Emerging Safety Science Workshop Summary (2008) / Chapter Skim
Currently Skimming:
6 Screening Technologies IV: Pharmacogenetics
6 Screening Technologies IV: Pharmacogenetics
Pages 59-64
The Chapter Skim interface presents what we've algorithmically identified as the most significant single chunk of text within every page in the chapter.
Select key terms on the right to highlight them within pages of the chapter.
From page 59... ...
Lai described how pharmacogenetics provided an answer to that question in the case of the anti-AIDS drug abacavir. Abacavir and the hypersensitivity reaction Abacavir is a reverse transcriptase inhibitor used against HIV.
|
From page 60... ...
Despite physician awareness, however, the rate of spontaneous HSR has not decreased, as it is not possible to predict whether a patient will exhibit HSR until abacavir is taken. The second part of the postmarket risk management program included a pharmacogenetics study designed to look for genetic factors associated with abacavir-related HSR.
|
From page 61... ...
SOURCE: Lai, 2007. Figure 6 -1 The Identification of HLA-B57 Initial calculations, derived from such assumptions as the allele frequency of the causative locus and the effect of the locus's being variably penetrant, implied that it would take 500 case-control pairs to power the study adequately.
|
From page 62... ...
After screening became a routine practice, however -- from the beginning of 2004 through July 2005 -- only 1 of 49 patients exhibited HRS. That patient was known to be positive for the biomarker but chose to try abacavir anyway because there were no other options.
|
From page 63... ...
Skin-patch testing provides a much better clinical indi Note that following the workshop, the PREDICT-1 study results were published online in Pharmaceutical Statistics on May 29, 2007, and results from the SHAPE study were presented at the 4th International AIDS Society Conference on July 22–25, 2007, in Sydney, Australia.
|
From page 64... ...
One group at GSK, run by Clive Bowman, has begun developing a method for the real-time management of patients' adverse events. This method includes • creating a collection of genetic markers -- a thousand or more -- to examine in people who present with an adverse drug event; • creating a control set of genetic markers by genotyping people who have taken the drug without adverse effects; and • as patients report with HSR or some other adverse reaction, genotyping them and comparing their genetic markers with those of the control group.
|
Key Terms
This material may be derived from roughly machine-read images, and so is provided only to facilitate research.
More
information on Chapter Skim is available.