Lenacapavir Plus Cabotegravir as Combination Treatment: Real-world Use Cases From the National Clinician Consultation Center

Abstract Background The use of long-acting injectable (LAI) lenacapavir (LEN) plus cabotegravir (CAB) +/− rilpivirine (RPV) may increase viral suppression in people with HIV (PWH) with a history of oral antiretroviral therapy (ART) adherence challenges or drug-resistant virus. Data on the LEN+ CAB+/−RPV effectiveness and tolerability are limited. Methods We report observations on real-world LEN+ CAB+/−RPV use from the National Clinician Consultation Center (NCCC), a federally funded teleconsultation resource for US-based clinicians. Providers contacting NCCC from 1 December 2022 to 30 August 2024 for cases related to ART modification to LEN+ CAB+/−RPV were surveyed. Data from NCCC's secure database and survey responses were summarized using descriptive statistics. Results Among 76 potential cases, 50 (66%) surveys were completed. Of these, 14 (28%) modified ART to LEN+ CAB+/−RPV, including 9 (64%) who changed to LEN+ CAB/RPV and 1 (7%) to LEN+ CAB, and 4 (29%) with no regimen details. ART modification was not made in 35 cases, and in one, the provider was unsure of changes. Nonexclusive reasons for LAI-ART modifications included viremia on oral ART (n = 6, 43%), inability/refusal to take oral ART (3, 21%), non-nucleoside reverse transcriptase inhibitor mutation(s) (3, 21%), integrase strand transferase inhibitor mutation(s) (2, 14%), or persistent viremia on CAB/RPV alone (2, 14%). LEN+ CAB+/−RPV was effective and well-tolerated: among 10 cases with follow-up information, viral load decreased by a mean of 3.88log10 copies/mL within a median of 56 days (range = 29–166 days), and 5 experienced injection-site reactions rated as “not at all” to “slightly” problematic. Conclusions These data support further investigations into LEN+ CAB+/−RPV use among PWH with oral ART challenges and/or drug resistance.