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Antiretroviral concentration measurements as an additional tool to manage virologic failure in resource limited settings: a case control study


Buzibye, Allan; Musaazi, Joseph; von Braun, Amrei; Nanzigu, Sarah; Sekaggya-Wiltshire, Christine; Kambugu, Andrew; Fehr, Jan; Lamorde, Mohammed; Gutteck, Ursula; Muller, Daniel; Sowinski, Stefanie; Reynolds, Steven J; Castelnuovo, Barbara (2019). Antiretroviral concentration measurements as an additional tool to manage virologic failure in resource limited settings: a case control study. AIDS Research and Therapy, 16(1):39.

Abstract

BACKGROUND: Several studies demonstrate a correlation between sub-therapeutic concentrations of antiretroviral drugs and virologic failure. We examined the sensitivity, specificity and predictive values of sub-therapeutic drug levels in predicting viralogic failure.
METHODS: This was a case control study with cases being samples of participants with virologic failure, and controls samples of participants with virologic suppression. We analyzed samples obtained from participants that had been on antiretroviral treatment (ART) for at least 6 months. Virologic failure was defined as HIV-RNA viral load ≥ 1000 copies/ml. Sub-therapeutic drug levels were defined according to published reference cutoffs. The diagnostic validity of drug levels for virologic failure was assessed using plasma viral loads as a gold standard.
RESULTS: Sub-therapeutic ART concentrations explained only 38.2% of virologic failure with a probability of experiencing virologic failure of 0.66 in a patient with low drug levels versus 0.25 for participants with measurements within or above the normal range. Approximately 90% of participants with ART concentrations above the lower clinical cut off did not have virologic failure.
CONCLUSIONS: These results support prior indication for therapeutic drug monitoring in cases of suspected virologic failure.

Abstract

BACKGROUND: Several studies demonstrate a correlation between sub-therapeutic concentrations of antiretroviral drugs and virologic failure. We examined the sensitivity, specificity and predictive values of sub-therapeutic drug levels in predicting viralogic failure.
METHODS: This was a case control study with cases being samples of participants with virologic failure, and controls samples of participants with virologic suppression. We analyzed samples obtained from participants that had been on antiretroviral treatment (ART) for at least 6 months. Virologic failure was defined as HIV-RNA viral load ≥ 1000 copies/ml. Sub-therapeutic drug levels were defined according to published reference cutoffs. The diagnostic validity of drug levels for virologic failure was assessed using plasma viral loads as a gold standard.
RESULTS: Sub-therapeutic ART concentrations explained only 38.2% of virologic failure with a probability of experiencing virologic failure of 0.66 in a patient with low drug levels versus 0.25 for participants with measurements within or above the normal range. Approximately 90% of participants with ART concentrations above the lower clinical cut off did not have virologic failure.
CONCLUSIONS: These results support prior indication for therapeutic drug monitoring in cases of suspected virologic failure.

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Item Type:Journal Article, refereed, original work
Communities & Collections:04 Faculty of Medicine > University Hospital Zurich > Institute of Clinical Chemistry
04 Faculty of Medicine > Epidemiology, Biostatistics and Prevention Institute (EBPI)
04 Faculty of Medicine > University Hospital Zurich > Clinic for Infectious Diseases
Dewey Decimal Classification:610 Medicine & health
540 Chemistry
Scopus Subject Areas:Life Sciences > Molecular Medicine
Life Sciences > Virology
Health Sciences > Pharmacology (medical)
Uncontrolled Keywords:Molecular Medicine, Pharmacology (medical), Virology
Language:English
Date:1 December 2019
Deposited On:05 Feb 2020 18:23
Last Modified:11 May 2020 19:33
Publisher:BioMed Central
ISSN:1742-6405
OA Status:Gold
Free access at:PubMed ID. An embargo period may apply.
Publisher DOI:https://doi.org/10.1186/s12981-019-0255-x
PubMed ID:31810468

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