BACKGROUND:Long-acting cabotegravir + rilpivirine (CAB+RPV LA) is the first US Food and Drug Administration-approved complete long-acting regimen for people with HIV who are virologically suppressed. Long-acting CAB+RPV may alleviate adherence challenges with daily oral therapy. OBJECTIVE:To evaluate and compare real-world adherence, persistence, and health care resource utilization in people with HIV who switched to CAB+RPV LA vs maintained daily oral antiretroviral therapy (ART). METHODS:ABOVE is a retrospective US cohort study using Symphony Health Solutions Integrated Dataverse administrative claims data from January 1, 2020, to August 31, 2023. The study included people with HIV aged 12 years and older on stable oral ART and with continuous clinical activity for at least 12 months before the index date, categorized into people initiating CAB+RPV LA (LA ART cohort) and people remaining on oral ART (oral ART cohort). The index date was defined as the first injection of CAB+RPV LA or imputed for the oral ART cohort. We used standardized mortality ratio weighting based on propensity scores to balance baseline characteristics. Adherence (proportion of days covered ≥0.9 over 12 months following index) and persistence to the index regimen (days from index to earliest of treatment discontinuation or end of follow-up) were compared. A doubly robust logistic regression model estimated the adjusted odds ratio and 95% CI. Health care resource utilization including preventive care was compared using the doubly robust generalized linear model, with results reported as incidence rate ratios and corresponding 95% CIs. RESULTS:After applying eligibility criteria, the study included 1,245 people in the LA ART cohort (mean age, 47 years; 24.1% female). The oral ART cohort included 58,644 people (mean age, 50 years; 23.3% female). In the standardized mortality ratio-weighted analysis, the LA ART cohort had higher adherence rates (73.7% vs 30.1%) and higher persistence (median [IQR], 424 [201, 537] vs 393 [174, 431] days; P < 0.001 for all) compared with the oral ART cohort. Over 12 months, we observed significantly higher odds of adherence for the LA ART vs oral ART cohorts (adjusted odds ratio = 8.06; 95% CI = 6.62-9.81; P < 0.001). The LA ART cohort also had higher rates of vaccinations, cancer and STI screenings, and bone density testing and lower hospitalization rates. CONCLUSIONS:People who switched to LA ART had significantly higher 12-month adherence and persistence over the follow-up compared with people remaining on oral ART. Higher key preventive measure rates and lower hospitalization rates among people who switched to LA ART highlight increased medical engagement benefits.

The LATITUDE trial demonstrated that cabotegravir + rilpivirine long-acting (CAB+RPV LA) is superior in efficacy compared to daily oral antiretroviral therapy (ART) in people with HIV (PWH) with documented prior adherence challenges. The real-world experiences of PWH from PREFER-LA (Perspectives on Treatment with CAB+RPV LA Injectable Therapy from PWH in the US with Prior Adherence Challenges to Oral ART) are presented.Figure 1.PWH (survey) and HCP (eCRF) reasons for switching to CAB+RPV-LA (n = 159, multiple choices allowed)Figure 2.PWH concerns before and after switching to CAB+RPV-LA (PWH survey, n = 159, multiple choices allowed) PREFER-LA was an observational real-world study of PWH from across the US receiving CAB+RPV LA for ≥6 months to ≤18 months with documented adherence challenges to prior oral ART. The study consisted of: (1) cross-sectional survey of PWH to evaluate experiences of historical oral ART use and perspectives of treatment with CAB+RPV LA, (2) corresponding retrospective medical chart review (eCRF) to establish treatment history and clinical outcomes, and (3) cross-sectional survey of healthcare providers (HCP) from each site.Figure 3.Treatment Preference (PWH survey, n=159)Figure 4.HCP reported benefits of implementing CAB+RPV-LA for adherence challenged PWH and reasons why HCPs think PWH will remain on CAB+RPV-LA long-term (HCP survey, n=13) Median age of participants (n=159) was 39 years old and median time since HIV diagnosis was 11.7 years. Majority were Black/African American (57%). The primary driver for switching to CAB+RPV LA for both PWH and HCP focused on adherence (Figure 1). Most PWH concerns about switching to a long-acting injectable were alleviated after switching to CAB+RPV LA (Figure 2). The majority of PWH agreed that switching to CAB+RPV LA has positively affected their HIV control (79%), their overall health (67%), quality of life (79%) and better fits their lifestyle (83%). When prompted, PWH reported more positive feelings towards themselves (79%) since switching to CAB+RPV LA and 90% of PWH were very likely to recommend CAB+RPV LA to other PWH with adherence challenges. Almost all PWH preferred CAB+RPV LA over daily oral ART (Figure 3). HCPs reported several benefits for CAB+RPV LA (Figure 4) and that 95% of PWH would remain on CAB+RPV LA long term. Most PWH (77%) reported benefits from regular clinic visits, including ensured adherence, HIV control, and more opportunities to discuss health concerns. In this observational real-world study, PWH switching to CAB+RPV LA after experiencing prior adherence challenges on oral ART overwhelmingly preferred CAB+RPV LA due to numerous benefits of switching to a long-acting injectable. Zachary Henry, DO, gilead: Grant/Research Support|Therapharmaceutical: Grant/Research Support|ViiV Healthcare: Grant/Research Support Stephanie Kirk, PharmD, ViiV Healthcare: Grant/Research Support Maurice Brownlee, APRN, EMD Serono: Grant/Research Support|EMD Serono: Honoraria|Gilead Sciences: Grant/Research Support|Gilead Sciences: Honoraria|Napo Pharmaceuticals: Grant/Research Support|Napo Pharmaceuticals: Honoraria|ViiV Healthcare: Grant/Research Support|ViiV Healthcare: Honoraria Neil Reynolds, PhD, Adelphi Real World: Advisor/Consultant Hannah Wallis, MS, Adelphi Real World: Advisor/Consultant Mona Amet, MPH, Adelphi Real World: Advisor/Consultant Ann Linskey, PharmD, AAHIVP, ViiV Healthcare: employee|ViiV Healthcare: Stocks/Bonds (Public Company) Jimena Patarroyo, PharmD, AAHIVP, ViiV Healthcare: Stocks/Bonds (Private Company) Deanna Merrill, PharmD, MBA, AAHIVP, ViiV Healthcare: employee Edgar T. Overton, MD, ViiV Healthcare: Employment|ViiV Healthcare: Stocks/Bonds (Public Company) Cindy Garris, MS, ViiV Healthcare: employee|ViiV Healthcare: Stocks/Bonds (Public Company) Andrew P. Brogan, PhD, ViiV Healthcare: Employee|ViiV Healthcare: Stocks/Bonds (Public Company)

