Lopinavir/Ritonavir in Pregnancy
OBJECTIVE:The Antiretroviral Pregnancy Registry was established in 1989 to collect data on birth defects after pregnancy exposures to antiretroviral therapy. Using Registry data, this study estimates the birth defect risk after pregnancy exposures to lopinavir/ritonavir. METHODS:The analysis populat...
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Veröffentlicht in: | Journal of acquired immune deficiency syndromes (1999) 2009-08, Vol.51 (4), p.456-461 |
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creator | Roberts, Susan S Martinez, Marisol Covington, Deborah L Rode, Richard A Pasley, Mary V Woodward, William C |
description | OBJECTIVE:The Antiretroviral Pregnancy Registry was established in 1989 to collect data on birth defects after pregnancy exposures to antiretroviral therapy. Using Registry data, this study estimates the birth defect risk after pregnancy exposures to lopinavir/ritonavir.
METHODS:The analysis population includes all prospective lopinavir/ritonavir-exposed pregnancies enrolled in the Registry from September 2000 through July 2007. Birth defect prevalence after pregnancy exposure is compared with rates from a population-based surveillance system, and first-trimester exposures are compared with combined second/third-trimester exposures.
RESULTS:Among 955 live births prenatally exposed to lopinavir/ritonavir, 23 cases with birth defects were reported [2.4%, 95% confidence interval (CI) = 1.5 to 3.6). Among 267 live births with first-trimester exposures, 5 had birth defects (1.9%, 95% CI = 0.6 to 4.3). These rates are similar to the population-based comparator rate of 2.67% and the rate in infants with second/third-trimester exposures (2.6%, 95% CI = 1.6 to 4.1). No pattern of birth defects suggestive of a common etiology was seen.
CONCLUSIONS:The prevalence of birth defects among infants prenatally exposed to lopinavir/ritonavir is not significantly different from internal or external comparison groups. These data provide reassuring information to patients and clinicians about the safety of lopinavir/ritonavir in the treatment of HIV-positive pregnant women. |
doi_str_mv | 10.1097/QAI.0b013e3181a2813f |
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METHODS:The analysis population includes all prospective lopinavir/ritonavir-exposed pregnancies enrolled in the Registry from September 2000 through July 2007. Birth defect prevalence after pregnancy exposure is compared with rates from a population-based surveillance system, and first-trimester exposures are compared with combined second/third-trimester exposures.
RESULTS:Among 955 live births prenatally exposed to lopinavir/ritonavir, 23 cases with birth defects were reported [2.4%, 95% confidence interval (CI) = 1.5 to 3.6). Among 267 live births with first-trimester exposures, 5 had birth defects (1.9%, 95% CI = 0.6 to 4.3). These rates are similar to the population-based comparator rate of 2.67% and the rate in infants with second/third-trimester exposures (2.6%, 95% CI = 1.6 to 4.1). No pattern of birth defects suggestive of a common etiology was seen.
