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Introduction <p>Long-acting injectable cabotegravir (hereafter referred to as cabotegravir) is the first long-acting injectable approved for pre-exposure prophylaxis (PrEP) based on the HPTN 083 and 084 trials. Long-acting injectable lenacapavir (hereafter referred to as lenacapavir) was approved for PrEP based on the PURPOSE 1 and 2 trials. In the absence of a head-to-head trial, we conducted an indirect treatment comparison (ITC) to assess efficacy of lenacapavir versus cabotegravir in reducing the risk of HIV acquisition.</p> Methods <p>A systematic literature review identified all relevant trials. Efficacy inputs for this ITC were derived from re-adjudicated data from the injection phase of the HPTN trials or published data from the PURPOSE trials. The ITC was performed using 2 network approaches: (1) using no PrEP and (2) using daily oral tenofovir disoproxil fumarate/emtricitabine (TDF/FTC) as common comparators, with adjustments accounting for differing levels of adherence to TDF/FTC across trials. Sensitivity analyses were also performed using data from both the oral lead-in and injection phases of the HPTN trials.</p> Results <p>Both network approaches estimated high and comparable efficacy of cabotegravir and lenacapavir. Using no PrEP (network approach 1), the base case estimated hazard ratio (95% CrI) of lenacapavir versus cabotegravir was 1.04 (0.19, 5.69) in men who have sex with men and transgender women and 0.00 (0.00, 3.21) in cisgender women. Predicted efficacy (95% CrI) rates of cabotegravir versus no PrEP were high in men who have sex with men and transgender women 96% (90%, 98%)] and cisgender women [98% (89%, 100%)] in the HPTN trials, which were comparable to the PURPOSE trials [men and gender-diverse people, 96% (82%, 99%); cisgender women, 100%(96%,100%)]. Sensitivity analyses confirmed these findings.</p> Conclusion <p>Based on this ITC, cabotegravir and lenacapavir offer similar and high efficacy in preventing HIV acquisitions compared with no PrEP or TDF/FTC.</p> <p>Graphical abstract and video abstract available for this article.</p>

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Indirect Treatment Comparison of the Efficacy of Long-Acting Injectable Cabotegravir Compared With Lenacapavir for HIV Pre-exposure Prophylaxis

  • 期刊论文

  • 出版模式：

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  • 发表日期：

    2026年5月22日

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  • Neil Hawkins,
  • Aniruddha Hazra,
  • Marisa Brizzi,
  • Juliette Thompson,
  • Richard Grove,
  • Marius Sieverding,
  • Piotr Budnik,
  • Jenny Scherzer,
  • Natalya Danchenko,
  • Sarah-Jane Anderson,
  • Laure Dupont-Benjamin

摘要

Introduction

Long-acting injectable cabotegravir (hereafter referred to as cabotegravir) is the first long-acting injectable approved for pre-exposure prophylaxis (PrEP) based on the HPTN 083 and 084 trials. Long-acting injectable lenacapavir (hereafter referred to as lenacapavir) was approved for PrEP based on the PURPOSE 1 and 2 trials. In the absence of a head-to-head trial, we conducted an indirect treatment comparison (ITC) to assess efficacy of lenacapavir versus cabotegravir in reducing the risk of HIV acquisition.

Methods

A systematic literature review identified all relevant trials. Efficacy inputs for this ITC were derived from re-adjudicated data from the injection phase of the HPTN trials or published data from the PURPOSE trials. The ITC was performed using 2 network approaches: (1) using no PrEP and (2) using daily oral tenofovir disoproxil fumarate/emtricitabine (TDF/FTC) as common comparators, with adjustments accounting for differing levels of adherence to TDF/FTC across trials. Sensitivity analyses were also performed using data from both the oral lead-in and injection phases of the HPTN trials.

Results

Both network approaches estimated high and comparable efficacy of cabotegravir and lenacapavir. Using no PrEP (network approach 1), the base case estimated hazard ratio (95% CrI) of lenacapavir versus cabotegravir was 1.04 (0.19, 5.69) in men who have sex with men and transgender women and 0.00 (0.00, 3.21) in cisgender women. Predicted efficacy (95% CrI) rates of cabotegravir versus no PrEP were high in men who have sex with men and transgender women 96% (90%, 98%)] and cisgender women [98% (89%, 100%)] in the HPTN trials, which were comparable to the PURPOSE trials [men and gender-diverse people, 96% (82%, 99%); cisgender women, 100%(96%,100%)]. Sensitivity analyses confirmed these findings.

Conclusion

Based on this ITC, cabotegravir and lenacapavir offer similar and high efficacy in preventing HIV acquisitions compared with no PrEP or TDF/FTC.

Graphical abstract and video abstract available for this article.