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<meta name="keywords" content="C1840547, abacavir hypersensitivity, abacavir hypersensitivity, susceptibility to, finding, hla-b, ziagen hypersensitivity, autosomal dominant, autosomal recessive, birth defects, chromosomal disease, chromosome, clinical features, clinical findings, clinical genetics, clinical recommendations, clinvar, congenital chromosomal disease, consumer genetic resources, cytogenetic location, disease characteristics, disease definitions, disease descriptions, disease ontology, disease synonyms, disease vocabulary, dysmorphology, entrez, familial disease, gene, gene-disease relationship, genereviews, genetic disease, genetic disorder, genetic terminology, genetic testing registry, genetics home reference, genomic disease, gtr, hereditary disease, heritable disease, hpo, human phenotype ontology, inherited disease, management guidelines, maternal inheritance, medgen, medical genetics, medical subject headings, mesh, mitochondrial inheritance, mode of inheritance, national center for biotechnology information, national institutes of health, national library of medicine, ncbi, nih, nlm, omim, ordo, orphanet, paternal inheritance, phenome, position statements, professional practice guidelines, rare disease, reference sequence, refseq, snomed ct, syndrome, undiagnosed diseases, x-linked recessive" /><meta name="description" content="Abacavir is a nucleoside reverse transcriptase inhibitor indicated for the treatment of HIV infection, in combination with other medications, as part of highly active antiretroviral therapy. Although abacavir is generally well tolerated, ~5–8% of patients experience a hypersensitivity reaction (HSR) during the first 6 weeks of treatment. Suspicion of an HSR requires immediate discontinuation of abacavir. Drug re-challenge is contraindicated because immediate life-threatening reactions can occur. HLA-B is a member of the major histocompatibility complex gene family and patients with at least one HLA-B*57:01 allele may develop HSR when treated with abacavir. HLA-B allele status has no effect on abacavir pharmacodynamics or pharmacokinetics; it only influences the likelihood that an HSR will occur. Guidelines regarding the use of pharmacogenomic tests in dosing for abacavir have been published in Clinical Pharmacology and Therapeutics by the Clinical Pharmacogenetics Implementation Consortium (CPIC) and are available on the PharmGKB website." /><meta name="robots" content="index,nofollow,noarchive" />
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<!--
UID=326759
ConceptID=C1840547
-->
<!--imgCountBooks = 0--><h1 class="medgenTitle"><div class="MedGenTitleText">Abacavir hypersensitivity</div></h1><div class="aux"><div class="resc"><dl class="rprtid"><dt>MedGen UID: </dt><dd>326759</dd><dt><span class="dotprefix"> •</span>Concept ID: </dt><dd><a href="/medgen/docs/help/#sources" target="_blank" title="Concept Unique Identifier from NLM's Unified Medical Language system (UMLS)&#10;Click for more information."><span class="highlight" style="background-color:">C1840547</span></a></dd><dt><span class="dotprefix"> •</span></dt><dd>Finding</dd></dl></div></div><table class="medgenTable"><tbody><tr><td>Synonym:</td>
<td>Ziagen hypersensitivity</td></tr>
<tr><td>Drug:</td>
<td>
<div class="divPopper rprt" id="drug_143311"><div><strong>Abacavir</strong><div class="aux"><div class="resc"><dl class="rprtid"><dt>MedGen UID: </dt><dd>143311</dd><dt><span class="dotprefix"> •</span>Concept ID: </dt><dd><a href="/medgen/docs/help/#sources" target="_blank" title="Concept Unique Identifier from NLM's Unified Medical Language system (UMLS)&#10;Click for more information.">C0663655</a></dd><dt><span class="dotprefix"> •</span></dt><dd>Pharmacologic Substance</dd></dl></div></div></div>
<div class="spaceAbove">A nucleoside reverse transcriptase inhibitor analog of guanosine. This agent decreases HIV viral loads, retards or prevents the damage to the immune system, and reduces the risk of developing AIDS. [from NCI]</div></div>
<div class="hangingIndent"><a title="click for more information" class="jig-ncbipopper" href="#drug_143311" data-jigconfig="hasArrow: true, openEvent: 'click', closeEvent: 'mouseout', openAnimation: 'fadeIn', closeAnimation: 'fadeOut', triggerPosition: 'center right', destPosition: 'center left', arrowDirection: 'left'">Abacavir</a></div></td></tr>
<tr><td colspan="2" class="small"> </td></tr><tr><td><a class="help jig-ncbi-popper" data-jig="ncbipopper" href="#target-gene-loc">Gene (location):<img class="pulldown" src="//static.pubmed.gov/portal/portal3rc.fcgi/4223267/img/4204968" /></a><div class="display-none" id="target-gene-loc">
Gene(s) directly associated with<br />
this condition or phenotype.</div></td>
<td><a target="_blank" title="HLA-B - ID: 3106 - NCBI Gene" href="/gene/3106" class="medgenPMinfo">HLA-B</a> (6p21.33)</td></tr>
<tr><td colspan="2" class="small"> </td></tr><tr><td>OMIM<span class="superscript">®</span>:</td>
<td><a href="https://omim.org/entry/142830" target="_blank">142830</a></td></tr>
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<div class="portlet mgSection" id="ID_100">
<div class="portlet_head mgSectionHead ui-widget-header"><h1 class="nl" id="Definition">Definition</h1><a sid="100" href="#" class="portlet_shutter" title="Show/hide content"></a></div>
<div class="portlet_content ln">Abacavir is a nucleoside reverse transcriptase inhibitor indicated for the treatment of HIV infection, in combination with other medications, as part of highly active antiretroviral therapy. Although abacavir is generally well tolerated, ~5–8% of patients experience a hypersensitivity reaction (HSR) during the first 6 weeks of treatment. Suspicion of an HSR requires immediate discontinuation of abacavir. Drug re-challenge is contraindicated because immediate life-threatening reactions can occur. HLA-B is a member of the major histocompatibility complex gene family and patients with at least one HLA-B*57:01 allele may develop HSR when treated with abacavir. HLA-B allele status has no effect on abacavir pharmacodynamics or pharmacokinetics; it only influences the likelihood that an HSR will occur. Guidelines regarding the use of pharmacogenomic tests in dosing for abacavir have been published in Clinical Pharmacology and Therapeutics by the Clinical Pharmacogenetics Implementation Consortium (CPIC) and are available on the PharmGKB website. [from <a title="The Pharmacogenomics Knowledge Base" href="http://www.pharmgkb.org" class="defSource" target="_blank">PharmGKB</a>]</div>
</div>
<div class="portlet mgSection" id="ID_117">
