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1. Human Leukocyte Antigen (HLA) Pharmacogenomic Tests: Potential and Pitfalls

Author

K. Daly, Ann

Abstract

Adverse drug reactions involving a range of prescribed drugs and affecting the skin, liver and other organs show strong associations with particular HLA alleles. For some reactions, HLA typing prior to prescription, so that those positive for the risk allele are not given the drug associated with the reaction, shows high positive and negative predictive values. The best example of clinical implementation relates to the hypersensitivity reaction induced by the anti-HIV drug abacavir. When this reaction is phenotyped accurately, 100% of those who develop it are positive for HLA-B*57:01. Drug regulators worldwide now recommend genotyping for HLA-B*57:01 before abacavir is prescribed. Serious skin rashes including Stevens-Johnson syndrome and toxic epidermal necrosis can be induced by carbamazepine and other anticonvulsant drugs. In certain East Asians, these reactions are significantly associated with HLA-B*15:02, and typing for this allele is now recommended prior to carbamazepine prescription in these populations. Other HLA associations have been described for skin rash induced by carbamazepine, allopurinol and nevirapine and for liver injury induced by flucloxacillin, amoxicillin-clavulanate, lapatanib, lumiracoxib and ticlopidine. However, the predictive values for typing HLA alleles associated with these adverse reactions are lower. Clinical implementation therefore seems unlikely. Performing HLA typing is relatively complex compared with genotyping assays for single nucleotide polymorphisms. With emphasis on HLA-B*57:01, the approaches used commonly, including use of sequence-specific oligonucleotide PCR primers and DNA sequencing are considered, together with their successful implementation. Genotyping single nucleotide polymorphisms tagging HLA alleles is a simpler alternative to HLA typing but appears insufficiently accurate for clinical use.

Published
2014

2. STrengthening the Reporting Of Pharmacogenetic Studies: Development of the STROPS guideline

Author

Marty Chaplin, Jamie J. Kirkham, Kerry Dwan, Derek J. Sloan, Geraint Davies, Andrea L. Jorgensen, Irma Aguilar-Delfín, José A G Agúndez, Sophie M Argon, M J Arranz, Derrick A Bennett, Stefan Böhringer, Lawrence Brody, Ingolf Cascorbi, Erika Cecchin, Mandy Crommentuijn-van Rhenen, Ann K Daly, Nur Aizati Athirah Daud, Jorge Duconge, Chiara Fabbri, Alison Fitches, Andrea Gaedigk, Donato Gemmati, Claudia Maria Dan Hawcutt, Rachel Huddart, Evelyne Jacqz-Aigrain, Slobodan M Janković, Theodora Katsila, Gideon Koren, Beata S Lipska-Ziętkiewicz, Thomas Liehr, A H Maitland-van der Zee, Lisanne E N Manson, Martin H Maurer, Juan Eduardo Megías-Vericat, Taichi Ochi, Daniel J O'Connor, Laura B Ramsey, Gad Rennert, Francesco Rucci, Gaetano Santulli, Aris Saoulidis, Rashmi R Shah, Alessandro Serretti, Andrew Somogyi, Gere Sunder-Plassmann, Virginia Boso-Ribelles, Caroline F Thorn, Evangelia Eirini Tsermpini, Satyanarayana Chakradhara Rao Uppugunduri, Michael A van Es, Magdalena Zarowiecki, University of St Andrews. School of Medicine, University of St Andrews. Infection and Global Health Division, Chaplin, Marty, Kirkham, Jamie J., Dwan, Kerry, Sloan, Derek J., Davies, Geraint, Jorgensen, Andrea L., Aguilar-Delfín, Irma, G Agúndez, José A, M Argon, Sophie, J Arranz, M, A Bennett, Derrick, Böhringer, Stefan, Brody, Lawrence, Cascorbi, Ingolf, Cecchin, Erika, Crommentuijn-van Rhenen, Mandy, K Daly, Ann, Aizati Athirah Daud, Nur, Duconge, Jorge, Fabbri, Chiara, Fitches, Alison, Gaedigk, Andrea, Gemmati, Donato, Maria Dan Hawcutt, Claudia, Huddart, Rachel, Jacqz-Aigrain, Evelyne, M Janković, Slobodan, Katsila, Theodora, Koren, Gideon, S Lipska-Ziętkiewicz, Beata, Liehr, Thoma, H Maitland-van der Zee, A, N Manson, Lisanne E, H Maurer, Martin, Eduardo Megías-Vericat, Juan, Ochi, Taichi, J O'Connor, Daniel, B Ramsey, Laura, Rennert, Gad, Rucci, Francesco, Santulli, Gaetano, Saoulidis, Ari, R Shah, Rashmi, Serretti, Alessandro, Somogyi, Andrew, Sunder-Plassmann, Gere, Boso-Ribelles, Virginia, F Thorn, Caroline, Eirini Tsermpini, Evangelia, Chakradhara Rao Uppugunduri, Satyanarayana, A van Es, Michael, and Zarowiecki, Magdalena

