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1. Pattern of arterial inflammation and inflammatory markers in people living with HIV compared with uninfected people

Author

Taglieri, Nevio, Bonfiglioli, Rachele, Bon, Isabella, Malosso, Pietro, Corovic, Andrej, Bruno, Matteo, Le, Elizabeth, Granozzi, Bianca, Palmerini, Tullio, Ghetti, Gabriele, Tamburello, Martina, Bruno, Antonio Giulio, Saia, Francesco, Tarkin, Jason M., Rudd, James H. F., Calza, Leonardo, Fanti, Stefano, Re, Maria Carla, and Galié, Nazzareno

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

Author

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

Published
2022
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3. Cancer in people with multidrug-resistant HIV.

Author

Clemente, Tommaso, Pontillo, Domenico, Malagnino, Vincenzo, Calza, Leonardo, Di Biagio, Antonio, Cenderello, Giovanni, Lolatto, Riccardo, Manzillo, Elio, Moioli, Maria Cristina, De Socio, Giuseppe Vittorio, Castagna, Antonella, and Spagnuolo, Vincenzo

Published
2024
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4. Use of next-generation sequencing on HIV-1 DNA to assess archived resistance in highly treatment-experienced people with multidrug-resistant HIV under virological control: data from the PRESTIGIO Registry.

Author

Armenia, Daniele, Spagnuolo, Vincenzo, Bellocchi, Maria C, Galli, Laura, Duca, Leonardo, Marchegiani, Greta, Clemente, Tommaso, Carioti, Luca, Lolatto, Riccardo, Calza, Leonardo, Celesia, Benedetto M, Cascio, Antonio, Francisci, Daniela, Saracino, Annalisa, Torti, Carlo, Zazzi, Maurizio, Castagna, Antonella, Santoro, Maria M, and Group, PRESTIGIO Study

Subjects
NUCLEOTIDE sequencing, DNA sequencing, DRUG resistance, GENOTYPES, GENETIC mutation
Abstract

Background To clarify whether next-generation sequencing (NGS) can be useful for resistance assessment in virologically suppressed highly treatment-experienced (HTE) individuals with MDR HIV. Methods Ninety-one participants from the PRESTIGIO Registry were included. NGS was performed on HIV-DNA at 1%, 5% and 20% cut-offs; major drug resistance mutations (DRMs) were evaluated and compared with those detected in historical plasma genotypic resistance testing (h-GRT). APOBEC editing was also characterized. Results Participants had a complex and long treatment history [median 23 (IQR 21–25) years of ART exposure) and had been virologically suppressed since a median of 3 (IQR 2–5) years. Among all major DRMs detected by HIV-DNA NGS and/or h-GRT, 30% were exclusively found through NGS. The highest detection rate of historical major DRMs was reached with NGS set at 1%, but unusual substitutions and extensive APOBEC hypermutations suggest technical issues and poor clinical relevance in the 1%–5% interval. At NGS set at 5%, 67.2% of historical major DRMs were detected. The number of major DRMs detected exclusively by DNA-NGS as minority variants (frequency 5%–20%) was significantly higher in individuals who later experienced virological rebound compared with those who maintained virological control [median 2 (IQR 1–3) versus 1 (0–2), P  = 0.030] and positively correlated with viraemia levels at rebound (rho = 0.474, P  = 0.030). Conclusions In non-viraemic people with an MDR virus, HIV-1 DNA NGS set at 5% is an acceptable technical cut-off that might help to reveal mutations with a potential clinical relevance. Moreover, the number of minority resistance mutations additionally detected by NGS might be associated with loss of virological control. [ABSTRACT FROM AUTHOR]

