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Session 125
Poster Abstracts Viral Load Assays Thursday, 1:30 - 3:30 pm Hall A |
Background: Patients with optimally suppressed plasma
HIV-1 RNA concentrations occasionally experience transient increases in HIV-1
RNA, commonly referred to as “blips.” This may be the result of factors such as
short treatment interruption, development of drug resistance, intermittent
illness, or recent immunization. It has been reported that falsely elevated
HIV-1 RNA levels are associated with the use of Plasma Preparation Tubes™
(PPT). We observed that patients at Northwestern Memorial Hospital (NMH)
experienced blips during a period of time (January to August 2003) when the
HIV-1 RNA specimen collection procedure changed from using standard ethylenediaminetetraacetic acid (EDTA) tubes to PPT tubes. Prior
to and after this period, specimens were collected in EDTA tubes. We
investigated whether transient HIV-1 RNA elevations were related to the type of
tube used for plasma collection.
Methods: The CDC NMH HIV Out-Patient Study (HOPS)
database was surveyed to determine the frequency of blips during periods of PPT
or EDTA tube use for plasma HIV-1 RNA collection. Patients with ≥ 3
undetectable HIV-1 RNA levels (< 50 copies/mL,
Roche Ultrasensitive Amplicor®
v1.0 or 1.5) during the initial period of EDTA use and ≥ 1 HIV-1 RNA
measurement during the periods of PPT and resumed EDTA use were evaluated.
Results: Of 595 NMH HOPS patients, 68 had optimally
suppressed HIV-1 RNA prior to the switch to PPT tubes and ≥ 1 measurement
during PPT and resumed EDTA tube use. HIV-1 RNA blips (range 50 to 1779, mean
267 copies/mL) occurred in 53% (n = 36) of patients
during the period of PPT use, 7% (n = 5) during both EDTA and PPT periods, and
in only 6% (n = 4) during EDTA tube use (p
= 0.002). Of patients maintained, 25% suppressed HIV-1 RNA levels without
blips. Viral blips resulted in 43% (19 of 45) of patients with ≥ 1
unplanned repeat blood draws for HIV-1 RNA measurement. At least one patient
had an ART regimen change because of the blip.
Conclusions: The use of PPT tubes for
plasma HIV-1 RNA measurement resulted in a viral “blip” in > 50% of patients.
This prompted early and not clinically indicated
repeat blood draws for HIV-1 RNA testing and additional clinic visits, as well
as a medication change in at least 1 patient. Although processing of PPT tubes
is considered safer, the increased costs related to blips indicate that PPT
tubes should not be used for HIV-1 RNA monitoring
in maximally suppressed HIV-infected patients or in clinical trials where HIV-1
RNA is a clinical endpoint.
Keywords: HIV RNA; Treatment monitoring ; Viral rebound
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