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1. Impact of social determinants on antiretroviral therapy access and outcomes entering the era of universal treatment for people living with HIV in Italy

Author

Saracino, Annalisa, Zaccarelli, Mauro, Lorenzini, Patrizia, Bandera, Alessandra, Marchetti, Giulia, Castelli, Francesco, Gori, Andrea, Girardi, Enrico, Mussini, Cristina, Bonfanti, Paolo, Ammassari, Adriana, D'Arminio Monforte, Antonella, Moroni, M., Andreoni, M., Angarano, G., Antinori, A., D'Arminio Monforte, A., Castelli, F., Cauda, R., Di Perri, G., Galli, M., Iardino, R., Ippolito, G., Lazzarin, A., Perno, C. F., Von Schloesser, F., Viale, P., Castagna, A., Ceccherini-Silberstein, F., Cozzi-Lepri, A., Girardi, E., Lo Caputo, S., Mussini, C., Puoti, M., Ammassari, A., 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., Maggiolo, F., Marchetti, G., Marcotullio, S., Monno, L., Quiros Roldan, E., Rusconi, S., Saracino, A., Cicconi, P., Fanti, I., Galli, L., Lorenzini, P., Shanyinda, M., Tavelli, A., Giacometti, A., Costantini, A., Mazzoccato, S., Santoro, 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, C., Alessandrini, A., Piscopo, R., Mazzarello, G., Mastroianni, C., Belvisi, V., Caramma, I., Chiodera, A., Castelli, A. P., Rizzardini, G., Ridolfo, A. L., Piolini, R., Salpietro, S., Carenzi, L., Moioli, M. C., Tincati, C., Puzzolante, C., Abrescia, N., Chirianni, A., Borgia, G., Guida, M. G., Gargiulo, M., Gentile, I., Orlando, R., 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., Zaccarelli, M., Viviani, F., Sasset, L., Mura, M. S., Rossetti, B., Caramello, P., Orofino, G. C., Sciandra, M., Bassetti, M., Londero, A., Pellizzer, G., Manfrin, V., Saracino, A., Zaccarelli, M., Lorenzini, P., Bandera, A., Marchetti, G., Castelli, F., Gori, A., Girardi, E., Mussini, C., Bonfanti, P., Ammassari, A., D'Arminio Monforte, A., Moroni, M., Andreoni, M., Angarano, G., Antinori, A., Cauda, R., Di Perri, G., Galli, M., Iardino, R., Ippolito, G., Lazzarin, A., Perno, C. F., Von Schloesser, F., Viale, P., Castagna, A., Ceccherini-Silberstein, F., Cozzi-Lepri, A., Lo Caputo, S., Puoti, M., Balotta, C., Bonora, S., Borderi, M., Capobianchi, M. R., Cingolani, A., Cinque, P., De Luca, A., Di Biagio, A., Gianotti, N., Guaraldi, G., Lapadula, G., Lichtner, M., Madeddu, G., Maggiolo, F., Marcotullio, S., Monno, L., Quiros Roldan, E., Rusconi, S., Cicconi, P., Fanti, I., Galli, L., Shanyinda, M., Tavelli, A., Giacometti, A., Costantini, A., Mazzoccato, S., Santoro, 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, C., Alessandrini, A., Piscopo, R., Mazzarello, G., Mastroianni, C., Belvisi, V., Caramma, I., Chiodera, A., Castelli, A. P., Rizzardini, G., Ridolfo, A. L., Piolini, R., Salpietro, S., Carenzi, L., Moioli, M. C., Tincati, C., Puzzolante, C., Abrescia, N., Chirianni, A., Borgia, G., Guida, M. G., Gargiulo, M., Gentile, I., Orlando, R., 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., Viviani, F., Sasset, L., Mura, M. S., Rossetti, B., Caramello, P., Orofino, G. C., Sciandra, M., Bassetti, M., Londero, A., Pellizzer, G., Manfrin, V., Saracino, A, Zaccarelli, M, Lorenzini, P, Bandera, A, Marchetti, G, Castelli, F, Gori, A, Girardi, E, Mussini, C, Bonfanti, P, Ammassari, A, D'Arminio Monforte, A, Moroni, M, Andreoni, M, Angarano, G, Antinori, A, Cauda, R, Di Perri, G, Galli, M, Iardino, R, Ippolito, G, Lazzarin, A, Perno, C, Von Schloesser, F, Viale, P, Castagna, A, Ceccherini-Silberstein, F, Cozzi-Lepri, A, Lo Caputo, S, Puoti, M, Balotta, C, Bonora, S, Borderi, M, Capobianchi, M, Cingolani, A, Cinque, P, De Luca, A, Di Biagio, A, Gianotti, N, Guaraldi, G, Lapadula, G, Lichtner, M, Madeddu, G, Maggiolo, F, Marcotullio, S, Monno, L, Quiros Roldan, E, Rusconi, S, Cicconi, P, Fanti, I, Galli, L, Shanyinda, M, Tavelli, A, Giacometti, A, Costantini, A, Mazzoccato, S, Santoro, C, Suardi, C, Vanino, E, Verucchi, G, Minardi, C, Quirino, T, Abeli, C, Manconi, P, Piano, P, Vecchiet, J, Falasca, K, Sighinolfi, L, Segala, D, Mazzotta, F, Cassola, G, Viscoli, C, Alessandrini, A, Piscopo, R, Mazzarello, G, Mastroianni, C, Belvisi, V, Caramma, I, Chiodera, A, Castelli, A, Rizzardini, G, Ridolfo, A, Piolini, R, Salpietro, S, Carenzi, L, Moioli, M, Tincati, C, Puzzolante, C, Abrescia, N, Chirianni, A, Borgia, G, Guida, M, Gargiulo, M, Gentile, I, Orlando, R, Baldelli, F, Francisci, D, Parruti, G, Ursini, T, Magnani, G, Ursitti, M, Vullo, V, D'Avino, A, Gallo, L, Nicastri, E, Acinapura, R, Capozzi, M, Libertone, R, Tebano, G, Viviani, F, Sasset, L, Mura, M, Rossetti, B, Caramello, P, Orofino, G, Sciandra, M, Bassetti, M, Londero, A, Pellizzer, G, Manfrin, V, Bandera, Alessandra, Perno, C.F., Capobianchi, M.R., Manconi, P.E., Castelli, A.P., Ridolfo, A.L., Moioli, M.C., Guida, M.G., Ursitti, M.A., Mura, M.S., Orofino, G.C., and on behalf of the Icona Foundation Study, Group

Subjects
Male, 0301 basic medicine, Social Determinants of Health, HIV Infections, Socioeconomic Factor, Health Services Accessibility, Social determinant, Men who have sex with men, Cohort Studies, 0302 clinical medicine, Risk Factors, Universal Health Insurance, Epidemiology, Medicine, HIV Infection, 030212 general & internal medicine, lcsh:Public aspects of medicine, Middle Aged, Antiretroviral therapy, Treatment Outcome, Anti-Retroviral Agents, Italy, Antiretroviral therapy, HIV, ICONA, Social determinants, Cohort, HIV, ICONA, Social determinants, Public Health, Environmental and Occupational Health, Female, Public Health, Human, Research Article, Cohort study, Adult, medicine.medical_specialty, NO, 03 medical and health sciences, Humans, Social determinants of health, Risk factor, business.industry, Risk Factor, Environmental and Occupational Health, antiretroviral therapy, hiv, icona, social determinants, public health, environmental and occupational health, lcsh:RA1-1270, 030112 virology, Discontinuation, Regimen, Socioeconomic Factors, Anti-Retroviral Agent, Cohort Studie, business, Demography
Abstract

Background: Social determinants are known to be a driving force of health inequalities, even in high income countries. Aim of our study was to determine if these factors can limit antiretroviral therapy (ART) access, outcome and retention in care of people living with HIV (PLHIV) in Italy. Methods: All ART naïve HIV+ patients (pts) of Italian nationality enrolled in the ICONA Cohort from 2002 to 2016 were included. The association of socio-demographic characteristics (age, sex, risk factor for HIV infection, educational level, occupational status and residency area) with time to: ART initiation (from the first positive anti-HIV test), ART regimen discontinuation, and first HIV-RNA < 50 cp/mL, were evaluated by Cox regression analysis, Kaplan Meier method and log-rank test. Results: A total of 8023 HIV+ pts (82% males, median age at first pos anti-HIV test 36 years, IQR: 29-44) were included: 6214 (77.5%) started ART during the study period. Women, people who inject drugs (PWID) and residents in Southern Italy presented the lowest levels of education and the highest rate of unemployment compared to other groups. Females, pts aged > 50 yrs., unemployed vs employed, and people with lower educational levels presented the lowest CD4 count at ART initiation compared to other groups. The overall median time to ART initiation was 0.6 years (yrs) (IQR 0.1-3.7), with a significant decrease over time [2002-2006 = 3.3 yrs. (0.2-9.4); 2007-2011 = 1.0 yrs. (0.1-3.9); 2012-2016 = 0.2 yrs. (0.1-2.1), p < 0.001]. By multivariate analysis, females (p < 0.01) and PWID (p < 0.001), presented a longer time to ART initiation, while older people (p < 0.001), people with higher educational levels (p < 0.001), unemployed (p = 0.02) and students (p < 0.001) were more likely to initiate ART. Moreover, PWID, unemployed vs stable employed, and pts. with lower educational levels showed a lower 1-year probability of achieving HIV-RNA suppression, while females, older patients, men who have sex with men (MSM), unemployed had higher 1-year risk of first-line ART discontinuation. Conclusions: Despite median time to ART start decreased from 2002 to 2016, socio-demographic factors still contribute to disparities in ART initiation, outcome and durability.

Published
2018
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2. Triglyceride/HDL ratio and its impact on the risk of diabetes mellitus development during ART

Author

Squillace, Nicola, Lorenzini, Patrizia, Lapadula, Giuseppe, Bandera, Alessandra, Cozzi Lepri, Alessandro, Rusconi, Stefano, Puoti, Massimo, Castagna, Antonella, Antinori, Andrea, Gori, Andrea, D'arminio Monforte, Antonella, Moroni M, Andreoni M, Angarano G, Antinori A, D'arminio Monforte A, Castelli F, Cauda R, Di Perri G, Galli M, Iardino R, Ippolito G, Lazzarin A, Perno Cf, Von Schloesser F, Viale P, Castagna A, Ceccherini-silberstein F, Cozzi-lepri A, Girardi E, Lo Caputo S, Mussini C, Puoti M, Ammassari A, Balotta C, Bonfanti P, Bonora S, Borderi M, Capobianchi Mr, Cingolani A, Cinque P, De Luca A, Di Biagio A, Gianotti N, Gori A, Guaraldi G, Lapadula G, Lichtner M, Madeddu G, Maggiolo F, Marchetti G, Marcotullio S, Monno L, Quiros Roldan E, Rusconi S, Saracino A, Cicconi P, Fanti I, Galli L, Lorenzini P, Rodano A, Shanyinda M, Tavelli A, Giacometti A, Costantini A, Mazzoccato S, Santoro C, Suardi C, Vanino E, Verucchi G, Minardi C, Quirino T, Abeli C, Manconi Pe, Piano P, Vecchiet J, Falasca K, Sighinolfi L, Segala D, Mazzotta F, Cassola G, Viscoli C, Alessandrini A, Piscopo R, Mazzarello G, Mastroianni C, Belvisi V, Caramma I, Chiodera A, Castelli Ap, Rizzardini G, Ridolfo Al, Piolini R, Salpietro S, Carenzi L, Moioli Mc, Tincati C, Puzzolante C, Abrescia N, Chirianni A, Borgia G, Guida Mg, Gargiulo M, Gentile I, Orlando R, Baldelli F, Francisci D, Parruti G, Ursini T, Magnani G, Ursitti Ma, Vullo V, D'avino A, Gallo L, Nicastri E, Acinapura R, Capozzi M, Libertone R, Tebano G, Zaccarelli M, Viviani F, Sasset L, Mura Ms, Rossetti B, Caramello P, Orofino Gc, Sciandra M, Bassetti M, Londero A, Pellizzer G, Manfrin V., Squillace, Nicola, Lorenzini, Patrizia, Lapadula, Giuseppe, Bandera, Alessandra, Cozzi lepri, Alessandro, Rusconi, Stefano, Puoti, Massimo, Castagna, Antonella, Antinori, Andrea, Gori, Andrea, D'arminio Monforte, Antonella, Squillace, N, Lorenzini, P, Lapadula, G, Bandera, A, Cozzi-Lepri, A, Rusconi, S, Puoti, M, Castagna, A, Antinori, A, Gori, A, d'Arminio Monforte, A, Cozzi Lepri, Alessandro, Moroni, M, Andreoni, M, Angarano, G, D'arminio Monforte, A, Castelli, F, Cauda, R, Di Perri, G, Galli, M, Iardino, R, Ippolito, G, Lazzarin, A, Perno, Cf, Von Schloesser, F, Viale, P, Ceccherini-silberstein, F, Cozzi-lepri, A, Girardi, E, Lo Caputo, S, Mussini, C, Ammassari, A, Balotta, C, Bonfanti, P, Bonora, S, Borderi, M, Capobianchi, Mr, Cingolani, A, Cinque, P, De Luca, A, Di Biagio, A, Gianotti, N, Guaraldi, G, Lichtner, M, Madeddu, G, Maggiolo, F, Marchetti, G, Marcotullio, S, Monno, L, Quiros Roldan, E, Saracino, A, Cicconi, P, Fanti, I, Galli, L, Rodano, A, Shanyinda, M, Tavelli, A, Giacometti, A, Costantini, A, Mazzoccato, S, Santoro, C, Suardi, C, Vanino, E, Verucchi, G, Minardi, C, Quirino, T, Abeli, C, Manconi, Pe, Piano, P, Vecchiet, J, Falasca, K, Sighinolfi, L, Segala, D, Mazzotta, F, Cassola, G, Viscoli, C, Alessandrini, A, Piscopo, R, Mazzarello, G, Mastroianni, C, Belvisi, V, Caramma, I, Chiodera, A, Castelli, Ap, Rizzardini, G, Ridolfo, Al, Piolini, R, Salpietro, S, Carenzi, L, Moioli, Mc, Tincati, C, Puzzolante, C, Abrescia, N, Chirianni, A, Borgia, G, Guida, Mg, Gargiulo, M, Gentile, I, Orlando, R, Baldelli, F, Francisci, D, Parruti, G, Ursini, T, Magnani, G, Ursitti, Ma, Vullo, V, D'Avino, A, Gallo, L, Nicastri, E, Acinapura, R, Capozzi, M, Libertone, R, Tebano, G, Zaccarelli, M, Viviani, F, Sasset, L, Mura, M, Rossetti, B, Caramello, P, Orofino, Gc, Sciandra, M, Bassetti, M, Londero, A, Pellizzer, G, and Manfrin, V.

