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J Infect Dis. 2007 Dec 15;196(12):1773-8. doi: 10.1086/523704.

Decreased adherence to antiretroviral therapy observed prior to transient human immunodeficiency virus type 1 viremia.

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  • 1Global Pharmaceutical Research and Development, Abbott Laboratories, 200 Abbott Park Road, Abbott Park, IL 60064, USA. thomas.podsadecki@abbott.com

Abstract

BACKGROUND:

To identify potential causes and clinical implications of transient increases in plasma viral load (hereafter, "blips").

METHODS:

M99-056 and M02-418 were prospective, randomized trials evaluating the safety and efficacy of lopinavir/ritonavir (LPV/r) capsules administered twice per day or once per day to subjects infected with human immunodeficiency virus-1 (HIV-1). Plasma viral load was measured every 4 weeks (from baseline through week 24, excluding week 12 and week 20 in M02-418), every 8 weeks (from week 24 through week 48), and every 12 weeks (from week 48 through week 96). Blips were defined by 1 plasma viral load measurement of between 50-1000 copies/mL, immediately preceded and immediately followed by a measurement of <50 copies/mL. A medication event monitoring system was used to record the date and time subjects administered a dose of LPV/r.

RESULTS:

Of 228 subject enrolled, event monitor data were available for 223 (98%) subjects (92 of whom received twice-daily LPV/r therapy, and 131 of whom received once-daily therapy). Viral load blips (median plasma viral load, 82 copies/mL [range, 51-858 copies/mL]) were identified in 60 (27%) of the subjects (21 in the LPV/r twice-daily group and 39 in the LPV/r once-daily group). Neither the baseline plasma viral load nor the CD4(+) T cell count were associated with blips. During the week prior to a blip, the mean number of days that the subject administered the prescribed number of doses was lower than the number during a matched period for the same subject during which a blip did not occur (5.55 vs. 6.22 days; P = .007). Blips were not associated with virologic failure or the development of drug resistance.

CONCLUSIONS:

Blips were associated with decreased adherence, but not with virologic failure or development of drug resistance in these studies of LPV/r.

TRIAL REGISTRATION:

Clinicaltrials.gov identifier: NCT00043966 .

Comment in

PMID:
18190257
[PubMed - indexed for MEDLINE]
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