{"id":1881,"date":"2018-12-31T00:00:03","date_gmt":"2018-12-30T17:00:03","guid":{"rendered":"https:\/\/www.hivnat.org\/en\/?p=1881"},"modified":"2018-12-31T00:00:03","modified_gmt":"2018-12-30T17:00:03","slug":"hiv-nat223-rtv-gpo-tablet-study","status":"publish","type":"post","link":"https:\/\/www.hivnat.org\/en\/studies\/1881\/","title":{"rendered":"RTV GPO tablet study"},"content":{"rendered":"\n\t\t\t\t\n<p class=\"wp-block-paragraph\"><strong>Project no.:<\/strong> HIV-NAT 223<\/p>\n\n\n\n<p class=\"wp-block-paragraph\">This is pharmacokinetics, boosting\nefficacy and safety of GP-ritonavir tablets in HIV patients currently stable on\nboosted-protease inhibitor regimen<\/p>\n\n\n\n<p class=\"wp-block-paragraph\"><strong>Brief Summary:<\/strong> Ritonavir (RTV) tablet was not available in Thailand until it was manufactured by Government Pharmaceutical Organization of Thailand. We assessed pharmacokinetics (PK), safety and efficacy of generic RTV-boosted atazanavir (ATV) in virologically suppressed HIV-1 infected Thai adults.<\/p>\n\n\n\n<p class=\"wp-block-paragraph\">Virologically\nsuppressed HIV-1 infected Thai adults who currently use ATV (either 200 or 300\nmg) with Norvir\u00ae soft gel capsule (SGC) 100 mg-based regimen were enrolled into\nthis prospective, 48-week single-arm study. Participants switched from Norvir\u00ae\nSGC to generic RTV. Plasma trough concentration (C<sub>trough<\/sub>) was\nassessed at baseline before switching to generic RTV and week 24 in all\nparticipants, with the target ATV C<sub>trough<\/sub>&nbsp;of 0.15 mg\/l. Plasma\nHIV-1 RNA and other laboratory safety parameters were assessed until week 48.<\/p>\n\n\n\n<p class=\"wp-block-paragraph\">Of 100 participants (51% males), enrolled, 50% was using ATV 200 mg and 50% was using 300 mg at the time RTV SGC were changed into generic tablets. All participants used 2 nucleoside reverse transcriptase (NRTIs) as backbone. There were no significant changes in mean (SD) C<sub>trough<\/sub> of RTV (0.20 [0.33] vs 0.23 [0.39], p = 0.21) and ATV (0.83 [0.93] vs 0.88 [0.95], p = 0.62) between baseline and week 24. From entry to week 48, median ALT significantly increased from 25 to 30 IU\/l (p = 0.001) and total bilirubin significantly decreased from 1.7 to 1.3, p = 0.04. One study drug-related grade 3 adverse event was reported. All but one participant maintained plasma HIV-1 RNA &lt; 50 copies\/ml after 48 weeks.<\/p>\n\n\n\n<p class=\"wp-block-paragraph\">(Source:\nHiransuthikul A<sup>, <\/sup>et al., Antivir Ther.&nbsp;2018 Sep 28. doi: 10.3851\/IMP3267)<\/p>\n\t\t","protected":false},"excerpt":{"rendered":"<p>\t\t\t\tThis is pharmacokinetics, boosting efficacy and safety of GP-ritonavir tablets in HIV patients currently stable on boosted-protease inhibitor regimen\t\t<\/p>\n","protected":false},"author":1,"featured_media":0,"comment_status":"closed","ping_status":"closed","sticky":false,"template":"","format":"standard","meta":{"footnotes":""},"categories":[24],"tags":[],"class_list":["post-1881","post","type-post","status-publish","format-standard","hentry","category-studies"],"_links":{"self":[{"href":"https:\/\/www.hivnat.org\/en\/wp-json\/wp\/v2\/posts\/1881","targetHints":{"allow":["GET"]}}],"collection":[{"href":"https:\/\/www.hivnat.org\/en\/wp-json\/wp\/v2\/posts"}],"about":[{"href":"https:\/\/www.hivnat.org\/en\/wp-json\/wp\/v2\/types\/post"}],"author":[{"embeddable":true,"href":"https:\/\/www.hivnat.org\/en\/wp-json\/wp\/v2\/users\/1"}],"replies":[{"embeddable":true,"href":"https:\/\/www.hivnat.org\/en\/wp-json\/wp\/v2\/comments?post=1881"}],"version-history":[{"count":0,"href":"https:\/\/www.hivnat.org\/en\/wp-json\/wp\/v2\/posts\/1881\/revisions"}],"wp:attachment":[{"href":"https:\/\/www.hivnat.org\/en\/wp-json\/wp\/v2\/media?parent=1881"}],"wp:term":[{"taxonomy":"category","embeddable":true,"href":"https:\/\/www.hivnat.org\/en\/wp-json\/wp\/v2\/categories?post=1881"},{"taxonomy":"post_tag","embeddable":true,"href":"https:\/\/www.hivnat.org\/en\/wp-json\/wp\/v2\/tags?post=1881"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}