1034 - Patient Perspectives on Implementation of a Long-Acting Injectable Antiretroviral Therapy Regimen in HIV US Healthcare Settings: Interim Results from the CUSTOMIZE study

Background: Cabotegravir and rilpivirine long-acting (CAB+RPV LA) administered by monthly injection demonstrated non-inferiority compared to standard daily oral antiretroviral therapy (ART) at 48 weeks. This novel treatment offers a less frequent dosing alternative to daily oral pills but requires more frequent clinic visits. Patient perspectives on implementation of CAB + RPV LA in US healthcare settings were evaluated in an innovative Hybrid III implementation-effectiveness study (CUSTOMIZE).

Methods: This single-arm study enrolled virologically suppressed patients to receive monthly CAB+RPV LA across eight diverse US clinics. Patients were surveyed at Baseline (BL) prior to the first injection and at Month 4 (M4) prior to the fourth injection to evaluate clinic implementation of CAB+RPV LA, including Acceptability of Intervention (AIM) and Intervention Appropriateness (IAM) Measures. Subgroups were compared with Fisher's exact test.

Results: A total of 109 and 105 patients completed BL and M4 surveys, respectively, and were 87% male; 59% Caucasian and 35% African American; 27% Hispanic/Latino; mean age 39 years (range 20-65). At BL, 33% reported hiding their oral ART from others, 22% reported problems remembering to take daily ART (female 43% > male 19%, p< 0.05), while 47% reported no problems with daily ART (male 51% > female 21%, p< 0.05). Patient “interest in a more convenient treatment option” (83%) was a top reason for choosing CAB+RPV LA treatment. Acceptability and appropriateness of CAB+RPV LA were high at BL and M4 (Figures).  At M4, 84% of patients reported that monthly clinic visits were very/extremely acceptable and 66% reported no logistical challenges to clinic administered CAB+RPV LA.  Injection pain/soreness was the most common worry at BL (58%); at M4, 28% reported injection pain/soreness as a concern. For Months 2-4, 95% of injections were within a +/-7-day dosing window (5% were early, -7 to -14 days). No patients missed an injection or required oral bridging.Figure 1. Acceptability of CAB+RPV LA: AIM
Figure 2: Appropriateness of CAB+RPV LA: IAM


Conclusion: Most patients found CAB+RPV LA to be acceptable and appropriate, and a majority reported monthly appointments were highly acceptable.  Initial implementation data suggest CAB+RPV LA is a convenient, appealing alternative treatment option for patients, with few reported logistical challenges.