Session: 262. HIV: Antiretroviral Therapy, Saturday, 12:15-1:30 p.m.
Background : The SWORD-1 and SWORD-2 studies previously demonstrated that high rates of virologic suppression were maintained for 148 weeks after switching virologically suppressed HIV-1 infected adults from their current 3- or 4-drug antiretroviral regimen (CAR) to the 2-drug regimen (2DR) of dolutegravir + rilpivirine on Day 1 (Early Switch (ES) DTG+RPV group). This abstract reports the pooled SWORD-1/2 results of patient reported outcomes (PRO) measures through Week 148.
Methods : HIV Treatment Satisfaction Questionnaire (HIVTSQ) and Symptom Distress Module (SDM) were secondary PRO endpoints in the SWORD trials. For HIVTSQ, high scores represent greater treatment satisfaction (range 0 to 60). SDM was assessed using the Symptom Bother Score with low values indicating less symptom bother (range 0 to 80). The EQ-5D-5L measure of general health status was assessed as an exploratory endpoint with maximum utility score of 1 to indicate perfect health. Change from Baseline in these endpoints was calculated for the ES subjects (over 148 weeks). Subjects randomized to CAR switched to DTG+RPV at Week 52 (Late Switch (LS) DTG+RPV group) and change from LS Baseline (i.e. last pre-switch assessment) was calculated (over 96 weeks).
Low Symptom Bother (9.6 and 10.3) and high TSQ scores (54.4 and 54.3) were reported pre-switch in the ES and LS groups respectively.
ES subjects reported modest improvements from Baseline in both symptom burden and overall treatment satisfaction in all visits through Week 148 (Figures 1&2). Among the LS group, there was little change in symptom burden but similar improvement in treatment satisfaction. Pre-switch health status was high in ES and LS groups (EQ-5D mean utility: 0.96 and 0.94, respectively) and remained stable in both groups at all timepoints.
Conclusion : High treatment satisfaction and low symptom burden that were observed in patients under CAR were maintained long term after switching to DTG+RPV. These results corroborate DTG+RPV as a well-tolerated 2DR alternative treatment option in patients currently suppressed on other 3/4-drug regimens without previous virologic failure.
Alan Oglesby– Sr. Director, ViiV Healthcare, Research Triangle Park, NC
Kostas Angelis– Biostatistician, GSK, London, England, United Kingdom
Yogesh Punekar– Sr. Director, ViiV Healthcare, Brentford, England, United Kingdom
Vasiliki Chounta– Manager, ViiV Healthcare, Brentford, England, United Kingdom
Antonio Antela– Atending Physician, Hospital Clínico Universitario de santiago de Compostela, Spain, Coruna, Galicia, Spain
Jessica Matthews– Clinical Development Director, ViiV Healthcare, RTP, NC
Lesley Kahl– Director, Clinical Development, ViiV Healthcare, Brentford, England, United Kingdom
Martin Gartland– Medicine Development Lead, ViiV Healthcare, Research Triangle Park, NC
Brian Wynne– Director, ViiV Healthcare, Durham, NC
Miranda Murray– Head, ViiV Healthcare, Brentford, England, United Kingdom
Jean Andre Van Wyk– Global Medical Lead, ViiV Healthcare, Brentford, England, United Kingdom