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Genotypic tropism testing in proviral DNA to guide maraviroc initiation in aviremic subjects: 48‐week analysis of the PROTEST study

Authors :
Garcia, Federico
Poveda, Eva
Pérez?Elías, Maria Jesús
Quero, José Hernández
Ribas, Maria Àngels
Martínez?Madrid, Onofre J.
Flores, Juan
Crespo, Manel
Gutiérrez, Félix
García?Deltoro, Miguel
Imaz, Arkaitz
Ocampo, Antonio
Artero, Arturo
Blanco, Francisco
Bernal, Enrique
Pasquau, Juan
Mínguez?Gallego, Carlos
Pérez, Núria
Aiestarán, Aintzane
Paredes, Roger
Source :
Journal of the International AIDS Society. November, 2014, Vol. 17
Publication Year :
2014

Abstract

Introduction: In a previous interim 24‐week virological safety analysis of the PROTEST study [1], initiation of Maraviroc (MVC) plus 2 nucleoside reverse‐transcriptase inhibitors (NRTIs) in aviremic subjects based on genotypic tropism testing of proviral HIV‐1 DNA was associated with low rates of virological failure. Here we present the final 48‐week analysis of the study. Methods: PROTEST was a phase 4, prospective, single‐arm clinical trial (ID: NCT01378910) carried on in 24 HIV care centres in Spain. Maraviroc‐naïve HIV‐1‐positive adults with HIV‐1 RNA (VL) 10% in a singleton), initiated MVC with 2 NRTIs and were followed for 48 weeks. Virological failure was defined as two consecutive VL>50 c/mL. Recent adherence was calculated as: (# pills taken/# pills prescribed during the previous week)*100. Results: Tropism results were available from 141/175 (80.6%) subjects screened: 87/141 (60%) were R5 and 74/87 (85%) were finally included in the study. Their median age was 48 years, 16% were women, 31% were MSM, 36% had CDC category C at study entry, 62% were HCV+ and 10% were HBV+. Median CD4+ counts were 616 cells/mm[sup.3] at screening, and median nadir CD4+ counts were 143 cells/mm[sup.3]. Previous ART included PIs in 46 (62%) subjects, NNRTIs in 27 (36%) and integrase inhibitors (INIs) in 1 (2%). The main reasons for treatment change were dyslipidemia (42%), gastrointestinal symptoms (22%), and liver toxicity (15%). MVC was given alongside TDF/FTC in 40 (54%) subjects, ABC/3TC in 30 (40%), AZT/3TC in 2 (3%) and ABC/TDF in 2 (3%). Sixty‐two (84%) subjects maintained VL Conclusions: Initiation of MVC plus 2 NRTIs in aviremic subjects based on genotypic tropism testing of proviral HIV‐1 DNA is associated with low rates of virological failure up to one year.<br />Table 1: Subject ART Week of VF HIV‐1 VL at VF (c/mL) Plasma tropism at VF (FPR,%) Recent adherence at VF (%) Resistance mutations at VF (IAS‐USA 2013) ART after [...]

Details

Language :
English
ISSN :
17582652
Volume :
17
Database :
Gale General OneFile
Journal :
Journal of the International AIDS Society
Publication Type :
Academic Journal
Accession number :
edsgcl.723606821
Full Text :
https://doi.org/10.7448/IAS.17.4.19520