<div class="portlet_head mgSectionHead ui-widget-header"><h1 class="nl" id="Additional_description">Additional description</h1><a sid="117" href="#" class="portlet_shutter" title="Show/hide content"></a></div>
<div class="portlet_content ln"><div class="mgSection"><strong>From Medical Genetics Summaries</strong><br />Abacavir (brand name Ziagen) is used in the treatment of human immunodeficiency virus (HIV) infection. Abacavir is a nucleoside (and nucleotide) reverse transcriptase inhibitor (NRTI), and is used in combination with other medications as part of highly active antiretroviral therapy (HAART).&#13;
Hypersensitivity reactions associated with abacavir can be severe and potentially fatal. Symptoms include fever, rash, vomiting, and shortness of breath. They typically appear within the first 42 days of treatment (11 days median onset).&#13;
HLA-B*57:01 significantly increases the risk of hypersensitivity reactions when abacavir is administered. Approximately 6% of Caucasians and 2-3% of African Americans carry this allele in the human leukocyte antigen B (HLA-B) gene. The HLA-B gene plays an important role in how the immune system recognizes and responds to pathogens, and mediates hypersensitivity reactions. HLA-B*57:01 has been found to be associated with abacavir hypersensitivity across different ethnicities, including Caucasians, Hispanics, and individuals of African origin.&#13;
Screening for the HLA-B*57:01 allele before starting abacavir therapy is recommended for all patients according to the FDA drug label for abacavir. Even if previously tolerated, screening should happen before restarting abacavir therapy if HLA-B*57:01 status is unknown. Abacavir is contraindicated in HLA-B*5701-positive patients, and in patients with a prior hypersensitivity reaction to abacavir. Dosing guidelines from the professional societies, Clinical Pharmacogenetics Implementation Consortium (CPIC) and the Dutch Pharmacogenetics Working Group (DPWG) of the Royal Dutch Association for the Advancement of Pharmacy (KNMP), also recommend that HLA-B*57:01 screening should be performed prior to initiation of abacavir therapy and an alternate drug be administered for patients with the allele.  <a target="_blank" href="https://www.ncbi.nlm.nih.gov/books/NBK315783">https://www.ncbi.nlm.nih.gov/books/NBK315783</a></div></div>
</div>
<div class="portlet mgSection" id="ID_118">
<div class="portlet_head mgSectionHead ui-widget-header"><h1 class="nl" id="Term_Hierarchy">Term Hierarchy</h1><a sid="118" href="#" class="portlet_shutter" title="Show/hide content"></a></div>
<div class="portlet_content ln HierarchyGTR"><div class="jig-ncbitabs"><ul><li><a href="#tabGTR">GTR</a></li><li><a href="#tabMGEN">MeSH</a></li></ul><div id="tabGTR"><div class="search_result"><div class="rprts"><div class="chiclet_legend"><span class="chiclet_list" style="position:static;"><span title="Clinical test" class="chiclet Ccolor round">C</span><span>Clinical test,  </span><span title="Research test" class="chiclet Rcolor round">R</span><span>Research test,  </span><span title="OMIM" class="chiclet Ocolor ">O</span><span>OMIM,  </span><span title="GeneReview" class="chiclet Gcolor">G</span><span><em>GeneReviews</em>,  </span><span title="ClinVar" class="chiclet Vcolor">V</span><span>ClinVar  </span></span></div><div id="hierarchy" class="margin_t1"><div class="ds_tree"><ul><li class="TLclosed"><span class="chiclet_list"><span class="chiclet Ccolor round" title="Clinical test"><a target="_blank" href="/gtr/tests/?term=CN297565[DISCUI]&amp;test_type=Clinical" ref="ncbi_uid=979898">C</a></span><span class="chiclet unavailable round" title="Research Tests">R</span><span class="chiclet unavailable" title="OMIM">O</span><span class="chiclet unavailable" title="GeneReviews">G</span><span class="chiclet unavailable" title="ClinVar">V</span></span><span class="TLline"><a href="/medgen/979898" ref="tree=GTR&amp;ncbi_uid=979898&amp;link_uid=979898" title="View MedGen record for 'Abacavir response'">Abacavir response</a></span><ul><li class="matched_ds"><span class="chiclet_list"><span class="chiclet Ccolor round" title="Clinical test"><a target="_blank" href="/gtr/tests/?term=C1840547[DISCUI]&amp;test_type=Clinical" ref="ncbi_uid=326759">C</a></span><span class="chiclet unavailable round" title="Research Tests">R</span><span class="chiclet Ocolor" title="OMIM"><a ref="ncbi_uid=326759" target="_blank" href="/omim/142830">O</a></span><span class="chiclet unavailable" title="GeneReviews">G</span><span class="chiclet Vcolor" title="ClinVar"><a target="_blank" href="/clinvar?LinkName=medgen_clinvar&amp;from_uid=326759" ref="ncbi_uid=326759">V</a></span></span><span class="TLline">Abacavir hypersensitivity</span></li></ul></li></ul></div></div></div></div></div><div id="tabMGEN"><div class="ds_tree"><ul><li><span class="TLline"><a href="/medgen/979898" ref="tree=MeSH" title="MedGen record for Abacavir response">Abacavir response</a></span><ul><li><span class="matched_ds">Abacavir hypersensitivity</span></li></ul></li></ul></div></div></div></div>
</div>
<div class="portlet mgSection" id="ID_105">
<div class="portlet_head mgSectionHead ui-widget-header"><h1 class="nl" id="Professional_guidelines">Professional guidelines</h1><a sid="105" href="#" class="portlet_shutter" title="Show/hide content"></a></div>
<div class="portlet_content ln"><h3 class="subhead">PubMed<a class="help jig-ncbi-popper" data-jig="ncbipopper" href="#guidelinesHelpPM"><img class="pulldown" src="//static.pubmed.gov/portal/portal3rc.fcgi/4223267/img/4204968" /></a></h3>
<div class="nl"><a target="_blank" href="/pubmed/28162244">Pharmacogenetics of hypersensitivity drug reactions.</a></div>
<div class="portlet_content ln"><span class="medgenPMauthor">Negrini S,
Becquemont L</span><br />
<span class="medgenPMjournal">Therapie</span>
2017 Apr;72(2):231-243.
Epub 2017 Jan 3
doi: 10.1016/j.therap.2016.12.009.
<span class="bold">PMID: </span><a href="/pubmed/28162244" target="_blank">28162244</a></div>
<div class="nl"><a target="_blank" href="/pubmed/22920398">HLA and pharmacogenetics of drug hypersensitivity.</a></div>
<div class="portlet_content ln"><span class="medgenPMauthor">Pavlos R,
Mallal S,
Phillips E</span><br />
<span class="medgenPMjournal">Pharmacogenomics</span>
2012 Aug;13(11):1285-306.
doi: 10.2217/pgs.12.108.
<span class="bold">PMID: </span><a href="/pubmed/22920398" target="_blank">22920398</a></div>
<div class="nl"><a target="_blank" href="/pubmed/20602616">Pharmacogenetics of drug hypersensitivity.</a></div>
<div class="portlet_content ln"><span class="medgenPMauthor">Phillips EJ,
Mallal SA</span><br />
<span class="medgenPMjournal">Pharmacogenomics</span>
2010 Jul;11(7):973-87.
doi: 10.2217/pgs.10.77.
