3rd International AIDS Society Conference on HIV Pathogenesis and Treatment Rio de Janeiro - July 24 - 27, 2005

VIRAL SUPPRESSION IN CSF AND GENITAL TRACT IN RITONAVIR-BOOSTED "ATAZANAVIR ONLY" MAINTENANCE THERAPY (ATARITMO-STUDY)

IAS Conf HIV Pathog Treat 2005 Jul 24-27;3rd: Abstract No. WeOa0204

Vernazza P.¹, Daneel S.¹, Schiffer V.², Decosterd L.³, Hirschel B.², and the Swiss HIV Cohort S.^1
1Cantonal Hospital, St. Gallen, Switzerland, ²University Hospital Geneva, Geneva, Switzerland, ³CHUV, Lausanne, Switzerland

INTRODUCTION: Antiretroviral maintenance treatment (ART) with only one protease inhibitor (PI) might be an attractive method for simplification of long-term ART-maintenance. Reduced compartment penetration of PIs might constitute a limitation of such a strategy.

METHODS: Open-label, non-comparative 24-week pilot study for the evaluation of the efficacy in blood and genital/CSF-compartment of ritonavir-boosted atazanavir (AZV/r) mono-maintenance ART. All patients had to be on a stable, fully suppressive (RNA <50) triple-ART with no previous history of drug failure. Patients were switched to AZV/r (300/100mg) only at inclusion and ultrasensitive HIV-RNA (<50cp/ml) measured every 4 weeks. 9 Patients were included from a previous protease-mono-trial with indinavir/r (AIDS. 2004 Apr 9;18(6):955-7). Semen and CSF samples were obtained from consenting patients at BL (semen) and Wk24 (semen+CSF). The primary end-point was defined as an HIV-RNA value above 400 cp/ml.

RESULTS: To date, 24 (22 male) of the planned 30 patients are included. The median duration of previous VL-suppression was 9.4 months. 18 (9 from IDV/r study) patients have reached the 24-week endpoint and all patients remained with suppressed HIV-RNA <100cp/ml (all <50 except 1:80cp/ml). Eleven spinal fluid samples were obtained at Wk24, 8 are analysed to date. One of 8 patients had an HIV-RNA level of 800cp/ml (<50 in blood plasma). The remaining 7 had HIV-RNA <50cp/ml in CSF (and blood). All of 7 semen samples analyzed so far had undetectable HIV-RNA. One patient reached a primary endpoint (HIV-RNA 500 cp/ml) at week 8 and terminated the study. Additional data on CSF (HIV-RNA, Atazanavir levels), semen, immunology and metabolism will be presented.

CONCLUSIONS: Ritonavir-boosted atazanavir mono therapy might be a potentially attractive strategy for long-term maintenance of ART. However, due to the limited penetration into compartments, more data on the safety and compartment penetration of protease-mono ART are needed.

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050724
Clinical | WeOa0204 | Pietro Vernazza
Antiretroviral treatment strategies

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