Trial reportOpen forum infectious diseases2026
Effectiveness and Safety of Lenacapavir-Containing Regimens in Highly Experienced HIV-Infected Patients With Multidrug Resistance: Real-world Results From the French Compassionate Use Program
Trial report in Open forum infectious diseases, 2026. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Not yet cited in PubMed.
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Authors and funding
16 authors.
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Abstract
Background: Lenacapavir (LEN) with an optimized background regimen (OBR) was evaluated in a French cohort of participants with multidrug-resistant human immunodeficiency virus (HIV) via compassionate use. Methods: Adults (n = 42) with HIV-1 (PLWH1, n = 33) or HIV-2 (PLWH2, n = 9), receiving at least 1 dose of LEN plus OBR, were prospectively followed between January 2021 and December 2023. The primary endpoint was virological suppression (plasma HIV-1 RNA [VL] <50 copies/mL at week 26 (W26)) or maintenance, using the US Food and Drug Administration Snapshot algorithm. Secondary endpoints included long-term VL, resistance emergence, LEN plasma concentration, and drug safety. Results: At baseline, PLWH1 presented with a median VL of 4.0 log Conclusions: LEN plus OBR showed robust efficacy and safety in PLWH1 but limited antiviral activity in PLWH2 due to limited OBR. These findings support LEN as an effective option in highly treatment-experienced PLWH1, while underscoring challenges for PLWH2.
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