TY - JOUR
T1 - Switching to darunavir/ritonavir 800/100mg once-daily containing regimen maintains virological control in fully suppressed pre-treated patients infected with HIV-1
AU - Ghosn, Jade
AU - Slama, Laurence
AU - Chermak, Aziza
AU - Houssaini, Allal
AU - Lambert-Niclot, Sidonie
AU - Schneider, Luminita
AU - Fourn, Erwan
AU - Duvivier, Claudine
AU - Simon, Anne
AU - Courbon, Eve
AU - Murphy, Robert
AU - Flandre, Philippe
AU - Peytavin, Gilles
AU - Katlama, Christine
AU - Marcelin, Anne Genevieve
AU - Calvez, Vincent
AU - Valantin, Marc Antoine
AU - Pialoux, Gilles
AU - Delfraissy, Jean Francois
AU - Herson, Serge
AU - Bricaire, Francois
AU - Lortholary, Olivier
AU - Lecardonnel, Francois
AU - Pauchard, Michele
AU - Bourse, Patricia
AU - Mole, Martine
AU - Adda, Anne
AU - Touam, Fatima
AU - Pochon, Francoise
AU - Sordet, Fabien
AU - Descamps, Diane
AU - Mentre, France
AU - Poirie, Jean Marie
AU - Lascoux-Combe, Caroline
PY - 2013/1/1
Y1 - 2013/1/1
N2 - The objective of this study was to evaluate the switch to once-daily darunavir/ritonavir 800/100mg in treatment-experienced patients with suppressed HIV-1 replication on a twice-daily ritonavir-boosted protease-inhibitor (bid PI/r) containing regimen, that is in a setting where genotypic resistance test cannot be performed. In this open label, non-comparative, multicenter study, patients on a bid PI/r-containing triple combination, with suppressed viral replication, were switched to once-daily darunavir/r 800/100mg containing triple combination. The primary endpoint was the proportion of patients with plasma HIV-RNA<50copies/ml 24 weeks after the switch. Intensive darunavir pharmacokinetic evaluation was performed at Week 4 (W4) in 11 patients. Eighty-five patients were enrolled. All had HIV-RNA<50copies/ml at screening with a pre-exposure to a median of 2 PI/r (1-5). By intent-to-treat analysis (missing=failure), 78/85 patients (92%, 95% CI [83;96]) maintained an HIV-RNA<50copies/ml at W24. Seven patients experienced protocol-defined treatment failure between baseline and W24: Two had confirmed low-level viral rebound, one discontinued study treatment for adverse event, three withdrew their consent, and one was lost to follow-up. By on-treatment analysis, 78/80 patients (97%, 95% CI [91;99]) maintained an HIV-RNA<50copies/ml at W24. Results were similar at Week 48. The median area under the darunavir plasma concentration-time curve measured in 11 patients was 61,380nghr/ml; darunavir median trough concentration 1,340ng/ml and darunavir half-life was 12.2hr. Tolerability of once-daily darunavir/r 800/100mg was excellent. Optimally suppressed, treatment-experienced patients can switch safely from a twice-daily PI/r regimen to a once-daily darunavir/r 800/100mg containing regimen.
AB - The objective of this study was to evaluate the switch to once-daily darunavir/ritonavir 800/100mg in treatment-experienced patients with suppressed HIV-1 replication on a twice-daily ritonavir-boosted protease-inhibitor (bid PI/r) containing regimen, that is in a setting where genotypic resistance test cannot be performed. In this open label, non-comparative, multicenter study, patients on a bid PI/r-containing triple combination, with suppressed viral replication, were switched to once-daily darunavir/r 800/100mg containing triple combination. The primary endpoint was the proportion of patients with plasma HIV-RNA<50copies/ml 24 weeks after the switch. Intensive darunavir pharmacokinetic evaluation was performed at Week 4 (W4) in 11 patients. Eighty-five patients were enrolled. All had HIV-RNA<50copies/ml at screening with a pre-exposure to a median of 2 PI/r (1-5). By intent-to-treat analysis (missing=failure), 78/85 patients (92%, 95% CI [83;96]) maintained an HIV-RNA<50copies/ml at W24. Seven patients experienced protocol-defined treatment failure between baseline and W24: Two had confirmed low-level viral rebound, one discontinued study treatment for adverse event, three withdrew their consent, and one was lost to follow-up. By on-treatment analysis, 78/80 patients (97%, 95% CI [91;99]) maintained an HIV-RNA<50copies/ml at W24. Results were similar at Week 48. The median area under the darunavir plasma concentration-time curve measured in 11 patients was 61,380nghr/ml; darunavir median trough concentration 1,340ng/ml and darunavir half-life was 12.2hr. Tolerability of once-daily darunavir/r 800/100mg was excellent. Optimally suppressed, treatment-experienced patients can switch safely from a twice-daily PI/r regimen to a once-daily darunavir/r 800/100mg containing regimen.
KW - Free fraction
KW - HIV-1
KW - Once-daily
KW - Protease inhibitors
KW - Semen
KW - Simplification
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U2 - 10.1002/jmv.23404
DO - 10.1002/jmv.23404
M3 - Article
C2 - 23024008
AN - SCOPUS:84869218671
VL - 85
SP - 8
EP - 15
JO - Journal of Medical Virology
JF - Journal of Medical Virology
SN - 0146-6615
IS - 1
ER -