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Introduction Long-acting injectable antiretroviral therapy (LA-ART) represents a major advance in HIV treatment, offering sustained viral suppression without daily pill adherence dosing since its approval by the Food and Drug Administration in 2021.1,2 However, empirical uptake in the Medicare population with HIV, including among individuals from minoritized racial and ethnic groups and across diverse regions in the country, remains poorly understood. This knowledge gap is particularly salient given that many Medicare beneficiaries are older,3 have complex multimorbidity with increased susceptibility to bone and kidney complications from certain oral ART regimens, and may face cost-related and access barriers. We quantify use of LA-ART among Medicare beneficiaries with HIV and characterize the differences between people receiving oral ART vs LA-ART. Methods This cross-sectional study was approved by the Harvard institutional review board, which waived informed consent given the deidentified data. We followed the STROBE guidelines for cross-sectional studies. We used 100% Medicare data to identify people with HIV (PWH) enrolled in Medicare Parts B and D between 2021 to 2023. Prior to the year of assessing ART regimens, we applied the Chronic Conditions Warehouse algorithm with a 2-year look-back period (2019-2022) to identify HIV and other chronic conditions, such as heart failure, mental health disorders (defined as major depressive disorder, schizophrenia or related psychotic disorders, and bipolar disease), and dementia. We used Part D outpatient and carrier files to determine oral ART vs LA-ART (cabotegravir or rilpivirine). Demographics included age, sex, race and ethnicity (determined using the RTI Race Variable, which applies an algorithm on self-reported data, and classified as American Indian or Alaska Native, Asian, Black, Hispanic, White, unknown, or any other race), Medicaid dual eligibility, enrollment in Traditional Medicare vs Medicare Advantage, rurality, and state. Data on race and ethnicity are included in this study given known racial disparities in ART use.4 Next, we determined the number and proportion of PWH taking oral ART vs LA-ART yearly. For 2023, we reported patient demographics and calculated adjusted odds ratios (aORs) of receiving LA-ART using logistic regressions. Statistical significance was defined as 2-sided P < .05. Variables used in our model for adjustment included demographics, chronic conditions, rurality, and region. Data were analyzed using SAS version 8.5 (SAS Institute, Inc) from October 2025 to April 2026. Results The sample included 638 PWH (0.4%) taking LA-ART vs 162 495 (99.6%) taking oral ART in 2021, 3202 (1.9%) taking LA-ART vs 165 059 (98.1%) taking oral ART in 2022, and 5162 (3.0%) taking LA-ART vs 167 836 (97.0%) taking oral ART in 2023. PWH taking LA-ART were younger (aged <55 years, 1719 PWH [33.3%] vs 30 499 PWH [18.2%]; standardized mean difference [SMD] = 0.351), more likely to be dual eligible for Medicaid (3828 PWH [74.2%] vs 110 964 PWH [66.0%]; SMD = 0.180), and less likely to live in the South (2070 PWH [41.1%] vs 76 480 PWH [45.6%]; SMD = 0.111) vs those taking oral ART (Table 1). In adjusted analyses (Table 2), older PWH were less likely to receive LA-ART (aged, 55-64 years, aOR, 0.60 [95% CI, 0.56-0.65]; aged ≥65 years, aOR, 0.40 [95% CI, 0.37-0.43) than PWH younger than 55 years. American Indian or Alaska Native individuals were also less likely to receive LA-ART than White PWH (aOR, 0.52; 95% CI, 0.29-0.92); there were no significant differences for other racial and ethnic groups or by sex. PWH in rural areas and the South were significantly less likely than their counterparts to receive LA-ART. Dual-eligible individuals (aOR, 1.12; 