A phase 3 trial has met its primary endpoint, showing a similar efficacy of a once-a-month injectable 2DR of cabotegravir and rilpivirine compared to daily, oral 3DR.
An international phase 3 trial evaluating a once-a-month, long-acting, injectable 2-drug regimen (2DR) of cabotegravir and rilpivirine for the treatment of HIV has met its primary endpoint, showing similar efficacy to the standard of care, an oral 3-drug regimen to be taken daily.
“This novel approach is another step towards potentially reducing the treatment burden of people living with HIV,” John C. Pottage, Jr., MD, chief scientific and medical officer of ViiV, said in a recent statement. “The data from ATLAS suggest a long-acting, injectable 2DR of cabotegravir and rilpivirine may offer an alternative to daily, oral 3-drug therapy for people who have previously achieved viral suppression.”
He added that if the injectable is approved by the US Food and Drug Administration, it would change the lives of those on antiretroviral treatment—individuals can potentially go from 365 dosing days per year to just 12.
For the phase 3 Antiretroviral Therapy as Long-Acting Suppression (ATLAS) trial, investigators sought to find out if adults with HIV-1 who had maintained a viral suppression for at least 6 months on a daily regimen consisting of 2 nucleoside reverse transcriptase inhibitors (NRTIs) plus a third agent, could maintain similar rates of viral suppression when switched to receive the investigative treatment regimen.
The primary endpoint for the trial is noninferiority, the proportion of participants with plasma HIV-1 RNA ≥50 c/mL per the FDA Snapshot algorithm at week 48 (missing, switch, or discontinuation = failure, intent-to-treat exposed population), according to ViiV. Participants were required to be virally suppressed for 6 months or longer, on the first or second regimen, without any prior failure of treatment.
The investigators found that the investigative long-acting injectable, administered just once a month, demonstrated similar efficacy to the daily, 3-drug standard of care at week 48. As such, the investigative regimen met the trial’s primary endpoint for non-inferiority. Furthermore, investigators noted that the data collected pertaining to safety, virologic response, and drug resistance for the regimen proved consistent with results gleaned from the previous phase 2 trials referred to as LATTE and LATTE-2.
The full results collected from the phase 3 ATLAS trial will be shared at an upcoming scientific meeting, according to ViiV. Furthermore, headline results collected from a second pivotal trial, FLAIR, which was conducted to assess the effectiveness of the injectable treatment regimen in treatment-naïve participants, are expected in late 2018.