Role of Pharmacogenomics in Drug Development – An Industry ...

Role of Pharmacogenomics in Drug Development – An Industry ... Role of Pharmacogenomics in Drug Development – An Industry ...

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Abacavir HSR and HLA B*5701Performance characteristics among ethnic groupsStudyGroupCasennp valueSensitivitySpecificityPPVNPVOR(95%CI)CNA30027Whites56744x10 -1457%99%69%98%97(12-751)CNA30032Whites1821678x10 -2348%96%37%97%21(10-48)CNA30032Hispanics51532x10 -422%100%100%95%30(2-531)CNA30032Blacks37410.278%98%12%96%4(0-36)Mallalet al18167

Abacavir HSR Prospective PGx study• A prospective study evaluate the utility ofHLA-B*5701 screening on Abacavir HSR rate• 6 weeks treatment with Abacavir containingantiviral regimens (2 x 900 patients)• Comparison of HSR rates between patients Receiving current standard of care (all comers)versus Prospective HLA-B*5701 screening and inclusion ofmarker negative patients (marker positive patientsexcluded)

Abacavir HSR and HLA B*5701Performance characteristics among ethnic groupsStudyGroupCasennp valueSensitivitySpecificityPPVNPVOR(95%CI)CNA30027Whites56744x10 -1457%99%69%98%97(12-751)CNA30032Whites1821678x10 -2348%96%37%97%21(10-48)CNA30032Hispanics51532x10 -422%100%100%95%30(2-531)CNA30032Blacks37410.278%98%12%96%4(0-36)Mallalet al18167

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