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Real World Use of Lenacapavir, as an add-on to an Optimized Background Regimen in France

Recruitingn/aAges 18 Years - anyAllCentre de Recherches et d'Etude sur la Pathologie…
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In plain words

What the trial is, and whether it could suit you

For most people with HIV (PWH), an effective antiretroviral regimen can be devised. However, some PWH have multiple treatment failures due to viral resistance or unacceptable side effects to medication and no longer have durable viral suppression. People with multidrug-resistant HIV-1 are at increased risk for hospitalization, progression to acquired immunodeficiency syndrome, and death. Lenacapavir (LEN) is a first-in-class capsid inhibitor and has been evaluated through the CAPELLA phase 3 trial in PWH with replicative multidrug-resistant HIV-1. In this trial, LEN combined with an optimized background regimen (OBR) led to high levels of viral suppression, as more than 80% of participants achieved undetectable plasma HIV-RNA, associated with increasing in CD4 T cell counts. LEN has become publicly available in France from June 20, 2023, and prescriptions are discussed and validated by

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📋 Eligibility rules (as published)
Inclusion Criteria: * Adults (≥18 years); * With HIV-1 infection; * Who received a first dose of LEN (oral or injectable) with and OBR from the ending of the French national early access program (20 June 2023) to 30 June 2024; * Who did not refuse the collection and use of their data. Exclusion Criteria: \- HIV-2 infection.
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What it tests

  • Lenacapavir Injection
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Where

1 site
Hôpital Pitié-Salpêtrière
Paris, France
🤝 Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible — always decide together with your own doctor.
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