<span class="bold">PMID: </span><a href="/pubmed/20602616" target="_blank">20602616</a><a href="/pmc/articles/PMC2937181" target="_blank" class="PubMedFree">Free PMC Article</a></div>
<div><a target="_blank" href="https://pubmed.ncbi.nlm.nih.gov/?term=(%22abacavir%20hypersensitivity%22%5Btiab%3A~0%5D)%20AND%20(%22english%20and%20humans%22%5BFilter%5D)%20AND%20(%20(%22practice%20guideline%22%5BFilter%5D)%20OR%20(practice*%5Btitl%5D%20AND%20(guideline%5Btitl%5D%20OR%20parameter%5Btitl%5D%20OR%20resource%5Btitl%5D%20OR%20bulletin%5Btitl%5D%20OR%20best%5Btitl%5D))%20OR%20(genetic*%5Btitl%5D%20AND%20(evaluation%5Btitl%5D%20OR%20counseling%5Btitl%5D%20OR%20screening%5Btitl%5D%20OR%20test*%5Btitl%5D))%20OR%20(clinical%5Btitl%5D%20AND%20((expert%5Btitl%5D%20AND%20consensus%5Btitl%5D)%20OR%20utility%5Btitl%5D%20OR%20guideline*%5Btitl%5D))%20OR%20(management%5Btitl%5D%20AND%20(clinical%5Btitl%5D%20OR%20diagnos*%5Btitl%5D%20OR%20recommendation%5Btitl%5D%20OR%20pain%5Btitl%5D%20OR%20surveillance%5Btitl%5D%20OR%20emergency%5Btitl%5D%20OR%20guideline*%5Btitl%5D%20OR%20therap*))%20OR%20(treatment%5Btitl%5D%20AND%20((evaluation%5Btitl%5D%20AND%20diagnosis%5Btitl%5D)%20OR%20(assessment%5Btitl%5D%20AND%20prevention%5Btitl%5D)%20OR%20therap*))%20OR%20(Diagnos*%5Btitl%5D%20AND%20(prenatal%5Btitl%5D%20OR%20treatment%5Btitl%5D%20OR%20follow-up%5Btitl%5D%20OR%20statement%5Btitl%5D%20OR%20criteria%5Btitl%5D%20OR%20newborn%5Btitl%5D%20OR%20differential%5Btitl%5D%20OR%20neonatal%5Btitl%5D%20OR%20neonate%5Btitl%5D))%20OR%20(guideline*%5Btitl%5D%20AND%20(pharmacogenetic*%5Btitl%5D%20OR%20recommendation%5Btitl%5D%20OR%20therap*%5Btitl%5D%20OR%20evidence-based%5Btitl%5D%20OR%20consensus%5Btitl%5D%20OR%20(technical%5Btitl%5D%20AND%20standard*%5Btitl%5D)%20OR%20(molecular%5Btitl%5D%20AND%20testing%5Btitl%5D)))%20OR%20(risk%5Btitl%5D%20AND%20assessment%5Btitl%5D)%20OR%20(recommendation*%5Btitl%5D%20AND%20(statement%5Btitl%5D%20OR%20Evidence-based%5Btitl%5D%20OR%20Consensus%5Btitl%5D))%20OR%20(care%20AND%20((Patient%5Btitl%5D%20AND%20standard*%5Btitl%5D)%20OR%20primary%5Btitl%5D%20OR%20psychosocial%5Btitl%5D))%20OR%20(Health%5Btitl%5D%20AND%20supervision%5Btitl%5D)%20OR%20(statement%5Btitl%5D%20AND%20(policy%5Btitl%5D%20OR%20position%5Btitl%5D%20OR%20Consensus%5Btitl%5D))%20OR%20(pharmacogenetics%5Btitl%5D%20AND%20(Dosing%5Btitl%5D%20OR%20therap*%5Btitl%5D%20OR%20genotype*%5Btitl%5D%20OR%20drug*%5Btitl%5D))%20OR%20(Chemotherapy%5Btitl%5D%20AND%20decision*%5Btitl%5D)%20OR%20(screening%5Btitl%5D%20AND%20(newborn%5Btitl%5D%20OR%20neonat*%5Btitl%5D%20OR%20detection%5Btitl%5D%20OR%20diagnos*%5Btitl%5D))%20OR%20(criteria%5Btitl%5D%20OR%20genotype*%5Btitl%5D)%20)%20NOT%20(%22Case%20reports%22%5BPublication%20type%5D%20OR%20%22clinical%20study%22%5BPublication%20Type%5D%20OR%20%22randomized%20controlled%20trial%22%5BPublication%20Type%5D)" title="PubMed search">See all (25)</a></div><h3 class="subhead">Curated<a class="help jig-ncbi-popper" data-jig="ncbipopper" href="#guidelinesHelpCurated"><img class="pulldown" src="//static.pubmed.gov/portal/portal3rc.fcgi/4223267/img/4204968" /></a></h3><h3 class="nl vspace"><a href="https://clinicalinfo.hiv.gov/sites/default/files/guidelines/documents/adult-adolescent-arv/guidelines-adult-adolescent-arv.pdf" target="_blank">Panel on Antiretroviral Guidelines for Adults and Adolescents. Guidelines for the Use of Antiretroviral Agents in Adults and Adolescents with HIV. Department of Health and Human Services.</a></h3>
<h3 class="nl vspace"><a href="https://dailymed.nlm.nih.gov/dailymed/lookup.cfm?setid=80c1702a-973c-436a-90f8-69b29674dca0" target="_blank">DailyMed Drug Label, ABACAVIR SULFATE, 2022</a></h3>
<h3 class="nl vspace"><a href="https://www.aacc.org/science-and-practice/practice-guidelines/pharmacogenetics" target="_blank">National Academy of Clinical Biochemistry, Clinical practice considerations. In: Laboratory medicine practice guidelines: guidelines and recommendations for laboratory analysis and application of pharmacogenetics to clinical practice, 2010</a></h3>
</div>
</div>
<div class="display-none help-popup" id="guidelinesHelpPM">These guidelines are articles in PubMed that match specific search criteria developed by MedGen to capture the most relevant practice guidelines. This list may not be comprehensive and may include broader topics as well. See the <a href="/medgen/docs/faq/" title="Frequently asked questions" target="_blank">FAQ</a> for details.</div><div class="display-none help-popup" id="guidelinesHelpCurated">These guidelines are manually curated by the MedGen team
to supplement articles available in PubMed. See the <a href="/medgen/docs/faq/" title="Frequently asked questions" target="_blank">FAQ</a> for details.</div>
<div class="portlet mgSection" id="ID_114">
<div class="portlet_head mgSectionHead ui-widget-header"><h1 class="nl" id="Suggested_Reading">Suggested Reading</h1><a sid="114" href="#" class="portlet_shutter" title="Show/hide content"></a></div>
<div class="portlet_content ln"><h3 class="subhead">PubMed</h3>
<div class="nl"><a target="_blank" href="/pubmed/18256392">HLA-B*5701 screening for hypersensitivity to abacavir.</a></div>
<div class="portlet_content ln"><span class="medgenPMauthor">Mallal S,
Phillips E,
Carosi G,
Molina JM,
Workman C,
Tomazic J,
Jägel-Guedes E,
Rugina S,
Kozyrev O,
Cid JF,
Hay P,
Nolan D,
Hughes S,
Hughes A,
Ryan S,
Fitch N,
Thorborn D,
Benbow A;
PREDICT-1 Study Team</span><br />
<span class="medgenPMjournal">N Engl J Med</span>
2008 Feb 7;358(6):568-79.
doi: 10.1056/NEJMoa0706135.
<span class="bold">PMID: </span><a href="/pubmed/18256392" target="_blank">18256392</a></div>
<div><a target="_blank" href="https://pubmed.ncbi.nlm.nih.gov/?term=" title="PubMed search"></a></div></div>
</div>
<div class="portlet mgSection" id="ID_103">
<div class="portlet_head mgSectionHead ui-widget-header"><h1 class="nl" id="Recent_clinical_studies">Recent clinical studies</h1><a sid="103" href="#" class="portlet_shutter" title="Show/hide content"></a></div>
<div class="portlet_content ln"><h3 class="subhead">Etiology</h3>
<div class="nl"><a target="_blank" href="/pubmed/36790777">Worldwide Prevalence of Antibiotic-Associated Stevens-Johnson Syndrome and Toxic Epidermal Necrolysis: A Systematic Review and Meta-analysis.</a></div>
<div class="portlet_content ln"><span class="medgenPMauthor">Lee EY,
Knox C,
Phillips EJ</span><br />
<span class="medgenPMjournal">JAMA Dermatol</span>
2023 Apr 1;159(4):384-392.
doi: 10.1001/jamadermatol.2022.6378.
<span class="bold">PMID: </span><a href="/pubmed/36790777" target="_blank">36790777</a><a href="/pmc/articles/PMC9932945" target="_blank" class="PubMedFree">Free PMC Article</a></div>
<div class="nl"><a target="_blank" href="/pubmed/34463914">Non-IgE-Mediated Drug Hypersensitivity Reactions.</a></div>
<div class="portlet_content ln"><span class="medgenPMauthor">Joshi SR,
Khan DA</span><br />
<span class="medgenPMjournal">Curr Allergy Asthma Rep</span>
2021 Aug 31;21(7):41.
doi: 10.1007/s11882-021-01018-7.
<span class="bold">PMID: </span><a href="/pubmed/34463914" target="_blank">34463914</a></div>
<div class="nl"><a target="_blank" href="/pubmed/34314511">DrugWAS: Drug-wide Association Studies for COVID-19 Drug Repurposing.</a></div>
<div class="portlet_content ln"><span class="medgenPMauthor">Bejan CA,
Cahill KN,
Staso PJ,
Choi L,
Peterson JF,
Phillips EJ</span><br />
<span class="medgenPMjournal">Clin Pharmacol Ther</span>
2021 Dec;110(6):1537-1546.
Epub 2021 Aug 10
doi: 10.1002/cpt.2376.
