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Abstract N Engl J Med 1996;335:1091-8.
The Relation of Virologic and Immunologic Markers to Clinical Outcomes After Nucleoside Therapy in HIV-Infected Adults with 200 to 500 CD4 Cells Per Cubic Millimeter
Authors: Katzenstein DA, Hammer S, Hughs MD, Gundacker H, Jackson JB, Fiscus S, Rasheed S, Elbeik T, Reichman R, Japour A, Merigan TC, and Hirsch MS, For the AIDS Clinical Trials Group Study 175 Virology Study Team
Methods:
The 391 subjects, each of whom entered the study with a single screening CD4 cell count of 200 to 500 per cubic millimeter, were randomly assigned to receive zidovudine alone, didanosine alone, zidovudine plus didanosine or zidovudine plus zalcitabine. Plasma concentrations of HIV RNA were assessed in 366 subjects, and viral isolates from 332 subjects were assayed for the presence of the syncytium-inducing phenotype.
Results:
After eight weeks, the mean (+SE) decrease from base line in the concentration of HIV RNA, expressed as the change in the base 10 log of the number of copies per millimeter, was 0.26+0.06 for patients treated with zidovudine alone, 0.65+0.07 for the didanosine alone, 0.93+0.10 for zidovudine plus didanosine, and 0.89+0.06 for zidovudine plus zalcitabine (P<0.001 for each of the pairwise comparisons with zidovudine alone). Multivariate proportional-hazards models showed that higher baseline concentrations of plasma HIV RNA, less suppression of plasma HIV RNA by treatment, and the presence of the syncytium-inducing phenotype were associated with an increased risk of progression to the acquired immunodeficiency syndrome and death. After adjustment for these measures of viral replication and for the viral phenotype, CD4 cell counts were not significant predictors of clinical outcome.
Conclusion:
Both the risk of the progression of HIV disease and the efficacy of antiretroviral therapy are strongly associated with the plasma level of HIV RNA and with the viral phenotype. The changes in the plasma concentration of HIV RNA predict the change in CD4 cell counts and survival after treatment with reverse-transcriptase inhibitors (N Engl J Med 1996;335:1091-8.)
For complete details consult the October 10, 1996 issue of the New England Journal of Medicine, volume 335, pages 10991-8.
Reference: 1. Katzenstein DA, Hammer S, Hughs MD, Gundacker H, Jackson JB, Fiscus S, Rasheed S, Elbeik T,
Reichman R, Japour A, Merigan TC, Hirsch MS, et al. The relation of virologic and immunologic markers to clinical outcomes after nucleoside therapy in HIV-infected adults with 200 to 500 CD4 cells per cubic millimeter. N Engl J Med 1996;335:1091-8.
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