Long-acting cabotegravir plus rilpivirine (CAB + RPV LA) administered monthly or every 2 months is recommended by treatment guidelines for maintenance of virologic suppression in people with human immunodeficiency virus type 1 (HIV-1). In clinical trials, CAB + RPV LA demonstrated noninferiority versus United States (US) Food and Drug Administration-approved daily oral therapy, and outcomes in real-world settings can supplement these results. We present month 12 results of BEYOND. BEYOND is an ongoing, 2-year, multicenter, prospective, observational real-world study of adults initiating CAB + RPV LA in the US. Key outcomes included reasons for initiating, virologic outcomes, adherence, and patient-reported outcomes related to treatment satisfaction and treatment challenges at baseline and month 12. In total, 308 participants (median age, 45 years; 83% identified as male; 39% identified as Black) initiated CAB + RPV LA most commonly because of treatment fatigue, adherence anxiety with daily oral therapy, and/or convenience. Of participants with baseline viral load data, 97% (194/200) had a viral load <50 copies/mL for their most recent test reported at month 12. Mean treatment satisfaction scores increased significantly from baseline to month 12 and 97% (223/229) of participants preferred LA versus oral treatment at month 12. Proportions of participants reporting "always" or "often" experiencing challenges related to HIV-1 treatment (fear of disclosure, adherence anxiety, reminder of HIV-1 status, and feeling stigmatized) decreased from baseline to month 12. Month 12 results from the real-world BEYOND study support the effectiveness of CAB + RPV LA for maintenance of virologic suppression and as a preferred treatment option for people with HIV-1.

Abstract Background CAB+RPV LA is a complete HIV regimen which offers less frequent (monthly or every 2 months) dosing than daily oral ART. This real-world study provides additional utilization data of CAB+RPV LA and characterizes the experiences of people with HIV (PWH) receiving CAB+RPV LA in the US. Methods Data were obtained from the Adelphi HIV Disease Specific Programme™, a real-world, cross-sectional survey containing retrospective longitudinal data of healthcare professionals (HCP) and their PWH on CAB+RPV LA and over two periods (Jul 2021-Mar 2022 and Sept 2023-Feb 2024). HCPs reported demographics, clinical characteristics, and adherence for PWH on CAB+RPV LA aged ≥18 years. PWH surveys included treatment satisfaction, treatment preference and health-related quality of life (HRQoL) (HIV-specific PozQoL [score range 13-65], and EQ-5D-5L-US [score range 0-1]). Data were analyzed descriptively. Results HCPs (n=77) reported data for 237 PWH on CAB+RPV LA treatment for a median [IQR] of 1.0 [0.5, 1.7] years (n=202) at time of data collection, with 65% receiving CAB+RPV LA every 2 months (n=205). Mean age was 42 years, 20% were cisgender female, 43% were non-white (n=205) (Table 1). Top HCP-reported reasons for initiating CAB+RPV LA were tolerability (51%) and virologic potency (50%) (Figure 1). Top PWH-reported reasons for initiating CAB+RPV LA were “more convenient for my life” (43%) and “more convenient when travelling” (36%) (Figure 1). High levels of HCP-reported adherence were seen: 92% (n=205) of PWH received injections either early or within ± 7-day dosing window despite only 64% (n=103) of PWH reported to be completely adherent to prior oral ART. HCP-reported treatment satisfaction was high (93% satisfied/very satisfied). Of PWH who completed a survey, 95% (38/40) were satisfied/very satisfied with CAB+RPV LA. PWH had high HRQoL (PozQoL summary score 49.0 [SD 8.3; n=38] and EQ-5D-5L-US mean 0.88 [SD 0.14], n=39). PWH (82%) reported that fitting injection visits into their schedule was easy/extremely easy (Figure 2). CAB+RPV LA was preferred by 93%, and PWH reported numerous benefits of in-person visits to receive CAB+RPV LA (Figure 2). Conclusion PWH receiving CAB+RPV LA are adherent, highly satisfied, have high HRQoL, prefer LA regimens and reported benefits of in-person visits. Disclosures Andrew P. Brogan, PhD, GSK: Stocks/Bonds (Public Company)|ViiV Healthcare: Employee Tim Holbrook, BSc, Adelphi Real World: Employee|ViiV Healthcare: The Adelphi Real World Disease Specific Programme is wholly owned by Adelphi Real World; ViiV healthcare is one subscriber and paid for the analysis Fritha Hennessy, PhD, Adelphi Real World: Employee|ViiV Healthcare: The Adelphi Real World Disease Specific Programme is wholly owned by Adelphi Real World; ViiV healthcare is one subscriber and paid for the analysis Will Ambler, PhD, Adelphi Real World: Employee|ViiV Healthcare: The Adelphi Real World Disease Specific Programme is wholly owned by Adelphi Real World; ViiV healthcare is one subscriber and paid for the analysis Oliver-Thomas Carter, BSc, Adelphi Real World: Employee|ViiV Healthcare: The Adelphi Real World Disease Specific Programme is wholly owned by Adelphi Real World; ViiV healthcare is one subscriber and paid for the analysis Cindy Garris, MS, GSK: Stocks/Bonds (Public Company)|ViiV Healthcare: Employee

