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Abstract



INDINAVIR INTENSIFICATION FOR SALVAGE THERAPY IN HIV INFECTED PATIENTS HEAVILY PRE-TREATED: INDINAVIR/RITONAVIR BID 800/200 MG VS 400/400 MG

MALLOLAS J, BLANCO J, SARASA M, ARNEDO M, LÓPEZ-PÚA Y, MARTÍNEZ E, MILINKOVIC A, GARCÍA-VIEJO M, PUMAROLA T, GATELL J

Background: Ritonavir (Rtv) enhance the pharmacokinetic properties of indinavir potentially allowing to reach plasma levels above the IC-90 of some resistant strains. Objective: To evaluate if HIV patients failing a regimen including Ind 800 mg TID can be rescued with Ind/Rtv and to compare which regimen could be better in terms of efficacy and tolerance: Ind/Rtv BID 800/200 mg vs 400/400 mg. Methods: Patients receiving Ind 800 mg TID were elegible if 2 consecutive plasma viral load were above 2000 copies/mL and the adherence to antiretroviral therapy was considered good (> 90%). They were allocated to 800/200 BID vs 400/400 BID while the same two backbone nucleoside analogs were maintained at least until the week 3. At baseline and at week 3,12 and 24 weeks a clinical, virological and immunological evaluation were performed and trough and peak Ind and Rtv plasma levels measured. Results: Fifteen patients were included in the group A (800/200) and 12 in the B (400/400). The mean number of previous treatments, previous protease inhibitors, months on Ind,, baseline plasma viral load, CD4 cell and mean number of protease gene mutations were 4, 2.2, 18.7, 94603, 448 and 3 for the group A and 6.2, 2.4, 12.1, 99738, 302 and 3 for the group B (p=ns). In the group A, 1 out of 15 patients withdrew therapy due to renal colic and in the group B, 4 out of 12 patients withdrew therapy due to gastrointestinal intolerance. VL < 200 ? VL-log10 (*) ? CD4/mL Trough level (*) Peak level (*) Copies/mL (**) Ind-Rtv (**) Ind-Rtv Week 3: - A (n:14) 7 (50%) - 0.8 + 70 1.77 - 0.81 7.40 – 1.97 - B (n: 8) 3 (38%) + 0.1 - 1 0.67 – 1.29 2.75 – 3.50 Week 12: - A (n:8) 5 (62%) - 1 + 88 1.71 – 0.92 7.3 – 1.23 - B (n: 5) 2 (40%) - 0.5 + 122 0.93 – 1.1 2.23 – 3.85 (*) Mean (**) ?g/mL. Conclusion: Patients treated with Ind 800 mg TID can be rescued with Ind/Rtv. Ind/Rtv 800/200 mg BID seems to be better than 400/400 mg BID in terms of virological efficacy and tolerance 




The 1st. IAS Conference on HIV Pathogenesis and Treatment
Abstract no. 112


Suggested Citation
"MALLOLASJ, et al. INDINAVIR INTENSIFICATION FOR SALVAGE THERAPY IN HIV INFECTED PATIENTS HEAVILY PRE-TREATED: INDINAVIR/RITONAVIR BID 800/200 MG VS 400/400 MG. Oral Presentation: The 1st. IAS Conference on HIV Pathogenesis and Treatment : Abstract no. 112"