Rilpivirine in HIV-1-positive women initiating pregnancy: to switch or not to switch?
Abstract Background Safety data about rilpivirine use during pregnancy remain scarce, and rilpivirine plasma concentrations are reduced during second/third trimesters, with a potential risk of viral breakthroughs. Thus, French guidelines recommend switching to rilpivirine-free combinations (RFCs) du...
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creator | Frange, Pierre Tubiana, Roland Sibiude, Jeanne Canestri, Ana Arvieux, Cédric Brunet-Cartier, Cécile Cotte, Laurent Reynes, Jacques Mandelbrot, Laurent Warszawski, Josiane Le Chenadec, Jérôme |
description | Abstract
Background
Safety data about rilpivirine use during pregnancy remain scarce, and rilpivirine plasma concentrations are reduced during second/third trimesters, with a potential risk of viral breakthroughs. Thus, French guidelines recommend switching to rilpivirine-free combinations (RFCs) during pregnancy.
Objectives
To describe the characteristics of women initiating pregnancy while on rilpivirine and to compare the outcomes for virologically suppressed subjects continuing rilpivirine until delivery versus switching to an RFC.
Methods
In the ANRS-EPF French Perinatal cohort, we included women on rilpivirine at conception in 2010–18. Pregnancy outcomes were compared between patients continuing versus interrupting rilpivirine. In women with documented viral suppression ( |
doi_str_mv | 10.1093/jac/dkaa017 |
format | Article |
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Background
Safety data about rilpivirine use during pregnancy remain scarce, and rilpivirine plasma concentrations are reduced during second/third trimesters, with a potential risk of viral breakthroughs. Thus, French guidelines recommend switching to rilpivirine-free combinations (RFCs) during pregnancy.
Objectives
To describe the characteristics of women initiating pregnancy while on rilpivirine and to compare the outcomes for virologically suppressed subjects continuing rilpivirine until delivery versus switching to an RFC.
Methods
In the ANRS-EPF French Perinatal cohort, we included women on rilpivirine at conception in 2010–18. Pregnancy outcomes were compared between patients continuing versus interrupting rilpivirine. In women with documented viral suppression (<50 copies/mL) before 14 weeks of gestation (WG) while on rilpivirine, we compared the probability of viral rebound (≥50 copies/mL) during pregnancy between subjects continuing rilpivirine versus those switching to RFC.
Results
Among 247 women included, 88.7% had viral suppression at the beginning of pregnancy. Overall, 184 women (74.5%) switched to an RFC (mostly PI/ritonavir-based regimens) at a median gestational age of 8.0 WG. Plasma HIV-1 RNA nearest delivery was <50 copies/mL in 95.6% of women. Among 69 women with documented viral suppression before 14 WG, the risk of viral rebound was higher when switching to RFCs than when continuing rilpivirine (20.0% versus 0.0%, P = 0.046). Delivery outcomes were similar between groups (overall birth defects, 3.8/100 live births; pregnancy losses, 2.0%; preterm deliveries, 10.6%). No HIV transmission occurred.
Conclusions
In virologically suppressed women initiating pregnancy, continuing rilpivirine was associated with better virological outcome than changing regimen. We did not observe a higher risk of adverse pregnancy outcomes.</description><identifier>ISSN: 0305-7453</identifier><identifier>EISSN: 1460-2091</identifier><identifier>DOI: 10.1093/jac/dkaa017</identifier><identifier>PMID: 32157283</identifier><language>eng</language><publisher>England: Oxford University Press</publisher><subject>Human health and pathology ; Life Sciences</subject><ispartof>Journal of antimicrobial chemotherapy, 2020-05, Vol.75 (5), p.1324-1331</ispartof><rights>The Author(s) 2020. Published by Oxford University Press on behalf of the British Society for Antimicrobial Chemotherapy. All rights reserved. For permissions, please email: journals.permissions@oup.com. 2020</rights><rights>The Author(s) 2020. Published by Oxford University Press on behalf of the British Society for Antimicrobial Chemotherapy. All rights reserved. For permissions, please email: journals.permissions@oup.com.