A Phase 1b trial investigating the safety and efficacy of the investigational broadly neutralizing antibodies (bNAbs) GS-5423 and GS-2872 in combination with lenacapavir in virologically suppressed adults with HIV.
This article describes strategic approaches undertaken in the PURPOSE 2 trial to optimize engagement of underrepresented individuals.
Lenacpavir is a first-generation capsid inhibitor that retains efficacy against mutations that confer resistance to other ARV classes. Approvals for an MDR indication were sought from the FDA and EMA June and August 2021, respectively.
Lenacapavir in MDR HIV: phase 3 results of CAPELLA study published Read More »
The currently available HIV treatments can be grouped into 7 categories based on which step of the HIV infection pathway they target: chemokine receptor antagonists, attachment inhibitors, post-attachment inhibitors, nucleoside reverse transcriptase inhibitors (NRTIs), non-nucleoside reverse transcriptase inhibitors (NNRTIs) fusion inhibitors, integrase strand transfer inhibitors (INSTIs), and protease inhibitors (PIs).4 Anyone with an HIV infection
An introduction to HIV treatments Read More »
The ongoing human immunodeficiency virus (HIV) epidemic mandates advancements in its prevention and treatment. The focus of antiretroviral therapy is shifting to long-acting therapies that provide decreases in frequency of administration, multiple mechanisms of action, and high barriers to resistance.
On May 16, the Food and Drug Administration (FDA) lifted its clinical hold on lenacapavir, Gilead Sciences’ investigational long-acting HIV capsid inhibitor, after the company switched to a different type of glass vial. Lenacapavir continues to show promise as a treatment both for people starting antiretroviral therapy for the first time and for treatment-experienced people
FDA Lifts Clinical Hold on Long-Acting Lenacapavir Read More »
Competition from deep-pocketed rivals like GSK, Johnson & Johnson and Merck & Co. has pushed Gilead to innovate. On that front, the company has identified lenacapavir as one of its most valuable assets.
Gilead, having resolved manufacturing issues, forges ahead with HIV drug Read More »
The US Food and Drug Administration (FDA) has removed the clinical hold on Gilead Sciences’ Investigational New Drug Application (IND) of injectable lenacapavir for treating and preventing human immunodeficiency virus (HIV) infection. An investigational long-acting HIV-1 capsid inhibitor, lenacapavir is intended to hinder HIV-1 at various stages of its lifecycle.
Gilead’s lenacapavir for HIV has clinical hold lifted by FDA Read More »
While A114S conferred reduced susceptibility to ISL, it increased susceptibility to approved nucleoside reverse transcriptase inhibitors (NRTIs). This differential impact of A114S on ISL, an NRTTI, compared to NRTIs likely results from the different mechanisms of action. Altogether, the results demonstrate that ISL has a high barrier to resistance and a differentiated mechanism compared to
In patients with multidrug-resistant HIV-1 infection, those who received lenacapavir had a greater reduction from baseline in viral load than those who received placebo.
Capsid Inhibition with Lenacapavir in Multidrug-Resistant HIV-1 Infection Read More »