Abstract Background Administering intramuscular CABENUVA at infusion centers (ICs) offers a convenient alternative for patients to receive treatment. Giving Long Acting CABENUVA in Infusion centERs (GLACIER) examined feasibility and fidelity of delivering monthly and every 2-monthly CABENUVA at ICs from the perspective of patient study participants (PSP) over 8 months. Methods Study data includes clinical data and questionnaires to examine PSPs experiences receiving CABENUVA in IC routine care. Quantitative questionnaires include the Feasibility of Intervention Measure (FIM), the Acceptability of Intervention Measure (AIM), and implementation questions. Qualitative interviews were completed with a subset of PSPs. Results Enrolled participants (n=44) had a mean age of 46.8, 20.5% female at birth, and 51.2% had not previously received CABENUVA. 96.4% (187/194) of injections were within the treatment window. No study withdrawal or treatment discontinuation were due to AEs. There were 16 ISR AEs in 12 participants and 19 treatment related AE in 13 participants; most were mild (Grade 1) or moderate (Grade 2). Injection site discomfort (14%) and pain (14%) were cited most frequently. No SAEs were reported. At Month 8, IC administration was highly feasible (FIM: M=4.41) and acceptable (AIM: M=4.51). Advantages of ICs included ease of parking, convenient location, ease of scheduling/rescheduling, privacy, others not knowing what medication they received, and reduced stigma (Table 1). At Month 8, 94.6% of PSPs reported being very or extremely satisfied with the ICs care. Qualitative interviews highlighted positive views of IC administration, including staff relationships and continuity in care as key acceptability factors. Conclusion CABENUVA administration at ICs was safe, effective, and convenient. High levels of adherence to the treatment window, acceptability, and feasibility were reported. Rapport with IC staff, continuity in care, reduction in logistical barriers and the perception of decreased stigma highlight that ICs can be a valuable alternative site of care for CAEBNUVA administration. ICs should be considered to improve convenience of treatment administration and when HCP offices have limited capacity. Disclosures Cassidy Gutner, PhD, GSK: Stocks/Bonds (Public Company)|ViiV Healthcare: Employee Conn M. Harrington, BA, GSK: Stocks/Bonds (Public Company)|ViiV Healthcare: Employee Gilda Bontempo, MD, GSK: Stocks/Bonds (Public Company)|ViiV Healthcare: Employee Sivakumar Pazhamalai, BPharm, GSK: Employee Abhishek Kumar, MSc, GSK: Employee|GSK: Stocks/Bonds (Public Company) Kelly Rimler, MS, GSK: Employee Karen Davis, MS, RN, GSK: Stocks/Bonds (Public Company)|ViiV Healthcare: Employee Will Williams, n/a, GSK: Employee|GSK: Stocks/Bonds (Public Company) Deanna Merrill, PharmD, MBA, AAHIVP, GSK: Stocks/Bonds (Public Company)|ViiV Healthcare: Employee Lisa Petty, MT(ASCP), GSK: Stocks/Bonds (Public Company)|ViiV Healthcare: Employee Cindy Garris, MS, GSK: Stocks/Bonds (Public Company)|ViiV Healthcare: Employee Supriya Sarkar, PhD, MPH, GSK: Stocks/Bonds (Public Company)|ViiV Healthcare: Full time employee Patrick Daniele, MS, GSK: Advisor/Consultant|ViiV Healthcare: Advisor/Consultant Bridget Gaglio, PhD, MPH, Thermo Fisher Scientific: Stocks/Bonds (Public Company) Maggie Czarnogorski, MD MPH, GSK: Stocks/Bonds (Public Company)|ViiV Healthcare: Employee

Background Cabotegravir (CAB) + rilpivirine (RPV) dosed monthly or every 2 months is a complete long-acting (LA) regimen for the maintenance of human immunodeficiency virus type 1 virologic suppression. Across the phase 3/3b trials, the most frequently reported adverse events were injection site reactions (ISRs).Methods We present pooled ISR characteristics and outcomes for participants receiving CAB + RPV LA through week 96 of the FLAIR and ATLAS-2M studies, and survey results from healthcare providers (HCPs) giving injections (eg, injectors) in the ATLAS, FLAIR, and ATLAS-2M studies to determine optimal injection techniques. Surveys were anonymous, self-administered online questionnaires that queried provider demographics, injection experience, and techniques to minimize pre-/postinjection discomfort. Data were summarized using descriptive statistics.Results Overall, 8453 ISRs were reported by 801 participants receiving >= 1 injection of CAB LA/RPV LA. Most ISRs were mild to moderate in severity (grade 1-2, 99%), with a median duration of 3 days (interquartile range, 2-4 days), and rarely led to withdrawal (2%). Surveys were completed by 181 HCPs across 113 sites. Pushing the intramuscular injection at slow speed (66%), bringing the medication to room temperature (58%), and relaxing the gluteus muscle before injecting (53%) were ranked as effective preinjection/injection procedure practices for minimizing pain. Most injectors (60%) indicated that a prone position provided optimal patient comfort, and 41% had no preference on injection medication order.Conclusions Taken together, the data demonstrate favorable tolerability with CAB + RPV LA injections over the long term and simple techniques routinely used by injectors to help optimize the administration of CAB + RPV LA injections. Most injection site reactions were mild to moderate in severity and short-lived, decreased in frequency over time, and infrequently led to withdrawal, demonstrating favorable tolerability with cabotegravir + rilpivirine long-acting injections. Graphical Abstract This graphical abstract is also available at Tidbit: https://tidbitapp.io/institutional-portal/open-forum-infectious-diseases/tidbits/cabotegravir-rilpivirine-long-acting-overview-of-injection-guidance-injection-site-reactions-and-best-practices-for-intramuscular-injection-administration

Treatment of HIV has historically required taking daily oral antiretroviral therapy (ART). A recent alternative to daily oral ART is long-acting injectable ART with cabotegravir plus rilpivirine, administered monthly or every 2 months. The purpose of this qualitative study was to evaluate the concept relevance and interpretability of five previously developed questions: one treatment preference question and four questions designed to assess how the emotional burden associated with HIV treatment impacts treatment preferences. Thirty adults in the United States currently receiving HIV treatment were enrolled in a cross-sectional study involving one-on-one concept confirmation and cognitive debriefing interviews. Concept confirmation interviews included topics, questions, and probes designed to elicit information about the emotional burden of HIV and current perceptions of a participant's treatment regimen. Cognitive debriefing assessed the relevance and clarity of instructions, questions, response options, and recall periods. Transcripts were analyzed with MAXQDA. Mean age of participants was 49 years (range: 29-68), with 60% being male and 40% female. Racial demographics included Blacks (40%), Whites (40%), and other (20%). During concept confirmation, participants endorsed concepts relevant to HIV treatment preference: fear of disclosure of HIV status (47%), forgetting to take daily oral medication (40%), and current treatment regimen as a bothersome daily reminder of HIV status (40%). During cognitive debriefing, participants interpreted the instructions, question, response options, and recall periods as intended for the treatment preference question. Additionally, participants confirmed that the preference question's response options were appropriate and relevant to the experiences of people living with HIV. Participants also consistently interpreted the questions related to fear of disclosure of HIV status, anxiety associated with forgetting to take HIV medication, and HIV medication being an uncomfortable reminder of HIV status; however, participants provided variable responses to the question designed to assess treatment ease of use. These results support the concept relevance and interpretability of the single treatment preference question and three of the four emotional well-being questions among adults living with HIV.

