Durability of different initial regimens in HIV-infected patients starting antiretroviral therapy with CD4+ counts <200 cells/mm3 and HIV-RNA >5 log10 copies/mL
Author:
Gianotti Nicola1ORCID, Lorenzini Patrizia2, Cozzi-Lepri Alessandro3, De Luca Andrea4, Madeddu Giordano5ORCID, Sighinolfi Laura6, Pinnetti Carmela2, Santoro Carmen7, Meraviglia Paola8, Mussini Cristina9, Antinori Andrea2, d'Arminio Monforte Antonella10, d’Arminio Monforte A, 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, d’Arminio Monforte A, Antinori A, Castagna A, Ceccherini-Silberstein F, Cozzi-Lepri A, Girardi E, Lo Caputo S, Mussini C, Puoti M, Andreoni M, Ammassari A, Antinori A, Balotta C, Bandera A, Bonfanti P, Bonora S, Borderi M, Calcagno A, Calza L, Capobianchi M R, Castagna A, Ceccherini-Silberstein F, 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, Marcotullio S, Monno L, Mussini C, Nozza S, Puoti M, Quiros Roldan E, Rossotti R, Rusconi S, Santoro M M, Saracino A, Zaccarelli M, Cozzi-Lepri A, Fanti I, Galli L, Lorenzini P, Rodano A, Shanyinde M, Tavelli A, Carletti F, Carrara S, Di Caro A, Graziano S, Petrone F, Prota G, Quartu S, Truffa S, Giacometti A, Costantini A, Valeriani C, Angarano G, Monno L, Santoro C, Maggiolo F, Suardi C, Viale P, Donati V, Verucchi G, Castelli F, Quiros E, Minardi C, Quirino T, Abeli C, Manconi P E, Piano P, Cacopardo B, Celesia B, Vecchiet J, Falasca K, Sighinolfi L, Segala D, Mazzotta F, Vichi F, Cassola G, Viscoli C, Alessandrini A, Bobbio N, Mazzarello G, Mastroianni C, Belvisi V, Bonfanti P, Caramma I, Chiodera A, Castelli A P, Galli M, Lazzarin A, Rizzardini G, Puoti M, d’Arminio Monforte A, Ridolfo A L, Piolini R, Castagna A, Salpietro S, Carenzi L, Moioli M C, Tincati C, Marchetti G, Mussini C, Puzzolante C, Gori A, Lapadula G, 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, Cauda R, Andreoni M, Antinori A, Vullo V, Cristaudo A, Cingolani A, Baldin G, Cicalini S, Gallo L, Nicastri E, Acinapura R, Capozzi M, Libertone R, Savinelli S, Latini A, Cecchetto M, Viviani F, Mura M S, Madeddu G, De Luca A, Rossetti B, Caramello P, Di Perri G, C Orofino G, Bonora S, Sciandra M, Bassetti M, Londero A, Pellizzer G, Manfrin V,
Affiliation:
1. Department of Infectious Diseases, San Raffaele Scientific Institute, Milan, Italy 2. Clinical Division, National Institute for Infectious Diseases ‘Lazzaro Spallanzani’ IRCCS, Rome, Italy 3. Institute for Global Health, University College London, London, UK 4. Infectious Diseases Unit, Azienda Ospedaliera Universitaria Senese, Department of Medical Biotechnologies, University of Siena, Siena, Italy 5. Department of Clinical and Experimental Medicine, University of Sassari, Sassari, Italy 6. Department of Infectious Diseases, S. Anna Hospital, Ferrara, Italy 7. Clinic of Infectious Diseases, University of Bari, University Hospital Policlinico, Bari, Italy 8. Department of Infectious Diseases, ASST Fatebenefratelli-Sacco, Milan, Italy 9. Infectious Disease Clinic, Department of Medical and Surgical Sciences for Children & Adults, University of Modena and Reggio Emilia, Modena, Italy 10. Clinic of Infectious and Tropical Diseases, ASST Santi Paolo and Carlo, Department of Health Sciences, University of Milan, Milan, Italy
Abstract
Abstract
Objectives
Our aim was to investigate the durability of different initial regimens in patients starting ART with CD4+ counts <200 cells/mm3 and HIV-RNA >5 log10 copies/mL.
Methods
This was a retrospective study of HIV-infected patients prospectively followed in the ICONA cohort. Those who started ART with boosted protease inhibitors (bPIs), NNRTIs or integrase strand transfer inhibitors (InSTIs), with CD4+ <200 cells/mm3 and HIV-RNA >5 log10 copies/mL, were included. The primary endpoint was treatment failure (TF), a composite endpoint defined as virological failure (VF, first of two consecutive HIV-RNA >50 copies/mL after 6 months of treatment), discontinuation of class of the anchor drug or death. Independent associations were investigated by Poisson regression analysis in a model including age, gender, mode of HIV transmission, CDC stage, HCV and HBV co-infection, pre-treatment HIV-RNA, CD4+ count and CD4+/CD8+ ratio, ongoing opportunistic disease, fibrosis FIB-4 index, estimated glomerular filtration rate, haemoglobin, platelets, neutrophils, calendar year of ART initiation, anchor drug class (treatment group) and nucleos(t)ide backbone.
Results
A total of 1195 patients fulfilled the inclusion criteria: 696 started ART with a bPI, 315 with an InSTI and 184 with an NNRTI. During 2759 person-years of follow up, 642 patients experienced TF. Starting ART with bPIs [adjusted incidence rate ratio (aIRR) (95% CI) 1.62 (1.29–2.03) versus starting with NNRTIs; P < 0.001] and starting ART with InSTIs [aIRR (95% CI) 0.68 (0.48–0.96) versus starting with NNRTIs; P = 0.03] were independently associated with TF.
Conclusions
In patients starting ART with <200 CD4+ cells/mm3 and >5 log10 HIV-RNA copies/mL, the durability of regimens based on InSTIs was longer than that of NNRTI- and bPI-based regimens.
Funder
ICONA Foundation Abbvie BMS Gilead Jannsen MSD ViiV
Publisher
Oxford University Press (OUP)
Subject
Infectious Diseases,Pharmacology (medical),Pharmacology,Microbiology (medical)
Reference33 articles.
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