drug therapy
Abstract

The purpose of this study is to evaluate the frequency of central nervous system adverse events (CNS-AE) on dolutegravir (DTG) and non-DTG containing ART, and their reversibility, in the observational prospective SCOLTA cohort. Factors associated with CNS-AE were estimated using a Cox proportional-hazards model. 4939 people living with HIV (PLWH) were enrolled in DTG (n = 1179) and non-DTG (n = 3760) cohorts. Sixty-six SNC-AE leading to ART discontinuation were reported, 39/1179 (3.3%) in DTG and 27/3760 (0.7%) in non-DTG cohort. PLWH naïve to ART, with higher CD4 + T count and with psychiatric disorders were more likely to develop a CNS-AE. The risk was lower in non-DTG than DTG-cohort (aHR 0.33, 95% CI 0.19−0.55, p < 0.0001). One-year follow-up was available for 63/66 PLWH with CNS-AE. AE resolution was reported in 35/39 and 23/24 cases in DTG and non-DTG cohorts, respectively. The probability of AE reversibility was not different based on ART class, sex, ethnicity, CDC stage, or baseline psychiatric disorder. At the same time, a lower rate of event resolution was found in PLWH older than 50 years (p = 0.017). In conclusion, CNS-AE leading to ART discontinuation was more frequent in DTG than non-DTG treated PLWH. Most CNS-AE resolved after ART switch, similarly in both DTG and non-DTG cohorts.

Published
2022
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45. Durability of Dolutegravir-Based Regimens: A 5-Year Prospective Observational Study.

Author

Taramasso L, De Vito A, Ricci ED, Orofino G, Squillace N, Menzaghi B, Molteni C, Gulminetti R, De Socio GV, Pellicanò GF, Sarchi E, Celesia BM, Calza L, Rusconi S, Valsecchi L, Martinelli CV, Cascio A, Maggi P, Vichi F, Angioni G, Guadagnino G, Cenderello G, Dentone C, Bandera A, Falasca K, Bonfanti P, Di Biagio A, and Madeddu G

Subjects
Cohort Studies, Female, Heterocyclic Compounds, 3-Ring, Humans, Middle Aged, Oxazines therapeutic use, Piperazines, Prospective Studies, Pyridones, Anti-HIV Agents adverse effects, HIV Infections drug therapy
Abstract

This study evaluates the frequency and causes of dolutegravir (DTG) discontinuation along 5 years of follow-up, in both antiretroviral treatment (ART)-naive and experienced people living with HIV (PLWH). This is a prospective multi-center cohort study enrolling PLWH on DTG from July 2014 until November 2020. DTG-durability was investigated using the Kaplan-Meier survival curve. The Cox proportional-hazards model was used for estimating the hazard ratio (HR) of DTG discontinuation for any cause, and for adverse events (AEs). Nine hundred sixty-three PLWH were included, 25.3% were women and 28.0% were ART-naive. Discontinuations for any causes were 10.1 [95% confidence interval (95% CI) 8.9-11.5] per 100 person-years, similar in most regimens, with the apparent exception of tenofovir alafenamide/emtricitabine+DTG ( p  < 0.0001). In the multivariable Cox regression model, non-Caucasian ethnicity, age ≥50 years, and lower estimated glomerular filtration rate (eGFR) were associated with a higher probability of DTG interruption. The incidence rate of virological failure was 0.4 (95% CI 0.2-0.7) per 100 person-years, while the estimated discontinuation rate for AEs was 4.0 (3.2-4.9) per 100 person-years. Thirty-four DTG interruptions were due to grade ≥3 events (10 central nervous system, 6 hypersensitivity, 3 renal, 3 myalgia/asthenia, 3 abdominal pain, 2 gastrointestinal, and 7 other events). People with lower body mass index, age ≥50 years, and lower eGFR were at higher risk of AEs, while dual combinations were protective (HR 0.41 compared with abacavir/lamivudine/DTG, 95% CI 0.22-0.77). In this prospective observational study, we found high DTG durability and a low rate of virological failures. Dual therapies seemed protective toward AEs and might be considered, when feasible, a suitable option to minimize drug interactions and improve tolerability.