Abstract Background CAB+RPV LA is the only complete long-acting regimen for treatment of virologically suppressed people with HIV (PWH). Administered monthly or every 2 months by a healthcare provider (HCP), CAB+RPV LA may alleviate challenges associated with daily oral antiretroviral therapy (ART). Perspectives of PWH receiving CAB+RPV LA in real-world US healthcare settings are needed. Methods This 2-year prospective, observational study enrolled treatment experienced PWH following the decision to switch to CAB+RPV LA (monthly or every 2 months) across 30 participating US sites. Participants completed baseline (BL) surveys prior to first injection and follow-up surveys at Month 6 (M6). Surveys assessed challenges with daily oral ART, reasons for initiating CAB+RPV LA, HIV treatment satisfaction using the HIV Treatment Satisfaction Questionnaire (HIVTSQ), preference for daily oral vs. injectable, and benefits of more frequent clinic visits. Results A total of 308 PWH were enrolled and completed BL surveys (Table 1); 217 PWH had reached the M6 timepoint and completed M6 surveys as of data cut-off (Jan 2023); of the 217 PWH, 8 reported they had discontinued CAB+RPV LA. At BL, 49% respondents reported sometimes, often, or always hiding their prior oral ART for fear of disclosing HIV status. The common primary reasons PWH chose to start CAB+RPV LA were: tired of taking daily oral ART, wanted a more convenient treatment option, and worried about missing a dose (Table 2). At M6, PWH receiving CAB + RPV LA reported a decrease from BL in fear of disclosure, anxiety around adherence, and daily reminder of HIV. At M6, 88% of PWH reported CAB+RPV LA was rarely or never an unwelcome reminder of their HIV status vs. 50% at BL with prior oral ART. Most participants preferred CAB+RPV LA (95%), 2% preferred daily oral ART, and 2% had no preference at M6. Treatment satisfaction increased from BL to M6; most reported multiple additional benefits with more frequent clinic visits (Table 3). Conclusion Switching to CAB + RPV LA demonstrated improvements in fear of disclosure, anxiety around adherence, and daily reminder of HIV status at M6 (Fig. 1-3). PWH reported a strong preference for CAB+RPV LA, increased treatment satisfaction, and more opportunities to engage with their HIV care. Disclosures Dima Dandachi, MD, MPH, ViiV Healthcare: Advisor/Consultant|ViiV Healthcare: Grant/Research Support Douglas Cunningham, DO, ViiV Healthcare: Advisor/Consultant William M. Valenti, MD, FIDSA, Gilead: Grant/Research Support|ViiV Healthcare: Grant/Research Support John Phoenix, MSN, APRN, FNP-C, Gilead: Grant/Research Support|Gilead: Speaker Bureau|Huntridge Family Clinic: Ownership Interest|Napo Pharmaceuticals: Speaker Bureau|ViiV Healthcare: Grant/Research Support|ViiV Healthcare: Speaker Bureau Paula Teichner, PharmD, GlaxoSmithKline: Stocks/Bonds|ViiV Healthcare: Employment Maria Reynolds, MStat, RTI Health Solutions: Employment|ViiV Healthcare: Grant/Research Support Cindy Garris, MS, GSK: Stocks/Bonds|ViiV Healthcare: Employee

Abstract Background Shared decision-making tools (SDT) support conversations between healthcare providers (HCPs) and patients around evidence-based care options. With the FDA approval of long-acting injectable (LA) pre-exposure prophylaxis (PrEP) creating the choice of daily oral or LA PrEP for HIV prevention, formative research was conducted to inform the development and assessment of a prototype PrEP SDT. Methods People who may benefit from PrEP (PWBP) (n=41) and PrEP HCPs (n=20) participated in in-depth interviews (IDIs) in Spanish or English at two sites in Washington, D.C. to explore knowledge and perceptions of daily oral and LA PrEP through 2021 and 2022. Based on input from IDIs, including on desired SDT content, a prototype PrEP SDT was developed and piloted in 37 PWBP-HCP mock encounters, including ten in Spanish, at sites in D.C. and North Carolina through 2022 and 2023. Field notes from post-encounter exit interviews were analyzed to identify content and format refinement as well as implementation implications. Matrices were used to synthesize and compare findings across populations and sites. Results A diverse sample of PWBP and HCPs participated in IDIs (Table 1) and exit interviews (Table 2). Participants found the language, visuals, content and flow of the prototype SDT to be broadly acceptable with minor suggestions for additional content. PWBP felt the SDT addressed knowledge deficits about PrEP and that the format aided PrEP decision-making. HCPs liked that the SDT systematized clinic visits and was appropriate for never and ever PrEP users. The SDT was seen to normalize PrEP conversations and reduce stigma around PrEP use by facilitating non-judgmental and more interactive dialogue. Themes related to implementation included: the potential benefit of reviewing the SDT prior to a clinical visit and provider orientation on SDT use; the value of access to additional details on side effects and research on oral and LA PrEP; and the importance of PWBP-HCP dynamics. Conclusion The prototype PrEP SDT supported PrEP knowledge and choice for both ever and never PWBP while reducing stigma around PrEP use across settings and populations. It provided HCPs with content and a format that ensured comprehensive, acceptable delivery of PrEP choice information. Disclosures Aimee A. Metzner, PharmD, AAHIVP, ViiV Healthcare: Full-time employee (salary/benefits/etc.)|ViiV Healthcare: Stocks/Bonds Alan Oglesby, MPH, GlaxoSmithKline: Employment|GlaxoSmithKline: Stocks/Bonds Cindy Garris, MS, GSK: Stocks/Bonds|ViiV Healthcare: Employee David A. Wohl, M.D., Gilead: Advisor/Consultant|Gilead: Grant/Research Support|Janssen: Advisor/Consultant|Theratech: Advisor/Consultant|ViiV: Advisor/Consultant

