Bixlenvo (bictegravir/lenacapavir) / Gilead - LARVOL DELTA

Gilead Sciences…announced that the U.S. Food and Drug Administration (FDA) approved Bixlenvo (bictegravir 75 mg/lenacapavir 50 mg), the smallest once-daily single tablet regimen (STR) for the treatment of HIV in adults who are virologically suppressed (Businesswire) - "Bixlenvo is now the first and only STR option for virologically suppressed people with HIV who are on complex regimens and unable to take currently available STRs....The FDA approval is based on results from the Phase 3 ARTISTRY-1 (NCT05502341) and ARTISTRY-2 (NCT06333808) trials..."

FDA approval • Human Immunodeficiency Virus • Infectious Disease

Study of Bictegravir/Lenacapavir in Children and Adolescents With HIV-1 (clinicaltrials.gov) - P2/3 | N=75 | Active, not recruiting | Sponsor: Gilead Sciences | Recruiting ➔ Active, not recruiting | Trial completion date: Aug 2028 ➔ Dec 2030 | Trial primary completion date: Feb 2028 ➔ Jul 2030

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

U.S. FDA Grants Priority Review of New Drug Application for Gilead’s Once-Daily HIV Treatment of Bictegravir Plus Lenacapavir (Businesswire) - "The FDA has granted priority review of the application and assigned a Prescription Drug User Fee Act (PDUFA) action date of August 27, 2026....The NDA submission is supported by positive Phase 3 data from the ARTISTRY-1 (NCT05502341) and ARTISTRY-2 (NCT06333808) trials, which evaluated BIC/LEN in adults with HIV with virological suppression, including those who switched from complex multi-tablet regimens or from Biktarvy (bictegravir 50 mg/emtricitabine 200 mg/tenofovir alafenamide 25 mg)."

FDA filing • PDUFA • Priority review • Human Immunodeficiency Virus

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