51. Incidence and risk factors for liver enzyme elevation among naive HIV-1-infected patients receiving ART in the ICONA cohort
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Taramasso, L., Lorenzini, P., Di Biagio, A., Lichtner, M., Marchetti, G., Rossotti, R., Lapadula, G., Cozzi-Lepri, A., Vichi, F., Antinori, A., Bonora, S., D'Arminio Monforte, A., ICONA Foundation Study Group:, A d'Arminio Monforte, Antinori, A, Andreoni, M, Castagna, A, Castelli, F, Cauda, R, G Di Perri, Galli, M, Iardino, R, Ippolito, G, Lazzarin, A, C Marchetti, G, Rezza, G, F von Schloesser, Viale, P, A d'Arminio Monforte, Ceccherini-Silberstein, F, Cozzi-Lepri, A, Girardi, E, S Lo Caputo, Mussini, C, Puoti, M, F Perno, C, Bai, F, Balotta, C, Bandera, A, Bonora, S, Borderi, M, Calcagno, A, Capetti, A, R Capobianchi, M, Cicalini, S, Cingolani, A, Cinque, P, A De Luca, A Di Biagio, Gianotti, N, Gori, A, Guaraldi, G, Lapadula, G, Lichtner, M, Madeddu, G, Maggiolo, F, Marchetti, G, Monno, L, Nozza, S, Pinnetti, C, QUIROS ROLDAN, Maria Eugenia, Rossotti, R, Rusconi, S, M Santoro, M, Saracino, A, Sarmati, L, Fanti, I, Galli, L, Lorenzini, P, Rodano', A, Macchia, M, Tavelli, A, Carletti, F, Carrara, S, A Di Caro, Graziano, S, Petroni, F, Prota, G, Truffa, S, Giacometti, A, Costantini, A, Barocci, V, Angarano, G, Milano, E, Suardi, C, Donati, V, Verucchi, G, Castelnuovo, F, Minardi, C, Menzaghi, B, Abeli, C, Cacopardo, B, Celesia, B, Vecchiet, J, Falasca, K, Pan, A, Lorenzotti, S, Sighinolfi, L, Segala, D, Blanc, P, Vichi, F, Cassola, G, Viscoli, C, Alessandrini, A, Bobbio, N, Mazzarello, G, Vita, S, Bonfanti, P, Molteni, C, Chiodera, A, Milini, P, Nunnari, G, Pellicanò, G, Rizzardini, G, S Cannizzo, E, C Moioli, M, Piolini, R, Bernacchia, D, Salpietro, S, Tincati, C, Puzzolante, C, Migliorino, C, Sangiovanni, V, Borgia, G, Esposito, V, F Di Martino, Gentile, I, Rizzo, V, M Cattelan, A, Marinello, S, Cascio, A, Trizzino, M, Baldelli, F, Schiaroli, E, Parruti, G, Sozio, F, Magnani, G, A Ursitti, M, Cristaudo, A, Vullo, V, Acinapura, R, Moschese, D, Capozzi, M, Mondi, A, M Rivano Capparuccia, Iaiani, G, Latini, A, Gagliardini, R, M Plazzi, M, Savinelli, S, Vergori, A, Cecchetto, M, Viviani, F, A De Vito, Rossetti, B, Montagnani, F, Franco, A, R Fontana Del Vecchio, Francisci, D, C Di Giuli, Caramello, P, C Orofino, G, Sciandra, M, Bassetti, M, Londero, A, Pellizzer, G, Manfrin, V, Starnini, G, Ialungo, A, Taramasso, L, Lorenzini, P, Di Biagio, A, Lichtner, M, Marchetti, G, Rossotti, R, Lapadula, G, Cozzi-Lepri, A, Vichi, F, Antinori, A, Bonora, S, D'Arminio Monforte, A, d'Arminio Monforte, A, Andreoni, M, Castagna, A, Castelli, F, Cauda, R, Di Perri, G, Galli, M, Iardino, R, Ippolito, G, Lazzarin, A, Marchetti, Gc, Rezza, G, von Schloesser, F, Viale, P, Ceccherini-Silberstein, F, Girardi, E, Lo Caputo, S, Mussini, C, Puoti, M, Perno, Cf, Bai, F, Balotta, C, Bandera, A, Borderi, M, Calcagno, A, Capetti, A, Capobianchi, Mr, Cicalini, S, Cingolani, A, Cinque, P, De Luca, A, Gianotti, N, Gori, A, Guaraldi, G, Madeddu, G, Maggiolo, F, Monno, L, Nozza, S, Pinnetti, C, Quiros Roldan, E, Rusconi, S, Santoro, Mm, Saracino, A, Sarmati, L, Fanti, I, Galli, L, Rodano', A, Macchia, M, Tavelli, A, Carletti, F, Carrara, S, Di