Abstract Background CAB+RPV LA is the only complete long-acting regimen for treatment of virologically suppressed PWH. Administered monthly or every 2 months by a healthcare provider, CAB+RPV LA may alleviate adherence challenges with daily oral therapy. The ABOVE study evaluated real-world adherence and persistence to CAB+RPV LA versus remaining on oral ART regimens. Methods ABOVE was a retrospective US cohort study using Symphony Health Solutions Integrated Dataverse administrative claims database from 01/01/2020 to 12/31/2022. PWH ≥12 years of age on stable guideline-recommended oral ART were categorized into those initiating CAB+RPV LA and those remaining on oral ART. Index date was defined as first injection between 01/01/2021 and 6/30/2022 (CAB+RPV LA cohort) or imputed for the oral ART cohort. PWH were required to have ≥6 months of follow-up after index. Standardized mortality ratio (SMR) weights were generated based on propensity scores to balance baseline characteristics between cohorts. Adherence (proportion of days covered (PDC) ≥0.9 over 6-months following index) and persistence to the index regimen (days from index to the earliest of treatment discontinuation or end of follow-up) were compared. Logistic regression model was used to estimate the odds ratio (OR) and 95% confidence interval (CI) for adherence. Results 393,484 PWH were identified during the study period. After applying eligibility criteria, 130,362 in the oral ART cohort (N=950 after weighting) and 947 in the CAB+RPV LA cohort comprised the analysis sample. Key baseline characteristics were balanced post SMR weighting (Table 1). Majority of CAB+RPV LA dosing was every two months only (50%) or switched from monthly to every two months (33%). A higher proportion of PWH in the CAB+RPV LA cohort were adherent (72% vs 43%, p< 0.001) and had higher persistence (274 vs 256 days, p< 0.001) compared with the oral ART cohort (Table 2). PWH in the CAB+RPV LA cohort had significantly higher adjusted odds of being adherent compared to the oral ART cohort (OR: 4.43, 95% CI: 2.38, 8.24, p< 0.001). Conclusion These data demonstrate that, among US PWH on stable oral ART, switching to long-acting ART resulted in significantly higher adherence and persistence, a critical aspect of long-term success of HIV treatment, compared with remaining on oral ART. Disclosures Cindy Garris, MS, GSK: Stocks/Bonds|ViiV Healthcare: Employee Raj Desai, PhD, Analysis Group, Inc: Employment|ViiV Healthcare: Grant/Research Support Rose Chang, ScD, Analysis Group, Inc.: Employee|ViiV Healthcare: Grant/Research Support Louise Clear, MPH, Analysis Group, Inc.: Employment|ViiV Healthcare: Grant/Research Support Zhuo Chen, MPH, Analysis Group, Inc.: Employment|ViiV Healthcare: Grant/Research Support Daisy Liu, MS, Analysis Group, Inc.: Employment|ViiV Healthcare: Grant/Research Support Maral DerSarkissian, PhD, Analysis Group, Inc: Employment|ViiV Healthcare: Grant/Research Support Paula Teichner, PharmD, GlaxoSmithKline: Stocks/Bonds|ViiV Healthcare: Employment Edgar T. Overton, MD, ViiV Healthcare: Employment|ViiV Healthcare: Stocks/Bonds

Abstract Background Cisgender women (CGW) account for 48% of new HIV infections globally and 18% of new HIV infections in the United States (US) but comprise only 8% of daily oral PrEP users in the US. Social-structural factors including stigma, gender norms, and medical provider bias have been linked to daily oral PrEP inequities among CGW. These factors influencing PrEP utilization merit further attention as additional options emerge, including long-acting (LA) injectable PrEP. Methods PrEP preferences, barriers, and facilitators to uptake were explored through 60 in-depth interviews with CGW with indications for PrEP (n=40), and HIV and reproductive healthcare providers (HCPs) (n=20) in Washington, DC, US and Santo Domingo, Dominican Republic (DR) in 2021 and 2022 (Table 1). CGW in the DR were female sex workers (FSW), while those in DC were seeking reproductive health services. Thematic content analysis was employed. Results Participants noted low awareness of PrEP, particularly LA PrEP, among CGW across settings and indicated this may be in part due to ongoing emphasis on PrEP for men who have sex with men and transgender women compared to CGW. In DC and the DR, PrEP was often seen as a potential empowerment tool by CGW to address social-structural constraints, gender-related pressures and responsibilities, and inequitable partner dynamics. The perceived need for and preferences regarding daily oral vs. LA injectable PrEP was mixed among CGW in DC due to varied self-assessment regarding PrEP as a priority and some CGW’s comfort with pill taking. LA PrEP was described by some CGW as a means to improve adherence and reduce stigma associated with pill taking. FSW in the DR were particularly interested in LA PrEP as they found it more compatible with their work. Suggested facilitators of PrEP uptake noted across settings included financial and logistical support (transport, childcare) and HCP training on CGW’s PrEP needs. Conclusion Tailored CGW-centered awareness campaigns and sensitivity training for HCPs related to PrEP options for CGW are needed. Access to LA PrEP for FSW is critical given the disproportionate impact of HIV on this community and their work-related PrEP preferences. Interventions must address social-structural factors among CGW to support equitable PrEP uptake. Disclosures Aimee A. Metzner, PharmD, AAHIVP, ViiV Healthcare: Full-time employee (salary/benefits/etc.)|ViiV Healthcare: Stocks/Bonds Alan Oglesby, MPH, GlaxoSmithKline: Employment|GlaxoSmithKline: Stocks/Bonds Cindy Garris, MS, GSK: Stocks/Bonds|ViiV Healthcare: Employee Rachel Scott, MD,MPH,FACOG, Gilead Science: Grant/Research Support|ViiV/GSK: Grant/Research Support

A long-acting injectable (LAI) antiretroviral therapy (ART) regimen is now available as a treatment option for virologically suppressed adults with HIV-1. This study assessed preference for a LAI regimen using an online survey of virally suppressed people living with HIV (PLWH) and physicians treating HIV in the US and Canada. Preference was elicited in a discrete choice experiment (DCE) with three choice options (switch to a LAI regimen, switch to another daily oral ART regimen, or stay on their current daily oral ART regimen) and four treatment attributes. A total of 553 PLWH and 450 physicians completed the survey. From the DCE results, 59% of PLWH were predicted to prefer a LAI over an alternative oral ART or staying on their current oral treatment, and 55–66% of physicians were predicted to recommend LAI for PLWH, depending on the treatment challenge scenario presented. PLWH indicated LAI would remove daily reminders of HIV (75%) and reduce feelings of being stigmatized (68%). A majority of PLWH and physicians preferred a LAI over oral ART to overcome treatment challenges such as daily pill burden and adherence. These benefits of LAI ART along with preferences of PLWH and physicians can help to inform ART choice.

