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. Rizzardini^6,7, 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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