[ThOrB1440] Treatment discontinuation in patients who started antiretroviral therapy following the 1996 IAS-USA Recommendations. A prospective randomized trial

14th International AIDS Conference

Barcelona, Spain — July 7-12, 2002

[TITLE:] Treatment discontinuation in patients who started antiretroviral therapy following the 1996 IAS-USA Recommendations. A prospective randomized trial

[AUTHOR(S):] A J Krolewiecki, C Zala, A Gun, C Ochoa, H Perez, M B Bouzas, P Cahn¹, I Cassetti²

Int Conf AIDS. 2002 Jul 7-12;14:Abstract No. ThOrB1440

BACKGROUND: HIV treatment guidelines have evolved to a delayed indication to start therapy. Patients who have started therapy under older guidelines might benefit from treatment discontinuation. Toxicity, cost, quality of life (QOL) and drug preservation are areas where these discontinuations might have an impact.

METHODS: HIV+ individuals on HAART for >6 months and no history of failure, with a nadir CD4 count >350 cells and a pre-therapy viral load (VL) under 60000 copies/mL are randomized to stop (DISC) or continue (CON) with current HAART. The CON group receives standard care; and the DISC is followed at monthly intervals for 24 weeks and every 8 weeks until week (W) 48. Clinical, virologic, immunologic and metabolic parameters are followed in both groups. QOL and economic analysis are performed. Patients are re-started on therapy when they reach clinical or laboratory endpoints (CD4<350 or VL >1 log from pre-therapy at 2 consecutive visits).

RESULTS: Accrual as of 12/2001 was 28 patients. Baseline CD4 counts were 610 and 618 in the DISC and CON groups respectively. No clinical events were seen and no clinical or laboratory endpoints were reached. VL in the DISC group became detectable with peaks between weeks 4 and 12. At W12 and W24 all patients had VL's within 1 log of the pre-therapy values (mean VL of 4.28, 4.20 and 3,79 at pre-therapy, W12 and W24 respectively). Mean CD4 was 544 cells at W12. LDL showed a decrease from a mean of 132mg/dl at baseline to 116 and 90 in W12 and W24. In the CON group CD4 and metabolic parameters remained stable. Lipodystrophy developed in 2 patients after discontinuation. Two patients interrupted therapy in the CON group due to side effects. Economic and QOL analysis are ongoing.

CONCLUSIONS: Patients who would not have been started on HAART with current guidelines can safely stop therapy and remain off-drugs for at least 24 weeks. Longer follow-up is warranted to confirm these preliminary results.

Presenting author: A J Krolewiecki

1 Fundacion Huesped, peluffo 3932, (1202), Buenos Aires, Argentina

2 FUNCEI, Buenos Aires, Argentina

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