Oral Abstract Submission
David Margolis, MD, MPH
Director of HIV Drug Development
Research Triangle Park, North Carolina
Disclosure: ViiV Healthcare: Employee, Shareholder, Other Financial or Material Support, Salary and stock options
Cabotegravir (CAB) and rilpivirine (RPV) are under development as a novel long acting (LA) regimen for maintenance of HIV virologic suppression. Pooled Week 48 data from pivotal Phase 3 trials demonstrated non-inferiority of CAB LA + RPV LA vs. current antiretroviral regimen (CAR) on the primary endpoint, proportion of subjects with HIV-1 RNA ≥50 c/mL (1.9% and 1.7%, respectively). Adherence to dosing visits, use of oral dosing (bridging) to cover planned missed injections and injection tolerability were examined for subjects in the ATLAS & FLAIR studies.
Virologically suppressed subjects (HIV-1 RNA < 50 c/mL) were randomized to switch to CAB LA + RPV LA or to continue CAR. On-time injections occurred Q4 weeks within a + 7-day dosing window of the projected dosing date. Adherence to LA therapy was calculated as the number of on-time injection visits divided by the number of expected dosing visits through Week 48. Injection visits outside the pre-specified window and missed injection visits with/without use of oral dosing were quantified. Injection tolerability was assessed via adverse event reporting.
14,682 injections of CAB and RPV were administered to 581 subjects during 6,920 injection visits. 98% of injection visits took place within the allowed ± 7-day dosing window with 3194 (46%) on the projected dosing date. 46 (<1%) injection visits were early and 106 (2%) were late. Oral bridging was used in 16 subjects overall; 8 planned missed injection visits were successfully covered, with no change to virologic suppression status. No subject with HIV-1 RNA ≥ 50 c/mL at Week 48 had missed/late injection visits. 25% (3663/14,682) of injections were associated with local injection site reactions (ISRs). The most common ISR was pain (3087/3663=84%). Most ISRs were grade 1-2 (99%), short duration (median 3 days), with few associated discontinuations (<1%).
Subjects receiving CAB LA + RPV LA demonstrated high rates of adherence to injection visits through week 48, with 98% of injections occurring within the ± 7-day dosing window. Oral bridging with CAB and RPV was an effective strategy for maintaining viral load suppression to cover missed injection visits. Injections were well-tolerated with few associated discontinuations.