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Publication Details
AFRICAN RESEARCH NEXUS
SHINING A SPOTLIGHT ON AFRICAN RESEARCH
medicine
Effectiveness of dolutegravir-based regimens as either first-line or switch antiretroviral therapy: data from the Icona cohort
Journal of the International AIDS Society, Volume 22, No. 1, Article e25227, Year 2019
Notification
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Description
Introduction: Concerns about dolutegravir (DTG) tolerability in the real-life setting have recently arisen. We aimed to estimate the risk of treatment discontinuation and virological failure of DTG-based regimens from a large cohort of HIV-infected individuals. Methods: We performed a multicentre, observational study including all antiretroviral therapy (ART)-naïve and virologically suppressed treatment-experienced (TE) patients from the Icona (Italian Cohort Naïve Antiretrovirals) cohort who started, for the first time, a DTG-based regimen from January 2015 to December 2017. We estimated the cumulative risk of DTG discontinuation regardless of the reason and for toxicity, and of virological failure using Kaplan–Meier curves. We used Cox regression model to investigate predictors of DTG discontinuation. Results: About 1679 individuals (932 ART-naïve, 747 TE) were included. The one- and two-year probabilities (95% CI) of DTG discontinuation were 6.7% (4.9 to 8.4) and 11.5% (8.7 to 14.3) for ART-naïve and 6.6% (4.6 to 8.6) and 7.6% (5.4 to 9.8) for TE subjects. In both ART-naïve and TE patients, discontinuations of DTG were mainly driven by toxicity with an estimated risk (95% CI) of 4.0% (2.6 to 5.4) and 2.5% (1.3 to 3.6) by one year and 5.6% (3.8 to 7.5) and 4.0% (2.4 to 5.6) by two years respectively. Neuropsychiatric events were the main reason for stopping DTG in both ART-naïve (2.1%) and TE (1.7%) patients. In ART-naïve, a concomitant AIDS diagnosis predicted the risk of discontinuing DTG for any reason (adjusted relative hazard (aRH) = 3.38, p = 0.001), whereas starting DTG in combination with abacavir (ABC) was associated with a higher risk of discontinuing because of toxicity (aRH = 3.30, p = 0.009). TE patients starting a DTG-based dual therapy compared to a triple therapy had a lower risk of discontinuation for any reason (adjusted hazard ratio (aHR) = 2.50, p = 0.037 for ABC-based triple-therapies, aHR = 3.56, p = 0.012 for tenofovir-based) and for toxicity (aHR = 5.26, p = 0.030 for ABC-based, aHR = 6.60, p = 0.024 for tenofovir-based). The one- and two-year probabilities (95% CI) of virological failure were 1.2% (0.3 to 2.0) and 4.6% (2.7 to 6.5) in the ART naïve group and 2.2% (1.0 to 3.3) and 2.9% (1.5 to 4.3) in the TE group. Conclusions: In this large cohort, DTG showed excellent efficacy and optimal tolerability both as first-line and switching ART. The low risk of treatment-limiting toxicities in ART-naïve as well as in treated individuals reassures on the use of DTG in everyday clinical practice. © 2019 The Authors. Journal of the International AIDS Society published by John Wiley & Sons Ltd on behalf of the International AIDS Society.
Available Materials
https://efashare.b-cdn.net/share/pmc/articles/PMC6340053/bin/JIA2-22-e25227-s001.docx
Authors & Co-Authors
Mondi, Annalisa
Italy, Rome
Irccs Istituto Nazionale Malattie Infettive Lazzaro Spallanzani
Cozzi-Lepri, Alessandro
United Kingdom, London
University College London
Tavelli, Alessandro
Italy, Milan
Icona Foundation
Rusconi, Stefano
Italy, Milan
Università Degli Studi Di Milano
Ceccherini-Silberstein, Francesca
Italy, Rome
Università Degli Studi Di Roma Tor Vergata
Calcagno, A.
Italy, Turin
Ospedale Amedeo Di Savoia
De Luca, Andrea
Italy, Siena
Università Degli Studi Di Siena
Maggiolo, Franco
Unknown Affiliation
Antinori, Andrea
Italy, Rome
Irccs Istituto Nazionale Malattie Infettive Lazzaro Spallanzani
D'Arminio Monforte, Antonella D.
