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

NCT06799338 | Recruiting DMC

• 1 other identifier: CREPATS 20
• Study Type: observational
• Target: 80
• Locations: 1 country
• Sites: 1

Brief Summary

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 multidisciplinary committees in the hospitals, including HIV physicians, virologists and pharmacologists. From the time LEN was made publicly available in France, no real-world data have been generated to describe the real-world use of LEN, in association with an OBR, in various patient's profiles who may differ from the subjects included the CAPELLA trial. Thus, investigators plan to conduct a national, multicenter, retrospective observational study to describe baseline socio-demographic, clinical and biological profiles of PWH receiving LEN + OBR in French real-world settings, to determine the continuation of LEN injections at weeks 26 and 52, and to determine the reasons for stopping LEN in case of no continuation of LEN injections. In its current indication, LEN is reserved for a minority of PWH. However, France is the second-largest prescribing country for this drug, and one year after it was first marketed, it seems essential to review its use. Whether LEN injections are continued 6 and 12 months after starting treatment is a crucial question for understanding its use in treatment centers. Lenacapavir has become publicly available in France in June 20, 2023. LEN prescriptions in France are discussed and validated by multidisciplinary committees, including HIV physicians, virologists and pharmacologists in the hospitals.

Conditions

HIV I Infection

Outcome Measures

Primary Outcomes (2)

• Measure the number of participants who received lenecapavir injection

  Week26

• Measure the number of participants who received a lenacapavir injection

  Week 52

Study Arms (1)

LENAddOn is a retrospective, observational, national, multicenter study

Data will be collected from medical records in 21 centers, and captured with a dedicated eCRF created on the study purpose. Patients will be included if they initiated LEN from 20 June 2023 to 30 June 2024. All collected data are routinely reported by clinicians in medical records. All clinical decisions All collected data are routinely reported by clinicians in medical records, and will be collected using a dedicated electronic case report form (eCRF) created on this purpose, to ensure confidentiality of data.

Drug: Lenacapavir Injection

Interventions

Lenacapavir Injection DRUG

Patients will be included if they initiated LEN from 20 June 2023 to 30 June 2024. All collected data are routinely reported by clinicians in medical records. All clinical decisions All collected data are routinely reported by clinicians in medical records, and will be collected using a dedicated electronic case report form (eCRF) created on this purpose, to ensure confidentiality of data.

LENAddOn is a retrospective, observational, national, multicenter study

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

We anticipated about 120 patients initiating LEN from 20 June 2023 to 30 June 2024 in France. We plan to include 80 subjects, followed in 21 French centers.

You may qualify if:

• 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.

You may not qualify if:

• \- HIV-2 infection.

Sponsors & Collaborators

• Centre de Recherches et d'Etude sur la Pathologie Tropicale et le Sida: lead

Study Sites (1)

Hôpital Pitié-Salpêtrière

Paris, Île-de-France Region, 75013, France

RECRUITING

MeSH Terms

Interventions

lenacapavir

Study Officials

• Romain PALICH, MD

  Pitie-Salpetriere Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Yasmine DUDOIT

CONTACT

+33 (0)1 42 16 41 81; yasmine.dudoit@aphp.fr

Romain PALICH, MD

CONTACT

+33 (0)1 42 16 01 71

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: OTHER
• Target Duration: 52 Weeks
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 23, 2025
• First Posted: January 29, 2025
• Study Start: March 3, 2025
• Primary Completion: August 31, 2025
• Study Completion: December 31, 2025
• Last Updated: May 22, 2025

Record last verified: 2025-05

Data Sharing

• IPD Sharing: Will not share

Locations

FR (1)