Published
2024
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5. 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, Nicolò, primary, Menzaghi, Barbara, additional, Orofino, Giancarlo, additional, Guastavigna, Marta, additional, Lagi, Filippo, additional, Di Biagio, Antonio, additional, Taramasso, Lucia, additional, De Socio, Giuseppe Vittorio, additional, Molteni, Chiara, additional, Madeddu, Giordano, additional, Salomoni, Elena, additional, Pellicanò, Giovanni Francesco, additional, Pontali, Emanuele, additional, Bellagamba, Rita, additional, Celesia, Benedetto Maurizio, additional, Cascio, Antonio, additional, Sarchi, Eleonora, additional, Gulminetti, Roberto, additional, Calza, Leonardo, additional, Maggi, Paolo, additional, Cenderello, Giovanni, additional, Bandera, Alessandra, additional, Carleo, Maria Aurora, additional, Falasca, Katia, additional, Ferrara, Sergio, additional, Martini, Salvatore, additional, Guadagnino, Giuliana, additional, Angioni, Goffredo, additional, Bargiacchi, Olivia, additional, Ricci, Elena Delfina, additional, Squillace, Nicola, additional, and Bonfanti, Paolo, additional

Published
2024
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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

9. Improvement in insulin sensitivity after switching from an integrase inhibitor‐based regimen to doravirine/tenofovir disoproxil fumarate/lamivudine in people with significant weight gain.

Author

Calza, Leonardo, Giglia, Maddalena, Colangeli, Vincenzo, Bon, Isabella, Vitale, Salvatore, and Viale, Pierluigi

Subjects
*LAMIVUDINE, *COMBINATION drug therapy, *GLUCOSE, *ANTIRETROVIRAL agents, *INSULIN sensitivity, *NON-nucleoside reverse transcriptase inhibitors, *HOMEOSTASIS, *SCIENTIFIC observation, *HIV-positive persons, *HIV infections, *TREATMENT effectiveness, *RETROSPECTIVE studies, *INSULIN, *EMTRICITABINE-tenofovir, *LONGITUDINAL method, *LOW density lipoproteins, *WEIGHT gain, *PHARMACODYNAMICS
Abstract

Objectives: We performed an observational, retrospective, cohort study to assess changes in insulin sensitivity after a switch from dolutegravir/lamivudine (DOL/3TC) or bictegravir/emtricitabine/tenofovir alafenamide (BIC/F/TAF) to doravirine/tenofovir disoproxil fumarate/3TC (DOR/TDF/3TC) in virologically suppressed people living with HIV with recent significant weight gain. Methods: All non‐diabetic patients with HIV treated with DOL/3TC or BIC/F/TAF for ≥12 months, with HIV RNA <20 copies/mL, and with a weight increase ≥3 kg in the last year, who underwent a switch to DOR/TDF/3TC were enrolled into the study. Serum levels of glucose, insulin, and homeostasis model assessment of insulin resistance (HOMA‐IR) index were evaluated every 6 months during a 12‐month follow‐up. Results: Overall, 81 patients were enrolled: 41 were treated with DOL/3TC and 40 with BIC/F/TAF. At baseline, median HOMA‐IR index was 3.18 and insulin resistance (HOMA‐IR index >2.5) was present in 49 subjects (60%). At 12 months after the switch to DOR/TDF/3TC, change in mean serum glucose concentration was not significant, but the reduction in median concentration of insulin was significant (−3.54 mcrUI/L [interquartile range −4.22 to −2.87]; p = 0.012), associated with a significant reduction in mean HOMA‐IR index (−0.54 [interquartile range −0.91 to −0.18]; p = 0.021). A significant reduction in total and low‐density lipoprotein cholesterol was also reported, whereas decreases in mean body weight and mean body mass index were not significant. Conclusions: In our retrospective study in virologically suppressed people living with HIV treated with DOL/3TC or BIC/F/TAF and with recent weight gain, the switch to DOR/TDF/3TC led to a significant improvement in insulin sensitivity and plasma lipids, with a trend to decreased body weight. [ABSTRACT FROM AUTHOR]

Published
2024
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13. Cohort profile: PRESTIGIO, an Italian prospective registry-based cohort of people with HIV-1 resistant to reverse transcriptase, protease and integrase inhibitors