Published
2021
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46. Human cytomegalovirus (HCMV)-specific CD4+ and CD8+ T cells are both required for prevention of HCMV disease in seropositive solid-organ transplant recipients.

Author

Gabanti E, Bruno F, Lilleri D, Fornara C, Zelini P, Cane I, Migotto C, Sarchi E, Furione M, and Gerna G

Subjects
Adult, Aged, CD4-Positive T-Lymphocytes virology, CD8-Positive T-Lymphocytes virology, Cells, Cultured, Cytomegalovirus Infections immunology, Cytomegalovirus Infections virology, Dendritic Cells cytology, Humans, Middle Aged, Retrospective Studies, Transplant Recipients, Viral Load, CD4-Positive T-Lymphocytes immunology, CD8-Positive T-Lymphocytes immunology, Cytomegalovirus immunology, Cytomegalovirus Infections diagnosis, Dendritic Cells virology
Abstract

In solid-organ transplant recipients (SOTR) the protective role of human cytomegalovirus (HCMV)-specific CD4+, CD8+ and γδ T-cells vs. HCMV reactivation requires better definition. The aim of this study was to investigate the relevant role of HCMV-specific CD4+, CD8+ and γδ T-cells in different clinical presentations during the post-transplant period. Thirty-nine SOTR underwent virologic and immunologic follow-up for about 1 year after transplantation. Viral load was determined by real-time PCR, while immunologic monitoring was performed by measuring HCMV-specific CD4+ and CD8+ T cells (following stimulation with autologous HCMV-infected dendritic cells) and γδ T-cells by flow cytometry. Seven patients had no infection and 14 had a controlled infection, while both groups maintained CD4+ T-cell numbers above the established cut-off (0.4 cell/µL blood). Of the remaining patients, 9 controlled the infection temporarily in the presence of HCMV-specific CD8+ only, until CD4+ T-cell appearance; while 9 had to be treated preemptively due to a viral load greater than the established cut-off (3×10(5) DNA copies/mL blood) in the absence of specific CD4+ T-cells. Polyfunctional CD8+ T-cells as well as Vδ2- γδ T-cells were not associated with control of infection. In conclusion, in the absence of HCMV-specific CD4+ T-cells, no long-term protection is conferred to SOTR by either HCMV-specific CD8+ T-cells alone or Vδ2- γδ T-cell expansion.

Published
2014
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47. Evolving surgical techniques for pulmonary endarterectomy according to the changing features of chronic thromboembolic pulmonary hypertension patients during 17-year single-center experience.

Author

Morsolini M, Nicolardi S, Milanesi E, Sarchi E, Mattiucci G, Klersy C, and D'Armini AM

Subjects
Cardiac Surgical Procedures methods, Case-Control Studies, Chronic Disease, Female, Hemodynamics, Humans, Hypothermia, Induced, Linear Models, Male, Middle Aged, Retrospective Studies, Time Factors, Treatment Outcome, Endarterectomy trends, Hypertension, Pulmonary surgery
Abstract

Objective: An increasing number of elderly patients are referred for pulmonary endarterectomy. The distinction between operable and inoperable lesions has been challenged over time. Hence, we developed alternative cardiopulmonary bypass management and cerebral protection strategies to obtain satisfactory surgical results according to the changing patient features., Methods: From April 1994 to March 2011, 347 pulmonary endarterectomies were performed at our center. We began with the technique championed by the San Diego Group, adopting a single period of deep hypothermic circulatory arrest for each side (group A). Since 2003, we began to perform short periods of intermittent deep hypothermic circulatory arrest followed by periods of reperfusion (group B). We then adopted moderate, instead of deep, hypothermia (group C). Finally, we modified our technique further performing shorter (5-7-minute) periods of circulatory arrest (group D)., Results: The hemodynamic results after surgery were excellent in all 4 groups. The patients' age increased significantly. A trend toward an increase in the number of Jamieson type 3 lesions was observed. Associated with our protocol changes, we observed better postoperative respiratory function, a reduction in the length of mechanical ventilation and postoperative infections, and a remarkable improvement in uneventful postoperative courses. Despite the increased total circulatory arrest time, a trend toward a reduction in the incidence of transient neurologic events was observed, and operative mortality was not affected., Conclusions: In our experience, our alternative strategy resulted in a better combination of surgical accuracy and cerebral protection and improved outcomes., (Copyright © 2012 The American Association for Thoracic Surgery. Published by Mosby, Inc. All rights reserved.)