CONCLUSIONS:The prevalence of birth defects among infants prenatally exposed to lopinavir/ritonavir is not significantly different from internal or external comparison groups. These data provide reassuring information to patients and clinicians about the safety of lopinavir/ritonavir in the treatment of HIV-positive pregnant women.</description><identifier>ISSN: 1525-4135</identifier><identifier>EISSN: 1944-7884</identifier><identifier>DOI: 10.1097/QAI.0b013e3181a2813f</identifier><identifier>PMID: 19381099</identifier><identifier>CODEN: JDSRET</identifier><language>eng</language><publisher>Hagerstown, MD: Lippincott Williams & Wilkins, Inc</publisher><subject>Abnormalities, Drug-Induced - epidemiology ; Acquired Immunodeficiency Syndrome - drug therapy ; Adult ; Anti-HIV Agents - adverse effects ; Antiretroviral drugs ; Biological and medical sciences ; Comparative analysis ; Drug therapy ; Epidemiology ; Estimates ; Female ; Fundamental and applied biological sciences. Psychology ; Human viral diseases ; Humans ; Infectious diseases ; Lopinavir ; Medical sciences ; Microbiology ; Miscellaneous ; Pregnancy ; Pregnancy Complications, Infectious - drug therapy ; Pyrimidinones - adverse effects ; Registries ; Risk factors ; Ritonavir - adverse effects ; Viral diseases ; Virology ; Women</subject><ispartof>Journal of acquired immune deficiency syndromes (1999), 2009-08, Vol.51 (4), p.456-461</ispartof><rights>2009 Lippincott Williams & Wilkins, Inc.</rights><rights>2009 INIST-CNRS</rights><rights>Copyright Lippincott Williams & Wilkins Aug 2009</rights><lds50>peer_reviewed</lds50><oa>free_for_read</oa><woscitedreferencessubscribed>false</woscitedreferencessubscribed><citedby>FETCH-LOGICAL-c489f-1c9a698f7b8fc1c0cc37dea66bdc97c2d8fec4f6853e776eb8fc16aee5a6db073</citedby><cites>FETCH-LOGICAL-c489f-1c9a698f7b8fc1c0cc37dea66bdc97c2d8fec4f6853e776eb8fc16aee5a6db073</cites></display><links><openurl>$$Topenurl_article</openurl><openurlfulltext>$$Topenurlfull_article</openurlfulltext><thumbnail>$$Tsyndetics_thumb_exl</thumbnail><link.rule.ids>314,777,781,27905,27906</link.rule.ids><backlink>$$Uhttp://pascal-francis.inist.fr/vibad/index.php?action=getRecordDetail&idt=21737116$$DView record in Pascal Francis$$Hfree_for_read</backlink><backlink>$$Uhttps://www.ncbi.nlm.nih.gov/pubmed/19381099$$D View this record in MEDLINE/PubMed$$Hfree_for_read</backlink></links><search><creatorcontrib>Roberts, Susan S</creatorcontrib><creatorcontrib>Martinez, Marisol</creatorcontrib><creatorcontrib>Covington, Deborah L</creatorcontrib><creatorcontrib>Rode, Richard A</creatorcontrib><creatorcontrib>Pasley, Mary V</creatorcontrib><creatorcontrib>Woodward, William C</creatorcontrib><title>Lopinavir/Ritonavir in Pregnancy</title><title>Journal of acquired immune deficiency syndromes (1999)</title><addtitle>J Acquir Immune Defic Syndr</addtitle><description>OBJECTIVE:The Antiretroviral Pregnancy Registry was established in 1989 to collect data on birth defects after pregnancy exposures to antiretroviral therapy. Using Registry data, this study estimates the birth defect risk after pregnancy exposures to lopinavir/ritonavir.
METHODS:The analysis population includes all prospective lopinavir/ritonavir-exposed pregnancies enrolled in the Registry from September 2000 through July 2007. Birth defect prevalence after pregnancy exposure is compared with rates from a population-based surveillance system, and first-trimester exposures are compared with combined second/third-trimester exposures.
RESULTS:Among 955 live births prenatally exposed to lopinavir/ritonavir, 23 cases with birth defects were reported [2.4%, 95% confidence interval (CI) = 1.5 to 3.6). Among 267 live births with first-trimester exposures, 5 had birth defects (1.9%, 95% CI = 0.6 to 4.3). These rates are similar to the population-based comparator rate of 2.67% and the rate in infants with second/third-trimester exposures (2.6%, 95% CI = 1.6 to 4.1). No pattern of birth defects suggestive of a common etiology was seen.
