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Predicting resistance as indicator for need to switch from first-line antiretroviral therapy among patients with elevated viral loads: Development of a risk score algorithm

Rutstein, SE and Hosseinipour, MC and Weinberger, M and Wheeler, SB and Biddle, AK and Wallis, CL and Balakrishnan, P and Mellors, JW and Morgado, M and Saravanan, S and Tripathy, S and Vardhanabhuti, S and Eron, JJ and Miller, WC (2016) Predicting resistance as indicator for need to switch from first-line antiretroviral therapy among patients with elevated viral loads: Development of a risk score algorithm. BMC Infectious Diseases, 16 (1).

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Abstract

Background: In resource-limited settings, where resistance testing is unavailable, confirmatory testing for patients with high viral loads (VL) delays antiretroviral therapy (ART) switches for persons with resistance. We developed a risk score algorithm to predict need for ART change by identifying resistance among persons with persistently elevated VL. Methods: We analyzed data from a Phase IV open-label trial. Using logistic regression, we identified demographic and clinical characteristics predictive of need for ART change among participants with VLs ≥1000 copies/ml, and assigned model-derived scores to predictors. We designed three models, including only variables accessible in resource-limited settings. Results: Among 290 participants with at least one VL ≥1000 copies/ml, 51 % (148/290) resuppressed and did not have resistance testing; among those who did not resuppress and had resistance testing, 47 % (67/142) did not have resistance and 53 % (75/142) had resistance (ART change needed for 25.9 % (75/290)). Need for ART change was directly associated with higher baseline VL and higher VL at time of elevated measure, and inversely associated with treatment duration. Other predictors included body mass index and adherence. Area under receiver operating characteristic curves ranged from 0.794 to 0.817. At a risk score ≥9, sensitivity was 14.7-28.0 % and specificity was 96.7-98.6 %. Conclusions: Our model performed reasonably well and may be a tool to quickly transition persons in need of ART change to more effective regimens when resistance testing is unavailable. Use of this algorithm may result in public health benefits and health system savings through reduced transmissions of resistant virus and costs on laboratory investigations.


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Details

Item Type: Article
Status: Published
Creators/Authors:
CreatorsEmailPitt UsernameORCID
Rutstein, SE
Hosseinipour, MC
Weinberger, M
Wheeler, SB
Biddle, AK
Wallis, CL
Balakrishnan, P
Mellors, JWjwm1@pitt.eduJWM1
Morgado, M
Saravanan, S
Tripathy, S
Vardhanabhuti, S
Eron, JJ
Miller, WC
Date: 13 June 2016
Date Type: Publication
Access Restriction: No restriction; Release the ETD for access worldwide immediately.
Journal or Publication Title: BMC Infectious Diseases
Volume: 16
Number: 1
DOI or Unique Handle: 10.1186/s12879-016-1611-2
Institution: University of Pittsburgh
Schools and Programs: School of Medicine > Infectious Diseases and Microbiology
Refereed: Yes
Date Deposited: 15 Jul 2016 17:41
Last Modified: 30 Mar 2021 14:56
URI: http://d-scholarship.pitt.edu/id/eprint/28627

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