Benzinga | Dec 22, 2021 04:58AM EST

Gilead on Tuesday Announced Clinical Hold on Studies Evaluating Injectable Lenacapavir for HIV Treatment and Prevention Due to Vial Quality Concerns

Gilead Sciences, Inc. (NASDAQ:GILD) today announced that the U.S. Food and Drug Administration (FDA) has placed a clinical hold on the use of injectable lenacapavir in borosilicate vials in all ongoing clinical studies for HIV treatment and HIV pre-exposure prophylaxis (PrEP). The FDA's clinical hold is due to emerging concerns about the compatibility of vials made of borosilicate glass with lenacapavir solution, which could potentially lead to the formation of sub-visible glass particles in the solution of lenacapavir. Dosing of oral formulations of lenacapavir will continue. The company remains confident about the future potential of lenacapavir and is committed to resolving this vial quality issue.

During the clinical hold, screening and enrollment of study participants and the dosing of injectable lenacapavir will not be permitted across all lenacapavir studies. All other study activities, including the monitoring of participants and the dosing of participants in comparator arms, will continue according to the relevant study protocol.

"We are committed to working diligently with FDA to resolve this glass vial compatibility quality issue and resume injectable lenacapavir dosing in the affected studies in a timely fashion," said Merdad Parsey, MD, PhD, Chief Medical Officer, Gilead Sciences.

The following studies have been placed on clinical hold:

Study

Phase



Title

GS-US-200-4625

Phase 2/3

(NCT 04150068)

A Phase 2/3 Study to Evaluate the Safety and Efficacy of Long Acting Capsid Inhibitor GS-6207 in Combination with an Optimized Background Regimen in Heavily Treatment Experienced People Living With HIV-1 Infection with Multidrug Resistance

GS-US-200-4334

Phase 2

(NCT 04143594)

A Phase 2 Randomized, Open Label, Active Controlled Study Evaluating the Safety and Efficacy of Long-acting Capsid Inhibitor GS-6207 in Combination with Other Antiretroviral Agents in People Living with HIV

GS-US-200-5709

Phase 1

A Phase 1 Study in Healthy Participants to Evaluate the Safety, Tolerability, and Pharmacokinetics of Lenacapavir (LEN)

GS-US-412-5624

Phase 3

(NCT 04994509)

A Phase 3, Double-Blinded, Multicenter, Randomized Study to Evaluate Safety and Efficacy of Twice Yearly Long-Acting Subcutaneous Lenacapavir, and Daily Oral Emtricitabine/Tenofovir Alafenamide for Pre-Exposure Prophylaxis in Adolescent Girls and Young Women at Risk of HIV Infection (PURPOSE-1)

GS-US-528-9023

Phase 3

(NCT 04925752)

A Phase 3, Double-Blind, Multicenter, Randomized Study to Evaluate the Efficacy and Safety of Subcutaneous Twice Yearly Long-Acting Lenacapavir for HIV Pre-Exposure Prophylaxis in Cisgender Men, Transgender Women, Transgender Men, and Gender Non-binary People 16 Years of Age Who Have Sex With Partners Assigned Male at Birth and Are at Risk for HIV Infection

GS-US-536-5816

Phase 1b

(NCT 04811040)

A Phase 1b Randomized, Blinded, Proof-of-Concept Study to Evaluate the Safety and Efficacy of Broadly Neutralizing Antibodies (bNAbs) GS-5423 and GS-2872 in Combination with Capsid Inhibitor Lenacapavir (GS-6207) in Virologically Suppressed Adults with HIV-1 Infection

GS-US-200-5710

Phase 1

A Phase 1 Study in Healthy Participants to Evaluate the Safety, Tolerability, and Pharmacokinetics of Subcutaneous and Intramuscular Lenacapavir

GS-US-200-5717

Phase 1

A Phase 1 Study in Healthy Participants to Evaluate the Safety, Tolerability, and Pharmacokinetics of Subcutaneous and Intramuscular Lenacapavir

GS-US-528-5744

Phase 1

A Phase 1, Open-Label, Single-Arm, Single-Dose Study to Evaluate the Pharmacokinetics and Distribution of Long-Acting HIV Capsid Inhibitor, Lenacapavir (LEN), into Rectal and Female Genital Tract Tissues in HIV-Seronegative Participants

GS-US-200-4540

Phase 1

A Phase 1 Study to Evaluate the Effect of Subcutaneous (SC) Injection Sites on the Pharmacokinetics (PK) of Lenacapavir (LEN)

Lenacapavir is an investigational compound and is not approved by any regulatory authority for any use and its safety and efficacy are not known. There is no cure for HIV or AIDS.