Author

Clemente, Tommaso, primary, Galli, Laura, additional, Lolatto, Riccardo, additional, Gagliardini, Roberta, additional, Lagi, Filippo, additional, Ferrara, Micol, additional, Cattelan, Anna Maria, additional, Focà, Emanuele, additional, Di Biagio, Antonio, additional, Cervo, Adriana, additional, Calza, Leonardo, additional, Maggiolo, Franco, additional, Marchetti, Giulia, additional, Cenderello, Giovanni, additional, Rusconi, Stefano, additional, Zazzi, Maurizio, additional, Santoro, Maria Mercedes, additional, Spagnuolo, Vincenzo, additional, and Castagna, Antonella, additional

Published
2024
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18. Risk of virological failure after drug burden reduction in people with 4-class drug-resistant HIV on virological suppression: A retrospective cohort analysis of data from the PRESTIGIO Registry

Author

Clemente, Tommaso, Diotallevi, Sara, Lolatto, Riccardo, Gagliardini, Roberta, Giacomelli, Andrea, Fiscon, Marta, Ferrara, Micol, Cervo, Adriana, Calza, Leonardo, Maggiolo, Franco, Rusconi, Stefano, Santoro, Maria Mercedes, Castagna, Antonella, and Spagnuolo, Vincenzo

Published
2024
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22. 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, Paolo, primary, Ricci, Elena Delfina, additional, Martinelli, Canio Vito, additional, De Socio, Giuseppe Vittorio, additional, Squillace, Nicola, additional, Molteni, Chiara, additional, Masiello, Addolorata, additional, Orofino, Giancarlo, additional, Menzaghi, Barbara, additional, Bellagamba, Rita, additional, Vichi, Francesca, additional, Celesia, Benedetto Maurizio, additional, Madeddu, Giordano, additional, Pellicanò, Giovanni Francesco, additional, Carleo, Maria Aurora, additional, Cascio, Antonio, additional, Parisini, Andrea, additional, Taramasso, Lucia, additional, Valsecchi, Laura, additional, Calza, Leonardo, additional, Rusconi, Stefano, additional, Sarchi, Eleonora, additional, Martini, Salvatore, additional, Bargiacchi, Olivia, additional, Falasca, Katia, additional, Cenderello, Giovanni, additional, Ferrara, Sergio, additional, Di Biagio, Antonio, additional, and Bonfanti, Paolo, additional

Published
2023
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26. 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

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

Author

Taramasso, Lucia, Ricci, Elena, Cascio, Antonio, Valsecchi, Laura, Menzaghi, Barbara, Squillace, Nicola, Maggi, Paolo, De Socio, Giuseppe Vittorio, Dentone, Chiara, Madeddu, Giordano, Pellicanò, Giovanni F., Calza, Leonardo, Angioni, Goffredo, Bonfanti, Paolo, Di Biagio, Antonio, and CISAI Study Group

Published
2019
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34. 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

36. Additional file 1 of Growing old with antiretroviral therapy or elderly people in antiretroviral therapy: two different profiles of comorbidity?

Author

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

Additional file 1: Table S1. Comorbidities by age class (%), comparison with the general Italian population.

Published
2022
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37. Viral resistance burden and APOBEC editing correlate with virological response in heavily treatment-experienced people living with multi-drug resistant HIV

Author

Armenia, Daniele, primary, Santoro, Maria Mercedes, additional, Bellocchi, Maria Concetta, additional, Carioti, Luca, additional, Galli, Laura, additional, Galli, Andrea, additional, Scutari, Rossana, additional, Salsi, Eleonora, additional, Mussini, Cristina, additional, Sterrantino, Gaetana, additional, Calza, Leonardo, additional, Rossetti, Barbara, additional, Zazzi, Maurizio, additional, and Castagna, Antonella, additional

Published
2022
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39. 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

44. Efficacy and safety of atazanavir-ritonavir plus abacavir-lamivudine or tenofovir-emtricitabine in patients with hyperlipidaemia switched from a stable protease inhibitor-based regimen including one thymidine analogue

Author

Calza, Leonardo, Manfredi, Roberto, Colangeli, Vincenzo, Pocaterra, Daria, Rosseti, Nirmala, Pavoni, Michele, and Chiodo, Francesco

