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Efficacy and safety of dolutegravir–rilpivirine for maintenance of virological suppression in adults with HIV-1: 100-week data from the randomized, open-label, phase 3 SWORD-1 and SWORD-2 studies

The Lancet HIV Sep 10, 2019

Aboud M, Orkin C, Podzamczer D, et al. - Researchers reported efficacy and safety data from the 100-week analysis of the SWORD-1 and SWORD-2 trials in view of the 48-week analysis indicating non-inferiority of switching to a two-drug regimen of dolutegravir plus rilpivirine to continuing a standard three-drug or four-drug antiretroviral regimen for maintenance of virological suppression in people with HIV-1. SWORD-1 and SWORD-2 were identically designed, randomized, open-label, phase 3 studies, which were conducted at 65 centers in 13 countries and 60 centers in 11 countries, respectively. In these trials, adults on a standard three- or four-drug antiretroviral therapy (ART) who had < 50 HIV-1 RNA copies per mL of plasma for ≥ 6 months were included. Participants were randomized (1:1) to receive either 50-mg dolutegravir plus 25-mg rilpivirine orally once daily (early-switch group; n = 513) or to continue their standard regimen (n = 511) for 52 weeks; of these, 477 were switched to the dolutegravir plus rilpivirine combination at 52 weeks (ie, the late-switch group). This analysis of week 100 data revealed a low frequency of virological failure in correlation with the combination of dolutegravir plus rilpivirine sustained virological suppression of HIV-1 with a favorable safety profile. Findings support its value as a nucleoside reverse transcriptase inhibitor-sparing and protease inhibitor-sparing alternative to three-drug regimens that decreases overall exposure to ART.

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