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Human leukocyte antigen (HLA) ‐B*5701 screening identifies patients at increased risk for abacavir ( ABC ) hypersensitivity reaction ( HSR ). Screening was adopted in GlaxoSmithKline and ViiV Healthcare clinical trials in 2007 and human immunodeficiency virus treatment guidelines in 2008. Company meta‐analyses of trials pre– HLA ‐B*5701 screening reported  HSR  rates of 4–8%. We analyzed the effectiveness of  HLA ‐B*5701 screening on reducing  HSR  rates using clinical trial, Observational Pharmaco‐Epidemiology Research & Analysis ( OPERA ) cohort, and spontaneous reporting data.    Methods  A meta‐analysis examined 12 trials in 3063  HLA ‐B*5701–negative patients receiving an  ABC ‐containing regimen from April 9, 2007, to September 22, 2015. Potential cases were identified using prespecified Medical Dictionary for Regulatory Activities (Med DRA ) preferred terms ( drug hypersensitivity, hypersensitivity, anaphylactic reaction, anaphylaxis ) and adjudicated against a Company  ABC HSR  case definition. Investigator‐diagnosed cases were identified and rates were calculated. In the  OPERA  cohort, 9619 patients initiating their first  ABC ‐containing regimen from January 1, 1999, to January 1, 2016, were identified. Patients were observed from regimen start until the earliest‐following censoring event:  ABC  discontinuation, loss to follow‐up, death, or study end (July 31, 2016).  OPERA  physicians evaluated events against  OPERA  definitions for definite/probable cases of  ABC HSR ; rates were calculated pre‐ and post‐2008. The Company case definition was used to identify spontaneously reported cases for four marketed  ABC ‐containing products; reporting rates were calculated using estimated exposure from sales data, through December 31, 2016.    Results  Suspected  ABC HSR  rates were 1.3% or less in the meta‐analysis. In the  OPERA  cohort, the rate was 0.4% among patients initiating  ABC  post‐2008 versus 1.3% pre‐2008 (p<0.0001). Spontaneous reporting rates were low post‐2008 (54 to 22 cases per 100,000 patient‐years exposure [ PYE ]) versus pre‐2008 (618 to 55 cases per 100,000  PYE ).    Conclusions  Clinically suspected  ABC HSR  rates were 1.3% or less in  HLA ‐B*5701–negative patients. Recognizing their limitations, data from the  OPERA  cohort and spontaneous reporting indicate that  HLA ‐B*5701 screening has reduced reporting rates of suspected  HSR  in clinical practice. Where screening for  HLA ‐B*5701 is standard care, patients should be confirmed negative for this allele before starting  ABC  treatment.

Abacavir Hypersensitivity Reaction Reporting Rates During a Decade of HLA ‐B*5701 Screening as a Risk‐Mitigation Measure