Background Long-acting injectable (LAI) antiretroviral therapy (ART) has the potential to improve medication adherence, reduce HIV stigma, and promote equity in care outcomes among people with HIV (PWH). We describe our early experience implementing LAI-cabotegravir/rilpivirine (CAB/RPV) for maintenance HIV-1 treatment. Methods We launched a pilot LAI-ART program at a large Ryan White-funded clinic in the Southeast, accepting provider-initiated referrals from 4/14/2021—12/1/2021. Our interdisciplinary program team (Clinician-Pharmacy-Nursing) verified clinical eligibility and pursued medication access for eligible patients. We describe demographic and clinical variables of PWH referred and enrolled, and early outcomes among those accessing LAI-CAB/RPV. Results Among 58 referrals, characteristics were median age 39 (Q1-Q3 30.25-50) years, 74% male, 81% Black, and payor source distribution was 26% Private, 21% Medicare, 19% Medicaid, and 34% ADAP. Forty-five patients (78%) met clinical eligibility for LAI-CAB/RPV; ineligibility concerns included evidence of confirmed or possible RPV resistance (n = 8), HIV non-suppression (n = 3), possible RPV hypersensitivity (n = 1), and pregnancy (n = 1). Among 45 eligible PWH, 39 (87%) enrolled and 15 (38%) initiated LAI-CAB/RPV after a median of 47 (Q1-Q3 31-95) days since enrollment. Conclusions Implementing LAI-ART at a Southern U.S. Ryan White-funded clinic has been challenged by substantial human resource capital to attain drug, administer injections, support enrolled patients; delayed therapy initiation due to insurance denials; patient ineligibility primarily due to possible RPV resistance; and inability to provide drug regardless of payor source. These barriers may perpetuate disparities in ART access and outcomes among PWH and should be urgently addressed so that LAI-ART can be offered equitably.

Background In January 2021, the first ever long-acting injectable (LAI) antiretroviral therapy (ART), cabotegravir/rilpivirine (CAB/RPV), was approved for maintenance HIV-1 treatment in select patients with virologic suppression. LAI-ART has the potential to improve ART adherence, reduce HIV stigma, and promote equity in care outcomes, however, implementation in real-world settings has yet to be evaluated. Methods We launched a pilot LAI-ART program at the largest Ryan White-funded HIV clinic in the Southeast. From 4/14/21 to 5/14/21, providers referred patients interested and willing to switch to LAI-CAB/RPV who met screening criteria. Our interdisciplinary LAI team (Clinician-Pharmacy-Nursing) verified clinical eligibility (HIV-1 < 200 c/ml ≥6 months and no history of virologic failure, resistance to either drug, or chronic HBV infection) and pursued medication access for 28-day oral lead-in and monthly injectable CAB/RPV. We describe demographic and clinical variables of referred PWH and early outcomes in accessing LAI-ART. Results Among 42 referrals, median age was 40.5 (Q1-Q3, 32-52) years, 83% were men, and 76% Black. Payor source distribution was 26% Private, 19% Medicare, 10% Medicaid, and 45% ADAP. At the time of referral, median CD4 count was 583 (Q1-Q3, 422-742) cells/mm3 and median sustained HIV-1 RNA < 200 c/ml was 1427 (Q1-Q3, 961-2534) days. A total of 35 patients (74%) met clinical eligibility for LAI-CAB/RPV, including 4 patients who required a transition off proton pump inhibitor therapy to accommodate oral RPV. Ineligible PWH were excluded due to evidence of RPV resistance (n=5), possible RPV hypersensitivity (n=1), and HIV non-suppression (n=1). The table summarizes the process of pursuing LAI-ART access for the initial 10 enrollees by insurance status. Conclusion Our experience implementing LAI-ART at a Ryan White-funded HIV clinic in the Southern U.S. has been challenged by substantial human resource capital to attain drug, delayed therapy initiation due to insurance denials, and patient ineligibility primarily due to concern for potential RPV resistance. These barriers may perpetuate disparities in ART access and virologic suppression among PWH and need to be urgently addressed so that LAI-ART can be offered equitably. Disclosures Lauren F. Collins, MD, MSc, Nothing to disclose Bradley L. Smith, Pharm.D., AAHIVP, Gilead Sciences, Inc (Advisor or Review Panel member) Wendy Armstrong, MD, Nothing to disclose Jonathan Colasanti, MD, Integritas CME (Consultant, develop and deliver CME content around Rapid Entry/Rapid ART)

BackgroundSpecialty pharmacy (SP) provides timely medication delivery to patients and seeks to improve patient adherence through monthly pharmacist medication therapy management (MTM). Patients living with HIV/AIDS have both high cost medications and complex disease states and thus will benefit from SP. We report on the outcome of HIV therapy after 3 years of a pilot SP ina southern inner city RW funded clinic.MethodsThis is a single center retrospective chart review of patients at our clinic who were enrolled in the SP from 6/3/13–5/1/16 for at least 6 months. Baseline demographic characteristics and HIV markers (CD4, viral load) were collected. Outcomes of interest were: change in CD4 count, percent with viral suppression (VS), emergency room (ER) and hospital admission usage, as well as percent of scheduled providers’ appointment kept. Each individual had the same follow up time before and after SP initiation. Bivariate analysis compared outcomes preSP and during SP using Chi-square or Fisher exact tests for categorical and Wilcoxon rank-sum test for continuous variables.ResultsDuring the 3-year period, there were 212 individuals referred to SP, of which 170 participated in the program. There were 92(54%) men, 136(80%) black. The median age was 48.3 years (IQR: 28.5–56.3). The average duration of follow up pre and during SP was 22.1(IQR: 16.5–27) months. In terms of insurance, 69(40%) had Medicare, 22(13%) had Medicaid, 22(13%) had private insurance, 54(32%) received AIDS drug Assistance Program (ADAP), and 3(2%) had Ryan White. Patients resided an average distance from the clinic of 17.4(IQR: 8.8–25) miles. The respective outcomes before and during SP were: CD4: 350(IQR: 181–551) vs. 413(IQR: 263–611 cells/mL (P < 0.0001), VS in 78 ± 30% vs. 91 ± 20% (P < 0.0001). The proportion of patients with emergency room usage or hospital admissions was 68(40%) vs. 49(29%) (P = 0.036). There was no difference in the rate of kept providers’ appointment (66.6 %(IQR: 53.8–78.6%) vs. 63.8 %(50-77%) (P = 0.19). There was no reported death during the follow –up period.ConclusionThis pilot SP program at the RW clinic showed statistically significant improvement of CD4 count and VS, as well as 40 % decrease in odds of using ER or hospital admission. Further studies are needed to determine whether SP is beneficial to people living with HIV/AIDS in other settings.Disclosures M. Patel, ViiV: Scientific Advisor, Consulting fee