{"id":14819,"date":"2011-04-01T15:25:11","date_gmt":"2011-04-01T15:25:11","guid":{"rendered":"http:\/\/i-base.info\/htb\/?p=14819"},"modified":"2011-04-01T15:25:11","modified_gmt":"2011-04-01T15:25:11","slug":"lopinavirr-monotherapy-for-pmtct","status":"publish","type":"post","link":"https:\/\/i-base.info\/htb\/14819","title":{"rendered":"Lopinavir\/r monotherapy for PMTCT"},"content":{"rendered":"<p><strong>Polly Clayden, HIV i-Base<\/strong><\/p>\n<p>In an oral late breaker, Roland Tubiana presented findings from a French multisite PMTCT study &#8211; PRIMEVA (NCT00424814) \u0096 designed to evaluate the use of lopinavir\/r (LPV\/r) monotherapy in pregnancy for women not needing treatment for their own health.<\/p>\n<p>This was an open label, phase II\/III trial. Untreated women with CD4 &gt;350 cells\/mm3 and viral load &lt;30,000 copies\/mL were randomised 2:1 to receive either LPV\/r monotherapy (n=69) or LPV\/r + AZT + 3TC (n=36), from 26 weeks gestation until delivery.<\/p>\n<p>The primary endpoint of the trial was &gt;75% women with viral load &lt;200 copies\/mL at week 8 of treatment. Secondary endpoints included viral load at delivery and comparative analysis of safety outcomes during pregnancy and until 24 months in children.<\/p>\n<p>The baseline characteristics were similar between arms; women had a median CD4 count of 525 cells\/mm3 and viral load of 2952 copies\/mL.<\/p>\n<p>Intent-to-treat analysis of the monotherapy arm revealed a viral load &lt;200 copies\/mL at week 8 in 61\/69 women (88.4%, 95% CI 78.4-94.9). This was similar to that observed in the control arm (94.4%, 95% CI 81.3-99.3) p=0.18.<\/p>\n<p>The proportions of women with viral load &lt;200 copies\/mL at delivery was similar between the LPV\/r and control arms, 91.3% (95% CI, 82.0-96.7) vs 97.2% (95% CI, 85.5-99.9), p=0.41. But when the investigators looked at viral load &lt;50 copies\/mL at the same time point, a greater proportion of women in the control arm achieved this, 79.7% (95% CI 63.3-88.4) vs 97.2% 985.5-99.9) in the LPV\/r and control arms respectively, p=0.01.<\/p>\n<p>Similar proportions of cesarean section delivery (49.5%) and pre-term delivery (10.5%) were observed in both arms. Changes of ART due to tolerability were significantly less frequent the monotherapy arm compared to control, respectively 1.4% vs 11.1%, p=0.046.<\/p>\n<p>There was one case of transmission in the control and none in the monotherapy arm.<\/p>\n<p>Evaluation of the infants is ongoing.<\/p>\n<p>Reference:<\/p>\n<p>Tubiana R et al. LPV\/r monotherapy during pregnancy for PMTCT of HIV-1: The PRIMEVA\/ANRS 135 randomised Trial, pregnancy outcomes. 18th CROI. Boston. February 2011. Oral abstract 125LB.<br \/>\n<a href=\"http:\/\/www.retroconference.org\/2011\/Abstracts\/42568.htm\">http:\/\/www.retroconference.org\/2011\/Abstracts\/42568.htm<\/a><\/p>\n","protected":false},"excerpt":{"rendered":"<p>Polly Clayden, HIV i-Base In an oral late breaker, Roland Tubiana presented findings from a French multisite PMTCT study &#8211; PRIMEVA (NCT00424814) \u0096 designed to evaluate the use of lopinavir\/r (LPV\/r) monotherapy in pregnancy for women not needing treatment for &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],"tags":[65],"class_list":["post-14819","post","type-post","status-publish","format-standard","hentry","category-conference-reports","category-antiretrovirals","category-pmtct-and-maternal-health","tag-croi-2011"],"_links":{"self":[{"href":"https:\/\/i-base.info\/htb\/wp-json\/wp\/v2\/posts\/14819","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=14819"}],"version-history":[{"count":0,"href":"https:\/\/i-base.info\/htb\/wp-json\/wp\/v2\/posts\/14819\/revisions"}],"wp:attachment":[{"href":"https:\/\/i-base.info\/htb\/wp-json\/wp\/v2\/media?parent=14819"}],"wp:term":[{"taxonomy":"category","embeddable":true,"href":"https:\/\/i-base.info\/htb\/wp-json\/wp\/v2\/categories?post=14819"},{"taxonomy":"post_tag","embeddable":true,"href":"https:\/\/i-base.info\/htb\/wp-json\/wp\/v2\/tags?post=14819"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}