Sword 1 and 2: Subgroup Analysis of 48 Week Results by Age, Race and Gender

Abstract

Background. Switching to the 2‐drug regimen (2DR) of DTG+RPV was proven non‐inferior to continuing a suppressive PI‐, INI‐ or NNRTI‐ based current antiretroviral regimen (CAR) at Week 48. This analysis evaluated the efficacy and safety of switching from CAR to DTG+RPV by age, race and gender subgroups. Methods. Two identically designed, open‐label, multicenter, global, phase III, non‐inferiority studies compared the efficacy and safety of switching from a 3 or 4‐drug CAR to DTG + RPV once daily in HIV‐1‐infected adults, with HIV‐1 RNA<50 c/mL. Primary endpoint was proportion of patients with VL<50 c/mL at Wk48 using FDA Snapshot. Additional analysis were performed to summarize efficacy base on age, race and gender subgroups for each individual study and pooled. Results. 1024 patients were randomized and exposed (DTG+RPV 513; CAR 511), across both studies. Treatment arms were well matched for demographic and baseline characteristics. Median age across both arms was 43.4 years, with 29% and 28% ≥ 50 years in DTG+RPV and CAR, respectively. 23% and 21% were female while 18% and 22% were non‐white for DTG+RPV and CAR. For the pooled studies and for SWORD‐1 and SWORD‐2 individually, switching to DTG+RPV was non‐inferior to CAR at Wk48. Similar response rates were observed in the DTG+RPV arm compared with CAR across subgroups (Table 1). More AEs were reported in the DTG+/RPV arm across all subgroups except Asian race; no unexpected AEs were identified for either drug. Conclusion. Switch to a novel, once daily 2DR of DTG+RPV in patients with a suppressed viral load, was an effective and well tolerated treatment option across age, race, and gender subgroups which were consistent with overall results.