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Quantitation of HIV-1 RNA in Plasma Predicts Outcome after Seroconversion

John W. Mellors, MD; Lawrence A. Kingsley, DrPH; Charles R. Rinaldo, PhD; John A. Todd, PhD; Brad S. Hoo, MS; Robert P. Kokka, DrPH; and Phalguni Gupta, PhD
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From the University of Pittsburgh, Pittsburgh, Pennsylvania, and Chiron Corporation, Emeryville, California. Requests for Reprints: John W. Mellors, MD, 403 Parran Hall, Graduate of School of Public Health, University of Pittsburgh, Pittsburgh, PA 15261. Acknowledgments: The authors thank Jim Liebmann and Philip McKenna for technical assistance, Susan Y. Z. Zhou for statistical consultation, and the participants of the Pitt Men's Study. Grant Support: By Public Health Service contract N01-AI-72632 and cooperative agreement U01-AI-35041 and by the National Institutes of Health (R01 AI34301-01 and AI34294-O1A2), the Medical Research Service of the Department of Veterans Affairs, and the Pathology Education and Research Foundation of the University of Pittsburgh Medical Center.

Copyright ©2004 by the American College of Physicians

Ann Intern Med. 1995;122(8):573-579. doi:10.7326/0003-4819-122-8-199504150-00003
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Objective: To investigate the relation between the quantity of human immunodeficiency virus type 1 (HIV-1) RNA in plasma and the risk for the acquired immunodeficiency syndrome (AIDS) or a decline in the CD4+ T-cell count after seroconversion.

Design: Prospective study.

Patients: 62 homosexual men with documented HIV-1 seroconversion.

Setting: University outpatient setting.

Measurements: Clinical status, CD4+ T-cell counts, and plasma and serum samples were obtained every 6 months. Human immunodeficiency virus RNA in plasma was quantitated with a branched-DNA (bDNA) assay. Serum samples were assayed for neopterin, β2-microglobulin, and immune complex dissociated HIV-1 p24 antigen.

Results: 18 of 62 (29%) men developed AIDS; 21 (34%) had a significant decline in the CD4+ T-cell count without AIDS; and 23 [37%] had a stable CD4+ T-cell count. For each participant, HIV-1 RNA results were categorized into one of four groups: 1) detection of HIV-1 RNA (>1 × 104 genome equivalents/mL [Eq/mL]) in all samples; 2) detection in most samples [≥ 50%]; 3) detection in fewer than 50% of samples; and 4) detection in none of the samples. Detection of HIV-1 RNA in all or most samples was strongly associated with AIDS (16 of 18 patients) and a decline in the CD4+ T-cell count (13 of 21 patients) compared with a stable CD4+ T-cell count (4 of 23 patients; P < 0.001). Conversely, the absence of HIV-1 RNA (<1 × 104 Eq/mL) in all or most samples was associated with stable CD4+ T-cell counts (19 of 23 patients) and a lower risk for AIDS or decline in the CD4+ T-cell count (10 of 39 patients; P < 0.001). In multivariate analysis of all laboratory values at the seroconversion visit, a plasma HIV-1 RNA level greater than 1 × 105 Eq/mL was the most powerful predictor of AIDS (odds ratio, 10.8; P = 0.01).

Conclusions: Plasma HIV-1 RNA is a strong, CD4+ T-cell-independent predictor of a rapid progression to AIDS after HIV-1 seroconversion.


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Figure 1.
Longitudinal plasma HIV-1 RNA levels and CD4+ T-cell counts from five nonprogressors with stable CD4+ T-cell counts (top) and five persons who progressed to AIDS (bottom).

The letters A, B, C, D, and E refer to patients.

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Figure 2.
Median longitudinal serum neopterin (top) and β2-microglobulin levels (bottom) in the three outcome groups.
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Figure 3.
Longitudinal detection of serum immune complex dissociated (ICD) p24 antigen (top) and plasma HIV-1 RNA (bottom) in the three outcome groups.4

The data are the proportion of each outcome group having detectable serum ICD p24 antigen (>12 pg/mL) or plasma HIV-1 RNA (>1 × 10 Eq/mL). The asterisk indicates that no patient in the stable CD4 group was p24 or HIV-1 RNA positive.

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