Subjects
Liver Cirrhosis, Male, 0301 basic medicine, HIV Infections, Adult, Anti-Retroviral Agents, Antiretroviral Therapy, Highly Active, Diabetes Mellitus, Female, Hepatitis C Antibodies, Humans, Lipoproteins, HDL, Middle Aged, Retrospective Studies, Risk Assessment, Triglycerides, Triglyceride, Gastroenterology, chemistry.chemical_compound, 0302 clinical medicine, High-density lipoprotein, Retrospective Studie, HIV Infection, Pharmacology (medical), 030212 general & internal medicine, individual, hiv-infected patient, dysfunction, Diabetes Mellitu, cohort, high-density-lipoprotein, c virus-infection, Settore MED/07 - Microbiologia e Microbiologia Clinica, Not available, Infectious Diseases, Cohort, symbols, Human, Microbiology (medical), medicine.medical_specialty, HDL, Lipoproteins, Liver Cirrhosi, Antiretroviral Therapy, insulin-resistance, NO, 03 medical and health sciences, symbols.namesake, Insulin resistance, Diabetes mellitus, Internal medicine, medicine, Highly Active, Poisson regression, Risk factor, Pharmacology, business.industry, association, cholesterol, Retrospective cohort study, medicine.disease, 030104 developmental biology, Endocrinology, chemistry, Relative risk, Anti-Retroviral Agent, Hepatitis C Antibodie, business
Abstract

Objectives Our primary aim was to study diabetes mellitus (DM) arising during combination ART (cART) and to attempt to identify associations between these cases and triglycerides (TRG) and the TRG to HDL-cholesterol (TRG/HDL) ratio. Our secondary aim was to analyse the association between DM development and hepatic fibrosis. Methods This was a retrospective cohort study. Patients from the Icona Foundation study initiating first-line cART between 1997 and 2013 were selected and observed until new-onset DM or most recent clinical follow-up. The predictive value of TRG and TRG/HDL ratio levels on DM was evaluated using multivariable Poisson regression models. Results Three-thousand, five-hundred and forty-six patients (males, 73.7%; median age, 38 years; median BMI, 23.1 kg/m2; and hepatitis C virus antibody positive, 22.1%) were included. Of these, 80 developed DM over 13 911 person-years of follow-up (PYFU), corresponding to 5.7 cases per 1000 PYFU (95% CI = 4.6–7.1). At multivariable analysis, latest TRG/HDL ratio, when high, was associated with significant increases in DM risk [relative risk (RR) = 1.63; 95% CI = 1.32–2.01 per 10 points higher], while current TRG, in contrast, was associated with new-onset DM only at crude analysis. Advanced liver fibrosis (defined as fibrosis-4 index >3.25) was also shown to be an independent risk factor for DM (RR = 2.91; 95% CI = 1.10–7.72). Conclusions High TRG/HDL ratio predicted risk of new-onset DM, independently of other traditional risk factors. Furthermore, our findings suggest that advanced hepatic fibrosis, estimated using the fibrosis-4 score, could provide an additional predictor for DM.

Published
2016
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3. Discontinuation of initial antiretroviral therapy in clinical practice: Moving toward individualized therapy

Author

Di Biagio, Antonio, Cozzi Lepri, Alessandro, Prinapori, Roberta, Angarano, Gioacchino, Gori, Andrea, Quirino, Tiziana, De Luca, Andrea, Costantini, Andrea, Mussini, Cristina, Rizzardini, Giuliano, Castagna, Antonella, Antinori, Andrea, Monforte, Antonella D'arminio, Moroni, M., Andreoni, M., Angarano, G., Antinori, A., D'Arminio Monforte, A., Castelli, F., Cauda, R., Di Perri, G., Galli, M., Iardino, R., Ippolito, G., Lazzarin, A., Perno, C. F., Von Schloesser, F., Viale, P., Castagna, A., Ceccherini Silberstein, F., Cozzi Lepri, A., Girardi, E., Lo Caputo, S., Mussini, C., Puoti, M., Ammassari, A., Balotta, C., Bandera, A., Bonfanti, P., Bonora, S., Borderi, M., Calcagno, A., Calza, L., 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., Maggiolo, F., Marchetti, G., Marcotullio, S., Monno, L., Quiros Roldan, E., Rossotti, R., Rusconi, S., Santoro, M., Saracino, A., Zaccarelli, M., Fanti, I., Galli, L., Lorenzini, P., Rodano, A., Shanyinde, M., Tavelli, A., Giacometti, A., Costantini, A., Mazzoccato, S., Santoro, 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, C., Alessandrini, A., Piscopo, R., Mazzarello, G., Mastroianni, C., Belvisi, V., Caramma, I., Chiodera, A., Castelli, A. P., Rizzardini, G., Ridolfo, A. L., Piolini, R., Salpietro, S., Carenzi, L., Moioli, M. C., Tincati, C., Puzzolante, C., Abrescia, N., Chirianni, A., Borgia, G., Guida, M. G., Gargiulo, M., Orlando, R., 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., Viviani, F., Sasset, L., Mura, M. S., Rossetti, B., Caramello, P., Orofino, G. C., Sciandra, M., Bassetti, M., Londero, A., Pellizzer, G., Manfrin, V., GENTILE, Ivan, Di Biagio, Antonio, Cozzi-lepri, Alessandro, Prinapori, Roberta, Angarano, Gioacchino, Gori, Andrea, Quirino, Tiziana, De Luca, Andrea, Costantini, Andrea, Mussini, Cristina, Rizzardini, Giuliano, Castagna, Antonella, Antinori, Andrea, Monforte, Antonella D'arminioA, for the ICONA Foundation Study, Group, Lazzarin, A, Di Biagio, A, Cozzi Lepri, A, Prinapori, R, Angarano, G, Gori, A, Quirino, T, De Luca, A, Costantini, A, Mussini, C, Rizzardini, G, Castagna, A, Antinori, A, Monforte, A, Moroni, M, Andreoni, M, D'Arminio Monforte, A, Castelli, F, Cauda, R, Di Perri, G, Galli, M, Iardino, R, Ippolito, G, Perno, C, Von Schloesser, F, Viale, P, Ceccherini Silberstein, F, Girardi, E, Lo Caputo, S, Puoti, M, Ammassari, A, Balotta, C, Bandera, A, Bonfanti, P, Bonora, S, Borderi, M, Calcagno, A, Calza, L, Capobianchi, M, Cingolani, A, Cinque, P, Gianotti, N, Guaraldi, G, Lapadula, G, Lichtner, M, Madeddu, G, Maggiolo, F, Marchetti, G, Marcotullio, S, Monno, L, Quiros Roldan, E, Rossotti, R, Rusconi, S, Santoro, M, Saracino, A, Zaccarelli, M, Fanti, I, Galli, L, Lorenzini, P, Rodano, A, Shanyinde, M, Tavelli, A, Giacometti, A, Mazzoccato, S, Santoro, C, Suardi, C, Vanino, E, Verucchi, G, Minardi, C, Abeli, C, Manconi, P, Piano, P, Vecchiet, J, Falasca, K, Sighinolfi, L, Segala, D, Mazzotta, F, Cassola, G, Viscoli, C, Alessandrini, A, Piscopo, R, Mazzarello, G, Mastroianni, C, Belvisi, V, Caramma, I, Chiodera, A, Castelli, A, Ridolfo, A, Piolini, R, Salpietro, S, Carenzi, L, Moioli, M, Tincati, C, Puzzolante, C, Abrescia, N, Chirianni, A, Borgia, G, Guida, M, Gargiulo, M, Gentile, I, Orlando, R, Baldelli, F, Francisci, D, Parruti, G, Ursini, T, Magnani, G, Ursitti, M, Vullo, V, D'Avino, A, Gallo, L, Nicastri, E, Acinapura, R, Capozzi, M, Libertone, R, Tebano, G, Viviani, F, Sasset, L, Mura, M, Rossetti, B, Caramello, P, Orofino, G, Sciandra, M, Bassetti, M, Londero, A, Pellizzer, G, Manfrin, V, Cozzi Lepri, Alessandro, Monforte, Antonella D'arminio, Moroni, M., Andreoni, M., Angarano, G., Antinori, A., D'Arminio Monforte, A., Castelli, F., Cauda, R., Di Perri, G., Galli, M., Iardino, R., Ippolito, G., Lazzarin, A., Perno, C. F., Von Schloesser, F., Viale, P., Castagna, A., Ceccherini Silberstein, F., Cozzi Lepri, A., Girardi, E., Lo Caputo, S., Mussini, C., Puoti, M., Ammassari, A., Balotta, C., Bandera, A., Bonfanti, P., Bonora, S., Borderi, M., Calcagno, A., Calza, L., 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., Maggiolo, F., Marchetti, G., Marcotullio, S., Monno, L., Quiros Roldan, E., Rossotti, R., Rusconi, S., Santoro, M., Saracino, A., Zaccarelli, M., Fanti, I., Galli, L., Lorenzini, P., Rodano, A., Shanyinde, M., Tavelli, A., Giacometti, A., Costantini, A., Mazzoccato, S., Santoro, 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, C., Alessandrini, A., Piscopo, R., Mazzarello, G., Mastroianni, C., Belvisi, V., Caramma, I., Chiodera, A., Castelli, A. P., Rizzardini, G., Ridolfo, A. L., Piolini, R., Salpietro, S., Carenzi, L., Moioli, M. C., Tincati, C., Puzzolante, C., Abrescia, N., Chirianni, A., Borgia, G., Guida, M. G., Gargiulo, M., Gentile, Ivan, Orlando, R., 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., Viviani, F., Sasset, L., Mura, M. S., Rossetti, B., Caramello, P., Orofino, G. C., Sciandra, M., Bassetti, M., Londero, A., Pellizzer, G., Manfrin, V., Cozzi-Lepri, Alessandro, d'Arminio Monforte, Antonella, for the ICONA Foundation Study Group: [.., P Viale, E Vanino, G Verucchi, and ]

Subjects
0301 basic medicine, Male, Time Factors, HIV Infections, 0302 clinical medicine, Quality of life, HIV Infection, Pharmacology (medical), 030212 general & internal medicine, Precision Medicine, Antiretroviral therapy, Discontinuation, First-line therapy, HIV-1, Resumption treatment, Single-tablet regimen, Adolescent, Adult, Anti-HIV Agents, Drug Therapy, Combination, Female, Humans, Middle Aged, Young Adult, Infectious Diseases, Lamivudine, Clinical Science, Toxicity, Combination, ComputingMethodologies_DOCUMENTANDTEXTPROCESSING, medicine.drug, Human, medicine.medical_specialty, Time Factor, Infectious Disease, Settore MED/17 - MALATTIE INFETTIVE, NO, 03 medical and health sciences, Zidovudine, Pharmacotherapy, Drug Therapy, Internal medicine, medicine, Antiretroviral therapy Discontinuation First-line therapy HIV-1 Resumption treatment Single-tablet regimen, Antiretroviral therapy, Discontinuation, First-line therapy, HIV-1, Resumption treatment, Single-tablet regimen, Proportional hazards model, business.industry, Anti-HIV Agent, 030112 virology, Surgery, Regimen, business
Abstract

Supplemental Digital Content is Available in the Text., Background: Study aim was to estimate the rate and identify predictors of discontinuation of first combination antiretroviral therapy (cART) in recent years. Methods: Patients who initiated first cART between January 2008 and October 2014 were included. Discontinuation was defined as stop of at least 1 drug of the regimen, regardless of the reason. All causes of discontinuation were evaluated and 3 main endpoints were considered: toxicity, intolerance, and simplification. Predictors of discontinuation were examined separately for all 3 endpoints. Kaplan–Meier analysis was used for the outcome discontinuation of ≥1 drug regardless of the reason. Cox regression analysis was used to identify factors associated with treatment discontinuation because of the 3 reasons considered. Results: A total of 4052 patients were included. Main reason for stopping at least 1 drug were simplification (29%), intolerance (21%), toxicity (19%), other causes (18%), failure (8%), planned discontinuation (4%), and nonadherence (2%). In a multivariable Cox model, predictors of discontinuation for simplification were heterosexual transmission (P = 0.007), being immigrant (P = 0.017), higher nadir lymphocyte T CD4+ cell (P = 0.011), and higher lymphocyte T CD8+ cell count (P = 0.025); for discontinuation due to intolerance: the use of statins (P = 0.029), higher blood glucose levels (P = 0.050). About toxicity: higher blood glucose levels (P = 0.010) and the use of zidovudine/lamivudine as backbone (P = 0.044). Conclusions: In the late cART era, the main reason for stopping the initial regimen is simplification. This scenario reflects the changes in recommendations aimed to enhance adherence and quality of life, and minimize drug toxicity.

