CROI 2024 Abstract eBook

Abstract eBook

Poster Abstracts

623

Real-World Effectiveness of Cabotegravir + Rilpivirine vs Standard of Care Oral Regimens in the US Ricky K Hsu 1 , Michael Sension 2 , Jennifer S. Fusco 3 , Laurence Brunet 3 , Quateka Cochran 4 , Gayathri Sridhar 5 , Vani Vannappagari 6 , Jean Van Wyk 7 , Michael B. Wohlfeiler 8 , Brooke Levis 3 , Gregory P. Fusco 3 1 AIDS Healthcare Foundation, New York, NY, USA, 2 CAN Community Health, Sarasota, FL, USA, 3 Epividian, Raleigh, NC, USA, 4 AIDS Healthcare Foundation, Fort Lauderdale, FL, USA, 5 ViiV Healthcare, Durham, NC, USA, 6 ViiV Healthcare, London, United Kingdom, 7 ViiV Healthcare, London, England, UK, 8 AIDS Healthcare Foundation, Miami, FL, USA Background: In trials, long-acting (LA) injectable antiretroviral therapy (ART) with cabotegravir plus rilpivirine (CAB+RPV) was shown to be non-inferior to oral ART regimens in virologically suppressed (viral load [VL] <50 copies/mL) individuals. We assessed real world effectiveness after a switch to CAB+RPV or a new oral ART regimen. Methods: From the OPERA cohort, ART-experienced, suppressed adults with HIV switching to CAB+RPV or a new oral ART regimen between 21Jan2021 31Dec2022 were followed through 30June2023. Confirmed virologic failure (VF; 2 VL ≥200 copies/mL or 1 VL ≥200 copies/mL + regimen change) was assessed among those with ≥1 follow-up VL. Logistic regression models were fit to assess the risk of VF by regimen, adjusted for age (linear & quadratic terms), sex, race, injection drug use (IDU), history of AIDS-defining events (ADE), CD4 count (linear & quadratic terms), comorbid conditions, and prior regimen class. In those receiving CAB+RPV injections, age, sex, race, US region, IDU, history of ADE, CD4 count (per 100 cells/μL), comorbid conditions, prior regimen class, and BMI were evaluated as potential predictors of VF. Results: In OPERA, 1362 virologically suppressed adults switched to CAB+RPV injections and 2783 switched to a new oral ART regimen. CAB+RPV users were younger (aged ≥50 years: 29% vs. 41%), had been on their prior regimen for a shorter period (20 vs. 37 months), were more likely to switch from an INSTI (74% vs. 68%), but had similar median CD4 counts at initiation (686 [IQR 496-902] vs. 700 [524-913] cells/μL) compared to oral ART users. Risk of VF out of individuals with a follow-up VL (CAB+RPV: n=1236; oral ART: n=2432) did not statistically differ (adjusted OR: 0.64; 95% CI: 0.41, 1.02). Only baseline CD4 marginally predicted VF; every 100 CD4 cells/μL increase was associated with 15% lower risk of VF (Fig 1). Of the 25 CAB+RPV VF, 40% went to INSTI oral therapy, 40% remained on CAB+RPV, 16% went to multi-core agents, and 1 remained off therapy. Of the 19 with VL, 95% achieved <200 and 79% <50 after VF. In contrast, of the 78 oral VF, 69% stayed on the same ART, 23% went to INSTI regimen, 3 remained off therapy, and the remainder went on a variety of other regimens. Of the 43 with VL, 84% achieved <200 and 72% <50 after VF. Conclusion: In routine clinical care in the US, the risk of VF did not differ between virologically suppressed adults switching to CAB+RPV injections or oral ART regimens. Lower CD4 count at initiation was the only predictor of VF with CAB+RPV.

