Incidence and risk factors for liver enzyme elevation among naive HIV-1-infected patients receiving ART in the ICONA cohort
Author:
Taramasso Lucia12ORCID, Lorenzini Patrizia3, Di Biagio Antonio4ORCID, Lichtner Miriam5, Marchetti Giulia6, Rossotti Roberto7, Lapadula Giuseppe8, Cozzi-Lepri Alessandro9, Vichi Francesca10, Antinori Andrea3, Bonora Stefano11, d’Arminio Monforte Antonella6, d’Arminio Monforte A, Antinori A, Andreoni M, Castagna A, Castelli F, Cauda R, Di Perri G, Galli M, Iardino R, Ippolito G, Lazzarin A, Marchetti G C, Rezza G, von Schloesser F, Viale P, d’Arminio Monforte A, Antinori A, Castagna A, Ceccherini-Silberstein F, Cozzi-Lepri A, Girardi E, Lo Caputo S, Mussini C, Puoti M, Perno C F, Antinori A, Bai F, Balotta C, Bandera A, Bonora S, Borderi M, Calcagno A, Capetti A, Capobianchi M R, Castagna A, Ceccherini-Silberstein F, Cicalini S, Cingolani A, Cinque P, Cozzi-Lepri A, d’Arminio Monforte A, De Luca A, Di Biagio A, Girardi E, Gianotti N, Gori A, Guaraldi G, Lapadula G, Lichtner M, Lo Caputo S, Madeddu G, Maggiolo F, Marchetti G, Monno L, Mussini C, Nozza S, Perno C F, Pinnetti C, Puoti M, Quiros Roldan E, Rossotti R, Rusconi S, Santoro M M, Saracino A, Sarmati L, Cozzi-Lepri A, Fanti I, Galli L, Lorenzini P, 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, Monno L, Milano E, Maggiolo F, Suardi C, Viale P, Donati V, Verucchi G, Castelnuovo F, Minardi C, Quiros Roldan E, 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, Lichtner M, Vita S, Bonfanti P, Molteni C, Chiodera A, Milini P, Nunnari G, Pellicanò G, d’Arminio Monforte A, Galli M, Lazzarin A, Rizzardini G, Puoti M, Castagna A, Cannizzo E S, Moioli M C, Piolini R, Bernacchia D, Salpietro S, Tincati C, Mussini C, Puzzolante C, Migliorino C, Lapadula G, Sangiovanni V, Borgia G, Esposito V, Di Martino F, Gentile I, Rizzo V, Cattelan A M, Marinello S, Cascio A, Trizzino M, Baldelli F, Schiaroli E, Parruti G, Sozio F, Magnani G, Ursitti M A, Andreoni M, Antinori A, Cauda R, Cristaudo A, Vullo V, Acinapura R, Moschese D, Capozzi M, Mondi A, Cingolani A, Capparuccia M Rivano, Iaiani G, Latini A, Gagliardini R, Plazzi M M, Savinelli S, Vergori A, Cecchetto M, Viviani F, Madeddu G, De Vito A, Rossetti B, Montagnani F, Franco A, Fontana Del Vecchio R, Francisci D, Di Giuli C, Caramello P, Di Perri G, Bonora S, Orofino G C, Sciandra M, Bassetti M, Londero A, Pellizzer G, Manfrin V, Starnini G, Ialungo A,
Affiliation:
1. Department of Health Sciences (DISSAL), University of Genoa, Genoa, Italy 2. Infectious Diseases Unit, Department of Internal Medicine, Fondazione IRCCS Ca' Granda Ospedale Maggiore Policlinico, Milan, Italy 3. HIV/AIDS Clinical Department, National Institute for Infectious Diseases Lazzaro Spallanzani, Rome, Italy 4. Infectious Diseases Clinic, Policlinico San Martino Hospital, Genoa, Italy 5. Department of Infectious Diseases, La Sapienza University, Polo Pontino, Latina, Italy 6. Department of Health Sciences, Clinic of Infectious and Tropical Diseases, University of Milan, Milan, Italy 7. Infectious Diseases Department, ASST GOM Niguarda, Milan, Italy 8. Infectious Diseases Unit, Ospedale San Gerardo, Monza, Italy 9. University College London, London, UK 10. Unit of Infectious Diseases, Santa Maria Annunziata Hospital, Florence, Italy 11. Unit of Infectious Diseases, Department of Medical Sciences, University of Torino, Torino, Italy
Abstract
Abstract
Objectives
To 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 methods
In 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.
Results
One 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.
Conclusions
In 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.
Publisher
Oxford University Press (OUP)
Subject
Infectious Diseases,Pharmacology (medical),Pharmacology,Microbiology (medical)
Cited by
16 articles.
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