Italy, Milan
Università Degli Studi Di Milano
Andreoni, Massimo G.
Unknown Affiliation
Castagna, Antonella
Unknown Affiliation
Castelli, Francesco
Unknown Affiliation
Cauda, Roberto
Unknown Affiliation
Di Perri, Giovanni
Unknown Affiliation
Galli, Massimo
Unknown Affiliation
Iardino, Rosaria
Unknown Affiliation
Ippolito, Giuseppe
Unknown Affiliation
Rezza, Giovanni
Unknown Affiliation
Viale, Pierluigi
Unknown Affiliation
Girardi, Enrico
Unknown Affiliation
Lo Caputo, Sergio
Unknown Affiliation
Mussini, Cristina
Unknown Affiliation
Puoti, Massimo
Unknown Affiliation
Perno, Carlo Federico
Unknown Affiliation
Balotta, Claudia
Unknown Affiliation
Bandera, Alessandra
Unknown Affiliation
Bonora, Stefano
Unknown Affiliation
Borderi, Marco
Unknown Affiliation
Capetti, Amedeo Ferdinando
Unknown Affiliation
Capobianchi, Maria Rosaria
Unknown Affiliation
Cicalini, Stefania
Unknown Affiliation
Cingolani, A.
Unknown Affiliation
Cinque, P.
Unknown Affiliation
Di Biagio, Antonio
Unknown Affiliation
Gianotti, Nicola
Unknown Affiliation
Gori, Andrea
Unknown Affiliation
Guaraldi, Giovanni
Unknown Affiliation
Lapadula, Giuseppe
Unknown Affiliation
Lichtner, Miriam
Unknown Affiliation
Monno, Laura
Unknown Affiliation
Nozza, Silvia
Unknown Affiliation
Quiròs-Roldan, Eugenia
Unknown Affiliation
Santoro, Maria Mercedes
Unknown Affiliation
Sarmati, Loredana
Unknown Affiliation
Fanti, Iuri
Unknown Affiliation
Lorenzini, Patrizia
Unknown Affiliation
Rodano’, A.
Unknown Affiliation
Carrara, Stefania
Unknown Affiliation
Di Caro, Antonino
Unknown Affiliation
Quartu, Serena
Unknown Affiliation
Angarano, Gioacchino
Unknown Affiliation
Fabrizio, Claudia
Unknown Affiliation
Verucchi, Gabriella
Unknown Affiliation
Menzaghi, Barbara
Unknown Affiliation
Cacopardo, Bruno Santi
Unknown Affiliation
Celesia, Benedetto Maurizio
Unknown Affiliation
Pan, Angelo
Unknown Affiliation
Segala, D.
Unknown Affiliation
Bonfanti, Paolo
Unknown Affiliation
Rizzardini, Giuliano
Unknown Affiliation
Bai, Francesca
Unknown Affiliation
Ridolfo, Anna Lisa
Unknown Affiliation
Tincati, Camilla
Unknown Affiliation
Sangiovanni, Vincenzo
Unknown Affiliation
Cattelan, Anna María
Unknown Affiliation
Cascio, Antonio
Unknown Affiliation
Colomba, Claudia
Unknown Affiliation
Parruti, Giustino
Unknown Affiliation
Sozio, Federica
Unknown Affiliation
Cristaudo, Antonio
Unknown Affiliation
Vullo, Vincenzo
Unknown Affiliation
Acinapura, Rosa
Unknown Affiliation
Baldin, Gianmaria
Unknown Affiliation
Vergori, Alessandra
Unknown Affiliation
Rossetti, Barbara
Unknown Affiliation
Caramello, Pietro
Unknown Affiliation
Orofino, Giancarlo
Unknown Affiliation
Bassetti, Matteo
Unknown Affiliation
Pellizzer, Giampietro P.
Unknown Affiliation
Manfrin, Vinicio
Unknown Affiliation
Statistics
Citations: 39
Authors: 81
Affiliations: 8
Identifiers
Doi:
10.1002/jia2.25227
ISSN:
17582652
Research Areas
Environmental
Infectious Diseases
Study Design
Cohort Study