Surveillance monitoring for safety of in utero antiretroviral therapy exposures: current strategies and challenges
Identifieur interne : 000461 ( Pmc/Checkpoint ); précédent : 000460; suivant : 000462Surveillance monitoring for safety of in utero antiretroviral therapy exposures: current strategies and challenges
Auteurs : Rebecca M. Zash [États-Unis] ; Paige L. Williams [États-Unis] ; Jeanne Sibiude ; Hermione Lyall [Royaume-Uni] ; Fatima Kakkar [Canada]Source :
- Expert opinion on drug safety [ 1474-0338 ] ; 2016.
Abstract
The use of antiretroviral therapy (ART) in pregnancy to prevent vertical HIV transmission has been one of the most successful public health programs in the last decade. As a result, an unprecedented number of women are taking ART at conception and during pregnancy. Given few randomized studies evaluating safety of different ART regimens in pregnancy, ongoing drug safety surveillance is critical.
This review aims to provide a rationale for ART drug safety surveillance, describe changing patterns of ART use and summarize current surveillance efforts in both low-resource and high-resource settings. Additionally, biostatistical approaches to and challenges in analysis of observational surveillance data are discussed.
The global landscape of ART use in pregnancy is rapidly increasing and evolving. Any increase in adverse effects of in-utero exposure to ART has the potential to reduce the impact of improvements in infant morbidity and mortality gained from decreased vertical HIV transmission. ART drug safety surveillance should therefore be a critical piece of programs to prevent mother to child transmission in both high- and low-resource settings. Current surveillance efforts could be strengthened with long-term follow-up of exposed children, pooling of data across cohorts and standardized approaches to analysis.
Url:
DOI: 10.1080/14740338.2016.1226281
PubMed: 27552003
PubMed Central: 5071158
Affiliations:
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As a result, an unprecedented number of women are taking ART at conception and during pregnancy. Given few randomized studies evaluating safety of different ART regimens in pregnancy, ongoing drug safety surveillance is critical.</p></sec><sec id="S2"><title>Areas Covered</title><p id="P2">This review aims to provide a rationale for ART drug safety surveillance, describe changing patterns of ART use and summarize current surveillance efforts in both low-resource and high-resource settings. Additionally, biostatistical approaches to and challenges in analysis of observational surveillance data are discussed.</p></sec><sec id="S3"><title>Expert Opinion</title><p id="P3">The global landscape of ART use in pregnancy is rapidly increasing and evolving. Any increase in adverse effects of in-utero exposure to ART has the potential to reduce the impact of improvements in infant morbidity and mortality gained from decreased vertical HIV transmission. ART drug safety surveillance should therefore be a critical piece of programs to prevent mother to child transmission in both high- and low-resource settings. Current surveillance efforts could be strengthened with long-term follow-up of exposed children, pooling of data across cohorts and standardized approaches to analysis.</p></sec></div></front></TEI><pmc article-type="research-article"><pmc-comment>The publisher of this article does not allow downloading of the full text in XML form.</pmc-comment>
<pmc-dir>properties manuscript</pmc-dir>
<front><journal-meta><journal-id journal-id-type="nlm-journal-id">101163027</journal-id><journal-id journal-id-type="pubmed-jr-id">30478</journal-id><journal-id journal-id-type="nlm-ta">Expert Opin Drug Saf</journal-id><journal-id journal-id-type="iso-abbrev">Expert Opin Drug Saf</journal-id><journal-title-group><journal-title>Expert opinion on drug safety</journal-title></journal-title-group><issn pub-type="ppub">1474-0338</issn><issn pub-type="epub">1744-764X</issn></journal-meta><article-meta><article-id pub-id-type="pmid">27552003</article-id><article-id pub-id-type="pmc">5071158</article-id><article-id pub-id-type="doi">10.1080/14740338.2016.1226281</article-id><article-id pub-id-type="manuscript">NIHMS816486</article-id><article-categories><subj-group subj-group-type="heading"><subject>Article</subject></subj-group></article-categories><title-group><article-title>Surveillance monitoring for safety of in utero antiretroviral therapy exposures: current strategies and challenges</article-title></title-group><contrib-group><contrib contrib-type="author"><name><surname>Zash</surname><given-names>Rebecca M.</given-names></name><xref ref-type="aff" rid="A1">1</xref><xref ref-type="aff" rid="A2">2</xref><xref ref-type="aff" rid="A3">3</xref></contrib><contrib contrib-type="author"><name><surname>Williams</surname><given-names>Paige L.