</rights><rights>Distributed under a Creative Commons Attribution 4.0 International License</rights><lds50>peer_reviewed</lds50><woscitedreferencessubscribed>false</woscitedreferencessubscribed><citedby>FETCH-LOGICAL-c354t-7aebcb40a56f2e7425e89bb86f19997c9c3ed99ac519e6de53707b15a4f69ba63</citedby><cites>FETCH-LOGICAL-c354t-7aebcb40a56f2e7425e89bb86f19997c9c3ed99ac519e6de53707b15a4f69ba63</cites><orcidid>0000-0002-4920-8369 ; 0000-0003-2332-2507 ; 0000-0003-0685-0578 ; 0000-0002-6150-2376 ; 0000-0002-8218-8814 ; 0000-0002-0242-4566 ; 0000-0003-3242-7247 ; 0000-0003-1780-8746 ; 0000-0002-7022-2990 ; 0000-0002-6817-8951 ; 0000-0001-7057-768X ; 0000-0002-5883-7597</orcidid></display><links><openurl>$$Topenurl_article</openurl><openurlfulltext>$$Topenurlfull_article</openurlfulltext><thumbnail>$$Tsyndetics_thumb_exl</thumbnail><link.rule.ids>230,314,780,784,885,1584,27924,27925</link.rule.ids><backlink>$$Uhttps://www.ncbi.nlm.nih.gov/pubmed/32157283$$D View this record in MEDLINE/PubMed$$Hfree_for_read</backlink><backlink>$$Uhttps://hal.science/hal-02548822$$DView record in HAL$$Hfree_for_read</backlink></links><search><creatorcontrib>Frange, Pierre</creatorcontrib><creatorcontrib>Tubiana, Roland</creatorcontrib><creatorcontrib>Sibiude, Jeanne</creatorcontrib><creatorcontrib>Canestri, Ana</creatorcontrib><creatorcontrib>Arvieux, Cédric</creatorcontrib><creatorcontrib>Brunet-Cartier, Cécile</creatorcontrib><creatorcontrib>Cotte, Laurent</creatorcontrib><creatorcontrib>Reynes, Jacques</creatorcontrib><creatorcontrib>Mandelbrot, Laurent</creatorcontrib><creatorcontrib>Warszawski, Josiane</creatorcontrib><creatorcontrib>Le Chenadec, Jérôme</creatorcontrib><creatorcontrib>ANRS EPF CO1/CO11 Study Group</creatorcontrib><creatorcontrib>ANRS EPF CO1/CO11 Study Group</creatorcontrib><title>Rilpivirine in HIV-1-positive women initiating pregnancy: to switch or not to switch?</title><title>Journal of antimicrobial chemotherapy</title><addtitle>J Antimicrob Chemother</addtitle><description>Abstract
Background
Safety data about rilpivirine use during pregnancy remain scarce, and rilpivirine plasma concentrations are reduced during second/third trimesters, with a potential risk of viral breakthroughs. Thus, French guidelines recommend switching to rilpivirine-free combinations (RFCs) during pregnancy.
Objectives
To describe the characteristics of women initiating pregnancy while on rilpivirine and to compare the outcomes for virologically suppressed subjects continuing rilpivirine until delivery versus switching to an RFC.
Methods
In the ANRS-EPF French Perinatal cohort, we included women on rilpivirine at conception in 2010–18. Pregnancy outcomes were compared between patients continuing versus interrupting rilpivirine. In women with documented viral suppression (<50 copies/mL) before 14 weeks of gestation (WG) while on rilpivirine, we compared the probability of viral rebound (≥50 copies/mL) during pregnancy between subjects continuing rilpivirine versus those switching to RFC.
Results
Among 247 women included, 88.7% had viral suppression at the beginning of pregnancy. Overall, 184 women (74.5%) switched to an RFC (mostly PI/ritonavir-based regimens) at a median gestational age of 8.0 WG. Plasma HIV-1 RNA nearest delivery was <50 copies/mL in 95.6% of women. Among 69 women with documented viral suppression before 14 WG, the risk of viral rebound was higher when switching to RFCs than when continuing rilpivirine (20.0% versus 0.0%, P = 0.046). Delivery outcomes were similar between groups (overall birth defects, 3.8/100 live births; pregnancy losses, 2.0%; preterm deliveries, 10.6%). No HIV transmission occurred.