<span class="bold">PMID: </span><a href="/pubmed/34314511" target="_blank">34314511</a><a href="/pmc/articles/PMC8426999" target="_blank" class="PubMedFree">Free PMC Article</a></div>
<div class="nl"><a target="_blank" href="/pubmed/30558872">Antibiotic allergy.</a></div>
<div class="portlet_content ln"><span class="medgenPMauthor">Blumenthal KG,
Peter JG,
Trubiano JA,
Phillips EJ</span><br />
<span class="medgenPMjournal">Lancet</span>
2019 Jan 12;393(10167):183-198.
Epub 2018 Dec 14
doi: 10.1016/S0140-6736(18)32218-9.
<span class="bold">PMID: </span><a href="/pubmed/30558872" target="_blank">30558872</a><a href="/pmc/articles/PMC6563335" target="_blank" class="PubMedFree">Free PMC Article</a></div>
<div class="nl"><a target="_blank" href="/pubmed/18673126">Pharmacogenomics of antiretrovirals.</a></div>
<div class="portlet_content ln"><span class="medgenPMauthor">Roca B</span><br />
<span class="medgenPMjournal">Recent Pat Antiinfect Drug Discov</span>
2008 Jun;3(2):132-5.
doi: 10.2174/157489108784746650.
<span class="bold">PMID: </span><a href="/pubmed/18673126" target="_blank">18673126</a></div>
<div><a target="_blank" href="https://pubmed.ncbi.nlm.nih.gov/?term=%22Abacavir%20hypersensitivity%22%20AND%20Etiology%2Fbroad%5Bfilter%5D%20%20AND%20%22english%20and%20humans%22%5Bfilter%5D%20NOT%20comment%5BPTYP%5D%20NOT%20letter%5BPTYP%5D" title="PubMed search">See all (89)</a></div><h3 class="subhead">Diagnosis</h3>
<div class="nl"><a target="_blank" href="/pubmed/35469622">Pharmacogenomics of Drug Hypersensitivity: Technology and Translation.</a></div>
<div class="portlet_content ln"><span class="medgenPMauthor">Kuruvilla R,
Scott K,
Pirmohamed SM</span><br />
<span class="medgenPMjournal">Immunol Allergy Clin North Am</span>
2022 May;42(2):335-355.
Epub 2022 Mar 31
doi: 10.1016/j.iac.2022.01.006.
<span class="bold">PMID: </span><a href="/pubmed/35469622" target="_blank">35469622</a></div>
<div class="nl"><a target="_blank" href="/pubmed/34463914">Non-IgE-Mediated Drug Hypersensitivity Reactions.</a></div>
<div class="portlet_content ln"><span class="medgenPMauthor">Joshi SR,
Khan DA</span><br />
<span class="medgenPMjournal">Curr Allergy Asthma Rep</span>
2021 Aug 31;21(7):41.
doi: 10.1007/s11882-021-01018-7.
<span class="bold">PMID: </span><a href="/pubmed/34463914" target="_blank">34463914</a></div>
<div class="nl"><a target="_blank" href="/pubmed/34314511">DrugWAS: Drug-wide Association Studies for COVID-19 Drug Repurposing.</a></div>
<div class="portlet_content ln"><span class="medgenPMauthor">Bejan CA,
Cahill KN,
Staso PJ,
Choi L,
Peterson JF,
Phillips EJ</span><br />
<span class="medgenPMjournal">Clin Pharmacol Ther</span>
2021 Dec;110(6):1537-1546.
Epub 2021 Aug 10
doi: 10.1002/cpt.2376.
<span class="bold">PMID: </span><a href="/pubmed/34314511" target="_blank">34314511</a><a href="/pmc/articles/PMC8426999" target="_blank" class="PubMedFree">Free PMC Article</a></div>
<div class="nl"><a target="_blank" href="/pubmed/30558872">Antibiotic allergy.</a></div>
<div class="portlet_content ln"><span class="medgenPMauthor">Blumenthal KG,
Peter JG,
Trubiano JA,
Phillips EJ</span><br />
<span class="medgenPMjournal">Lancet</span>
2019 Jan 12;393(10167):183-198.
Epub 2018 Dec 14
doi: 10.1016/S0140-6736(18)32218-9.
<span class="bold">PMID: </span><a href="/pubmed/30558872" target="_blank">30558872</a><a href="/pmc/articles/PMC6563335" target="_blank" class="PubMedFree">Free PMC Article</a></div>
<div class="nl"><a target="_blank" href="/pubmed/25017682">Antiviral drug allergy.</a></div>
<div class="portlet_content ln"><span class="medgenPMauthor">Milpied-Homsi B,
Moran EM,
Phillips EJ</span><br />
<span class="medgenPMjournal">Immunol Allergy Clin North Am</span>
2014 Aug;34(3):645-62, ix.
doi: 10.1016/j.iac.2014.04.011.
<span class="bold">PMID: </span><a href="/pubmed/25017682" target="_blank">25017682</a><a href="/pmc/articles/PMC4140860" target="_blank" class="PubMedFree">Free PMC Article</a></div>
<div><a target="_blank" href="https://pubmed.ncbi.nlm.nih.gov/?term=%22Abacavir%20hypersensitivity%22%20AND%20Diagnosis%2Fbroad%5Bfilter%5D%20%20AND%20%22english%20and%20humans%22%5Bfilter%5D%20NOT%20comment%5BPTYP%5D%20NOT%20letter%5BPTYP%5D" title="PubMed search">See all (59)</a></div><h3 class="subhead">Therapy</h3>
<div class="nl"><a target="_blank" href="/pubmed/36790777">Worldwide Prevalence of Antibiotic-Associated Stevens-Johnson Syndrome and Toxic Epidermal Necrolysis: A Systematic Review and Meta-analysis.</a></div>
<div class="portlet_content ln"><span class="medgenPMauthor">Lee EY,
Knox C,
Phillips EJ</span><br />
<span class="medgenPMjournal">JAMA Dermatol</span>
2023 Apr 1;159(4):384-392.
doi: 10.1001/jamadermatol.2022.6378.
<span class="bold">PMID: </span><a href="/pubmed/36790777" target="_blank">36790777</a><a href="/pmc/articles/PMC9932945" target="_blank" class="PubMedFree">Free PMC Article</a></div>
<div class="nl"><a target="_blank" href="/pubmed/30558872">Antibiotic allergy.</a></div>
<div class="portlet_content ln"><span class="medgenPMauthor">Blumenthal KG,
Peter JG,
Trubiano JA,
Phillips EJ</span><br />
<span class="medgenPMjournal">Lancet</span>
2019 Jan 12;393(10167):183-198.
Epub 2018 Dec 14
doi: 10.1016/S0140-6736(18)32218-9.
<span class="bold">PMID: </span><a href="/pubmed/30558872" target="_blank">30558872</a><a href="/pmc/articles/PMC6563335" target="_blank" class="PubMedFree">Free PMC Article</a></div>
<div class="nl"><a target="_blank" href="/pubmed/25017682">Antiviral drug allergy.</a></div>
<div class="portlet_content ln"><span class="medgenPMauthor">Milpied-Homsi B,
Moran EM,
Phillips EJ</span><br />
<span class="medgenPMjournal">Immunol Allergy Clin North Am</span>
2014 Aug;34(3):645-62, ix.
doi: 10.1016/j.iac.2014.04.011.
