A Study to Evaluate Efficacy and Safety of Cabotegravir (CAB) Long Acting (LA) Plus (+) Rilpivirine (RPV) LA Versus BIKTARVY® (BIK) in Participants With Human Immunodeficiency Virus (HIV)-1 Who Are Virologically Suppressed

Summary

This study is designed to assess the antiviral activity and safety of a two-drug regimen of CAB LA + RPV LA compared with maintenance of BIK. BIKTARVY is a registered trademark of Gilead Sciences.

Timeline

Start

2020-11-09

Primary completion

2022-07-13

Completion

2023-04-17

Outcome

Met primary endpoint

paper was non-inferior to continuing daily oral bictegravir/emtricitabine/tenofovir alafenamide (BIC/FTC/TAF). PMID 40383512 ↗

release “12-month findings from the SOLAR study showed that the every-two-month regimen of CAB+RPV LA demonstrated non-inferior efficacy compared to continuation of daily oral BIC/FTC/TAF” viivhealthcare.com ↗

release “The SOLAR study met its primary endpoint at Month 12, when CAB+RPV LA demonstrated non-inferior efficacy versus daily oral BIC/FTC/TAF” viivhealthcare.com ↗

Publications

• Background Karver TS, Pascual-Bernaldez M, Berni A, Hnoosh A, Castagna A, Messiaen P, Puerto MJG, Bloch M, Adachi E, Sinclair G, Felizarta F, Angel JB, Sutton K, Sutherland-Phillips D, D'Amico R, Kerrigan D. Factors Associated with Health Care Providers' Preference for Forgoing an Oral Lead-In Phase When Initiating Long-Acting Injectable Cabotegravir and Rilpivirine in the SOLAR Clinical Trial. AIDS Patient Care STDS. 2023 Jan;37(1):53-59. doi: 10.1089/apc.2022.0168.
• Background Ramgopal MN, Castagna A, Cazanave C, Diaz-Brito V, Dretler R, Oka S, Osiyemi O, Walmsley S, Sims J, Di Perri G, Sutton K, Sutherland-Phillips D, Berni A, Latham CL, Zhang F, D'Amico R, Pascual Bernaldez M, Van Solingen-Ristea R, Van Eygen V, Patel P, Chounta V, Spreen WR, Garges HP, Smith K, van Wyk J. Efficacy, safety, and tolerability of switching to long-acting cabotegravir plus rilpivirine versus continuing fixed-dose bictegravir, emtricitabine, and tenofovir alafenamide in virologically suppressed adults with HIV, 12-month results (SOLAR): a randomised, open-label, phase 3b, non-inferiority trial. Lancet HIV. 2023 Sep;10(9):e566-e577. doi: 10.1016/S2352-3018(23)00136-4. Epub 2023 Aug 8.
• Adachi E, Yokomaku Y, Watanabe D, Gatanaga H, Oka S, Shirasaka T, D'Amico R, Sutton K, Sutherland-Phillips D, Roberts J, Thornhill J, Murungi A, Brown K. Month 12 outcomes of switching to long-acting cabotegravir + rilpivirine with an oral lead-in versus continuing bictegravir/emtricitabine/tenofovir alafenamide in the Phase 3b randomized SOLAR study. J Infect Chemother. 2025 Dec;31(12):102834. doi: 10.1016/j.jiac.2025.102834. Epub 2025 Oct 17.
• Adachi E, Yokomaku Y, Watanabe D, Gatanaga H, Oka S, Shirasaka T, Wakatabe R, Chamay N, Sutton K, Sutherland-Phillips D, Urbaityte R, D'Amico R, van Wyk J. Efficacy and safety of switching to long-acting cabotegravir + rilpivirine versus continuing bictegravir/emtricitabine/tenofovir alafenamide in Japanese participants: 12-month results from the phase 3b randomized SOLAR trial. J Infect Chemother. 2025 Jul;31(7):102734. doi: 10.1016/j.jiac.2025.102734. Epub 2025 May 16.
• Tan DHS, Antinori A, Eu B, Galindo Puerto MJ, Kinder C, Sweet D, Van Dam CN, Sutton K, Sutherland-Phillips D, Berni A, Zhang F, Urbaityte R, Baugh B, Spreen W, van Wyk J, Garges HP, Patel P, Batterham R, D'Amico R. Weight and Metabolic Changes With Long-Acting Cabotegravir and Rilpivirine or Bictegravir/Emtricitabine/Tenofovir Alafenamide. J Acquir Immune Defic Syndr. 2025 Apr 1;98(4):401-409. doi: 10.1097/QAI.0000000000003584. Epub 2025 Feb 19.

Drugs

Evaluation	Drug	Modality	Dose	Route
Comparator	Bictegravir	Small molecule	50 mg	—
Subject	Cabotegravir	Small molecule	30 mg	Oral
Subject	Cabotegravir	Small molecule	600 mg	Oral
Subject	Rilpivirine	Small molecule	25 mg	Oral
Subject	Rilpivirine	Small molecule	900 mg	Oral
Comparator	emtricitabine	Other / unclassified	200 mg	—
Comparator	tenofovir alafenamide	Small molecule	25 mg	—

Indications