CONCLUSIONS:The prevalence of birth defects among infants prenatally exposed to lopinavir/ritonavir is not significantly different from internal or external comparison groups. These data provide reassuring information to patients and clinicians about the safety of lopinavir/ritonavir in the treatment of HIV-positive pregnant women.</description><subject>Abnormalities, Drug-Induced - epidemiology</subject><subject>Acquired Immunodeficiency Syndrome - drug therapy</subject><subject>Adult</subject><subject>Anti-HIV Agents - adverse effects</subject><subject>Antiretroviral drugs</subject><subject>Biological and medical sciences</subject><subject>Comparative analysis</subject><subject>Drug therapy</subject><subject>Epidemiology</subject><subject>Estimates</subject><subject>Female</subject><subject>Fundamental and applied biological sciences. Psychology</subject><subject>Human viral diseases</subject><subject>Humans</subject><subject>Infectious diseases</subject><subject>Lopinavir</subject><subject>Medical sciences</subject><subject>Microbiology</subject><subject>Miscellaneous</subject><subject>Pregnancy</subject><subject>Pregnancy Complications, Infectious - drug therapy</subject><subject>Pyrimidinones - adverse effects</subject><subject>Registries</subject><subject>Risk factors</subject><subject>Ritonavir - adverse effects</subject><subject>Viral diseases</subject><subject>Virology</subject><subject>Women</subject><issn>1525-4135</issn><issn>1944-7884</issn><fulltext>true</fulltext><rsrctype>article</rsrctype><creationdate>2009</creationdate><recordtype>article</recordtype><sourceid>EIF</sourceid><recordid>eNp9kNtKAzEQhoMoWg9vIFIE8WprZpPN4bIUT1DwgF6HbHaiq9vdmnQV395oi0IvvJq5-Oafn4-QQ6AjoFqe3Y2vR7SkwJCBApsrYH6DDEBznkml-Gbai7zIOLBih-zG-EIpCM71NtkBzVQK0QMynHbzurXvdTi7rxfdzzas2-FtwKfWtu5zn2x520Q8WM098nhx_jC5yqY3l9eT8TRzXGmfgdNWaOVlqbwDR51jskIrRFk5LV1eKY-Oe6EKhlIK_MGERSysqEoq2R45XebOQ_fWY1yYWR0dNo1tseujkVxQSO2_yeM18qXrQ5vKmZwxUYBkPEF8CbnQxRjQm3moZzZ8GqDm259J_sy6v3R2tMruyxlWf0crYQk4WQE2Otv4kBzV8ZfL03MJIBKnltxH1ywwxNem_8BgntE2i-f_O3wBFc2Khw</recordid><startdate>200908</startdate><enddate>200908</enddate><creator>Roberts, Susan S</creator><creator>Martinez, Marisol</creator><creator>Covington, Deborah L</creator><creator>Rode, Richard A</creator><creator>Pasley, Mary V</creator><creator>Woodward, William C</creator><general>Lippincott Williams & Wilkins, Inc</general><general>Lippincott Williams & Wilkins</general><general>Lippincott Williams & Wilkins Ovid Technologies</general><scope>IQODW</scope><scope>CGR</scope><scope>CUY</scope><scope>CVF</scope><scope>ECM</scope><scope>EIF</scope><scope>NPM</scope><scope>AAYXX</scope><scope>CITATION</scope><scope>7T2</scope><scope>7T5</scope><scope>7TK</scope><scope>7U7</scope><scope>7U9</scope><scope>C1K</scope><scope>H94</scope><scope>K9.</scope></search><sort><creationdate>200908</creationdate><title>Lopinavir/Ritonavir in Pregnancy</title><author>Roberts, Susan S ; Martinez, Marisol ; Covington, Deborah L ; Rode, Richard A ; Pasley, Mary V ; Woodward, William C</author></sort><facets><frbrtype>5</frbrtype><frbrgroupid>cdi_FETCH-LOGICAL-c489f-1c9a698f7b8fc1c0cc37dea66bdc97c2d8fec4f6853e776eb8fc16aee5a6db073</frbrgroupid><rsrctype>articles</rsrctype><prefilter>articles</prefilter><language>eng</language><creationdate>2009</creationdate><topic>Abnormalities, Drug-Induced - epidemiology</topic><topic>Acquired Immunodeficiency Syndrome - drug therapy</topic><topic>Adult</topic><topic>Anti-HIV Agents - adverse effects</topic><topic>Antiretroviral drugs</topic><topic>Biological and medical sciences</topic><topic>Comparative analysis</topic><topic>Drug therapy</topic><topic>Epidemiology</topic><topic>Estimates</topic><topic>Female</topic><topic>Fundamental and applied biological sciences. Psychology</topic><topic>Human viral diseases</topic><topic>Humans</topic><topic>Infectious diseases</topic><topic>Lopinavir</topic><topic>Medical sciences</topic><topic>Microbiology</topic><topic>Miscellaneous</topic><topic>Pregnancy</topic><topic>Pregnancy Complications, Infectious - drug therapy</topic><topic>Pyrimidinones - adverse effects</topic><topic>Registries</topic><topic>Risk factors</topic><topic>Ritonavir - adverse effects</topic><topic>Viral