<span class="bold">PMID: </span><a href="/pubmed/25017682" target="_blank">25017682</a><a href="/pmc/articles/PMC4140860" target="_blank" class="PubMedFree">Free PMC Article</a></div>
<div class="nl"><a target="_blank" href="/pubmed/19255258">The impact of pharmacogenetics on HIV therapy.</a></div>
<div class="portlet_content ln"><span class="medgenPMauthor">Mahungu TW,
Johnson MA,
Owen A,
Back DJ</span><br />
<span class="medgenPMjournal">Int J STD AIDS</span>
2009 Mar;20(3):145-51.
doi: 10.1258/ijsa.2008.008369.
<span class="bold">PMID: </span><a href="/pubmed/19255258" target="_blank">19255258</a></div>
<div class="nl"><a target="_blank" href="/pubmed/18673126">Pharmacogenomics of antiretrovirals.</a></div>
<div class="portlet_content ln"><span class="medgenPMauthor">Roca B</span><br />
<span class="medgenPMjournal">Recent Pat Antiinfect Drug Discov</span>
2008 Jun;3(2):132-5.
doi: 10.2174/157489108784746650.
<span class="bold">PMID: </span><a href="/pubmed/18673126" target="_blank">18673126</a></div>
<div><a target="_blank" href="https://pubmed.ncbi.nlm.nih.gov/?term=%22Abacavir%20hypersensitivity%22%20AND%20Therapy%2Fbroad%5Bfilter%5D%20%20AND%20%22english%20and%20humans%22%5Bfilter%5D%20NOT%20comment%5BPTYP%5D%20NOT%20letter%5BPTYP%5D" title="PubMed search">See all (130)</a></div><h3 class="subhead">Prognosis</h3>
<div class="nl"><a target="_blank" href="/pubmed/34143437">Immunopharmacogenomics: Mechanisms of HLA-Associated Drug Reactions.</a></div>
<div class="portlet_content ln"><span class="medgenPMauthor">Deshpande P,
Hertzman RJ,
Palubinsky AM,
Giles JB,
Karnes JH,
Gibson A,
Phillips EJ</span><br />
<span class="medgenPMjournal">Clin Pharmacol Ther</span>
2021 Sep;110(3):607-615.
Epub 2021 Jul 17
doi: 10.1002/cpt.2343.
<span class="bold">PMID: </span><a href="/pubmed/34143437" target="_blank">34143437</a><a href="/pmc/articles/PMC8500648" target="_blank" class="PubMedFree">Free PMC Article</a></div>
<div class="nl"><a target="_blank" href="/pubmed/32173028">New genetic predictors for abacavir tolerance in HLA-B*57:01 positive individuals.</a></div>
<div class="portlet_content ln"><span class="medgenPMauthor">Pavlos R,
Deshpande P,
Chopra A,
Leary S,
Strautins K,
Nolan D,
Thorborn D,
Shaefer M,
Rauch A,
Dunn D,
Montaner J,
Rachlis A,
Almeida CA,
Choo L,
James I,
Redwood AJ,
Li Y,
Gaudieri S,
Mallal SA,
Phillips EJ</span><br />
<span class="medgenPMjournal">Hum Immunol</span>
2020 Jun;81(6):300-304.
Epub 2020 Mar 12
doi: 10.1016/j.humimm.2020.02.011.
<span class="bold">PMID: </span><a href="/pubmed/32173028" target="_blank">32173028</a><a href="/pmc/articles/PMC7266722" target="_blank" class="PubMedFree">Free PMC Article</a></div>
<div class="nl"><a target="_blank" href="/pubmed/28162244">Pharmacogenetics of hypersensitivity drug reactions.</a></div>
<div class="portlet_content ln"><span class="medgenPMauthor">Negrini S,
Becquemont L</span><br />
<span class="medgenPMjournal">Therapie</span>
2017 Apr;72(2):231-243.
Epub 2017 Jan 3
doi: 10.1016/j.therap.2016.12.009.
<span class="bold">PMID: </span><a href="/pubmed/28162244" target="_blank">28162244</a></div>
<div class="nl"><a target="_blank" href="/pubmed/19255258">The impact of pharmacogenetics on HIV therapy.</a></div>
<div class="portlet_content ln"><span class="medgenPMauthor">Mahungu TW,
Johnson MA,
Owen A,
Back DJ</span><br />
<span class="medgenPMjournal">Int J STD AIDS</span>
2009 Mar;20(3):145-51.
doi: 10.1258/ijsa.2008.008369.
<span class="bold">PMID: </span><a href="/pubmed/19255258" target="_blank">19255258</a></div>
<div class="nl"><a target="_blank" href="/pubmed/19207023">Genetic association studies to detect adverse drug reactions: abacavir hypersensitivity as an example.</a></div>
<div class="portlet_content ln"><span class="medgenPMauthor">Hughes AR,
Brothers CH,
Mosteller M,
Spreen WR,
Burns DK</span><br />
<span class="medgenPMjournal">Pharmacogenomics</span>
2009 Feb;10(2):225-33.
doi: 10.2217/14622416.10.2.225.
<span class="bold">PMID: </span><a href="/pubmed/19207023" target="_blank">19207023</a></div>
<div><a target="_blank" href="https://pubmed.ncbi.nlm.nih.gov/?term=%22Abacavir%20hypersensitivity%22%20AND%20Prognosis%2Fbroad%5Bfilter%5D%20%20AND%20%22english%20and%20humans%22%5Bfilter%5D%20NOT%20comment%5BPTYP%5D%20NOT%20letter%5BPTYP%5D" title="PubMed search">See all (59)</a></div><h3 class="subhead">Clinical prediction guides</h3>
<div class="nl"><a target="_blank" href="/pubmed/36790777">Worldwide Prevalence of Antibiotic-Associated Stevens-Johnson Syndrome and Toxic Epidermal Necrolysis: A Systematic Review and Meta-analysis.</a></div>
<div class="portlet_content ln"><span class="medgenPMauthor">Lee EY,
Knox C,
Phillips EJ</span><br />
<span class="medgenPMjournal">JAMA Dermatol</span>
2023 Apr 1;159(4):384-392.
doi: 10.1001/jamadermatol.2022.6378.
<span class="bold">PMID: </span><a href="/pubmed/36790777" target="_blank">36790777</a><a href="/pmc/articles/PMC9932945" target="_blank" class="PubMedFree">Free PMC Article</a></div>
<div class="nl"><a target="_blank" href="/pubmed/34314511">DrugWAS: Drug-wide Association Studies for COVID-19 Drug Repurposing.</a></div>
<div class="portlet_content ln"><span class="medgenPMauthor">Bejan CA,
Cahill KN,
Staso PJ,
Choi L,
Peterson JF,
Phillips EJ</span><br />
<span class="medgenPMjournal">Clin Pharmacol Ther</span>
2021 Dec;110(6):1537-1546.
Epub 2021 Aug 10
doi: 10.1002/cpt.2376.
<span class="bold">PMID: </span><a href="/pubmed/34314511" target="_blank">34314511</a><a href="/pmc/articles/PMC8426999" target="_blank" class="PubMedFree">Free PMC Article</a></div>
<div class="nl"><a target="_blank" href="/pubmed/25017682">Antiviral drug allergy.</a></div>
<div class="portlet_content ln"><span class="medgenPMauthor">Milpied-Homsi B,
Moran EM,
Phillips EJ</span><br />
<span class="medgenPMjournal">Immunol Allergy Clin North Am</span>
2014 Aug;34(3):645-62, ix.
doi: 10.1016/j.iac.2014.04.011.
<span class="bold">PMID: </span><a href="/pubmed/25017682" target="_blank">25017682</a><a href="/pmc/articles/PMC4140860" target="_blank" class="PubMedFree">Free PMC Article</a></div>
<div class="nl"><a target="_blank" href="/pubmed/19744523">Pharmacogenetics of antiretrovirals.</a></div>
<div class="portlet_content ln"><span class="medgenPMauthor">Tozzi V</span><br />
<span class="medgenPMjournal">Antiviral Res</span>
2010 Jan;85(1):190-200.
Epub 2009 Sep 8
doi: 10.1016/j.antiviral.2009.09.001.
