Gilead's Twice-Yearly Lenacapavir Achieves 81% Viral Suppression in Multidrug-Resistant HIV Patients at Week 26
Jul 19, 2021 01:39
CST Updated
01:39
Gilead Sciences
Antiviral Drug Developer
July 19, 2021 /BioonBIOON/ -- Gilead Sciences recently at the 2021 11th International AIDS Society (IAS) HIV ScienceConferenceannounced the latest results of the Phase 2/3 CAPELLA trial (NCT04150068). The trial is being conducted in heavily treatment-experienced (HTE) patients with multidrug-resistant (MDR) HIV-1 infection and is evaluatingLong-acting HIV-1 capsid inhibitor lenacapavir (GS-6207)efficacy and safety.
Data released at the meeting show:In HIV-1-infected individuals whose virus no longer responds effectively to treatment，Administered subcutaneously once every 6 months.Lenacapavir, in combination with other antiretroviral drugs, achieved a high virologic suppression rate at Week 26 of treatment. Specifically: in this patient population with high unmet medical need,With lenacapavir in combination with an optimized background regimen, 81% of patients (n=29/36) achieved an undetectable viral load at Week 26 (virologic suppression, HIV-1 RNA <50 copies/mL).。
Chemical Structure of Lenacapavir (GS-6207)
Additionally, the patients' CD4 cell count increased by a mean of 81 cells/μL. Regarding the primary endpoint of the CAPELLA trial,At the end of the 14-day functional monotherapy, a significantly higher proportion of patients in the lenacapavir group achieved a reduction in viral load of ≥0.5 log10 copies/mL from baseline compared with the placebo group (88% vs 17%, p < 0.0001).. In addition,During functional monotherapy, the mean reduction in viral load was statistically significantly greater in the lenacapavir group than in the placebo group (-1.93 log10 copies/mL vs -0.29 log10 copies/mL, p < 0.0001).
These data support the ongoing evaluation of lenacapavir for the treatment of HIV-1 infection and form the basis for the recently submitted New Drug Application (NDA). In late June this year, Gilead Sciences to the United StatesFDASubmitted the NDA for lenacapavir: in combination with other antiretroviral drugs, for the treatment of heavily treatment-experienced (HTE) patients with multidrug-resistant (MDR) HIV-1 infection.If approved, lenacapavir will become the first capsid inhibitor and the only HIV-1 treatment regimen administered once every six months.
Mechanism of Action of Lenacapavir (GS-6207)
Lenacapavir is a potential first-in-class capsid inhibitor with potent antiviral activity that rapidly reduces viral load following a single subcutaneous injection.Lenacapavir has no overlapping resistance with currently approved antiretroviral therapies (ART). The drug inhibits HIV-1 replication by interfering with multiple critical steps in the viral life cycle, including capsid-mediated uptake of HIV-1 proviral DNA, viral assembly and release, and capsid core formation.In May 2019, the United StatesFDABreakthrough Therapy Designation (BTD) was granted to lenacapavir, in combination with other antiretroviral drugs, for the treatment of heavily treatment-experienced (HTE) patients with multidrug-resistant (MDR) HIV-1 infection.
Currently, lenacapavir is being developed as a subcutaneous injection administered once every 6 months, in combination with other antiretroviral agents, for the treatment of adults and pediatric patients weighing ≥35 kg with multidrug-resistant (MDR) HIV-1 infection who are failing their current antiretroviral regimens due to resistance, intolerance, or safety concerns.
Lenacapavir represents a significant breakthrough innovation with transformative potential for individuals living with multidrug-resistant HIV who have very limited treatment options. This drug is expected to provide an innovative therapeutic option, helping to overcome barriers to achieving viral suppression and addressing the high unmet medical need among patients with multidrug-resistant HIV.
Frank Duff, Executive Vice President and Head of Viral Therapeutics at Gilead Sciences, said: “Lenacapavir is a breakthrough innovation in the field of HIV research. If approved, lenacapavir has the potential to become a cornerstone of future long-acting HIV treatment regimens. Scientific advancement is key to helping end the HIV epidemic. Our researchers are dedicated to addressing unmet medical needs among people living with HIV, including exploring alternative dosing intervals that may align with routine clinical visits.” (Bioon.com)