Published
2016

4. CD4/CD8 ratio normalisation and non-AIDS-related events in individuals with HIV who achieve viral load suppression with antiretroviral therapy: An observational cohort study

Author

Mussini, C, Lorenzini, P, Cozzi Lepri, A, LAPADULA, GIUSEPPE, Marchetti, G, Nicastri, E, Cingolani, A, Lichtner, M, Antinori, A, GORI, ANDREA, Monforte, A, Moroni, M, Andreoni, M, Angarano, G, d'Arminio Monforte, A, Castelli, F, Cauda, R, Di Perri, G, Galli, M, Iardino, R, Ippolito, G, Lazzarin, A, Perno, C, von Schloesser, F, Viale, P, Castagna, A, Ceccherini Silberstein, F, Girardi, E, Lo Caputo, S, Puoti, M, Ammassari, A, Balotta, C, Bonfanti, P, Bonora, S, Borderi, M, Capobianchi, M, Cinque, P, De Luca, A, Di Biagio, A, Gianotti, N, Gori, A, Guaraldi, G, Lapadula, G, Madeddu, G, Maggiolo, F, Marcotullio, S, Monno, L, Quiros Roldan, E, Rusconi, S, Saracino, A, Cicconi, P, Fanti Galli, I, Tavelli, A, Giacometti, A, Costantini, A, Mazzoccato, S, Santoro, C, Suardi, C, Vanino, E, Verucchi, G, Minardi, C, Quirino, T, Abeli, C, E. Manconi, P, Piano, P, Vecchiet, J, Falasca, K, Sighinolfi, L, Segala, D, Mazzotta, F, Cassola, G, Viscoli, C, Alessandrini, A, Piscopo, R, Mazzarello, G, Mastroianni, C, Belvisi, V, Caramma, I, Chiodera, A, Castelli, A, Rizzardini, G, Ridolfo, A, Piolini, R, Salpietro, S, Carenzi, L, Moioli, M, Tincati, C, Puzzolante, C, Abrescia, N, Chirianni, A, Guida, M, Gargiulo, M, Baldelli, F, Francisci, D, Parruti, G, Ursini, T, Magnani, G, Ursitti, M, Vullo, V, D'Avino, A, Gallo, L, Acinapura, R, Capozzi, M, Libertone, R, Tebano, G, Cattelan, A, Sasset, L, Mura, M, Rossetti, B, Caramello, P, Orofino, G, Sciandra, M, Bassetti, M, Londero, A, Pellizzer, G, Manfrin, V., Mussini, C, Lorenzini, P, Cozzi Lepri, A, Lapadula, G, Marchetti, G, Nicastri, E, Cingolani, A, Lichtner, M, Antinori, A, Gori, A, Monforte, A, Moroni, M, Andreoni, M, Angarano, G, d'Arminio Monforte, A, Castelli, F, Cauda, R, Di Perri, G, Galli, M, Iardino, R, Ippolito, G, Lazzarin, A, Perno, C, von Schloesser, F, Viale, P, Castagna, A, Ceccherini Silberstein, F, Girardi, E, Lo Caputo, S, Puoti, M, Ammassari, A, Balotta, C, Bonfanti, P, Bonora, S, Borderi, M, Capobianchi, M, Cinque, P, De Luca, A, Di Biagio, A, Gianotti, N, Guaraldi, G, Madeddu, G, Maggiolo, F, Marcotullio, S, Monno, L, Quiros Roldan, E, Rusconi, S, Saracino, A, Cicconi, P, Fanti Galli, I, Tavelli, A, Giacometti, A, Costantini, A, Mazzoccato, S, Santoro, C, Suardi, C, Vanino, E, Verucchi, G, Minardi, C, Quirino, T, Abeli, C, E. Manconi, P, Piano, P, Vecchiet, J, Falasca, K, Sighinolfi, L, Segala, D, Mazzotta, F, Cassola, G, Viscoli, C, Alessandrini, A, Piscopo, R, Mazzarello, G, Mastroianni, C, Belvisi, V, Caramma, I, Chiodera, A, Castelli, A, Rizzardini, G, Ridolfo, A, Piolini, R, Salpietro, S, Carenzi, L, Moioli, M, Tincati, C, Puzzolante, C, Abrescia, N, Chirianni, A, Guida, M, Gargiulo, M, Baldelli, F, Francisci, D, Parruti, G, Ursini, T, Magnani, G, Ursitti, M, Vullo, V, D'Avino, A, Gallo, L, Acinapura, R, Capozzi, M, Libertone, R, Tebano, G, Cattelan, A, Sasset, L, Mura, M, Rossetti, B, Caramello, P, Orofino, G, Sciandra, M, Bassetti, M, Londero, A, Pellizzer, G, Manfrin, V, Cristina, Mussini, Patrizia, Lorenzini, Alessandro, Cozzi-lepri, Giuseppe, Lapadula, Giulia, Marchetti, Emanuele, Nicastri, Antonella, Cingolani, Miriam, Lichtner, Andrea, Antinori, Andrea, Gori, Antonella D'arminio, Monforte, behalf the Icona Foundation Study Group, On, Castagna, Antonella, Mussini, Cristina, Lorenzini, Patrizia, Cozzi-Lepri, Alessandro, Lapadula, Giuseppe, Marchetti, Giulia, Nicastri, Emanuele, Cingolani, Antonella, Lichtner, Miriam, Antinori, Andrea, Gori, Andrea, Monforte, Antonella d'Arminio, Moroni, M., Andreoni, M., Angarano, G., Antinori, A., d'Arminio Monforte, A., Castelli, F., Cauda, R., Di Perri, G., Galli, M., Iardino, R., Ippolito, G., Lazzarin, A., Perno, C.F., von Schloesser, F., Viale, P., Castagna, A., Ceccherini-Silberstein, F., Cozzi-Lepri, A., Girardi, E., Lo Caputo, S., Mussini, C., Puoti, M., Ammassari, A., 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, Giordano, Maggiolo, F., Marchetti, G., Marcotullio, S., Monno, L., Quiros Roldan, E., Rusconi, S., Saracino, A., Cicconi, P., Fanti Galli, I., Lorenzini, P., Tavelli, A., Giacometti, A., Costantini, A., Mazzoccato, S., Santoro, C., Suardi, C., Vanino, E., Verucchi, G., Minardi, C., Quirino, T., Abeli, C., E Manconi, P., Piano, P., Vecchiet, J., Falasca, K., Sighinolfi, L., Segala, D., Mazzotta, F., Cassola, G., Viscoli, C., Alessandrini, A., Piscopo, R., Mazzarello, G., Mastroianni, C., Belvisi, V., Caramma, I., Chiodera, A., Castelli, A.P., Rizzardini, G., Ridolfo, A.L., Piolini, R., Salpietro, S., Carenzi, L., Moioli, M.C., Tincati, 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., Sasset, L., Mura, M.S., Rossetti, B., Caramello, P., Orofino, G.C., Sciandra, M., Bassetti, M., Londero, A., Pellizzer, G., and Manfrin, V.

Subjects
Adult, Male, medicine.medical_specialty, Anti-HIV Agents, Epidemiology, Immunology, Infectious Diseases, Virology, CD4 Lymphocyte Count, CD4-CD8 Ratio, Cohort Studies, Female, HIV Infections, HIV-1, Humans, Italy, Middle Aged, Viral Load, Population, Infectious Disease, Settore MED/17 - MALATTIE INFETTIVE, NO, symbols.namesake, Acquired immunodeficiency syndrome (AIDS), Internal medicine, epidemiology, immunology, infectious diseases, virology, medicine, Poisson regression, education, education.field_of_study, business.industry, Adult, Anti-HIV Agents, CD4 Lymphocyte Count, CD4-CD8 Ratio, Cohort Studies, Female, HIV Infections, HIV-1, Humans, Italy, Male, Middle Aged, Viral Load, medicine.disease, Cohort, symbols, business, Viral load, Cohort study
Abstract

Background: In patients with HIV, immune reconstitution after antiretroviral therapy (ART) is often incomplete. We assessed the probability of patients reaching a CD4/CD8 ratio of 1 or more after the start of ART and its association with the onset of non-AIDS-defining events and death. Methods: We did an analysis of the ICONA cohort, which recruited treatment-naive patients with HIV in Italy. We included participants in the cohort who started ART, reached an undetectable viral load (≤80 copies per mL), and had a CD4/CD8 ratio of less than 0·8 at the time of an undetectable viral load. We defined ratio normalisation in patients as two consecutive values of 1 or more. We used Kaplan-Meier curves to estimate the cumulative probability of ratio normalisation. We then used Poisson regression models to identify factors independently associated with normalisation and with progression to non-AIDS-defining events or death. Findings: We included 3236 participants, enrolled between Jan 22, 1997, and Feb 25, 2013. At the start of ART, median CD4/CD8 ratio in our population was 0·39 (IQR 0·26-0·55). 458 (14%) patients reached a CD4/CD8 ratio of 1 or more; the estimated probability of normalisation was 4·4% (95% CI 3·7-5·2) by 1 year from baseline, 11·5% (10·2-13·0) by 2 years, and 29·4% (26·7-32·4) by 5 years. Factors associated with normalisation were high pre-ART CD4 cell counts, a high CD4/CD8 ratio at baseline, and negative cytomegalovirus serological findings. The incidence rate of non-AIDS-defining events for patients with a CD4/CD8 ratio of less than 0·30 (4·2 per 100 patient-years, 95% CI 3·4-5·3) was double that for those with a ratio of 0·30-0·45 (2·3, 2·1-2·5) or more than 0·45 (2·2, 1·7-2·9). A ratio of less than 0·30 was independently associated with an increased risk of non-AIDS-defining events or death compared with one of more than 0·45. Interpretation: Few patients had normalised CD4/CD8 ratios, even though they had viral suppression. Low ratios were associated with increased risk of serious events and deaths. The CD4/CD8 ratio could be used by clinicians to identity patients at risk of non-AIDS-related events. Funding: AbbVie, Bristol-Myers Squibb, Gilead, Janssen, Merck Sharp & Dohme, ViiV Italy.

Published
2015

5. Incidence and factors associated with the risk of sexually transmitted diseases in HIV-infected people seen for care in Italy: Data from the Icona Foundation cohort

Author

Cingolani, A, Zona, S., Girardi, E., Cozzi Lepri, A., Monno, L., Quiros Roldan, E., Guaraldi, G., Antinori, A., D'Arminio Monforte, A., Marcotullio, S., Ammassari, A., Castagna, A., Cingolani, A., De Luca, A., Di Biagio, A., Gori, A., Lazzarin, A., d'Arminio Monforte, A., Balotta, C., Perno, C. F., Mussini, C., Castelli, F., Ceccherini Silberstein, F., Maggiolo, F., von Schloesser, F., Angarano, G., DI PERRI, Giovanni, Ippolito, G., Lapadula, G., Madeddu, G., Marchetti, G., Fanti, I., Galli, L., Andreoni, M., Borderi, M., Galli, M., Lichtner, M., Moroni, M., Puoti, M., Capobianchi, M. R., Gianotti, N., Bonfanti, P., Cicconi, P., Cinque, P., Lorenzini, P., Viale, P., Cauda, R., Iardino, R., Bonora, Stefano, Lo Caputo, S., Rusconi, S., Formenti, T., Giacometti, A., Costantini, A., Mazzoccato, S., Santoro, 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, C., Alessandrini, A., Piscopo, R., Mazzarello, G., Mastroianni, C., Belvisi, V., Caramma, I., Chiodera, A., Castelli, A. P., Rizzardini, G., Ridolfo, A. L., Piolini, R., Salpietro, S., Carenzi, L., Moioli, M. C., Tincati, 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., Sasset, L., Mura, M. S., Rossetti, B., Caramello, P., Di Perri, G., Orofino, G. C., Bonora, S., Sciandra, M., Bassetti, M., Londero, A., Pellizzer, G., Manfrin, V., Cingolani, A., Zona, S., Girardi, E., Cozzi-Lepri, A., Monno, L., Quiros Roldan, E., Guaraldi, G., Antinori, A., D'Arminio Monforte, A., Marcotullio, F., on behalf of the Community-Oriented Study Group of the Icona Foundation Study, Group, Castagna, A, Cingolani, A, Zona, S, Girardi, E, Cozzi-Lepri, A, Monno, L, Quiros Roldan, E, Guaraldi, G, Antinori, A, D'Arminio Monforte, A, Marcotullio, S, Ammassari, A, De Luca, A, Di Biagio, A, Gori, A, Lazzarin, A, Balotta, C, Perno, C, Mussini, C, Castelli, F, Ceccherini-Silberstein, F, Maggiolo, F, von Schloesser, F, Angarano, G, Di Perri, G, Ippolito, G, Lapadula, G, Madeddu, G, Marchetti, G, Fanti, I, Galli, L, Andreoni, M, Borderi, M, Galli, M, Lichtner, M, Moroni, M, Puoti, M, Capobianchi, M, Gianotti, N, Bonfanti, P, Cicconi, P, Cinque, P, Lorenzini, P, Viale, P, Cauda, R, Iardino, R, Bonora, S, Lo Caputo, S, Rusconi, S, Formenti, T, Giacometti, A, Costantini, A, Mazzoccato, S, Santoro, C, Suardi, C, Vanino, E, Verucchi, G, Minardi, C, Quirino, T, Abeli, C, Manconi, P, Piano, P, Vecchiet, J, Falasca, K, Sighinolfi, L, Segala, D, Mazzotta, F, Cassola, G, Viscoli, C, Alessandrini, A, Piscopo, R, Mazzarello, G, Mastroianni, C, Belvisi, V, Caramma, I, Chiodera, A, Castelli, A, Rizzardini, G, Ridolfo, A, Piolini, R, Salpietro, S, Carenzi, L, Moioli, M, Tincati, C, Puzzolante, C, Abrescia, N, Chirianni, A, Guida, M, Gargiulo, M, Baldelli, F, Francisci, D, Parruti, G, Ursini, T, Magnani, G, Ursitti, M, D'Avino, A, Gallo, L, Nicastri, E, Acinapura, R, Capozzi, M, Libertone, R, Tebano, G, Cattelan, A, Sasset, L, Mura, M, Rossetti, B, Caramello, P, Orofino, G, Sciandra, M, Bassetti, M, Londero, A, Pellizzer, G, Manfrin, V, Cingolani A, Zona S, Girardi E, Cozzi-Lepri, Monno L, Quiros Roldan E, Guaraldi G, Antinori A, D'Arminio Monforte A, Marcotullio S, Ammassari A, Castagna A, De Luca A, Di Biagio A, Gori A, Lazzarin A, d'Arminio Monforte A, Balotta C, Perno C.F, Mussini C, Castelli Fl, Ceccherini-Silberstein F, Maggiolo F, von Schloesser F, Angarano G, Di Perri G, Ippolito G, Lapadula G, Madeddu G, Marchetti G, Fanti I, Galli L, Andreoni M, Borderi M, Galli M, Lichtner M, Moroni M, Puoti M, Capobianchi M.R, Gianotti N, Bonfanti P, Cicconi P, Cinque P, Lorenzini P, Cauda R Iardino R, Bonora S, Lo Caputo S, Rusconi S, Formenti T, Giacometti A, Costantini A, Mazzoccato S, Santoro C, Suardi C, Viale P, Vanino E, Verucchi G, Castelli F, Minardi C, Quirino T, Abeli C, Manconi P.E, Piano P, Vecchiet J, Falasca K, Sighinolfi L, Segala D, Mazzotta F, Cassola G, Viscoli C, Alessandrini A, Piscopo R, Mazzarello G, Mastroianni C, Belvisi V, Caramma I, Chiodera A, Castelli A.P, Rizzardini G, Ridolfo A.L, Piolini R, Salpietro S, Carenzi L, Moioli M.C, Tincati 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, Cauda R, Vullo V, d'Avino A, Gallo L, Nicastri E, Acinapura R, Capozzi M, Libertone R, Tebano G, Cattelan A, Sasset L, Mura M.S, Rossetti B, Caramello P, Orofino G.C, Sciandra M, Bassetti M, Londero A, Pellizzer G, and Manfrin V.

