MAGGIOLO F, RIPAMONTI D, GREGIS G, QUINZAN G, ARICI C, RAVASIO L, CALLEGARO A, SUTER F; Interscience Conference on Antimicrobial Agents and Chemotherapy (43rd: 2003: Chicago, Ill.).

Abstr Intersci Conf Antimicrob Agents Chemother Intersci Conf Antimicrob Agents Chemother. 2003 Sep 14-17; 43: abstract no. H-448.

Ospedali Riuniti, Bergamo, Italy.

BACKGROUND: STI are a possible strategy in HIV management. We evaluated individualized STIs according to the immunological response in a prospective, randomized study. METHODS: patients on an effective ARV therapy (HIV-RNA < 50 copies/ml) and with a sustained immunological response (CD4 > 800 cells/mcl) were randomized (2:1) to either interrupt or to continue their ongoing treatment. In the STI arm the goal was to maintain a CD4 count > 400 cells. The primary end-point was the proportion of subjects remaining in the randomized arm. The ITT approach was used in the analysis. 18 months results are presented RESULTS: 114 patients (76 stop; 38 ongoing) were enrolled. At baseline they were comparable for age, sex, risk factors, previous drug exposure, time on therapy and time with HIV RNA BLD. In the control group 8 patients interrupted treatment (1 viral failure, 1 tolerability failure, 1 lost to FU, 5 withdrawal of consent). In the STI arm only 1 patient withdrew permanently because of a severe HIV-induced piastrinopenia. 21% patients re-started therapy (1 patient twice) because of a drop of CD4 count and the per-patient mean time on treatment was 12.1% of the follow-up period. According to multiple logistic regression, the only independent predictor of CD4 depletion was the nadir value of CD4 cells (P< 0.001). The mean duration of the first off-therapy period was 6.9 months (never exceeding 10 months) for patients with a nadir CD4 count >200 cells/mcL, 14.1 months for patients with a nadir CD4 200-350, 17.8 months for those which a nadir 351-500, while no patient with a nadir >500 resumed therapy. All patients resuming therapy had a quick increment of CD4 counts. CONCLUSIONS: ARV therapy can be safely and steadily interrupted in patients who started it with high CD4 counts (>350 cells/mcl). In patients with a lower nadir count the risk of a more rapid decrement of CD4 is significantly higher. This observation opens new questions about the optimal timing to start ARV treatment

Publication Types:

• Meeting Abstracts

Keywords:

• Acquired Immunodeficiency Syndrome
• Antiretroviral Therapy, Highly Active
• CD4 Lymphocyte Count
• CD4-Positive T-Lymphocytes
• HIV Infections
• HIV Seropositivity
• Humans
• Prospective Studies
• drug therapy
• therapy

Other ID:

• GWAIDS0025633

UI: 102265257

From Meeting Abstracts