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204 results on '"Colafigli M"'

1. The effect of switching to Maraviroc + Darunavir/ritonavir dual therapy in virologically suppressed patients on the progression of liver fibrosis: findings from a randomized study

Author

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

Published
2019
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2. Efficacy and durability of two‐ vs . three‐drug integrase inhibitor‐based regimens in virologically suppressed HIV‐infected patients: Data from real‐life ODOACRE cohort

Author

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

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

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

Published
2021

5. Genotypic testing on HIV-1 DNA as a tool to assess HIV-1 co-receptor usage in clinical practice: results from the DIVA study group

Author

Svicher, V., Alteri, C., Montano, M., Nori, A., D’Arrigo, R., Andreoni, M., Angarano, G., Antinori, A., Antonelli, G., Allice, T., Bagnarelli, P., Baldanti, F., Bertoli, A., Borderi, M., Boeri, E., Bon, I., Bruzzone, B., Barresi, R., Calderisi, S., Callegaro, A. P., Capobianchi, M. R., Gargiulo, F., Castelli, F., Cauda, R., Ceccherini-Silberstein, F., Clementi, M., Chirianni, A., Colafigli, M., D’Arminio Monforte, A., De Luca, A., Di Biagio, A., Di Nicuolo, G., Di Perri, G., Di Santo, F., Fadda, G., Galli, M., Gennari, W., Ghisetti, V., Costantini, A., Gori, A., Gulminetti, R., Leoncini, F., Maffongelli, G., Maggiolo, F., Maserati, R., Mazzotta, F., Meini, G., Micheli, V., Monno, L., Mussini, C., Nozza, S., Paolucci, S., Palù, G., Parisi, S., Parruti, G., Pignataro, A. R., Quirino, T., Re, M. C., Rizzardini, G., Sanguinetti, M., Santangelo, R., Scaggiante, R., Sterrantino, G., Turriziani, O., Vatteroni, M. L., Viscoli, C., Vullo, V., Zazzi, M., Lazzarin, A., and Perno, C. F.

Published
2014
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9. Integrase Inhibitors Use and Cytomegalovirus Infection Predict Immune Recovery in People Living With HIV Starting First-Line Therapy

Author

Fabbiani, M., Borghetti, A., Squillace, N., Colafigli, M., Taramasso, L., Lombardi, A. (ORCID:0000-0002-9139-9269), Rossetti, B., Ciccullo, A., Colella, E., Picarelli, C., Berruti, M., Latini, A., Montagnani, F., Sambo, M., Di Biagio, A., Gori, A., Di Giambenedetto, S. (ORCID:0000-0001-6990-5076), Bandera, A., Fabbiani, M., Borghetti, A., Squillace, N., Colafigli, M., Taramasso, L., Lombardi, A. (ORCID:0000-0002-9139-9269), Rossetti, B., Ciccullo, A., Colella, E., Picarelli, C., Berruti, M., Latini, A., Montagnani, F., Sambo, M., Di Biagio, A., Gori, A., Di Giambenedetto, S. (ORCID:0000-0001-6990-5076), and Bandera, A.

Abstract

BACKGROUND: We explored predictors of CD4/CD8 ratio improvement and optimal immunological recovery (OIR) after initiation of antiretroviral therapy (ART) in naive people living with HIV (PLWH). METHODS: Retrospective multicenter study including naive PLWH starting ART with 2 nucleos(t)ide reverse transcriptase inhibitors + 1 integrase strand transfer inhibitor (InSTI) or non-NRTI or protease inhibitor (PI). PLWH were followed from the time of ART initiation (baseline) to the discontinuation of first-line regimen, virological failure, death, or loss to follow-up. Estimated incidence and predictors of time to CD4/CD8 ratio normalization (defined as ≥1) and OIR (defined as CD4/CD8 ratio ≥ 1 plus CD4 ≥ 500 cells/µL plus CD4% ≥ 30%) were explored by Kaplan-Meier curves and Cox regression analysis. RESULTS: Overall, 1428 PLWH (77.8% males, median age 39 years, 55.1% with positive cytomegalovirus (CMV) antibodies, median HIV-RNA 4.80 log copies/mL, median CD4 323 cells/µL, median CD4/CD8 ratio 0.32) were included, of which 21.5% (n = 307), 44.5% (n = 636), and 34% (n = 485) treated with InSTI-, PI-, and NNRTI-based regimens, respectively. The estimated proportion of CD4/CD8 normalization and OIR at 36 months was 38.6% and 32.9%, respectively. Multivariate analysis showed that InSTI-based regimens had a higher probability of CD4/CD8 ratio normalization and OIR both in the total population (P < 0.001 versus PI) and in advanced naive PLWH (P ≤ 0.001 versus PI and NNRTI). Moreover, subjects with positive CMV serology showed a lower probability of CD4/CD8 ratio normalization and OIR (P < 0.001). CONCLUSIONS: InSTI-based regimens showed a better immune recovery, suggesting that the type of first-line ART can influence immune reconstitution. PLWH with positive CMV serology showed an increased risk of suboptimal immune recovery.

Published
2021

10. Overall Tolerability of Integrase Inhibitors in Clinical Practice: Results from a Multicenter Italian Cohort

Author

Ciccullo, A., Baldin, G., Borghi, V., Sterrantino, G., Madeddu, G., Latini, A., D'Ettorre, G., Lanari, A., Mazzitelli, M., Colafigli, Manuela, Capetti, A. F., Oreni, L., Lagi, F., Rusconi, S., Di Giambenedetto, Simona, Colafigli M., DI Giambenedetto S. (ORCID:0000-0001-6990-5076), Ciccullo, A., Baldin, G., Borghi, V., Sterrantino, G., Madeddu, G., Latini, A., D'Ettorre, G., Lanari, A., Mazzitelli, M., Colafigli, Manuela, Capetti, A. F., Oreni, L., Lagi, F., Rusconi, S., Di Giambenedetto, Simona, Colafigli M., and DI Giambenedetto S. (ORCID:0000-0001-6990-5076)

Abstract

International guidelines recommend the use of integrase strand transfer inhibitor (INI)-based regimens as first-line antiretroviral (ARV) in both naive and experienced HIV-infected patients. We analyzed a multicenter cohort of HIV-infected patients, both naive and experienced, starting an ARV, including an INI. Chi-square test and nonparametric tests were used to assess differences in categorical and continuous variables, respectively. Kaplan-Meier survival analysis was performed to estimate the probability of maintaining the study drug and Cox-regression analysis to evaluate predictors of discontinuation. We enrolled 4,343 patients: 3,143 (72.4%) were males, with a median age of 49 years (interquartile range 41-55). Naive patients were 733 (16.9%), of whom 168 (22.9%) were AIDS presenters. Overall, 2,282 patients (52.5%) started dolutegravir (DTG), 1,426 (32.8%) raltegravir (RAL), and 635 (14.7%) elvitegravir (EVG). During 10,032 patient years of follow-up (PYFU), we observed 1,278 discontinuations (13 per 100 PYFU); 448 of them (35%) due to simplification and 355 (28%) to toxicities (98 for central nervous system toxicity). Reasons of discontinuation were different between INIs. Estimated probability of maintaining DTG at 3 and 4 years were 81.5% [95% confidence interval (CI): 80.5-82.5] and 76.3% (95% CI: 73.9-78.7), respectively; RAL 61.6% (95% CI: 60.2-63.0) and 54.1% (95% CI: 52.7-55.5); EVG 71.6% (95% CI: 69.2-74.0) and 68.3% (95% CI: 65.3-71.3) (p < .001). At a multivariable analysis, being on a RAL-based ARV [vs. DTG, adjusted hazard ratio (aHR) 2.9, 95% CI: 2.3-3.6, p < .001], a EVG-based ARV (vs. DTG, aHR 1.3 95% CI: 1.1-1.7, p = .049), and a peak HIV-RNA >500k cp/mL (aHR 1.3, 95% CI: 1.1-1.6, p = .006) predicted INI discontinuation. Our data confirm the good tolerability of INIs in clinical practice. Differences emerge between the three drugs in reasons for discontinuation.

