Lenacapavir also demonstrated superior prevention of HIV infections when compared with once-daily oral Truvada (emtricitabine 200mg and tenofovir disoproxil fumarate 300mg; F/TDF).
PURPOSE 1 met its key efficacy endpoints of superiority of twice-yearly lenacapavir to once-daily oral Truvada ® (emtricitabine 200mg and tenofovir disoproxil fumarate 300mg; F/TDF) and background HIV incidence (bHIV).
Overall, Grade 2 adverse events were comparable between study groups, with 20% assessed as related to study product (19% for cabotegravir arm, 21% for FTC/TDF arm).
CAB-LA and FTC/TDF tablets were both well tolerated throughout the study, with most adverse events being mild or moderate in severity and with the frequency largely balanced between both treatment arms.
CAB-LA and FTC/TDF tablets were both well tolerated throughout the study, with most adverse events being mild or moderate in severity and with the frequency largely balanced between both treatment arms.
Final analysis has since confirmed the superiority of long-acting cabotegravir, which was 66% more effective at preventing HIV when compared to daily oral FTC/TDF tablets.
Final analysis has since confirmed the superiority of long-acting cabotegravir, which was 66% more effective at preventing HIV when compared to daily oral FTC/TDF tablets.
The study achieved its primary objective of non-inferiority with the difference approaching superiority in favour of cabotegravir, pending final analysis.