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1. Cost of surgical intervention for reconstructive therapy of HIV-associated facial lipoatrophy

Author

Massella M, Ivanovic J, Bellagamba R, De Vita R, Fracasso L, Tozzi V, Fragola V, Rizzica M, and Narciso P

Subjects
Medicine (General), R5-920
Abstract

M Massella¹, J Ivanovic², R Bellagamba², R De Vita³, L Fracasso³, V Tozzi², V Fragola¹, M Rizzica², P Narciso²¹Istituto Superiore Sanità, Rome, Italy; ²National Institute for Infectious Disease – Lazzaro Spallanzani, Rome, Italy; ³Regina Elena National Cancer Institute of Rome, ItalyAbstract: This study aims to assess direct cost of reconstructive interventions with facial fillers for treatment of HIV (human immunodeficiency virus)-associated facial lipoatrophy (FLA). Evaluation was performed on data from patients enrolled in one arm of a comparative study of immediate versus delayed reconstructive treatment of facial lipoatrophy. Median costs were standardized for efficacy, estimated using data reported by physicians and patient reported outcomes. The variations of the results were evaluated with a sensitivity analysis. Evaluation was performed on 66 patients characterized by significant differences in terms of severity of FLA. Total cost resulted of €140,416.15, with a median cost per patient of €2126.04 (interquartile range [IQR]: 1599–2822). Taking into consideration severity of disease, median costs were €1641.67 (IQR: 1326.67–2126.04) and 2557.12 (IQR: 1939.34–2872.04) (P = 0.0) respectively for patients with low and high severity scores at baseline. Significant differences in term of cost-effectiveness ratios were also found between patients with different severity of FLA, and sensitivity analysis showed that these ratios increase with higher severity scores at baseline and vary widely depending on the costs of filler. Although these results cannot be considered representative because of important limitations, the present study suggests the severity of disease as an important determinant of costs.Keywords: dermal fillers, antiretroviral therapy, lipodystrophic syndrome, HAART

Published
2011

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

Author

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

Published
2024

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

Author

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

Abstract

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

Published
2024

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

Author

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

Abstract

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

Published
2023

7. Prophylactic heparin and risk of orotracheal intubation or death in patients with mild or moderate COVID-19 pneumonia

Author

Vergori, A., Lorenzini, P., Cozzi-Lepri, A., Donno, D. R., Gualano, G., Nicastri, E., Iacomi, F., Marchioni, L., Campioni, P., Schinina, V., Cicalini, S., Agrati, C., Capobianchi, M. R., Girardi, E., Ippolito, G., Vaia, F., Petrosillo, N., Antinori, A., Taglietti, F., The ReCOVeRI Study Group: Abbonizio, M. A., Abdeddaim, A., Agostini, E., Albarello, F., Amadei, G., Amendola, A., Antonica, M. A., Antonini, M., Bartoli, T. A., Baldini, F., Barbaro, R., Bartolini, B., Bellagamba, R., Benigni, M., Bevilacqua, N., Biava, G., Bibas, M., Bordi, L., Bordoni, V., Boumis, E., Branca, M., Buonomo, R., Busso, D., Camici, M., Canichella, F., Capone, A., Caporale, C., Caraffa, E., Caravella, I., Carletti, F., Castilletti, C., Cataldo, A., Cerilli, S., Cerva, C., Chiappini, R., Chinello, P., Cianfarani, M. A., Ciaralli, C., Cimaglia, C., Cinicola, N., Ciotti, V., Colavita, F., Corpolongo, A., Cristofaro, M., Curiale, S., D'Abramo, A., Dantimi, C., De Angelis, A., De Angelis, G., De Palo, M. G., De Zottis, F., Di Bari, V., Di Lorenzo, R., Di Stefano, F., D'Offizi, G., Evangelista, F., Faraglia, F., Farina, A., Ferraro, F., Fiorentini, L., Frustaci, A., Fusetti, M., Fusto, M., Galati, V., Gagliardini, R., Galli, P., Garotto, G., Gaviano, I., Tekle, S. G., Giancola, M. L., Giansante, F., Giombini, E., Granata, G., Greci, M. C., Grilli, E., Grisetti, S., Iaconi, M., Iannicelli, G., Inversi, C., Lalle, E., Lamanna, M. E., Lanini, S., Lapa, D., Lepore, L., Libertone, R., Lionetti, R., Liuzzi, G., Loiacono, L., Lucia, A., Lufrani, F., Macchione, M., Maffongelli, G., Marani, A., Mariano, A., Marini, M. C., Maritti, M., Mastrobattista, A., Mastrorosa, I., Matusali, G., Mazzotta, V., Mencarini, P., Meschi, S., Messina, F., Micarelli, S., Mogavero, G., Mondi, A., Montalbano, M., Montaldo, C., Mosti, S., Murachelli, S., Musso, M., Nardi, M., Navarra, A., Nocioni, M., Noto, P., Noto, R., Oliva, A., Onnis, I., Ottou, S., Palazzolo, C., Pallini, E., Palmieri, F., Palombi, G., Pareo, C., Passeri, V., Pelliccioni, F., Penna, G., Petrecchia, A., Petrone, A., Pianura, E., Pinnetti, C., Pisciotta, M., Piselli, P., Pittalis, S., Pontarelli, A., Proietti, C., Puro, V., Ramazzini, P. M., Rianda, A., Rinonapoli, G., Rosati, S., Rubino, D., Rueca, M., Ruggeri, A., Sacchi, A., Sampaolesi, A., Sanasi, F., Santagata, C., Scarabello, A., Scarcia, S., Scognamiglio, P., Scorzolini, L., Stazi, G., Strano, G., Taibi, C., Taloni, G., Nardi, T., Tonnarini, R., Topino, S., Tozzi, M., Vairo, F., Valli, M. B., Vincenzi, L., Visco-Comandini, U., Vita, S., Vittozzi, P., Zaccarelli, M., Zanetti, A., Zito, S., Vergori, A., Lorenzini, P., Cozzi-Lepri, A., Donno, D. R., Gualano, G., Nicastri, E., Iacomi, F., Marchioni, L., Campioni, P., Schinina, V., Cicalini, S., Agrati, C., Capobianchi, M. R., Girardi, E., Ippolito, G., Vaia, F., Petrosillo, N., Antinori, A., Taglietti, F., Abbonizio, M. A., Abdeddaim, A., Agostini, E., Albarello, F., Amadei, G., Amendola, A., Antonica, M. A., Antonini, M., Bartoli, T. A., Baldini, F., Barbaro, R., Bartolini, B., Bellagamba, R., Benigni, M., Bevilacqua, N., Biava, G., Bibas, M., Bordi, L., Bordoni, V., Boumis, E., Branca, M., Buonomo, R., Busso, D., Camici, M., Canichella, F., Capone, A., Caporale, C., Caraffa, E., Caravella, I., Carletti, F., Castilletti, C., Cataldo, A., Cerilli, S., Cerva, C., Chiappini, R., Chinello, P., Cianfarani, M. A., Ciaralli, C., Cimaglia, C., Cinicola, N., Ciotti, V., Colavita, F., Corpolongo, A., Cristofaro, M., Curiale, S., D'Abramo, A., Dantimi, C., De Angelis, A., De Angelis, G., De Palo, M. G., De Zottis, F., Di Bari, V., Di Lorenzo, R., Di Stefano, F., D'Offizi, G., Evangelista, F., Faraglia, F., Farina, A., Ferraro, F., Fiorentini, L., Frustaci, A., Fusetti, M., Fusto, M., Galati, V., Gagliardini, R., Galli, P., Garotto, G., Gaviano, I., Tekle, S. G., Giancola, M. L., Giansante, F., Giombini, E., Granata, G., Greci, M. C., Grilli, E., Grisetti, S., Iaconi, M., Iannicelli, G., Inversi, C., Lalle, E., Lamanna, M. E., Lanini, S., Lapa, D., Lepore, L., Libertone, R., Lionetti, R., Liuzzi, G., Loiacono, L., Lucia, A., Lufrani, F., Macchione, M., Maffongelli, G., Marani, A., Mariano, A., Marini, M. C., Maritti, M., Mastrobattista, A., Mastrorosa, I., Matusali, G., Mazzotta, V., Mencarini, P., Meschi, S., Messina, F., Micarelli, S., Mogavero, G., Mondi, A., Montalbano, M., Montaldo, C., Mosti, S., Murachelli, S., Musso, M., Nardi, M., Navarra, A., Nocioni, M., Noto, P., Noto, R., Oliva, A., Onnis, I., Ottou, S., Palazzolo, C., Pallini, E., Palmieri, F., Palombi, G., Pareo, C., Passeri, V., Pelliccioni, F., Penna, G., Petrecchia, A., Petrone, A., Pianura, E., Pinnetti, C., Pisciotta, M., Piselli, P., Pittalis, S., Pontarelli, A., Proietti, C., Puro, V., Ramazzini, P. M., Rianda, A., Rinonapoli, G., Rosati, S., Rubino, D., Rueca, M., Ruggeri, A., Sacchi, A., Sampaolesi, A., Sanasi, F., Santagata, C., Scarabello, A., Scarcia, S., Scognamiglio, P., Scorzolini, L., Stazi, G., Strano, G., Taibi, C., Taloni, G., Nardi, T., Tonnarini, R., Topino, S., Tozzi, M., Vairo, F., Valli, M. B., Vincenzi, L., Visco-Comandini, U., Vita, S., Vittozzi, P., Zaccarelli, M., Zanetti, A., and Zito, S.