<span class="bold">PMID: </span><a href="/pubmed/19744523" target="_blank">19744523</a></div>
<div class="nl"><a target="_blank" href="/pubmed/19255258">The impact of pharmacogenetics on HIV therapy.</a></div>
<div class="portlet_content ln"><span class="medgenPMauthor">Mahungu TW,
Johnson MA,
Owen A,
Back DJ</span><br />
<span class="medgenPMjournal">Int J STD AIDS</span>
2009 Mar;20(3):145-51.
doi: 10.1258/ijsa.2008.008369.
<span class="bold">PMID: </span><a href="/pubmed/19255258" target="_blank">19255258</a></div>
<div><a target="_blank" href="https://pubmed.ncbi.nlm.nih.gov/?term=%22Abacavir%20hypersensitivity%22%20AND%20Clinical%20prediction%20guides%2Fbroad%5Bfilter%5D%20%20AND%20%22english%20and%20humans%22%5Bfilter%5D%20NOT%20comment%5BPTYP%5D%20NOT%20letter%5BPTYP%5D" title="PubMed search">See all (64)</a></div></div>
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<div class="nl"><a target="_blank" href="/pubmed/36790777">Worldwide Prevalence of Antibiotic-Associated Stevens-Johnson Syndrome and Toxic Epidermal Necrolysis: A Systematic Review and Meta-analysis.</a></div>
<div class="portlet_content ln"><span class="medgenPMauthor">Lee EY,
Knox C,
Phillips EJ</span><br />
<span class="medgenPMjournal">JAMA Dermatol</span>
2023 Apr 1;159(4):384-392.
doi: 10.1001/jamadermatol.2022.6378.
<span class="bold">PMID: </span><a href="/pubmed/36790777" target="_blank">36790777</a><a href="/pmc/articles/PMC9932945" target="_blank" class="PubMedFree">Free PMC Article</a></div>
<div class="nl"><a target="_blank" href="/pubmed/36058225">Safety and efficacy of abacavir for treating infants, children, and adolescents living with HIV: a systematic review and meta-analysis.</a></div>
<div class="portlet_content ln"><span class="medgenPMauthor">Jesson J,
Saint-Lary L,
Revegue MHDT,
O'Rourke J,
Townsend CL,
Renaud F,
Penazzato M,
Leroy V</span><br />
<span class="medgenPMjournal">Lancet Child Adolesc Health</span>
2022 Oct;6(10):692-704.
Epub 2022 Sep 2
doi: 10.1016/S2352-4642(22)00213-9.
<span class="bold">PMID: </span><a href="/pubmed/36058225" target="_blank">36058225</a><a href="/pmc/articles/PMC9474298" target="_blank" class="PubMedFree">Free PMC Article</a></div>
<div class="nl"><a target="_blank" href="/pubmed/31899808">Genetic variants associated with T cell-mediated cutaneous adverse drug reactions: A PRISMA-compliant systematic review-An EAACI position paper.</a></div>
<div class="portlet_content ln"><span class="medgenPMauthor">Oussalah A,
Yip V,
Mayorga C,
Blanca M,
Barbaud A,
Nakonechna A,
Cernadas J,
Gotua M,
Brockow K,
Caubet JC,
Bircher A,
Atanaskovic-Markovic M,
Demoly P,
Kase-Tanno L,
Terreehorst I,
Laguna JJ,
Romano A,
Guéant JL,
Pirmohamed M;
Task Force “Genetic predictors of drug hypersensitivity” of the European Network on Drug Allergy (ENDA), European Academy of Allergy and Clinical Immunology (EAACI)</span><br />
<span class="medgenPMjournal">Allergy</span>
2020 May;75(5):1069-1098.
doi: 10.1111/all.14174.
<span class="bold">PMID: </span><a href="/pubmed/31899808" target="_blank">31899808</a></div>
<div class="nl"><a target="_blank" href="/pubmed/26847228">Adverse events associated with abacavir use in HIV-infected children and adolescents: a systematic review and meta-analysis.</a></div>
<div class="portlet_content ln"><span class="medgenPMauthor">Jesson J,
Dahourou DL,
Renaud F,
Penazzato M,
Leroy V</span><br />
<span class="medgenPMjournal">Lancet HIV</span>
2016 Feb;3(2):e64-75.
Epub 2015 Dec 7
doi: 10.1016/S2352-3018(15)00225-8.
<span class="bold">PMID: </span><a href="/pubmed/26847228" target="_blank">26847228</a></div>
<div class="nl"><a target="_blank" href="/pubmed/25074854">Virological efficacy of abacavir: systematic review and meta-analysis.</a></div>
<div class="portlet_content ln"><span class="medgenPMauthor">Cruciani M,
Mengoli C,
Malena M,
Serpelloni G,
Parisi SG,
Moyle G,
Bosco O</span><br />
<span class="medgenPMjournal">J Antimicrob Chemother</span>
2014 Dec;69(12):3169-80.
Epub 2014 Jul 28
doi: 10.1093/jac/dku279.
<span class="bold">PMID: </span><a href="/pubmed/25074854" target="_blank">25074854</a></div>
<div><a target="_blank" href="https://pubmed.ncbi.nlm.nih.gov/?term=%22Abacavir%20hypersensitivity%22%20AND%20systematic%5Bsb%5D%20AND%20%22english%20and%20humans%22%5Bfilter%5D%20NOT%20comment%5BPTYP%5D%20NOT%20letter%5BPTYP%5D" title="PubMed search">See all (5)</a></div></div>
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<div class="portlet_head mgSectionHead ui-widget-header"><h1 class="nl" id="Therapeutic_recommendations">Therapeutic recommendations</h1><a sid="120" href="#" class="portlet_shutter" title="Show/hide content"></a></div>
<div class="portlet_content ln" id="therapeutic"><strong>From <a href="https://www.ncbi.nlm.nih.gov/books/NBK315783" target="_blank">Medical Genetics Summaries</a></strong><br /><div id="TheraputicContent"><div class="divPopper rprt" id="abacavir_REF_1" style="display: none;">1. ABACAVIR- abacavir tablet, film coated [package insert]. Miami, FL; 2017 May. Available from: <a href="https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=0d791375-e311-41f9-87b8-940657e6318c" target="_blank">https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=0d791375-e311-41f9-87b8-940657e6318c</a></div><div class="divPopper rprt" id="abacavir_REF_5" style="display: none;">5. Royal Dutch Pharmacists Association (KNMP). Dutch Pharmacogenetics Working Group (DPWG). Pharmacogenetic Guidelines [Internet]. Netherlands. Abacavir – HLA-B*5701 [Cited July 2017]. Available from: <a href="http://kennisbank.knmp.nl" target="_blank">http://kennisbank.knmp.nl</a> [Access is restricted to KNMP membership.]</div><p><b>This section contains excerpted</b>
<sup>1</sup>
<b>information on gene-based dosing recommendations. Neither this section nor other parts of this review contain the complete recommendations from the sources.</b>
</p><h2>2017 Statement from the US Food and Drug Administration (FDA)</h2><p>Serious and sometimes fatal hypersensitivity reactions have occurred with abacavir sulfate. These hypersensitivity reactions have included multi-organ failure and anaphylaxis and typically occurred within the first 6 weeks of treatment with abacavir sulfate (median time to onset was 9 days); although abacavir hypersensitivity reactions have occurred any time during treatment. Patients who carry the <i>HLA-B*57:01</i> allele are at a higher risk of abacavir hypersensitivity reactions; although, patients who do not carry the <i>HLA-B*57:01</i> allele have developed hypersensitivity reactions. Hypersensitivity to abacavir was reported in approximately 206 (8%) of 2,670 patients in 9 clinical trials with abacavir-containing products where <i>HLA-B*57:01</i> screening was not performed. The incidence of suspected abacavir hypersensitivity reactions in clinical trials was 1% when subjects carrying the <i>HLA-B*57:01</i> allele were excluded. In any patient treated with abacavir, the clinical diagnosis of hypersensitivity reaction must remain the basis of clinical decision making.