bictegravir/lenacapavir (BIC/LEN FDC) / Gilead - LARVOL DELTA

ARTISTRY-1: Study to Compare Bictegravir/Lenacapavir Versus Current Therapy in People With HIV-1 Who Are Successfully Treated With a Complicated Regimen (clinicaltrials.gov) - P2/3 | N=689 | Active, not recruiting | Sponsor: Gilead Sciences | Recruiting ➔ Active, not recruiting | Trial completion date: Nov 2028 ➔ Jul 2028 | Trial primary completion date: Jan 2026 ➔ Sep 2025

Enrollment closed • Trial completion date • Trial primary completion date • Human Immunodeficiency Virus • Infectious Disease

Pharmacokinetic (PK) analysis of oral once‐daily bictegravir (BIC) plus lenacapavir (LEN) administered separately (BIC 75 mg + LEN 25 mg; BIC 75 mg + LEN 50 mg) and as BIC/LEN 75/50 mg single‐tablet regimen to support phase III dose selection (HIV-Glasgow 2024) - P2/3 | "We report the PK of BIC and LEN, either as single agents co-administered (SAC), or as BIC/LEN FDC. Our analyses support the use of BIC/LEN 75/50 mg FDC for phase III, which will match the exposure experience of BIC 75 mg + LEN 50 mg in phase II. This dose combination was chosen based on efficacy, safety, cumulative PK in phase II and rBA, and additional consideration of the exposure coverage for potential missed doses, projected by popPK analysis."

P3 data • PK/PD data • Human Immunodeficiency Virus • Infectious Disease

Study of Bictegravir/Lenacapavir in Children and Adolescents With HIV-1 (clinicaltrials.gov) - P2/3 | N=75 | Recruiting | Sponsor: Gilead Sciences | Not yet recruiting ➔ Recruiting

Enrollment open • Human Immunodeficiency Virus • Infectious Disease

Study of Bictegravir/Lenacapavir in Children and Adolescents With HIV-1 (clinicaltrials.gov) - P2/3 | N=75 | Not yet recruiting | Sponsor: Gilead Sciences

New P2/3 trial • Human Immunodeficiency Virus • Infectious Disease

Study to Compare Bictegravir/Lenacapavir Versus Current Therapy in People With HIV-1 Who Are Successfully Treated With a Complicated Regimen (clinicaltrials.gov) - P2/3 | N=671 | Recruiting | Sponsor: Gilead Sciences | Active, not recruiting ➔ Recruiting

Enrollment open • Human Immunodeficiency Virus • Infectious Disease

Study to Compare Bictegravir/Lenacapavir Versus Current Therapy in People With HIV-1 Who Are Successfully Treated With a Complicated Regimen (clinicaltrials.gov) - P2/3 | N=671 | Active, not recruiting | Sponsor: Gilead Sciences

Trial completion date • Trial primary completion date • Human Immunodeficiency Virus • Infectious Disease

Study to Compare Bictegravir/Lenacapavir Versus Current Therapy in People With HIV-1 Who Are Successfully Treated With a Complicated Regimen (clinicaltrials.gov) - P2/3 | N=671 | Active, not recruiting | Sponsor: Gilead Sciences | Recruiting ➔ Active, not recruiting

Enrollment closed • Human Immunodeficiency Virus • Infectious Disease • CD4

Study to Compare Bictegravir/Lenacapavir Versus Current Therapy in People With HIV-1 Who Are Successfully Treated With a Complicated Regimen (clinicaltrials.gov) - P2/3 | N=671 | Recruiting | Sponsor: Gilead Sciences | Not yet recruiting ➔ Recruiting

Enrollment open • Human Immunodeficiency Virus • Infectious Disease • CD4