Subjects
Protease inhibitors -- Dosage and administration, Protease inhibitors -- Research, Hyperlipidemia -- Drug therapy, Hyperlipidemia -- Research, Drug therapy, Combination -- Health aspects, Drug therapy, Combination -- Research, Thymidine -- Health aspects, Thymidine -- Research, Health
Abstract

Randomized, open-label, prospective clinical trial assessing efficacy and safety on hyperlipidemia of a switching from a regimen including one protease inhibitor and one thymidine analogue to atazanavir/ritonavir plus abacavir/lamivudine or tenofovir/emtricitabine. Adult HIV-infected patients on their first antiretroviral therapy (of at least 48-week duration), including one protease inhibitor and zidovudine or stavudine, with stable immunovirologic features, and having diagnosis of persisting hyperlipidemia, were randomized to replace current treatment with atazanavir/ritonavir plus abacavir/lamivudine (arm A) or tenofovir/emtricitabine (arm B), and were followed for 48 weeks. Eighty-nine patients were enrolled: 42 patients were randomized to arm A, and 47 to arm B. At the end of the 48-week follow-up, incidence of virologic failure was comparable in both arms, and associated with a poor drug compliance. Increase in CD4 lymphocyte count was significantly higher in arm A after a 24-week study period (62.5 versus 39.2 x [10.sup.6] cells/L; p < 0.05), while immunologic responses were comparable at the end of 48-week follow-up (91.5 versus 83.6; p > 0.05). A statistically significant reduction (-15.4%) in mean triglyceridaemia versus respective baseline values was reported in both groups (p < 0.05), without statistically significant difference between arm A and B. Similar results were reported for total cholesterol and low-density lipoprotein (LDL) cholesterol levels. Safety and tolerability profiles were comparable in both groups. Switching from a protease inhibitor- and thymidine analogue-based antiretroviral regimen to atazanavir/ ritonavir plus abacavir/lamivudine or tenofovir/emtricitabine proved effective in the management of hyperlipidemia, without significant differences in lipid-lowering effect, virologic efficacy, and safety profile between these regimens.

Published
2009

47. Recent availability of two novel, fixed formulations of antiretroviral nucleoside analogues: a 12-month prospective, open-label survey of their practical use and therapeutic perspectives in antiretroviral-naive and -experienced patients

Author

Manfredi, Roberto and Calza, Leonardo

Subjects
HIV patients -- Health aspects, HIV patients -- Surveys, Reverse transcriptase -- Health aspects, Reverse transcriptase -- Surveys, Highly active antiretroviral therapy -- Surveys, Highly active antiretroviral therapy -- Health aspects, Nucleosides -- Surveys, Nucleosides -- Health aspects, Health
Abstract

