Background: HIV-1-infected patients with a CD4+ lymphocyte count > or = 500 x 10(6)/l may be selected for antiretroviral treatment when viral load is above a given cut-off point.
Objectives: To assess the stability of viral load measurement at CD4+ T-cell counts above 500 x 10(6)/l, and the proportion of patients selected for treatment if a cut-off point of 10,000 or 30,000 RNA copies/ml is used.
Design and methods: Seventy-eight consecutive asymptomatic antiretroviral-naive HIV-1-infected patients with CD4+ lymphocyte counts > or = 500 x 10(6)/l, presenting for previously scheduled medical visits as outpatients, were enrolled. None of the patients had suffered from symptomatic primary infection or seroconverted within 6 months before enrollment. Two blood samples separated by a 1-month interval [day -30 (screening) and day 0 (enrollment)] were collected in an EDTA tube. Plasma was separated and frozen at -70 degrees C within 4 h of collection. HIV-1 RNA was quantified by polymerase chain reaction. CD4+ T cells were measured by flow cytometry.
Results: Viral load was fairly stable, and only four (13%) out of 30 pairs had a variation > or = 0.5 log10. At day -30 and day 0, log10 HIV RNA levels (mean +/- SD) were 4.24 +/- 0.7 and 4.35 +/- 0.87 log10 copies/ml plasma (P = 0.23). The difference of the mean was -0.11 (95% confidence interval, -0.28 to 0.07). At day 0 (n = 78) mean +/- SD value was 35730 +/- 73700 RNA copies/ml (range, < 200-438480; median, 9331; 25th and 75th percentiles, 1518 and 37193, respectively). In 13 patients (16%) the viral load was < 2000 copies RNA/ml. Seven out of 10 patients, who fulfilled the criteria of long-term non-progressors (LTNP), had viral load > 10,000 RNA copies/ml, and two patients had > 30,000 RNA copies/ml. Only two of the 13 patients with CD4+ T-cell counts > 750 x 10(6)/l had viral load > 10,000 copies/ml.
Conclusions: A single-point viral load assessment is enough in asymptomatic patients with CD4+ lymphocytes counts > or = 500 x 10(6)/l since plasma HIV RNA measurements obtained 1 month apart are fairly stable. Approximately 25% of these patients (including some patients with LTNP criteria) will be selected for treatment if 30,000 RNA copies/ml is used as cut-off point, and approximately 50% if the cut-off point is 10,000 RNA copies/ml. Viral load > or = 10,000 is very unusual in patients with CD4+ T-cell counts > 750 x 10(6)/l.