RITONAVIR(RTV)/AMPRENAVIR(APV) COMBINATION THERAPY IN HIV INFECTED PATIENTS WHO FAILED SEVERAL PROTEASE INHIBITOR CONTAINING REGIMEN.
Objective: To assess the antiviral efficacy of a RTV-APV containing regimen in patients having failed several PI containing regimen. 68 patients (pts) with a failure regimen defined as viral load (VL) >1000 copies/ml following therapies including all 3 classes of drugs who received a RTV/APV containing regimen. Results : We evaluated 68 pts with, at baseline, median CD4 cells of 227/mm3 (range 0 to 994), HIV RNA 32500 copies/ml (range 1094 to 106), prior ARV therapy was 7,7 years (range 1 to 13) ; 33/68 (49%) pts were AIDS; 46/68 (68%) pts had received>3 PIs;. 31/68 (46%) pts had genotypic resistance profile with a median associated mutations nb of 2 to NRTI (range 0 to 7), 1 to NNRTI (range 0 to 3) and 3 to PI (range 0 to 8): 82A (39%) ; 54V (35%), 90M (26%), 46L/I (26%). Treatment consisted in RTV/APV (100/600 mg bid) in 59 pts (88%) RTV/APV (200/600 mg bid) in 9 pts; 12/68 had second PI associated to APV. By ITT analysis, the median decrease in VL was –1.53 log10 at W12(n=66), -1.14 log10 at W24(n=38), -1.55 log10 at W48 (n=28). 44/66 (67%) at W12, 21/38 (55%) at W24 and 18/28 (64%) at W48 had >1 log10 VL reduction. The proportion of patients with VL<200 copies/ml was 32% at W12, 32% at W24, 36% at W48. The median increase in CD4 cells was +47/mm3 at W12, +55/mm3 at W24, +83/mm3 at W48. Main side effects were: ABC hypersensitivity (2), APV intolerance (1), digestive symptoms (27). Conclusion: This pilot retrospective study shows that in patients with multiple failures to PI containing regimen, RTV/APV (100/600 mg bid) appears as a potent antiviral option with a 1.5 log10 median reduction in VL at week 48.
KATLAMA C, SCHNEIDER L, AGHER R, DELAUGERRE C, CALVEZ V, LEGRAND M, TUBIANA R
HOPITAL PITIE SALPETRIERE