Published 2019 | Version v1
Publication

Durability of first-line regimens including integrase strand transfer inhibitors ({INSTIs}): data from a real-life setting

Antonella d'Arminio Monforte
Alessandro Cozzi-Lepri
Antonio Di Biagio
Giulia Marchetti
Sergio Lo Caputo
Stefano Rusconi
Nicola Gianotti
Valentina Mazzotta
Giovanni Mazzarello
Andrea Costantini
Antonella Castagna
Andrea Antinori
A d'Arminio Monforte
A Antinori
M Andreoni
A Castagna
F Castelli
R Cauda
G Di Perri
M Galli
R Iardino
G Ippolito
A Lazzarin
G C Marchetti
G Rezza
F von Schloesser
P Viale
A d'Arminio Monforte
A Antinori
A Castagna
F Ceccherini-Silberstein
A Cozzi-Lepri
E Girardi
S Lo Caputo
C Mussini
M Puoti
C F Perno
A Antinori
C Balotta
A Bandera
S Bonora
M Borderi
A Calcagno
A Capetti
M R Capobianchi
A Castagna
F Ceccherini-Silberstein
S Cicalini
A Cingolani
P Cinque
A Cozzi-Lepri
A d'Arminio Monforte
A De Luca
A Di Biagio
E Girardi
N Gianotti
A Gori
G Guaraldi
G Lapadula
M Lichtner
S Lo Caputo
G Madeddu
F Maggiolo
G Marchetti
L Monno
C Mussini
S Nozza
C F Perno
C Pinnetti
M Puoti
E Quiros Roldan
R Rossotti
S Rusconi
M M Santoro
A Saracino
L Sarmati
A Cozzi-Lepri
I Fanti
L Galli
P Lorenzini
A Rodan(`(o))'
M Macchia
A Tavelli
F Carletti
S Carrara
A Di Caro
S Graziano
F Petrone
G Prota
S Quartu
S Truffa
A Giacometti
A Costantini
V Barocci
G Angarano
L Monno
C Fabrizio
F Maggiolo
C Suardi
P Viale
V Donati
G Verucchi
F Castelnuovo
C Minardi
E Quiros Roldan
B Menzaghi
C Abeli
B Cacopardo
B Celesia
J Vecchiet
K Falasca
A Pan
S Lorenzotti
L Sighinolfi
D Segala
P Blanc
F Vichi
G Cassola
C Viscoli
A Alessandrini
N Bobbio
G Mazzarello
M Lichtner
I Pozzetto
P Bonfanti
C Molteni
A Chiodera
P Milini
G Nunnari
G Pellican(`(o))
A d'Arminio Monforte
M Galli
A Lazzarin
G Rizzardini
M Puoti
A Castagna
F Bai
M C Moioli
R Piolini
A L Ridolfo
S Salpietro
C Tincati
C Mussini
C Puzzolante
C Migliorino
G Lapadula
V Sangiovanni
G Borgia
V Esposito
F Di Martino
I Gentile
L Maddaloni
A M Cattelan
S Marinello
A Cascio
C Colomba
F Baldelli
E Schiaroli
G Parruti
F Sozio
G Magnani
M A Ursitti
M Andreoni
A Antinori
R Cauda
A Cristaudo
V Vullo
R Acinapura
G Baldin
M Capozzi
A Mondi
A Cingolani
M Rivano Capparucia
G Iaiani
A Latini
R Gagliardini
M M Plazzi
S Savinelli
A Vergori
M Cecchetto
F Viviani
G Madeddu
P Bagella
A De Luca
B Rossetti
A Franco
R Fontana Del Vecchio
D Francisci
C Di Giuli
P Caramello
G Di Perri
S Bonora
G C Orofino
M Sciandra
M Bassetti
A Londero
G Pellizzer
V Manfrin
G Starnini
A Ialungo and
Others:
d'Arminio Monforte, Antonella
Cozzi-Lepri, Alessandro
DI BIAGIO, Antonio
Marchetti, Giulia
Lo Caputo, Sergio
Rusconi, Stefano
Gianotti, Nicola
Mazzotta, Valentina
Mazzarello, Giovanni
Costantini, Andrea
Castagna, Antonella
Antinori, Andrea
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
C Marchetti, G
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
F Perno, C
Antinori, A
Balotta, C
Bandera, A
Bonora, S
Borderi, M
Calcagno, A
Capetti, A
R Capobianchi, M
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
F Perno, C
Pinnetti, C
Puoti, M
Quiros Roldan, E
Rossotti, R
Rusconi, S
M Santoro, M
Saracino, A
Sarmati, L
Cozzi-Lepri, A
Fanti, I
Galli, L
Lorenzini, P
Rodan(`(o))', A
Macchia, M
Tavelli, A
Carletti, F
Carrara, S
Di Caro, A
Graziano, S
Petrone, F
Prota, G
Quartu, S
Truffa, S
Giacometti, A
Costantini, A
Barocci, V
Angarano, G
Monno, L
Fabrizio, C
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
Pozzetto, I
Bonfanti, P
Molteni, C
Chiodera, A
Milini, P
Nunnari, G
Pellican(`(o)), G
d'Arminio Monforte, A
Galli, M
Lazzarin, A
Rizzardini, G
Puoti, M
Castagna, A
Bai, F
C Moioli, M
Piolini, R
L Ridolfo, A
Salpietro, S
Tincati, C
Mussini, C
Puzzolante, C
Migliorino, C
Lapadula, G
Sangiovanni, V
Borgia, G
Esposito, V
Di Martino, F
Gentile, I
Maddaloni, L
M Cattelan, A
Marinello, S
Cascio, A
Colomba, C
Baldelli, F
Schiaroli, E
Parruti, G
Sozio, F
Magnani, G
A Ursitti, M
Andreoni, M
Antinori, A
Cauda, R
Cristaudo, A
Vullo, V
Acinapura, R
Baldin, G
Capozzi, M
Mondi, A
Cingolani, A
Rivano Capparucia, M
Iaiani, G
Latini, A
Gagliardini, R
M Plazzi, M
Savinelli, S
Vergori, A
Cecchetto, M
Viviani, F
Madeddu, G
Bagella, P
De Luca, A
Rossetti, B
Franco, A
Fontana Del Vecchio, R
Francisci, D
Di Giuli, C
Caramello, P
Di Perri, G
Bonora, S
C Orofino, G
Sciandra, M
Bassetti, M
Londero, A
Pellizzer, G
Manfrin, V
Starnini, G
Ialungo and, A

