{"id":1851,"date":"2018-12-31T00:00:52","date_gmt":"2018-12-30T17:00:52","guid":{"rendered":"https:\/\/www.hivnat.org\/en\/?p=1851"},"modified":"2022-03-30T10:06:57","modified_gmt":"2022-03-30T03:06:57","slug":"a-phase-3b-randomized-open-label-study-of-the-antiviral-activity-and-safety-of-dolutegravir-compared-to-lopinavir-ritonavir-both-administered-with-dual-nucleoside-reverse-transcriptase-inhibitor-the","status":"publish","type":"post","link":"https:\/\/www.hivnat.org\/en\/studies\/1851\/","title":{"rendered":"A phase 3b, randomized, open-label study of the antiviral activity and safety of Dolutegravir compared to Lopinavir\/Ritonavir both administered with dual nucleoside reverse transcriptase inhibitor therapy in HIV-1 infected adult subjects with treatment failure on first line therapy"},"content":{"rendered":"\n<p class=\"wp-block-paragraph\">This study is conducted to demonstrate\nnon-inferior antiviral activity at 48 weeks of a dolutegravir (DTG) containing\nregimen compared to a WHO-recommended standard of care regimen for second line\ntreatment, LPV\/RTV + two NRTIs, in HIV-1 infected patients failing first line\ntherapy. <\/p>\n\n\n\n<p class=\"wp-block-paragraph\"><strong>Results: <\/strong>624 adults were randomized and treated. Subjects were well matched for demographic and baseline characteristics. The IDMC decision had limited impact on the primary endpoint as all LPV\/r subjects who switched or discontinued due to the IDMC decision had a viral load value at Week 48\/52. At Week 48, 84% (261\/312) of subjects on DTG versus 70% (219\/312) on LPV\/r achieved HIV-1 RNA &lt; 50 c\/mL (adjusted difference 13.8%, 95% CI: 7.3% to 20.3%, p &lt; 0.001 for superiority). The difference was primarily driven by lower rates of Snapshot virologic nonresponse (VL \u2265 50 c\/mL) in subjects on DTG. The overall safety profile of DTG+2NRTIs was favourable compared to LPV\/r+2NRTIs with more drug-related adverse events reported in the LPV\/r group. Of 11 DTG subjects who met protocol-defined virologic withdrawal criteria through Week 52, one had treatment-emergent primary integrase-strand transfer inhibitor (INSTI) and NRTI resistance mutations while another had INSTI mutations only; in comparison, 30 LPV\/r subjects met virologic withdrawal criteria, and 3 had emergent NRTI but no protease inhibitor mutations. (Source: Aboud M, et al., Superior efficacy of dolutegravir (DTG) plus 2 nucleoside reverse transcriptase inhibitors (NRTIs) compared with lopinavir\/ritonavir (LPV\/r) plus 2 NRTIs in second-line treatment &#8211; 48-week data from the DAWNING Study. Abstract # THPEB040. Presented at AIDS Conference 2018) <\/p>\n","protected":false},"excerpt":{"rendered":"<p>\t\t\t\tThis study is conducted to demonstrate non-inferior antiviral activity at 48 weeks of a dolutegravir (DTG) containing regimen compared to a WHO-recommended standard of care regimen for second line treatment, LPV\/RTV + two NRTIs, in HIV-1 infected patients failing first line therapy. \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-1851","post","type-post","status-publish","format-standard","hentry","category-studies"],"_links":{"self":[{"href":"https:\/\/www.hivnat.org\/en\/wp-json\/wp\/v2\/posts\/1851","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=1851"}],"version-history":[{"count":1,"href":"https:\/\/www.hivnat.org\/en\/wp-json\/wp\/v2\/posts\/1851\/revisions"}],"predecessor-version":[{"id":3347,"href":"https:\/\/www.hivnat.org\/en\/wp-json\/wp\/v2\/posts\/1851\/revisions\/3347"}],"wp:attachment":[{"href":"https:\/\/www.hivnat.org\/en\/wp-json\/wp\/v2\/media?parent=1851"}],"wp:term":[{"taxonomy":"category","embeddable":true,"href":"https:\/\/www.hivnat.org\/en\/wp-json\/wp\/v2\/categories?post=1851"},{"taxonomy":"post_tag","embeddable":true,"href":"https:\/\/www.hivnat.org\/en\/wp-json\/wp\/v2\/tags?post=1851"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}