{"id":37141,"date":"2020-02-24T08:41:45","date_gmt":"2020-02-24T08:41:45","guid":{"rendered":"http:\/\/i-base.info\/htb\/?p=37141"},"modified":"2020-02-24T15:33:09","modified_gmt":"2020-02-24T15:33:09","slug":"antiretroviral-pregnancy-registry-dolutegravir-update","status":"publish","type":"post","link":"https:\/\/i-base.info\/htb\/37141","title":{"rendered":"Antiretroviral pregnancy registry: dolutegravir update"},"content":{"rendered":"

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

Antiretroviral pregnancy registry (APR) data do not demonstrate an increased risk of overall birth defects with dolutegravir (DTG) use above the expected population rate. [1, 2]<\/span><\/b><\/span><\/p>\n

And, although one neural tube defect (NTD) is reported in this data set, the denominator is too small to draw any conclusions about an association between periconception DTG and NTDs.<\/span><\/b><\/span><\/p>\n

These findings were presented at EACS 2019 and are also described in the most recent version of the APR interim report.<\/span><\/span><\/p>\n

By 31 July 2019, 667 pregnancies with exposure to DTG were prospectively reported to APR: 357 periconception (2 weeks before through 28 days after conception) exposures, 67 later during the first trimester, and 243 during the second\/third trimesters. <\/span><\/span><\/p>\n

Median maternal age at conception was 29 years; just over 60% of women were black and approximately 80% were from the United States. At enrollment over 80% had CD4 count greater than 200 cells\/mm3<\/sup>. <\/span><\/span><\/p>\n

Among the 667 DTG exposed pregnancies there were 614 live singleton births: 312 with periconception exposure, 63<\/span><\/span>later during the first trimester, and 239 during the second\/third trimesters.<\/span><\/p>\n

There were 21\/614 defects overall: prevalence 3.4% (95% CI 2.1 to 5.2). With periconception exposure there were 10\/312 defects: prevalence 3.2% (95% CI 1.6 to 5.8). Defect prevalence for later first trimester and second\/third trimester were both similar.<\/span><\/p>\n

These data do not show a risk of overall defects above the population expected rate of defects: <\/span>2.72 and 4.17\/100 live births from Metropolitan Atlanta Congenital Defects Program (<\/span>MACDP)and Texas Birth Defects Registry (TBDR) respectively.<\/span><\/p>\n

There was 1\/312 neural tube defect (NTD) case of anencephaly with periconception DTG exposure.<\/span><\/span><\/p>\n

The next interim APR report will include data through 31 January 2020.<\/span><\/span><\/p>\n

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

Although 1\/312 gives an NTD prevalence of 0.3%, similar to data from the Tsepamo study in Botswana, the number of periconception outcomes is not sufficient (2000 needed to rule out a 3-fold increase) to refute or confirm an association between DTG and NTD. <\/span><\/b><\/span><\/p>\n

References<\/span><\/span><\/p>\n

    \n
  1. Vannappagari V<\/span><\/span>et al. –<\/span>\u00a0<\/span>Dolutegravir (DTG) use during pregnancy and birth outcomes: data from the Antiretroviral Pregnancy Registry (APR). <\/span><\/span>17th European AIDS Conference (EACS). Basel, Switzerland. 6\u20139 November, 2019. Oral abstract <\/span><\/span>PS1\/2.
    \nhttp:\/\/europeanaidsconference.eacs.cyim.com\/mediatheque\/media.aspx?mediaId=78029&channel=28172<\/a> (webcast)<\/li>\n
  2. Antiretroviral Pregnancy Registry Steering Committee. Antiretroviral Pregnancy Registry Interim Report for 1 January 1989 through 31 July 2019.
    \n    http:\/\/www.apregistry.com\/forms\/interim_report.pdf<\/a> (PDF)<\/li>\n<\/ol>\n","protected":false},"excerpt":{"rendered":"

    Polly Clayden, HIV i-Base Antiretroviral pregnancy registry (APR) data do not demonstrate an increased risk of overall birth defects with dolutegravir (DTG) use above the expected population rate. [1, 2] And, although one neural tube defect (NTD) is reported in …<\/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":[276],"class_list":["post-37141","post","type-post","status-publish","format-standard","hentry","category-conference-reports","category-pmtct-and-maternal-health","tag-eacs-17-basel-2019"],"_links":{"self":[{"href":"https:\/\/i-base.info\/htb\/wp-json\/wp\/v2\/posts\/37141","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=37141"}],"version-history":[{"count":0,"href":"https:\/\/i-base.info\/htb\/wp-json\/wp\/v2\/posts\/37141\/revisions"}],"wp:attachment":[{"href":"https:\/\/i-base.info\/htb\/wp-json\/wp\/v2\/media?parent=37141"}],"wp:term":[{"taxonomy":"category","embeddable":true,"href":"https:\/\/i-base.info\/htb\/wp-json\/wp\/v2\/categories?post=37141"},{"taxonomy":"post_tag","embeddable":true,"href":"https:\/\/i-base.info\/htb\/wp-json\/wp\/v2\/tags?post=37141"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}