ViiV Healthcare has reported positive three-year data from the Phase III Sword 1 & 2 clinical trials of Juluca in HIV-1-infected virologically suppressed adults.
The 148-week studies evaluated the antiviral activity and safety of Juluca, a two-drug combination of ViiV’s dolutegravir and Janssen Sciences Ireland’s rilpivirine, compared to current antiretroviral therapy.
During the trials, 84% of patients who switched from their current three or four-drug antiretroviral regimen to Juluca were observed to maintain viral suppression.
Results from the ‘late switch arm’, where subjects switched to the two-drug regiment at 52 weeks, demonstrated similar virologic suppression to those in the early switch arm at week 100.
Only 11 out of the total 990 patients receiving Juluca had confirmed virologic withdrawals.
In addition, drug-related grade 2-4 adverse events occurred in 47 patients in the two-drug regimen groups, and discontinuation due to adverse events was reported in 61 of the participants.
Sword investigator 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 two-drug regimen of dolutegravir and rilpivirine.”
Findings from the trials have been presented at the 25th Annual Conference of the British HIV Association (BHIVA) in Bournemouth, UK.
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 two-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 suppressed adults living with HIV.”
Juluca has received regulatory approvals in multiple countries, including the US, with additional applications submitted.