{"id":36121,"date":"2019-05-20T08:48:40","date_gmt":"2019-05-20T08:48:40","guid":{"rendered":"http:\/\/i-base.info\/htb\/?p=36121"},"modified":"2019-05-28T10:48:54","modified_gmt":"2019-05-28T10:48:54","slug":"no-increased-adverse-outcomes-among-women-starting-dolutegravir-before-conception-in-the-advance-study","status":"publish","type":"post","link":"https:\/\/i-base.info\/htb\/36121","title":{"rendered":"No increased adverse outcomes among women starting dolutegravir before conception in the ADVANCE study"},"content":{"rendered":"

Polly Clayden, HIV i-Base<\/span><\/strong><\/p>\n

Women who started dolutegravir (DTG)-based ART before conception did not have higher rates of adverse pregnancy outcomes compared with those starting efavirenz (EFV) in a South African study comparing three first-line regimens \u2013 according to data presented at 13th INTEREST workshop.<\/span><\/b><\/p>\n

The ongoing, 96-week, phase 3, randomised ADVANCE study (n=1053) is evaluating the safety and efficacy of DTG + tenofovir alafenamide (TAF) + emtricitabine (FTC) vs DTG + tenofovir disoproxil fumarate (TDF) + FTC vs EFV + TDF + FTC.<\/p>\n

The pregnancy sub study included all women who completed week 48, receiving ART before conception, had gestational age assessment (early ultrasound) and congenital foetal anomaly screening.<\/p>\n

Women in the DTG arms were switched to alternative \u2028regimens if pregnancy was less than 8 weeks\u2019 gestation.<\/p>\n

Adverse outcomes included: spontaneous abortion, elective termination, preterm delivery, small for gestational age, still birth and neonatal death. The sub study also evaluated neonate HIV status and birth defects.<\/p>\n

There were 78 pregnancies among 625 women participating in ADVANCE (12.5%). Of these 15 (19.2%) were spontaneous abortion, 19 (24.4%) elective abortion, 1 (1.3%) stillbirth, 1 (1.3%) neonatal death, 34 (43.6%) live births and 8 (10.3%) pregnancies were ongoing at the time of analysis.<\/span><\/p>\n

Approximately two thirds of pregnancies were among women in the DTG arms: 29 DTG + TAF + FTC and 21 in DTG + TDF + FTC.<\/span><\/p>\n

Median birth weight was similar across treatment arms: 3.1 kg (IQR 2.9 to 3.3). A slightly higher proportion of infants exposed to EFV + TDF + FTC\u00a0were small for gestational age: 22.2% vs 12.5% with DTG + TAF + FTC and\u00a0\u202816.7% with DTG + TDF + FTC arms, p=0.768. All <\/span>subgroup comparisons for all adverse pregnancy outcomes were p\u2028>0.10.<\/p>\n

There were no vertical transmissions in this sub study. Two infants in the DTG arms had minor birth defects: naevus flammeus and \u2028umbilical hernia.<\/p>\n

comment<\/span><\/h3>\n

Presenting author Dr Chandiwana reminded us of the importance of pooling data across similar trials and of prospective birth surveillance studies in African countries.<\/span><\/strong><\/p>\n

She noted that these data will also be submitted to the Antiretroviral Pregnancy Registry.<\/span><\/strong><\/p>\n

More data from the Botswana Tsepamo study is expected at IAS 2019. <\/span><\/strong><\/p>\n

Polly Clayden is<\/i><\/b>on the scientific advisory committee of the<\/i><\/b>ADVANCE study.<\/i>\u00a0\u00a0<\/b><\/p>\n

Reference<\/span><\/p>\n

ChandiwanaN et al. <\/span>Pregnancy and infant outcomes among HIV positive women on dolutegravir versus efavirenz-based antiretroviral therapy: week 48 analysis of the ADVANCE trial. 13th INTEREST. Accra, Ghana. 14\u201317 May 2019. Mini oral abstract 15.<\/p>\n

\n<\/p>","protected":false},"excerpt":{"rendered":"

Polly Clayden, HIV i-Base Women who started dolutegravir (DTG)-based ART before conception did not have higher rates of adverse pregnancy outcomes compared with those starting efavirenz (EFV) in a South African study comparing three first-line regimens \u2013 according to data …<\/p>\n","protected":false},"author":3,"featured_media":0,"comment_status":"open","ping_status":"closed","sticky":false,"template":"","format":"standard","meta":{"footnotes":""},"categories":[4,35],"tags":[],"class_list":["post-36121","post","type-post","status-publish","format-standard","hentry","category-conference-reports","category-pmtct-and-maternal-health"],"_links":{"self":[{"href":"https:\/\/i-base.info\/htb\/wp-json\/wp\/v2\/posts\/36121","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\/3"}],"replies":[{"embeddable":true,"href":"https:\/\/i-base.info\/htb\/wp-json\/wp\/v2\/comments?post=36121"}],"version-history":[{"count":0,"href":"https:\/\/i-base.info\/htb\/wp-json\/wp\/v2\/posts\/36121\/revisions"}],"wp:attachment":[{"href":"https:\/\/i-base.info\/htb\/wp-json\/wp\/v2\/media?parent=36121"}],"wp:term":[{"taxonomy":"category","embeddable":true,"href":"https:\/\/i-base.info\/htb\/wp-json\/wp\/v2\/categories?post=36121"},{"taxonomy":"post_tag","embeddable":true,"href":"https:\/\/i-base.info\/htb\/wp-json\/wp\/v2\/tags?post=36121"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}