Laboratory Guidelines for the Practical Use of HIV Drug Resistance Tests in Patient Follow-Up

Author:

Vandamme A-M1,Houyez F2,Bànhegyi D3,Clotet B4,De Schrijver G5,De Smet KAL6,Hall WW7,Harrigan R8,Hellmann N9,Hertogs K10,Holtzer C11,Larder B10,Pillay D12,Race E13,Schmit J-C14,Schuurman R15,Shulse E16,Sönnerborg A17,Miller V18

Affiliation:

1. AIDS Reference Laboratory, Rega Institute and University Hospitals, KU Leuven, Leuven, Belgium

2. Vaincre Le Sida, Paris, France

3. Szent Lâszlo Korhaz, Budapest, Hungary

4. Fundacio IRSI-Caixa, Badalona, Spain

5. Lage Heirweg 21, 9830 Sint Martens Latem, Belgium

6. Innogenetics, Gent, Belgium

7. Virus Reference Laboratory, University College, Dublin, Ireland

8. BC Center for Excellence in HIV/AIDS, Vancouver, Canada (currently at Virco, UK)

9. ViroLogic, South San Francisco, USA

10. Virco, Mechelen, Belgium and Virco, UK

11. Visible Genetics, Paris, France

12. PHLS Antiviral Susceptibility Reference Unit, University of Birmingham Medical School, UK

13. Hôpital Bichat-Claude Bernard, France (currently at VIRalliance, France)

14. Centre Hospitalier de Luxembourg, Luxembourg

15. Eijkman-Winkler Institute, Utrecht University, Utrecht, The Netherlands

16. Applied Biosystems, Foster City, Calif., USA

17. Karolinska Institutet, Huddinge, Sweden

18. Klinikum der JW Goethe Universität, Frankfurt, Germany

Abstract

HIV drug resistance is one of the major limitations in the successful treatment of HIV-infected patients using currently available antiretroviral combination therapies. When appropriate, drug susceptibility profiles should be taken into consideration in the choice of a specific combination therapy. Guidelines recommending resistance testing in certain circumstances have been issued. Many clinicians have access to resistance testing and will increasingly use these results in their treatment decisions. In this document, we comment on the different methods available, and the relevant issues relating to the clinical application of these tests. Specifically, the following recommendations can be made: (i) genotypic and phenotypic HIV-1 drug resistance analyses can yield complementary information for the clinician. However, insufficient information currently exists as to which approach is preferable in any particular clinical setting; (ii) when HIV-1 drug resistance testing is required, it is recommended that testing be performed on plasma samples obtained before starting, stopping or changing therapy, on samples that have a viral load above the detection limit of the resistance test; (iii) the panel recommends that genotypic and phenotypic HIV-1 drug resistance testing for clinical purposes be performed in a certified laboratory under strict quality control and quality assurance standards; and (iv) the panel recommends that resistance testing laboratories provide clinicians with resistance reports that include a list of drug-related resistance mutations (genotype) and/or a list of drug-related fold resistance values (phenotype), with interpretations of each by an experienced virologist. The interpretation of genotypic and phenotypic analysis is a complex and developing science, and in order to understand HIV-1 drug resistance reports, communication between the requesting clinician and the expert that interpreted the resistance report is recommended.

Publisher

SAGE Publications

Subject

Infectious Diseases,Pharmacology (medical),Pharmacology

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