{"id":8953,"date":"2004-09-06T10:17:31","date_gmt":"2004-09-06T10:17:31","guid":{"rendered":"http:\/\/i-base.info\/htb\/?p=8953"},"modified":"2014-05-22T16:45:26","modified_gmt":"2014-05-22T16:45:26","slug":"abbott-applies-for-once-daily-license-for-lopinavirr","status":"publish","type":"post","link":"https:\/\/i-base.info\/htb\/8953","title":{"rendered":"Abbott applies for once-daily license for lopinavir\/r"},"content":{"rendered":"<p><strong>Abbott Laboratories has submitted a supplemental New Drug Application to both the US Food and Drug Administration (FDA) and a Marketing Authorisation variation to the European Medicines Agency (EMA), seeking approval of once-daily dosing for its protease inhibitor (PI) Kaletra (lopinavir\/ritonavir).<\/strong><\/p>\n<p>The submission package includes data from a clinical study in which once-daily Kaletra had comparable efficacy to twice-daily Kaletra, both dosed in a regimen containing tenofovir and emtricitabine, in treatment-na\u00efve patients.<\/p>\n<p>Among patients who participated in the study submitted, Kaletra was generally well tolerated. In the 48-week study comparing a Kaletra once-daily vs. twice-daily based antiretroviral regimen, the most frequent drug-related adverse events of moderate or greater intensity reported were diarrhoea and nausea.<\/p>\n<p>Diarrhoea was reported more frequently in patients on once-daily therapy (16%) versus patients on twice-daily therapy (5%).<\/p>\n<p>Source: Abbott press release<\/p>\n","protected":false},"excerpt":{"rendered":"<p>Abbott Laboratories has submitted a supplemental New Drug Application to both the US Food and Drug Administration (FDA) and a Marketing Authorisation variation to the European Medicines Agency (EMA), seeking approval of once-daily dosing for its protease inhibitor (PI) Kaletra &hellip;<\/p>\n","protected":false},"author":4,"featured_media":0,"comment_status":"open","ping_status":"closed","sticky":false,"template":"","format":"standard","meta":{"footnotes":""},"categories":[3],"tags":[],"class_list":["post-8953","post","type-post","status-publish","format-standard","hentry","category-antiretrovirals"],"_links":{"self":[{"href":"https:\/\/i-base.info\/htb\/wp-json\/wp\/v2\/posts\/8953","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\/4"}],"replies":[{"embeddable":true,"href":"https:\/\/i-base.info\/htb\/wp-json\/wp\/v2\/comments?post=8953"}],"version-history":[{"count":0,"href":"https:\/\/i-base.info\/htb\/wp-json\/wp\/v2\/posts\/8953\/revisions"}],"wp:attachment":[{"href":"https:\/\/i-base.info\/htb\/wp-json\/wp\/v2\/media?parent=8953"}],"wp:term":[{"taxonomy":"category","embeddable":true,"href":"https:\/\/i-base.info\/htb\/wp-json\/wp\/v2\/categories?post=8953"},{"taxonomy":"post_tag","embeddable":true,"href":"https:\/\/i-base.info\/htb\/wp-json\/wp\/v2\/tags?post=8953"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}