Subjects
Adult, Male, Health Knowledge, Attitudes, Practice, sexually transmitted diseases, Sexual Behavior, cohort, HIV, incidence, sexually transmitted diseases, Infectious Disease, Settore MED/17 - MALATTIE INFETTIVE, NO, Age Distribution, Risk Factors, HIV Seropositivity, Humans, Pharmacology (medical), Original Research, Aged, Sexually transmitted diseases, Practice, Cohort, HIV, Incidence, CD4 Lymphocyte Count, Female, Italy, Middle Aged, Sexually Transmitted Diseases, Viral Load, Health Policy, Infectious Diseases, Risk Factor, Health Knowledge, virus diseases, Sexually transmitted disease, cohort, incidence, Attitudes, Human
Abstract

Objectives: The aims of this study were to identify temporal trends in the incidence of sexually transmitted diseases (STDs) in a cohort of HIV-infected people and to evaluate factors associated with the risk of a new STD diagnosis. Methods: All HIV-infected patients in the Icona Foundation Study cohort enrolled after 1998 were included in this study. STD incidence rates (IRs) were calculated and stratified by calendar period. Predictors of STDs were identified using a Poisson regression model with sandwich estimates for standard errors. Results: Data for 9168 participants were analysed [median age 37.3 (range 18-81) years; 74% male; 30% men who have sex with men (MSM)]. Over 46736 person-years of follow-up (PYFU), 996 episodes of STDs were observed [crude IR 21.3/1000 PYFU; 95% confidence interval (CI) 20.0-22.6/1000 PYFU]. In multivariable Poisson regression analysis, MSM [rate ratio (RR) 3.03; 95% CI 2.52-3.64 versus heterosexuals], calendar period (RR 1.67; 95% CI 1.42-1.97 for 2008-2012 versus 1998-2002), HIV RNA>50 HIV-1 RNA copies/mL (RR 1.44; 95% CI 1.19-1.74 versus HIV RNA≤50 copies/mL) and a current CD4 count 500 cells/μL) were associated with an increased risk of STDs. In contrast, older age (RR 0.82 per 10 years older; 95% CI 0.77-0.89) and being currently on ART (RR 0.38; 95% CI 0.33-0.45) compared with being ART-naïve or on a treatment interruption were associated with a lower risk of developing STDs. Conclusions: An increase in the incidence of STDs was observed in more recent years. Interventions to prevent STDs and potential spread of HIV should target the younger population, MSM and people currently not receiving ART.

Published
2015

6. Evaluation of the Prognostic Value of Impaired Renal Function on Clinical Progression in a Large Cohort of HIV-Infected People Seen for Care in Italy

Author

Bandera, Alessandra, Gori, Andrea, Sabbatini, Francesca, Madeddu, Giordano, Bonora, Stefano, Libertone, Raffaella, Mastroianni, Claudio, Bonfanti, Paolo, Monforte, Antonella D'Arminio, Cozzi Lepri, Alessandro, Giacometti, A., Costantini, A., Mazzoccato, S., Angarano, G., Monno, L., Santoro, C., Maggiolo, F., Suardi, C., Viale, P., Borderi, M., Vanino, E., Verucchi, G., Castelli, Francesco, Roldan, E. Quiros, Minardi, C., Quirino, T, Abeli, C, Manconi, Paolo Emilio, Piano, Paola, Vecchiet, J., Falasca, K., Sighinolfi, L., Segala, D., Mazzotta, F., Lo Caputo, S., Cassola, G., Viscoli, C., Di Biagio, A., Alessandrini, A., Piscopo, R., Mazzarello, G., Belvisi, V., Caramma, I., Chiodera, A., Castelli, P., Moroni, M., Puoti, M., Galli, M., Lazzarin, A., Rizzardini, G., Ridolfo, A. L., Piolini, R., Rusconi, S., Balotta, C., Castagna, A., Marchetti, G., Tincati, C., Cicconi, P., Moioli, M. C., Cinque, P., Gianotti, N., Salpietro, S., Galli, L., Carenzi, L., Iardino, R., Tavelli, A., Mussini, C., Guaraldi, G., Marcotullio, S., Puzzolante, C., Lapadula, G., Abrescia, N., Chirianni, A., Borgia, G., Maddaloni, A., Gargiulo, M., Gentile, I., Orlando, R., Baldelli, F., Francisci, D., Parruti, G., Ursini, T., Magnani, G., Ursitti, M. a., Cauda, R., Antinori, A., Andreoni, M., Vullo, V., Ceccherini Silberstein, F., Cingolani, A., Girardi, E., D'Avino, A., Fanti, I., Gallo, L., Ippolito, G., Perno, C. Federico, Lichtner, M., Capobianchi, M. R., Nicastri, E., Acinapura, R., Ammassari, A., Capozzi, M., Tebano, G., Lorenzini, P., Von Schloesser, F., Zaccarelli, M., Viviani, F., Sasset, L., Mura, M. S., De Luca, A., Rossetti, B., Caramello, P., Di Perri, G., Orofino, G., Sciandra, M., Bassetti, M., Londero, A., Pellizzer, G., Manfrin, V., QUIROS ROLDAN, Maria Eugenia, Bandera, A, Gori, A, Sabbatini, F, Madeddu, G, Bonora, S, Libertone, R, Mastroianni, C, Bonfanti, P, Monforte, A, Cozzi Lepri, A, Giacometti, A, Costantini, A, Mazzoccato, S, Angarano, G, Monno, L, Santoro, C, Maggiolo, F, Suardi, C, Viale, P, Borderi, M, Vanino, E, Verucchi, G, Castelli, F, Roldan, E, Minardi, C, Quirino, T, Abeli, C, Manconi, P, Piano, P, Vecchiet, J, Falasca, K, Sighinolfi, L, Segala, D, Mazzotta, F, Lo Caputo, S, Cassola, G, Viscoli, C, Di Biagio, A, Alessandrini, A, Piscopo, R, Mazzarello, G, Belvisi, V, Caramma, I, Chiodera, A, Castelli, P, Moroni, M, Puoti, M, Galli, M, Lazzarin, A, Rizzardini, G, Ridolfo, A, Piolini, R, Rusconi, S, Balotta, C, Castagna, A, Marchetti, G, Tincati, C, Cicconi, P, Moioli, M, Cinque, P, Gianotti, N, Salpietro, S, Galli, L, Carenzi, L, Iardino, R, Tavelli, A, Mussini, C, Guaraldi, G, Marcotullio, S, Puzzolante, C, Lapadula, G, Abrescia, N, Chirianni, A, Borgia, G, Maddaloni, A, Gargiulo, M, Gentile, I, Orlando, R, Baldelli, F, Francisci, D, Parruti, G, Ursini, T, Magnani, G, Ursitti, M, Cauda, R, Antinori, A, Andreoni, M, Vullo, V, Ceccherini Silberstein, F, Cingolani, A, Girardi, E, D'Avino, A, Fanti, I, Gallo, L, Ippolito, G, Perno, C, Lichtner, M, Capobianchi, M, Nicastri, E, Acinapura, R, Ammassari, A, Capozzi, M, Tebano, G, Lorenzini, P, Von Schloesser, F, Zaccarelli, M, Viviani, F, Sasset, L, Mura, M, De Luca, A, Rossetti, B, Caramello, P, Di Perri, G, Orofino, G, Sciandra, M, Bassetti, M, Londero, A, Pellizzer, G, Manfrin, V, Bandera, Alessandra, Gori, Andrea, Sabbatini, Francesca, Madeddu, Giordano, Bonora, Stefano, Libertone, Raffaella, Mastroianni, Claudio, Bonfanti, Paolo, D'Arminio Monforte, Antonella, Cozzi-Lepri, Alessandro, on behalf the Icona Foundation Study, Group, Castagna, Antonella, Monforte, Antonella D'arminio, Cozzi-lepri, Alessandro, Giacometti, A., Costantini, A., Mazzoccato, S., Angarano, G., Monno, L., Santoro, C., Maggiolo, F., Suardi, C., Viale, P., Borderi, M., Vanino, E., Verucchi, G., Castelli, F., Roldan, E. Quiro, Minardi, C., Manconi, Paolo Emilio, Piano, Paola, Vecchiet, J., Falasca, K., Sighinolfi, L., Segala, D., Mazzotta, F., Lo Caputo, S., Cassola, G., Viscoli, C., Di Biagio, A., Alessandrini, A., Piscopo, R., Mazzarello, G., Belvisi, V., Caramma, I., Chiodera, A., Castelli, P., Moroni, M., Puoti, M., Galli, M., Lazzarin, A., Rizzardini, G., Ridolfo, A. L., Piolini, R., Rusconi, S., Balotta, C., Castagna, A., Marchetti, G., Tincati, C., Cicconi, P., Moioli, M. C., Cinque, P., Gianotti, N., Salpietro, S., Galli, L., Carenzi, L., Iardino, R., Tavelli, A., Mussini, C., Guaraldi, G., Marcotullio, S., Puzzolante, C., Lapadula, G., Abrescia, N., Chirianni, A., Borgia, G., Maddaloni, A., Gargiulo, M., Gentile, I., Orlando, R., Baldelli, F., Francisci, D., Parruti, G., Ursini, T., Magnani, G., Ursitti, M. A., Cauda, R., Antinori, A., Andreoni, M., Vullo, V., Ceccherini-silberstein, F., Cingolani, A., Girardi, E., D'Avino, A., Fanti, I., Gallo, L., Ippolito, G., Perno, C. Federico, Lichtner, M., Capobianchi, M. R., Nicastri, E., Acinapura, R., Ammassari, A., Capozzi, M., Tebano, G., Lorenzini, P., Von Schloesser, F., Zaccarelli, M., Viviani, F., Sasset, L., Mura, M. S., De Luca, A., Rossetti, B., Caramello, P., Di Perri, G., Orofino, G., Sciandra, M., Bassetti, M., Londero, A., Pellizzer, G., Manfrin, V., Bandera A, Gori A, Sabbatini F, Madeddu G, Bonora S, Libertone R, Mastroianni C, Bonfanti P, Monforte A.D, Cozzi-Lepri A, Giacometti A, Costantini A, Mazzoccato S, Angarano G, Monno L, Santoro C, Maggiolo F, Suardi C, Viale P, Borderi M, Vanino E, Verucchi G, Castelli F, Roldan E.Q, Minardi C, Quirino T, Abeli C, Manconi P.E, Piano P, Vecchiet J, Falasca K, Sighinolfi L, Segala D, Mazzotta F, Lo Caputo S, Cassola G, Viscoli C, Di Biagio A, Alessandrini A, Piscopo R, Mazzarello G, Belvisi V, Caramma I, Chiodera A, Castelli P, Moroni M, Puoti M, Galli M, Lazzarin A, Rizzardini G, Ridolfo A.L., Piolini R, Rusconi S, Balotta C, Castagna A, Marchetti G, Tincati C, Cicconi P, Moioli M.C, Cinque P, Gianotti N, Salpietro S, Galli L, Carenzi L, Iardino R, Tavelli A, Mussini C, Guaraldi G, Marcotullio S, Puzzolante C, Lapadula G, Abrescia N, Chirianni A, Borgia G, Maddaloni A, Gargiulo M, Gentile I, Orlando R, Baldelli F, Francisci D, Parruti G, Ursini T, Magnani G, Ursitti Ma, Cauda R, Antinori A, Andreoni M, Vullo V, Ceccherini-Silberstein F, Cingolani A, Girardi E, D'Avino A, Fanti I, Gallo L, Ippolito G, Perno C.F, Lichtner M, Capobianchi M.R, Nicastri E, Acinapura R, Ammassari A, Capozzi M, Tebano G, Lorenzini P, Von Schloesser F, Zaccarelli M, Viviani F, Sasset L, Mura M.S, De Luca A, Rossetti B, Caramello P, Di Perri G, Orofino G, Sciandra M, Bassetti M, Londero A, Pellizzer G, and Manfrin V.

