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Title
Similar inflammatory markers after switching to cabotegravir + rilpivirine long-acting vs. continuing bictegravir/emtricitabine/tenofovir alafenamide: data from the Phase 3b SOLAR study
Presenter
David A. Baker
Authors
E. Elliot1, D.A. Baker2, E. Adachi3, J. Rodriguez4, M. Montero Alonso5, G. Rizzardini6,7, P. Patel8, C.L. Latham8, D. Sutherland-Phillips8, R. Urbaityte9, K. Sutton8, H.P. Garges8, K. Smith8, B. Baugh10, R. D'Amico8, J. van Wyk1
Institutions
1ViiV Healthcare, Brentford, United Kingdom, 2East Sydney Doctors, Darlinghurst, Australia, 3The University of Tokyo Hospital, Tokyo, Japan, 4Global Research Institute, California, United States, 5Hospital Universitario y Politécnico La Fe, Valencia, Spain, 6Fatebenefratelli Sacco Hospital, Milan, Italy, 7University of the Witwatersrand, Johannesburg, South Africa, 8ViiV Healthcare, Durham, United States, 9GSK, London, United Kingdom, 10Janssen Research & Development, Titusville, United States

BACKGROUND: Cabotegravir + rilpivirine (CAB+RPV) administered every 2 months (Q2M) is the only complete long-acting (LA) regimen for the maintenance of HIV-1 suppression. Here, we present changes from baseline to Month (M) 6 and M12 in key inflammatory markers from the Phase 3b SOLAR study, overall and by subgroups.
METHODS: SOLAR (NCT04542070) is a randomized (2:1), open-label, multicenter, noninferiority study assessing virologically suppressed adults switching to CAB+RPV LA Q2M vs. continuing daily bictegravir/emtricitabine/tenofovir alafenamide (BIC/FTC/TAF). Subgroup analyses were carried out by sex at birth, age (<35, 35–<50, =50 years), and body mass index (BMI; =30, <30 kg/m2. Key inflammatory markers (platelet-poor plasma D-dimer, serum interleukin-6 [IL-6], serum C-reactive protein [CRP], CD4/CD8 ratio, serum soluble (s) CD14, and sCD163) were measured at baseline, M6, and M12, and were compared between treatments and subgroups.
RESULTS: Overall, 454 participants received CAB+RPV LA and 227 received BIC/FTC/TAF; 18% of the total population were female, 20% were aged =50 years, and 22% had a BMI =30 kg/m2. Overall, at M12, CAB+RPV LA demonstrated noninferior virologic efficacy vs. BIC/FTC/TAF (HIV-1 RNA =50 copies/mL, 1% [n=5/447] vs. <1% [n=1/223]) (presented elsewhere). There were no significant differences between CAB+RPV LA and BIC/FTC/TAF in change from baseline to M6 or M12 for key inflammatory markers (treatment geometric mean ratio [CAB+RPV LA:BIC/FTC/TAF; 95% confidence interval]): D-dimer, M6: 0.98 (0.94–1.02), p=0.258, M12: 1.00 (0.96–1.05), p=0.826; IL-6, M6: 0.94 (0.84–1.05), p=0.256, M12: 0.96 (0.84–1.10), p=0.574; CRP, M6: 0.96 (0.83–1.11), p=0.582, M12: 0.99 (0.84–1.17), p=0.927. Changes in CD4/CD8 ratio, sCD14, and sCD163 were similar between treatment groups. Changes in inflammatory parameters were similar across key subgroups for CAB+RPV LA (Table).


CONCLUSIONS: Over 12 months, CAB+RPV LA administered Q2M demonstrated noninferior virologic efficacy vs. daily oral BIC/FTC/TAF, with similar changes in inflammatory markers overall and by subgroups.

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