9th Conference on Retroviruses and Opportunistic Infections Seattle, Washington - February 24 -February 28, 2002

Conf Retroviruses Opportunistic Infect 2002 Feb 24-28;9:abstract no. 13
F. Palella¹, M. Knoll¹, J. Chmiel¹, A. Moorman², K. Wood³, A. Greenberg², and S. Holmberg² for the HIV Outpatient Study (HOPS) Investigators
¹Northwestern Univ., Chicago, IL; ²CDC, Atlanta, GA; and ³Cerner Corp., Vienna, VA

BACKGROUND: Optimal timing of antiretroviral therapy (ART) initiation for HIV-infected patients is of great clinical and public health importance, yet remains unclear. Clinicians variably advocate earlier (higher CD4⁺ cell count [CD4]) vs later (lower CD4) ART initiation, but sparse data exist to support either strategy.

METHODS: Patients well-characterized by CD4 and ART use history from January 1996 to March 2001 at 8 U.S. clinics participating in the HOPS were grouped by pre-ART CD4 into 3 strata: 501-750, 351-500, 201-350 cells/mm³. In a prospective analysis, we compared mortality rates (excluding suicide and trauma) in each pre-ART CD4 stratum for patients who initiated ART while in that stratum to patients who delayed ART until a lower stratum.

RESULTS: Data from 126 patients with CD4 501-750 cells/mm³, 315 with CD4 351-500, and 377 with CD4 201-350 were analyzed. ART initiators vs delayers within each stratum had many similar demographics. In each of the 3 CD4 strata, more than two-thirds of delayers started ART in the next lower stratum. Median years of follow-up for initiators and delayers were, respectively, 5.9 and 5.3 for those with CD4 501-750; 3.7 and 3.4 for CD4 351-500; and 3.0 and 3.3 for CD4 201-350 cells/mm(3 )(p>0.3 for each). For those with CD4 501-750, 7.5 deaths/1000 person-years occurred in 54 initiators and 3.0/1000 person-years in 72 delayers (rate ratio [RR]=2.52; 95% CI: 0.23, 27.8; p>0.4), but only 3 deaths occurred in this stratum, none apparently HIV-related. For those with CD4 between 351-500, 229 initiated and 86 delayed ART, with 10.7 and 18.2 deaths/1000 person years, respectively (RR= 0.59; 95% CI: 0.21, 1.65; p>0.3). For those with CD4 201-350, 325 initiated and 52 delayed ART, with 20.8 and 70.6 deaths/1000 person years, respectively (RR= 0.29; 95% CI: 0.15, 0.58; p<.001).

CONCLUSIONS: These preliminary data suggest that initiation of ART for patients with CD4 201-350 cells/mm³, and possibly those with CD4 351-500, is associated with reduction in mortality in comparison with those for whom such therapy is delayed. Such survival benefits should be considered when evaluating the optimal timing of ART initiation.

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