Caro, A, Graziano, S, Petroni, F, Prota, G, Truffa, S, Giacometti, A, Costantini, A, Barocci, V, Angarano, G, Milano, E, Suardi, C, Donati, V, Verucchi, G, Castelnuovo, F, Minardi, C, Menzaghi, B, Abeli, C, Cacopardo, B, Celesia, B, Vecchiet, J, Falasca, K, Pan, A, Lorenzotti, S, Sighinolfi, L, Segala, D, Blanc, P, Cassola, G, Viscoli, C, Alessandrini, A, Bobbio, N, Mazzarello, G, Vita, S, Bonfanti, P, Molteni, C, Chiodera, A, Milini, P, Nunnari, G, Pellicanò, G, Rizzardini, G, Cannizzo, E, Moioli, Mc, Piolini, R, Bernacchia, D, Salpietro, S, Tincati, C, Puzzolante, C, Migliorino, C, Sangiovanni, V, Borgia, G, Esposito, V, Di Martino, F, Gentile, I, Rizzo, V, Cattelan, Am, Marinello, S, Cascio, A, Trizzino, M, Baldelli, F, Schiaroli, E, Parruti, G, Sozio, F, Magnani, G, Ursitti, Ma, Cristaudo, A, Vullo, V, Acinapura, R, Moschese, D, Capozzi, M, Mondi, A, Capparuccia, Mr, Iaiani, G, Latini, A, Gagliardini, R, Plazzi, Mm, Savinelli, S, Vergori, A, Cecchetto, M, Viviani, F, De Vito, A, Rossetti, B, Montagnani, F, Franco, A, Fontana Del Vecchio, R, Francisci, D, Di Giuli, C, Caramello, P, Orofino, Gc, Sciandra, M, Bassetti, M, Londero, A, Pellizzer, G, Manfrin, V, Starnini, G, Ialungo, A, Taramasso L., Lorenzini P., Di Biagio A., Lichtner M., Marchetti G., Rossotti R., Lapadula G., Cozzi-Lepri A., Vichi F., Antinori A., Bonora S., Cascio A., D'Arminio Monforte A., Cascio A. in ICONA Foundation Study Group., Taramasso, L., Lorenzini, P., Di Biagio, A., Lichtner, M., Marchetti, G., Rossotti, R., Lapadula, G., Cozzi-Lepri, A., Vichi, F., Antinori, A., Bonora, S., D'Arminio Monforte, A., Castagna, A., and A d'Arminio Monforte,i, M Andreoni, A Castagna, F Castelli, R Cauda, G Di Perri, M Galli, R Iardino, G Ippolito, A Lazzarin, G Rezza, F von Schloesser, F Ceccherini-Silberstein, E Girardi, S Lo Caputo, C Mussini, M Puoti, C F Perno, F Bai, C Balotta, A Bandera, M Borderi, A Calcagno, A Capetti, M R Capobianchi, S Cicalini, A Cingolani, P Cinque, A De Luca, E Girardi, N Gianotti, A Gori, G Guaraldi, G Madeddu, F Maggiolo, L Monno, S Nozza, C Pinnetti, E Quiros Roldan, S Rusconi, M M Santoro, A Saracino, L Sarmati, I Fanti, A Rodano', M Macchia, A Tavelli, F Carletti, S Carrara, A Di Caro, S Graziano, F Petroni, G Prota, S Truffa, A Giacometti, A Costantini, V Barocci, G Angarano, L Monno, E Milano, F Maggiolo, C Suardi, P Viale, V Donati, G Verucchi, F Castelnuovo, C Minardi, B Menzaghi, C Abeli, B Cacopardo, B Celesia, J Vecchiet, K Falasca, A Pan, S Lorenzotti, L Sighinolfi, D Segala, P Blanc, G Cassola, C Viscoli, A Alessandrini, N Bobbio, G Mazzarello, S Vita, P Bonfanti, C Molteni, A Chiodera, P Milini, G Nunnari, G Pellicanò, G Rizzardini, E S Cannizzo, M C Moioli, R Piolini, D Bernacchia, S Salpietro, C Tincati, C Puzzolante, C Migliorino, V Sangiovanni, G Borgia, V Esposito, F Di Martino, I Gentile, V Rizzo, A M Cattelan, S Marinello, A Cascio, M Trizzino, F Baldelli, E Schiaroli, G Parruti, F Sozio, G Magnani, M A Ursitti, A Cristaudo, V Vullo, R Acinapura, D Moschese, M Capozzi, A Mondi, M Rivano Capparuccia, G Iaiani, A Latini, R Gagliardini, M M Plazzi, S Savinelli, A Vergori, M Cecchetto, F Viviani, G Madeddu, A De Vito, B Rossetti, F Montagnani, A Franco, R Fontana Del Vecchio, D Francisci, C Di Giuli, P Caramello, G C Orofino, M Sciandra, M Bassetti, A Londero, G Pellizzer, V Manfrin, G Starnini, A Ialungo
