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Clinical Trial
. 2025 Jul 11;231(6):1440-1444.
doi: 10.1093/infdis/jiaf159.

Lenacapavir Plus 2 Broadly Neutralizing Antibodies, Teropavimab and Zinlirvimab, for People With HIV-1 Highly Susceptible to Either Teropavimab or Zinlirvimab

Joseph J Eron  1 , Paul P Cook  2 , Megha L Mehrotra  3 , Hailin Huang  4 , Marina Caskey  5 , Gordon E Crofoot  6 , Linda Gorgos  7 , Laurie A VanderVeen  8 , Yanan Zheng  9 , Sean E Collins  10 , Olayemi O Osiyemi  11 , Cynthia Brinson  12 , Edwin DeJesus  13
Affiliations
Clinical Trial

Lenacapavir Plus 2 Broadly Neutralizing Antibodies, Teropavimab and Zinlirvimab, for People With HIV-1 Highly Susceptible to Either Teropavimab or Zinlirvimab

Joseph J Eron et al. J Infect Dis. .

Abstract

Background: The combination of 2 broadly neutralizing antibodies (bNAbs), teropavimab and zinlirvimab, plus the capsid inhibitor lenacapavir, is a potential twice-yearly regimen for HIV-1 treatment. The level of bNAb susceptibility to maintain virologic suppression is unknown; therefore, we evaluated this combination in participants meeting stringent viral sensitivity criteria to only 1 of the 2 bNAbs.

Methods: This was a pilot study within a proof-of-concept phase 1b study.

Results: No serious treatment-emergent adverse events occurred and 8 of 10 participants remained virologically suppressed at week 26.

Conclusions: More inclusive bNAb susceptibility criteria may be appropriate for future studies of this combination treatment. Clinical Trials Registration. NCT04811040.

Keywords: HIV; HIV-1; HIV-1 therapy; adherence; bnAbs; lenacapavir; long acting; susceptibility; teropavimab; zinlirvimab.

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Conflict of interest statement

Potential conflict of interests. J. J. E. reports grants/contract payments and consulting fees from Gilead Sciences, Inc and ViiV; and consulting fees from Merck. P. P. C. reports grants/contract payments from National Institutes of Health, ViiV, Janssen Pharmaceuticals, and Gilead Sciences; and data safety monitoring or advisory board participation for Westat. M. C. reports advisory board participation for Gilead Sciences, Inc. G. E. C. reports grants/contract payments from ViiV, Merck, AbbVie, and Janssen Pharmaceuticals; and grants/contract payments and support for attending meetings from Gilead Sciences, Inc. L. G. reports grants/contract payments from Gilead Sciences, Inc and Merck; and honoraria from AIDS Education and Training Center, South Central. O. O. O. reports speaker program for ViiV; and speaker and advisory board for Gilead Sciences, Inc, ViiV, and Merck. C. B. reports funding, speaker honoraria, and support for attending principal investigator meetings from Gilead Sciences, Inc; speaker honoraria and support for attending principal investigator meetings from ViiV; and support for attending principal investigator meetings from GSK, P. P. D. (Thermo Fisher Scientific), Merck, Viking Therapeutics, Syneos Health, Novo Nordisk A/S, AbbVie, Regeneron Pharmaceuticals Inc, and Janssen and Shionogi & Co. Ltd. E. D. reports grants/contract payments from ViiV, Merck, AbbVie, TeroTechnology/Taimed Biologic, and Gilead Sciences, Inc. M. L. M., H. H., L. A. V., Y. Z., and S. E. C. are employees and shareholders of Gilead Sciences, Inc.

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