Introduction CUSTOMIZE evaluated the implementation of long-acting (LA) cabotegravir + rilpivirine, a novel healthcare provider-administered injectable antiretroviral therapy regimen, in diverse US healthcare settings. Findings from staff-study participants (SSPs) through 12 months of implementation are reported. Methods CUSTOMIZE was a phase IIIb, 12-month, single-arm, hybrid III implementation-effectiveness study conducted from July 2019 to October 2020 at eight US clinics of five clinic types: private practice (n = 2), federally qualified health centre (n = 2), university (n = 2), AIDS Healthcare Foundation (n = 2) and health maintenance organization (n = 1). Eligible patient participants received monthly cabotegravir + rilpivirine LA injections after a 1-month oral lead-in. At baseline, month 4 and month 12, SSPs (n = 3 each per clinic), including physicians, nurses or injectors, and administrators, completed quantitative surveys and semi-structured interviews to assess implementation outcomes (acceptability, appropriateness and feasibility of intervention measures), programme sustainability and SSP perceptions of, attitudes towards, and expectations for cabotegravir + rilpivirine LA. Month 12 data collection occurred during the COVID-19 pandemic. Results In surveys, SSPs reported high mean total scores for acceptability, appropriateness and feasibility of cabotegravir + rilpivirine LA implementation at baseline (4.43, 4.52 and 4.38 of 5, respectively) and month 12 (4.45, 4.61 and 4.46 of 5, respectively), regardless of clinic type. At month 12, SSPs were positive about the implementation sustainability (mean Program Sustainability Assessment Tool score, 5.83 out of 7). At baseline, SSPs' top concern was patients' ability to maintain monthly appointments (81%); at month 12, 39% had this concern. The proportion of SSPs reporting patient injection pain or soreness as a barrier was consistent at month 12 versus baseline (48% vs. 46%). Most (78%) SSPs reported optimal implementation of cabotegravir + rilpivirine LA in their clinics was achieved in 1-3 months. In interviews, SSP-reported strategies for successful implementation included teamwork, using a web-based treatment planner and having a designated person to track appointment scheduling. In month 12 interviews, SSP-reported structural changes needed for implementation included changing clinic hours and purchasing refrigerators. Conclusions In CUSTOMIZE, cabotegravir + rilpivirine LA was successfully implemented across a range of US healthcare settings. Barriers were mitigated with minor process adjustments.

Abstract Background Pill burden associated with antiretroviral multiple-tablet regimens (MTR) can impact adherence. The shift to single-tablet regimens (STR) has lagged for people living with HIV (PLWH) covered by Medicaid. This study examines persistence, adherence, healthcare resource utilization (HCRU), and costs by STR or MTR use for new initiators and treatment-experienced PLWH over a 1-year study period. Methods A linked patient population was applied using data from IQVIA’s Prescription Claims (Rx), Professional Fee Claims (Dx), and Hospital Charge Data Master (CDM). A 6-month pre-index period was used to assess study eligibility and baseline characteristics. A 12-month post-index period was used to descriptively evaluate treatment patterns and HCRU/costs. Two mutually exclusive cohorts were created based on STR or MTR use during the selection window (01/2018-07/2019). For the STR cohort, date of the first STR claim during the selection window was termed the index date. For the MTR cohort, the date of the first MTR drug during the selection window was termed the index date. Results The final sample comprised 4,603 PLWH in the STR cohort and 2,728 in the MTR cohort (Table 1). The proportion persistent over the 1-year follow-up was higher among treatment experienced compared to new initiators, and higher for STR compared to MTR (Figure 1A). The proportion adherent was higher among treatment experienced compared to new initiators, and higher for STR compared to MTR (Figure 1B). HIV-specific per member per month (PMPM) pharmacy costs were higher among treatment experienced compared to new initiators, and higher for MTR compared to STR (Figure 2). Adherent PLWH had a lower proportion with ≥ 1 all-cause emergency room visit compared to non-adherent PLWH within a cohort/treatment status category; minimal differences in ≥ 1 all-cause hospitalization. Adherent PLWH had higher mean all-cause costs than non-adherent PLWH, driven by pharmacy costs. STR PLWH had lower mean all-cause total costs compared to MTR PLWH with the same adherence/treatment experience status (Figure 3). Conclusion PLWH enrolled in Medicaid are more persistent and adherent to STR than MTR. Among PLWH adherent to antiretroviral therapy, STR offer potential cost savings over MTR for appropriate patients. Disclosures Andrew P. Brogan, PhD, ViiV Healthcare: Employee, Salary|ViiV Healthcare: Stocks/Bonds Cindy Garris, MS, ViiV Healthcare: Employee|ViiV Healthcare: Stocks/Bonds Julie Priest, MSPH, ViiV Healthcare: Employee, Salary|ViiV Healthcare: Stocks/Bonds Victoria Divino, BA, IQVIA: Employee, Salary|ViiV Healthcare: Grant/Research Support Jing He, PhD, IQVIA: Employee, Salary|ViiV Healthcare: Grant/Research Support Justin Chen, MHS, IQVIA: Employee, Salary|ViiV Healthcare: Grant/Research Support Mitch DeKoven, MHSA, IQVIA: Employee, Salary|ViiV Healthcare: Grant/Research Support.