Published
2021

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

Author

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

Abstract

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

Published
2018

12. Atazanavir/ritonavir with lamivudine as maintenance therapy in virologically suppressed HIV-infected patients: 96 week outcomes of a randomized trial

Author

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

Abstract

Objectives: To investigate the long-term safety and efficacy of a treatment switch to dual ART with atazanavir/ritonavir+lamivudine versus continuing a standard regimen with atazanavir/ritonavir+2NRTI in virologically suppressed patients. Methods: ATLAS-M is a 96 week open-label, randomized, non-inferiority (margin -12%) trial enrolling HIV-infected adults on atazanavir/ritonavir+2NRTI, with stable HIV-RNA < 50 copies/mL and CD4 counts.200 cells/mm3. At baseline, patients were randomized 1:1 to switch to atazanavir/ritonavir+lamivudine or to continue the previous regimen. Here, we report the 96 week efficacy and safety data. The study was registered with ClinicalTrials.gov, number NCT01599364. Results: Overall, 266 subjects were enrolled (133 in each arm). At 96 weeks, in the ITT population, patients free of treatment failure totalled 103 (77.4%) with atazanavir/ritonavir+lamivudine and 87 (65.4%) with triple therapy (difference +12.0%, 95% CI +1.2/+22.8, P=0.030), demonstrating the superiority of dual therapy. Two (1.5%) and 9 (6.8%) virological failures occurred in the dual-therapy arm and the triple-therapy arm, respectively, without development of resistance to any study drug. Clinical adverse events occurred at similar rates in both arms. A higher frequency of grade 3-4 hyperbilirubinemia (66.9% versus 50.4%, P=0.006) and hypertriglyceridaemia (6.8% versus 1.5%, P=0.031) occurred with dual therapy, although this never led to treatment discontinuation. A significant improvement in renal function and lumbar spine bone mineral density occurred in the dual-therapy arm. The evolution of CD4, HIV-DNA levels and neurocognitive performance was similar in both arms. Conclusions: In this randomized study, a treatment switch to atazanavir/ritonavir+lamivudine was superior over the continuation of atazanavir/ritonavir+2NRTI in virologically suppressed patients, with a sustained benefit in terms of improved renal function and bone mineral density.

Published
2018

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

Author

Quiros-Roldan, E., Magro, P., Raffetti, E., Izzo, I., Borghetti, A., Lombardi, F., Saracino, A., Maggiolo, F., Castelli, F., Carosi, G., Paraninfo, G. E., Torti, C., Cauda, R., Di Giambenedetto, S., Fabbiani, M., Colafigli, M., Scalzini, A., Castelnuovo, F., El Hamad, I., Mazzotta, F., Locaputo, S., Marino, N., Pierotti, P., Di Pietro, M., Ble, C., Vichi, F., Sighinolfi, L., Angarano, G., Ladisa, N., Monno, L., Maggi, P., Pan, A., Costarelli, S., Gori, A., Lapadula, G., Puoti, M., Viale, P., Colangeli, V., Borderi, M., Borghetti A., Lombardi F. (ORCID:0000-0001-5757-8346), Carosi G., Torti C., Cauda R. (ORCID:0000-0002-1498-4229), Di Giambenedetto S. (ORCID:0000-0001-6990-5076), Colafigli M., Di Pietro M. (ORCID:0000-0002-3893-8788), Quiros-Roldan, E., Magro, P., Raffetti, E., Izzo, I., Borghetti, A., Lombardi, F., Saracino, A., Maggiolo, F., Castelli, F., Carosi, G., Paraninfo, G. E., Torti, C., Cauda, R., Di Giambenedetto, S., Fabbiani, M., Colafigli, M., Scalzini, A., Castelnuovo, F., El Hamad, I., Mazzotta, F., Locaputo, S., Marino, N., Pierotti, P., Di Pietro, M., Ble, C., Vichi, F., Sighinolfi, L., Angarano, G., Ladisa, N., Monno, L., Maggi, P., Pan, A., Costarelli, S., Gori, A., Lapadula, G., Puoti, M., Viale, P., Colangeli, V., Borderi, M., Borghetti A., Lombardi F. (ORCID:0000-0001-5757-8346), Carosi G., Torti C., Cauda R. (ORCID:0000-0002-1498-4229), Di Giambenedetto S. (ORCID:0000-0001-6990-5076), Colafigli M., and Di Pietro M. (ORCID:0000-0002-3893-8788)

Abstract

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

Published
2018

16. HIV MDR is still a relevant issue despite its dramatic drop over the years

Author

Armenia, D, primary, Di Carlo, D, primary, Flandre, P, primary, Bouba, Y, primary, Borghi, V, primary, Forbici, F, primary, Bertoli, A, primary, Gori, C, primary, Fabeni, L, primary, Gennari, W, primary, Pinnetti, C, primary, Mondi, A, primary, Cicalini, S, primary, Gagliardini, R, primary, Vergori, A, primary, Bellagamba, R, primary, Malagnino, V, primary, Montella, F, primary, Colafigli, M, primary, Latini, A, primary, Marocco, R, primary, Licthner, M, primary, Andreoni, M, primary, Mussini, C, primary, Ceccherini-Silberstein, F, primary, Antinori, A, primary, Perno, C F, primary, and Santoro, M M, primary

Published
2020
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18. Treatment simplification to atazanavir/ritonavir+lamivudine versus maintenance of atazanavir/ritonavir+two NRTIs in virologically suppressed HIV-1-infected patients: 48 week results from a randomized trial (ATLAS-M)

Author

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

Abstract

Background: Combination ART (cART)-related toxicities and costs have prompted the need for treatment simplification. The ATLAS-M trial explored 48 week non-inferior efficacy of simplification to atazanavir/ritonavir + lamivudine versus maintaining three-drug atazanavir/ritonavir-based cART in virologically suppressed patients. Methods: We performed an open-label, multicentre, randomized, non-inferiority study, enrolling HIV-infected adults on atazanavir/ritonavir+two NRTIs, with stable HIV-RNA <50 copies/mL and CD4+>200 cells/mm3. Main exclusion criteria were hepatitis B virus coinfection, past virological failure on or resistance to study drugs, recent AIDS and pregnancy. Patients were randomly assigned 1:1 to either switch to 300mg of atazanavir/ 100mg of ritonavir once daily and 300mg of lamivudine once daily (atazanavir/ritonavir+lamivudine arm) or to continue the previous regimen (atazanavir/ritonavir+two NRTIs arm). The primary study outcome was the maintenance of HIV-RNA <50 copies/mL at week 48 of the ITT-exposed (ITT-e) analysis with switch"failure. The non-inferiority margin was 12%. This study is registered at ClinicalTrials.gov, number NCT01599364. Results: Between July 2011 and June 2014, 266 patients were randomized (133 to each arm). After 48 weeks, the primary study outcome was met by 119 of 133 patients (89.5%) in the atazanavir/ritonavir+lamivudine arm and 106 of 133 patients (79.7%) in the atazanavir/ritonavir+two NRTIs arm [difference atazanavir/ritonavir+ lamivudine versus atazanavir/ritonavir+two NRTIs arm: +9.8% (95% CI+1.2 to+18.4)], demonstrating non-inferiority and superior efficacy of the atazanavir/ritonavir+lamivudine arm. Virological failure occurred in two (1.5%) patients in the atazanavir/ritonavir+lamivudine arm and six (4.5%) patients in the atazanavir/ritonavir+ two NRTIs arm, without resistance selection. A similar proportion of adverse events occurred in both arms. Conclusions: Treatment simplification to atazanavir/rito