Subjects
Male, medicine.medical_treatment, Rome, Kaplan-Meier Estimate, 030204 cardiovascular system & hematology, Severity of Illness Index, 0302 clinical medicine, Retrospective Studie, Coagulopathy, Clinical endpoint, Intubation, Respiratory function, 030212 general & internal medicine, Multidisciplinary, Middle Aged, Medicine, Female, Human, medicine.medical_specialty, Patients, medicine.drug_class, Science, Low molecular weight heparin, Risk Assessment, Article, NO, 03 medical and health sciences, Internal medicine, Severity of illness, medicine, Intubation, Intratracheal, Humans, Retrospective Studies, Aged, business.industry, SARS-CoV-2, COVID-19, Thrombocytopenia, Retrospective cohort study, Heparin, Low-Molecular-Weight, medicine.disease, Respiration, Artificial, COVID-19 Drug Treatment, respiratory tract diseases, Pneumonia, Viral infection, business
Abstract

Prophylactic low molecular weight heparin (pLMWH) is currently recommended in COVID-19 to reduce the risk of coagulopathy. The aim of this study was to evaluate whether the antinflammatory effects of pLMWH could translate in lower rate of clinical progression in patients with COVID-19 pneumonia. Patients admitted to a COVID-hospital in Rome with SARS-CoV-2 infection and mild/moderate pneumonia were retrospectively evaluated. The primary endpoint was the time from hospital admission to orotracheal intubation/death (OTI/death). A total of 449 patients were included: 39% female, median age 63 (IQR, 50–77) years. The estimated probability of OTI/death for patients receiving pLMWH was: 9.5% (95% CI 3.2–26.4) by day 20 in those not receiving pLMWH vs. 10.4% (6.7–15.9) in those exposed to pLMWH; p-value = 0.144. This risk associated with the use of pLMWH appeared to vary by PaO2/FiO2 ratio: aHR 1.40 (95% CI 0.51–3.79) for patients with an admission PaO2/FiO2 ≤ 300 mmHg and 0.27 (0.03–2.18) for those with PaO2/FiO2 > 300 mmHg; p-value at interaction test 0.16. pLMWH does not seem to reduce the risk of OTI/death mild/moderate COVID-19 pneumonia, especially when respiratory function had already significantly deteriorated. Data from clinical trials comparing the effect of prophylactic vs. therapeutic dosage of LMWH at various stages of COVID-19 disease are needed.

Published
2021

8. Very high pre-therapy viral load is a predictor of virological rebound in HIV-1-infected patients starting a modern first-line regimen

Author

Armenia, D, Carlo, D, Cozzi-Lepri, A, Calcagno, A, Borghi, V, Gori, C, Bertoli, A, Gennari, W, Bellagamba, R, Castagna, A, Latini, A, Pinnetti, C, Cicalini, S, Saracino, A, Lapadula, G, Rusconi, S, Castelli, F, Giambenedetto, S, Andreoni, M, Perri, G, Antinori, A, Mussini, C, Ceccherini-Silberstein, F, D'Arminio Monforte, A, Perno, C, Santoro, M, Armenia D., Carlo D. D., Cozzi-Lepri A., Calcagno A., Borghi V., Gori C., Bertoli A., Gennari W., Bellagamba R., Castagna A., Latini A., Pinnetti C., Cicalini S., Saracino A., Lapadula G., Rusconi S., Castelli F., Giambenedetto S. D., Andreoni M., Perri G. D., Antinori A., Mussini C., Ceccherini-Silberstein F., D'Arminio Monforte A., Perno C. F., Santoro M. M., Armenia, D, Carlo, D, Cozzi-Lepri, A, Calcagno, A, Borghi, V, Gori, C, Bertoli, A, Gennari, W, Bellagamba, R, Castagna, A, Latini, A, Pinnetti, C, Cicalini, S, Saracino, A, Lapadula, G, Rusconi, S, Castelli, F, Giambenedetto, S, Andreoni, M, Perri, G, Antinori, A, Mussini, C, Ceccherini-Silberstein, F, D'Arminio Monforte, A, Perno, C, Santoro, M, Armenia D., Carlo D. D., Cozzi-Lepri A., Calcagno A., Borghi V., Gori C., Bertoli A., Gennari W., Bellagamba R., Castagna A., Latini A., Pinnetti C., Cicalini S., Saracino A., Lapadula G., Rusconi S., Castelli F., Giambenedetto S. D., Andreoni M., Perri G. D., Antinori A., Mussini C., Ceccherini-Silberstein F., D'Arminio Monforte A., Perno C. F., and Santoro M. M.

Abstract

Background: Pre-cART (combined antiretroviral therapy) plasma viral load >500,000 copies/ml has been associated with a lower probability of achieving virological suppression, while few data about its role on maintenance of virological suppression are available. In this study we aimed to clarify whether high levels of pre-cART viraemia are associated with virological rebound (VR) after virological suppression. Methods: HIV-infected individuals who achieved virological suppression after first-line cART were included. VR was defined as the first of two consecutive viraemia >50 copies/ml (VR50) or, in an alternative analysis, >200 copies/ml (VR200). The impact of pre-cART viraemia on the risk of VR was evaluated by survival analyses. Results: Among 5,766 patients included, 59.2%, 31.4%, 5.2% and 4.2% had pre-cART viraemia ≤100,000, 100,001–500,000, 500,001–1,000,000 and >1,000,000 copies/ml, respectively. Patients with pre-cART viraemia levels >1,000,000 copies/ml had the highest probability of VR (>1,000,000; 500,000–1,000,000; 100,000–500,000; <100,000 copies/ml; VR50: 28.4%; 24.3%; 17.6%; 13.8%, P<0.0001; VR200: 14.4%; 11.1%; 7.2%; 7.6%; P=0.009). By Cox multivariable analyses, patients with pre-cART viraemia >500,000 and >1,000,000 copies/ml showed a significantly higher risk of VR regardless of the VR end point used. No difference in the risk of VR was found between patients with pre-cART viraemia ranging 500,000–1,000,000 copies/ml and those with pre-cART viraemia >1,000,000 copies/ml, regardless of the VR end point used. Conclusions: Pre-cART plasma viral load levels >500,000 copies/ml can identify fragile patients with poorer chance of maintaining virological control after an initial response. An effort in defining effective treatment strategies is mandatory for these patients that remain difficult to treat.

Published
2019

9. 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

10. Impact of new DAA therapy on real clinical practice: a multicenter region-wide cohort study

Author

Lanini, Simone, Scognamiglio, Paola, Mecozzi, Alessandra, Lombardozzi, Lorella, Vullo, Vincenzo, Angelico, Mario, Gasbarrini, Antonio, Taliani, Gloria, Attili, Adolfo Francesco, Perno, Carlo Federico, De Santis, Adriano, Puro, Vincenzo, Cerqua, Fabio, D'Offizi, Gianpiero, Pellicelli, Adriano, Armignacco, Orlando, Mennini, Francesco Saverio, Siciliano, Massimo, Girardi, Enrico, Panella, Vincenzo, Ippolito, Giuseppe, Sarrecchia, C., Di Paolo, M. D., Francioso, S., Brega, A., Lenci, I., Sarmati, L., Pompili, Maurizio, Grieco, Antonio, Tamburrini, Enrica, Apaccini, R., Miele, Luca, D'Ettorre, G., Mezzaroma, I., Furlan, C., Accapezzato, D., Paoletti, F., Merili, M., Corradini, S., Sereno, S., Fimiani, C., Mastropietro, C., Labbadia, G., Gentile, Giuseppe, Pasquazzi, C., Marignani, M., Guarisco, R., Puoti, C., Spilabotti, L., Montalbano, M., Boumis, E., Visco-Comandini, U., Zaccarelli, M., Ammassari, A., Lionetti, R., Murachelli, S., Loiacono, L., Antinori, Armando, Noto, P., Palmieri, F., Cicalini, S., Cerilli, S., Sampaolesi, A., Vincenzi, L., Bellagamba, R., Galati, V., Abdeddaim, A., Iacomi, F., Iannicelli, G., Mastroianni, Chiara, Lichtner, M., Ridola, L., Coluzzi, T., Mercurio, V., Del Borgo, C., Fondacaro, L., Cerasari, G., Guarascio, P., D'Ambrosio, C., Starnini, G., Caterini, A., Villani, Emanuele Rocco, Sarracino, L., Casinelli, K., Moretti, A., Vespasiani, U., Galati, G., Cecere, R., Bonaventura, M., and Scudieri, M.

Subjects
Male, Cirrhosis, Investigational, chronic hepatitis c, clinical study, direct acting antiviral, hepatitis c virus, liver cirrhosis, liver damage, mixed effect model, multicenter cohort study, new therapy, treatment efficacy, Logistic regression, Chronic hepatitis C, Cohort Studies, 0302 clinical medicine, Clinical study, Direct acting antiviral, Hepatitis C virus, Liver cirrhosis, Liver damage, Mixed effect model, Multicenter cohort study, New therapy, Treatment efficacy, Adult, Aged, Aged, 80 and over, Antiviral Agents, Drug Therapy, Combination, Drugs, Investigational, Female, Follow-Up Studies, Hepatitis C, Chronic, Humans, Liver Cirrhosis, Middle Aged, Therapies, Investigational, 80 and over, 030212 general & internal medicine, Stage (cooking), Chronic, Confounding, Drugs, Hepatitis C, Infectious Diseases, Cohort, Combination, Settore SECS-P/03 - Scienza delle Finanze, 030211 gastroenterology & hepatology, Cohort study, Research Article, medicine.medical_specialty, Side effect, Hepatitis C virus, Chronic hepatitis C, Liver cirrhosis, Direct acting antiviral, Multicenter cohort study, Mixed effect model, Liver damage, Treatment efficacy, Clinical study, New therapy, lcsh:Infectious and parasitic diseases, 03 medical and health sciences, Drug Therapy, Internal medicine, medicine, lcsh:RC109-216, business.industry, Settore MED/09 - MEDICINA INTERNA, medicine.disease, Clinical trial, Therapies, business
Abstract

Background Management of chronic hepatitis C (CHC) has significantly accelerated in the last few years. Currently, second generation direct acting antivirals (DAAs) promise clearance of infection in most of patients. Here we present the results of the first analysis carried out on data of Lazio clinical network for DAAs. Methods The study was designed as a multicenter cohort: a) to assess the evolution of treatment during the first 24 months of the activity of the Clinical Network; b) to report overall efficacy of treatments; c) to analyze potential factors associated with lack of virological response at 12 weeks after therapy (SVR12); d) to evaluate the variation of ALT at baseline and 12 weeks after therapy in those who achieved SVR12 in comparison to those who did not. Analyses of efficacy were carried out with multilevel mixed effect logistic regression model. ALT temporal variation was assessed by mixed effect model mixed models with random intercept at patient’s level and random slope at the level of the time; i.e. either before or after therapy. Results Between 30 December 2014 and 31 December 2016 5279 patients started a DAA treatment; of those, 5127 (in 14 clinical centers) had completed the 12-week follow-up. Overall proportion of SVR12 was 93.41% (N = 4780) with no heterogeneity between the 14 clinical centers. Interruption as the consequence of severe side effect was very low (only 23 patients). Unadjusted analysis indicates that proportion of SVR12 significantly changes according to patient’s baseline characteristics, however after adjusting for potential confounders only adherence to current guidelines, stage of liver diseases, gender, transplant and HIV status were independently associated with the response to therapy. Analysis of ALT temporal variation showed that ALT level normalized in most, but not, all patients who achieved SVR12. Conclusion Our study confirmed the extraordinary efficacy of DAAs outside clinical trials. The advantage of DAAs was particularly significant for those patients who were previously considered as difficult-to-treat and did not have treatment options before DAAs era. Intervention based on network of select centers and prioritization of patients according to diseases severity was successful. Further studies are needed to establish whether clearance of HCV after DAAs therapy can arrest or even revert liver fibrosis in non-cirrhotic patients and/or improve life quality and expectancy in those who achieve SVR12 with cirrhosis.