Background: Long-acting injectable (LAI) cabotegravir/rilpivirine (CAB/RPV) provides a novel treatment option for people with HIV (PWH). However, missed and late injections potentially jeopardize viral suppression, increases risk of resistance development, and requires extensive resources to track adherence and proactively reschedule missed injections. Methods: We conducted a retrospective cohort study at the University of California San Diego Owen Clinic. Adult PWH who received LAI CAB/RPV for at least 6 months from May 2021 through August 2023 were included. Data collected included demographics, baseline HIV RNA and CD4 count, distance from the clinic, substance use, CAB/RPV dosing regimen, office visit no-shows one year prior to switching to LAI CAB/RPV, injection visit no-shows, injections outside of the dosing widow, and virologic outcomes. PWH were excluded if they had a late injection due to COVID-19 infection or planned/known travel. Cox-proportional hazards regression was performed to evaluate predictors of no-show to injection visits or late injections. Results: A total of 287 PWH were included with median age of 42 years, 54.4% were non-white, 38% Hispanic ethnicity, and 15% female sex assigned at birth (SAB). Median follow up time (IQR) on LAI CAB/RPV was 450 days (344-548 days), and median distance to the clinic was 4.8 miles (2.5-11.8 miles). A total of 92 (32.1%) had at least one no-show to a scheduled injection visit and 44 (15.3%) had at least one injection outside the recommended dosing window. Younger age (HR 0.97, 95%CI 0.95-0.98) and ≥ 1 office visit no-show in the year prior to switch (HR 2.03, 95%CI 1.32-3.12) were independently associated with having a no-show to an injection visit (Figure 1). The number of pre switch no-shows was also significantly associated with post-switch no-shows (p<0.001) and those with at least one injection visit no-show had a higher frequency of late injections, 30.4% vs. 8.2%, p<0.0001. Male SAB (HR 9.18, 95%CI 1.26-66.9) after adjustment for age, was independently associated with late injection visits. There was no relationship between no-shows to injection visits or late injections and having a detectable viral load or virologic failure (n=3) after switch to LAI CAB/RPV. Conclusion: Evaluating attendance to office visits prior to switching to LAI CAB/ RPV may help identify those more likely to miss injection visits, however it was not associated with late injections or having a detectable viral load or virologic failure.

Poster Abstracts

625

Real-World Utilization of Cabotegravir + Rilpivirine in the US: Data From Trio Health Cohort Joseph J Eron 1 , Supriya Sarkar 2 , Andrew J. Frick 3 , Gayathri Sridhar 2 , Leigh Ragone 2 , Karam Mounzer 4 , Steven Santiago 5 , Jean Van Wyk 6 , Richard A. Elion 3 , Vani Vannappagari 2 1 University of North Carolina at Chapel Hill, Chapel Hill, NC, USA, 2 ViiV Healthcare, Durham, NC, USA, 3 Trio Health, Inc, Louisville, CO, USA, 4 Philadelphia FIGHT, Philadelphia, PA, USA, 5 Care Resource Community Health Centers, Inc, Miami, Florida, 6 ViiV Healthcare, Brentford, United Kingdom Background: Cabotegravir+Rilpirivine (CAB+RPV) is the first complete long-acting (LA) antiretroviral regimen approved in the United States for the treatment of HIV for ART-experienced people with undetectable viral load (VL <50 copies/ml). This study examines the utilization and effectiveness of CAB+RPV in real-world settings in the US. Methods: All ART-experienced adults with undetectable VL at initiation who received ≥1 documented CAB+RPV injection were identified from electronic health record data within the Trio Health Cohort between February 2021-July 2023. Discontinuation of CAB+RPV was defined as 2 consecutive missed injections or a regimen switch, while confirmed virologic failure (CVF) was

624

Predictors of Injection Visit Adherence in Those Receiving Injectable Cabotegravir/Rilpivirine Lucas Hill , Jeffrey Yin, Nimish Patel, Kari Abulhosn, Elvia Suarez, Afsana Karim, Laura Bamford University of California San Diego, La Jolla, CA, USA

CROI 2024 176