These results were presented at the 25th Annual Conference of the British HIV Association (BHIVA) taking place from 2-5 April in Bournemouth, UK.
Professor Chloe Orkin, Consultant Physician and Clinical Professor at Queen Mary University of London and SWORD investigator, said, “With the SWORD data we now have three year data showing the excellent effectiveness and tolerability of Juluca, the first approved dolutegravir-based 2-drug regimen. Importantly, the improvements in bone markers seen at earlier timepoints in the study are maintained over three years. Combined with the potential benefits of lowering the number of antiretroviral agents patients take, these data support the strategy of switching virologically-suppressed, stable patients to the 2-drug regimen of dolutegravir and rilpivirine.”
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.1 Improvements in bone biomarkers were reported across the study groups through week 148 (bone-specific alkaline phosphate change from baseline of -3.4μg/mmol (n=432) in early switch, -3.5μg/mmol (n=433) in late switch; osteocalcin change from baseline of -4.9μg/mmol (n=431) in early switch, -4.8μg/mmol (n=433) in late switch; procollagen 1 N-terminal propeptide change from baseline of -4.2μg/mmol (n=431) in early switch, -7.3μg/mmol (n=431) in late switch; type I collagen C-telopeptides change from baseline of -0.1μg/mmol (n=433) in early switch, -0.1μg/mmol (n=431) in late switch).1 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 -28.8μg/mmol (n=285) in early switch, -22.3μg/mmol (n=294) in late switch from a TDF baseline, and -2.3μg/mmol (n=114) in early switch, 0.4μg/mmol (n=125) in late switch from a no-TDF baseline).1 Across both early and late switch arms, no patients developed resistance to dolutegravir and few (n=6) to rilpivirine.
John C. Pottage, Jr, M. D. Chief Scientific Medical Officer at ViiV Healthcare, said, “The SWORD 1+2 studies are the first phase III HIV studies to show long-term data for switching from three-drug combination to an oral 2-drug regimen , and the efficacy, tolerability and barrier to resistance out to three years demonstrated in the study provides further reassurance of the suitability of Juluca for many virologically supressed adults living with HIV.”
Juluca has been approved in the EU2, the US3 and other countries, with further regulatory marketing applications submitted worldwide.
Source: Company Press Release