EACS2023: 593 Insights and experiences from the CAPELLA trial: perspectives of healthcare professionals and study coordinators on lenacapavir use amongst heavily treatment-experienced people with HIV J. Fang , O. Boiko , A.N Herbst , M. Dunbar , L. Temme , K. Dunn , D. Mezzio , M.S. Rhee , M. Bogart , B. Gaglio , W.R. Lenderking Evidera, Bethesda, United States, Evidera, London, United Kingdom, Gilead Sciences, Inc., Foster City, United States General data Abstract category: Access and delivery of care Abstract body Purpose: Lenacapavir (LEN) is the first-in-class capsid inhibitor approved for treating heavily treatment-experienced (HTE) people with multidrug-resistant HIV-1 (PWH), in combination with other antiretrovirals. CAPELLA is a Phase 2/3, randomized, placebo-controlled multicenter study evaluating the efficacy and safety of LEN. We explored experiences of investigators serving as healthcare professionals (HCPs) and study coordinators in CAPELLA to understand their perceptions of participant experiences with LEN and the potential impact of LEN on real‑world practice. Method: An online, cross-sectional survey of US CAPELLA HCPs (N=9) and coordinators (N=10) was conducted (March–June 2023). Survey domains included: LEN administration experience, interpretation of participants’ experience, strategies to support adherence to LEN and background regimens, and lessons for future LEN implementation. Data were summarized using descriptive statistics. Results: Among respondents, 1/9 HCPs and 7/10 coordinators directly administered LEN injections to participants. After starting LEN, respondents perceived decreasing concerns amongst study participants regarding fear of needles, pain, long-term side effects, drug interactions, or missing work for injection visits (Table 1). Most respondents (n=17/19) believed it was not difficult to ensure on-time LEN injection visits. No respondents felt that ISRs impeded participants’ willingness to continue LEN. Most respondents (n=16/19) considered system factors (e.g. insurance, cost) to be the most important potential barriers to real-world LEN use. Respondents reported that LEN has strong potential to improve clinical outcomes and quality of life (QoL) of HTE PWH (Table 2). Of 16 respondents with prior experience of administering intramuscular cabotegravir/rilpivirine, 9 (56%) considered LEN to be easier to administer, with none considering LEN as more difficult to administer. Table 1. Response Frequencies of US CAPELLA Trial HCP and Coordinator Perceptions of Patient Expectations of LEN How do you think participants in CAPELLA felt about LEN before vs after starting the medication? N=19 n (%) Not at all Mildly Moderately Very Extremely Don’t know My participants were concerned about receiving injections with a needle Before After 2 (11) 6 (32) 6 (32) 5 (26) 7 (37) 6 (32) 2 (11) 2 (11) 1 (5) 0 (0) 1 (5) 0 (0) My participants were concerned about experiencing pain or soreness from the injection Before After 1 (5) 2 (11) 5 (26) 8 (42) 8 (42) 6 (32) 3 (16) 1 (5) 1 (5) 2 (11) 1 (5) 0 (0) My participants were concerned about the possibility of long-term side effects Before After 3 (16) 6 (32) 6 (32) 10 (53) 8 (42) 3 (16) 1 (5) 0 (0) 0 (0) 0 (0) 1 (5) 0 (0) My participants were concerned about how LEN would affect the other medications Before After 4 (21) 10 (53) 9 (47) 7 (37) 4 (21) 2 (11) 1 (5) 0 (0) 0 (0) 0 (0) 1 (5) 0 (0) My participants were concerned about missing work for injection visits Before After 4 (21) 7 (37) 6 (32) 8 (42) 6 (32) 3 (16) 1 (5) 1 (5) 1 (5) 0 (0) 1 (5) 0 (0) What impact will integrating LEN into real-world clinical practice have on the outcomes of HTE PWH? N=19 n (%) Neither positive nor negative impact Somewhat positive impact Strong positive impact Don’t know Overall patient survival 1 (5) 5 (26) 13 (68) 0 (0) Virologic success (i.e. HIV-1 RNA <50 copies/mL) 0 (0) 2 (11) 17 (90) 0 (0) Improvement in CD4 cell count 1 (5) 3 (16) 15 (79) 0 (0) Adherence to HIV treatment 2 (11) 6 (32) 11 (58) 0 (0) Adherence to routine care visits 5 (26) 6 (32) 8 (42) 0 (0) Prevention of opportunistic infection or complications of AIDS 3 (16) 1 (5) 15 (79) 0 (0) Stigma perceived or experienced by clients 6 (32) 4 (21) 8 (42) 1 (5) Overall quality of life 0 (0) 7 (37) 12 (63) 0 (0) Conclusions: CAPELLA HCPs and coordinators reported favorable perceptions of participant experiences with LEN and identified a strong potential for LEN to improve the clinical outcomes and QoL of HTE PWH. These responses provide encouraging evidence for the incorporation of LEN into real-world practice. General conditions 1. 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