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

Publication date: Available online 12 July 2019Source: The Lancet HIVAuthor(s): Michael Aboud, Chloe Orkin, Daniel Podzamczer, Johannes R Bogner, David Baker, Marie-Aude Khuong-Josses, David Parks, Konstantinos Angelis, Lesley P Kahl, Elizabeth A Blair, Kimberly Adkison, Mark Underwood, Jessica E Matthews, Brian Wynne, Kati Vandermeulen, Martin Gartland, Kimberly SmithSummaryBackgroundPrimary analyses of the SWORD-1 and SWORD-2 trials at 48 weeks showed that switching to a two-drug regimen of dolutegravir plus rilpivirine was non-inferior to continuing a standard three-drug or four-drug antiretroviral regimen for maintenance of virological suppression in people with HIV-1. Here, we present efficacy and safety data from the 100-week analysis of the trials.MethodsSWORD-1 and SWORD-2 are identically designed, randomised, open-label phase 3 studies at 65 centres in 13 countries and 60 centres in 11 countries, respectively. Adults aged 18 years or older who were on a standard three-drug or four-drug antiretroviral therapy (ART) and had had fewer than 50 HIV-1 RNA copies per mL of plasma for at least 6 months were randomly assigned (1:1) to 50 mg dolutegravir plus 25 mg rilpivirine orally once daily (early-switch group) or to continue their standard regimen for 52 weeks before switching to the dolutegravir plus rilpivirine combination (ie, the late-switch group). In this analysis of week 100 data, the efficacy endpoint of interest was the proportion of participants with fewer than ...
Source: The Lancet HIV - Category: Infectious Diseases Source Type: research