Subjects
Male, Delphi Technique, Delphi method, Surveys, 030204 cardiovascular system & hematology, Guidelines and Guidance, Mathematical and Statistical Techniques, 0302 clinical medicine, Surveys and Questionnaires, Medicine and Health Sciences, 030212 general & internal medicine, Statistics, Politics, Stakeholder, Genomics, General Medicine, Research Assessment, Metaanalysis, Middle Aged, Checklist, Systematic review, Research Design, Physical Sciences, Research Reporting Guidelines, Medicine, Engineering and Technology, Female, Goals, Biotechnology, Adult, RM, medicine.medical_specialty, Drug Research and Development, Consensus, Systematic Reviews, MEDLINE, Bioengineering, Research and Analysis Methods, 03 medical and health sciences, Genomic Medicine, Stakeholder Participation, Genetics, medicine, Humans, Statistical Methods, Genetic Association Studies, Pharmacology, Publishing, Survey Research, business.industry, Biology and Life Sciences, DAS, Guideline, United Kingdom, RM Therapeutics. Pharmacology, Pharmacogenomic Testing, Pharmacogenetics, Sample size determination, Family medicine, Pharmacogenomics, business, Mathematics
Abstract

Background Large sample sizes are often required to detect statistically significant associations between pharmacogenetic markers and treatment response. Meta-analysis may be performed to synthesize data from several studies, increasing sample size and, consequently, power to detect significant genetic effects. However, performing robust synthesis of data from pharmacogenetic studies is often challenging because of poor reporting of key data in study reports. There is currently no guideline for the reporting of pharmacogenetic studies that has been developed using a widely accepted robust methodology. The objective of this project was to develop the STrengthening the Reporting Of Pharmacogenetic Studies (STROPS) guideline. Methods and findings We established a preliminary checklist of reporting items to be considered for inclusion in the guideline. We invited representatives of key stakeholder groups to participate in a 2-round Delphi survey. A total of 52 individuals participated in both rounds of the survey, scoring items with regards to their importance for inclusion in the STROPS guideline. We then held a consensus meeting, at which 8 individuals considered the results of the Delphi survey and voted on whether each item ought to be included in the final guideline. The STROPS guideline consists of 54 items and is accompanied by an explanation and elaboration document. The guideline contains items that are particularly important in the field of pharmacogenetics, such as the drug regimen of interest and whether adherence to treatment was accounted for in the conducted analyses. The guideline also requires that outcomes be clearly defined and justified, because in pharmacogenetic studies, there may be a greater number of possible outcomes than in other types of study (for example, disease–gene association studies). A limitation of this project is that our consensus meeting involved a small number of individuals, the majority of whom are based in the United Kingdom. Conclusions Our aim is for the STROPS guideline to improve the transparency of reporting of pharmacogenetic studies and also to facilitate the conduct of high-quality systematic reviews and meta-analyses. We encourage authors to adhere to the STROPS guideline when publishing pharmacogenetic studies., Marty Chaplin and co-authors recount the development of a guideline for reporting pharmacogenetic studies.

Published
2020
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