Performance of genotypic tropism testing in clinical practice using the enhanced sensitivity version of Trofile as reference assay: results from the OSCAR Study Group.
OBJECTIVE
The goal of the OSCAR programme is to evaluate the performances of genotypic HIV-1 tropism testing in clinical practice using the enhanced sensitivity version of Trofile (ESTA) as reference-assay.


METHODS
HIV-1 coreceptor-usage was assessed using plasma samples from 406 HIV-1 infected patients by ESTA and by gp120 V3 population-sequencing followed by Geno2pheno (set at a False Positive Rate [FPR] of 10% and 5%).


RESULTS
ESTA was successful in 365 (89.9%) samples indicating R5 in 254 (69.6%), and DM/X4 in 111 (30.4% of samples (104 [28.5%] DM and 7 [1.9%] X4). Genotypic-testing successfully assessed viral tropism for all 406 samples, including the 41 with undetermined result by ESTA. Genotypic-tropism testing at a FPR of 5% and 10% was 81.1% and 78.4% concordant with ESTA, respectively. Despite a sensitivity of 48.7% and 55.9% at a FPR of 5% and 10%, respectively, a high concordance (specificity: 95.3% for FPR of 5% and 88.2% for FPR of 10%) between genotypic-tropism testing and ESTA was reached in the detection of R5-tropic viruses.


CONCLUSIONS
Our results are in line with other European studies, and support the routine use of genotypic tropism testing in clinical-settings for monitoring of HIV-1 infected patients candidate to or failing CCR5-antagonists.
Svicher
Valentina
V
University of Rome Tor Vergata, Department of Experimental Medicine, Roma, Italy.
D'Arrigo
Roberta
R
Alteri
Claudia
C
Andreoni
Massimo
M
Angarano
Gioacchino
G
Antinori
Andrea
A
Antonelli
Guido
G
Bagnarelli
Patrizia
P
Baldanti
Fausto
F
Bertoli
Ada
A
Borderi
Marco
M
Boeri
Enzo
E
Bonn
Isabella
I
Bruzzone
Bianca
B
Callegaro
Anna Paola
AP
Cammarota
Roberta
R
Canducci
Filippo
F
Ceccherini-Silberstein
Francesca
F
Clementi
Massimo
M
Monforte
Antonella D'Arminio
AD
De Luca
Andrea
A
Di Biagio
Antonio
A
Di Gianbenedetto
Simona
S
Di Perri
Giovanni
G
Di Pietro
Massimo
M
Fabeni
Lavinia
L
Fadda
Giovanni
G
Galli
Massimo
M
Gennari
William
W
Ghisetti
Valeria
V
Giacometti
Andrea
A
Gori
Andrea
A
Leoncini
Francesco
F
Maggiolo
Franco
F
Maserati
Renato
R
Mazzotta
Francesco
F
Micheli
Valeria
V
Meini
Genny
G
Monno
Laura
L
Mussini
Cristina
C
Nozza
Silvia
S
Paolucci
Stefania
S
Parisi
Saverio
S
Pecorari
Monica
M
Pizzi
Daniele
D
Quirino
Tiziana
T
Re
Maria Carla
MC
Rizzardini
Giuliano
G
Santangelo
Rosaria
R
Soria
Alessandro
A
Stazi
Francesca
F
Sterrantino
Gaetana
G
Turriziani
Ombretta
O
Viscoli
Claudio
C
Vullo
Vincenzo
V
Lazzarin
Adriano
A
Perno
Carlo Federico
CF
D065100:CCR5 Receptor Antagonists; D005260:Female; D005838:Genotype; D015699:HIV Envelope Protein gp120 / Q000737:chemistry / Q000235:genetics; D015658:HIV Infections / Q000235:genetics / Q000378:metabolism / Q000821:virology*; D015497:HIV-1 / Q000145:classification / Q000235:genetics* / Q000302:isolation & purification / Q000502:physiology; D006801:Humans; D008297:Male; D017434:Protein Structure, Tertiary; D019713:Receptors, CCR5 / Q000235:genetics / Q000378:metabolism; D011991:Receptors, Virus / Q000235:genetics*; D056189:Viral Tropism
D065100:CCR5 Receptor Antagonists; D015699:HIV Envelope Protein gp120; D019713:Receptors, CCR5; D011991:Receptors, Virus