Subjects
CHRONIC KIDNEY-DISEASE, Genetics and Molecular Biology (all), Male, fumarates, lcsh:Medicine, hiv, HIV Infections, Kidney Function Tests, GLOMERULAR-FILTRATION-RATE, Gastroenterology, Biochemistry, Cohort Studies, chemistry.chemical_compound, MED/17 Malattie infettive, ANTIRETROVIRAL THERAPY, INSUFFICIENCY, Risk Factors, Cardiovascular Disease, HIV Infection, lcsh:Science, Adult, Cardiovascular Diseases, Female, Follow-Up Studies, Glomerular Filtration Rate, Humans, Italy, Prognosis, Proportional Hazards Models, Disease Progression, Agricultural and Biological Sciences (all), Biochemistry, Genetics and Molecular Biology (all), Medicine (all), fumarate tdf, Multidisciplinary, CYSTATIN C, biology, ASSOCIATION, Adult, Cardiovascular Diseases, Cohort Studies, Disease Progression, Female, Follow-Up Studies, Glomerular Filtration Rate, HIV Infections, Humans, Italy, Kidney Function Tests, Male, Prognosis, Proportional Hazards Models, Risk Factors, CREATININE, Cohort study, Human, Research Article, medicine.medical_specialty, Prognosi, Renal function, HIV-1-INFECTED PATIENTS, NO, Follow-Up Studie, EVENTS, Acquired immunodeficiency syndrome (AIDS), RISK-FACTOR, Internal medicine, Diabetes mellitus, medicine, Risk factor, Creatinine, Kidney Function Test, Proportional hazards model, business.industry, Risk Factor, lcsh:R, medicine.disease, Cystatin C, chemistry, Immunology, biology.protein, Proportional Hazards Model, lcsh:Q, Cohort Studie, business
Abstract

Whilst renal dysfunction, especially mild impairment (602 (mildly impaired). Characteristics of patients were described after stratification in these groups and compared using chi-square test (categorical variables) or Kruskal Wallis test comparing median values. Follow-up accrued from baseline up to the date of the CCVD or AIDS related events or death or last available visit. Kaplan Meier curves were used to estimate the cumulative probability of occurrence of the events over time. Adjusted analysis was performed using a proportional hazards Cox regression model. We included 7,385 patients, observed for a median follow-up of 43 months (inter-quartile range [IQR]: 21-93 months). Over this time, 130 cerebro-cardiovascular events (including 11 deaths due to CCVD) and 311 AIDS-related events (including 45 deaths) were observed. The rate of CCVD events among patients with eGFR >90, 60-89, 90, 60-89

Published
2015

7. Long-term durability of tenofovir-based antiretroviral therapy In relation to the Co-administration of other drug classes in routine clinical practice

Author

Costarelli, Silvia, Cozzi-Lepri, Alessandro, Lapadula, Giuseppe, Bonora, Stefano, Madeddu, Giordano, Maggiolo, Franco, Antinori, Andrea, Galli, Massimo, Di Perri, Giovanni, Viale, Pierluigi, D'Arminio Monforte, Antonella, Gori, Andrea, Moroni, M., Andreoni, M., Angarano, G., Castelli, F., Cauda, R., Iardino, R., Ippolito, G., Lazzarin, A., Perno, C. F., Von Schloesser, F., Castagna, A., Ceccherini-Silberstein, F., Girardi, E., Lo Caputo, S., Mussini, C., Puoti, M., Ammassari, A., Balotta, C., Bonfanti, P., Borderi, M., Capobianchi, M. R., Cingolani, A., Cinque, P., De Luca, A., Di Biagio, A., Gianotti, N., Guaraldi, G., Lichtner, M., Marchetti, G., Marcotullio, S., Monno, L., Quiros Roldan, E., Rusconi, S., Saracino, A., Cicconi, P., Fanti, I., Galli, L., Lorenzini, P., Tavelli, A., Giacometti, A., Costantini, A., Mazzoccato, S., Santoro, 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, C., Alessandrini, A., Piscopo, R., Mazzarello, G., Mastroianni, C., Belvisi, V., Caramma, I., Chiodera, A., Castelli, A. P., Rizzardini, G., Ridolfo, A. L., Piolini, R., Salpietro, S., Carenzi, L., Moioli, M. C., Tincati, 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., Sasset, L., Mura, M. S., Rossetti, B., Caramello, P., Orofino, G. C., Sciandra, M., Bassetti, M., Londero, A., Pellizzer, G., Manfrin, V., Costarelli, S, Cozzi Lepri, A, Lapadula, G, Bonora, S, Madeddu, G, Maggiolo, F, Antinori, A, Galli, M, Di Perri, G, Viale, P, D'Arminio Monforte, A, Gori, A, Moroni, M, Andreoni, M, Angarano, G, Castelli, F, Cauda, R, Iardino, R, Ippolito, G, Lazzarin, A, Perno, C, Von Schloesser, F, Castagna, A, Ceccherini Silberstein, F, Girardi, E, Lo Caputo, S, Mussini, C, Puoti, M, Ammassari, A, Balotta, C, Bonfanti, P, Borderi, M, Capobianchi, M, Cingolani, A, Cinque, P, De Luca, A, Di Biagio, A, Gianotti, N, Guaraldi, G, Lichtner, M, Marchetti, G, Marcotullio, S, Monno, L, Quiros Roldan, E, Rusconi, S, Saracino, A, Cicconi, P, Fanti, I, Galli, L, Lorenzini, P, Tavelli, A, Giacometti, A, Costantini, A, Mazzoccato, S, Santoro, C, Suardi, C, Vanino, E, Verucchi, G, Minardi, C, Quirino, T, Abeli, C, Manconi, P, Piano, P, Vecchiet, J, Falasca, K, Sighinolfi, L, Segala, D, Mazzotta, F, Cassola, G, Viscoli, C, Alessandrini, A, Piscopo, R, Mazzarello, G, Mastroianni, C, Belvisi, V, Caramma, I, Chiodera, A, Castelli, A, Rizzardini, G, Ridolfo, A, Piolini, R, Salpietro, S, Carenzi, L, Moioli, M, Tincati, C, Puzzolante, C, Abrescia, N, Chirianni, A, Guida, M, Gargiulo, M, Baldelli, F, Francisci, D, Parruti, G, Ursini, T, Magnani, G, Ursitti, M, Vullo, V, D'Avino, A, Gallo, L, Nicastri, E, Acinapura, R, Capozzi, M, Libertone, R, Tebano, G, Cattelan, A, Sasset, L, Mura, M, Rossetti, B, Caramello, P, Orofino, G, Sciandra, M, Bassetti, M, Londero, A, Pellizzer, G, Manfrin, V, Cozzi-Lepri, A, and ICONA Foundation Study, Group

Subjects
0301 basic medicine, Male, Genetics and Molecular Biology (all), Medical Doctors, Health Care Providers, Adult, Anti-HIV Agents, Drug Therapy, Combination, Female, HIV Infections, HIV Protease Inhibitors, Humans, Middle Aged, Reverse Transcriptase Inhibitors, Ritonavir, Tenofovir, Biochemistry, Genetics and Molecular Biology (all), Agricultural and Biological Sciences (all), lcsh:Medicine, Pharmacology, Toxicology, Pathology and Laboratory Medicine, Biochemistry, MED/17 Malattie infettive, 0302 clinical medicine, Medicine and Health Sciences, Medicine, HIV Infection, Public and Occupational Health, 030212 general & internal medicine, Enzyme Inhibitors, lcsh:Science, media_common, Multidisciplinary, Antimicrobials, Pharmaceutics, Medicine (all), virus diseases, Drugs, Antiretrovirals, HIV diagnosis and management, Antivirals, Vaccination and Immunization, Reverse Transcriptase Inhibitor, 3. Good health, Professions, Combination, Human, medicine.drug, Research Article, Drug, medicine.medical_specialty, Long term durability, media_common.quotation_subject, Immunology, Antiretroviral Therapy, Microbiology, NO, 03 medical and health sciences, Pharmacotherapy, Antiviral Therapy, Drug Therapy, Internal medicine, Microbial Control, Virology, Physicians, Protease Inhibitors, HIV Protease Inhibitor, Toxicity, business.industry, lcsh:R, Anti-HIV Agent, Biology and Life Sciences, Adult, Anti-HIV Agents, Drug Therapy, Combination, Female, HIV Infections, HIV Protease Inhibitors, Humans, Male, Middle Aged, Reverse Transcriptase Inhibitors, Ritonavir, Tenofovir, 030112 virology, Antiretroviral therapy, Diagnostic medicine, Discontinuation, Clinical trial, Health Care, People and Places, Enzymology, lcsh:Q, Population Groupings, Preventive Medicine, business
Abstract

BACKGROUND: In clinical trials, toxicity leading to tenofovir disoproxil fumarate (TDF) discontinuation is rare (3% by 2 years); however in clinical practice it seems to be higher, particularly when TDF is co-administered with ritonavir-boosted protease inhibitors (PI/r). Aims of this study were to assess the rate of TDF discontinuations in clinical practice and to identify factors associated with the risk of stopping TDF. METHODS: All antiretroviral treatment (ART)-naive patients initiating a TDF-based regimen were selected from the ICONA Foundation Study cohort. The primary outcome was TDF discontinuation regardless of the reason; secondary outcome measures were TDF discontinuation due to toxicity and selective TDF discontinuation (that is, TDF discontinuation or substitution, maintaining unchanged the remaining antiretroviral treatment). RESULTS: 3,618 ART-naïve patients were included: 54% started a PI/r-based and 46% a NNRTI-based based regimen. Two-hundred-seventy-seven patients discontinued TDF and reintroduced ART within 30 days without TDF. The probability of TDF discontinuation regardless of the reason was of 7.4% (95%CI:6.4-8.5) by 2 years and 14.1% (95%CI:12.2-16.1) by 5 years. The 5-year KM estimates in the PI/r vs. NNRTI group were 20.4% vs. 7.6%, respectively (log-rank p = 0.0001), for the outcome of stopping regardless of the reason, and 10.7% vs. 4.7% (p = 0.0001) for discontinuation due to toxicity. PI/r use and lower eGFR were associated with an increased risk of discontinuing TDF. CONCLUSION: In our cohort, the frequency of TDF discontinuations was higher than that observed in clinical trials. Co-administration of TDF with PI/r was associated with an increased rate of TDF discontinuations. Further studies are needed to clarify the mechanisms that might have led to this outcome.

Published
2016

8. Increased risk of virologic failure to the first antiretroviral regimen in HIV-infected migrants compared to natives: Data from the ICONA cohort

Author

Saracino, A, Lorenzini, P, Lo Caputo, S, Girardi, E, Castelli, F, Bonfanti, P, Rusconi, S, Caramello, P, Abrescia, N, Mussini, C, Monno, L, d'Arminio Monforte, A, Moroni, M, Andreoni, M, Angarano, G, Antinori, A, Cauda, R, Di Perri, G, Galli, M, Iardino, R, Ippolito, G, Lazzarin, A, Perno, C, von Schloesser, F, P. , V, Castagna, A, Ceccherini Silberstein, F, Cozzi Lepri, A, Puoti, M, Ammassari, A, Balotta, C, Bonora, S, Borderi, M, Capobianchi, M, Cingolani, A, Cinque, P, De Luca, A, Di Biagio, A, Gianotti, N, Guaraldi, G, Lichtner, M, Madeddu, G, Maggiolo, F, Marchetti, G, Marcotullio, S, Quiros Roldan, E, A. , S, Cicconi, P, Fanti, I, Galli, L, Shanyinda, M, Tavelli, A, Giacometti, A, Costantini, A, Mazzoccato, S, Santoro, C, Suardi, C, Viale, P, Vanino, E, Verucchi, G, Minardi, C, Quirino, T, Abeli, C, Manconi, P, Piano, P, Vecchiet, J, Falasca, K, Sighinolfi, L, Segala, D, Mazzotta, F, Cassola, G, Viscoli, C, Alessandrini, A, Piscopo, R, Mazzarello, G, Mastroianni, C, Belvisi, V, Caramma, I, Chiodera, A, Castelli, A, Rizzardini, G, Ridolfo, A, Piolini, R, Salpietro, S, Carenzi, L, Moioli, M, Tincati, C, Puzzolante, C, Gori, A, Lapadula, G, Chirianni, A, Borgia, G, Guida, M, Gargiulo, M, Gentile, I, Orlando, R, Baldelli, F, Francisci, D, Parruti, G, Ursini, T, Magnani, G, Ursitti, M, Vullo, V, D'Avino, A, Gallo, L, Nicastri, E, Acinapura, R, Capozzi, M, Libertone, R, Tebano, G, Zaccarelli, M, Viviani, F, Sasset, L, Mura, M, Rossetti, B, Orofino, G, Sciandra, M, Bassetti, M, Londero, A, Pellizzer, G, Manfrin, V., GORI, ANDREA, LAPADULA, GIUSEPPE, Saracino, A, Lorenzini, P, Lo Caputo, S, Girardi, E, Castelli, F, Bonfanti, P, Rusconi, S, Caramello, P, Abrescia, N, Mussini, C, Monno, L, d'Arminio Monforte, A, for the ICONA Foundation Study, Group, Castagna, A, Lazzarin, A, Moroni, M, Andreoni, M, Angarano, G, Antinori, A, Cauda, R, Di Perri, G, Galli, M, Iardino, R, Ippolito, G, Perno, C, von Schloesser, F, P., V, Ceccherini Silberstein, F, Cozzi Lepri, A, Puoti, M, Ammassari, A, Balotta, C, Bonora, S, Borderi, M, Capobianchi, M, Cingolani, A, Cinque, P, De Luca, A, Di Biagio, A, Gianotti, N, Gori, A, Guaraldi, G, Lapadula, G, Lichtner, M, Madeddu, G, Maggiolo, F, Marchetti, G, Marcotullio, S, Quiros Roldan, E, A., S, Cicconi, P, Fanti, I, Galli, L, Shanyinda, M, Tavelli, A, Giacometti, A, Costantini, A, Mazzoccato, S, Santoro, C, Suardi, C, Viale, P, Vanino, E, Verucchi, G, Minardi, C, Quirino, T, Abeli, C, Manconi, P, Piano, P, Vecchiet, J, Falasca, K, Sighinolfi, L, Segala, D, Mazzotta, F, Cassola, G, Viscoli, C, Alessandrini, A, Piscopo, R, Mazzarello, G, Mastroianni, C, Belvisi, V, Caramma, I, Chiodera, A, Castelli, A, Rizzardini, G, Ridolfo, A, Piolini, R, Salpietro, S, Carenzi, L, Moioli, M, Tincati, C, Puzzolante, C, Chirianni, A, Borgia, G, Guida, M, Gargiulo, M, Gentile, I, Orlando, R, Baldelli, F, Francisci, D, Parruti, G, Ursini, T, Magnani, G, Ursitti, M, Vullo, V, D'Avino, A, Gallo, L, Nicastri, E, Acinapura, R, Capozzi, M, Libertone, R, Tebano, G, Zaccarelli, M, Viviani, F, Sasset, L, Mura, M, Rossetti, B, Orofino, G, Sciandra, M, Bassetti, M, Londero, A, Pellizzer, G, Manfrin, V, Saracino, A., Lorenzini, P., Lo Caputo, S., Girardi, E., Castelli, F., Bonfanti, P., Rusconi, S., Caramello, P., Abrescia, N., Mussini, C., Gentile, Ivan, Borgia, Guglielmo, Orlando, Raffaele, Et, A, Monno, L., and d'Arminio Monforte, A.

