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Relations among CD4 Lymphocyte Count Nadir, Antiretroviral Therapy, and HIV-1 Disease Progression: Results from the EuroSIDA Study

Veronica Miller, PhD; Amanda Mocroft, PhD; Peter Reiss, MD; Christine Katlama, MD; Anthony I. Papadopoulos, MD; Terese Katzenstein, MD; Jan van Lunzen, MD; Francisco Antunes, MD; Andrew N. Phillips, PhD; Jens D. Lundgren, MD, for the EuroSIDA Study Group*
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From J.W. Goethe-Universität, Zentrum der Inneren Medizin, Frankfurt, Germany, and Universitätsklinikum Eppendorf, Hamburg, Germany; Royal Free Centre for HIV Medicine, London, United Kingdom; Academic Medical Center, Amsterdam, the Netherlands; Hôpital de la Pitiè-Salpêtière, Paris, France; 1st IKA Hospital, Athens, Greece; Rigshospitalet and Hvidovre University Hospital, Copenhagen, Denmark; and Hospital Santa Maria, Lisbon, Portugal.

Ann Intern Med. 1999;130(7):570-577. doi:10.7326/0003-4819-130-7-199904060-00005
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Background: The effect of previous CD4 cell count nadir on clinical progression in patients with increases in CD4 cell counts has not been investigated.

Objective: To assess risk for progression of HIV disease in patients with CD4 counts of at least 200 cells/mm3 (stratified by the lowest previous CD4 count) and compare the rate of progression in patients with CD4 counts less than 50 cells/mm3 with that in patients whose CD4 counts rebounded from less than 50 cells/mm3 to at least 200 cells/mm3.

Design: Prospective, observational multicenter study.

Setting: 52 HIV outpatient clinics in Europe.

Patients: Two groups were identified: those with CD4 counts of at least 200 cells/mm3 (group A) and those with CD4 counts less than 50 cells/mm3 (group B). Group A was stratified according to the lowest previous CD4 count: at least 150 cells/mm3 (stratum 1), 100 to 149 cells/mm3 (stratum 2), 50 to 99 cells/mm3 (stratum 3), and 1 to 50 cells/mm3 (stratum 4).

Measurements: Patients were followed until a progression event occurred (first AIDS-defining event, new AIDS-defining event, or death) or until the CD4 count decreased to less than 200 cells/mm3 (group A) or increased to more than 50 cells/mm3 (group B). Incidence rates were based on a patient-years analysis and reported as events per 100 patient-years of follow-up; the relative hazards for progression were based on Cox proportional-hazards models.

Results: The overall rate of disease progression in group A was 3.9 per 100 patient-years (95% CI, 3.5 to 4.3 per 100 patient-years), whereas in group B it was much higher (72.9 per 100 patient-years [CI, 69.0 to 76.8 per 100 patient-years]). In group A, the rate increased in patients with previous low CD4 cell count nadirs, resulting in a significant increase in the relative hazard for progression. The relative hazards for strata 2, 3, and 4 were 2.29 (CI, 1.30 to 4.03), 3.65 (CI, 1.94 to 6.85), and 2.94 (CI, 1.44 to 6.00), respectively.

Conclusions: Increases in CD4 counts from very low levels to at least 200 cells/mm3 are associated with a much reduced rate of disease progression. However, a previously low CD4 cell count nadir remains associated with a moderately higher risk for disease progression among patients with CD4 counts of at least 200 cells/mm3.

*For members of the EuroSIDA Study Group, see Appendix.


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Study design.3solid-line graphs3broken-line graph33

Disease progression for patients in group A was measured when CD4 count first reached a value of at least 200 cells/mm . Patients were stratified according to the previous CD4 cell nadir ( ). Follow-up for patients in group B began when the CD4 count first decreased to less than 50 cells/mm ( ). Dotted lines indicate the limits (≥ 200 cells/mm or <50 cells/mm ) used to define patient group A and group B.

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