Published
2017

22. Cohort profile: The Observational cohort for the study of DOlutegravir in Antiretroviral Combination REgimens (ODOACRE)

Author

Ciccullo, Arturo, Baldin, G., Capetti, A., Borghi, V., Sterrantino, G., Latini, A., Madeddu, G., Celani, L., Vignale, F., Rossetti, Barbara, Dusina, Alex, Cossu, M. V., Restelli, S., Gennari, W., Lagi, F., Giacomelli, A., Colafigli, M., Brescini, L., Borghetti, A., Mussini, C., Rusconi, S., Di Giambenedetto, Simona, Ciccullo A., Rossetti B., Dusina A., Di Giambenedetto S. (ORCID:0000-0001-6990-5076), Ciccullo, Arturo, Baldin, G., Capetti, A., Borghi, V., Sterrantino, G., Latini, A., Madeddu, G., Celani, L., Vignale, F., Rossetti, Barbara, Dusina, Alex, Cossu, M. V., Restelli, S., Gennari, W., Lagi, F., Giacomelli, A., Colafigli, M., Brescini, L., Borghetti, A., Mussini, C., Rusconi, S., Di Giambenedetto, Simona, Ciccullo A., Rossetti B., Dusina A., and Di Giambenedetto S. (ORCID:0000-0001-6990-5076)

Abstract

Purpose The Observational cohort for the study of DOlutegravir in Antiretroviral Combination REgimens (ODOACRE) cohort was established in Italy in 2016 to evaluate the overall efficacy and tolerability of dolutegravir (DTG)-based antiretroviral (ARV) regimens in clinical practice. Participants The ODOACRE cohort enrols all adult HIV-1-infected patients, both treatment-naïve and treatment-experienced, starting a DTG-based ARV regimen, in 11 clinical centres in Italy from 2014. Findings to date In recent years, various works by the ODOACRE cohort have been produced, demonstrating the high efficacy and tolerability of DTG-based ARV regimens in clinical practice, both in ART-naïve (in the setting of acute HIV-1 infection and late presenters patient) and experienced patients. We confirmed the virological efficacy of DTG-based regimens and we evaluated predictors of virological failure. We investigated cause of discontinuation and evaluated tolerability and metabolic profile of the regimens. Within these investigations, we explored particularly the use of DTG in simplification in two-drug regimen with either rilpivirine or lamivudine. We also compared DTG-based regimens with other integrase inhibitors in clinical practice. Future plans To continue to study long-term efficacy and tolerability of DTG-based regimens is the purpose of the ODOACRE cohort.

Published
2019

23. Viro-immunological efficacy and tolerability of dolutegravir-based regimens compared to regimens based on other integrase strand inhibitors, protease inhibitors, non-nucleoside reverse transcriptase inhibitors in patients with acute HIV-1 infection: a multicenter retrospective cohort study

Author

Lagi, F, Baldin, Gianmaria, Colafigli, Manuela, Capetti, A, Madeddu, G, Kiros, S Tekle, Di Giambenedetto, Simona, Sterrantino, G, Baldin, G, Colafigli, M, Di Giambenedetto, S (ORCID:0000-0001-6990-5076), Lagi, F, Baldin, Gianmaria, Colafigli, Manuela, Capetti, A, Madeddu, G, Kiros, S Tekle, Di Giambenedetto, Simona, Sterrantino, G, Baldin, G, Colafigli, M, and Di Giambenedetto, S (ORCID:0000-0001-6990-5076)

Abstract

OBJECTIVES: This study aims to compare the tolerability and viro-immunologic efficacy of dolutegravir-based regimens (DTG group) with regimens based on EVG, RAL, PI, NNRTI (NODTG group) in patients with acute HIV-1 infections (AHI). METHODS: All patients diagnosed with AHI between 2015 and 2017, who started ART in 5 different centers in Italy, were included and followed-up to 30th April 2018. AHI was defined by the presence of the positive p24 antigen with negative or indeterminate western blot. RESULTS: Forty-three patients were enrolled: 20 on DTG, 23 in NODTG. Nine patients (20.9%), 4 in DTG and 5 in NODTG group, were prescribed a four-drug regimen. In the cohort, 81.4% were Italian and 83.7% males with a median age of 41 years (IQR 31-48). The median time elapsed between HIV diagnosis and ART initiation was 12 days [IQR 5-28]. Seven patients harbored a virus with transmitted mutations at baseline (16.2%), all in DTG group (p=0.005). All patients achieved HIV-RNA undetectable at the end of follow up except two subjects, of whom one had 57 copies and one was lost to follow-up. In Kaplan-Meier analysis, time to virologic suppression was not different between the two groups (log rank: p= 0.7155). After achieving virologic suppression, four patients stopped first ART due to toxicity: 2 on DTG, 2 on EVG for neurological and gastrointestinal toxicity, respectively. CONCLUSION: In our setting, ART in AHI is started very early. DTG showed a good viro-immunologic efficacy even when NRTI transmitted mutations were present. DTG interruption rarely occurred. Copyright © 2019. Published by Elsevier B.V.

Published
2019

24. SLC22A2 variants and dolutegravir levels correlate with psychiatric symptoms in persons with HIV

Author

Borghetti, A, Calcagno, A, Lombardi, Francesca, Cusato, J, Belmonti, S, D'Avolio, A, Ciccarelli, Nicoletta, La Monica, S, Colafigli, Manuela, Delle Donne, Valentina, De Marco, R, Tamburrini, Enrica, Visconti, Elena, Di Perri, G, De Luca, Andrea, Bonora, S, Di Giambenedetto, Simona, Lombardi, F (ORCID:0000-0001-5757-8346), Ciccarelli, N (ORCID:0000-0002-7582-9142), Colafigli, M, Delle Donne, V, Tamburrini, E (ORCID:0000-0003-4930-426X), Visconti, E, De Luca, A (ORCID:0000-0002-8311-6935), Di Giambenedetto, S (ORCID:0000-0001-6990-5076), Borghetti, A, Calcagno, A, Lombardi, Francesca, Cusato, J, Belmonti, S, D'Avolio, A, Ciccarelli, Nicoletta, La Monica, S, Colafigli, Manuela, Delle Donne, Valentina, De Marco, R, Tamburrini, Enrica, Visconti, Elena, Di Perri, G, De Luca, Andrea, Bonora, S, Di Giambenedetto, Simona, Lombardi, F (ORCID:0000-0001-5757-8346), Ciccarelli, N (ORCID:0000-0002-7582-9142), Colafigli, M, Delle Donne, V, Tamburrini, E (ORCID:0000-0003-4930-426X), Visconti, E, De Luca, A (ORCID:0000-0002-8311-6935), and Di Giambenedetto, S (ORCID:0000-0001-6990-5076)

