ViiV Healthcare has reported promising one-year findings from its ongoing study of a two-drug long-acting injectable HIV treatment of cabotegravir and Edurant (rilpivirine), given every four weeks.
The ATLAS study is a Phase III open-label, active-controlled multicenter parallel group noninferiority trial including 618 adults living with HIV in various countries around the world, including the United States. The participants all had fully suppressed HIV for at least six months upon entering the trial, at which point they were taking a daily oral regimen including two nucleoside/nucleotide reverse transcriptase inhibitors (NRTIs) plus an additional oral ARV. Their oral regimen needed to have been either their first or second since first starting treatment for the virus.
The participants were then randomized to either stay on their current regimen or to switch to long-acting injectable cabotegravir and Edurant, given every four weeks.
At this time, ViiV can report that its primary concern—the difference in rates of those with a viral load of 50 or higher after 48 weeks of treatment—indicated that the long-acting injectable treatment was noninferior to, or as effective as, daily oral regimens.
Additionally, ATLAS’s results were comparable to LATTE and LATTE-2, two previous trials of the long-acting regimen, regarding safety measures, rates of full suppression of HIV and rates of drug resistance development among the participants.
The pharmaceutical company plans to release more detailed findings from ATLAS at an upcoming scientific meeting.
To read a press release about the study, click here.