Description

Objectives: To evaluate the durability of three integrase strand transfer inhibitors (INSTIs) and two NRTIs in ART-naive individuals.Methods: The study design was observational. Patients were HIV-positive, ART-naive subjects starting raltegravir, elvitegravir/cobicistat or dolutegravir with two NRTIs. The primary endpoint was time to treatment failure, i.e. occurrence of virological failure (first of two consecutive plasma HIV RNAs >= 200 copies/mL after 24 weeks) or INSTI discontinuation for any reason apart from simplification. Secondary endpoints were INSTI discontinuation due to toxicity/intolerance and CD4 count response. Survival analysis was done using Kaplan-Meier and Cox regression.Results: Two thousand and sixteen patients were included: 310 (15.4%) started raltegravir-based regimens, 994 (49.3%) started dolutegravir-based regimens and 712 (35.3%) started elvitegravir/cobicistat-based regimens. Over a median of 11months, 167 patients experienced treatment failure; the 1 year probability of treatment failure was 6.5% for raltegravir, 5.4% for dolutegravir and 6.7% for elvitegravir/cobicistat (P = 0.001). Sixty-eight patients (3.4%) discontinued INSTIs owing to toxicity/intolerance. By multivariable analysis, patients starting raltegravir had a 2.03-fold (95% CI = 1.2-3.2) higher risk and patients on elvitegravir/cobicistat a 1.88-fold (95% CI = 1.2-2.9) higher risk of treatment failure versus dolutegravir; there was no difference in risk of discontinuation due to toxicity/intolerance when comparing dolutegravir and raltegravir and marginal evidence for a difference when comparing elvitegravir/cobicistat and dolutegravir (adjusted relative hazard = 1.94 for elvitegravir/cobicistat versus dolutegravir, 95% CI = 1.00-3.76, P = 0.05).Conclusions: In our real-life setting, INSTI-based regimens showed high potency and durability. Among regimens currently recommended in Europe, those including dolutegravir are associated with a lower risk of treatment failure.

Additional details

Created:
May 12, 2023
Modified:
December 1, 2023