</p><p>Due to the potential for severe, serious, and possibly fatal hypersensitivity reactions with abacavir sulfate:</p><ul><li>All patients should be screened for the <i>HLA-B*57:01</i> allele prior to initiating therapy with abacavir tablets or reinitiation of therapy with abacavir tablets, unless patients have a previously documented <i>HLA-B*57:01</i> allele assessment.</li><li>Abacavir tablet is contraindicated in patients with a prior hypersensitivity reaction to abacavir and in <i>HLA-B*57:01</i> -positive patients.</li><li>Before starting abacavir tablets, review medical history for prior exposure to any abacavir-containing product. NEVER restart abacavir tablets or any other abacavir-containing product following a hypersensitivity reaction to abacavir, regardless of <i>HLA-B*57:01</i> status.</li><li>To reduce the risk of a life-threatening hypersensitivity reaction, regardless of <i>HLA-B*57:01</i> status, discontinue abacavir tablets immediately if a hypersensitivity reaction is suspected, even when other diagnoses are possible (e.g., acute onset respiratory diseases such as pneumonia, bronchitis, pharyngitis, or influenza; gastroenteritis; or reactions to other medications).</li><li>If a hypersensitivity reaction cannot be ruled out, do not restart abacavir tablets or any other abacavir-containing products because more severe symptoms which may include life-threatening hypotension and death, can occur within hours.</li><li>If a hypersensitivity reaction is ruled out, patients may restart abacavir tablets. Rarely, patients who have stopped abacavir for reasons other than symptoms of hypersensitivity have also experienced life-threatening reactions within hours of reinitiating abacavir therapy. Therefore, reintroduction of abacavir tablets or any other abacavir-containing product is recommended only if medical care can be readily accessed.</li><li>A Medication Guide and Warning Card that provide information about recognition of hypersensitivity reactions should be dispensed with each new prescription and refill.</li></ul><p><b>Please review the complete therapeutic recommendations that are located here: (</b>
<b>1</b>
<b>)</b>
.</p><h2>2014 Statement from the Clinical Pharmacogenetics Implementation Consortium (CPIC)</h2><p>We agree with others that <i>HLA-B*57:01</i> screening should be performed in all abacavir-naive individuals before initiation of abacavir-containing therapy (see Table 2); this is consistent with the recommendations of the FDA, the US Department of Health and Human Services, and the European Medicines Agency. In abacavir-naive individuals who are <i>HLA-B*57:01</i>-positive, abacavir is not recommended and should be considered only under exceptional circumstances when the potential benefit, based on resistance patterns and treatment history, outweighs the risk. <i>HLA-B*57:01</i> genotyping is widely available in the developed world and is considered the standard of care prior to initiating abacavir. Where <i>HLA-B*57:01</i> genotyping is not clinically available (such as in resource-limited settings), some have advocated initiating abacavir, provided there is appropriate clinical monitoring and patient counseling about the signs and symptoms of HSR [hypersensitivity reaction], although this remains at the clinician’s discretion.</p><p><b>Please review the complete therapeutic recommendations that are located here</b>
(3, 4).</p><h2>2017 Summary of Recommendations from the Dutch Pharmacogenetics Working Group (DPWG) of the Royal Dutch Association for the Advancement of Pharmacy (KNMP)</h2><p><i>HLA-B*57:01</i>-positive patients have a strongly increased risk of a hypersensitivity reaction to abacavir.</p><p><b>Recommendation:</b>
</p><p>Abacavir is contraindicated for <i>HLA-B*57:01</i>-positive patients.</p><ol><li>Advise the prescriber to prescribe an alternative according to the current guidelines.</li></ol><p><b>Background information</b>
</p><p><b>Mechanism:</b>
</p><p>Although the mechanism of hypersensitivity reactions to abacavir is not fully known, experimental data suggest the following mechanism.</p><p>Abacavir metabolites (aldehydes and acids) form a covalent bond with cellular proteins. Peptides derived from these modified proteins bind to <i>HLA-B*5701</i> and are recognised on the cell surface as foreign by the immune cells, which triggers an immune response against cells containing abacavir. For more information about the <i>HLA-B*57:01</i> genotype: see the general background information about HLA on the KNMP Knowledge Bank or on http://www.knmp.nl/ (search for HLA).</p><p><b>Other considerations:</b>
</p><p>If tests are performed for <i>HLA-B57</i> instead of <i>HLA-B*57:01</i>, some patients will incorrectly be denied treatment with abacavir. This is primarily the case in patients of African descent, where <i>HLA-B*57:03</i> is the most common <i>HLA-B57</i> sub-type and to a lesser extent for Caucasian patients, where <i>HLA-B*57:01</i> is the most common <i>HLA-B57</i> sub-type. If there are enough alternatives, it is not a problem that the patient is being denied abacavir incorrectly.</p><p><b>Clinical consequences:</b>
</p><p><i>HLA-B*5701</i>-positive patients have a strongly increased risk of a hypersensitivity reaction to abacavir (OR [odds ratio] 7 to 960 for clinically diagnosed hypersensitivity reactions and 900 to 1945 for immunologically confirmed hypersensitivity reactions).</p><p>Exclusion of <i>HLA-B*5701</i>-positive patients from abacavir therapy reduced the number of clinically diagnosed hypersensitivity reactions in predominantly white populations by 56-96% and the number of immunologically confirmed hypersensitivity reactions by 100%.</p><p>Hypersensitivity reactions to abacavir generally disappear spontaneously after stopping abacavir, but can be fatal in severe cases.</p><p><b>Please review the complete therapeutic recommendations that are located here: (</b>
<b>5</b>
<b>).</b>
</p><table id="abacavir.T.cpic_2014_recommended_therape" frame="hsides" rules="groups"><caption>Table 2. CPIC (2014) Recommended Therapeutic Use of Abacavir in relation to <i>HLA-B</i> Genotype<sup>a</sup>
</caption><tfoot><tr><td colspan="4"><i>HLA-B</i>, <i>human leukocyte antigen B.</i></td></tr><tr><td colspan="4"><sup>a</sup>
. The 2014 update states that the recommendations shown in the table from the 2012 guideline remain the same. This table has been adapted from the 2012 guideline (3, 4).</td></tr><tr><td colspan="4"><sup>b</sup>