Abstract Background The shift to antiretroviral single-tablet regimens (STR) from multiple-tablet regimens (MTR) has lagged for people living with HIV (PLWH) covered by Medicaid. This study examines STR and MTR utilization and pharmacy costs over a 5-year period for PLWH enrolled in Medicaid. Methods This retrospective study used IQVIA’s Prescription Claims (Rx) data to identify two mutually exclusive cohorts based on STR or MTR use within each of 5 calendar years (2016-2020). For the STR cohort, the date of the first STR claim in each calendar year was termed the index date. For the MTR cohort, the date of the first MTR drug in the first observed complete MTR regimen in each calendar year was termed the index date; a window of 5 days between prescription fills for the agents used in an MTR regimen was allowed. The regimen received on the index date was used to assign the study cohort for each year and study measures were reported for each of the 5 calendar years. Additional eligibility criteria are provided in Table 1. Results The final STR cohort was 47,140 (14.5% of the initial sample) in 2016 and 73,111 (13.5%) in 2020 (Table 1). The final MTR cohort was 36,007 (15.5%) in 2016 and 20,264 (13.5%) in 2020. The distribution of PLWH with Medicaid Fee-For-Service (FFS) or Medicaid managed care was generally similar by year for both STR and MTR cohorts from 2016 to 2019 (Figure 1); Medicaid managed care enrollment for both cohorts increased in 2020 (62.4-62.9%). Among PLWH, STR use increased annually from 56.7% in 2016 to 78.3% in 2020 (Figure 2). Conversely, MTR use decreased from 43.3% to 21.7% over the same time period. The increase in STR utilization over time was consistent for both plan types. Mean HIV-specific per member per month (PMPM) pharmacy costs were similar across years for both STR and MTR cohorts, ranging from $2,016-$2,342 for STR cohorts and $2,247-$2,380 for MTR cohorts (Figure 3). Conclusion Between 2019 and 2020, PLWH enrolled in Medicaid shifted from FFS towards managed care. STR use among PLWH enrolled in Medicaid increased from 2016 to 2020 with minimal differences in PMPM pharmacy costs compared with PLWH enrolled in Medicaid receiving MTR. Disclosures Andrew P. Brogan, PhD, ViiV Healthcare: Employee, Salary|ViiV Healthcare: Stocks/Bonds Cindy Garris, MS, ViiV Healthcare: Employee|ViiV Healthcare: Stocks/Bonds Julie Priest, MSPH, ViiV Healthcare: Employee, Salary|ViiV Healthcare: Stocks/Bonds Victoria Divino, BA, IQVIA: Employee, Salary|ViiV Healthcare: Grant/Research Support Jing He, PhD, IQVIA: Employee, Salary|ViiV Healthcare: Grant/Research Support Justin Chen, MHS, IQVIA: Employee, Salary|ViiV Healthcare: Grant/Research Support Mitch DeKoven, MHSA, IQVIA: Employee, Salary|ViiV Healthcare: Grant/Research Support.

Introduction The CUSTOMIZE hybrid III implementation-effectiveness study evaluated implementation of once-monthly long-acting (LA) cabotegravir + rilpivirine in diverse US healthcare settings. Here, we report patient participant perspectives after 12 months in CUSTOMIZE. Methods CUSTOMIZE was a phase IIIb, 12-month study conducted from July 2019 to October 2020 at eight diverse US HIV clinics that enrolled virologically suppressed people living with HIV-1 (PLHIV) on a stable oral regimen to receive monthly cabotegravir + rilpivirine LA injections after a 1-month oral lead-in. Participants were administered quantitative surveys before injections at months 1 (baseline), 4 and 12. A randomly selected subset of participants was interviewed at baseline and month 12. Data collection at month 12 was completed by October 2020 (during the COVID-19 pandemic). Results At baseline, 109 and 34 participants completed surveys and interviews, respectively; 87% were male; 35% were Black or African American. All participants who remained in the study at month 12 (n = 102) maintained HIV-1 RNA <50 copies/ml; two participants withdrew due to injection-related reasons. Mean total scores measuring acceptability and appropriateness of cabotegravir + rilpivirine LA were high at baseline (4.5-4.6 out of 5) and month 12 (4.7-4.9). At month 12, 74% of participants reported nothing interfered with receiving LA injections; injection pain or soreness was the most common concern (15%). Time spent in the clinic and coming to the clinic for monthly injections was very or extremely acceptable after 12 months for most participants (93% and 87%, respectively), with 64% reporting having spent <= 30 minutes in the clinic for injection visits. At month 12, 92% of participants preferred LA injections to daily oral tablets (3%); 97% plan to continue LA treatment going forward. In month 12 interviews, 24 (77%) of 31 participants reported the COVID-19 pandemic did not impact their ability to receive treatment. Conclusions Once-monthly cabotegravir + rilpivirine LA was highly acceptable among PLHIV who were virologically suppressed on a stable antiretroviral regimen and interested in trying LA therapy, with few participants reporting challenges receiving LA injections. Implementation data from CUSTOMIZE suggest that monthly LA injections provide a convenient and appealing treatment option for PLHIV.

Aims Single-tablet regimens (STRs) can improve antiretroviral therapy (ART) adherence; however, the relationship between long-term adherence and patient healthcare resource utilization (HRU) is unclear. The objective of this study was to assess long-term ART adherence among people living with HIV (PLHIV) using STRs and multi-tablet regimens (MTRs) and compare HRU over time by adherence. Materials and methods This retrospective study analyzed medical and pharmacy claims (Optum Clinformatics Data Mart Database). Included PLHIV were aged >= 18 years, had >= 1 medical claim with an HIV diagnosis, and had pharmacy claims for a complete STR or MTR. Adherence was analyzed as the proportion of days covered (PDC), stratified as >= 95%, very high; 90-95%, high; 80-90%, moderate; <80%, low. Cumulative all-cause and HIV-related HRU were calculated across 4 years. Among PLHIV with >= 4-year follow-up, HRU was assessed by adherence. Results Among 15,153 PLHIV included, 63% achieved PDC >= 90% during Year 1. Among the subgroup of PLHIV with >= 4-year follow-up (N = 3,818), the proportion maintaining PDC >= 90% fell from 67% in Year 1 to 54% by Year 4. The difference from Years 1 to 4 in the proportion of PLHIV with PDC >= 90% was 13% and 17% in the STR and MTR groups, respectively. Cumulative HRU across the 4-year follow-up was higher in PLHIV with low vs high adherence (27% with low adherence had >= 1 emergency room visit vs 17% for very high, p < .0001; 15% with low adherence had >= 1 inpatient stay vs 7% for very high, p < .0001). Conclusions ART adherence showed room for improvement, particularly over the long term. PLHIV receiving STRs exhibited higher adherence vs those receiving MTRs; this difference increased over time. The proportion of PLHIV with higher HRU was significantly higher among those with lower adherence and became greater over time. Interventions and alternative therapies to improve adherence among PLHIV should be explored.

