Background: Building on results from the Phase 2b LATTE2 study, a planned patient reported outcomes (PROs) secondary analysis was performed for the long-acting (LA) regimen of Cabotegravir (CAB)+ Rilpivirine (RPV). FLAIR, is a phase 3, open-label study in ART-naïve participants that demonstrated switching to a monthly LA regimen is non-inferior to DTG/ABC/3TC. PROs include tolerability, satisfaction, and acceptability of the regimens.
Methods: FLAIR participants received induction therapy with oral DTG/ABC/3TC for 20 weeks. Those with HIV-1 RNA < 50 c/mL at 16 weeks were eligible to enter the maintenance phase and be randomized (1:1) on day 1 to continue DTG/ABC/3TC or initiate LA injectable therapy following a daily oral CAB+ RPV lead-in for 4 weeks. The primary endpoint was HIV-1 RNA ≥ 50 c/mL at W48 using the FDA snapshot algorithm. Other endpoints include treatment satisfaction (HIV-Treatment Satisfaction Questionnaire, secondary) and preference (exploratory) for LA vs DTG/ABC/3TC at W48. Acceptability and tolerability of intramuscular injections (Perception of Injections (PIN)) were assessed in the LA arm only.
Results: 566 participants were randomized with a median age of 34 (11% ≥50 yrs); 22% female and 74% white. While 76% of participants in the LA arm reported maximum Grade 1 or 2 injection site pain, the frequency decreased over time. Mean scores on the PIN (bother of injection site reactions, leg movement, sleep, and acceptance) improved over time. LA participants reported greater improvement in treatment satisfaction compared with the DTG/ABC/3TC group on HIV-TSQc (W48 adjusted mean 29.6 vs. 25.5 p< 0.001). A total of 95% of participants on LA compared with 81% on DTG/ABC/3TC were “highly or very satisfied” to continue their therapy at W44 (HIV-TSQs). Overall, in the LA arm, 99% of participants who responded at W48 preferred LA compared to DTG/ABC/3TC received during the Induction Phase.
Conclusions: The FLAIR study showed that LA ART is non-inferior to a daily oral therapy. The patients'' perspective demonstrated a clear preference for monthly injectable ART compared to daily oral ART, despite demands of treatment including clinic visits for administration of LA injections. Overall, these results indicate an injectable LA ART regimen may become an important option for PLHIV.

Download the e-Poster