Abstract

Background: Neuropsychiatric symptoms (NPs) have been reported with dolutegravir use. We hypothesized that increasing dolutegravir trough concentrations (Ctrough) and/or polymorphism in the SLC22A2 gene, encoding the organic cation transporter-2 (OCT2), which is involved in monoamine clearance in the CNS and is inhibited by dolutegravir, might be associated with NPs. Methods: A cross-sectional cohort of HIV-positive patients treated with a dolutegravir-containing regimen underwent determination of allelic discrimination for SLC22A2 808 C → A polymorphism and dolutegravir Ctrough. The Symptom Checklist-90-R [investigating 10 psychiatric dimensions and reporting a general severity index (GSI)], a self-reported questionnaire and the Mini-International Neuropsychiatric Interview were offered to investigate current NPs. The effects of dolutegravir Ctrough and the SLC22A2 gene variant on NPs were explored by multivariable logistic regression. Results: A cohort of 203 patients was analysed: 71.4% were male, with median age 51 years and 11 years of ART exposure. Median time on dolutegravir was 18 months. Dolutegravir was associated with different antiretroviral combinations (mainly lamivudine, 38.9%, and abacavir/lamivudine, 35.5%). SLC22A2 CA genotype was independently associated with an abnormal GSI [adjusted OR (aOR) 2.43; P = 0.072], anxiety (aOR 2.61; P = 0.044), hostility (aOR 3.76; P = 0.012) and with moderate to severe headache (aOR 5.55; P = 0.037), and dolutegravir Ctrough was associated with hostility (fourth versus first quartile aOR 6.70; P = 0.007) and psychoticism (fourth versus first quartile aOR 19.01; P = 0.008). Other NPs were not associated with SLC22A2 polymorphism or dolutegravir Ctrough. Conclusions: A variant of the OCT2-encoding gene, in addition to or in synergy with higher dolutegravir Ctrough, is associated with a set of NPs observed during dolutegravir therapy.

Published
2019

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

Author

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

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

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

Published
2017

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

Author

Postorino, M, Quiros-Roldan, E, Maggiolo, F, di Giambenedetto, S, Ladisa, N, Lapadula, G, Lorenzotti, S, Sighinolfi, L, Castelnuovo, F, di Pietro, M, Gotti, D, Mazzini, N, Torti, C, Castelli, F, Carosi, G, Nasta, P, Paraninfo, G, Foca, E, Fabbiani, M, Colafigli, M, Scalzini, A, El Hamad, I, Mazzotta, F, Locaputo, S, Marino, N, Pierotti, P, Ble, C, Vichi, F, Angarano, G, Monno, L, Maggi, P, Pan, A, Costarelli, S, Gori, A, Puoti, M, Viale, P, Colangeli, V, Borderi, M, Postorino M. C., Quiros-Roldan E., Maggiolo F., di Giambenedetto S., Ladisa N., Lapadula G., Lorenzotti S., Sighinolfi L., Castelnuovo F., di Pietro M., Gotti D., Mazzini N., Torti C., Castelli F., Carosi G., Nasta P., Paraninfo G., Foca E., Fabbiani M., Colafigli M., Scalzini A., El Hamad I., Mazzotta F., Locaputo S., Marino N., Pierotti P., Ble C., Vichi F., Angarano G., Monno L., Maggi P., Pan A., Costarelli S., Gori A., Puoti M., Viale P., Colangeli V., Borderi M., Postorino, M, Quiros-Roldan, E, Maggiolo, F, di Giambenedetto, S, Ladisa, N, Lapadula, G, Lorenzotti, S, Sighinolfi, L, Castelnuovo, F, di Pietro, M, Gotti, D, Mazzini, N, Torti, C, Castelli, F, Carosi, G, Nasta, P, Paraninfo, G, Foca, E, Fabbiani, M, Colafigli, M, Scalzini, A, El Hamad, I, Mazzotta, F, Locaputo, S, Marino, N, Pierotti, P, Ble, C, Vichi, F, Angarano, G, Monno, L, Maggi, P, Pan, A, Costarelli, S, Gori, A, Puoti, M, Viale, P, Colangeli, V, Borderi, M, Postorino M. C., Quiros-Roldan E., Maggiolo F., di Giambenedetto S., Ladisa N., Lapadula G., Lorenzotti S., Sighinolfi L., Castelnuovo F., di Pietro M., Gotti D., Mazzini N., Torti C., Castelli F., Carosi G., Nasta P., Paraninfo G., Foca E., Fabbiani M., Colafigli M., Scalzini A., El Hamad I., Mazzotta F., Locaputo S., Marino N., Pierotti P., Ble C., Vichi F., Angarano G., Monno L., Maggi P., Pan A., Costarelli S., Gori A., Puoti M., Viale P., Colangeli V., and Borderi M.

Abstract

Background and Objectives: Renal toxicity due to tenofovir (TDF) has been largely described in patients with HIV infection. However, other antiretroviral drugs (such as atazanavir [ATV], especially when boosted by ritonavir, ATV/r) could perpetuate some degrees of renal impairment with or without TDF co-administration. Also, possible benefits of stopping TDF in patients without renal diseases is not well known. This study aimed at exploring evolution of renal function and lipid profile after switching from tenofovir/emtricitabine (TDF/FTC) to abacavir/lamivudine (ABC/3TC), maintaining the ATV/r component of the regimen. Methods: Patients in the Italian MASTER Cohort, who switched from TDF/FTC plus ATV/r to ABC/3TC plus ATV/r were included, provided that major renal diseases were not diagnosed before switching (i.e., baseline). Serum creatinine, estimated glomerular filtration rate (eGFR), total cholesterol, HDL and triglycerides were evaluated at baseline and at month 18 after switching. Results: 126 patients were selected (80% males). Patients were mostly Italians (92%). 79% had undetectable HIV-RNA and 44% were coinfected by HBV and/or HCV. Median age at switch was 47 years (IQR 43-55). A small but significant decrease in serum creatinine [from 1.06 mg/dl (SD: 0.3) to 0.94 mg/dl (SD: 0.2); p<0.001] with an improvement in eGFR [from 86.8 ml/min (SD: 33) to 96.4 ml/min (SD: 37); p<0.001] were observed in per protocol analysis at month 18. Also ITT analysis showed a decrease in mean serum creatinine [from 1.08 mg/dl (SD: 0.35) to 0.95 mg/dl (SD: 0.24); p<0.001] with an improvement in mean eGFR [from 86.9 ml/min/1.73m2 (SD: 24.11) to 95.8 ml/min/1.73m2 (SD: 19.99); p<0.001]. Total cholesterol increased [from 188 mg/dl (SD: 42) to 206 mg/dl (SD: 44); p<0.001] but also HDL increased as well [from 46 mg/dl (SD: 14) to 54 mg/dl (SD: 19); p=0.015]. An increase in triglycerides concentration was observed [from 162 mg/dl (SD: 144) to 214 mg/dl (SD: 109); p=0.0

