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New ART Lenacapavir Update - FDA Approval
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Sunlenca® (lenacapavir) Receives FDA Approval as a First-in-Class, Twice-Yearly Treatment Option for People Living With Multi-Drug Resistant HIV - (12/22/22)
FDA Product Insert - Sunlenca (lenacapavir) Receives FDA Approval - (12/29/22)
Simulations for once weekly dosing of oral lenacapavir
FDA Product Insert - Sunlenca (lenacapavir) Receives FDA Approval - (12/29/22)
Investigational Lenacapavir Receives Positive CHMP Opinion for People With Multi-Drug Resistant HIV
European Medicines Agency Validates Gilead's Marketing Authorization Application for Lenacapavir, an Investigational, Long-Acting Capsid Inhibitor for the Treatment of HIV-1 in People With Limited Therapy Options
In May 2019, the FDA granted Breakthrough Therapy Designation for the development of lenacapavir for the treatment of HIV-1 infection in heavily treatment-experienced patients with multi-drug resistance in combination with other antiretroviral drugs.
"Long-acting antiretroviral therapy may help address challenges with treatment adherence and treatment fatigue, providing additional options to people living with HIV," said Eric S. Daar, MD, Chief of the Division of HIV Medicine at the Lundquist Institute for Biomedical Innovation at Harbor-UCLA Medical Center and Professor of Medicine at the David Geffen School of Medicine at UCLA. "The promising safety and pharmacokinetic profiles of lenacapavir support continued evaluation of an every six-month dosing interval and further demonstrate the potential for a single subcutaneous injection of lenacapavir to be part of a long-acting HIV treatment regimen."
"Lenacapavir has the potential as an important breakthrough innovation to be transformative for people with multi-drug resistant HIV whose virus is no longer effectively responding to their current therapy," said Jared Baeten, MD, PhD, Vice President, HIV Clinical Development, Gilead Sciences. "This regulatory milestone moves us one step closer to providing an innovative treatment option that could meet the unmet needs of people who have severely limited therapy choices."
"There is a compelling unmet need for interventions that can potentially improve treatment adherence to chronic HIV therapy, including the development of long-acting formulations, which can be administered less frequently," said Diana Brainard, MD, Senior Vice President and Virology Therapeutic Area Head, Gilead Sciences. "We hope to make HIV a more manageable part of people's lives through continued treatment innovations, including the exploration of dosing intervals that coincide with regularly scheduled visits with healthcare providers."
Gilead Announces Investigational Long-Acting HIV-1 Capsid Inhibitor, Lenacapavir, Achieves Primary Endpoint in Phase 2/3 Study in Heavily Treatment-Experienced People Living With HIV
Study to Compare Bictegravir/Lenacapavir Versus Current Therapy in People With HIV-1 Who Are Successfully Treated With a Complicated Regimen
Experimental: Phase 2: Bictegravir (BIC) 75 mg + Lenacapavir (LEN) 25 mg. Participants will switch from their stable baseline regimen (SBR) to a regimen of BIC 75 mg plus LEN 25 mg or LEN 50 mg. Participants will receive a 2-day loading dose regimen of LEN 600 mg, in addition to the daily doses of BIC 75 mg plus LEN 25 mg starting on Day 1 up to the end of randomized treatment (ERT) visit, participants will be treated for at least 24 weeks during the Randomized Period.
• Week 52 Subgroup Efficacy Analyses of Long-Acting Subcutaneous Lenacapavir in Phase 2/3 in Heavily Treatment-Experienced People With Multidrug-Resistant HIV (CAPELLA Study) - (10/27/22)
In this study LEN (lenacapavir) was administered as a once daily oral pill, and by subcutaneous injection every 6 months.
Lenacapavir as part of a Combination Regimen in Treatment-Naïve People with HIV: Week 54 Results - CALIBRATE CROI 2022
The Phase 2 clinical trial evaluating an investigational oral once-weekly combination treatment regimen of islatravir and Gilead's lenacapavir in adults with HIV-1 infection who are virologically suppressed will resume under an amended protocol with a lower dose of islatravir.
Lenacapavir for HIV-1 - Potential Promise of a Long-Acting Antiretroviral Drug - EDITORIAL
Long-Acting Lenacapavir in People With Multidrug-Resistant HIV-1: Week 52 Results
Update on Gilead's HIV Prevention Trials - (12/12/22)
New PrEP Studies - Lenacapavir; Adolescent Girls, Young Women - (12/12/22)
Comparison of Recency Assays to Estimate HIV Incidence in the SIENA (Estimating HIV Incidence Among AGYW) Study in Uganda - (12/12/22)
Resistance Analysis of Long-Acting Lenacapavir in Highly Treatment-Experienced People With HIV After 52 Weeks of Treatment
Injection-Site Reaction Experience in Clinical Studies of People Using Lenacapavir For HIV Treatment
Absence of Cross-Resistance to Lenacapavir in HIV Entry Inhibitor-Resistant Isolates
IAS: Long-acting subcutaneous lenacapavir dosed every 6 months as part of a combination regimen in treatment-naïve people with HIV: interim 16-week results of a randomized, open-label, phase 2 induction-maintenance study (CALIBRATE) - (07/20/21)
Interim Resistance Analysis of Long-Acting Lenacapavir in Treatment-Naïve People with HIV at 28 Weeks (CALIBRATE) Common Adverse Events in Clinical Studies of People Using Lenacapavir for HIV Treatment - (10/28/22)
ID Week:
• Lenacapavir: 75% Sub-50 Response at 52 Weeks Despite Heavy ART Experience - (10/24/22)
• Efficacy and Safety of Long-Acting Subcutaneous Lenacapavir in Heavily Treatment-Experienced People With Multi-Drug Resistant HIV: Week 52 Results - (10/23/22)
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