Published
2018

11. 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

12. 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

13. Biomarkers of monitoring and functional reserve of physiological systems over time in HIV: expert opinions for effective secondary prevention

Author

Andreoni, M., Mussi, C., Bellagamba, R., Di Campli, F., vincenzo montinaro, and Babiloni, C.

Subjects
functional reserve, Aging, biomarkers of monitoring, HIV, secondary prevention, Settore MED/17 - Malattie Infettive, Biomarkers, Functional reserve, HIV monitoring, HIV Infections, Biomarkers of monitoring, Kidney, Anti-Retroviral Agents, Bone Density, Risk Factors, Secondary Prevention, Humans, Kidney Diseases, Cognition Disorders
Abstract

HIV-positive individuals are more vulnerable to poor health than HIV-negative individuals. This vulnerability is characterized by a higher risk of several common, age-related health problems, even after adjustment for established risk factors. This expert opinion report aims at identifying the optimal biomarkers for monitoring the structural integrity and function of physiological systems at risk across aging in HIV-seropositive subjects. These biomarkers, readily available locally and relatively cost-effective for clinicians in primary and secondary care, should allow early detection of the first preclinical structural and functional changes in renal, brain, cardiovascular, and skeleton systems or apparatus in HIV subjects across aging. A particular interest of this report is the definition of the concept of biomarker of the "organ functional reserve". This definition emphasizes the fact that some biomarkers for monitoring the molecular, structural and functional integrity of a given organ reflect a level of impairment that is basically irremediable despite effective pharmacological or nonpharmacological intervention.

Published
2018

14. Response to raltegravir-based salvage therapy in HIV-infected patients with hepatitis C virus or hepatitis B virus coinfection

Author

Weimer, L. E., Fragola, V., Floridia, M., Guaraldi, G., Ladisa, N., Francisci, D., Bellagamba, R., Degli Antoni, A., Parruti, G., Giacometti, A., Manconi, P. E., Vivarelli, A., D'Ettorre, G., Mura, M. S., Cicalini, S., Preziosi, R., Sighinolfi, L., Verucchi, G., Libertone, R., Tavio, M., Sarmati, L., Bucciardini, R., Angarano, G., Volpe, A., Vullo, V., Ceccarelli, G., Andreoni, M., Delle Rose, D., Tozzi, V., Narciso, P., Petrosillo, N., Pucillo, V., Tommasi, C., Segala, D., Armignacco, O., Ferrari, C., Cavalli, A., Sozio, F., Cosentino, L., Ortu, F., Viale, P., Tedeschi, S., Manfredi, R., Mannazzu, M., Cattari, G., Del Gobbo, R., Mataloni Paggi, A., Cirioni, O., Marchionni, E., Silvestri, C., Brescini, L., Sebastianelli, S., Baldelli, F., Mercuri, A., Bastianelli, S., Nardini, G., Massella, M., Baroncelli, S., Galluzzo, C. M., Pirillo, M. F., Mancini, M. G., Amici, R., Cara, A., Bona, R., Leone, P., Filati, P., Franco, M., Donnini, S., Weimer LE, Fragola V, Floridia M, Guaraldi G, Ladisa N, Francisci D, Bellagamba R, Degli Antoni A, Parruti G, Giacometti A, Manconi PE, Vivarelli A, D'Ettorre G, Mura MS, Cicalini S, Preziosi R, Sighinolfi L, Verucchi G, Libertone R, Tavio M, Sarmati L, and Bucciardini R on behalf of the ISS-NIA Study Group

Subjects
Male, HAART, maraviroc, viruses, HIV Infections, darunavir, hiv-1, Hepacivirus, medicine.disease_cause, Cohort Studies, hiv resistance, Pharmacology (medical), cd4 response, Original Research, Aged, 80 and over, Coinfection, virus diseases, Hepatitis C, Middle Aged, Hepatitis B, viral load, Treatment Outcome, integrase inhibitors, Infectious Diseases, hbv, Female, liver disease, Viral hepatitis, Viral load, medicine.drug, Adult, Microbiology (medical), Hepatitis B virus, Hepatitis C virus, HIV infection, HCV infection, HBV infection, antiretroviral therapy, viral hepatitis, etravirine, hcv, NO, Young Adult, Antiretroviral therapy, CD4 response, Darunavir, Etravirine, HBV, HCV, HIV resistance, HIV-1, Integrase inhibitors, Liver disease, Maraviroc, medicine, Humans, Aged, Salvage Therapy, Pharmacology, business.industry, Raltegravir, HIV, medicine.disease, Virology, digestive system diseases, Immunology, business, Follow-Up Studies
Abstract

OBJECTIVES: To define the impact of coinfection with hepatitis B virus (HBV) or hepatitis C virus (HCV) on viroimmunological response to raltegravir-based salvage regimens that also include new HIV inhibitors such as maraviroc, darunavir and etravirine. METHODS: We used data from a national observational study of patients starting raltegravir-based regimens to compare virological suppression and CD4 cell change from baseline in patients with and without concomitant HBV or HCV infection. RESULTS: Overall, 275 patients (107 coinfected and 168 non-coinfected) were evaluated. Coinfected patients were more commonly former intravenous drug users and had a longer history of HIV infection and higher baseline aminotransferase levels. Both HIV-RNA and CD4 response were similar in the two groups. Mean time to first HIV-RNA copy number

Published
2012

15. The problem of renal function monitoring in patients treated with the novel antiretroviral drugs

Author

Maggi, P, Montinaro, V, Rusconi, S, Di Biagio, A, Bellagamba, R, Bonfanti, P, Calza, L, Corsi, P, Montella, F, Mussini, C, Maggi P., Montinaro V., Rusconi S., Di Biagio A., Bellagamba R., Bonfanti P., Calza L., Corsi P., Montella F., Mussini C., Maggi, P, Montinaro, V, Rusconi, S, Di Biagio, A, Bellagamba, R, Bonfanti, P, Calza, L, Corsi, P, Montella, F, Mussini, C, Maggi P., Montinaro V., Rusconi S., Di Biagio A., Bellagamba R., Bonfanti P., Calza L., Corsi P., Montella F., and Mussini C.

Abstract

Chronic kidney disease (CKD) is currently considered a major comorbidity in patients affected by HIV infection. In addition, new generation antiretroviral drugs that interact with creatinine transporters were recently introduced. Rilpivirine, dolutegravir, and cobicistat, with different mechanisms, inhibit the amount of tubular secretion of creatinine causing a slight increase in serum creatinine levels and consensual eGFRcreat reduction. This will require an unprecedented attention to renal issues, because the new drugs can also be associated to old antiretroviral drugs that may exert renal toxic effects. Owing to the interference of these drugs with creatinine secretion, an alternative way of estimating GFR would be desirable. At the moment, methods of direct GFR measurement have a high impact on the patient, are not readily available, or are not reliable in HIV patients. Consequently, use of classic formulas to estimate GFR is still recommended, considering the apparent reduction of eGFRcreat due to these drugs. Tubular function needs to be carefully monitored with simple tests such as proteinuria, phosphatemia, urinary excretion of phosphate, normoglycemic glycosuria, and excretion of uric acid. More specific and sensitive markers of tubular damage are still not readily available in all clinical labs. HIV patients treated by the novel drugs need to be monitored on a monthly basis for the first 3 months. Subsequent monitoring should be performed on a quarterly basis or guided by comorbidities. © 2014 Thomas Land Publishers, Inc.

Published
2014

16. A randomized, pilot trial to evaluate glomerular filtration rate by creatinine or cystatin C in naive HIV-infected patients after tenofovir/emtricitabine in combination with atazanavir/ritonavir or efavirenz

Author

Albini, L, Cesana, B, Motta, D, Foca, E, Gotti, D, Calabresi, A, Izzo, I, Bellagamba, R, Fezza, R, Narciso, P, Sighinolfi, L, Maggi, P, Quiros-Roldan, E, Manili, L, Guaraldi, G, Lapadula, G, Torti, C, Albini L., Cesana B. M., Motta D., Foca E., Gotti D., Calabresi A., Izzo I., Bellagamba R., Fezza R., Narciso P., Sighinolfi L., Maggi P., Quiros-Roldan E., Manili L., Guaraldi G., Lapadula G., Torti C., Albini, L, Cesana, B, Motta, D, Foca, E, Gotti, D, Calabresi, A, Izzo, I, Bellagamba, R, Fezza, R, Narciso, P, Sighinolfi, L, Maggi, P, Quiros-Roldan, E, Manili, L, Guaraldi, G, Lapadula, G, Torti, C, Albini L., Cesana B. M., Motta D., Foca E., Gotti D., Calabresi A., Izzo I., Bellagamba R., Fezza R., Narciso P., Sighinolfi L., Maggi P., Quiros-Roldan E., Manili L., Guaraldi G., Lapadula G., and Torti C.