The recent introduction of novel, fixed nucleoside- nucleotide reverse transcriptase inhibitor (NRTI) combinations (tenofovir-emtricitabine, and abacavir-lamivudine) expanded the spectrum of available formulations and concurrently increased patients' adherence levels. A prospective survey of the open-label use of these two fixed combinations was performed in 158 patients belonging to our single-center cohort of more than 1,000 HIV-infected subjects enrolled in the last 18 months, and followed for at least 12 months. During the last 18 months, 95 consecutive, evaluable patients (60.1%) received for the first time tenofovir-emtricitabine, or abacavir-lamivudine (63 patients, 39.9%), and were followed for at least 12 months with periodic clinical and laboratory examinations. Among the 53 evaluable patients who were naive to all antiretrovirals, tenofovir- emtricitabine has been given to 42 subjects (79.2%), mostly associated with efavirenz (26 cases), or different boosted protease inhibitors 06 subjects), whereas abacavir-lamivudine was administered to 11 patients (in 10 cases of 11, together with boosted protease inhibitors). In the remaining 105 patients, tenofovir-emtricitabine or abacavir-lamivudine therapy represented a switch from a prior combination antiretroviral regimen, and was predominantly associated with boosted protease inhibitors (61 patients), versus efavirenz or nevirapine (26 cases), or other drug combinations containing protease inhibitors (the remaining 18 patients). Among the 105 pretreated patients, the prescription of tenofovir-emtricitabine (53 patients) was as frequent as that of abacavirlamivudine (52 cases), and the therapeutic change was primarily prompted by toxicity or poor tolerability (59 patients), followed by therapeutic failure and viral resistance (46 cases as a whole), and always encompassed a regimen simplification also. Both fixed combinations were well tolerated, and an adherence rate more than 90% was estimated among evaluable patients. From a tolerability point of view, the emtricitabine-tenofovir association was never withdrawn due to untoward events, while only two cases of early abacavir-lamivudine suspension occurred, due to a probable abacavir hypersensitivity reaction. From our preliminary experience, a major role seems to be played by tenofovir- emtricitabine in first-line treatments (preferably among 'compact' regimens based on efavirenz), while the proportionally in creased abacavir-lamivudine prescription to pretreated patients is mostly attributable to the different genetic barrier of abacavir (which was often associated with boosted protease inhibitors, in this last patient group). The present availability of two more fixed NRTI combinations favored by their single pill, once-daily administration strongly encourages randomized, controlled 'head to head' studies in both first-line and experienced patents, in order to better exploit and target their therapeutic potential, and their most effective associations.

Published
2008

48. Factors Associated With Weight Gain in People Treated With Dolutegravir

Author

Taramasso, L, Bonfanti, P, Ricci, E, Orofino, G, Squillace, N, Menzaghi, B, De Socio, G, Madeddu, G, Pellicanò, G, Pagnucco, L, Celesia, B, Calza, L, Conti, F, Martinelli, C, Valsecchi, L, Cascio, A, Bolla, C, Maggi, P, Vichi, F, Dentone, C, Angioni, G, Mastroianni, A, Falasca, K, Cenderello, G, Di Biagio, A, Taramasso, Lucia, Bonfanti, Paolo, Ricci, Elena, Orofino, Giancarlo, Squillace, Nicola, Menzaghi, Barbara, De Socio, Giuseppe Vittorio, Madeddu, Giordano, Pellicanò, Giovanni Francesco, Pagnucco, Layla, Celesia, Benedetto Maurizio, Calza, Leonardo, Conti, Federico, Martinelli, Canio Vito, Valsecchi, Laura, Cascio, Antonio, Bolla, Cesare, Maggi, Paolo, Vichi, Francesca, Dentone, Chiara, Angioni, Goffredo, Mastroianni, Antonio, Falasca, Katia, Cenderello, Giovanni, Di Biagio, Antonio, Taramasso, L, Bonfanti, P, Ricci, E, Orofino, G, Squillace, N, Menzaghi, B, De Socio, G, Madeddu, G, Pellicanò, G, Pagnucco, L, Celesia, B, Calza, L, Conti, F, Martinelli, C, Valsecchi, L, Cascio, A, Bolla, C, Maggi, P, Vichi, F, Dentone, C, Angioni, G, Mastroianni, A, Falasca, K, Cenderello, G, Di Biagio, A, Taramasso, Lucia, Bonfanti, Paolo, Ricci, Elena, Orofino, Giancarlo, Squillace, Nicola, Menzaghi, Barbara, De Socio, Giuseppe Vittorio, Madeddu, Giordano, Pellicanò, Giovanni Francesco, Pagnucco, Layla, Celesia, Benedetto Maurizio, Calza, Leonardo, Conti, Federico, Martinelli, Canio Vito, Valsecchi, Laura, Cascio, Antonio, Bolla, Cesare, Maggi, Paolo, Vichi, Francesca, Dentone, Chiara, Angioni, Goffredo, Mastroianni, Antonio, Falasca, Katia, Cenderello, Giovanni, and Di Biagio, Antonio

