16th International AIDS Conference Toronto, Canada - August 13 - 18, 2006

TIME TO HAART RESUME AFTER STRUCTURED TREATMENT INTERRUPTION IS STRONGLY ASSOCIATED WITH HIV DNA LEVEL IN PBMC AT INTERRUPTION: RESULTS OF THE ANRS 116 SALTO TRIAL

Int Conf AIDS. 2006 Aug 13-18;16 Abstract No. WeAb0205

Piketty C.¹, Weiss L.¹, Bachir-Cherif S.², Assoumou L.², Burgard M.³, Ragnaud J.-M.⁴, Bentata M.⁵, Girard P.-M.⁶, Rouzioux C.³, Costagliola D.², The ANRS 116 SALTO study group
¹ Hopital Europeen Georges Pompidou and Univ Paris 5, Paris, France, ² INSERM U720 and Univ Pierre et Marie Curie, Paris, France, ³ Hopital Necker and Univ Paris 5, Paris, France, ⁴ Hopital Pellegrin, Bordeaux, France, ⁵ Hopital Avicenne, Bobigny, France, ⁶ Hopital Saint Antoine, Paris, France

BACKGROUND: The aim of the study was to evaluate the safety and efficacy of structured treatment interruption (STI) in chronically HIV-infected patients who started treatment based on earlier guidelines and to assess the predictive factors of the duration of STI.

METHODS: A prospective, open-label, multicentre trial of STI in patients who have been treated with CD4 cell count >350 × 10⁶/L and plasma HIV-RNA (VL) <50,000 copies/ml, who have CD4 cell count >450 × 10⁶/L and stable VL <5000 copies/ml and ARV treatment within 6 months prior to inclusion and who exhibited no more than one prior treatment failure. Criteria to resume HAART were a decrease in CD4 cell count to 300 × 10⁶/L or the occurrence of an AIDS defining event. Results are expressed with median (min-max).

RESULTS: 99 patients were recruited in the study including 63 men (64%). Median duration of previous HAART was 5.3 years. CD4 cell count and VL at initiation of HAART and at inclusion were 457 × 10⁶/L (352 – 986) and 4.2 Log-copies/ml (2.6 – 4.7) and 809 × 10⁶/L (310 – 1557) and 2.6 Log-copies/ml (2.6 – 4.3), respectively. Median proviral HIV-DNA level at inclusion was 2.3 Log-copies/million PBMC (1.0 – 4.1). At 24 months, 88% of the patients (95% CI [80 – 93]) did not meet the criteria to resume HAART and 77% [67 – 84] did not resume HAART. In univariate Cox model, HIV-DNA level, CD4 nadir, CD4 at HAART initiation, CDC stage and group of transmission were significant risk factors of HAART resumption. In multivariate analysis, HIV-DNA level at treatment interruption and CD4 nadir were the only significant risk factors of HAART resumption (Hazard Ratio = 4.3 [1.2 – 14.3] and 0.18 [0.03 – 1.1], respectively).

CONCLUSIONS: Long term treatment interruption is feasible in patients who started HAART based on earlier guidelines. HIV-DNA level may be a useful tool to select patients who may benefit of a prolonged treatment interruption.

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2006-08-13
WeAb0205

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