Abstract

Background: Glomerular filtration rate (GFR) estimated by Chronic Kidney Disease Epidemiology Collaboration (CKD-EPI) equation based on creatinine or cystatine C may be more accurate methods especially in patients without chronic kidney disease. There is lack of data on GFR estimated by these methods in patients on highly active antiretroviral therapy. Methods: Antiretroviral-naive HIV-infected patients were randomized to tenofovir/emtricitabine in association with atazanavir/ritonavir (ATV/r) or efavirenz (EFV) Patients had to have an actual creatinine clearance >50 mL/minute (24-hour urine collection) and were followed for 48 weeks. RESULTS: Ninety-one patients (48 ATV/r, 43 EFV) were recruited. Using the CKD-EPI creatinine formula, there was a significant decrease in GFR up to week 48 in patients receiving ATV/r (4.9 mL/minute/m, P = 0.02) compared with a not statistically significant increment in patients prescribed EFV. Using the cystatin C-based equation, we found greater decrease in GFR in both arms, although, in the EFV arm, the decrease was not statistically significant (5.8 mL/minute/m, P = 0.92). At multivariable analysis, ATV/r was a significant predictor of greater decrease in estimated glomerular filtration rate (eGFR) (P = 0.0046) only with CKD-EPI creatinine. Conclusions: ATV/r plus tenofovir caused greater GFR decreases compared with EFV. The evaluation of eGFR by cystatin C confirmed this result, but this method seemed to be more stringent, probably precluding the possibility to detect a significant difference in the pattern of eGFR evolution between the two arms over time. More studies are needed to understand the clinical relevance of these alterations and whether cystatin C is a more appropriate method for monitoring GFR in clinical practice.

Published
2012

17. Pulmonary tuberculosis followed by sarcoidosis in an HIV-infected patient: A case report and a simplified diagnostic flowchart for diagnosis and treatment of sarcoidosis

Author

Mencarini, P., primary, Bellagamba, R., additional, Oliva, A., additional, Ghirga, P., additional, Giancola, M.L., additional, Corpolongo, A., additional, Ascoli Bartoli, T., additional, De Nardo, P., additional, Baiocchini, A., additional, Del Nonno, F., additional, Narciso, P., additional, and Nicastri, E., additional

Published
2016
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18. Switching to Coformulated Rilpivirine/Emtricitabine/Tenofovir in Virologically Suppressed Patients: Data From a Multicenter Cohort

Author

Pinnetti, C, Di Giambenedetto, Simona, Maggiolo, F, Fabbiani, Massimiliano, Sterrantino, G, Latini, A, Lorenzini, P, Ammassari, A, Loiacono, L, Bellagamba, R, Boumis, E, Cauda, Roberto, Antinori, A, Zaccarelli, M., Di Giambenedetto, Simona (ORCID:0000-0001-6990-5076), Cauda, Roberto (ORCID:0000-0002-1498-4229), Pinnetti, C, Di Giambenedetto, Simona, Maggiolo, F, Fabbiani, Massimiliano, Sterrantino, G, Latini, A, Lorenzini, P, Ammassari, A, Loiacono, L, Bellagamba, R, Boumis, E, Cauda, Roberto, Antinori, A, Zaccarelli, M., Di Giambenedetto, Simona (ORCID:0000-0001-6990-5076), and Cauda, Roberto (ORCID:0000-0002-1498-4229)

Abstract

No abstract available.

Published
2015

19. The potential impact of routine testing of individuals with HIV indicator diseases in order to prevent late HIV diagnosis

Author

Scognamiglio, Paola, Chiaradia, Giacomina, De Carli, Gabriella, Giuliani, Massimo, Mastroianni, Claudio Maria, Aviani Barbacci, Stefano, Buonomini, Anna R., Grisetti, Susanna, Sampaolesi, Alessandro, Corpolongo, Angela, Orchi, Nicoletta, Puro, Vincenzo, Ippolito, Giuseppe, Girardi, Enrico, Girardi, E., Orchi, N., Angeletti, C., Balzano, R., Elia, P., Navarra, A., Nurra, G., Palummieri, A., Alba, L., Ammassari, A., Antinori, A., Baldini, F., Bellagamba, R., Bevilacqua, N., Boumis, E., Capobianchi, M. R., Cerilli, S., Chinello, P., Corpolongo, A., D'Arrigo, R., De Carli, G., Null, D'Offizig, Forbici, F., Fusco, F. M., Galati, V., Ghirga, P., Giancola, L., Gori, C., Grisetti, S., Lauria, F. N., Liuzzi, G., Marconi, P., Mariano, A., Narciso, P., Nicastri, E., Noto, P., Palmieri, A. F., Perno, C. F., Petrosillo, N., Pisapia, R., Pittalis, S., Puro, V., Sampaolesi, A., Scognamiglio, P., Sciarrone, M. R., Selleri, M., Sias, C., Topino, S., Tozzi, V., Vincenzi, L., Visco Comandini, U., Vlassi, C., Zaccarelli, M., Zaniratti, S., Vullo, Vincenzo, Falciano, Mario, Andreoni, M., Sarmati, L., Buonomini, A. R., Di Carlo, A., Giuliani, M., Brancatella, R., Maggi, T., Errico, F., De Filippis, A., Di Bacco, R., Schito, S., Gattari, P., Spizzichino, L., Francesconi, M., Pace, G., Gallo, I., Anzalone, E., Tacconi, L., Mercurio, V. S., Lichtner, Miriam, Natalini Raponi, G., Pitorri, A., Caterini, A., and Aviani Barbacci, S.

Subjects
Adult, Male, Pediatrics, medicine.medical_specialty, Delayed Diagnosis, Tuberculosis, Adolescent, HIV Infections, Disease, HIV testing, Indicator diseases, Late diagnosis, Sexually transmitted infections, Aged, Aged, 80 and over, CD4 Lymphocyte Count, Diagnostic Tests, Routine, Female, Humans, Italy, Middle Aged, Retrospective Studies, Risk Factors, Young Adult, Infectious Diseases, Medical microbiology, Diagnostic Tests, 80 and over, Medicine, Routine, Young adult, business.industry, virus diseases, Seborrhoeic dermatitis, Retrospective cohort study, medicine.disease, Settore MED/17, Surgery, Population study, business, Viral hepatitis, Research Article
Abstract

Background The aim of our work was to evaluate the potential impact of the European policy of testing for HIV all individuals presenting with an indicator disease, to prevent late diagnosis of HIV. We report on a retrospective analysis among individuals diagnosed with HIV to assess whether a history of certain diseases prior to HIV diagnosis was associated with the chance of presenting late for care, and to estimate the proportion of individuals presenting late who could have been diagnosed earlier if tested when the indicator disease was diagnosed. Methods We studied a large cohort of individuals newly diagnosed with HIV infection in 13 counselling and testing sites in the Lazio Region, Italy (01/01/2004-30/04/2009). Considered indicator diseases were: viral hepatitis infection (HBV/HCV), sexually transmitted infections, seborrhoeic dermatitis and tuberculosis. Logistic regression analysis was performed to estimate association of occurrence of at least one indicator disease with late HIV diagnosis. Results In our analysis, the prevalence of late HIV diagnosis was 51.3% (890/1735). Individuals reporting at least one indicator disease before HIV diagnosis (29% of the study population) had a lower risk of late diagnosis (OR = 0.7; 95%CI: 0.5-0.8) compared to those who did not report a previous indicator disease. 52/890 (5.8%) late presenters were probably already infected at the time the indicator disease was diagnosed, a median of 22.6 months before HIV diagnosis. Conclusions Our data suggest that testing for HIV following diagnosis of an indicator disease significantly decreases the probability of late HIV diagnosis. Moreover, for 5.5% of late HIV presenters, diagnosis could have been anticipated if they had been tested when an HIV indicator disease was diagnosed. However, this strategy for enhancing early HIV diagnosis needs to be complemented by client-centred interventions that aim to increase awareness in people who do not perceive themselves as being at risk for HIV.

Published
2013

20. Limited occurrence of new grade 3-4 toxicity events with salvage regimens based on raltegravir and /or maraviroc: 96 weeks data from the ISS NIA cohort study

Author

Weimer, L. E., Floridia, M., Bucciardini, R., Baroncelli, S., Galluzzo, C. M., Pirillo, M. F., Fragola, V., Donnini, S., Mirra, M., Di Gragorio, M., Lucattini, S., Fucili, L., Angarano, G., Ladisa, N., Volpe, A., Vullo, V., D’Ettorre, G., Ceccarelli, G., Andreoni, M., Sarmati, L., Delle Rose, D., Tozzi, V., Petrosillo, N., Bellagamba, R., Libertone, R., Cicalini, S., Sighinolfi, L., Segala, D., Armignacco, O., Preziosi, R., Ferrari, C., Degli Antoni, A., Cavalli, A., Parruti, G., Sozio, F., Cosentino, L., Vivarelli, A., Manconi, Pe, Ort, F., Di Martino, M. L., Viale, P., Verucchi, G., Tedeschi, S., Mura, M. S., Mannazzu, M., Cattari, G., Tavio, M., Del Gobbo, R., Mataloni Paggi, A., Giacometti, A., Cirioni, O., Marchionni, E., Silvestri, C., Sebastianelli, S., Brescini, L., Baldelli, F., Francisci, D., Schiaroli, E., Bastianelli, S., Guaraldi, Giovanni, Nardini, Giulia, Stentarelli, Chiara, and Beghetto, Barbara

Subjects
HIV infection, antiretroviral therapy
Published
2013

21. TB Meningitis in HIV-Positive Patients in Europe and Argentina: Clinical Outcome and Factors Associated with Mortality