</given-names></name><xref ref-type="aff" rid="A2">2</xref></contrib><contrib contrib-type="author"><name><surname>Sibiude</surname><given-names>Jeanne</given-names></name><xref ref-type="aff" rid="A4">4</xref></contrib><contrib contrib-type="author"><name><surname>Lyall</surname><given-names>Hermione</given-names></name><xref ref-type="aff" rid="A5">5</xref></contrib><contrib contrib-type="author"><name><surname>Kakkar</surname><given-names>Fatima</given-names></name><xref ref-type="aff" rid="A6">6</xref></contrib></contrib-group><aff id="A1"><label>1</label>Beth Israel Deaconess Medical Center, Boston, MA</aff><aff id="A2"><label>2</label>Harvard T. H. Chan School of Public Health, Boston, MA</aff><aff id="A3"><label>3</label>Botswana Harvard AIDS Institute Partnership, Gaborone</aff><aff id="A4"><label>4</label>Groupe hospitalier Cochin Port Royal, Paris, France; INSERM CESP 1018, Le Kremlin Bicêtre France</aff><aff id="A5"><label>5</label>Imperial College Healthcare NHS Trust, London, United Kingdom</aff><aff id="A6"><label>6</label>Centre Hospitalier Universitaire, Sainte-Justine, Canada</aff><author-notes><corresp id="FN1">Corresponding author: Paige Williams, PhD, Senior Lecturer and Director of Graduate Studies, Department of Biostatistics, Harvard T.H Chan School of Public Health, 665 Huntington Avenue, Boston, MA 02115, USA, <email>paige@hsph.harvard.edu</email>, Phone: 617-432-3872</corresp><fn id="FN2"><p>Rebecca Zash, MD, Instructor in Medicine, Division of Infectious Diseases, and Assistant Director of the Global Health Program, Internal Medicine Residency, Beth Israel Deaconess Medical Center, 110 Lowry St, Suite GB, Boston, MA 02114, USA, <email>rzash@bidmc.harvard.edu</email>, Phone: 617-632-7706</p></fn><fn id="FN3"><p>Jeanne Sibiude, MD, MPH, Assistant Professor in Gynecology and Obstetrics, Groupe hospitalier Cochin Port Royal, 123 Bd de Port Royal, 75014, Paris, France, <email>jeannesibiude@yahoo.fr</email></p></fn><fn id="FN4"><p>Hermione Lyall, Bsc Hons, MbChB Hons, MD, FRCPCH, Consultant Paediatrician, Infectious Diseases, Imperial College Healthcare NHS Trust, St Mary Hospital, South Wharf Rd, London, W2 1NY, <email>Hermione.lyall@imperial.nhs.uk</email></p></fn><fn id="FN5"><p>Fatima Kakkar, MD, MPH, Assistant Professor of Pediatrics, Division of Infectious Diseases, Centre Hospitalier Universtaire Sainte-Justine, University of Montreal, 3175 Chemin de la Côte-Sainte-Catherine, Montréal, QC H3T 1C4, Canada, <email>fatima.kakkar.hsj@ssss.gouv.qc.ca</email></p></fn></author-notes><pub-date pub-type="nihms-submitted"><day>16</day><month>9</month><year>2016</year></pub-date><pub-date pub-type="epub"><day>6</day><month>9</month><year>2016</year></pub-date><pub-date pub-type="ppub"><month>11</month><year>2016</year></pub-date><pub-date pub-type="pmc-release"><day>01</day><month>11</month><year>2017</year></pub-date><volume>15</volume><issue>11</issue><fpage>1501</fpage><lpage>1513</lpage><pmc-comment>elocation-id from pubmed: 10.1080/14740338.2016.1226281</pmc-comment>
<abstract><sec id="S1"><title>Introduction</title><p id="P1">The use of antiretroviral therapy (ART) in pregnancy to prevent vertical HIV transmission has been one of the most successful public health programs in the last decade. As a result, an unprecedented number of women are taking ART at conception and during pregnancy. Given few randomized studies evaluating safety of different ART regimens in pregnancy, ongoing drug safety surveillance is critical.</p></sec><sec id="S2"><title>Areas Covered</title><p id="P2">This review aims to provide a rationale for ART drug safety surveillance, describe changing patterns of ART use and summarize current surveillance efforts in both low-resource and high-resource settings. Additionally, biostatistical approaches to and challenges in analysis of observational surveillance data are discussed.</p></sec><sec id="S3"><title>Expert Opinion</title><p id="P3">The global landscape of ART use in pregnancy is rapidly increasing and evolving. Any increase in adverse effects of in-utero exposure to ART has the potential to reduce the impact of improvements in infant morbidity and mortality gained from decreased vertical HIV transmission. ART drug safety surveillance should therefore be a critical piece of programs to prevent mother to child transmission in both high- and low-resource settings. Current surveillance efforts could be strengthened with long-term follow-up of exposed children, pooling of data across cohorts and standardized approaches to analysis.</p></sec></abstract><kwd-group><kwd>HIV</kwd><kwd>pregnancy</kwd><kwd>antiretroviral therapy</kwd><kwd>infant safety</kwd><kwd>surveillance programs</kwd></kwd-group></article-meta></front></pmc><affiliations><list><country><li>Canada</li><li>Royaume-Uni</li><li>États-Unis</li></country><region><li>Angleterre</li><li>Grand Londres</li><li>Massachusetts</li></region><settlement><li>Londres</li></settlement></list><tree><noCountry><name sortKey="Sibiude, Jeanne" sort="Sibiude, Jeanne" uniqKey="Sibiude J" first="Jeanne" last="Sibiude">Jeanne Sibiude</name></noCountry><country name="États-Unis"><region name="Massachusetts"><name sortKey="Zash, Rebecca M" sort="Zash, Rebecca M" uniqKey="Zash R" first="Rebecca M." last="Zash">Rebecca M. Zash</name></region><name sortKey="Williams, Paige L" sort="Williams, Paige L" uniqKey="Williams P" first="Paige L." last="Williams">Paige L. Williams</name><name sortKey="Zash, Rebecca M" sort="Zash, Rebecca M" uniqKey="Zash R" first="Rebecca M." last="Zash">Rebecca M. Zash</name></country><country name="Royaume-Uni"><region name="Angleterre"><name sortKey="Lyall, Hermione" sort="Lyall, Hermione" uniqKey="Lyall H" first="Hermione" last="Lyall">Hermione Lyall</name></region></country><country name="Canada"><noRegion><name sortKey="Kakkar, Fatima" sort="Kakkar, Fatima" uniqKey="Kakkar F" first="Fatima" last="Kakkar">Fatima Kakkar</name></noRegion></country></tree></affiliations></record>Pour manipuler ce document sous Unix (Dilib)
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