Subjects
0301 basic medicine, Male, Pediatrics, HIV Infections, Comorbidity, Kaplan-Meier Estimate, migrants, Rate ratio, 0302 clinical medicine, Antiretroviral Therapy, Highly Active, HIV Infection, 030212 general & internal medicine, Treatment Failure, Transients and Migrants, virological failure, Incidence (epidemiology), General Medicine, Middle Aged, Viral Load, Antiretroviral therapy, Virologic failure, Treatment Outcome, Infectious Diseases, Italy, Cohort, Female, HIV, ICONA, Migrants, Adult, Anti-HIV Agents, CD4 Lymphocyte Count, HIV-1, Humans, Risk, Human, Microbiology (medical), medicine.medical_specialty, 030106 microbiology, antiretroviral therapy, Settore MED/17 - MALATTIE INFETTIVE, NO, 03 medical and health sciences, Acquired immunodeficiency syndrome (AIDS), Transients and Migrant, medicine, Highly Active, business.industry, Migrant, Anti-HIV Agent, Odds ratio, medicine.disease, Confidence interval, Discontinuation, Regimen, business
Abstract

Migrant and Italian HIV-infected patients (n = 5773) enrolled in the ICONA cohort in 2004-2014 were compared for disparities in access to an initial antiretroviral regimen and/or risk of virologic failure (VF), and determinants of failure were evaluated. Variables associated with initiating antiretroviral therapy (ART) were analysed. Primary endpoint was time to failure after at least 6 months of ART and was defined as: VF, first of two consecutive virus loads (VL) >200 copies/mL; treatment discontinuation (TD) for any reason; and treatment failure as confirmed VL >200 copies/mL or TD. A Poisson multivariable analysis was performed to control for confounders. Migrants presented significantly lower CD4 counts and more frequent AIDS events at baseline. When adjusting for baseline confounders, migrants presented a lower likelihood to begin ART (odds ratio 0.80, 95% confidence interval (CI) 0.67-0.95, p 0.012). After initiating ART, the incidence VF rate was 6.4 per 100 person-years (95% CI 4.8-8.5) in migrants and 2.7 in natives (95% CI 2.2-3.3). Multivariable analysis confirmed that migrants had a higher risk of VF (incidence rate ratio 1.90, 95% CI 1.25-2.91, p 0.003) and treatment failure (incidence rate ratio 1.16, 95% CI 1.01-1.33, p 0.031), with no differences for TD. Among migrants, variables associated with VF were age, unemployment and use of a boosted protease inhibitor-based regimen versus nonnucleoside reverse transcriptase inhibitors. Despite the use of more potent and safer drugs in the last 10 years, and even in a universal health care setting, migrants living with HIV still present barriers to initiating ART and an increased risk of VF compared to natives.

Published
2016

9. Prognostic Value of the Fibrosis-4 Index in Human Immunodeficiency Virus Type-1 Infected Patients Initiating Antiretroviral Therapy with or without Hepatitis C Virus

Author

Mussini C., Lorenzini P., Puoti M., Lichtner M., Lapadula G., Di Giambenedetto S., Antinori A., Madeddu G., Cozzi-Lepri A., D'Arminio Monforte A., De Luca A., Moroni M., Andreoni M., Angarano G., Castelli F., Cauda R., Di Perri G., Galli M., Iardino R., Ippolito G., Lazzarin A., Perno C. F., von Schloesser F., Viale P., Castagna A., Ceccherini-Silber-Stein F., Girardi E., Lo Caputo S., Ammassari A., Balotta C., Bandera A., Bonfanti P., Bonora S., Borderi M., Calcagno A., Calza L., Capobianchi M. R., Ceccherini-Silberstein F., Cingolani A., Cinque P., Di Biagio A., Gianotti N., Gori A., Guaraldi G., Maggiolo F., Marchetti G., Marcotullio S., Monno L., Nozza S., Roldan E. Q., Rossotti R., Rusconi S., Santoro M. M., Saracino A., Zaccarelli M., Fanti I., Galli L., Rodano A., Shanyinde M., Tavelli A., Giacometti A., Costantini A., Mazzoccato S., Santoro 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 C., Alessandrini A., Piscopo R., Mazzarello G., Mastroianni C., Belvisi V., Caramma I., Chiodera A., Castelli A. P., Rizzardini G., Ridolfo A. L., Piolini R., Salpietro S., Carenzi L., Moioli M. C., Tincati C., Puzzolante C., Abrescia N., Chirianni A., Borgia G., Di Martino F., Maddaloni L., Gentile I., Orlando R., Baldelli F., Francisci D., Parruti G., Ursini T., Magnani G., Ursitti M. A., Vullo V., Baldin G., Gallo L., Nicastri E., Acinapura R., Capozzi M., Libertone R., Savinelli S., Cecchetto M., Viviani F., Mura M. S., Rossetti B., Caramello P., Oro-Fino G. C., Sciandra M., Bassetti M., Londero A., Pellizzer G., Manfrin V., Mussini, C, Lorenzini, P, Puoti, M, Lichtner, M, Lapadula, G, Di Giambenedetto, S, Antinori, A, Madeddu, G, Cozzi-Lepri, A, D'Arminio Monforte, A, De Luca, A, Moroni, M, Andreoni, M, Angarano, G, Castelli, F, Cauda, R, Di Perri, G, Galli, M, Iardino, R, Ippolito, G, Lazzarin, A, Perno, C, von Schloesser, F, Viale, P, Castagna, A, Ceccherini-Silber-Stein, F, Girardi, E, Lo Caputo, S, Ammassari, A, Balotta, C, Bandera, A, Bonfanti, P, Bonora, S, Borderi, M, Calcagno, A, Calza, L, Capobianchi, M, Ceccherini-Silberstein, F, Cingolani, A, Cinque, P, Di Biagio, A, Gianotti, N, Gori, A, Guaraldi, G, Maggiolo, F, Marchetti, G, Marcotullio, S, Monno, L, Nozza, S, Roldan, E, Rossotti, R, Rusconi, S, Santoro, M, Saracino, A, Zaccarelli, M, Fanti, I, Galli, L, Rodano, A, Shanyinde, M, Tavelli, A, Giacometti, A, Costantini, A, Mazzoccato, S, Santoro, C, Suardi, C, Vanino, E, Verucchi, G, Minardi, C, Quirino, T, Abeli, C, Manconi, P, Piano, P, Vecchiet, J, Falasca, K, Sighinolfi, L, Segala, D, Mazzotta, F, Cassola, G, Viscoli, C, Alessandrini, A, Piscopo, R, Mazzarello, G, Mastroianni, C, Belvisi, V, Caramma, I, Chiodera, A, Castelli, A, Rizzardini, G, Ridolfo, A, Piolini, R, Salpietro, S, Carenzi, L, Moioli, M, Tincati, C, Puzzolante, C, Abrescia, N, Chirianni, A, Borgia, G, Di Martino, F, Maddaloni, L, Gentile, I, Orlando, R, Baldelli, F, Francisci, D, Parruti, G, Ursini, T, Magnani, G, Ursitti, M, Vullo, V, Baldin, G, Gallo, L, Nicastri, E, Acinapura, R, Capozzi, M, Libertone, R, Savinelli, S, Cecchetto, M, Viviani, F, Mura, M, Rossetti, B, Caramello, P, Oro-Fino, G, Sciandra, M, Bassetti, M, Londero, A, Pellizzer, G, Manfrin, V, Mussini, Cristina, Lorenzini, Patrizia, Puoti, Massimo, Lichtner, Miriam, Lapadula, Giuseppe, Di Giambenedetto, Simona, Antinori, Andrea, Madeddu, Giordano, Cozzi Lepri, Alessandro, D'Arminio Monforte, Antonella, De Luca, Andrea, Moroni, M., Andreoni, ALESSANDRA MARIA, Angarano, G., Antinori, A., D'Arminio Monforte, A., Castelli, F., Cauda, R., Di Perri, G., Galli, M., Iardino, R., Ippolito, G., Lazzarin, A., Perno, C. F., Von Schloesser, F., Viale, P., Castagna, A., Ceccherini Silberstein, F., Cozzi Lepri, A., Girardi, E., Gentile, Ivan, Borgia, Guglielmo, Lo Caputo, S., Mussini, C., Puoti, M., Andreoni, M., Ammassari, A., Balotta, C., Bandera, A., Bonfanti, Patrizia, Bonora, S., Borderi, M., Calcagno, A., Calza, L., 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., Maggiolo, F., Marchetti, G., Marcotullio, S., Monno, L., Nozza, S., Quiros Roldan, E., Rossotti, R., Rusconi, S., Santoro, M. M., Saracino, A., Zaccarelli, M., Fanti, I., Galli, L., Lorenzini, P., Rodano, A., Shanyinde, M., Tavelli, A., C, Mussini, P. Lorenzini, M. Puoti, M. Lichtner, G. Lapadula, S. Di Giambenedetto, A. Antinori, G. Madeddu, A. Cozzi-Lepri, A. d’Arminio Monforte, A. De Luca, ICONA Foundation study group […, P Viale, E Vanino, G Verucchi, …], Cozzi-Lepri, Alessandro, D'arminio Monforte, Antonella, on behalf the ICONA Foundation Study, Grp, and Castagna, Antonella

Subjects
CD4-Positive T-Lymphocytes, Liver Cirrhosis, Male, Genetics and Molecular Biology (all), lcsh:Medicine, HIV Infections, hiv, Hepacivirus, medicine.disease_cause, Biochemistry, MED/17 Malattie infettive, Retrospective Studie, Risk Factors, HIV Infection, Prospective Studies, Viral, Chronic, lcsh:Science, Prospective cohort study, Multidisciplinary, Medicine (all), Adult, Anti-Retroviral Agents, Carcinoma, Hepatocellular, Female, HIV-1, Hepatitis C, Chronic, Humans, Liver, Liver Neoplasms, Middle Aged, Prognosis, RNA, Viral, Retrospective Studies, Viral Load, Agricultural and Biological Sciences (all), Biochemistry, Genetics and Molecular Biology (all), agricultural and biological sciences (all), biochemistry, genetics and molecular biology (all), medicine (all), virus diseases, Hepatitis C, Not available, CD4-Positive T-Lymphocyte, Liver Neoplasm, Hepatocellular carcinoma, Cohort, Viral load, Human, Research Article, Cart, medicine.medical_specialty, Prognosi, Hepatitis C virus, Liver Cirrhosi, Settore MED/17 - MALATTIE INFETTIVE, NO, Internal medicine, medicine, fibrosis, Hepaciviru, business.industry, Proportional hazards model, Risk Factor, lcsh:R, Carcinoma, Retrospective cohort study, Hepatocellular, medicine.disease, Prospective Studie, Immunology, RNA, lcsh:Q, Anti-Retroviral Agent, business
Abstract

Objective: To evaluate the Fibrosis (FIB)-4 index as a predictor of major liver-related events (LRE) and liver-related death (LRD) in human immunodeficiency virus (HIV) type-1 patients initiating combination antiretroviral therapy (cART). Design: Retrospective analysis of a prospective cohort study. Setting: Italian HIV care centers participating to the ICONA Foundation cohort. Participants: Treatment-naive patients enrolled in ICONA were selected who: initiated cART, had hepatitis C virus (HCV) serology results, were HBsAg negative, had an available FIB-4 index at cART start and during follow up. Methods: Cox regression models were used to determine the association of FIB4 with the risk of major LRE (gastrointestinal bleeding, ascites, hepatic encephalopathy, hepato-renal syndrome or hepatocellular carcinoma) or LRD. Results: Three-thousand four-hundred seventy-five patients were enrolled: 73.3% were males, 27.2% HCV seropositive. At baseline (time of cART initiation) their median age was 39 years, had a median CD4+ T cell count of 260 cells/uL, and median HIV RNA 4.9 log copies/mL, 65.9% had a FIB-4 3.25. Over a follow up of 18,662 person-years, 41 events were observed: 25 major LRE and 16 LRD (incidence rate, IR, 2.2 per 1,000 PYFU [95% confidence interval, CI 1.6–3.0]). IR was higher in HCV seropositives as compared to negatives (5.9 vs 0.5 per 1,000 PYFU). Higher baseline FIB-4 category as compared to 3.25: HR 4.25, 1.21–14.92) and time-updated FIB-4 (FIB-4 1.45–3.25: HR 3.40, 1.02–11.40; FIB-4 >3.25: HR 21.24, 6.75–66.84) were independently predictive of major LRE/LRD, after adjusting for HIV- and HCV-related variables, alcohol consumption and type of cART. Conclusions: The FIB-4 index at cART initiation, and its modification over time are risk factors for major LRE or LRD, independently of infection with HCV and could be used to monitor patients on cART.