Author

Efsen, A. M. W., Panteleev, A. M., Grint, D., Podlekareva, D. N., Vassilenko, A., Rakhmanova, A., Zeltina, I., Losso, M. H., Miller, R. F., Girardi, E., Cayla, J., Post, F. A., Miro, J. M., Bruyand, M., Furrer, H., Obel, N., Lundgren, J. D., Mocroft, A., Kirk, O., Toibaro, J. J., Warley, E., Tamayo, N., Cristina Ortiz, M., Scapelatto, P., Bottaro, E., Murano, F., Miachans, M., Contarelli, J., Massera, L., Corral, J., Hualde, M., Miglioranza, C., Corti, M., Metta, H., Casiro, A., Cuini, R., Laplume, H., David, D., Marson, C., Lupo, S., Trape, L., Garcia Messina, O., Gear, O., Bruguera, J. M., Karpov, I., Skrahina, E., Skrahin, A., Zhavoronok, S., Mitsura, V., Ruzanov, D., Bondarenko, V., Suetnov, O., Paduto, D., Gerstoft, J., Kronborg, G., Pedersen, C., Larsen, C. S., Pedersen, G., Laursen, A. L., Nielsen, L., Jensen, J., Dabis, F., Chene, G., Lawson-Ayayi, S., Thiebaut, R., Wittkop, L., Morlat, P., Bonnet, F., Bernard, N., Hessamfar, M., Lacoste, D., Vandenhende, M. A., Dupon, M., Dauchy, F. A., Dutronc, H., Longy-Boursier, M., Mercie, P., Duffau, P., Roger Schmeltz, J., Malvy, D., Pistone, T., Receveur, M. C., Neau, D., Cazanave, C., Ochoa, A., Vareil, M. O., Pellegrin, J. L., Viallard, J. F., Greib, C., Lazaro, E., Fleury, H., Lafon, M. E., Reigadas, S., Trimoulet, P., Breilh, D., Molimard, M., Bouchet, S., Titier, K., Moreau, J. F., Pellegrin, I., Haramburu, F., Arcachon, G., Dupont, A., Gerard, Y., Caunegre, L., Andre, K., Bonnal, F., Farbos, S., Gemain, M. C., Ceccaldi, J., Tchamgoue, S., De Witte, S., Courtault, K., Monlun, E., Gaborieau, V., Lataste, P., Meraud, J. P., Chossat, I., Carvalho, A. C., Basche, R., Hamad, I. E., Ricci, B. A., Maggiolo, F., Ravasio, V., Mussini, C., Prati, F., Castelletti, S., Ammassari, A., Antinori, A., Bellagamba, R., Busi Rizzi, E., Cicalini, S., Corpolongo, A., Capaldo, A., Di Caro, A., Goletti, D., Grisetti, S., Gualano, G., Lauria, F. N., Parracino, L., Palmieri, F., Petrosillo, N., Pinetti, C., Sampaolesi, A., Moroni, M., Angarano, G., Armignacco, O., d'Arminio Monforte, A., Castelli, F., Cauda, R., Di Perri, G., Galli, M., Iardino, R., Guzzinati, Ippolito, Lazzarin, A., Perno, C. F., von Schloesser, F., Viale, P., Castagna, A., Ceccherini-Silberstein, F., Cozzi-Lepri, A., Lo Caputo, S., Puoti, M., Andreoni, M., Balotta, C., Bonfanti, P., Bonora, S., Borderi, M., Capobianchi, M. R., Cingolani, A., Cinque, P., De Luca, A., Di Biagio, A., Gianotti, N., Gori, A., Guaraldi, G., Lapadula, G., Lichtner, M., Madeddu, G., Marchetti, G., Marcotullio, S., Monno, L., Quiros Roldan, E., Rusconi, S., Cicconi, P., Fanti, I., Formenti, T., Galli, L., Lorenzini, P., Giacometti, A., Costantini, A., Carrisa, C., Suardi, C., Vanino, E., Verucchi, G., Minardi, C., Quirino, T., Abeli, C., Manconi, P. E., Piano, P., Vecchiet, J., Falasca, K., Sighinolfi, L., Segala, D., Mazzotta, F., Cassola, G., Viscoli, G., Alessandrini, A., Piscopo, R., Mazzarello, G., Mastroianni, C., Belvisi, V., Caramma, I., Castelli, A. P., Rizzardini, G., Ridolfo, A. L., Piolini, R., Salpietro, S., Carenzi, L., Moioli, M. C., Puzzolante, C., Abrescia, N., Chirianni, A., Guida, M. G., Gargiulo, M., Baldelli, F., Francisci, D., Parruti, G., Ursini, T., Magnani, G., Ursitti, M. A., Vullo, V., D'Avino, A., Gallo, L., Nicastri, E., Acinapura, R., Capozzi, M., Libertone, R., Tebano, G., Cattelan, A., Mura, M. S., Caramello, P., Orofino, G. C., Sciandra, M., Pellizzer, G., Manfrin, V., Riekstina, V., Aldins, P., Duiculescu, D., Malashenkov, E., Kozlov, A., Buzunova, S., Garcia-Goez, J. F., Moreno Camacho, A., Martinez, J. A., Gonzalez, J., Garcia-Alcaide, F., de Lazzari, E., Gatell, J. M., Sanchez, P., Lopezcolomes, J. L., Martinez-Lacasa, X., Falco, V., Imaz, A., Ocana, I., Vidal, R., Sambeat, M. A., Moreno-Martinez, A., Orcau, A., Weber, R., Battegay, M., Hirschel, B., Cavassini, M., Bernasconi, E., Schmid, P., Rickenbach, M., Campbell, L., Arenas-Pinto, A., Chentsova, N., Kjaer, J., Efsen, Anne Marie W., Panteleev, Alexander M., Grint, Daniel, Podlekareva, Daria N., Vassilenko, Anna, Rakhmanova, Aza, Zeltina, Indra, Losso, Marcelo H., Miller, Robert F., Girardi, Enrico, Caylã¡, Joan, Post, Frank A., Miro, Jose M., Bruyand, Mathia, Furrer, Hansjakob, Obel, Niel, Lundgren, Jens D., Mocroft, Amanda, Kirk, Ole, Hiv/tb Study, Group, Castagna, Antonella, Efsen, A, Panteleev, A, Grint, D, Podlekareva, D, Vassilenko, A, Rakhmanova, A, Zeltina, I, Losso, M, Miller, R, Girardi, E, Caylá, J, Post, F, Miro, J, Bruyand, M, Furrer, H, Obel, N, Lundgren, J, Mocroft, A, Kirk, O, and Gori, A

Subjects
Genetics and Molecular Biology (all), Male, Pediatrics, Meningeal, Immunology and Microbiology (all), lcsh:Medicine, HIV Infections, Kaplan-Meier Estimate, Rate ratio, Biochemistry, Risk Factors, Adult, Argentina, CD4 Lymphocyte Count, Europe, Female, HIV, Humans, Treatment Outcome, Tuberculosis, Meningeal, Biochemistry, Genetics and Molecular Biology (all), HIV Infection, Mortality rate, General Medicine, symbols, Meningitis, Human, Research Article, medicine.medical_specialty, Tuberculosis, Settore MED/17 - Malattie Infettive, Article Subject, General Biochemistry, Genetics and Molecular Biology, Tuberculous meningitis, NO, symbols.namesake, Pharmacotherapy, medicine, Poisson regression, General Immunology and Microbiology, business.industry, Public health, Risk Factor, lcsh:R, medicine.disease, Immunology, business
Abstract

Objectives.The study aimed at describing characteristics and outcome of tuberculous meningitis (TBM) in HIV-positive patients and comparing these parameters with those of extrapulmonary TB (TBEP) and pulmonary TB (TBP).Methods.Kaplan-Meier estimation and Poisson regression models were used to assess the mortality following TB diagnosis and to evaluate potential prognostic factors for the 3 groups of TB patients separately.Results.A total of 100 patients with TBM, 601 with TBEP, and 371 TBP were included. Patients with TBM had lower CD4 cell counts and only 17.0% received antiretroviral therapy (ART) at TB diagnosis. The cumulative probability of death at 12 months following TB was 51.2% for TBM (95% CI 41.4–61.6%), 12.3% for TBP (8.9–15.7%), and 19.4% for TBEP (16.1–22.6) (P<0.0001; log-rank test). For TBM, factors associated with a poorer prognosis were not being on ART (adjusted incidence rate ratio (aIRR) 4.00 (1.72–9.09), a prior AIDS diagnosis (aIRR=4.82(2.61–8.92)), and receiving care in Eastern Europe (aIRR=5.41(2.58–11.34))).Conclusions.TBM among HIV-positive patients was associated with a high mortality rate, especially for patients from Eastern Europe and patients with advanced HIV-infection, which urgently calls for public health interventions to improve both TB and HIV aspects of patient management.

Published
2013
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22. Limited occurence of new grade 3-4 toxicity events with salvage regimens based on raltegravir and /or maraviroc: 96 weeks data from the ISS NIA cohort study

Author

Weimer, Le, Floridia, M., Bucciardini, R., Baroncelli, S., C M, Galluzzo, M F, Pirillo, Fragola, V., Donnini, S., Mirra, M., Di Gregorio, M., Lucattini, S., Fucili, L., Angarano, G., Ladisa, N., Volpe, A., Vullo, V., D Ettorre, G., Ceccarelli, G., Andreoni, M., Sarmati, L., Delle Rose, D., Tozzi, V., Petrosillo, N., Bellagamba, R., Libertone, R., Cicalini, S., Sighinolfi, L., Daniela Segala, Armignacco, O., Preziosi, R., Ferrari, C., Degli Antoni, A., Cavalli, A., Parruti, G., Sozio, F., Cosentino, L., Vivarelli, A., P E, Manconi, Ort, F., M L, Di Martino, Viale, P., Verrucchi, G., Tedeschi, S., M S, Mura, Mannazzu, M., Cattari, G., Tavio, M., Del Gobbo, R., Mataloni Paggi, A., Giacometti, A., Cirioni, O., Marchionni, E., Silvestri, C., Sebastianelli, S., Brescini, L., Baldelli, F., Guaraldi, Giovanni, Maria Giulia Bernardini, Stentarelli, Chiara, and Beghetto, Barbara

Subjects
maraviroc, HIV infection, raltegravir, NO
Published
2013

23. A magnifying glass onto renal function and serum lipid evolutions after tenofovir (TDF) and emtricitabine (FTC) in combination with atazanavir/ritonavir (ATV/r) versus efavirenz (EFV) as first‐line HAART (the INCA trial)

Author

Izzo, I, Albini, L, Calabresi, A, Motta, D, Bellagamba, R, Fezza, R, Narciso, P, Sighinolfi, L, Maggi, P, Focà, E, Mendeni, M, Manili, L, Magoni, M, Carosi, G, Quiros?Roldan, E, and Torti, C

Subjects
Efavirenz -- Dosage and administration -- Testing, Ritonavir -- Testing -- Dosage and administration, Highly active antiretroviral therapy -- Testing, Atazanavir -- Dosage and administration -- Testing, Blood lipids -- Health aspects -- Measurement, Glomerular filtration rate -- Measurement, Emtricitabine -- Dosage and administration -- Testing, HIV infection -- Drug therapy, Health
Abstract

7‐11 November 2010, Tenth International Congress on Drug Therapy in HIV Infection, Glasgow, UK, Background Measures of glomerular filtration rate (GFR) showed discordant results. CKD‐EPI creatinine formula resulted more accurate than other equations in subjects with normal or mildly decreased renal function in the [...]

