RT Conference Proceedings
T1 Genotypic tropism testing in proviral DNA to guide maraviroc initiation in aviremic subjects: 48-week analysis of the PROTEST study.
A1 Garcia, Federico
A1 Poveda, Eva
A1 Pérez-Elías, Maria Jesús
A1 Hernández Quero, José
A1 Ribas, Maria Angels
A1 Martínez-Madrid, Onofre J
A1 Flores, Juan
A1 Crespo, Manel
A1 Gutiérrez, Félix
A1 García-Deltoro, Miguel
A1 Imaz, Arkaitz
A1 Ocampo, Antonio
A1 Artero, Arturo
A1 Blanco, Francisco
A1 Bernal, Enrique
A1 Pasquau, Juan
A1 Mínguez-Gallego, Carlos
A1 Pérez, Núria
A1 Aiestarán, Aintzane
A1 Paredes, Roger
K1 Recuento de linfocito CD4
K1 Ciclohexanos
K1 ARN Polimerasas dirigidas por ADN
K1 Dislipidemias
K1 Exantema
K1 Infecciones por VIH
K1 Consentimiento informado
K1 Inhibidores de integrasa
K1 Hígado
K1 Perdida de seguimiento
K1 Neoplasias pulmonares
K1 Estudios prospectivos
K1 Infarto del miocardio
K1 Provirus
K1 ARN
K1 ADN
K1 Triazoles
K1 Tropismo
K1 España
AB INTRODUCTIONIn 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.METHODSPROTEST 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) <50 c/mL on stable ART during the previous 6 months, requiring an ART change due to toxicity, with no antiretroviral resistance to the ART started, and R5 HIV by proviral DNA genotypic tropism testing (defined as a G2P FPR >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.RESULTSTropism 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(3) at screening, and median nadir CD4+ counts were 143 cells/mm(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<50 c/mL through week 48, whereas 12 (16%) discontinued treatment: two (3%) withdrew informed consent, one (1%) had a R5→X4 shift in HIV tropism between the screening and baseline visits, one (1%) was lost to follow-up, one (1%) developed an ART-related adverse event (rash), two (3%) died due to non-study-related causes (1 myocardial infarction at week 0 and 1 lung cancer at week 36), and five (7%) developed protocol-defined virological failure, although two of them regained VL<50 c/mL with the same MVC regimen (Table 1).CONCLUSIONSInitiation 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.
PB BioMed Central
YR 2014
FD 2014-11-02
LK http://hdl.handle.net/10668/2320
UL http://hdl.handle.net/10668/2320
LA en
NO Garcia F, Poveda E, Pérez-Elías MJ, Quero JH, Ribas MA, Martínez-Madrid OJ, et al. Genotypic tropism testing in proviral DNA to guide maraviroc initiation in aviremic subjects: 48-week analysis of the PROTEST study. J Int AIDS Soc. 2014; 17(4 Suppl 3):19520
NO Journal Article; Oral presentation: The HIV Drug Therapy Glasgow Congress 2014
DS RISalud
RD Apr 4, 2025