95% CI, 1.04-1.20) and Medicare Advantage beneficiaries (aOR, 1.07; 95% CI, 1.00-1.13) were more likely to receive LA-ART than their respective counterparts. Notably, PWH with Alzheimer disease and related dementias, stroke disorders, heart failure, and chronic kidney disease or kidney failure were less likely to receive LA-ART, whereas people with mental health disorders were more likely to receive LA-ART. Table 1. Characteristics of Medicare Beneficiaries With HIV Receiving Oral ART vs LA-ART View LargeDownload (opens in new tab)Go to Figure in ArticleCharacteristicTotal No. of patientsPatients, No. (%)SMDaOral ARTLA-ARTYearb 2021163 133162 495 (99.6)638 (0.4)NA 2022168 261165 059 (98.1)3202 (1.9)NA 2023172 998167 836 (97.0)5162 (3.0)NACharacteristics of patients in 2023c Age, y <5532 21830 499 (18.2)1719 (33.3)0.351 55-6452 40350 709 (30.2)1694 (32.8)0.056 ≥6588 37786 628 (51.6)1749 (33.9)0.364 Sex Female47 52846 095 (27.5)1433 (27.8)0.007 Male125 470121 741 (72.5)3729 (72.3) Race and ethnicityd American Indian or Alaska Native637625 (0.4)12 (0.2)0.025 Asian19911941 (1.2)50 (1.0)0.018 Black73 01970 803 (42.2)2216 (42.9)0.015 Hispanic24 47223 718 (14.1)754 (14.6)0.014 White69 65367 617 (40.3)2036 (39.5)0.017 Any other race or unknown32263132 (1.9)94 (1.8)0.003 Medicare insurance typee Medicare Advantage111 932108 514 (64.7)3418 (66.2)0.033 Traditional Medicare61 06659 322 (35.3)1744 (33.8) Dual eligibility for Medicaid Yes114 522110 964 (66.0)3828 (74.2)0.180 No58 47657 142 (34.0)1334 (25.8) Region Midwest21 14620 326 (12.1)820 (15.9)0.109 Northeast39 89238 735 (23.1)1157 (22.4)0.016 South78 55076 480 (45.6)2070 (41.1)0.111 West33 41032 295 (19.2)1115 (21.6)0.059 Ruralityf Rural16 79616 408 (9.8)388 (7.5)0.080 Urban156 202151 428 (90.2)4774 (92.5) Chronic conditionsg Acute myocardial infarction or ischemic heart disease36 74035 779 (21.3)961 (18.6)0.066 Asthma or chronic obstructive pulmonary disease54 59252 826 (31.5)1766 (34.2)0.061 Alzheimer dementia and related disorders87298572 (5.1)157 (3.0)0.104 Cancer16 22315 810 (9.4)413 (8.0)0.049 Chronic kidney disease or kidney failure55 23853 850 (32.1)1388 (26.9)0.112 Diabetes57 87656 301 (33.5)1575 (30.5)0.063 Heart failure or nonischemic heart disease24 12623 528 (14.0)598 (11.6)0.072 Mental health disorders73 21670 798 (42.0)2718 (52.7)0.215 Stroke disorders12 30512 013 (7.2)292 (5.7)0.061 Substance use disorders38 80737 399 (22.3)1408 (27.3)0.116 Table 2. Likelihood of Receiving Long-Acting Antiretroviral Therapy by Patient Characteristics, 2023 View LargeDownload (opens in new tab)Go to Figure in ArticleCharacteristicUnadjusted OR (95% CI)aP valueAdjusted OR (95% CI)bP valueAge, y <551 [Reference]NA1 [Reference]NA 55-640.59 (0.55-0.63)<.0010.60 (0.56-0.65)<.001 ≥650.36 (0.33-0.38)<.0010.40 (0.37-0.43)<.001Sex Female1.01 (0.95-1.08).640.96 (0.90-1.03).28 Male1 [Reference]NA1 [Reference]NARace and ethnicity American Indian or Alaska Native0.64 (0.36-1.13).120.52 (0.29-0.92).03 Asian0.86 (0.64-1.14).280.82 (0.62-1.10).19 Black1.04 (0.98-1.10).221.03 (0.96-1.10).47 Hispanic1.06 (0.97-1.15).211.00 (0.92-1.10).92 White1 [Reference]NA1 [Reference]NA Any other race or unknown1.00 (0.81-1.23).981.04 (0.84-1.29).71Medicare insurance type Medicare Advantage1.07 (1.01-1.14).021.07 (1.00-1.13).04 Traditional Medicare1 [Reference]NA1 [Reference]NADual-eligible for Medicaid Yes1.48 (1.39-1.58)<.0011.12 (1.04-1.20).002 No1 [Reference]NA1 [Reference]NARegion Midwest1.49 (1.37-1.62)<.0011.42 (1.30-1.54)<.001 Northeast1.10 (1.03-1.19).0081.18 (1.10-1.27)<.001 West1.28 (1.18-1.37)<.0011.41 (1.30-1.52)<.001 South1 [Reference]NA1 [Reference]NARurality Rural0.75 (0.68-0.83)<.0010.73 (0.66-0.82)<.001 Urban1 [Reference]NA1 [Reference]NAChronic conditionsc Acute myocardial infarction or ischemic heart disease0.85 (0.79-0.91)<.0011.05 (0.97-1.14).23 Asthma or chronic obstructive pulmonary disease1.14 (1.07-1.21)<.0011.09 (1.02-1.16).007 Alzheimer dementia or Alzheimer dementia related disorder0.58 (0.50-0.69).0010.64 (0.54-0.75)<.001 Cancer0.84 (0.76-0.93)<.0011.01 (0.91-1.12).89 Chronic kidney disease or kidney failure0.78 (0.73-0.83)<.0010.93 (0.87-0.99).03 Diabetes0.87 (0.82-0.93)<.0010.98 (0.92-1.05).62 Heart failure or nonischemic heart disease0.81 (0.74-0.88)<.0010.85 (0.78-0.94).002 Mental health disorders1.54 (1.45-1.62)<.0011.32 (1.25-1.41)<.001 Stroke0.78 (0.69-0.88)<.0010.87 (0.77-0.99).03 Substance use disorders1.31 (1.23-1.39)<.0011.05 (0.99-1.13).12 Discussion In this national cross-sectional study, uptake of LA-ART among Medicare PWH was low, reaching only 3.0% by 2023. Early diffusion appeared uneven, with lower use among American Indian or Alaska Native beneficiaries and people living in rural areas or the South—patterns that mirror longstanding disparities in HIV care delivery and access to specialty services.4-7 In addition, despite potentially greater benefit from reduced daily adherence burden and lower risk of potential adverse effects of oral tenofovir–based regimens, older beneficiaries and people with complex chronic conditions, including Alzheimer disease and related dementias and chronic kidney disease or kidney failure, were less likely to receive LA-ART, possibly reflecting clinician concerns about drug-drug interactions.7,8 Conversely, dual-eligible beneficiaries, who automatically qualify for subsidized drug coverage under the Part D Low-Income Subsidy,9 and people enrolled in Medicare Advantage, who receive financial protections through out-of-pocket maximum caps and reduced cost-sharing, were more likely to receive LA-ART, suggesting that differences in structural access, system-level factors, and affordability may be barriers to LA-ART. Finally, higher use among beneficiaries with mental health disorders is encouraging, given LA-ART’s potential to mitigate adherence challenges in this population,7 and additional consideration for those with substance use disorders remains critical. This study has limitations. This descriptive study cannot establish causal reasons for different ART prescription patterns, including from logistical challenges, patient selection, and access to physicians. Other limitations included lack of clinical detail in data, inability to capture patient or physician-level factors associated with treatment choice (including affordability), limited generalizability to people enrolled in Medicaid and commercial insurance, and lack of data from 2024 and beyond. We could not quantify lenacapavir use because its billing code was introduced mid-2023. Nonetheless, these early patterns suggest the need for strategies that ensure equitable access to LA-ART through affordability protections, outreach to marginalized populations, and an improved understanding of treatment decisions for older PWH with complex multimorbidity. Back to top Article Information Accepted for Publication: April 21, 2026.Published: June 12, 2026. doi:10.1001/jamanetworkopen.2026.18029Open Access: This is an open access article distributed under the terms of the CC-BY-NC-ND License, which does not permit alteration or commercial use, including those for text and data mining, AI training, and similar technologies. © 2026 Figueroa JF et al. JAMA Network Open.Corresponding Author: Jose F. Figueroa, MD, MPH, Department of Health Policy & Management, Harvard T.H. Chan School of Public Health, 677 Huntington Ave, Kresge Room 402, Boston, MA 02115 ([email protected]).Author Contributions: Ms Stein had full access to all of the data in the study and takes responsibility for the integrity of the data and the accuracy of the data analysis.Concept and design: