{"id":24606,"date":"2014-02-01T10:17:00","date_gmt":"2014-02-01T10:17:00","guid":{"rendered":"http:\/\/i-base.info\/htb\/?p=24606"},"modified":"2014-02-03T12:00:09","modified_gmt":"2014-02-03T12:00:09","slug":"outcomes-in-infants-exposed-to-lopinavirritonavir-in-utero","status":"publish","type":"post","link":"https:\/\/i-base.info\/htb\/24606","title":{"rendered":"Outcomes in infants exposed to lopinavir\/ritonavir in utero"},"content":{"rendered":"<p><img loading=\"lazy\" decoding=\"async\" class=\"alignright\" alt=\"4th HIV and women workshop logo2\" src=\"https:\/\/i-base.info\/htb\/wp-content\/uploads\/2014\/02\/4th-womens-logo2.png\" width=\"186\" height=\"214\" \/><\/p>\n<p><strong>Polly Clayden, HIV i-Base<\/strong><\/p>\n<p><strong>A systematic review of outcomes of infants born to women receiving lopinavir\/ritonavir (LPV\/r) in pregnancy &#8211; performed by investigators from the originator company &#8211; suggests that in utero exposure may not increase the risk of preterm birth.<\/strong><\/p>\n<p>M Martinez presented data from an assessment of the vertical transmission rate and risk of adverse infant outcomes among women treated with LPV\/r based regimens in pregnancy at the 4th HIV &amp; Women Workshop, 2014.<\/p>\n<p>The investigators searched PubMed\/EMBASE databases and HIV conferences for studies published to the end of January 2013 or March 2013 respectively. They looked for randomised trials or prospective\/retrospective cohort studies of outcomes of infants exposed to LPV\/r in utero as a primary or secondary endpoint.<\/p>\n<p>The investigators also searched the AbbVie Global Safety Database for the infant outcome of prematurity to the end of December 2011.<\/p>\n<p>They included 27 publications (n=12) and abstract presentations (n=15) describing 17 studies in the review. These studies reported on 4331 women receiving LPV\/r in pregnancy, of these 2263 received LPV\/r 800\/200 mg\/day, 101 received &gt;800\/200 mg\/day, and for 1967 the dose was undocumented. Table 1 shows the results.<\/p>\n<table border=\"0\">\n<caption>Table 1: Infant outcomes from a systematic review of LPV\/r in pregnancy<\/caption>\n<tbody>\n<tr>\n<th scope=\"col\">Outcome<\/th>\n<th scope=\"col\">Studies reporting outcome (n)<\/th>\n<th scope=\"col\">Rate reported (%)<\/th>\n<\/tr>\n<tr>\n<td>Vertical transmission<\/td>\n<td>10<\/td>\n<td>0 &#8211; 2.8<\/td>\n<\/tr>\n<tr>\n<td>Preterm birth<\/td>\n<td>13<\/td>\n<td>8.7 &#8211; 25.0<\/td>\n<\/tr>\n<tr>\n<td>Very preterm birth<\/td>\n<td>6<\/td>\n<td>0.4 &#8211; 5.0<\/td>\n<\/tr>\n<tr>\n<td>Low birth weight<\/td>\n<td>6<\/td>\n<td>0.4 &#8211; 5.0<\/td>\n<\/tr>\n<tr>\n<td>Very low birth weight<\/td>\n<td>4<\/td>\n<td>0.3 &#8211; 3.0<\/td>\n<\/tr>\n<tr>\n<td>Still birth<\/td>\n<td>5<\/td>\n<td>1.0 &#8211; 4.8<\/td>\n<\/tr>\n<tr>\n<td>Infant mortality<\/td>\n<td>4<\/td>\n<td>0 &#8211; 5.8<\/td>\n<\/tr>\n<\/tbody>\n<\/table>\n<p>Post-marketing safety data from the company database showed a preterm rate of 0.66\/10,000 patient treatment years for LPV\/r.<\/p>\n<p>One study showed similar preterm, low birth weight and vertical transmission rates for women receiving 800\/200 mg and &gt;800\/200 mg LPV\/r.