Published
2012
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48. Kinetics of T-lymphocyte subsets and posttransplant opportunistic infections in heart and kidney transplant recipients.

Author

Calarota SA, Zelini P, De Silvestri A, Chiesa A, Comolli G, Sarchi E, Migotto C, Pellegrini C, Esposito P, Minoli L, Tinelli C, Marone P, and Baldanti F

Subjects
Adult, CD4-Positive T-Lymphocytes pathology, CD8-Positive T-Lymphocytes pathology, Female, Humans, Lymphocyte Count, Male, Middle Aged, Predictive Value of Tests, Retrospective Studies, Risk Factors, Time Factors, Heart Transplantation pathology, Kidney Transplantation pathology, Opportunistic Infections epidemiology, T-Lymphocyte Subsets pathology, Transplantation
Abstract

Background: The potential use of T-lymphocyte measurements as infection risk markers after solid organ transplant has not been fully investigated. We analyzed the kinetics of T-lymphocyte subsets within the first 8 months posttransplant and their correlation with opportunistic infections (OIs) in solid organ transplant recipients., Methods: Serial measurement of CD4 and CD8 T cells was performed retrospectively in 48 heart transplant recipients (HTR) and 42 kidney transplant recipients (KTR). Generalized estimating equation models were used to analyze longitudinal data separately for HTR and KTR., Results: An initial CD4 T-cell drop (at months 1 and 2, in HTR and KTR, respectively) coincided with the peak of OIs. HTR with a low nadir CD4 T-cell count (≤ 200/μL) showed poor CD4 T-cell recovery (175 ± 277 cells/μL at baseline vs 242 ± 99 cells/μL at month 8) and their CD8 T cells increased from 153 ± 194 cells/μL at baseline to 601 ± 399 cells/μL at month 8. KTR with a low nadir CD4 T-cell count (≤ 200/μL) showed a modest CD4 T-cell recovery (138 ± 46 cells/μL at baseline vs. 440 ± 448 cells/μL at month 8), and their CD8 T cells increased from 90 ± 41 cells/μL at baseline to 450 ± 242 cells/μL at month 8. HTR developing OIs had lower CD4 (P<0.001) and CD8 T cells (P=0.001) than those without infections, whereas in KTR the risk for OIs seemed restricted to patients with low CD8 T cells. HTR with OIs had a low CD4/CD8 T-cell ratio, whereas KTR had a high CD4/CD8 T-cell ratio., Conclusions: Determination of T-lymphocyte subsets is a simple and effective parameter to identify patients at risk of developing OIs.

Published
2012
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49. Surveillance of Toxoplasma gondii infection in recipients of thoracic solid organ transplants.

Author

Sarchi E, Genco F, Di Matteo A, Castiglioni B, Minoli L, and Meroni V

Subjects
Adult, Animals, Antibodies, Protozoan blood, Antiprotozoal Agents therapeutic use, Drug Therapy, Combination, Female, Humans, Immunoassay, Italy epidemiology, Male, Pyrimethamine therapeutic use, Reagent Kits, Diagnostic, Sentinel Surveillance, Seroepidemiologic Studies, Sulfalene therapeutic use, Toxoplasmosis blood, Toxoplasmosis prevention & control, Treatment Outcome, Heart Transplantation, Lung Transplantation, Toxoplasma immunology, Toxoplasmosis epidemiology
Abstract

We evaluated the frequency of seroconversion for toxoplasmosis in seronegative recipients of thoracic solid organ transplants with seronegative or seropositive donors and the efficacy of chemoprophylaxis with pyrimethamine+sulfametopirazine. One hundred and sixty one patients seronegative for toxoplasmosis were followed-up at different intervals. Six patients out of 79 R-/D- and twelve out of 82 R-/D+ seroconverted after chemoprophylaxis interruption. There was no difference between matched and mismatched recipients as to the frequency of seroconversion which therefore could not be related to donor seropositivity. Seroconversions were almost asymptomatic. All positive recipients should be tested if symptoms of infection are present.

Published
2007

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