Published
2016

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

Author

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

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

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

Published
2015

28. Viro-immunological efficacy and tolerability of dolutegravir-based regimens compared to regimens based on other integrase strand inhibitors, protease inhibitors or non-nucleoside reverse transcriptase inhibitors in patients with acute HIV-1 infection: A multicenter retrospective cohort study

Author

Lagi, F., primary, Baldin, G., additional, Colafigli, M., additional, Capetti, A., additional, Madeddu, G., additional, Kiros, S. Tekle, additional, Di Giambenedetto, S., additional, and Sterrantino, G., additional

Published
2019
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29. SLC22A2 variants and dolutegravir levels correlate with psychiatric symptoms in persons with HIV

Author

Borghetti, A, primary, Calcagno, A, additional, Lombardi, F, additional, Cusato, J, additional, Belmonti, S, additional, D’Avolio, A, additional, Ciccarelli, N, additional, La Monica, S, additional, Colafigli, M, additional, Delle Donne, V, additional, De Marco, R, additional, Tamburrini, E, additional, Visconti, E, additional, Di Perri, G, additional, De Luca, A, additional, Bonora, S, additional, and Di Giambenedetto, S, additional

Published
2018
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30. Use of efavirenz or atazanavir/ritonavir is associated with better clinical outcomes of HAART compared to other protease inhibitors: Routine evidence from the Italian MASTER Cohort

Author

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

Abstract

Randomized trials and observational cohorts reported higher rates of virological suppression after highly active antiretroviral therapy (HAART) including efavirenz (EFV), compared with boosted protease inhibitors (PIs). Correlations with immunological and clinical outcomes are unclear. Patients of the Italian MASTER cohort who started HAART from 2000 to 2010 were selected. Outstanding outcome (composite outcome for success (COS)) was introduced. We evaluated predictors of COS (no AIDS plus CD4+ count >500/mm3 plus HIV-RNA <500 copies/mL) and of eight single outcomes either at month 6 or at year 3. Multivariable logistic regression was conducted. There were 6259 patients selected. Patients on EFV (43%) were younger, had greater CD4+ count, presented with AIDS less frequently, and more were Italians. At year 3, 90% of patients had HIV RNA <500 copies/mL, but only 41.4% were prescribed EFV, vs. 34.1% prescribed boosted PIs achieved COS (p <0.0001). At multivariable analysis, patients on lopinavir/ritonavir had an odds ratio of 0.70 for COS at year 3 (p <0.0001). Foreign origin and positive hepatitis C virus-Ab were independently associated with worse outcome (OR 0.54, p <0.0001 and OR 0.70, p 0.01, respectively). Patients on boosted PIs developed AIDS more frequently either at month 6 (13.8% vs. 7.6%, p <0.0001) or at year 3 (17.1% vs. 13.8%, p <0.0001). At year 3, deaths of patients starting EFV were 3%, vs. 5% on boosted PIs (p 0.008). In this study, naïve patients on EFV performed better than those on boosted PIs after adjustment for imbalances at baseline. Even when virological control is achieved, COS is relatively rare. Hepatitis C virus-positive patients and those of foreign origin are at risk of not obtaining COS.

Published
2015

31. Changes of lipid profile after switching to E/C/F/TAF: data from the Italian Compassionate Use Program

Author

Vergori, A., Fabbri, G., Lorenzini, P., Plazzi, M., Maffongelli, G., Cerva, C., Vitiello, P., Quirino, T., Rossotti, R., Danieli, E., Tau, P., Puoti, M., Lanza, P., Castelli, F., Trizzino, M., Cascio, A., Costenaro, P., Manfrin, V., Ferretto, R., Colafigli, M., Latini, A., Cristaudo, C., Gianserra, L., Pennica, A., Rossetti, B., Modica, S., De Luca, A., Nardini, G., Guaraldi, G., Mussini, C., Schiaroli, E., Baldelli, F., Lapadula, G., Pastore, V., Gori, A., La Monica, S., Cauda, R., Badia, L., Viale, P., Corsini, R., Magnani, G., Carleo, M. A., Pellicano', Giovanni Francesco, Nunnari, Giuseppe, Chirianni, A., Andreoni, M., and Medicina Tropicale, A. Antinori con il patrocinio della Società Italiana di Malattie Infettive e.

Published
2017

33. Compassionate use of tenofovir alafenamide, coformulated with elvitegravir, cobicistat, and emtricitabine, in HIV-infected patients with renal impairment: an Italian experience

Author

Maffongelli, G., Cerva, C., Stingone, C., Plazzi, M. M., Fabbri, G., Vergori, A., Vitiello, P., Quirino, T., Rossotti, R., Danieli, E., Tau, P., Puoti, M., Gazzola, L., D’Arminio, A., Lanza, P., Castelli, F., Trizzino, M., Cascio, A., Costenaro, P., Manfrin, V., Ferretto, R., Colafigli, M., Latini, A., Cristaudo, C., Valentinotti, R., Luzzati, R., Salpietro, S., Carini, E., Castagna, A., Lazzarin, A., Di Biagio, A., Gianserra, L., Pennica, A., Rossetti, B., Modica, S., De Luca, A., Vittozzi, P., Pavone, P., Dettorre, G., Palmiero, G., Borgia, G., Nardini, G., Guaraldi, G., Mussini, C., Schiaroli, E., Baldelli, F., Lapadula, G., Pastore, V., Gori, A., La Monica, S., Cauda, R., Badia, L., Viale, P., Marino, R., Sozio, F., Parruti, G., Corsini, R., Magnani, G., Carleo, M. A., Pellicano', Giovanni Francesco, Nunnari, Giuseppe, Marinello, S., Cattelan, A. M., Trentalange, A., Marinaro, L., Bonora, S., Ferrara, S., Santantonio, T., Chirianni, A., Antinori, A., Sarmati, L., and Andreoni, M.

Published
2017

34. Impact of transmitted HIV-1 drug resistance on the efficacy of first-line antiretroviral therapy with two nucleos(t)ide reverse transcriptase inhibitors plus an integrase inhibitor or a protease inhibitor

Author

Spertilli Raffaelli, C, primary, Rossetti, B, additional, Paglicci, L, additional, Colafigli, M, additional, Punzi, G, additional, Borghi, V, additional, Pecorari, M, additional, Santoro, M M, additional, Penco, G, additional, Antinori, A, additional, Zazzi, M, additional, De Luca, A, additional, and Zanelli, G, additional

Published
2018
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35. Survival in HIV-infected patients after a cancer diagnosis in the cART era: Results of an Italian multicenter study