Conclusions
In virologically suppressed women initiating pregnancy, continuing rilpivirine was associated with better virological outcome than changing regimen. We did not observe a higher risk of adverse pregnancy outcomes.</description><subject>Human health and pathology</subject><subject>Life Sciences</subject><issn>0305-7453</issn><issn>1460-2091</issn><fulltext>true</fulltext><rsrctype>article</rsrctype><creationdate>2020</creationdate><recordtype>article</recordtype><recordid>eNp9kM1LwzAYh4Mobk5P3qUnUaQuH03SeJEx1AkDQZzXkKbpltk1tWk39t_b0Tlvnl7eHw_P4QHgEsF7BAUZLpUepl9KQcSPQB9FDIYYCnQM-pBAGvKIkh44834JIWSUxaegRzCiHMekD2bvNi_t2la2MIEtgsnrZ4jC0nlb27UJNm5linZvP1XbYh6UlZkXqtDbh6B2gd_YWi8CVwWFq_-Gx3Nwkqncm4v9HYDZ89PHeBJO315ex6NpqAmN6pArk-gkgoqyDBseYWpikSQxy5AQgmuhiUmFUJoiYVhqKOGQJ4iqKGMiUYwMwG3nXahclpVdqWornbJyMprK3QYxjeIY4zVq2ZuOLSv33Rhfy5X12uS5KoxrvMSEM0wgieMWvetQXTnvK5Md3AjKXXPZNpf75i19tRc3ycqkB_Y3cgtcd4Bryn9NP0yqidU</recordid><startdate>20200501</startdate><enddate>20200501</enddate><creator>Frange, Pierre</creator><creator>Tubiana, Roland</creator><creator>Sibiude, Jeanne</creator><creator>Canestri, Ana</creator><creator>Arvieux, Cédric</creator><creator>Brunet-Cartier, Cécile</creator><creator>Cotte, Laurent</creator><creator>Reynes, Jacques</creator><creator>Mandelbrot, Laurent</creator><creator>Warszawski, Josiane</creator><creator>Le Chenadec, Jérôme</creator><general>Oxford University Press</general><general>Oxford University Press (OUP)</general><scope>NPM</scope><scope>AAYXX</scope><scope>CITATION</scope><scope>7X8</scope><scope>1XC</scope><orcidid>https://orcid.org/0000-0002-4920-8369</orcidid><orcidid>https://orcid.org/0000-0003-2332-2507</orcidid><orcidid>https://orcid.org/0000-0003-0685-0578</orcidid><orcidid>https://orcid.org/0000-0002-6150-2376</orcidid><orcidid>https://orcid.org/0000-0002-8218-8814</orcidid><orcidid>https://orcid.org/0000-0002-0242-4566</orcidid><orcidid>https://orcid.org/0000-0003-3242-7247</orcidid><orcidid>https://orcid.org/0000-0003-1780-8746</orcidid><orcidid>https://orcid.org/0000-0002-7022-2990</orcidid><orcidid>https://orcid.org/0000-0002-6817-8951</orcidid><orcidid>https://orcid.org/0000-0001-7057-768X</orcidid><orcidid>https://orcid.org/0000-0002-5883-7597</orcidid></search><sort><creationdate>20200501</creationdate><title>Rilpivirine in HIV-1-positive women initiating pregnancy: to switch or not to switch?</title><author>Frange, Pierre ; Tubiana, Roland ; Sibiude, Jeanne ; Canestri, Ana ; Arvieux, Cédric ; Brunet-Cartier, Cécile ; Cotte, Laurent ; Reynes, Jacques ; Mandelbrot, Laurent ; Warszawski, Josiane ; Le Chenadec, Jérôme</author></sort><facets><frbrtype>5</frbrtype><frbrgroupid>cdi_FETCH-LOGICAL-c354t-7aebcb40a56f2e7425e89bb86f19997c9c3ed99ac519e6de53707b15a4f69ba63</frbrgroupid><rsrctype>articles</rsrctype><prefilter>articles</prefilter><language>eng</language><creationdate>2020</creationdate><topic>Human health and pathology</topic><topic>Life Sciences</topic><toplevel>peer_reviewed</toplevel><toplevel>online_resources</toplevel><creatorcontrib>Frange, Pierre</creatorcontrib><creatorcontrib>Tubiana, Roland</creatorcontrib><creatorcontrib>Sibiude, Jeanne</creatorcontrib><creatorcontrib>Canestri, Ana</creatorcontrib><creatorcontrib>Arvieux, Cédric</creatorcontrib><creatorcontrib>Brunet-Cartier, Cécile</creatorcontrib><creatorcontrib>Cotte, Laurent</creatorcontrib><creatorcontrib>Reynes, Jacques</creatorcontrib><creatorcontrib>Mandelbrot, Laurent</creatorcontrib><creatorcontrib>Warszawski, Josiane</creatorcontrib><creatorcontrib>Le Chenadec, Jérôme</creatorcontrib><creatorcontrib>ANRS EPF CO1/CO11 Study Group</creatorcontrib><creatorcontrib>ANRS EPF CO1/CO11 Study Group</creatorcontrib><collection>PubMed</collection><collection>CrossRef</collection><collection>MEDLINE - Academic</collection><collection>Hyper Article en Ligne (HAL)</collection><jtitle>Journal of antimicrobial chemotherapy</jtitle></facets><delivery><delcategory>Remote Search Resource</delcategory><fulltext>fulltext</fulltext></delivery><addata><au>Frange, Pierre</au><au>Tubiana, Roland</au><au>Sibiude, Jeanne</au><au>Canestri, Ana</au><au>Arvieux, Cédric</au><au>Brunet-Cartier, Cécile</au><au>Cotte, Laurent</au><au>Reynes, Jacques</au><au>Mandelbrot, Laurent</au><au>Warszawski, Josiane</au><au>Le Chenadec, Jérôme</au><aucorp>ANRS EPF CO1/CO11 Study Group</aucorp><aucorp>ANRS EPF CO1/CO11 Study Group</aucorp><format>journal</format><genre>article</genre><ristype>JOUR</ristype><atitle>Rilpivirine in HIV-1-positive women initiating pregnancy: to switch or not to switch?