{"id":30459,"date":"2016-08-01T09:06:51","date_gmt":"2016-08-01T09:06:51","guid":{"rendered":"http:\/\/i-base.info\/htb\/?p=30459"},"modified":"2016-08-14T20:10:21","modified_gmt":"2016-08-14T20:10:21","slug":"pharmacokinetics-of-antiretrovirals-comparable-to-that-in-non-pregnant-women-from-three-weeks-after-delivery","status":"publish","type":"post","link":"https:\/\/i-base.info\/htb\/30459","title":{"rendered":"Pharmacokinetics of antiretrovirals comparable to that in non-pregnant women from three weeks after delivery"},"content":{"rendered":"

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

When looking at pregnancy induced pharmacokinetic changes, timing of the postpartum control curve from three weeks after delivery was comparable to non-pregnant women, according to investigators form the PANNA study.<\/strong><\/p>\n

Pregnancy may induce changes in the pharmacokinetics (PK) of antiretrovirals, which could lead to sub-therapeutic levels. PANNA is a European clinical pharmacology network that investigates the PK of new antiretrovirals in HIV positive pregnant women.<\/p>\n

The PANNA protocol includes taking PK curves in the third trimester of pregnancy (at approximately 33- weeks gestational age) and postpartum (at least two weeks after delivery). The postpartum curve is used as the intrapatient control curve for the non-pregnant woman.<\/p>\n

The PANNA investigators found that sometimes, the postpartum curves are performed before the preferred period with a minimum of two weeks. They also noted that the choice of 2-6 weeks postpartum – although widely used in PK studies – has not been validated. So they assessed this timing and the effect of pregnancy on the PK of several antiretroviral agents in a study presented by Angela Colbers from PANNA at 17th International Workshop on Clinical Pharmacology of HIV & Hepatitis Therapy.<\/p>\n

Women with paired PK for the antiretrovirals for which lower exposure in pregnancy was observed were included in the analysis: emtricitabine, tenofovir DF, atazanavir\/ritonavir, darunavir\/ritonavir, raltegravir and maraviroc.<\/p>\n

The investigators calculated relative ratios for AUC and Cmax for each participant and antiretroviral agent. They divided the ratio of the AUC in the third trimester\/postpartum for each participant and antiretroviral agent by the geometric mean ratio of the third trimester\/ postpartum in the study population for that antiretroviral agent.<\/p>\n

There were 157 paired PK parameters, from 62 participants, generated in the PANNA study, included in the analysis. Median age at delivery was 32 years (range 19-45); 60% were black, 39% white and 1% of other ethnicity. Weight at postpartum PK sampling was 71 kg (range 43-126), and weight at third trimester PK sampling was 76 kg (range 48-139).<\/p>\n

The investigators reported they observed no statistically significant difference for AUC (p=0.337) or Cmax (p=0.227) relative to reference from week 3 postpartum onward (>week 8 pooled).<\/p>\n

They concluded that no time effect was observed for postpartum curves taken at least 3-weeks post- delivery, and these curves were comparable to non-pregnant population means. They added that dose reductions (after dose increase in pregnancy) should be considered from two weeks post-delivery onwards.<\/p>\n

Reference:<\/p>\n

Colbers A et al. Timing of the postpartum curve in pharmacokinetic studies in pregnancy should not be too early. 17th International Workshop on Clinical Pharmacology of HIV & Hepatitis Therapy. 8-10 June 2016, Washington DC, USA. Oral abstract O_3.
\nhttp:\/\/regist2.virology-education.com\/2016\/17HIVHEPPK\/04_Colbers.pdf<\/a>\u00a0(slides)<\/p>\n\n","protected":false},"excerpt":{"rendered":"

Polly Clayden, HIV i-Base When looking at pregnancy induced pharmacokinetic changes, timing of the postpartum control curve from three weeks after delivery was comparable to non-pregnant women, according to investigators form the PANNA study. Pregnancy may induce changes in the …<\/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":[228],"class_list":["post-30459","post","type-post","status-publish","format-standard","hentry","category-conference-reports","category-antiretrovirals","category-pmtct-and-maternal-health","tag-pk-workshop-2016"],"_links":{"self":[{"href":"https:\/\/i-base.info\/htb\/wp-json\/wp\/v2\/posts\/30459","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=30459"}],"version-history":[{"count":0,"href":"https:\/\/i-base.info\/htb\/wp-json\/wp\/v2\/posts\/30459\/revisions"}],"wp:attachment":[{"href":"https:\/\/i-base.info\/htb\/wp-json\/wp\/v2\/media?parent=30459"}],"wp:term":[{"taxonomy":"category","embeddable":true,"href":"https:\/\/i-base.info\/htb\/wp-json\/wp\/v2\/categories?post=30459"},{"taxonomy":"post_tag","embeddable":true,"href":"https:\/\/i-base.info\/htb\/wp-json\/wp\/v2\/tags?post=30459"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}