{"id":1865,"date":"2018-12-31T00:00:11","date_gmt":"2018-12-30T17:00:11","guid":{"rendered":"https:\/\/www.hivnat.org\/en\/?p=1865"},"modified":"2018-12-31T00:00:11","modified_gmt":"2018-12-30T17:00:11","slug":"pharmacokinetics-efficacy-and-safety-of-rilpivirin-in-virologic-suppressed-hiv-infected-thai-adolescents","status":"publish","type":"post","link":"https:\/\/www.hivnat.org\/en\/studies\/1865\/","title":{"rendered":"Pharmacokinetics, efficacy, and safety of Rilpivirin in virologic suppressed HIV-infected Thai adolescents"},"content":{"rendered":"\n\t\t\t\t\n<p class=\"wp-block-paragraph\"><strong>Project no.: <\/strong>HIV-NAT 220<\/p>\n\n\n\n<p class=\"wp-block-paragraph\">This is an\nopen-label, single arm study that will describe\nthe immunologic and virologic outcomes (HIV RNA, CD4) following switching from\nEFV to RPV in virologically suppressed adolescents.<\/p>\n\n\n\n<p class=\"wp-block-paragraph\"><strong>Brief Summary: <\/strong>Rilpivirine (RPV), a non-nucleoside reverse transcriptase inhibitor drug, could be a favourable drug for maintenance therapy in HIV-infected adolescents because it has few long-term side effects. However, data among adolescents switching from efavirenz (EFV) to RPV are limited. This study investigated the pharmacokinetics (PK), safety and efficacy of RPV in virologically suppressed HIV-1-infected adolescents after switching from EFV.<\/p>\n\n\n\n<p class=\"wp-block-paragraph\">Adolescents\naged 12-18 years on EFV-based antiretroviral therapy (ART) were switched from\nEFV to RPV (25 mg, once daily). Intensive 24-h blood samplings at 0 (pre-dose),\n1, 2, 4, 5, 6, 9, 12 and 24 h were performed 4 weeks after switching. PK\nparameters were calculated using a non-compartmental method and compared with\npublished data from the PAINT and pooled ECHO\/THRIVE substudies. HIV RNA level\nwas measured at weeks 12 and 24. Biochemical profiles were measured at baseline\nand week 24.<\/p>\n\n\n\n<p class=\"wp-block-paragraph\">From January to June 2016, 20 adolescents (12 male) were enrolled. Median (IQR) age was 16 (15-17) years and weight was 49 (42-59) kg. Mean (sd) AUC<sub>24 h<\/sub>, C<sub>24 h<\/sub>\u00a0and C<sub>max<\/sub>\u00a0of RPV were 2,041 (745) ng\u2022h\/ml, 69 (29) ng\/ml and 143 (65) ng\/ml, respectively. Median (IQR) T<sub>max<\/sub>\u00a0was 5 (2-9) h. Four adolescents had C<sub>24 h<\/sub> &lt; 40 ng\/ml. All PK parameters were comparable with published data. All adolescents remained virologically suppressed at week 24. Significant decreases in fasting total cholesterol, triglyceride and low-density lipoprotein were observed (P-value &lt; 0.05).<\/p>\n\n\n\n<p class=\"wp-block-paragraph\">Virologically\nsuppressed HIV-infected adolescents had adequate RPV exposure and remained\nvirologically suppressed after switching from EFV. RPV can be used as long-term\nmaintenance ART in HIV-infected adolescents.<\/p>\n\n\n\n<p class=\"wp-block-paragraph\">(Source:\nJantarabenjakul W, et al., Antivir\nTher. 2018;23(3):259-265)<\/p>\n\t\t","protected":false},"excerpt":{"rendered":"<p>\t\t\t\tThis is an open-label, single arm study that will describe the immunologic and virologic outcomes (HIV RNA, CD4) following switching from EFV to RPV in virologically suppressed adolescents.\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-1865","post","type-post","status-publish","format-standard","hentry","category-studies"],"_links":{"self":[{"href":"https:\/\/www.hivnat.org\/en\/wp-json\/wp\/v2\/posts\/1865","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=1865"}],"version-history":[{"count":0,"href":"https:\/\/www.hivnat.org\/en\/wp-json\/wp\/v2\/posts\/1865\/revisions"}],"wp:attachment":[{"href":"https:\/\/www.hivnat.org\/en\/wp-json\/wp\/v2\/media?parent=1865"}],"wp:term":[{"taxonomy":"category","embeddable":true,"href":"https:\/\/www.hivnat.org\/en\/wp-json\/wp\/v2\/categories?post=1865"},{"taxonomy":"post_tag","embeddable":true,"href":"https:\/\/www.hivnat.org\/en\/wp-json\/wp\/v2\/tags?post=1865"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}