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Introduction <p>Injection site reactions (ISRs) are a key consideration when selecting long-acting injectables (LAIs), and are central to healthcare provider (HCP) and patient shared decision-making. We evaluated the acceptability of ISR profiles alongside participant and HCP-reported preferences for long-acting cabotegravir (CAB LA) and lenacapavir (LEN LA).</p> Methods <p>CLARITY (NCT06970223) is an open-label, randomized, crossover study. Adults without HIV received single-dose CAB LA (intramuscular) and LEN LA (subcutaneous) on Days 1 and 15 (randomized so either CAB LA or LEN LA was the first injection). The primary endpoint was the proportion of participants reporting “very acceptable or totally acceptable” local reactions and pain 7 days post-injection using the Perception of Injection (PIN) questionnaire. Secondary endpoints included characterization of the ISR profile. Exploratory endpoints included participant and HCP preferences and participant perspectives using questionnaires and interviews.</p> Results <p>Overall, 61 participants received CAB LA and 62 received LEN LA. A higher proportion of participants reported local reactions and pain as “totally or very acceptable” with CAB LA injections versus LEN LA [69% (42/61) vs. 48% (29/60); odds ratio, 3.4 (95% CI, 1.25 to 9.22); <i>P</i> &lt; 0.019 post hoc]. CAB LA consistently showed more favorable PIN domain and individual items of assessment scores versus LEN LA. CAB LA demonstrated a favorable ISR profile versus LEN LA, including fewer visible ISR events (36 vs. 221). Ninety percent (54/60) of participants preferred CAB LA, whereas 10% (6/60) preferred LEN LA; 86% (6/7) of HCPs preferred CAB LA and 14% (1/7) preferred LEN LA. Participants reported less pain during CAB LA versus LEN LA injections.</p> Conclusion <p>CAB LA was more acceptable than LEN LA, had a more favorable ISR profile, and was preferred by a majority of participants and HCPs. These findings highlight differences in the injection experience that can inform shared decision-making when choosing LAIs.</p>

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Long-Acting Cabotegravir Injections Are More Acceptable Than Long-Acting Lenacapavir Injections After One Dose: Results From the CLARITY Randomized Crossover Study

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  • 出版模式：

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  • 发表日期：

    2026年7月24日

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  • Emilie R. Elliot,
  • Justine Boles,
  • Dainielle Fox,
  • Katherine L. Nelson,
  • Laure Dupont-Benjamin,
  • Apinya Vutikullird,
  • Amber Mottola,
  • Kim Fletcher,
  • Kehui Wang,
  • Suryakant Somvanshi,
  • Richard Grove,
  • Katie Strano,
  • Nanlesta Pilgrim,
  • Rebecca Borsi,
  • Piotr Budnik,
  • Jean van Wyk,
  • Harmony P. Garges,
  • Kimberley Brown

摘要

Introduction

Injection site reactions (ISRs) are a key consideration when selecting long-acting injectables (LAIs), and are central to healthcare provider (HCP) and patient shared decision-making. We evaluated the acceptability of ISR profiles alongside participant and HCP-reported preferences for long-acting cabotegravir (CAB LA) and lenacapavir (LEN LA).

Methods

CLARITY (NCT06970223) is an open-label, randomized, crossover study. Adults without HIV received single-dose CAB LA (intramuscular) and LEN LA (subcutaneous) on Days 1 and 15 (randomized so either CAB LA or LEN LA was the first injection). The primary endpoint was the proportion of participants reporting “very acceptable or totally acceptable” local reactions and pain 7 days post-injection using the Perception of Injection (PIN) questionnaire. Secondary endpoints included characterization of the ISR profile. Exploratory endpoints included participant and HCP preferences and participant perspectives using questionnaires and interviews.

Results

Overall, 61 participants received CAB LA and 62 received LEN LA. A higher proportion of participants reported local reactions and pain as “totally or very acceptable” with CAB LA injections versus LEN LA [69% (42/61) vs. 48% (29/60); odds ratio, 3.4 (95% CI, 1.25 to 9.22); P < 0.019 post hoc]. CAB LA consistently showed more favorable PIN domain and individual items of assessment scores versus LEN LA. CAB LA demonstrated a favorable ISR profile versus LEN LA, including fewer visible ISR events (36 vs. 221). Ninety percent (54/60) of participants preferred CAB LA, whereas 10% (6/60) preferred LEN LA; 86% (6/7) of HCPs preferred CAB LA and 14% (1/7) preferred LEN LA. Participants reported less pain during CAB LA versus LEN LA injections.

Conclusion

CAB LA was more acceptable than LEN LA, had a more favorable ISR profile, and was preferred by a majority of participants and HCPs. These findings highlight differences in the injection experience that can inform shared decision-making when choosing LAIs.