Cabotegravir and rilpivirine long-acting (CAB+RPV LA) administered by monthly injection has demonstrated non-inferiority compared to standard daily oral antiretroviral therapy (ART). Patient perspectives after one year of implementation of CAB+RPV LA in US healthcare settings were evaluated in an innovative implementation-effectiveness study (CUSTOMIZE). This single-arm study enrolled virologically suppressed patients to receive monthly CAB+RPV LA across eight US clinics. Surveys were administered at Baseline (BL) prior to first injection, Month 4 (M4) and Month 12 (M12) to evaluate patient experience with CAB+RPV LA implementation. At BL and M12, 109 and 102 patients completed surveys, respectively (BL: 87% male; 59% Caucasian; 27% Hispanic/Latino; mean age 39 years). At M12, majority (87%) reported monthly clinic visits and time spent in the clinic (93%) were very/extremely acceptable (M4: 84% and 89%, respectively). Most patients (64%) reported spending ≤30 minutes on average in clinic for each injection visit; 82% reported spending ≤15 minutes in the exam room waiting for the injection. Majority (92%) reported preferring CAB+RPV LA over daily oral tablets. At M12, 74% reported that nothing is interfering with their ability to receive CAB+RPV LA (M4: 66%). Injection pain/soreness was the most common worry at BL (58%); by M12, 15% reported this concern. Through M12, 94% of expected injections (1076/1140) occurred within the +/- 7 day dosing window, 4% were early, <1% were late, <1% were missed due to COVID but covered with short term oral ART. At M12, 97% stated they will use CAB+RPV LA injection treatment going forward. Most patients had no challenges with receiving monthly CAB+RPV LA dosing and reported monthly appointments and time spent in clinic to be highly acceptable after one year. Final implementation data suggest CAB+RPV LA is a convenient, appealing alternative treatment option for patients, with the vast majority preferring CAB+RPV LA over daily oral ART.

Abstract Background CAB+RPV LA administered monthly for HIV treatment is non-inferior to daily oral ART at maintaining viral suppression and preferred by most participants in clinical trials over daily ART. CUSTOMIZE, an implementation-effectiveness study, evaluated facilitators and barriers to clinic implementation of CAB+RPV LA from the patient perspective. Methods 115 participants were enrolled across 8 HIV clinics. Semi-structured phone interviews were conducted with a randomized subgroup of 3-6 participants per site, prior to the 1st (Baseline [BL], N=34) and 12th CAB+RPV LA injections (Month 12 [M12], N=31). Consolidated Framework for Implementation Research-guided interviews were recorded, transcribed, and coded using ATLAS.ti. Results At BL, 97% (n=33) of those interviewed indicated ≥1 challenge taking daily oral ART, including concerns about adherence (n=19; 56%), dosing frequency (n=13; 38%) and side effects (n=12; 35%). Twenty-seven (79%) reported anticipated challenges of CAB+RPV LA such as worry about side effects (n=15; 44%) and discomfort from injections (n=14; 41%). Participants reported at BL that CAB+RPV LA may help with adherence (n=17; 50%) or reduce fears of HIV status disclosure (n=10; 29%). At M12, 35% (n=11) reported some pain/discomfort from injections, but 87% (n=27) reported satisfaction with CAB+RPV LA, most commonly due to preferring the monthly regimen over the daily pill (n=15; 48%). Facilitators reported by participants as most helpful during early implementation were verbal education by clinic staff (14%), reminder texts/calls (13%), and an educational video about the regimen (6%). Most (n=25; 81%) indicated clinic hours were not a barrier, but 19% (n=6) noted taking time off work for the visits. Many participants (n=21; 68%) described positive aspects of going to the clinic each month, none complained about visit length, and 94% (n=29) reported intent to continue CAB+RPV LA after the study. Conclusion Interviewed participants reported several challenges with daily oral ART that monthly CAB+RPV LA may help overcome. Some initial concerns about receiving CAB+RPV LA were reported at BL, but most participants were satisfied with the regimen after one year and plan to continue receiving CAB+RPV LA following the study. Disclosures Cindy Garris, MS, GlaxoSmithKline (Shareholder)ViiV Healthcare (Employee) Larissa Stassek, MPH, GlaxoSmithKline (Consultant, Other Financial or Material Support, My company (Evidera) received funding from GSK to conduct this research. We did not receive funding for work on this abstract.) Ronald D’Amico, DO, MSc, GlaxoSmithKline (Shareholder)ViiV Healthcare (Employee) Marybeth Dalessandro, BS, ViiV Healthcare (Employee, Shareholder) Sheila Adkins, BS, GSK (Employee)GSK (Employee, Stock) Maggie Czarnogorski, MD, MPH, GlaxoSmithKline (Shareholder)ViiV Healthcare (Employee)

Cabotegravir and rilpivirine long-acting (CAB+RPV LA) is a novel monthly injectable therapy requiring a shift in delivery of HIV treatment. Gender differences in CAB+RPV LA implementation across US healthcare settings were explored. This single-arm study enrolled virologically suppressed patients with HIV to receive monthly CAB+RPV LA following 1 month of oral CAB+RPV. A mixed-methods approach was used to collect patient perspectives at Baseline (BL), Month 4 (M4) Month 12 (M12). Subgroups were compared with Fisher's exact test; p-values indicate statistical significance. A subset of patients was interviewed; results were coded and analyzed using ATLAS.ti. At BL, 109 patients (14 females) completed surveys and a subset of 34 (6 females) were interviewed; at M12, 102 (14 females) and 31 (6 females) completed surveys and interviews, respectively. In BL interviews, a higher proportion of females described taking a daily pill as a reminder of their HIV status (67% vs. 29% males). In BL survey, 43% of females reported problems remembering to take daily ART vs. 19% males (p<0.05). In M12 survey, females found coming to clinic on a monthly basis extremely acceptable (71% vs. 51% males) and reported that nothing is interfering with their ability to receive the treatment (100% vs. 69% males, p<0.05). Females favored “mode of administration” (57% vs. 37% males) while males favored “frequency of administration” (36% vs. 46% males) as the main advantage of CAB+RPV LA. At M12, acceptability of CAB+RPV LA was high amongst both genders, while all females completely agreed with appropriateness (vs. 73-78% males). All females stated they will use CAB+RPV LA going forward. Women in CUSTOMIZE found monthly CAB+RPV LA to be highly appropriate and convenient for their daily lifestyles. Similar to men, women highly preferred injectable LA treatment to daily oral therapy indicating this regimen may be a desirable alternative HIV treatment option.