|Efficacy and Safety of Once Daily Maraviroc Plus
Ritonavir-boosted Darunavir in Pretreated HIV-infected Patients in a Real Life
|J. Macías1, E. Recio1, M. Márquez2, C. García3, P. Jiménez4, D. Merino5, L. Muñoz6, J. Pasquau7, G. Ojeda2, P. Bancalero3, N. Chueca6, J.A. Pineda1|
|1University Hospital of Valme, Seville, Spain, 2Hospital of Virgen de la Victoria, Malaga, Spain, 3Hospital of Jerez de la Frontera, Cadiz, Spain, 4University Hospital of Puerto Real, Cadiz, Spain, 5Hospital of Huelva, Huelva, Spain, 6University Hospital San Cecilio, Granada, Spain, 7University Hospital Virgen de las Nieves, Granada, Spain|
|Background: First line antiretroviral drug (ART) combinations are based on two nucleos(t)ide analogs (NA). However, due to long-term toxicities, data on NA-sparing regimens are needed. Monotherapy with ritonavir-boosted protease inhibitors (PI/r)is less effective than triple ART combinations. Promising dual ART, NA-sparing, regimens are maraviroc (MVC) plus PI/r. Nevertheless, MVC plus darunavir/r(DRV/r) or plus atazanavir/r present lower response rates in clinical trials recruiting drug-naïve patients.|
Objectives: We assessed the efficacy and safety of MVC plus DRV/r qdin HIV-infected patients in real life conditions of use.
Methods: Retrospective cohort including patients starting MVC 150 mg plus DRV/r 800/100 mg qd, with CCR5 tropism and no resistance mutations for DRV/r.Primary efficacy end-point (intention to treat) was achievement of plasma HIV-ARN levels < 50 copies/mL at 48 weeks (48w). Continuous variables are expressed as median (IQR).
Results: 60 patients were recruited, 45 (75%) men. Age was 47 (43-50) years. 20 (33%) patients showed HCV-RNA(+).Reasons to start MVC+DRV/r were: Adverse effects in 38 (63%) individuals, simplification in 15 (25%), virologic failure in 7 (12%). 4 (6.7%) patients were lost to follow-up and 2 (3.3%) abandoned therapy. The main analysis (non-completers=failures) showed that 48 (80%) individuals at baseline and 44 (73%) patients at 48w achieved HIV-RNA < 50 copies/mL (p=1.0). CD4 cell counts increased from 491 (301-729) to 561 (367-793) cells/µL at 48w (p=0.013). One patient discontinued due to adverse effects and one patient died because of cancer. APRI decreased from 0.38 (0.24-0.87) to 0.33 (0.2-0.73) at 48w (p=0.004). Liver stiffness, available in 29 patients, was 6.4 (6.4-9.3) and 5.4 (4.5-10.9) KPa at baseline and 48w, respectively (p=0.151).
Conclusions: Individuals starting MVC+DRV/r qd because of simplification or adverse effects maintain HIV suppression. The combination was well tolerated and markers of liver damage improved during the follow-up.
Juan Macías , University Hospital of Valme , Seville , Spain
Assigned in sessions:
17.10.2013, 12:00-14:00, Poster Session, Poster Session 1, Exhibition
18.10.2013, 12:00-14:00, Poster Session, Poster Session 2, Exhibition