Abstract

Background An unexpected excess in weight gain has recently been reported in the course of dolutegravir (DTG) treatment. The aim of the present study was to investigate whether weight gain differs among different DTG-containing regimens. Methods Adult naïve and experienced people with HIV (PWH) initiating DTG-based antiretroviral therapy (ART) between July 2014 and December 2019 in the Surveillance Cohort Long-Term Toxicity Antiretrovirals (SCOLTA) prospective cohort were included. We used an adjusted general linear model to compare weight change among backbone groups and a Cox proportional hazard regression model to calculate hazard ratios (HRs) and 95% confidence intervals (CIs) for weight increases >10% from baseline. Results A total of 713 participants, 25.3% women and 91% Caucasian, were included. Of these, 195 (27.4%) started DTG as their first ART regimen, whereas 518 (72.6%) were ART-experienced. DTG was associated with abacavir/lamivudine in 326 participants, tenofovir disoproxil fumarate/emtricitabine (TDF/FTC) in 148, boosted protease inhibitors in 60, rilpivirine in 45, lamivudine in 75, and tenofovir alafenamide (TAF)/FTC in 59. At 6 and 12 months, weight gain was highest among PWH on TDF/FTC+DTG and TAF/FTC+DTG. Baseline CD4 <200 cells/mm3 (HR, 1.84; 95% CI, 1.15 to 2.96), being ART-naïve (HR, 2.24; 95% CI, 1.24 to 4.18), and treatment with TDF/FTC+DTG (HR, 1.92; 95% CI, 1.23 to 2.98) or TAF/FTC+DTG (HR, 3.80; 95% CI, 1.75 to 8.23) were associated with weight gain >10% from baseline. Higher weight (HR, 0.97 by 1 kg; 95% CI, 0.96 to 0.99) and female gender (HR, 0.54; 95% CI, 0.33 to 0.88) were protective against weight gain. Conclusions Naïve PWH with lower CD4 counts and those on TAF/FTC or TDF/FTC backbones were at higher risk of weight increase in the course of DTG-based ART.

Published
2020

49. Factors associated with hospital admission for COVID-19 in HIV patients

Author

Di Biagio, A, Ricci, E, Calza, L, Squillace, N, Menzaghi, B, Rusconi, S, Orofino, G, Bargiacchi, O, Molteni, C, Valsecchi, L, Cenderello, G, Ferrara, S, Saracino, A, Maggi, P, Falasca, K, Taramasso, L, Bonfanti, P, Di Biagio, Antonio, Ricci, Elena, Calza, Leonardo, Squillace, Nicola, Menzaghi, Barbara, Rusconi, Stefano, Orofino, Giancarlo, Bargiacchi, Olivia, Molteni, Chiara, Valsecchi, Laura, Cenderello, Giovanni, Ferrara, Sergio, Saracino, Annalisa, Maggi, Paolo, Falasca, Katia, Taramasso, Lucia, Bonfanti, Paolo, Di Biagio, A, Ricci, E, Calza, L, Squillace, N, Menzaghi, B, Rusconi, S, Orofino, G, Bargiacchi, O, Molteni, C, Valsecchi, L, Cenderello, G, Ferrara, S, Saracino, A, Maggi, P, Falasca, K, Taramasso, L, Bonfanti, P, Di Biagio, Antonio, Ricci, Elena, Calza, Leonardo, Squillace, Nicola, Menzaghi, Barbara, Rusconi, Stefano, Orofino, Giancarlo, Bargiacchi, Olivia, Molteni, Chiara, Valsecchi, Laura, Cenderello, Giovanni, Ferrara, Sergio, Saracino, Annalisa, Maggi, Paolo, Falasca, Katia, Taramasso, Lucia, and Bonfanti, Paolo

Abstract

This study reports on hospital admission and outcomes of 69 HIV-infected subjects who were diagnosed with SARS-CoV-2 infection between February and May 2020, in a network of Italian centers. Patients' characteristics and median days between symptoms and diagnosis were similar by hospital admission, whereas admitted patients were had lower nadir CD4 cells and current lymphocytes count. These values were also correlated to worse COVID-19 outcome. Antiretroviral drugs did not seem associated with disease severity.

Published
2020

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