Author

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

Abstract

Objectives: We studied survival and associated risk factors in an Italian nationwide cohort of HIV-infected individuals after an AIDS-defining cancer (ADC) or non-AIDS-defining cancer (NADC) diagnosis in the modern cART era. Methods: Multi-center, retrospective, observational study of HIV patients included in the MASTER Italian Cohort with a cancer diagnosis from January 1998 to September 2012. Malignancies were divided into ADC or NADC on the basis of the Centre for Disease Control-1993 classification. Recurrence of cancer and metastases were excluded. Survivals were estimated according to the Kaplan-Meier method and compared according to the log-rank test. Statistically significant variables at univariate analysis were entered in a multivariate Cox regression model. Results: Eight hundred and sixty-six cancer diagnoses were recorded among 13,388 subjects in the MASTER Database after 1998: 435 (51%) were ADCs and 431 (49%) were NADCs. Survival was more favorable after an ADC diagnosis than a NADC diagnosis (10-year survival: 62.7%±2.9% vs. 46%±4.2%; p = 0.017). Non-Hodgkin lymphoma had lower survival rates than patients with Kaposi sarcoma or cervical cancer (10-year survival: 48.2%±4.3% vs. 72.8%±4.0% vs. 78.5%±9.9%; p<0.001). Regarding NADCs, breast cancer showed better survival (10-year survival: 65.1%±14%) than lung cancer (1-year survival: 28%±8.7%), liver cancer (5-year survival: 31.9%±6.4%) or Hodgkin lymphoma (10-year survival: 24.8%±11.2%). Lower CD4+ count and intravenous drug use were significantly associated with decreased survival after ADCs or NADCs diagnosis. Exposure to cART was found to be associated with prolonged survival only in the case of ADCs. Conclusions: cART has improved survival in patients with an ADC diagnosis, whereas the prognosis after a diagnosis of NADCs is poor. Low CD4+ counts and intravenous drug use are risk factors for survival following a diagnosis of ADCs and Hodgkin lymphoma in the NADC group. © 2014 Gotti et al.

Published
2014

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

Author

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

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

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

Published
2012

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

Author

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

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

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

Published
2014

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

Author

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

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

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

Published
2012

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

Author

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

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

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

Published
2015

41. La riduzione della prevalenza di farmacoresistenza nei pazienti con esperienze terapeutiche: varie stime secondo le diverse metodologie impiegate in uno studio clinico di coorte

Author

DI GIAMBENEDETTO S, COLAFIGLI M, PINNETTI C, BRACCIALE L, SCHWARZ J, CAUDA R, DE LUCA A., PROSPERI, MATTIA, ANLAIDS, DI GIAMBENEDETTO, S, Colafigli, M, Pinnetti, C, Prosperi, Mattia, Bracciale, L, Schwarz, J, Cauda, R, and DE LUCA, A.

Abstract

The retrospective clinical, genomic and epidemiological data base of Catholic University of Sacro Cuore (UCSC - Institute of Infectious Disease) was mined to find significant associations (univariable, multivariable, survival analyses methods) between therapy change episode and related inputs with drug resistance reduction, also through time.

Published
2006

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

Author

Rossetti, B., Di Giambenedetto, S., Torti, C., Postorino, M. C., Punzi, G., Saladini, F., Gennari, W., Borghi, V., Monno, L., Pignataro, A. R., Polilli, E., Colafigli, M., Poggi, A., Tini, S., Zazzi, M., De Luca, A., and the Antiviral Response Cohort Analysis (ARCA) Collaborative Group

Subjects
HIV infection genetics, THERAPEUTIC use of protease inhibitors, ANTIRETROVIRAL agents, NON-nucleoside reverse transcriptase inhibitors, NUCLEOSIDE reverse transcriptase inhibitors, HIV infection epidemiology, HIV integrase inhibitors, CONFIDENCE intervals, DATABASES, DRUG resistance, HIV, HIV infections, MEDICAL information storage & retrieval systems, LONGITUDINAL method, GENETIC mutation, PROBABILITY theory, PUBLIC health surveillance, VIRAL load, ODDS ratio, THERAPEUTICS
Abstract

Objectives: The aim was to evaluate the evolution of transmitted HIV‐1 drug resistance (TDR) prevalence in antiretroviral therapy (ART)‐naïve patients from 2006 to 2016. Methods: HIV‐1 sequences were retrieved from the Antiviral Response Cohort Analysis (ARCA) database and TDR was defined as detection of at least one mutation from the World Health Organization (WHO) surveillance list. Results: We included protease/reverse transcriptase sequences from 3573 patients; 455 had also integrase sequences. Overall, 68.1% of the patients were Italian, the median CD4 count was 348 cells/μL [interquartile range (IQR) 169–521 cells/μL], and the median viral load was 4.7 log10 HIV‐1 RNA copies/mL (IQR 4.1–5.3 log10 copies/mL). TDR was detected in 10.3% of patients: 6% carried mutations to nucleos(t)ide reverse transcriptase inhibitors (NRTIs), 4.4% to nonnucleos(t)ide reverse transcriptase inhibitors (NNRTIs), 2.3% to protease inhibitors (PIs), 0.2% to integrase strand transfer inhibitors (INSTIs) and 2.1% to at least two drug classes. TDR declined from 14.5% in 2006 to 7.3% in 2016 (P = 0.003): TDR to NRTIs from 9.9 to 2.9% (P = 0.003) and TDR to NNRTIs from 5.1 to 3.7% (P = 0.028); PI TDR remained stable. The proportion carrying subtype B virus declined from 76.5 to 50% (P < 0.001). The prevalence of TDR was higher in subtype B vs. non‐B (12.6 vs. 4.9%, respectively; P < 0.001) and declined significantly in subtype B (from 17.1 to 8.8%; P = 0.04) but not in non‐B subtypes (from 6.1 to 5.8%; P = 0.44). Adjusting for country of origin, predictors of TDR were subtype B [adjusted odds ratio (AOR) for subtype B vs. non‐B 2.91; 95% confidence interval (CI) 1.93–4.39; P < 0.001], lower viral load (per log10 higher: AOR 0.86; 95% CI 0.75–0.99; P = 0.03), site in northern Italy (AOR for southern Italy/island vs. northern Italy, 0.61; 95% CI 0.40–0.91; P = 0.01), and earlier calendar year (per 1 year more recent: AOR 0.95; 95% CI 0.91–0.99; P = 0.02). Conclusions: The prevalence of HIV‐1 TDR has declined during the last 10 years in Italy. [ABSTRACT FROM AUTHOR]

Published
2018
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44. Impact of transmitted HIV-1 drug resistance on the efficacy of first-line antiretroviral therapy with two nucleos(t)ide reverse transcriptase inhibitors plus an integrase inhibitor or a protease inhibitor.

Author

Raffaelli, C Spertilli, Rossetti, B, Paglicci, L, Colafigli, M, Punzi, G, Borghi, V, Pecorari, M, Santoro, M M, Penco, G, Antinori, A, Spertilli Raffaelli, C, Zazzi, M, De Luca, A, and Zanelli, G

Subjects
DRUG resistance, ANTIRETROVIRAL agents, DRUG efficacy, HIV infections, GENOTYPES
Abstract

