Zavarsek S, Johnston RV; Health Technology Assessment International. Meeting (2nd : 2005 : Rome, Italy).
Ital J Public Health. 2005; 2: 177.
Health Technology Assessment Unit, Monash Institute of Health Services Research, Level 1 Block E, Locked Bag 29 Clayton, Melbourne, Victoria 3168 Australia Tel: +61 3 9594 7579, Fax: +61 3 9594 7552, E-mail: Silva.Zavarsek@med.monash.edu.au
Objectives: To assess the diagnostic accuracy and effectiveness of genotypic resistance testing of antiretrovirals in HIV. Methods: Relevant articles were identified from a systematic literature review of electronic databases, HTA and other relevant websites to April 2004. In the absence of a gold standard, the reference standard used to determine the diagnostic accuracy of the presence or absence of resistance mutation(s) identified by the genotype test was clinical follow-up. Treatment outcome was measured by virologic failure or success. The effectiveness of genotypic resistance testing was compared to standard of care and drug-susceptibility phenotyping assays. Results: Analysis of the diagnostic accuracy of the identification or absence of a mutation in HIV and subsequent resistance or sensitivity, respectively, to that particular antiretroviral drug was difficult to determine due to patients receiving a combination of drugs. The diagnostic characteristics of genotypic resistance testing varied across studies due to different drug combinations, study designs and the accumulation of further mutations in HIV during the studies. Patients treated by genotypic resistance testing were more likely to achieve an undetectable viral load at three and six months and were also more likely to receive a greater number of antiretrovirals compared with patients treated by standard of care. The incremental effectiveness of the genotype test and of the antiretrovirals themselves was difficult to determine. Conclusions: Genotypic resistance testing of antiretrovirals in HIV provides an example of the issues surrounding the use of clinical follow-up as a reference standard for determining the diagnostic accuracy of a genetic test.
Publication Types:
Keywords:
- AIDS Vaccines
- Acquired Immunodeficiency Syndrome
- Anti-HIV Agents
- Genotype
- HIV
- HIV Infections
- HIV Protease Inhibitors
- HIV Seropositivity
- Humans
- Phenotype
- Research Design
- Viral Load
- genetics
- hsrmtgs
UI: 103141158
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