A prospective randomized trial of treatment discontinuation in asymptomatic patients who started antiretrovirals with preserved immune function. 48 week data.

KROLEWIECKI A; ZALA C; BOUZAS MB; PEREZ H; VANZULLI C; CASSETTI I; CAHN P

Paris, Francia

Conferencia; The 2nd IAS Conference on Pathogenesis and Treatment; 2003

International AIDS Society

Background: Treatment interruption for patients on HAART with uncompromised clinical, virologic and immunologic conditions, is an attractive and popular strategy. However, evidence to support this practice is lacking. We present 48 week data on this randomized trial. Methods: HIV+ individuals on HAART for >6 months, with nadir CD4 count ³350 cells and a pre-ARV viral load (VL) £ 60000 c/ml were randomized to stop (DIS) or continue (CON) HAART. The CON group received standard care; the DIS group had monthly controls for 24 weeks then every 8 weeks until week (W) 48. Clinical, virologic, immunologic and metabolic parameters were followed in both groups. Therapy was restarted when patients reached clinical endpoints or with CD4<350 or VL >1 log from pre-therapy at 2 consecutive visits. QOL and economics were analysed. Results: 36 patients were randomized, 20 to DIS and 16 to CON. All patients completed 48 weeks follow up. Baseline (median) CD4 counts were 644 and 633 cells in the DIS and CON groups respectively. No clinical events were seen in either group. No laboratory endpoints were reached in the DIS group. One patient in the DIS group resumed therapy due to pregnancy. In the CON group there was one clinical endpoint (toxicity). At W48 all 19 (95%) patients in the DIS group had VL’s within 1-log of the pre-therapy values, and the median  DVL (pretherapy - W48) was 0.03 log (mean VL of 4.35 and 4.38 at pre-therapy and W48 respectively). Median CD4 was 486 at W48. In the CON group CD4 and metabolic parameters remained stable. Economic analysis revealed net savings of >3000 U$S/pt/yr in the DIS group. Significant decreases were seen in LDL of hypercholesterolemics and lactate in the DIS group. Conclusions: This randomized study confirms that stopping therapy in patients with nadir CD4 count >350 cells is safe and convenient. Pre-therapy VL is a good predictor of the VL after 48 weeks of treatment discontinuation.