Objectives: To examine the impact of transmitted drug resistance (TDR) on response to first-line regimens with integrase strand transfer inhibitors (INSTIs) or boosted protease inhibitors (bPIs).Methods: From an Italian observational database (ARCA) we selected HIV-1-infected drug-naive patients starting two NRTIs and either an INSTI or a bPI, with an available pre-ART resistance genotype. The endpoint was virological failure (VF; plasma HIV-1 RNA >200 copies/mL after week 24). WHO surveillance drug resistance mutations and the Stanford algorithm were used to classify patients into three resistance categories: no TDR (A), TDR but fully-active ART prescribed (B), TDR and at least low-level resistance to one or more prescribed drug (C).Results: We included 1365 patients with a median follow-up of 96 weeks (IQR 54-110): 1205 (88.3%) starting bPI and 160 (11.7%) INSTI. Prevalence of TDR was 6.1%, 12.5%, 2.6% and 0% for NRTI, NNRTI, bPI and INSTI, respectively. Cumulative Kaplan-Meier estimates for VF at 48 weeks were 11% (95% CI 10.1%-11.9%) for the bPI group and 7.7% (95% CI 5.4%-10%) for the INSTI group. In the INSTI group, cumulative estimates for VF at 48 weeks were 6% (95% CI 4%-8%) in resistance category A, 5% (95% CI 1%-10%) in B and 50% (95% CI 30%-70%) in C (P < 0.001). Resistance category C [versus A, adjusted hazard ratio (aHR) 12.6, 95% CI 3.2-49.8, P < 0.001] and nadir CD4 (+100 cells/mm3, aHR 0.6, 95% CI 0.4-0.9, P = 0.03) predicted VF. In the bPI group, VF rates were not influenced by baseline resistance.Conclusions: Our data support the need for NRTI resistance genotyping in patients starting an INSTI-based first-line ART. [ABSTRACT FROM AUTHOR]

Published
2018
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45. Evolution of transmitted HIV-1 drug resistance in HIV-1-infected patients in Italy from 2000 to 2010

Author

Colafigli, M, Torti, C, Trecarichi, Em, Albini, L, Rosi, A, Micheli, V, Manca, N, Penco, G, Bruzzone, B, Punzi, G, Corsi, P, Parruti, G, Bagnarelli, P, Monno, L, Gonnelli, A, Cauda, R, Di Giambenedetto, S, Arca, Ucsc, CollaboratorsFabbiani M, Brescia HIV resistance study g. r. o. u. p. s., Sidella, L, Mondi, A, Farina, S, D'Avino, A, Fanti, I, Doino, M, Prosperi, M, Gargiulo, F, Benini, A, Paraninfo, G, Quiros Roldan, E, Castelnuovo, F, Carosi, G, Scalzini, A, Castelli, F, Giacometti, A, Butini, L, del Gobbo, R, Menzo, S, Tacconi, D, Corbelli, G, Zanussi, S, Maggiolo, F, Callegaro, A, Calza, L, Carla, M, Pristera, R, Turconi, P, Mandas, A, Tini, S, Carnevale, G, Paolini, E, Amadio, G, Sighinolfi, L, Zuccati, G, Morfini, M, Manetti, R, Galli, L, Di Pietro, M, Bartalesi, F, Colao, G, Tosti, A, Di Biagio, A, Setti, M, Trezzi, M, Orani, A, Pardelli, R, De Gennaro, M, Chiodera, A, Palvarini, L, Almi, P, Todaro, G, Gianotti, N, Cicconi, P, Rusconi, S, Gismondo, Mr, Biondi, Ml, Capetti, A, Meraviglia, P, Boeri, E, Pecorari, M, Santirocchi, M, Brustia, D, Ravanini, P, Dal Bello, F, Romano, N, Mancuso, S, Calzetti, C, Maserati, Sm, Filice, G, Baldanti, F, Francisci, D, Polilli, E, Sacchini, D, Martinelli, C, and Consolini, Rita

Published
2012

46. Performance of genotypic tropism testing on proviral DNAin clinical practice: results from the DIVA Study Group

Author

Svicher, V, Alteri, C, Montano, M, D'Arrigo, R, Andreoni, M, Angarano, G, Antinori, A, Antonelli, G, Allice, T, Bagnarelli, P, Baldanti, F, Bertoli, A, Borderi, M, Boeri, E, Bon, I, Bruzzone, B, Callegaro, Ap, Capobianchi, Mr, Carosi, G, Cauda, R, Ceccherini Silberstein, F, Clementi, M, Chirianni, A, Colafigli, M, D'Arminio Monforte, A, De Luca, A, Di Biagio, A, Di Nicuolo, G, Di Perri, G, Di Pietro, M, Di Santo, F, Fabeni, L, Fadda, G, Galli, M, Gennari, W, Ghisetti, V, Giacometti, A, Gori, C, Gori, A, Gulminetti, R, Leoncini, F, Maffongelli, G, Maggiolo, F, Manca, G, Gargiulo, F, Martinelli, C, Maserati, R, Mazzotta, F, Meini, G, Micheli, V, Monno, L, Mussini, C, Narciso, P, Nozza, S, Paolucci, S, Pal, G, Parisi, S, Parruti, G, Pignataro, Ar, Pollicita, M, Quirino, T, Re, Mc, Rizzardini, G, Santangelo, R, Scaggiante, R, Sterrantino, G, Turriziani, O, Vatteroni, Ml, Vecchi, L, Viscoli, Claudio, Vullo, V, Zazzi, M, Lazzarini, A, and Perno, Cf

Subjects
HIV, Proviral DNA, Tropism
Published
2012

47. Efficacy of Maraviroc (MVC) as intensification strategy in immunological non-responder (INR) HIV-1-infected patients treated with HAART

Author

Rusconi, S., Vitiello, P., Adorni, F., Ferramosca, S., Foca, E., Capetti, A., Meraviglia, P., Quirino, T., Bonora, S., D Annunzio, M., Antonio Di Biagio, Di Pietro, M., Butini, L., Orofino, G., Colafigli, M., Vullo, V., Francisci, D., Andreoni, M., Merlini, E., and Marchetti, G.

Subjects
drug efficacy, HAART, HIV
Abstract

Background: Under HAART, 7-39% of HIV-infected patients (pts) fail to exhibit a recovery in CD4 cells despite full suppression of viral replication. In MOTIVATE trials, MVC was superior to OBT in increasing CD4 cells in ARV-experienced pts. This study evaluated the clinical efficacy of MVC in terms of CD4 cells recovery, viral replication and tolerability in INR pts. Methods: Randomised, multicentre, proof of concept study enrolling 100 pts divided into 2 arms: A HAART+MVC, B HAART. Planned F-U is 1 year. Ultrasensitive HIV-RNA was quantified via Amplicor HIV-1 Monitor Kit v1.5, followed by RT-PCR for quantifying 1-50 cp/mL. Naive CDRA+62L+, memory CD45RA-, activated HLADR+ CD38+, proliferating Ki67+ were measured by flow cytometry. T-test was used for intra and inter-group comparisons. ANCOVA was used to adjust the baseline values. Results: 100 pts have been randomized (50 pts/arm). 59 pts reached week 12: 30 in arm A and 29 in arm B. 2 HIV-unrelated clinical events were registered in arm B and 2 in arm A (not known the correlation with MVC administration) as well as 9 drop-outs at baseline (withdrawal of the informed consent). No grade 3-4 lab toxicity were reported. At baseline, CD4/CD8 and immune-phenotype was comparable in arm A and B. At week 12, no significant changes in mean CD4 recovery were seen between pts in arm A and B (+41,2 vs -11,6/?l; p=.12). A statistically significant change was observed in mean CD8+ count between pts in arm A and B (+99,3 vs -126,1/?l, p=.025) At baseline and week 12 an immunological study performed by flow cytometry was carried out in 24 out of 61 pts (13 in arm A, 11 in arm B): at week 12, while B pts experienced a progressive contraction of naive CD4 (81 to 67%, p=.02) and CD8 (81 to 77%, p=.04) with a parallel rise in memory CD4 (16 to 30%, p=.02) and CD8 (13 to 17%, p=.06), no significant loss of naive CD4 (70 to 57%, p=.18) and CD8 (69 to 66%, p=.42) was displayed by A pts with a tendency to higher gain in memory CD4 (24 to 40%, p=.06) and CD8 (11 to 25%, p=.008). By week 12, a similar reduction in activated HLA-DR+CD38+ CD8 and CD4 was shown in B (p=.05) and A pts (p=.03 and p=.02 for CD8 and CD4). No changes were shown in proliferating Ki67+CD4 in A (p=.42) and B pts (p=.47), while a tendency to Ki67+CD8 reduction was shown in A (p=.06) and not in B pts (p=.45). HIV-RNA quantification evidenced a trend to higher median values (BL vs week 12) in B pts: 2 vs 5 cp/mL (p=.37). No changes occurred in arm A. Conclusions: we can consider the use of MVC as intensification strategy that seems to impact T-cell peripheral immune-phenotype after examining the significant change in CD8* cells count and the evidence of not significant CD4 gain in arm A.Our findings of reduced loss of naive T-cells with a parallel robust rise in the memory pool suggest a role of MVC in reducing peripheral antigen-driven T-cell death, possibly preserving new T-cell production. However, further data are needed to confirm our results.