Published
2015

10. Evolution of HIV-1 tropism at quasispecies level after 5 years of combination antiretroviral therapy in patients always suppressed or experiencing episodes of virological failure

Author

Rozera, Gabriella, Abbate, Isabella, Giombini, Emanuela, Castagna, Antonella, De Luca, Andrea, Ceccherini-Silberstein, Francesca, Cozzi Lepri, Alessandro, Cassola, Giovanni, Torti, Carlo, d'Arminio Monforte, Antonella, Ippolito, Giuseppe, Capobianchi, Maria R., Quiros, Roldan, Moroni M, M. E., Andreoni, M, Angarano, G, Antinori, A, d'Arminio Monforte, A, Castelli, F, Cauda, R, Di Perri, G, Galli, M, Iardino, R, Ippolito, G, Lazzarin, A, Perno, C, von Schloesser, F, Viale, P, Castagna, A, Ceccherini-Silberstein, F, Cozzi-Lepri, A, Girardi, E, Lo Caputo, S, Mussini, C, Puoti, M, Ammassari, A, Balotta, C, Bonfanti, P, Bonora, S, Borderi, M, Capobianchi, M, Cingolani, A, Cinque, P, De Luca, A, Di Biagio, A, Gianotti, N, Gori, A, Guaraldi, G, Lapadula, G, Lichtner, M, Madeddu, G, Maggiolo, F, Marchetti, G, Marcotullio, S, Monno, L, Quiros Roldan, E, Rusconi, S, Cicconi, P, Fanti, I, Formenti, T, Galli, L, Lorenzini, P, Carletti, F, Carrara, S, Castrogiovanni, A, Di Caro, A, Petrone, F, Prota, G, Quartu, S, Giacometti, A, Costantini, A, Mazzoccato, S, Santoro, C, Suardi, C, Vanino, E, Verucchi, G, Minardi, C, Quirino, T, Abeli, C, Manconi, P, Piano, P, Vecchiet, J, Falasca, K, Sighinolfi, L, Segala, D, Mazzotta, F, Cassola, G, Viscoli, C, Alessandrini, A, Piscopo, R, Mazzarello, G, Mastroianni, C, Belvisi, V, Caramma, I, Chiodera, A, Castelli, A, Rizzardini, G, Ridolfo, A, Piolini, R, Salpietro, S, Carenzi, L, Moioli, M, Tincati, C, Puzzolante, C, Abrescia, N, Chirianni, A, Guida, M, Gargiulo, M, Baldelli, F, Francisci, D, Parruti, G, Ursini, T, Magnani, G, Ursitti, M, Vullo, V, D'Avino, A, Gallo, L, Nicastri, E, Acinapura, R, Capozzi, M, Libertone, R, Tebano, G, Cattelan, A, Sasset, L, Mura, M, Rossetti, B, Caramello, P, Orofino, G, Sciandra, M, Bassetti, M, Londero, A, Pellizzer, G, Manfrin, V., Rozera, G, Abbate, I, Giombini, E, Castagna, A, De Luca, A, Ceccherini Silberstein, F, Cozzi Lepri, A, Cassola, G, Torti, C, d'Arminio Monforte, A, Ippolito, G, Capobianchi, M, Gori, A, Rozera G, Abbate I, Giombini E, Castagna A, De Luca A, Ceccherini-Silberstein F, Cozzi Lepri A, Cassola G, Torti C, d'Arminio Monforte A, Ippolito G, Capobianchi MR, ICONA Foundation Group […, Moroni M, Andreoni M, Angarano G, Antinori A, Castelli F, Cauda R, Di Perri G, Galli M, Iardino R, Lazzarin A, Perno C, von Schloesser F, Girardi E, Lo Caputo S, Mussini C, Puoti M, Ammassari A, Balotta C, Bonfanti P, Bonora S, Borderi M, Cingolani A, Cinque P, Gianotti N, Gori A, Guaraldi G, Lapadula G, Lichtner M, Madeddu G, Maggiolo F, Marchetti G, Marcotullio S, Monno L, Quiros Roldan E, Rusconi S, Cicconi P, Fanti I, Formenti T, Galli L, Lorenzini P, Carletti F, Carrara S, Castrogiovanni A, Di Caro A, Petrone F, Prota G, Quartu S, Giacometti A, Costantini A, Mazzoccato S, Santoro C, Suardi C, Viale P, Vanino E, Verucchi G, Minardi C, Quirino T, Abeli C, Manconi P, Piano P, Vecchiet J, Falasca K, Sighinolfi L, Segala D, Mazzotta F, Viscoli C, Alessandrini A, Piscopo R, Mazzarello G, Mastroianni C, Belvisi V, Caramma I, Chiodera A, Castelli A, Rizzardini G, Ridolfo A, Piolini R, Salpietro S, Carenzi L, Moioli M, Tincati C, Puzzolante C, Abrescia N, Chirianni A, Guida M, Gargiulo M, Baldelli F, Francisci D, Parruti G, Ursini T, Magnani G, Ursitti M, Vullo V, d'Avino A, Gallo L, Nicastri E, Acinapura R, Capozzi M, Libertone R, Tebano G, Cattelan A, Sasset L, Mura M, Rossetti B, Caramello P, Orofino G, Sciandra M, Bassetti M, Londero A, Pellizzer G, Manfrin V, …], Rozera, Gabriella, Abbate, Isabella, Giombini, Emanuela, ICONA Fdn, Grp, and Castagna, Antonella

Subjects
Male, Time Factors, HIV Infections, Cohort Studies, Co-receptor usage, CART, HIV Infection, Pharmacology (medical), Prospective Studies, Ultra-deep pyrosequencing, education.field_of_study, Medicine (all), Provirus, Middle Aged, Viral Load, Settore MED/07 - Microbiologia e Microbiologia Clinica, Infectious Diseases, Anti-Retroviral Agents, Viral evolution, Combination, Drug Therapy, Combination, Female, Viral load, Human, Microbiology (medical), Adult, Time Factor, HIV quasispecies, Tropism switch, HIV-1, Humans, Tropism, Evolution, Molecular, Pharmacology, cART, co-receptor usage, tropism switch, ultra-deep pyrosequencing, Evolution, Population, Viremia, Viral quasispecies, Biology, Settore MED/17 - MALATTIE INFETTIVE, NO, Drug Therapy, medicine, education, Molecular, medicine.disease, HIV quasispecie, Virology, CART, Co-receptor usage, HIV quasispecies, Tropism switch, Ultra-deep pyrosequencing, Prospective Studie, Immunology, Tissue tropism, Anti-Retroviral Agent, Cohort Studie
Abstract

Received 27 February 2014; returned 15 April 2014; revised 29 May 2014; accepted 12 June 2014Objectives:Tropism evolution of HIV-1 quasispecies was analysed by ultra-deep pyrosequencing (UDPS) inpatients on first-line combination antiretroviral therapy (cART) always suppressed or experiencing virologicalfailure episodes.Methods:Among ICONA patients, two groups of 20 patients on cARTfor ≥5 years, matched for baseline viraemiaand therapy duration, were analysed [Group I, patients always suppressed; and Group II, patients experiencingepisode(s) of virological failure]. Viral tropism was assessed by V3 UDPS on plasma RNA before therapy (T0) andon peripheral blood mononuclearcell proviral DNA before–after therapy (T0-T1), using geno2pheno false positiverate (FPR) (threshold for X4: 5.75). For each sample, quasispecies tropism was assigned according to X4 variantfrequency: R5, ,0.3% X4; minority X4, 0.3%–19.9% X4; and X4, ≥20% X4. An R5–X4 switch was defined as achange from R5/minority X4 in plasma/proviral genomes at T0 to X4 in provirus at T1.Results: At baseline, mean FPR and %X4 of viral RNA were positively correlated with those of proviral DNA. Aftertherapy, proviral DNA load significantly decreased in Group I; mean FPR of proviral quasispecies significantlydecreased and %X4 increased in Group II. An R5–X4 switch was observed in five patients (two in Group I andthree in Group II), all harbouring minority X4 variants at T0.Conclusions:UDPS analysis revealsthat the tropism switch isnot an ‘on–off’ phenomenon, but may result fromaprofound re-shaping of viral quasispecies, even under suppressive cART. However, episodes of virological failureseem to prevent reduction of proviral DNA and to accelerate viral evolution, as suggested by decreased FPR andincreased %X4 at T1 in Group II patients.Keywords: cART, HIV quasispecies, co-receptor usage, ultra-deep pyrosequencing, tropism switch

Published
2014

11. Pregnancy Outcomes Among ART-Naive and ART-Experienced HIV-Positive Women: Data From the ICONA Foundation Study Group, Years 1997-2013

Author

Moroni, M, Andreoni, M, Angarano, G, Antinori, A, d'Arminio Monforte, A, Castelli, F, Cauda, R, Di Perri, G, Galli, M, Iardino, R, Ippolito, G, Lazzarin, A, Perno, CF, von Schloesser, F, Viale, P, Castagna, A, Ceccherini Silberstein, F, Cozzi Lepri, A, Girardi, E, Lo Caputo, S, Mussini, C, Puoti, M, Ammassari, A, Balotta, C, Bonfanti, P, Bonora, S, Borderi, M, Capobianchi, MR, Cingolani, A, Cinque, P, De Luca, A, Di Biagio, A, Gianotti, N, Guaraldi, G, Lapadula, G, Lichtner, M, Madeddu, G, Maggiolo, F, Marchetti, G, Marcotullio, S, Monno, L, Quiros Roldan, E, Rusconi, S, Cicconi, P, Fanti, I, Formenti, T, Galli, L, Lorenzini, P, Giacometti, A, Costantin, A, Mazzoccato, S, Santoro, C, Suardi, C, Vanino, E, Verucchi, G, Minardi, C, Quirino, T, Abeli, C, Manconi, PE, Piano, P, Vecchiet, J, Falasca, K, Sighinolfi, L, Segala, D, Mazzotta, F, Cassola, G, Viscoli, C, Alessandrini, A, Piscopo, R, Mazzarello, G, Mastroianni, C, Belvisi, V, Caramma, I, Chiodera, A, Castelli, AP, Rizzardini, G, Ridolfo, AL, Piolini, R, Salpietro, S, Carenzi, L, Moioli, MC, Tincati, C, Puzzolante, C, Gori, A, Abrescia, N, Chirianni, A, Guida, MG, Gargiulo, M, Baldelli, F, Francisci, D, Parruti, G, Ursini, T, Magnani, G, Ursitti, MA, Vullo, V, d'Avino, A, Gallo, L, Nicastri, E, Acinapura, R, Capozzi, M, Libertone, R, Tebano, G, Cattelan, A, Sasset, L, Mura, MS, Rossetti, B, Caramello, P, Orofino, GC, Sciandra, M, Bassetti, M, Londero, A, Pellizzer, G, Manfrin, V., GORI, ANDREA, d'Arminio Monforte, Antonella, Galli, Laura, Lo Caputo, Sergio, Lichtner, Miriam, Pinnetti, Carmela, Bobbio, Nicoletta, Francisci, Daniela, Costantini, Andrea, Cingolani, Antonella, Castelli, Francesco, Girardi, Enrico, Castagna, Antonella, Moroni, M, Andreoni, M, Angarano, G, Antinori, A, d'Arminio Monforte, A, Castelli, F, Cauda, R, Di Perri, G, Galli, M, Iardino, R, Ippolito, G, Lazzarin, A, Perno, C, von Schloesser, F, Viale, P, Castagna, A, Ceccherini Silberstein, F, Cozzi Lepri, A, Girardi, E, Lo Caputo, S, Mussini, C, Puoti, M, Ammassari, A, Balotta, C, Bonfanti, P, Bonora, S, Borderi, M, Capobianchi, M, Cingolani, A, Cinque, P, De Luca, A, Di Biagio, A, Gianotti, N, Gori, A, Guaraldi, G, Lapadula, G, Lichtner, M, Madeddu, G, Maggiolo, F, Marchetti, G, Marcotullio, S, Monno, L, Quiros Roldan, E, Rusconi, S, Cicconi, P, Fanti, I, Formenti, T, Galli, L, Lorenzini, P, Giacometti, A, Costantin, A, Mazzoccato, S, Santoro, C, Suardi, C, Vanino, E, Verucchi, G, Minardi, C, Quirino, T, Abeli, C, Manconi, P, Piano, P, Vecchiet, J, Falasca, K, Sighinolfi, L, Segala, D, Mazzotta, F, Cassola, G, Viscoli, C, Alessandrini, A, Piscopo, R, Mazzarello, G, Mastroianni, C, Belvisi, V, Caramma, I, Chiodera, A, Castelli, A, Rizzardini, G, Ridolfo, A, Piolini, R, Salpietro, S, Carenzi, L, Moioli, M, Tincati, C, Puzzolante, C, Abrescia, N, Chirianni, A, Guida, M, Gargiulo, M, Baldelli, F, Francisci, D, Parruti, G, Ursini, T, Magnani, G, Ursitti, M, Vullo, V, D'Avino, A, Gallo, L, Nicastri, E, Acinapura, R, Capozzi, M, Libertone, R, Tebano, G, Cattelan, A, Sasset, L, Mura, M, Rossetti, B, Caramello, P, Orofino, G, Sciandra, M, Bassetti, M, Londero, A, Pellizzer, G, and Manfrin, V