Published
2010
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25. Simplification to co-formulated rilpivirine/emtricitabine/tenofovir in virologically suppressed patients: Data from a multicenter cohort

Author

Pinnetti, C, Di Giambenedetto, Simona, Maggiolo, F, Lorenzini, P, Fabbiani, M, Tommasi, C, Latini, A, Ammassari, A, Loiacono, L, Sterrantino, G, Bellagamba, R, Boumis, E, Antinori, A, Zaccarelli, M., Di Giambenedetto, Simona (ORCID:0000-0001-6990-5076), Pinnetti, C, Di Giambenedetto, Simona, Maggiolo, F, Lorenzini, P, Fabbiani, M, Tommasi, C, Latini, A, Ammassari, A, Loiacono, L, Sterrantino, G, Bellagamba, R, Boumis, E, Antinori, A, Zaccarelli, M., and Di Giambenedetto, Simona (ORCID:0000-0001-6990-5076)

Abstract

To assess efficacy and safety of treatment simplification to co-formulated Rilpivirine/Emtricitabine/Tenofovir (RPV/FTC/TDF) in virologically suppressed patients.

Published
2014

26. Novel antiretroviral drugs and renal function monitoring of HIV patients

Author

Maggi, P, Montinaro, V, Mussini, C, Di Biagio, A, Bellagamba, R, Bonfanti, P, Calza, L, Cherubini, C, Corsi, P, Gargiulo, M, Montella, F, Rusconi, S, Maggi, Paolo, Montinaro, Vincenzo, Mussini, Cristina, Di Biagio, Antonio, Bellagamba, Rita, Bonfanti, Paolo, Calza, Leonardo, Cherubini, Chiara, Corsi, Paola, Gargiulo, Miriam, Montella, Francesco, Rusconi, Stefano, Maggi, P, Montinaro, V, Mussini, C, Di Biagio, A, Bellagamba, R, Bonfanti, P, Calza, L, Cherubini, C, Corsi, P, Gargiulo, M, Montella, F, Rusconi, S, Maggi, Paolo, Montinaro, Vincenzo, Mussini, Cristina, Di Biagio, Antonio, Bellagamba, Rita, Bonfanti, Paolo, Calza, Leonardo, Cherubini, Chiara, Corsi, Paola, Gargiulo, Miriam, Montella, Francesco, and Rusconi, Stefano

Abstract

Chronic kidney disease is a major comorbidity in patients affected by HIV infection. In addition, the introduction of new antiretroviral agents that interact with creatinine transporters is raising some concerns. In this review we analyze the currently available data about three new antiretroviral drugs and one new pharmacokinetic enhancer. Three of them (rilpivirine, cobicistat, dolutegravir) have shown some interactions with renal function, while tenofovir alafenamide fumarate reduces the plasmatic concentration of the parent drug. The future use of tenofovir alafenamide seems to be encouraging in order to reduce the renal interaction of tenofovir. Rilpivirine, cobicistat, and dolutegravir reduce the tubular secretion of creatinine, inducing a decrease of estimated glomerular filtration rate according to creatinine. Rilpivirine and dolutegravir block the uptake of creatinine from the blood, inhibiting organic cation transporter 2, and cobicistat interacts with the efflux inhibiting multidrug and toxin extrusion protein 1. This effect can then be considered a "reset" of the estimated glomerular filtration rate according to creatinine. However, clinicians should carefully monitor renal function in order to identify possible alterations suggestive of a true renal functional impairment. Owing to the interference of these drugs with creatinine secretion, an alternative way of estimation of glomerular filtration rate would be desirable. However, at the moment, other methods of direct glomerular filtration rate measurement have a high impact on the patient, are not readily available, or are not reliable in HIV patients. Consequently, use of classic formulas to estimate glomerular filtration rate is still recommended. Also, tubular function needs to be carefully monitored with simple tests such as proteinuria, phosphatemia, urinary excretion of phosphate, normoglycemic glycosuria, and excretion of uric acid.

Published
2014

27. ISS-NIA ITALIAN COHORT: NEW ANTI-HIV INHIBITORS IN PATIENTS EXPERIENCED TO IP, NRTI, NNRTI

Author

Bucciardini, R., Floridia, M., Weimer, Le, Fragola, V., Massella, M., Baroncelli, S., Pirillo, Mf, Galluzzo, Cm, Donnini, S., Mirra, M., Di Gregorio, M., Lucattini, S., Fucili, L., Baldelli, F., Francisci, D., Martinelli, L., Bastianelli, S., Pastore, G., Ladisa, N., Volpe, A., Vullo, V., D Ettore, G., Ceccarelli, G., Andreoni, M., Sarmati, L., Delle Rose, D., Montano, M., Tozzi, V., Libertone, R., Pucillo, L., Narciso, P., Bellagamba, R., Tommasi, C., Petrosillo, N., Cicalini, S., Sighinolfi, L., Daniela Segala, Armignacco, O., Preziosi, R., Ferrari, C., Antoni, Ad, Cavalli, A., Parruti, G., Sozio, F., Cosentino, L., Dionisio, D., Vivarelli, A., Manconi, Pe, Ortu, F., Di Martino, Ml, Chiodo, F., Biagelti, C., Borderi, M., Boni, P., Del Gobbo, R., Paggi, Am, Silvestri, C., Scalise, G., Giacometti, A., Cirioni, O., Mura, Ms, Mannazzu, M., Coinu, G., Bellissima, P., Bonfante, S., Neri, D., Guaraldi, G., and Beghetto, B.

Subjects
antiretroviral therapy, HIV, COHORT STUDY, NO
Published
2009

31. Determinants of virologic and immunologic outcomes in chronically HIV-infected subjects undergoing repeated treatment interruptions: The Istituto Superiore di Sanità-Pulsed Antiretroviral Therapy (ISS-PART) study

Author

Palmisano, L., Giuliano, M., Bucciardini, R., Fragola, V., Andreotti, M., Galluzzo, C. M., Pirillo, M. F., Weimer, L. E., Arcieri, R., Germinario, E. A. P., Amici, R., Mancini, M. G., D'Arminio Monforte, A., Castelli, F., Caramello, P., Vella, S., Abrescia, N., Figoni, M., Viglietti, R., Angarano, G., Saracino, A., Anselmo, M., Antinori, A., Sette, P., Zaccarelli, M., Liuzzi, G., Arlotti, M., Martelli, L. T., Ortolani, P., Bassetti, D., Di Biagio, A., Bisio, F., Bellissima, P., Branz, F., Dorigoni, N., Cadeo, G., Vangi, D., Bertelli, D., Bergamasco, A., Caggese, L., Volonterio, A., Orofino, G. C., Carosella, S., Gennero, L., Caremani, M., Tacconi, D., Carosi, G., Tomasoni, L., Patroni, A., Chiodo, F., Borderi, M., Calza, L., Gritti, F., Fasulo, G., Chirianni, A., Gargiulo, M., Colomba, A., Dalle Nogare, E. R., Di Lorenzo, F., Prestileo, T., Bini, T., Cicconi, P., De Lalla, F., Giordani, M. T., De Stefano, C., De Stefano, G., Delia, S., Ciardi, M., Di Perri, G., Sinicco, A., Sales, P., Dini, M., Simeone, M., Esposito, R., Guaraldi, G., Beghetto, B., Fatuzzo, F., La Rosa, R., Ferrari, C., Calzetti, C., Ferraro, T., Cosco, L., Ghinelli, F., Sighinolfi, L., Guadagnino, V., Caroleo, B., Izzi, A., Izzo, C., Franco, A., Lazzarin, A., Castagna, A., Fusetti, G., Leoncini, F., Pozzi, M., Sbaragli, S., Marzetti, M., Magnani, G., Bonazzi, L., Barchi, E., Zoboli, G., Pintus, A., Mandas, A., Soddu, M. L., Zucca, F., Mannucci, P. M., Gringeri, A., Marani Toro, G., Graziani, R. V., Consorti, A., Mazzotta, F., Di Pietro, M., Ble, C., Meneghetti, F., Sasset, L., Cattelan, A. M., Menichetti, F., Savalli, E., Mian, P., Pristera, R., Mignani, E., Artioli, S., Mura, M. S., Mannazzu, M., Narciso, P., Bellagamba, R., Orani, A., Perini, P., Ortona, L., De Luca, A., Murri, R., Pagano, G., Alessandrini, A., Paladini, A., Vinattieri, M. A., Carbonai, S., Pastore, G., Ladina, N., Tateo, M., Piersantelli, N., Penco, G., Petrelli, E., Balducci, M., Pippi, L., Gonnelli, A., Puppo, F., Murdaca, G., Raise, E., Pasquirucci, A., Riccio, G., Bartolacci, V., Carrega, G., Rizzardini, G., Migliorino, G., Russo, R., Casentino, S., Celesia, M., Soranzo, M. L., Macor, A., Salassa, B., Soscia, F., Roberti, L., Di Toro, M. T., Stagno, A., Beltrami, C., Suter, F., Maggiolo, F., Ripamonti, D., Tantimonaco, G., Grisorio, B., Tassara, A., Rossi, P., Tinelli, M., Regazzetti, A., Tirelli, U., Voltaggio, G., Cinelli, R., Toti, M., Baldari, M., Carli, T., Ricciardi, B., Trezzi, M., Vigevani, G. M., Capetti, A., Landonio, S., Vullo, V., Massetti, P., Zauli, T., and Casolari, S.

