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Title
Cabotegravir + rilpivirine long-acting outcomes by sex at birth, age, race, and body mass index: a subgroup analysis of the Phase 3b SOLAR study
Presenter
Beng Eu
Authors
B. Eu1, S. Oka2, J. Sims3, V. Estrada4, M. McKellar5, J. Flores6, A. Potthoff7,8, L.A. Gordon9, D. Sutherland-Phillips9, K. Sutton9, C.L. Latham9, A. Berni10, R. Urbaityte10, R. Van Solingen-Ristea11, R. D'Amico9, H.P. Garges9, K. Smith9, J. van Wyk12
Institutions
1Prahran Market Clinic, Melbourne, Australia, 2AIDS Clinical Center, National Center for Global Health and Medicine, Tokyo, Japan, 3St. Hope Foundation, Houston, United States, 4Hospital Clínico de San Carlos, Madrid, Spain, 5Duke University School of Medicine, Durham, United States, 6Hospital Arnau de Vilanova, Valencia, Spain, 7Walk In Ruhr, Center for Sexual Health and Medicine, Bochum, Germany, 8Ruhr-Universität Bochum, Bochum, Germany, 9ViiV Healthcare, Durham, United States, 10GSK, London, United Kingdom, 11Janssen Research and Development, Beerse, Belgium, 12ViiV Healthcare, Brentford, United Kingdom

BACKGROUND: Cabotegravir + rilpivirine (CAB+RPV) is a complete long-acting (LA) every 2 months (Q2M) regimen for maintaining HIV-1 virologic suppression. The Phase 3b SOLAR study demonstrated noninferior efficacy of CAB+RPV LA Q2M vs. continuing daily oral bictegravir/emtricitabine/tenofovir alafenamide (BIC/FTC/TAF) at Month (M) 12, with 90% of switch participants preferring LA therapy. We present outcomes within key subgroups who received CAB+RPV LA.
METHODS: SOLAR is a Phase 3b, randomized (2:1), open-label, multicenter, noninferiority study assessing switching virologically suppressed adults to CAB+RPV LA Q2M vs. continuing daily BIC/FTC/TAF. Data from participants receiving CAB+RPV LA were analyzed by sex at birth, age, race, and body mass index (BMI). Endpoints assessed at M12 included the proportion with plasma HIV-1 RNA =50 copies/mL and <50 copies/mL (FDA Snapshot algorithm), incidence of confirmed virologic failure (CVF; two consecutive HIV-1 RNA =200 copies/mL), change from baseline in CD4+ cell counts, and three single-item questions exploring an individual's fear of disclosure, anxiety relating to adherence requirements, and daily reminder of their HIV status (FAD questions).
RESULTS: Overall, 447 participants received CAB+RPV LA (modified intention-to-treat exposed population); 17% were female sex at birth, 19% were aged =50 years, 69% were White, 21% had a BMI =30 kg/m2. At M12, rates of virologic non-response (HIV-1 RNA =50 copies/mL) and suppression (HIV-1 RNA <50 copies/mL) with CAB+RPV LA ranged 0–2% and 89–92%, respectively, across subgroups. Overall, 2/447 (<1%) participants had CVF (Table). Changes from baseline in CD4+ cell counts were similar between subgroups. After 12 months on CAB+RPV LA, the proportion of participants reporting "never"/"rarely" for the three single-item FAD questions increased from baseline across all subgroups.


CONCLUSIONS: Switching to CAB+RPV LA Q2M from BIC/FTC/TAF was efficacious irrespective of sex at birth, age, race, or BMI, while also providing emotional well-being benefits, including alleviation from the fear of disclosure and anxiety surrounding adherence.

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