Objective: To study clinical, immunologic, and virologic outcomes in patients who stop antiretroviral therapy (ART) with relatively preserved CD4 cell counts.
Design and Methods: Patients with a documented CD4 cell count >250 cells/μL who stopped ART for any reason for at least 5 weeks were studied. Relevant clinical and laboratory data were collected using a standardized data collection form.
Main Outcome Measures: Patients were monitored for outcomes including Centers for Disease Control (CDC) category B or C events, time to restarting ART, and time to reaching a CD4 cell count of ≤250 cells/μL.
Results: A total of 107 patients were included. The median time on ART was 45 months and median number of antiretroviral medications was 4. The median pre-ART CD4 cell count and HIV viral load were 463 cells/μL and 4.35 log copies/mL, respectively. The median CD4 cell at time of ART stop was 739 cell/μL. The slope of the CD4 decrease was 65 cells/mo in the first 2 months, which was greater than the subsequent decline of 8 cells/mo thereafter (P < 0.01). Similarly the median viral load increase was 2.54 log copies/mL in the first 2 months after stopping and was unchanged after that point. Two patients experienced the retroviral rebound syndrome after ART cessation but no CDC category B or C events were observed during 10 months of follow-up. The median time from stopping ART to reaching the combined endpoint of CD4 <250 or restarting ART was 8.9 months. In multivariate analysis, pre-ART CD4 cell count >250 was protective of reaching the combined endpoint (odds ratio = 0.156, P = 0.03). Other predictors of reaching the combined endpoint in multivariate analysis were older age and number of prior ART agents. Patients who restarted ART had a favorable virologic and immunologic response.
Conclusions: Patients with relatively high CD4 cell counts prior to starting ART did well after stopping ART. Pre-ART CD4 cell count can be used to predict outcomes after ART cessation.
From the *University of Texas, Southwestern Medical Center, and †AMH Group, Dallas, TX.
Received for publication March 29, 2004;
accepted July 12, 2004.
Supported by AIDS Clinical Trials Group (U01 AI046376) (D.J.S.).
Reprints: Daniel J. Skiest, The University of Texas Southwestern Medical Center, 5323 Harry Hines Blvd., Dallas, TX 75390-9113 (e-mail: firstname.lastname@example.org).