HIV - Phase III SWORD 1&2 studies of Juluca shows efficacy at 148 weeks

ViiV Healthcare presented three year results from the SWORD 1 & 2 studies, demonstrating that 84% (432/513) of participants who switched from their current three- or four-drug antiretroviral regimen to a 2-drug regimen of Juluca (dolutegravir, from ViiV Healthcare, plus rilpivirine from Janssen Sciences, maintained viral suppression (viral load of 50 copies/mL or lower). Findings in the ‘late switch’ arm (n=477), where participants continued on their current antiretroviral regimen until week 52 before switching to the 2-drug regimen of dolutegravir and rilpivirine, showed comparable virologic suppression, tolerability and resistance to that seen in the early switch group at week 100. Through 148 weeks of the study, there was a low number of confirmed virologic withdrawals (CVWs) across study populations who received dolutegravir + rilpivirine (1%; 11/990). Drug-related grade 2-4 adverse events occurred in 5% (47/990) of patients, with adverse events leading to discontinuation reported in 6% (61/990) of patients.

Improvements in bone biomarkers were reported across the study groups through week 148 (bone-specific alkaline phosphate change from baseline of -3.4ug/mmol (n=432) in early switch, -3.5ug/mmol (n=433) in late switch; osteocalcin change from baseline of -4.9ug/mmol (n=431) in early switch, -4.8ug/mmol (n=433) in late switch; procollagen 1 N-terminal propeptide change from baseline of -4.2ug/mmol (n=431) in early switch, -7.3ug/mmol (n=431) in late switch; type I collagen C-telopeptides change from baseline of -0.1ug/mmol (n=433) in early switch, -0.1ug/mmol (n=431) in late switch). There were also improvements in the renal biomarkers for patients switching away from a TDF containing regimen to dolutegravir + rilpivirine (retinol-binding protein/creatinine ratio change of -28.8ug/mmol (n=285) in early switch, -22.3ug/mmol (n=294) in late switch from a TDF baseline, and -2.3ug/mmol (n=114) in early switch, 0.4ug/mmol (n=125) in late switch from a no-TDF baseline). Across both early and late switch arms, no patients developed resistance to dolutegravir and few (n=6) to rilpivirine. These results were presented at the 25th Annual Conference of the British HIV Association.