The study has achieved its primary objective, demonstrating that administration every 8 weeks is as effective in maintaining viral suppression compared with monthly administration.
Positive top-line results from the phase 3 ATLAS-2M study of an investigational, long-acting, 2-drug injectable regimen of cabotegravir and rilpivirine have been announced.
ATLAS-2M is a phase 3 randomized, open-label, active-controlled, multicenter, parallel-group, non-inferiority study evaluating the antiviral activity and safety of the cabotegravir + rilpivirine administered every 8 weeks compared with every 4-week administration throughout a 48-week treatment period in 1045 adults living with HIV.
The regimen is being co-developed as a collaboration between the Janssen Pharmaceutical Companies of Johnson & Johnson and ViiV Healthcare.
According to a statement issued by Janssen, ATLAS-2M has achieved its primary objective, demonstrating that injections administered every 8 weeks is as effective as injections every 4 weeks in maintaining viral suppression in adults who are virally suppressed.
Non-inferiority was measured by the proportion of participants with plasma HIV-RNA >50 copies per milliliter using the US Food and Drug Administration (FDA) Snapshot algorithm at Week 48 in the intent-to-treat exposed population.
The statement reports that results for safety, virologic response, and drug resistance were consistent with results from the phase 3 ATLAS study.
ATLAS was a phase 3 study, which enrolled 616 participants who had HIV-1 RNA <50 c/mL for > 6 months without virologic failure on oral ART regimens of either 2 nucleoside reverse transcriptase inhibitors plus 1 integrase strand transfer inhibitor (NRTI + ISTI), non-nucleoside reverse transcriptase inhibitors (NNRTI), or a protease inhibitor (PI). The 48-week results were presented at the Annual Conference on Retroviruses and Opportunistic Infections (CROI 2019).
The 308 patients in the treatment arm received oral cabotegravir 30 mg + rilpivirine 25 mg once daily for 4 weeks for safety monitoring. Then, the participants went on to receive single 3 mL loading doses of cabotegravir long-acting (LA) 600 mg (200 mg/mL) and rilpivirine long-acting 900 mg (300 mg/mL) via intramuscular injection, followed by 2 mL intramuscular injections every 4 + 1 weeks of cabotegravir LA 400 mg and rilpivirine long acting 600 mg.
The study investigators also report that the cabotegravir/rilpivirine arm was non-inferior to the current ART arm for the key secondary endpoint of HIV-1 RNA <50 c/mL (93% vs 95%).
The investigators also note that of the 275 cabotegravir/rilpivirine arm participants completing an HIV treatment satisfaction questionnaire at week 48, 98% reported being more satisfied with long-acting cabotegravir and rilpivirine compared with their daily oral treatment at study entry.
Contagion® spoke exclusively to Susan Swindells, MBBS, professor in the Department of Internal Medicine at the University of Nebraska Medical Center, who presented the findings of the study at the meeting.
“At 48 weeks we looked at the results and they were very similar in terms of the number of patients in each arm that had detectable virus—very small numbers in each arm—more than 90% suppressed in both arms,” she said. “It was a non-inferiority design, so non-inferiority was met and there were 3 virologic failures in the investigational arm with the injections."
ATLAS 2-M is being conducted at research centers in Australia, Argentina, Canada, France, Germany, Italy, Mexico, Russia, South Africa, South Korea, Spain, Sweden, and the United States
Detailed results of the study will be presented at an upcoming scientific meeting.
A priority review designation for the once-monthly injectable regimen was granted by the FDA with an expected action date of December 29, 2019.