Subjects
Pediatrics, Multivariate analysis, Infectious Disease Transmission, Protease Inhibitor, Human immunodeficiency virus (HIV), HIV Infections, medicine.disease_cause, Retrospective Studie, Pregnancy, Antiretroviral Therapy, Highly Active, Vertical, HIV Infection, Pharmacology (medical), Viral, Pregnancy Complications, Infectious, Multivariate Analysi, ART experienced, ART naives, Detectable viral load, Preterm delivery, Adult, Anti-HIV Agents, CD4 Lymphocyte Count, Female, Humans, Infant, Newborn, Infectious Disease Transmission, Vertical, Italy, Multivariate Analysis, Protease Inhibitors, RNA, Viral, Retrospective Studies, Viral Load, Pregnancy Outcome, Infectious Diseases, Infectious, Cohort, Viral load, Human, medicine.medical_specialty, Antiretroviral Therapy, Settore MED/17 - MALATTIE INFETTIVE, NO, medicine, Highly Active, Pregnancy outcomes, business.industry, Anti-HIV Agent, Infant, Retrospective cohort study, medicine.disease, Newborn, Antiretroviral therapy, Pregnancy Complications, Immunology, Pregnancy Complications, Infectiou, RNA, business
Abstract

Background: We analyzed antiretroviral therapy (ART) regimens and pregnancy outcomes in naive and ART-experienced HIV-positive women from Italian Cohort Naive Antiretrovirals cohort and investigated frequency and predictors of detectable viral load (VL) at delivery. Methods: All pregnancies resulting in live births were included. Based on ART at the beginning of pregnancy, pregnancies were allocated either to the ART-naive or ART-experienced group. Analyses were stratified according to calendar periods. Multivariate logistic regression was used to describe predictors of detectable VL at delivery. Results: One hundred fifty-eight of 2862 women experienced 169 pregnancies (88 in naives and 81 in 70 ART-experienced women). ART regimens varied according to calendar periods; mono-dual combination regimens progressively decreased over time (P value for trend 50 copies per milliliter at pregnancy ascertainment (adjusted odds ratio: 7.1, 95% confidence interval: 1.9 to 33.3, P = 0.006). Nevertheless, no cases of vertical transmission were diagnosed. Preterm birth rate of 17.3% (11.9% vs 22.6% naive and ART experienced, P = 0.1) was reported; this was not associated with ART duration or protease inhibitor-including regimens; 27.2% of infants had

Published
2014

12. Low-frequency drug-resistant HIV-1 and risk of virological failure to first-line NNRTI-based ART: a multicohort European case–control study using centralized ultrasensitive 454 pyrosequencing

Author

Cozzi-Lepri, Alessandro, Noguera-Julian, Marc, Di Giallonardo, Francesca, Schuurman, Rob, Däumer, Martin, Aitken, Sue, Ceccherini-Silberstein, Francesca, D'Arminio Monforte, Antonella, Geretti, Anna Maria, Booth, Clare L., Kaiser, Rolf, Michalik, Claudia, Jansen, Klaus, Masquelier, Bernard, Bellecave, Pantxika, Kouyos, Roger D., Castro, Erika, Furrer, Hansjakob, Schultze, Anna, Günthard, Huldrych F., Brun-Vezinet, Francoise, Paredes, Roger, Metzner, Karin J., Günthard, Huldrych, Brockmeyer, Norbert, Dabis, F., Bruyand, M., Chêne, G., Lawson-Ayayi, S., Thiébaut, R., Wittkop, L., André, K., Bonnal, F., Bonnet, F., Bernard, N., Caunègre, L., Cazanave, C., Ceccaldi, J., Chossat, I., Courtaud, K., Dauchy, F. A., De Witte, S., Dupon, M., Dupont, A., Duffau, P., Dutronc, H., Farbos, S., Gaborieau, V., Gemain, M. C., Gerard, Y., Greib, C., Hessamfar, M., Lacoste, D., Lataste, P., Lazaro, E., Longy-Boursier, M., Malvy, D., Meraud, J. P., Mercié, P., Monlun, E., Morlat, P., Neau, D., Ochoa, A., Pellegrin, J. L., Pistone, T., Receveur, M. C., Schmeltz, J. Roger, Tchamgoué, S., Vandenhende, M. A., Vareil, M.O., Viallard, J. F., Moreau, J. F., Pellegrin, I., Fleury, H., Lafon, M. E., Masquelier, B., Reigadas, S., Trimoulet, P., Bouchet, S., Breilh, D., Molimard, M., Titier, K., Haramburu, F., Miremont-Salamé., G., Blaizeau, M. J., Decoin, M., Delaune, J., Delveaux, S., D'Ivernois, C., Hanapier, C., Leleux, O., Lenaud, E., Uwamaliya-Nziyumvira, B., Sicard, X., Geffard, S., Le Marec, F., Conte, V., Frosch, A., Leray, J., Palmer, G., Touchard, D., Losso, M., Kundro, M., Ramos Mejia, J. M., Vetter, N., Zangerle, R., Karpov, I., Vassilenko, A., Mitsura, V. M., Suetnov, O., Clumeck, N., De Wit, S., Delforge, M., Florence, E., Vandekerckhove, L., Hadziosmanovic, V., Kostov, K., Begovac, J., Machala, L., Jilich, D., Sedlacek, D., Nielsen, J., Kronborg, G., Benfield, T., Larsen, M., Gerstoft, J., Katzenstein, T., Hansen, A.-B. E., Skinhøj, P., Pedersen, C., Ostergaard, L., Dragsted, U. B., Nielsen, L. N., Zilmer, K., Smidt, Jelena, Ristola, M., Katlama, C., Viard, J. P., Girard, P. M., Vanhems, P., Pradier, C., Duvivier, C., Rockstroh, J., Schmidt, R., van Lunzen, J., Degen, O., Stellbrink, H. J., Bickel, M., Bogner, J., Fätkenheuer, G., Kosmidis, J., Gargalianos, P., Xylomenos, G., Perdios, J., Sambatakou, H., Banhegyi, D., Gottfredsson, M., Mulcahy, F., Yust, I., Turner, D., Burke, M., Pollack, S., HassounRambam, G., Elinav, H., HaouziHadassah, M., EspositoI, R., Mazzotta, F., Vullo, V., Moroni, M., Andreoni, M., Angarano, G., Antinori, A., Castelli, F., Cauda, R., Di Perri, G., Galli, M., Iardino, R., Ippolito, G., Lazzarin, A., Perno, C. F., von Schloesser, F., Viale, P., Monforte, A. D'Arminio, Castagna, A., Ceccherini-Silberstein, F., Cozzi-Lepri, A., Girardi, E., Lo Caputo, S., Mussini, C., Puoti, M., Ammassari, A., 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., Maggiolo, F., Marchetti, G., Marcotullio, S., Monno, L., Quiros Roldan, E., Rusconi, S., Cicconi, P., Fanti, I., Formenti, T., Galli, L., Lorenzini, P., Carletti, F., Carrara, S., Castrogiovanni, A., Di Caro, A., Petrone, F., Prota, G., Quartu, S., Giacometti, A., Costantini, A., Mazzoccato, S., Santoro, 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., Cassola, G., Viscoli, C., Alessandrini, A., Piscopo, R., Mazzarello, G., Mastroianni, C., Belvisi, V., Caramma, I., Chiodera, A., Castelli, A. P., Rizzardini, G., D'Arminio Monforte, A., Ridolfo, A. L., Piolini, R., Salpietro, S., Carenzi, L., Moioli, M. C., Tincati, 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., d'Avino, A., Gallo, L., Nicastri, E., Acinapura, R., Capozzi, M., Libertone, R., Tebano, G., Cattelan, A., Sasset, L., Mura, M. S., Rossetti, B., Caramello, P., Orofino, G. C., Sciandra, M., Bassetti, M., Londero, A., Pellizzer, G., Manfrin, V., Brockmeyer, N. H., Skaletz-Rorowski, A., Dupke, S., Baumgarten, A., Carganico, A., Köppe, S., Kreckel, P., Lauenroth-Mai, E., Freiwald-Rausch, M., Gölz, J., Moll, A., Zeitz, M., Hower, M., Reuter, S., Jensen, B., Harrer, T., Esser, S., Brodt, H. R., Plettenberg, A., Stöhr, A., Buhk, T., Stoll, M., Kuhlmann, B., Mosthaf, F. A., Rieke, A., Becker, W., Volkert, R., Jäger, H., Hartl, H., Mutz, A., Ulmer, A., Müller, M., Aubert, V., Barth, J., Battegay, M., Bernasconi, E., Böni, J., Bucher, H. C., Burton-Jeangros, C., Calmy, A., Cavassini, M., Egger, M., Elzi, L., Fehr, J., Fellay, J., Furrer, H., Fux, C. A., Gorgievski, M., Günthard, H., Haerry, D., Hasse, B., Hirsch, H. H., Hösli, I., Kahlert, C., Kaiser, L., Keiser, O., Klimkait, T., Kovari, H., Kouyos, R., Ledergerber, B., Martinetti, G., Martinez de Tejada, B., Metzner, K., Müller, N., Nadal, D., Pantaleo, G., Rauch, A., Regenass, S., Rickenbach, M., Rudin, C., Schmid, P., Schultze, D., Schöni-Affolter, F., Schüpbach, J., Speck, R., Staehelin, C., Tarr, P., Telenti, A., Trkola, A., Vernazza, P., Weber, R., Yerly, S., Universitat de Vic. Càtedra de la Sida i Malalties Relacionades, CHAIN Minority HIV-1 Variants Working Group, Paredes, R., Metzner, KJ., Cozzi-Lepri, A., Schuurman, R., Brun-Vezinet, F., Günthard, H., Ceccherini-Silberstein, F., Kaiser, R., Geretti, AM., Brockmeyer, N., Masquelier, B., University of Zurich, and Metzner, Karin J

Subjects
Male, HIV Infections, Drug resistance, Gastroenterology, 2726 Microbiology (medical), Cohort Studies, 10234 Clinic for Infectious Diseases, chemistry.chemical_compound, 0302 clinical medicine, Antiretroviral Therapy, Highly Active, 2736 Pharmacology (medical), Pharmacology (medical), Treatment Failure, 030212 general & internal medicine, minority drug-resistant HIV-1 variants, CHAIN, antiretroviral therapy, European multicentre study, Original Research, 0303 health sciences, High-Throughput Nucleotide Sequencing, Antiretrovirals, Sida -- Tractament, Settore MED/07 - Microbiologia e Microbiologia Clinica, Virological failure, Antiretroviral therapy, 3. Good health, Europe, Infectious Diseases, 3004 Pharmacology, Reverse Transcriptase Inhibitors, Female, Cohort study, medicine.drug, Adult, Microbiology (medical), medicine.medical_specialty, Efavirenz, Nevirapine, Genotype, minority drug-resistant HIV-1 variants, First line, antiretroviral therapy, 610 Medicine & health, Biology, Risk Assessment, NO, Young Adult, 03 medical and health sciences, European multicentre study, Internal medicine, Drug Resistance, Viral, Minority drug-resistant HIV-1 variants, medicine, VIH (Virus), Humans, CHAIN, 030304 developmental biology, Pharmacology, Case-control study, Computational Biology, Sequence Analysis, DNA, 2725 Infectious Diseases, Virology, chemistry, Case-Control Studies, HIV-1, Pyrosequencing
Abstract

Objectives: It is still debated if pre-existing minority drug-resistant HIV-1 variants (MVs) affect the virological outcomes of first-line NNRTI-containing ART. Methods: This Europe-wide case–control study included ART-naive subjects infected with drug-susceptible HIV-1 as revealed by population sequencing, who achieved virological suppression on first-line ART including one NNRTI. Cases experienced virological failure and controls were subjects from the same cohort whose viraemia remained suppressed at a matched time since initiation of ART. Blinded, centralized 454 pyrosequencing with parallel bioinformatic analysis in two laboratories was used to identify MVs in the 1%–25% frequency range. ORs of virological failure according to MV detection were estimated by logistic regression. Results: Two hundred and sixty samples (76 cases and 184 controls), mostly subtype B (73.5%),were used for the analysis. Identical MVs were detected in the two laboratories. 31.6% of cases and 16.8% of controls harboured pre-existing MVs. Detection of at least one MV versus no MVs was associated with an increased risk of virological failure (OR¼2.75, 95% CI¼1.35–5.60, P¼0.005); similar associations were observed for at least one MV versus no NRTIMVs (OR¼2.27, 95% CI¼0.76–6.77, P¼0.140) and at least oneMV versus no NNRTIMVs (OR¼2.41, 95% CI¼1.12–5.18, P¼0.024). A dose–effect relationship between virological failure and mutational loadwas found. Conclusions: Pre-existing MVs more than double the risk of virological failure to first-line NNRTI-based ART.

Published
2015
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