London-based ViiV Healthcare has announced three-year results from its Sword-1 and Sword-2 trials.
These trials evaluated viral suppression rates of human immunodeficiency virus (HIV) patients who switched from a three or four-drug antiretroviral regimen to two-drug regimen Juluca, which is a combination of ViiV’s dolutegravir and Janssen’s rilpivirine.
The Phase III trials demonstrated that 84% of participants who switched to Juluca maintained viral suppression, the primary endpoint in the study.
The results also showed that the so-called ‘late switch’ arm, where participants switched to Juluca 52 weeks into the study, had similar virologic suppression rates to participants of the early switch group at week 100.
At week 148, there were only 11 confirmed virologic withdrawals across the Juluca groups, this represents 1% of the total participant number.
During the Sword studies, Juluca’s two components – dolutegravir and rilpivirine – were administered separately.
Sword investigator and Queen Marry University of London consultant physician and clinical professor Chloe Orkin said: “With the SWORD data we now have three year data showing the excellent effectiveness and tolerability of Juluca, the first approved dolutegravir-based two-drug regimen.
“Importantly, the improvements in bone markers seen at earlier time points 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.”
ViiV Healthcare chief scientific medical officer John Pottage 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.
“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.”
These results were presented at the 25Th Annual Conference of the British HIV association in Bournemouth, UK.
Juluca was approved in the US in November 2017 and in Europe in May 2018 based on 48 week data from the Sword 1 and 2 trials.