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3rd International AIDS Society Conference on HIV Pathogenesis and TreatmentRio de Janeiro - July 24 - 27, 2005 |
FOSCARNET USED IN SALVAGE THERAPY OF MULTIDRUG RESISTANT HIV-1 INFECTED PATIENTS
IAS Conf HIV Pathog Treat 2005 Jul 24-27;3rd: Abstract No.WePe12.9C16
Katlama C.1, Canestri A.1, Wirden M.2, Marguet F.1, Ghosn J.1, Ouagari Z.1, Boubezari I.1, Ktorza N.1, Agher R.1, Bossi P.1, Caumes E.1, Calvez V.2
1Service de Maladies Infectieuses, Hôpital Pitié-Salpetriere, Inserm U720, Université Pierre et Marie Curie, Paris, France, 2Service de Virologie, Hôpital Pitié-Salpetriere, Université Pierre et Marie Curie, Paris, France
INTRODUCTION: We evaluated the efficacy of Foscarnet in patients with late stage disease who have exhausted all therapeutic options.
METHODS: A pilot, open-label, add-on study. Patients with 4 drug classes experience including T 20 and Tipranavir (8/10), with plasma HIV-RNA (VL) >50,000 cp/ml, CD4 <100/mm³, were enrolled between 04/04 and 01/05. Foscarnet was given as 5g IV bid with 1500 cc saline isotonic for 6 weeks in addition to their stable failing ART. Patients with >1 log10 decrease in VL at W6 were given a maintenance therapy (MT) with Foscarnet 5g IV bid, 2 consecutive days/week. Primary end-point was the percentage of patients with >1 log10 reduction in VL at W6.
RESULTS: Ten patients were included with a median [range] baseline (BL) VL of 5.16 log10 cp/ml [4.72 – 6.66], a median CD4 of 8 cells/mm³ [1 – 54], a median of 9 NRTI resistance mutation (rm) including 4 TAMs, 2 NNRTI rm and 12 PI rm. One patient discontinued Foscarnet at week 2 for toxicity. By ITT, the median change in VL from BL (DVL) was -2.05 log10 cp/ml [-0.50 – -2.49] at W2, -1.46 log10 cp/ml [-1.02 – -2.88] at W4, -1.63 log10 cp/ml [-2.88 – 0.11] at W6. Overall, 6/10 had >-1 log10 DVL with a median CD4 count of 50 cells/mm³ [1 – 126] at W6. Maintenance Therapy was started in 6 patients. Two patients discontinued for virological failure: at MT-W4 (DVL: -0.38 log10 cp/ml) and at MT-W12 (DVL: -0.25 log10 cp/ml). Median DVL at MT-W12 was -0.85 log10 cp/ml (n=4) [0.04 – -2.81] with a median CD4 of 91 cells/mm³ [17 – 151]. Three patients have reached MT >W24 with sustained VL <5000 cp/ml. No renal insufficiency was observed in MT.
CONCLUSIONS: Foscarnet in addition to HAART induces a profound reduction in VL in patients severely immunosuppressed, with no therapeutic options. This may allow to wait for more potent regimens.
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Clinical | WePe12.9C16 | Christine Katlama
Treatment Failure and Salvage Therapy
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