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Measuring Safety and Satisfaction of ABC/DTG/3TC
(Triumeq) in a Switch Trial: Secondary Endpoints from the STRIVING Study
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Reported by Jules Levin
EACS 2015 Oct 21-24 Barcelona, Spain - 15th European AIDS Conference
J Koteff1, C Brennan1, M Aboud2, C Granier3, B Wynne1, M Gartland1, M Murray2
1ViiV Healthcare, research Triangle Park, NC, USA; 2 ViiV Healthcare, London, UK; 3 GlaxoWellcome, Londom, UK
Program Abstract
Objective: In STRIIVING, once-daily ABC/DTG/3TC (Triumeq) was non-inferior to continuing ART in virologically suppressed, HIV-1 infected adults. This analysis compares the safety and satisfaction of switching to Triumeq versus maintaining current ART.
Methods: STRIIVING evaluated the efficacy, safety, and satisfaction of switching from a current ART regimen to Triumeq in virologically-suppressed (HIV-1 RNA< 50c/mL), HIV-1 infected adults. Subjects were enrolled into this open label, North American study and randomized 1:1 to Triumeq or continue ART for 24 weeks.
Primary endpoint was non-inferiority (-10% margin) of Triumeq versus ART in maintaining plasma HIV-1 RNA < 50c/mL at Week 24 by Snapshot. The proportion of subjects who discontinued treatment because of adverse events, and treatment satisfaction were secondary endpoints. Treatment satisfaction was measured with the HIV treatment satisfaction questionnaire (2006).
Results: STRIIVING randomised and treated 551 suppressed individuals on ART for a median of 52 months. Switching to Triumeq was non-inferior to continuing ART at Week24 for HIV RNA < 50 c/mL in ITT-E [85% versus 88% (adjusted difference -3.4%; 95% CI: -9.1, 2.3)]. At Week 24, more discontinuations due to adverse events occurred in the Triumeq group [10 (4%) versus 0]. At baseline, overall treatment satisfaction scores were similar between groups. HIV TSQ total scores increased in both groups, with a statistically significant difference in favor of the Triumeq group at Week 24 (Table 1). Mean change from baseline in the HIV TSQ general satisfaction/clinical and lifestyle/ease subscale scores showed statistically significant differences between groups consistent with the HIV TSQ total score.
Conclusion: When switching to Triumeq, more adverse events were reported, but statistically significant differences in increases were observed in the HIV TSQ total score and subscales versus staying on current ART treatment at Week 24.
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