HIV resistance testing: Difference between revisions
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==Advantage== | ==Advantage== | ||
Despite limitations of resistance assays and their interpretation, several randomized controlled studies have demonstrated that virologic outcome, at least over the short term, may be improved when genotypic or phenotypic data are used to guide choice of drug regimens in patients with loss of virologic response to prior regimens.<ref name="pmid10894268">{{cite journal |author=Baxter JD, Mayers DL, Wentworth DN, Neaton JD, Hoover ML, Winters MA, Mannheimer SB, Thompson MA, Abrams DI, Brizz BJ, Ioannidis JP, Merigan TC |title=A randomized study of antiretroviral management based on plasma genotypic antiretroviral resistance testing in patients failing therapy. CPCRA 046 Study Team for the Terry Beirn Community Programs for Clinical Research on AIDS |journal=AIDS |volume=14 |issue=9 |pages=F83–93 |year=2000 |month=June |pmid=10894268 |doi= |url=http://meta.wkhealth.com/pt/pt-core/template-journal/lwwgateway/media/landingpage.htm?issn=0269-9370&volume=14&issue=9&spage=F83 |accessdate=2012-05-30}}</ref><ref name="pmid11873001">{{cite journal |author=Cohen CJ, Hunt S, Sension M, Farthing C, Conant M, Jacobson S, Nadler J, Verbiest W, Hertogs K, Ames M, Rinehart AR, Graham NM |title=A randomized trial assessing the impact of phenotypic resistance testing on antiretroviral therapy |journal=AIDS |volume=16 |issue=4 |pages=579–88 |year=2002 |month=March |pmid=11873001 |doi= |url=http://meta.wkhealth.com/pt/pt-core/template-journal/lwwgateway/media/landingpage.htm?issn=0269-9370&volume=16&issue=4&spage=579 |accessdate=2012-05-30}}</ref> | Despite limitations of resistance assays and their interpretation, several randomized controlled studies have demonstrated that virologic outcome, at least over the short term, may be improved when genotypic or phenotypic data are used to guide choice of drug regimens in patients with loss of virologic response to prior regimens.<ref name="pmid10894268">{{cite journal |author=Baxter JD, Mayers DL, Wentworth DN, Neaton JD, Hoover ML, Winters MA, Mannheimer SB, Thompson MA, Abrams DI, Brizz BJ, Ioannidis JP, Merigan TC |title=A randomized study of antiretroviral management based on plasma genotypic antiretroviral resistance testing in patients failing therapy. CPCRA 046 Study Team for the Terry Beirn Community Programs for Clinical Research on AIDS |journal=AIDS |volume=14 |issue=9 |pages=F83–93 |year=2000 |month=June |pmid=10894268 |doi= |url=http://meta.wkhealth.com/pt/pt-core/template-journal/lwwgateway/media/landingpage.htm?issn=0269-9370&volume=14&issue=9&spage=F83 |accessdate=2012-05-30}}</ref><ref name="pmid11873001">{{cite journal |author=Cohen CJ, Hunt S, Sension M, Farthing C, Conant M, Jacobson S, Nadler J, Verbiest W, Hertogs K, Ames M, Rinehart AR, Graham NM |title=A randomized trial assessing the impact of phenotypic resistance testing on antiretroviral therapy |journal=AIDS |volume=16 |issue=4 |pages=579–88 |year=2002 |month=March |pmid=11873001 |doi= |url=http://meta.wkhealth.com/pt/pt-core/template-journal/lwwgateway/media/landingpage.htm?issn=0269-9370&volume=16&issue=4&spage=579 |accessdate=2012-05-30}}</ref> | ||
== | ==FDA recommendation for Resistance testing== | ||
The FDA recommends that characterization of resistance and cross-resistance be a part of antiretroviral drug development so that clinically relevant information is available at the time of approval. | The FDA recommends that characterization of resistance and cross-resistance be a part of antiretroviral drug development so that clinically relevant information is available at the time of approval. | ||
Revision as of 21:15, 30 May 2012
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Overview
The emergence of resistance to one or more antiretroviral drugs is one of the more common reasons for therapeutic failure in the treatment of HIV. In addition, the emergence of resistance to one antiretroviral drug sometimes confers a reduction in or a loss of susceptibility to other or all drugs of the same class. The application of laboratory technologies, such as gene amplification, automated nucleic acid sequencing, and nucleic acid hybridization, and the availability of recombinant viruses for testing phenotypic susceptibility have permitted advances in HIV resistance testing. Many clinicians and investigators are currently using these technologies in the clinical management of HIV.
Advantage
Despite limitations of resistance assays and their interpretation, several randomized controlled studies have demonstrated that virologic outcome, at least over the short term, may be improved when genotypic or phenotypic data are used to guide choice of drug regimens in patients with loss of virologic response to prior regimens.[1][2]
FDA recommendation for Resistance testing
The FDA recommends that characterization of resistance and cross-resistance be a part of antiretroviral drug development so that clinically relevant information is available at the time of approval.
Limitations
- Performance characteristics (e.g., sensitivity, specificity, and reproducibility) for many of the assays in investigational use have not been fully established.
- The clinical significance of many mutations or mutational patterns has not been defined completely for many antiretroviral drugs.
- The quantitative relationship between reductions of cell culture susceptibility and loss of clinical activity has not been established for most drugs.
Reference
- ↑ Baxter JD, Mayers DL, Wentworth DN, Neaton JD, Hoover ML, Winters MA, Mannheimer SB, Thompson MA, Abrams DI, Brizz BJ, Ioannidis JP, Merigan TC (2000). "A randomized study of antiretroviral management based on plasma genotypic antiretroviral resistance testing in patients failing therapy. CPCRA 046 Study Team for the Terry Beirn Community Programs for Clinical Research on AIDS". AIDS. 14 (9): F83–93. PMID 10894268. Retrieved 2012-05-30. Unknown parameter
|month=ignored (help) - ↑ Cohen CJ, Hunt S, Sension M, Farthing C, Conant M, Jacobson S, Nadler J, Verbiest W, Hertogs K, Ames M, Rinehart AR, Graham NM (2002). "A randomized trial assessing the impact of phenotypic resistance testing on antiretroviral therapy". AIDS. 16 (4): 579–88. PMID 11873001. Retrieved 2012-05-30. Unknown parameter
|month=ignored (help)