. Rating scheme described in supplementary data online (3, 4).</td></tr><tr><td colspan="4">Please see 2014 Statement from the Clinical Pharmacogenetics Implementation Consortium (CPIC) for more information from CPIC. Table adapted from (3).</td></tr></tfoot><thead><tr><th id="hd_h_abacavir.T.cpic_2014_recommended_therape_1_1_1_1" valign="top" align="left" scope="col" rowspan="1" colspan="1">Genotype</th><th id="hd_h_abacavir.T.cpic_2014_recommended_therape_1_1_1_2" valign="top" align="left" scope="col" rowspan="1" colspan="1">Implications for phenotypic measures</th><th id="hd_h_abacavir.T.cpic_2014_recommended_therape_1_1_1_3" valign="top" align="left" scope="col" rowspan="1" colspan="1">Recommendations for abacavir</th><th id="hd_h_abacavir.T.cpic_2014_recommended_therape_1_1_1_4" valign="top" align="left" scope="col" rowspan="1" colspan="1">Classification of recommendations<sup>b</sup>
</th></tr></thead><tbody><tr><td headers="hd_h_abacavir.T.cpic_2014_recommended_therape_1_1_1_1" valign="top" align="left" scope="row" rowspan="1" colspan="1">“Negative”<br />Noncarrier of<br /><i>HLA-B*57:01</i></td><td headers="hd_h_abacavir.T.cpic_2014_recommended_therape_1_1_1_2" valign="top" align="left" rowspan="1" colspan="1">Low or reduced risk of abacavir hypersensitivity</td><td headers="hd_h_abacavir.T.cpic_2014_recommended_therape_1_1_1_3" valign="top" align="left" rowspan="1" colspan="1">Use abacavir per standard dosing guidelines</td><td headers="hd_h_abacavir.T.cpic_2014_recommended_therape_1_1_1_4" valign="top" align="left" rowspan="1" colspan="1">Strong</td></tr><tr><td headers="hd_h_abacavir.T.cpic_2014_recommended_therape_1_1_1_1" valign="top" align="left" scope="row" rowspan="1" colspan="1">“Positive”<br />Carrier of<br /><i>HLA-B*57:01</i></td><td headers="hd_h_abacavir.T.cpic_2014_recommended_therape_1_1_1_2" valign="top" align="left" rowspan="1" colspan="1">Significantly increased risk of abacavir hypersensitivity</td><td headers="hd_h_abacavir.T.cpic_2014_recommended_therape_1_1_1_3" valign="top" align="left" rowspan="1" colspan="1">Abacavir is not recommended</td><td headers="hd_h_abacavir.T.cpic_2014_recommended_therape_1_1_1_4" valign="top" align="left" rowspan="1" colspan="1">Strong</td></tr></tbody></table><p><sup>1</sup>
The FDA labels specific drug formulations. We have substituted the generic names for any drug labels in this excerpt. The FDA may not have labeled all formulations containing the generic drug. Certain terms, genes and genetic variants may be corrected in accordance to nomenclature standards, where necessary. We have given the full name of abbreviations, shown in square brackets, where necessary.</p></div></div>
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<div class="portlet_content ln"><ul class="a_poppers"><li><a target="_blank" href="https://pubmed.ncbi.nlm.nih.gov/?term=(%22abacavir%20hypersensitivity%22%5Btiab%3A~0%5D)%20AND%20(%22english%20and%20humans%22%5BFilter%5D)%20AND%20(%20(%22practice%20guideline%22%5BFilter%5D)%20OR%20(practice*%5Btitl%5D%20AND%20(guideline%5Btitl%5D%20OR%20parameter%5Btitl%5D%20OR%20resource%5Btitl%5D%20OR%20bulletin%5Btitl%5D%20OR%20best%5Btitl%5D))%20OR%20(genetic*%5Btitl%5D%20AND%20(evaluation%5Btitl%5D%20OR%20counseling%5Btitl%5D%20OR%20screening%5Btitl%5D%20OR%20test*%5Btitl%5D))%20OR%20(clinical%5Btitl%5D%20AND%20((expert%5Btitl%5D%20AND%20consensus%5Btitl%5D)%20OR%20utility%5Btitl%5D%20OR%20guideline*%5Btitl%5D))%20OR%20(management%5Btitl%5D%20AND%20(clinical%5Btitl%5D%20OR%20diagnos*%5Btitl%5D%20OR%20recommendation%5Btitl%5D%20OR%20pain%5Btitl%5D%20OR%20surveillance%5Btitl%5D%20OR%20emergency%5Btitl%5D%20OR%20guideline*%5Btitl%5D%20OR%20therap*))%20OR%20(treatment%5Btitl%5D%20AND%20((evaluation%5Btitl%5D%20AND%20diagnosis%5Btitl%5D)%20OR%20(assessment%5Btitl%5D%20AND%20prevention%5Btitl%5D)%20OR%20therap*))%20OR%20(Diagnos*%5Btitl%5D%20AND%20(prenatal%5Btitl%5D%20OR%20treatment%5Btitl%5D%20OR%20follow-up%5Btitl%5D%20OR%20statement%5Btitl%5D%20OR%20criteria%5Btitl%5D%20OR%20newborn%5Btitl%5D%20OR%20differential%5Btitl%5D%20OR%20neonatal%5Btitl%5D%20OR%20neonate%5Btitl%5D))%20OR%20(guideline*%5Btitl%5D%20AND%20(pharmacogenetic*%5Btitl%5D%20OR%20recommendation%5Btitl%5D%20OR%20therap*%5Btitl%5D%20OR%20evidence-based%5Btitl%5D%20OR%20consensus%5Btitl%5D%20OR%20(technical%5Btitl%5D%20AND%20standard*%5Btitl%5D)%20OR%20(molecular%5Btitl%5D%20AND%20testing%5Btitl%5D)))%20OR%20(risk%5Btitl%5D%20AND%20assessment%5Btitl%5D)%20OR%20(recommendation*%5Btitl%5D%20AND%20(statement%5Btitl%5D%20OR%20Evidence-based%5Btitl%5D%20OR%20Consensus%5Btitl%5D))%20OR%20(care%20AND%20((Patient%5Btitl%5D%20AND%20standard*%5Btitl%5D)%20OR%20primary%5Btitl%5D%20OR%20psychosocial%5Btitl%5D))%20OR%20(Health%5Btitl%5D%20AND%20supervision%5Btitl%5D)%20OR%20(statement%5Btitl%5D%20AND%20(policy%5Btitl%5D%20OR%20position%5Btitl%5D%20OR%20Consensus%5Btitl%5D))%20OR%20(pharmacogenetics%5Btitl%5D%20AND%20(Dosing%5Btitl%5D%20OR%20therap*%5Btitl%5D%20OR%20genotype*%5Btitl%5D%20OR%20drug*%5Btitl%5D))%20OR%20(Chemotherapy%5Btitl%5D%20AND%20decision*%5Btitl%5D)%20OR%20(screening%5Btitl%5D%20AND%20(newborn%5Btitl%5D%20OR%20neonat*%5Btitl%5D%20OR%20detection%5Btitl%5D%20OR%20diagnos*%5Btitl%5D))%20OR%20(criteria%5Btitl%5D%20OR%20genotype*%5Btitl%5D)%20)%20NOT%20(%22Case%20reports%22%5BPublication%20type%5D%20OR%20%22clinical%20study%22%5BPublication%20Type%5D%20OR%20%22randomized%20controlled%20trial%22%5BPublication%20Type%5D)" title="PubMed search">PubMed</a><div class="help-popup">See practice and clinical guidelines in PubMed. The search results may include broader topics and may not capture all published guidelines. See the <a href="/medgen/docs/faq/" title="Frequently asked questions" target="_blank">FAQ</a> for details.</div></li><li><a target="_blank" href="/books/?term=((%22clinical%20guidelines%22%5BResource%20Type%5D)%20OR%20%22practice%20guideline%22%5BPublication%20Type%5D)%20AND%20(%22Abacavir%20hypersensitivity%22)">Bookshelf</a><div class="help-popup">See practice and clinical guidelines in NCBI Bookshelf. The search results may include broader topics and may not capture all published guidelines. See the <a href="/medgen/docs/faq/" title="Frequently asked questions" target="_blank">FAQ</a> for details.</div></li></ul><h3 class="subhead">Curated</h3><ul class="a_poppers"><li><a target="_blank" href="https://clinicalinfo.hiv.gov/sites/default/files/guidelines/documents/adult-adolescent-arv/guidelines-adult-adolescent-arv.pdf">PAGAA, 2024</a><div>Panel on Antiretroviral Guidelines for Adults and Adolescents. Guidelines for the Use of Antiretroviral Agents in Adults and Adolescents with HIV. Department of Health and Human Services.</div></li><li><a target="_blank" href="https://dailymed.nlm.nih.gov/dailymed/lookup.cfm?setid=80c1702a-973c-436a-90f8-69b29674dca0">DailyMed Drug Label, 2022</a><div>DailyMed Drug Label, ABACAVIR SULFATE, 2022</div></li><li><a target="_blank" href="https://www.aacc.org/science-and-practice/practice-guidelines/pharmacogenetics">NACB, 2010</a><div>National Academy of Clinical Biochemistry, Clinical practice considerations. In: Laboratory medicine practice guidelines: guidelines and recommendations for laboratory analysis and application of pharmacogenetics to clinical practice, 2010</div></li></ul></div>
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