Published
2010

49. Survival in HIV-infected patients after a cancer diagnosis in the cART era: Results of an Italian multicenter study

Author

Gotti, D., Raffetti, E., Albini, L., Sighinolfi, L., Maggiolo, F., Di Filippo, E., Ladisa, N., Angarano, G., Lapadula, G., Pan, A., Esposti, A. D., Fabbiani, M., Foca, E., Scalzini, A., Donato, Federica, Quiros-Roldan, E., Castelli, F., Torti, Carlo, Casari, S., Nasta, P., Castelnuovo, F., El Hamad, I., Saracino, A. L., Monno, L., Cauda, Roberto, Di Giambenedetto, Simona, Colafigli, Manuela, Mazzotta, F., Lo Caputo, S., Pierotti, P., Di Pietro, Maria Luisa, Ble, C., Carnevale, G., Gori, A., Costarelli, S., Donato F., Torti C., Cauda R. (ORCID:0000-0002-1498-4229), Di Giambenedetto S. (ORCID:0000-0001-6990-5076), Colafigli M., Di Pietro M. (ORCID:0000-0002-3893-8788), Gotti, D., Raffetti, E., Albini, L., Sighinolfi, L., Maggiolo, F., Di Filippo, E., Ladisa, N., Angarano, G., Lapadula, G., Pan, A., Esposti, A. D., Fabbiani, M., Foca, E., Scalzini, A., Donato, Federica, Quiros-Roldan, E., Castelli, F., Torti, Carlo, Casari, S., Nasta, P., Castelnuovo, F., El Hamad, I., Saracino, A. L., Monno, L., Cauda, Roberto, Di Giambenedetto, Simona, Colafigli, Manuela, Mazzotta, F., Lo Caputo, S., Pierotti, P., Di Pietro, Maria Luisa, Ble, C., Carnevale, G., Gori, A., Costarelli, S., Donato F., Torti C., Cauda R. (ORCID:0000-0002-1498-4229), Di Giambenedetto S. (ORCID:0000-0001-6990-5076), Colafigli M., and Di Pietro M. (ORCID:0000-0002-3893-8788)

Abstract

Objectives: We studied survival and associated risk factors in an Italian nationwide cohort of HIV-infected individuals after an AIDS-defining cancer (ADC) or non-AIDS-defining cancer (NADC) diagnosis in the modern cART era. Methods: Multi-center, retrospective, observational study of HIV patients included in the MASTER Italian Cohort with a cancer diagnosis from January 1998 to September 2012. Malignancies were divided into ADC or NADC on the basis of the Centre for Disease Control-1993 classification. Recurrence of cancer and metastases were excluded. Survivals were estimated according to the Kaplan-Meier method and compared according to the log-rank test. Statistically significant variables at univariate analysis were entered in a multivariate Cox regression model. Results: Eight hundred and sixty-six cancer diagnoses were recorded among 13,388 subjects in the MASTER Database after 1998: 435 (51%) were ADCs and 431 (49%) were NADCs. Survival was more favorable after an ADC diagnosis than a NADC diagnosis (10-year survival: 62.7%±2.9% vs. 46%±4.2%; p = 0.017). Non-Hodgkin lymphoma had lower survival rates than patients with Kaposi sarcoma or cervical cancer (10-year survival: 48.2%±4.3% vs. 72.8%±4.0% vs. 78.5%±9.9%; p<0.001). Regarding NADCs, breast cancer showed better survival (10-year survival: 65.1%±14%) than lung cancer (1-year survival: 28%±8.7%), liver cancer (5-year survival: 31.9%±6.4%) or Hodgkin lymphoma (10-year survival: 24.8%±11.2%). Lower CD4+ count and intravenous drug use were significantly associated with decreased survival after ADCs or NADCs diagnosis. Exposure to cART was found to be associated with prolonged survival only in the case of ADCs. Conclusions: cART has improved survival in patients with an ADC diagnosis, whereas the prognosis after a diagnosis of NADCs is poor. Low CD4+ counts and intravenous drug use are risk factors for survival following a diagnosis of ADCs and Hodgkin lymphoma in the NADC group. © 2014 Gotti et al.

Published
2014

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

Author

De Luca, A, de Gaetano Donati, K, Colafigli, M, Cozzi Lepri, A, De Curtis, A, Gori, A, Sighinolfi, L, Giacometti, A, Capobianchi, M, D'Avino, A, Iacoviello, L, Cauda, R, D'Arminio Monforte, A, D'Arminio Monforte, A., GORI, ANDREA, De Luca, A, de Gaetano Donati, K, Colafigli, M, Cozzi Lepri, A, De Curtis, A, Gori, A, Sighinolfi, L, Giacometti, A, Capobianchi, M, D'Avino, A, Iacoviello, L, Cauda, R, D'Arminio Monforte, A, D'Arminio Monforte, A., and GORI, ANDREA

Abstract

Background: Elevated high-sensitivity C-reactive protein (hsCRP) increases the risk of cardiovascular disease (CVD) in the general population, but its role as a predictive marker in HIV-positive patients remains unclear. Aim of the study was to evaluate whether hsCRP or other biomarkers are independent predictors of CVD risk in HIV-infected patients.Methods: Retrospective, nested case-control study. HIV-positive men and women (35-69 years of age) receiving combination antiretroviral therapy (cART) were included. Cases (n = 35) had a major CVD event. Controls (n = 74) free from CVD events for at least 5 years from starting ART were matched on diabetes and smoking. HsCRP, D-dimer, P-selectin, interleukin-6 (IL-6), tissue plasminogen activator, plasminogen activator inhibitor-1 levels were measured.Results: High hsCRP was associated with CVD risk, independently of traditional cardiovascular risk factors, HIV replication and the type of ART received at the time of sampling (adjusted odds ratio 8.00 [1.23-51.94] comparing >3.3 mg/L with <0.9 mg/L; P = 0.03). Higher IL-6 and P-selectin levels were also independently associated with increased CVD risk, although the association was weaker than for hsCRP. Higher total cholesterol and lower HDL cholesterol increased CVD risk, independent of hsCRP.Conclusion: hsCRP may be a useful additional biomarker to predict CVD risk in HIV-infected patients receiving cART. © 2013 De Luca et al.; licensee BioMed Central Ltd.

Published
2013

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