</atitle><jtitle>Journal of antimicrobial chemotherapy</jtitle><addtitle>J Antimicrob Chemother</addtitle><date>2020-05-01</date><risdate>2020</risdate><volume>75</volume><issue>5</issue><spage>1324</spage><epage>1331</epage><pages>1324-1331</pages><issn>0305-7453</issn><eissn>1460-2091</eissn><abstract>Abstract
Background
Safety data about rilpivirine use during pregnancy remain scarce, and rilpivirine plasma concentrations are reduced during second/third trimesters, with a potential risk of viral breakthroughs. Thus, French guidelines recommend switching to rilpivirine-free combinations (RFCs) during pregnancy.
Objectives
To describe the characteristics of women initiating pregnancy while on rilpivirine and to compare the outcomes for virologically suppressed subjects continuing rilpivirine until delivery versus switching to an RFC.
Methods
In the ANRS-EPF French Perinatal cohort, we included women on rilpivirine at conception in 2010–18. Pregnancy outcomes were compared between patients continuing versus interrupting rilpivirine. In women with documented viral suppression (<50 copies/mL) before 14 weeks of gestation (WG) while on rilpivirine, we compared the probability of viral rebound (≥50 copies/mL) during pregnancy between subjects continuing rilpivirine versus those switching to RFC.
Results
Among 247 women included, 88.7% had viral suppression at the beginning of pregnancy. Overall, 184 women (74.5%) switched to an RFC (mostly PI/ritonavir-based regimens) at a median gestational age of 8.0 WG. Plasma HIV-1 RNA nearest delivery was <50 copies/mL in 95.6% of women. Among 69 women with documented viral suppression before 14 WG, the risk of viral rebound was higher when switching to RFCs than when continuing rilpivirine (20.0% versus 0.0%, P = 0.046). Delivery outcomes were similar between groups (overall birth defects, 3.8/100 live births; pregnancy losses, 2.0%; preterm deliveries, 10.6%). No HIV transmission occurred.
Conclusions
In virologically suppressed women initiating pregnancy, continuing rilpivirine was associated with better virological outcome than changing regimen. We did not observe a higher risk of adverse pregnancy outcomes.</abstract><cop>England</cop><pub>Oxford University Press</pub><pmid>32157283</pmid><doi>10.1093/jac/dkaa017</doi><tpages>8</tpages><orcidid>https://orcid.org/0000-0002-4920-8369</orcidid><orcidid>https://orcid.org/0000-0003-2332-2507</orcidid><orcidid>https://orcid.org/0000-0003-0685-0578</orcidid><orcidid>https://orcid.org/0000-0002-6150-2376</orcidid><orcidid>https://orcid.org/0000-0002-8218-8814</orcidid><orcidid>https://orcid.org/0000-0002-0242-4566</orcidid><orcidid>https://orcid.org/0000-0003-3242-7247</orcidid><orcidid>https://orcid.org/0000-0003-1780-8746</orcidid><orcidid>https://orcid.org/0000-0002-7022-2990</orcidid><orcidid>https://orcid.org/0000-0002-6817-8951</orcidid><orcidid>https://orcid.org/0000-0001-7057-768X</orcidid><orcidid>https://orcid.org/0000-0002-5883-7597</orcidid></addata></record> |
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source | Oxford University Press Journals All Titles (1996-Current); EZB-FREE-00999 freely available EZB journals; Alma/SFX Local Collection; Free Full-Text Journals in Chemistry |
subjects | Human health and pathology Life Sciences |
title | Rilpivirine in HIV-1-positive women initiating pregnancy: to switch or not to switch? |
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