Figueroa, Stein, Hyle.Acquisition, analysis, or interpretation of data: All authors.Drafting of the manuscript: Figueroa, Hyle.Critical review of the manuscript for important intellectual content: All authors.Statistical analysis: Stein, Phelan, Orav.Obtained funding: Figueroa, Hyle.Administrative, technical, or material support: Figueroa, Luu.Supervision: Figueroa, Mukerji, Hyle.Conflict of Interest Disclosures: Dr Figueroa reported receiving grants from Commonwealth Fund, Laura and John Arnold Foundation, Robert Wood Johnson Foundation, SCAN Foundation, and Department of Veterans of Affairs and personal fees from Project Hope for editorial services outside the submitted work. Dr Mukerji reported receiving grants from Massachusetts General Hospital during the conduct of the study. Dr Hyle reported receiving grants from Massachusetts General Hospital during the conduct of the study and personal fees from UpToDate outside the submitted work. No other disclosures were reported.Funding/Support: This publication was supported by grants R01AG081151 (to Drs Figueroa, Orav, Mukerji, and Hyle), R01AG069575 (to Drs Figueroa and Hyle) and RF1AG088640 (to Drs Figueroa and Orav) from the National Institute on Aging.Role of the Funder/Sponsor: The funder had no role in the design and conduct of the study; collection, management, analysis, and interpretation of the data; preparation, review, or approval of the manuscript; and decision to submit the manuscript for publication.Data Sharing Statement: See the Supplement. References 1.Orkin C, Arasteh K, Górgolas Hernández-Mora M, et al; FLAIR Study Group. Long-acting cabotegravir and rilpivirine after oral induction for HIV-1 infection. N Engl J Med. 2020;382(12):1124-1135. doi:10.1056/NEJMoa1909512PubMedGoogle ScholarCrossref2.DHHS Panel on Antiretroviral Guidelines for Adults and Adolescents. HHS Adults and Adolescents Antiretroviral Guidelines Panel recommendation for the long-acting injectable antiretroviral regimen of cabotegravir and rilpivirine. February 18, 2021. Accessed December 20, 2025. https://clinicalinfo.hiv.gov/sites/default/files/guidelines/archive/adult-arv-cabotegravir-rilpivirine-2021-02-18.pdf3.Figueroa JF, Katz IT, Hyle EP, et al. The association of HIV with health care spending and use among Medicare beneficiaries. Health Aff (Millwood). 2022;41(4):581-588. doi:10.1377/hlthaff.2021.01793PubMedGoogle ScholarCrossref4.Figueroa JF, Duggan C, Phelan J, et al. Antiretroviral therapy use and disparities among Medicare beneficiaries with HIV. J Gen Intern Med. 2024;39(12):2196-2205. doi:10.1007/s11606-024-08847-yPubMedGoogle ScholarCrossref5.Haser GC, Balter L, Gurley S, et al. Early implementation and outcomes among people with HIV who accessed long-acting injectable cabotegravir/rilpivirine at two Ryan White Clinics in the U.S. South. AIDS Res Hum Retroviruses. 2024;40(12):690-700. doi:10.1089/AID.2024.0007PubMedGoogle ScholarCrossref6.Centers for Disease Control and Prevention. Estimated HIV incidence and prevalence in the United States. September 5, 2024. Accessed December 20, 2025. https://www.cdc.gov/hiv-data/nhss/estimated-hiv-incidence-and-prevalence.html#:~:text=At%20a%20glance,fell%2016%25%20in%20the%20South7.Nachega JB, Scarsi KK, Gandhi M, et al. Long-acting antiretrovirals and HIV treatment adherence. Lancet HIV. 2023;10(5):e332-e342. doi:10.1016/S2352-3018(23)00051-6PubMedGoogle ScholarCrossref8.O’Shea JG, Cholli P, Heil EL, Buchacz K. Considerations for long-acting antiretroviral therapy in older persons with HIV. AIDS. 2023;37(15):2271-2286. doi:10.1097/QAD.0000000000003704PubMedGoogle ScholarCrossref9.Roberts ET, Phelan J, Schwartz AL, et al. Loss of subsidized drug coverage and mortality among Medicare beneficiaries. N Engl J Med. 2025;392(20):2025-2034. doi:10.1056/NEJMsa2414435PubMedGoogle ScholarCrossref