<\/p>\n<p>Three studies reporting birth defects showed a prevalence of 2% to 8.5%, which compared to the Antiretroviral Pregnancy Registry (APR) rate of 2.4%.<\/p>\n<p>In one study the incidence of mortality among preterm infants was similar with LPV\/r based treatment to that for women treated with triple NRTIs.<\/p>\n<p>The authors concluded: &#8220;Preterm birth rates in the included studies reflected the rate for the geographical area in which the study was conducted; these data and post-marketing safety data suggest that in utero exposure to LPV\/r may not increase risk of preterm birth. Infants born to women who received LPV\/r 800\/200 mg\/day and those born to women who received &gt;800\/200 mg\/day had similar rates of preterm birth, low birth weight, and MTCT.&#8221;<\/p>\n<h3>Comment<\/h3>\n<p><strong>Although analyses (particularly conclusions) performed by the originator company need to be approached with a little caution, these can be useful and results from this one supports the current APR data for LPV\/r.<\/strong><\/p>\n<p>Reference:<\/p>\n<p>Martinez M et al. Systematic review of clinical outcomes of infants born to women receiving lopinavir\/ritonavir-based antiretroviral therapy (ART) during pregnancy. 4th International Workshop on HIV &amp; Women, Washington DC. 13-14 January 2014. Oral Abstract_21.<br \/>\n<a href=\"http:\/\/regist2.virology-education.com\/2014\/4hivwomen\/docs\/31_Martinez.pdf\">http:\/\/regist2.virology-education.com\/2014\/4hivwomen\/docs\/31_Martinez.pdf<\/a><\/p>\n","protected":false},"excerpt":{"rendered":"<p>Polly Clayden, HIV i-Base A systematic review of outcomes of infants born to women receiving lopinavir\/ritonavir (LPV\/r) in pregnancy &#8211; performed by investigators from the originator company &#8211; suggests that in utero exposure may not increase the risk of preterm &hellip;<\/p>\n","protected":false},"author":2,"featured_media":0,"comment_status":"open","ping_status":"closed","sticky":false,"template":"","format":"standard","meta":{"footnotes":""},"categories":[4,3,35,32],"tags":[185],"class_list":["post-24606","post","type-post","status-publish","format-standard","hentry","category-conference-reports","category-antiretrovirals","category-pmtct-and-maternal-health","category-paediatric-care","tag-intl-workshop-on-hiv-and-women-4th-2014"],"_links":{"self":[{"href":"https:\/\/i-base.info\/htb\/wp-json\/wp\/v2\/posts\/24606","targetHints":{"allow":["GET"]}}],"collection":[{"href":"https:\/\/i-base.info\/htb\/wp-json\/wp\/v2\/posts"}],"about":[{"href":"https:\/\/i-base.info\/htb\/wp-json\/wp\/v2\/types\/post"}],"author":[{"embeddable":true,"href":"https:\/\/i-base.info\/htb\/wp-json\/wp\/v2\/users\/2"}],"replies":[{"embeddable":true,"href":"https:\/\/i-base.info\/htb\/wp-json\/wp\/v2\/comments?post=24606"}],"version-history":[{"count":0,"href":"https:\/\/i-base.info\/htb\/wp-json\/wp\/v2\/posts\/24606\/revisions"}],"wp:attachment":[{"href":"https:\/\/i-base.info\/htb\/wp-json\/wp\/v2\/media?parent=24606"}],"wp:term":[{"taxonomy":"category","embeddable":true,"href":"https:\/\/i-base.info\/htb\/wp-json\/wp\/v2\/categories?post=24606"},{"taxonomy":"post_tag","embeddable":true,"href":"https:\/\/i-base.info\/htb\/wp-json\/wp\/v2\/tags?post=24606"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}