Total Lymphocyte Count, Hemoglobin, and Delayed-Type Hypersensitivity as Predictors of Death and AIDS Illness in HIV-1-Infected Women Receiving Highly Active Antiretroviral Therapy

Background: Total lymphocyte count (TLC) and hemoglobin level have been suggested as useful and inexpensive parameters to indicate need for HAART in settings in which CD4⁺ cell counts are unavailable. If delayed-type hypersensitivity (DTH) response predicts clinical response in persons using highly active antiretroviral therapy (HAART), it may also prove useful in resource-poor settings. Objective: To examine whether TLC, hemoglobin, and DTH response observed prior to initiation of HAART predict post-HAART clinical response. Design: Prospective cohort study. Participants: 873 women in the Women's Interagency HIV Study. Measurements: TLC, hemoglobin, CD4⁺ cell counts, and DTH testing using mumps, candida, and tetanus toxoid antigens, performed within 1 year prior to HAART initiation; death; self-report of initiation of HAART use and AIDS-defining illness (ADI). Results: Three different multivariate analyses were performed: 2 models that excluded CD4 ⁺ cell count and assessed TLC at either <850 or <1250 cells/μL, and 1 model that excluded TLC and included CD4⁺ <200 cells/μL. TLC <850, TLC <1250, CD4⁺ <200 cells/μL, anergy to DTH testing, hemoglobin <10.6 g/dL, and a pre-HAART report of ADI were each consistently independently associated both with death and with incident ADI. Log likelihood χ² values suggested similar power among the 3 models in predicting both death and incident ADI. Conclusions: Pre-HAART TLC, hemoglobin level, anergy to DTH testing, and clinical disease each independently predicted morbidity and death after HAART initiation. These findings support the use of TLC to guide decision-making for HAART initiation and suggest that further study of TLC, hemoglobin level, and DTH responses as an indication to provide HAART may be useful in resource-limited settings.