{"id":34677,"date":"2018-08-03T11:42:27","date_gmt":"2018-08-03T11:42:27","guid":{"rendered":"http:\/\/i-base.info\/htb\/?p=34677"},"modified":"2018-08-03T17:39:02","modified_gmt":"2018-08-03T17:39:02","slug":"once-daily-reduced-dose-darunavirritonavir-400-mg100-mg-is-non-inferior-to-twice-daily-lopinavirritonavir-in-south-african-switch-study","status":"publish","type":"post","link":"https:\/\/i-base.info\/htb\/34677","title":{"rendered":"Once-daily reduced dose darunavir\/ritonavir (400 mg\/100 mg) is non-inferior to twice-daily lopinavir\/ritonavir in South African switch study\u00a0\u00a0"},"content":{"rendered":"

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

\"\"Stable patients on a twice-daily lopinavir\/ritonavir (LPV\/r)-based second-line regimen who switched to a once-daily 400\/100 mg darunavir\/ritonavir (DRV\/r) one maintained similar virological suppression to those who remained on LPV\/r at 48 weeks. [1] These data from Johannesburg were presented at AIDS 2018.\u00a0\u00a0\u00a0 <\/strong><\/p>\n

The approved dose of DRV\/r is 800\/100 mg once daily for people with no PI resistance. [2] DRV\/r is rarely used in sub-Saharan Africa because of its high cost. DRV\/r is considered to be a good candidate for dose optimisation. [2]<\/p>\n

In this study, 300 participants, stable on 2 NRTI + LPV\/r with viral load < 50 copies\/mL, were randomised to 2 NRTI + DRV\/r 400\/100 mg once daily (n=148) or to continue on their LPV\/r-based regimen (n=152).<\/p>\n

The study defined treatment success as viral load <50 copies\/mL at week 48 (FDA snapshot). Treatment arms were compared using the new FDA non-inferiority margin for switch studies of -4%, using the Intent to Treat (ITT) population.<\/p>\n

At baseline participants were 68% female and 99.7% black, with median of age 42 years, and CD4 count >600 cells\/mm3.<\/p>\n

In the primary efficacy analysis, viral load < 50 copies\/mL by week 48 was 95.3% in the DRV\/r arm versus 93.4% in the LPV\/r arm. Difference +1.9% (95% CI: -3.7% to +6.5).<\/p>\n

DRV\/r at the lower dose of 400\/100 mg once daily showed non-inferior efficacy to LPV\/r in this switch study.<\/p>\n

comment<\/h3>\n

These results support further studies with low dose DRV\/r, including in PI-naive second-line patients.<\/strong><\/p>\n

Optimised DRV\/r 400\/100 mg could be cheaper to produce than LPV\/r and atazanavir\/r.\u00a0<\/strong><\/p>\n

References<\/p>\n

    \n
  1. Venter F et al. Non-inferior efficacy for darunavir\/ritonavir 400\/100 mg once daily versus lopinavir\/ritonavir, for patients with HIV RNA below 50 copies\/mL in South Africa: The 48-week WRHI 052 study. IAS 2018. 23\u201327 July 2018. Oral abstract TUAB0107LB.
    \nhttp:\/\/programme.aids2018.org\/Abstract\/Abstract\/13192<\/a><\/li>\n<\/ol>\n
      \n
    1. Clayden P. Fit for Purpose: antiretroviral treatment optimisation. July 2018.
      \n      https:\/\/i-base.info\/htb\/34533<\/a><\/li>\n<\/ol>\n\n","protected":false},"excerpt":{"rendered":"

      Polly Clayden, HIV i-Base Stable patients on a twice-daily lopinavir\/ritonavir (LPV\/r)-based second-line regimen who switched to a once-daily 400\/100 mg darunavir\/ritonavir (DRV\/r) one maintained similar virological suppression to those who remained on LPV\/r at 48 weeks. [1] These data from …<\/p>\n","protected":false},"author":3,"featured_media":0,"comment_status":"open","ping_status":"closed","sticky":false,"template":"","format":"standard","meta":{"footnotes":""},"categories":[4,41],"tags":[255],"class_list":["post-34677","post","type-post","status-publish","format-standard","hentry","category-conference-reports","category-treatment-strategies","tag-world-aids-22-amsterdam-2018"],"_links":{"self":[{"href":"https:\/\/i-base.info\/htb\/wp-json\/wp\/v2\/posts\/34677","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=34677"}],"version-history":[{"count":0,"href":"https:\/\/i-base.info\/htb\/wp-json\/wp\/v2\/posts\/34677\/revisions"}],"wp:attachment":[{"href":"https:\/\/i-base.info\/htb\/wp-json\/wp\/v2\/media?parent=34677"}],"wp:term":[{"taxonomy":"category","embeddable":true,"href":"https:\/\/i-base.info\/htb\/wp-json\/wp\/v2\/categories?post=34677"},{"taxonomy":"post_tag","embeddable":true,"href":"https:\/\/i-base.info\/htb\/wp-json\/wp\/v2\/tags?post=34677"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}