diseases</topic><topic>Virology</topic><topic>Women</topic><toplevel>peer_reviewed</toplevel><toplevel>online_resources</toplevel><creatorcontrib>Roberts, Susan S</creatorcontrib><creatorcontrib>Martinez, Marisol</creatorcontrib><creatorcontrib>Covington, Deborah L</creatorcontrib><creatorcontrib>Rode, Richard A</creatorcontrib><creatorcontrib>Pasley, Mary V</creatorcontrib><creatorcontrib>Woodward, William C</creatorcontrib><collection>Pascal-Francis</collection><collection>Medline</collection><collection>MEDLINE</collection><collection>MEDLINE (Ovid)</collection><collection>MEDLINE</collection><collection>MEDLINE</collection><collection>PubMed</collection><collection>CrossRef</collection><collection>Health and Safety Science Abstracts (Full archive)</collection><collection>Immunology Abstracts</collection><collection>Neurosciences Abstracts</collection><collection>Toxicology Abstracts</collection><collection>Virology and AIDS Abstracts</collection><collection>Environmental Sciences and Pollution Management</collection><collection>AIDS and Cancer Research Abstracts</collection><collection>ProQuest Health & Medical Complete (Alumni)</collection><jtitle>Journal of acquired immune deficiency syndromes (1999)</jtitle></facets><delivery><delcategory>Remote Search Resource</delcategory><fulltext>fulltext</fulltext></delivery><addata><au>Roberts, Susan S</au><au>Martinez, Marisol</au><au>Covington, Deborah L</au><au>Rode, Richard A</au><au>Pasley, Mary V</au><au>Woodward, William C</au><format>journal</format><genre>article</genre><ristype>JOUR</ristype><atitle>Lopinavir/Ritonavir in Pregnancy</atitle><jtitle>Journal of acquired immune deficiency syndromes (1999)</jtitle><addtitle>J Acquir Immune Defic Syndr</addtitle><date>2009-08</date><risdate>2009</risdate><volume>51</volume><issue>4</issue><spage>456</spage><epage>461</epage><pages>456-461</pages><issn>1525-4135</issn><eissn>1944-7884</eissn><coden>JDSRET</coden><abstract>OBJECTIVE:The Antiretroviral Pregnancy Registry was established in 1989 to collect data on birth defects after pregnancy exposures to antiretroviral therapy. Using Registry data, this study estimates the birth defect risk after pregnancy exposures to lopinavir/ritonavir.
METHODS:The analysis population includes all prospective lopinavir/ritonavir-exposed pregnancies enrolled in the Registry from September 2000 through July 2007. Birth defect prevalence after pregnancy exposure is compared with rates from a population-based surveillance system, and first-trimester exposures are compared with combined second/third-trimester exposures.
RESULTS:Among 955 live births prenatally exposed to lopinavir/ritonavir, 23 cases with birth defects were reported [2.4%, 95% confidence interval (CI) = 1.5 to 3.6). Among 267 live births with first-trimester exposures, 5 had birth defects (1.9%, 95% CI = 0.6 to 4.3). These rates are similar to the population-based comparator rate of 2.67% and the rate in infants with second/third-trimester exposures (2.6%, 95% CI = 1.6 to 4.1). No pattern of birth defects suggestive of a common etiology was seen.
CONCLUSIONS:The prevalence of birth defects among infants prenatally exposed to lopinavir/ritonavir is not significantly different from internal or external comparison groups. These data provide reassuring information to patients and clinicians about the safety of lopinavir/ritonavir in the treatment of HIV-positive pregnant women.</abstract><cop>Hagerstown, MD</cop><pub>Lippincott Williams & Wilkins, Inc</pub><pmid>19381099</pmid><doi>10.1097/QAI.0b013e3181a2813f</doi><tpages>6</tpages><oa>free_for_read</oa></addata></record> |
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subjects | Abnormalities, Drug-Induced - epidemiology Acquired Immunodeficiency Syndrome - drug therapy Adult Anti-HIV Agents - adverse effects Antiretroviral drugs Biological and medical sciences Comparative analysis Drug therapy Epidemiology Estimates Female Fundamental and applied biological sciences. Psychology Human viral diseases Humans Infectious diseases Lopinavir Medical sciences Microbiology Miscellaneous Pregnancy Pregnancy Complications, Infectious - drug therapy Pyrimidinones - adverse effects Registries Risk factors Ritonavir - adverse effects Viral diseases Virology Women |
title | Lopinavir/Ritonavir in Pregnancy |
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