Subjects
Adult, Male, medicine.medical_specialty, Anti-HIV Agents, medicine.medical_treatment, HIV Infections, Drug resistance, Drug Administration Schedule, law.invention, Randomized controlled trial, Drug Resistance, Multiple, Viral, law, Internal medicine, medicine, Humans, Pharmacology (medical), Protease inhibitor (pharmacology), Structured treatment interruptions, Chemotherapy, Reverse-transcriptase inhibitor, biology, business.industry, HIV, Middle Aged, biology.organism_classification, CD4 Lymphocyte Count, Clinical trial, Chronic infection, Regimen, Infectious Diseases, Immunology, Lentivirus, RNA, Viral, Female, business, medicine.drug
Abstract

Background: Factors influencing the outcome of structured treatment interruptions (STIs) in HIV chronic infection are not fully elucidated. Methods: In ISS-PART, 273 subjects were randomly assigned to arm A (137 assigned to continuous highly active antiretroviral therapy [HAART]) and arm B (136 assigned to 5 STIs of 1, 1, 2, 2, and 3 months'duration, each followed by 3 months of therapy). Main outcome measures were the proportion of subjects with a CD4 count >500 cells/mm 3 , the rate of virologic failure, and the emergence of resistance at 24 months. Results: The proportion of subjects with a CD4 count >500 cells/mm 3 was higher in arm A than in arm B (86.5% vs. 69.1%; P = 0.0075). Pre-HAART CD4 cell count and male gender were independent predictors of a CD4 count >500 cells/mm 3 in arm B. The overall risk of virologic failure was not increased in arm B; however, it was higher in the 38 subjects who had resistance mutations in the rebounding virus. Archived mutations at baseline and the use of a regimen that included an unboosted protease inhibitor (PI), compared with nonnucleoside reverse transcriptase inhibitor-based HAART, independently predicted the emergence of plasma mutations during STI (P = 0.002 for DNA mutations and P = 0.048 for PI-based HAART). Conclusions: Our results suggest that patients with preexisting mutations and treated with unboosted PI-based HAART should not be enrolled in studies of time-fixed treatment interruptions, being at higher risk of developing plasma mutations during STI and virologic failure at therapy reinstitution.

Published
2007

32. Impact of new lymph node staging on lymphadenectomy and on the prognosis of patients undergoing surgery for gastric cancer

Author

Ramacciato G, Paolo AURELLO, D'Angelo F, Pezzoli F, Bellagamba R, Nigri G, Cicchini C, Ravaioli M, Ercolani G, Vetrone G, Del Gaudio M, and De Angelis R

Subjects
Adult, Aged, 80 and over, Male, Stomach Neoplasms, Lymphatic Metastasis, Humans, Lymph Node Excision, Female, Middle Aged, Prognosis, Aged, Neoplasm Staging
Abstract

The TNM system has become the principal method for assessing the extent of disease, determining prognosis in gastric cancer patients, and influencing therapeutic strategies. The extent of lymph node metastases is the most important prognostic factor. The aim of the study was to compare the 4th and 6th TNM edition N-classifications and to retrospectively evaluate the prognostic value of the 2002 TNM edition. We evaluated 344 patients who underwent curative total or subtotal gastrectomy. Our data confirm the simplicity and easy application of the new staging and the better prognostic stratification of the N-stage. In multivariate analysis the difference between the old and new TNM staging is minimal. We therefore suggest comparing lymph node location and number in larger series. For the purposes of correct N-staging, 10 lymph nodes in early gastric cancer and at least 16 in the other pT stages seem sufficient to achieve effective pNO staging.

Published
2006

34. [Ciliated hepatic foregut cysts: a case report]

Author

Balducci, G, Bellagamba, R, De Siena, T, Mercantini, P, Rebonato, Alberto, and Ziparo, V.

Subjects
Cysts, Liver Diseases, Humans, Female, Middle Aged, Epithelium
Abstract

The ciliated hepatic foregut cysts (CHFC) are uncommon benign lesions with columnar ciliated epithelium covering a connective lapse tissue. They are solitary uniloculate cysts localized in the left lobe of the liver. The diagnosis is made occasionally during autopsy or imaging studies for not related symptoms. The Authors report a case of CHFC with a review of the literature that allowed them to find only 60 cases.

Published
2003

35. Cost of surgical intervention for reconstructive therapy of HIV-associated facial lipoatrophy

Author

Massella,M, Ivanovic,J, Bellagamba,R, De Vita,R, Fracasso,L, Tozzi,V, Fragola,V, Rizzica,M, Narciso,P, Massella,M, Ivanovic,J, Bellagamba,R, De Vita,R, Fracasso,L, Tozzi,V, Fragola,V, Rizzica,M, and Narciso,P

Abstract

M Massella¹, J Ivanovic², R Bellagamba², R De Vita³, L Fracasso³, V Tozzi², V Fragola¹, M Rizzica², P Narciso²¹Istituto Superiore Sanità, Rome, Italy; ²National Institute for Infectious Disease – Lazzaro Spallanzani, Rome, Italy; ³Regina Elena National Cancer Institute of Rome, ItalyAbstract: This study aims to assess direct cost of reconstructive interventions with facial fillers for treatment of HIV (human immunodeficiency virus)-associated facial lipoatrophy (FLA). Evaluation was performed on data from patients enrolled in one arm of a comparative study of immediate versus delayed reconstructive treatment of facial lipoatrophy. Median costs were standardized for efficacy, estimated using data reported by physicians and patient reported outcomes. The variations of the results were evaluated with a sensitivity analysis. Evaluation was performed on 66 patients characterized by significant differences in terms of severity of FLA. Total cost resulted of €140,416.15, with a median cost per patient of €2126.04 (interquartile range [IQR]: 1599–2822). Taking into consideration severity of disease, median costs were €1641.67 (IQR: 1326.67–2126.04) and 2557.12 (IQR: 1939.34–2872.04) (P = 0.0) respectively for patients with low and high severity scores at baseline. Significant differences in term of cost-effectiveness ratios were also found between patients with different severity of FLA, and sensitivity analysis showed that these ratios increase with higher severity scores at baseline and vary widely depending on the costs of filler. Although these results cannot be considered representative because of important limitations, the present study suggests the severity of disease as an important determinant of costs.Keywords: dermal fillers, antiretroviral therapy, lipodystrophic syndrome, HAART

Published
2011

36. Incidence of bacterial colonization in the throat and in urines at paediatric age with evaluation of sensitivity to common antibiotics

Author

Catania S, Maria Teresa Mascellino, Ajassa C, Berardelli G, Bellagamba R, Tzanzoglou S, Iegri F, Mp, Ronchetti, and Catania N

Subjects
Male, Bacteria, Bacteriuria, bacterial colonization, microbiology, Microbial Sensitivity Tests, preschool, sensitivity to antibiotics, Anti-Bacterial Agents, anti-bacterial agents, bacteria, bacteriuria, child, drug effects, female, humans, male, microbial sensitivity tests, paediatric patients, pharmacology, pharynx, Child, Preschool, Humans, Pharynx, Female, Child
Abstract

To evaluate the incidence of bacterial colonization in the throat and in urines of children admitted to a paediatric ward in the year 1994. To test the sensitivity of isolates on the most common antibiotics used in therapy.The investigation was carried out on a group of 270 children (125 male and 145 female), aged between 3 months and 12 years, hospitalized with feverish infectious pathology in the department of infectious and Tropical Diseases of the University "La Sapienza" of Rome. The cultures of the throat swabs and on urines were performed on the admission of the children before the beginning of the therapy.The throat-swab cultures showed pathogenous microrganisms in 232 samples (85.9%) with a slight prevalence of Gram-negative bacteria (122) with respect to Gram-positive (110) and saprophytic microbial flora (38). The urine cultures proved to be positive in 81 cases (30%) with a prevalence of Gram-negative (56) above Gram-positive isolates (25).The two/thirds of paediatric patients hospitalized in an Infectious Diseases Department appeared to be colonized in the upper respiratory tract, whereas in about 10% of them a marked bacteriuria was clearly evident, often in the absence of specific symptoms. A few isolates either from the throat or from urines, showed resistance to the common antibacterial agents.

Published
1996

40. [Clinical-therapeutic considerations in a case of miliary tuberculosis in an indonesian girl]

Author

Ajassa C, Am, Angelici, Rendina E, Trinchieri V, Berardelli G, Bellagamba R, Catania N, Falciano M, Maria Teresa Mascellino, and Causo T

Subjects
drug therapy/microbiology/pathology, ethnology, Italy, Indonesia, Tuberculosis, Miliary, Child, Female, Humans, Tuberculosis, Miliary
Abstract

The authors describe the case of widespread miliary tuberculosis, that arose in a ten year-old Indonesian girl of middle-class, who has been living in Italy from about three years. The girl was probably contaminated by a subject belonging to the same ethnic-social community, who was affected with tubercular disease. The diagnosis was effected on the ground of: clinical picture including continued-remitting fever, a loose cough, asthenia, anorexia, weight reduction, aching tumefaction on the left side of the neck; isolation of Mycobacterium tuberculosis from the expectoration, blood, urine, and a lymph node located on the left side of the neck; radiological picture that revealed a widespread miliary tuberculosis. In spite of polychemotherapy with isoniazid , rifampicin, pirazinamide, and streptomycin that was subsequently replaced by ethambutol, the course of the illness worsened and it was characterized with fever, cachexia, respiratory insufficiency and repeated episodes of pneumothorax. For such reasons on the ground of susceptibility to the antibiogram amikacin and ciprofloxacin, as well as glucocorticoids to limit the fibrousness, were added to the specific therapy that was already being out. For persisting of relapsing pneumothoraxes, the patient underwent a thoracoscopy and plerodesis with talcum powder. After four months of antitubercular therapy, the research of M. tuberculosis resulted negative in the expectoration, urine, bronchus-alveolar washing liquid and blood, in addition to improvement in general state of health with remission of fever was noticed.

Published
1993

45. Specific enfuvirtide-associated mutational pathways in HIV-1 Gp41 are significantly correlated with an increase of CD4+ cell count, despite virological failure.

Author

Svicher V, Aquaro S, D'Arrigo R, Artese A, Dimonte S, Alcaro S, Santoro MM, Di Perri G, Lo Caputo S, Bellagamba R, Zaccarelli M, Visco-Comandini U, Antinori A, Narciso P, Ceccherini-Silberstein F, and Perno C

Abstract

BACKGROUND: Human immunodeficiency virus type 1 (HIV-1) gp41 is a crucial determinant for HIV-1 pathogenicity. We investigated the correlation of enfuvirtide (ENF)-associated gp41 mutational clusters with viroimmunological parameters, as well as the potential underlying mechanisms. METHODS: A total of 172 gp41 sequences and clinical follow-up data from 73 ENF-treated patients were analyzed monthly, from baseline to week 48. RESULTS: There were 7 novel gp41 mutations positively associated with ENF treatment and correlated with classic ENF mutations. The ENF-associated clusters [V38A + N140I ] and [V 38A +T18A ] significantly correlated with an increase in CD4 cell count at week 48 ( an increase from baseline of 112 and 209 cells/microL, respectively), whereas [Q40H + L45M + 268A] significantly correlated with a decrease in CD4 cell count (-53 cells/microL), without a change in the level of viremia. Residues 38 and 18 are located complementarily to each other in the Rev-responsive element, whereas analysis of molecular dynamics showed that the copresence of [V38A + N140 I] abolishes the interaction between residue 38 and 145 important for stabilization of the 6-helix bundle. In contrast, T268A localizes in the gp41 calmodulin-binding domain responsible for gp41-induced CD4(+) T lymphocyte apoptosis. CONCLUSION: Specific gp41 mutational clusters associated with ENF treatment significantly correlate with increases in CD4(+) cell count. Structural analysis suggests that this immunological gain is associated with mechanisms that act at both the protein level and the RNA level (even under conditions of virological failure). This result may help in the selection of patients who can benefit most from ENF treatment and represents a driving force for the design of the next generation of entry inhibitors. Copyright © 2008 Infectious Diseases Society of America [ABSTRACT FROM AUTHOR]

Published
2008
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47. Laparoscopic adrenalectomy: A worthwhile procedure performed in a general surgery department

Author

Giovanni Ramacciato, Lombardi, M., Amodio, P. M., Mercantini, P., Petrocca, S., Stipa, F., Di Giacomo, G., Bellagamba, R., Puce, E., and Ziparo, V.

