Lenacapavir

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.

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

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.

The primary objective of this study is to evaluate the antiviral activity of lenacapavir (formerly GS-6207) administered as an add-on to a failing regimen (functional monotherapy) in people living with HIV (PLWH) with multi-drug resistance (MDR).

The primary objective of this study is to evaluate the efficacy of lenacapavir (formerly GS-6207) containing regimens in people living with HIV (PLWH).

The HIV-1 variability poses a challenge for the accuracy and efficiency of diagnostic and treatment tools. This study analyzes p24 diversity among HIV-1 variants and within its secondary structure in HIV-1 M, O, P, and N groups. All available HIV-1 p24 nucleotide sequences were downloaded from the Los Alamos HIV Sequence Database, selecting 23,671 sequences

We sought to determine whether combination of lenacapavir with islatravir, rilpivirine, or cabotegravir displayed synergy, additivity, or antagonism.

Lenacapavir susceptibility in the SC assay showed an inverse relationship between replication capacity and resistance. In Study 4072, all 29 participants receiving lenacapavir showed a robust virological response with no rebound. At baseline, no participant had resistance mutations to lenacapavir, and all had WT susceptibility to lenacapavir. Post-monotherapy analyses revealed the emergence of CA mutation

Lenacapavir, a long-acting HIV capsid inhibitor that could potentially be given every six months, continues to show good viral suppression, both in people starting antiretroviral therapy for the first time and in highly treatment-experienced people with multidrug-resistant virus, according to studies presented last week at the Conference on Retroviruses and Opportunistic Infections (CROI 2022).

Ongoing studies are evaluating long-acting dosing of lenacapavir for treating HIV-1 in combination with other antiretrovirals and preventing HIV-1 as a single agent.