Session: 042. HIV Complications: Bone Complications, Thursday, 12:15-1:30 p.m.
Background : HIV infection and antiretroviral therapy (ART), particularly tenofovir (TDF), is associated with loss of bone mineral density (BMD). The SWORD studies demonstrated noninferiority of the 2-drug regimen (2DR) dolutegravir (DTG) + rilpivirine (RPV) to continuing current triple-therapy ART (CAR) at 48 Wks and continued viral suppression on DTG+RPV through Wk 148. A substudy of SWORD 1&2 evaluated change in BMD by DEXA for those participants (pts) who switched from triple ART containing TDF to DTG+RPV. The primary analysis reported at 48 Wks showed a significant increase in total hip and lumbar spine BMD and a significant decrease in bone turnover markers in pts receiving DTG+RPV compared to CAR. Here we present data through Wk 148.
Methods : HIV-infected adult pts with HIV-1 RNA < 50c/mL received ART containing TDF for ≥ 6 months prior to randomization to DTG+RPV (Early Switch group, ES) or CAR on Day 1 (Baseline, BL) through Wk 48 in SWORD-1/2. CAR pts suppressed at Wk 48 switched to DTG+RPV at Wk 52 (Late Switch group, LS). Hip and lumbar spine BMD were measured by DEXA scans read centrally. Secondary endpoints include change in BMD and bone turnover markers through Wk 148.
Results : Following switch to DTG+RPV significant increases were observed for total hip in the ES and LS groups through 100 wks with a non-significant increase at Wk 148 in ES (Fig 1a). Lumbar spine BMD significantly increased from BL at 48 Wks post switch, remained increased, though not significantly from BL through Wk 148 (Fig 1b). The BMD of the LS group was similar to that of the ES group through 100 wks exposure. The majority of pts remained in their pre-switch T-score category or improved a category for both hip and spine through Wk148 (Tbl 1). Through Wk148, BMI increased minimally and bone turnover markers significantly decreased (p < 0.001 to 0.042 across markers) from BL/LS BL except Type I Collagen C-Telopeptide at Wk148 in the LS group (p=0.279).
Conclusion : Switch to the DTG+RPV 2DR was associated with sustained improvements in BMD through Wk 148, along with reduction in bone markers. The favorable effects on skeletal health were observed despite the ageing of study pts and other factors decreasing BMD. A switch to DTG+RPV in suppressed pts provides a robust option for preserving bone health while continuing suppressive HIV treatment.
Lesley Kahl– Director, Clinical Development, ViiV Healthcare, Brentford, England, United Kingdom
Grace A McComsey– Professor of Pediatrics and Medicine, University Hospitals of Cleveland and Case Western Reserve University, Cleveland, OH
Monica Coronado Poggio– Nuclear Medicine Physician, Hospital Universitario La Paz, Madrid, Madrid, Spain
Sergio Lupo– Director of CAICI Institute, CAICI Institute, Rosario, Santa Fe, Argentina
Joss de Wet– Clinical assistant professor, University of British Columbia Canada, Vancouver, BC, Canada
David Parks– President and Director of Clinical Research, Central West Healthcare, St. Louis, MO
Brian Wynne– Director, ViiV Healthcare, Durham, NC
Martin Gartland– Medicine Development Lead, ViiV Healthcare, Research Triangle Park, NC
Kostas Angelis– Biostatistician, GSK, London, England, United Kingdom
Alicia Aylott– Statistician, GSK, Uxbridge, England, United Kingdom
Michael Cupo– Manager, Clinical Development, GlaxoSmithKline, Collegeville, PA
Kati Vandermeulen– Senior Director, Janssen R&D, Beerse, Antwerpen, Belgium
Jean van Wyk– Medical Director, ViiV Healthcare, Brentford, England, United Kingdom
Kimberly Smith– VP and Head, Global Research and Medical Strategy, ViiV Healthcare, Research Triangle Park, NC