Subjects
Adult, Male, Treatment Outcome, Humans, Adrenalectomy, Female, Laparoscopy, General Medicine, Middle Aged, Aged, Retrospective Studies
Abstract

A laparoscopic procedure is considered the treatment of choice for adrenalectomy. We report the experience of a nonreferring unit for adrenal pathology; we have evaluated its safety and feasibility in a series of 40 patients. From 1994 to 2001, forty consecutive patients underwent laparoscopic adrenalectomy, 37 with transperitoneal and 3 with retroperitoneal approach. The mean operative time was 129 ± 51.7 minutes (range 60–300): 107 ± 29 minutes (range 60–100) for the right-sided transperitoneal adrenalectomy and 144 ± 62 minutes (range 90–300) for the left-sided transperitoneal adrenalectomy. The mean intraoperative blood loss was 90 mL (range 40–200). The procedure laparoscopic was converted to open in one case for the presence of a voluminous angiolipoma arising from the retroperitoneal fat strictly adherent to the adrenal gland. The postoperative morbidity rate was 5.1 per cent. Pain medication was required for a mean period of 1.6 ± 0.6 days (range 1–3). The patients were able to resume solid food after an average time of 1.8 ± 0.7 days (range 1–4). Postoperative hospital stay was 3 ± 1.4 days (range 2–8). We believe that laparoscopic adrenalectomy is safe and effective in removing benign functioning or nonfunctioning adrenal masses and also in a general surgery department.

48. Radiation therapy in the treatment of HIV-related Kaposi's sarcoma

Author

Donato, V., Guarnaccia, R., Dognini, J., Pascalis, G., Caruso, C., Bellagamba, R., and Aldo Morrone

Subjects
Adult, Male, Acquired Immunodeficiency Syndrome, radiation therapy, hiv, kaposisarcoma, HIV, Radiotherapy Dosage, Chemoradiotherapy, Middle Aged, Prognosis, Humans, Pain Management, Sarcoma, Kaposi, Follow-Up Studies, Neoplasm Staging
Abstract

Kaposi's sarcoma (KS) is the most frequent neoplasm occurring in patients with HIV-related AIDS and very often exhibits multifocal distribution so that a systemic approach is needed. KS is considered a radiosensitive tumor and (RT) has always played an important role in the therapeutic strategy of its various forms. RT is a valuable means of pain relief, bleeding control and edema palliation, but it is also an effective treatment modality for local control of skin and mucosal lesions in KS. The purpose of the present article is to report the results obtained by the Radiotherapy Unit of S. Camillo-Forlanini Hospital in Rome in the management of 38 AIDS-associated KS lesions and to assess the efficacy of RT in the treatment and local control of KS.Eighteen patients histologically-diagnosed with HIV-related KS underwent RT in the period between January 2002 and January 2012 at the Radiotherapy Unit of S. Camillo-Forlanini Hospital in Rome. In all cases, the lesions caused pain or discomfort and a thorough careful clinical evaluation had indicated a radiation treatment. A total of 38 lesions were treated with radiotherapy. Fifteen patients received systemic chemotherapy. Eight patients with multiple cutaneous lesions on their legs and arms were treated with a radiation schedule prescribing extended cutaneous irradiation using 6-18 MeV electron beam energy, 200 cGy per fraction and a total dose between 24-30 Gy, according to the depth of lesions. One of these patients had also a cutaneous lesion on an eyelid that was treated with a radiation schedule using 6 MeV electron beam energy and bolus of 1 cm, 200 cGy per fraction and a total dose of 30 Gy. Seven patients with single cutaneous lesions on the legs and arms were treated using a photon regimen of 6 Mv energy, 200 cGy per fraction and a total dose between 20 and 36 Gy. Two patients had oral mucosa lesions and they were treated with a radiation schedule prescribing irradiation using 6 Mev photon regimen and personal mask, 200 cGy per fraction and a total dose of 24 and 30 Gy, respectively. A patient with a single bone lesion on the spinal column was treated with irradiation using 6 Mev photon regimen, 300 cGy per fraction and a total dose of 30 Gy.At the time of reporting, 14 patients were alive and four patients had died. One patient died due to complications from HIV infection. The follow-up from the end of the treatment ranged from four to 124 months (mean=51.17 months). The overall survival for the group was 88.8% at one year. The mean overall survival was 57.4 months. A complete response was achieved for 31 lesions (83.8 %); a partial response with a tumor regression was observed for six lesions (16.2 %). No relapses were observed during the period of follow-up, but we observed new lesions in one patient. According to the Radiation Therapy Oncology Group scale we observed erythematic and dry desquamation (grade 1) in eight sites (21%); in only one patient (2.6%) did stomatitis occur (grade 1). Good cosmetic results were described for 25 (65.7%) out of 31 lesions. Effective palliative action was obtained for all lesions except for two (5.2%) located in a vertebra and hard palate.RT will be a mainstay of cure for this group of patients especially when of young age and the will to preserve the cosmetic appearance is a primary need.

49. Treatment of Recurrent Hepatocellular Carcinoma with Sorafenib in a HIV/HCV Co-Infected patient in HAART: A Case Report

Author

De Nardo Pasquale, Viscione Magdalena, Corpolongo Angela, Bellagamba Rita, Vennarecci Giovanni, Ettorre Giuseppe, Gentilotti Elisa, Tommasi Chiara, and Nicastri Emanuele

Subjects
HAART, Sorafenib, Fosamprenavir, TDM, Hepatocarcinoma, HIV/HCV co-infection, Neoplasms. Tumors. Oncology. Including cancer and carcinogens, RC254-282, Infectious and parasitic diseases, RC109-216
Abstract

Abstract Background Liver disease is the second cause of death among HIV patients receiving highly active antiretroviral therapy (HAART) in Europe. HIV patients have a high prevalence of chronic HBV (6–10%) and HCV (33%) co-infection, and accelerated progression of viral hepatitis. Furthermore, the long duration of both HIV and HCV diseases in the HAART era increases the risk of hepatocellular carcinoma. Findings We report the case of a 49 year -old HIV/HCV co-infected male patient who developed hepatocellular carcinoma. The patient underwent a partial hepatectomy, and a few months later was treated with transcatheter arterial chemoembolisation due to hepatocarcinoma recurrence. Two months later, advanced hepatocellular carcinoma was diagnosed and sorafenib therapy was initiated. The patient achieved partial response of the main lesions, complete regression of the smallest lesions and did not experience clinical progression during the 20-month follow-up period. During therapy with sorafenib, the patient was treated with HAART with good viral and immunological responses. We used the therapeutic drug monitoring to assess antiretroviral concentrations during co-administration of sorafenib. Fosamprenavir Ctrough was found under the minimum level recommended by international guidelines. No grade 3 or 4 toxicities were observed. At month 20 of treatment, new liver lesions with portal vein thrombosis were diagnosed. After 28 months of sorafenib therapy, the patient deceased for severe liver insufficiency. Conclusions Sorafenib monotherapy demonstrated a marked delay in HCC disease progression in an HIV/HCV co-infected patient. Fosamprenavir Ctrough was found under the minimum level recommended by international guidelines, suggesting a possible interaction.

Published
2012
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50. Haemolytic anaemia in an HIV-infected patient with severe falciparum malaria after treatment with oral artemether-lumefantrine

Author

Corpolongo Angela, De Nardo Pasquale, Ghirga Piero, Gentilotti Elisa, Bellagamba Rita, Tommasi Chiara, Paglia Maria, Nicastri Emanuele, and Narciso Pasquale

Subjects
Severe malaria, Artemisinin-based combination therapy (ACT), Haemolytic anaemia, Drugs and haemolytic anaemia, Arctic medicine. Tropical medicine, RC955-962, Infectious and parasitic diseases, RC109-216
Abstract

Abstract Intravenous (i.v.) artesunate is now the recommended first-line treatment of severe falciparum malaria in adults and children by WHO guidelines. Nevertheless, several cases of haemolytic anaemia due to i.v. artesunate treatment have been reported. This paper describes the case of an HIV-infected patient with severe falciparum malaria who was diagnosed with haemolytic anaemia after treatment with oral artemether-lumefantrine. The patient presented with fever, headache, and arthromyalgia after returning from Central African Republic where he had been working. The blood examination revealed acute renal failure, thrombocytopaenia and hypoxia. Blood for malaria parasites indicated hyperparasitaemia (6%) and Plasmodium falciparum infection was confirmed by nested-PCR. Severe malaria according to the laboratory WHO criteria was diagnosed. A treatment with quinine and doxycycline for the first 12 hours was initially administered, followed by arthemeter/lumefantrine (Riamet®) for a further three days. At day 10, a diagnosis of severe haemolytic anaemia was made (Hb 6.9 g/dl, LDH 2071 U/l). Hereditary and autoimmune disorders and other infections were excluded through bone marrow aspiration, total body TC scan and a wide panel of molecular and serologic assays. The patient was treated by transfusion of six units of packed blood red cell. He was discharged after complete remission at day 25. At present, the patient is in a good clinical condition and there is no evidence of haemolytic anaemia recurrence. This is the first report of haemolytic anaemia probably associated with oral artemether/lumefantrine. Further research is warranted to better define the adverse events occurring during combination therapy with artemisinin derivatives.

Published
2012
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