Early implementation and clinical outcomes of long-acting injectable cabotegravir and rilpivirine in a safety-net HIV clinic

BACKGROUND: Registrational trials of long-acting cabotegravir-rilpivirine (CAB/RPV-LA) required viral suppression (VS) on oral antiretrovirals, but CAB/RPV-LA may benefit patients who are unable to attain VS due to adherence challenges. We sought to assess the feasibility and early clinical outcomes of CAB/RPV-LA implementation in a large safety-net HIV clinic.
METHODS: Informed by the capability-opportunity-motivation behavior (COM-B) model, Ward 86 in San Francisco developed a pilot program to support provider initiation and patient adherence to CAB/RPV-LA. Provider supports included education/training and a clinic pharmacy team for review, insurance authorization, and initiation. Patient referral eligibility consisted of regular clinic attendance, no RPV and '¤1 integrase inhibitor mutation, and locator information. Patient-centered supports included education, a direct-to-inject option, and reminder/follow-up phone calls/texts. Additionally, patients without VS had individualized plans, including identification of community-based supports (e.g. case managers), community-based injection sites, and financial incentives. Appointment attendance and viral load (VL) monitoring for all patients were aided by electronic medical record reports and reviewed in multidisciplinary (MD/RN/pharmacy) case conferences. We defined viral suppression as VL<40 copies/mL.
RESULTS: From February-November 2021, providers referred 70 patients, of whom 16 are in process and 29 are on hold due to patient/provider preference. Of 25 patients who started CAB/RPV-LA, median age was 46; 8% were cis-women, 20% Black, 16% Latinx, 36% experiencing homelessness/unstable housing, and 56% currently using stimulants. Twenty-three (92%) patients have had 100% on-time injection attendance, defined as within +/- 7 days of a 28-day injection cycle, with the other two patients late for only one injection each. Of 14 starting with VS (median CD4 680), 11 (79%) direct-to-inject, with median 4 injections (2'6 injections), 13 (96%) have maintained VS and 1 patient is without follow-up VL due to unexpected travel. Of 11 starting without VS (median CD4 135, mean log10 VL 4.93), all direct-to-inject, with median 4 injections (3-8 injections), 8 (73%) have achieved VS. For the 3 patients without VS, 100% have had a two-log VL decline by median 22 days.
CONCLUSIONS: Our data demonstrate the feasibility and promise of a patient-centered approach for CAB/RPV-LA implementation for both those with VS and those with challenges adhering to oral therapy.

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