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0301 basic medicine ,Male ,Integrase inhibitor ,Hepatitis B Surface Antigen ,HIV Infections ,0302 clinical medicine ,Risk Factors ,hivh epatitis c rna surface antigens follow-up homosexuality integrase inhibitors hepatitis b virus hepatitis b virus measurement hiv infections hepatotoxicity hepatitis c virus coinfection nucleoside reverse transcriptase inhibitors non-nucleoside reverse transcriptase inhibitors cox proportional hazards models baseline value liver enzyme raltegravir ,Pharmacology (medical) ,HIV Infection ,030212 general & internal medicine ,Prospective Studies ,Prospective cohort study ,Coinfection ,Incidence (epidemiology) ,Liver Disease ,Incidence ,Liver Diseases ,virus diseases ,Hepatitis C ,Middle Aged ,Reverse Transcriptase Inhibitor ,Infectious Diseases ,Cohort ,Population study ,Regression Analysis ,Reverse Transcriptase Inhibitors ,Female ,medicine.drug ,Human ,Microbiology (medical) ,Adult ,medicine.medical_specialty ,Anti-HIV Agents ,Regression Analysi ,NO ,03 medical and health sciences ,Internal medicine ,medicine ,Humans ,HIV Integrase Inhibitors ,HIV Protease Inhibitor ,Pharmacology ,Hepatitis B Surface Antigens ,business.industry ,Anti-HIV Agent ,HIV, ART ,HIV Protease Inhibitors ,medicine.disease ,Raltegravir ,030112 virology ,HIV Integrase Inhibitor ,Prospective Studie ,HIV-1 ,business ,Adult, Anti-HIV Agents, Coinfection, Female, Hepatitis B Surface Antigens, Hepatitis C, HIV Infections, HIV Integrase Inhibitors, HIV Protease Inhibitors, HIV-1, Humans, Incidence, Liver Diseases, Male, Middle Aged, Prospective Studies, Regression Analysis, Reverse Transcriptase Inhibitors, Risk Factors - Abstract
ObjectivesTo evaluate the incidence and risk factors for liver enzyme elevations (LEE) in patients initiating first-line ART in the ICONA prospective observational cohort, between June 2009 and December 2017.Patients and methodsIn total, 6575 ART-naive patients were selected, initiating two NRTIs with the third drug being a boosted PI (n=2436; 37.0%), an NNRTI (n=2384; 36.3%) or an integrase strand transfer inhibitor (INSTI) (n=1755; 26.7%). HBV surface antigen and HCV RNA were detected in 3.9% and 5.8% of the study population. Inverse probability weighted Cox regression analysis was used to calculate the HRs, according to first-line regimen, for LEE, defined as ALT or AST increases of ≥2.5× upper limit of normal (ULN) for patients with normal baseline values or ≥2.5× baseline for patients with higher baseline values.ResultsOne hundred and eighty-three LEE occurred over 20722 patient-years of follow-up. After adjusting for the main confounders, the risk of LEE halved with INSTIs compared with NNRTIs (HR 0.46, 95% CI 0.25–0.86), with a significant reduction in the raltegravir group (HR 0.11, 95% CI 0.02–0.84 using the NNRTI class as reference). HRs for LEE were significantly higher in subjects with HBV or HCV coinfection, in patients with poorly controlled HIV infection and in those who acquired HIV through homosexual transmission.ConclusionsIn our study, INSTI use almost halved the risk of LEE compared with other regimens. This finding could be particularly important for choosing ART in patients with risk factors for liver toxicity such as HCV and HBV coinfections.
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- 2019