Lenacapavir

Generic Name: Lenacapavir

Brand Names: Sunlenca

Drug Type: Small Molecule

Chemical Formula: C_₃₉H_₃₂ClF_₁₀N_₇O_₅S_₂

CAS Number: 2189684-44-2

Unique Ingredient Identifier: A9A0O6FB4H

Background: HIV/AIDS remains an area of concern despite the introduction of numerous successful therapies, mainly due to the emergence of multidrug resistance and patient difficulty in adhering to treatment regimens. Lenacapavir is a first-in-class capsid inhibitor that demonstrates picomolar HIV-1 inhibition as a monotherapy in vitro, little to no cross-resistance with existing antiretroviral agents, and extended pharmacokinetics with subcutaneous dosing.

Lenacapavir was first globally approved on August 22, 2022 by the European Commission to treat adults with multi-drug resistant HIV infection. On December 22, 2022, it was also approved by the FDA.

Indication: Lenacapavir, in combination with other antiretroviral(s), is indicated for the treatment of multidrug-resistant human immunodeficiency virus type 1 (HIV-1) infection in heavily treatment-experienced adults who are experiencing a failure of their current antiretroviral regimen due to resistance, intolerance, or safety considerations.

Associated Conditions: Multidrug resistant HIV-1 infection

Associated Therapies: -

Clinical Trials

Gilead, MSD say HIV combo could be weekly, oral HIV drug

Gilead Sciences and MSD's antiretroviral combination, islatravir and Sunlenca, maintained HIV suppression with a single weekly oral dose in a phase 2 trial, advancing to phase 3. The regimen showed non-inferior efficacy compared to daily Biktarvy, potentially improving adherence and reducing stigma.

clinicaltrialsarena.com

3 months ago

Gilead reports updated data from trial of acclaimed HIV PrEP drug

Gilead's twice-yearly PrEP lenacapavir showed nearly perfect efficacy in two pivotal studies, outperforming Truvada. The drug was well-tolerated with few serious adverse events, and reduced HIV infections by 96% compared to background HIV incidence. Gilead plans to use trial data to support global regulatory filings for lenacapavir as PrEP by end of 2024.

Related Clinical Trials:

Study of Lenacapavir for HIV Pre-Exposure Prophylaxis in People Who Are at Risk for HIV Infection

Pre-Exposure Prophylaxis Study of Lenacapavir and Emtricitabine/Tenofovir Alafenamide in Adolescent Girls and Young Women at Risk of HIV Infection

gilead.com

3 months ago

Gilead to Present Late Breaking Data Highlighting Antiviral Portfolio Innovative Research

Gilead Sciences to present new findings from antiviral research at IDWeek 2024, including data from HIV, COVID-19, and viral hepatitis studies, highlighting commitment to treating and preventing viral diseases.

Related Clinical Trials:

Pre-Exposure Prophylaxis Study of Lenacapavir and Emtricitabine/Tenofovir Alafenamide in Adolescent Girls and Young Women at Risk of HIV Infection

Study of Lenacapavir for HIV Pre-Exposure Prophylaxis in People Who Are at Risk for HIV Infection

Study to Evaluate the Safety and Efficacy of Bictegravir/Emtricitabine/Tenofovir Alafenamide Versus Abacavir/Dolutegravir/Lamivudine in Human Immunodeficiency Virus-1 (HIV-1) Infected, Antiretroviral Treatment-Naive Adults

Study to Evaluate the Safety and Efficacy of Bictegravir/Emtricitabine/Tenofovir Alafenamide Versus Dolutegravir + Emtricitabine/Tenofovir Alafenamide in Human Immunodeficiency Virus (HIV-1) Infected, Antiretroviral Treatment-Naive Adults

Study to Evaluate the Safety and Efficacy of Lenacapavir (GS-6207) in Combination With an Optimized Background Regimen (OBR) in Heavily Treatment Experienced Participants Living With HIV-1 Infection With Multidrug Resistance

Study of Obeldesivir in Participants With COVID-19 Who Have a High Risk of Developing Serious or Severe Illness

Study of Obeldesivir in Nonhospitalized Participants With COVID-19

Study of Obeldesivir to Treat Nonhospitalized Adults With Acute Respiratory Syncytial Virus (RSV) Infection

healthpolicy-watch.news

3 months ago

Gilead Urged To Expand Voluntary Licences For Its Breakthrough HIV Treatment

Gilead has authorized six generic manufacturers to sell its HIV treatment, lenacapavir, in 120 low- and middle-income countries, but activists urge expansion to include Brazil, Colombia, and Mexico. Lenacapavir, sold as Sunlenca in the US for $42,250 per year, has shown 100% efficacy in preventing HIV in women and nearly 100% in men and gender minorities. Gilead CEO Daniel O’Day emphasizes the need for rapid, broad availability, while critics highlight the exclusion of key countries and the unknown price for generics.

managedhealthcareexecutive.com

8 months ago

FDA Approves First-in-Class HIV-1 Treatment

FDA approved Gilead Sciences’ Sunlenca (lenacapavir) for treating multi-drug resistant HIV-1 in heavily treated adults. It's a twice-yearly treatment with a unique mechanism, costing $42,250 initially, then $39,000 annually. Sunlenca, a capsid inhibitor, offers a new option for patients with limited therapy choices, supported by CAPELLA trial data showing significant viral load reduction and CD4 count increase.

Lenacapavir

Gilead, MSD say HIV combo could be weekly, oral HIV drug

Gilead reports updated data from trial of acclaimed HIV PrEP drug

Related Clinical Trials:

Study of Lenacapavir for HIV Pre-Exposure Prophylaxis in People Who Are at Risk for HIV Infection

Pre-Exposure Prophylaxis Study of Lenacapavir and Emtricitabine/Tenofovir Alafenamide in Adolescent Girls and Young Women at Risk of HIV Infection

Gilead to Present Late Breaking Data Highlighting Antiviral Portfolio Innovative Research

Related Clinical Trials:

Pre-Exposure Prophylaxis Study of Lenacapavir and Emtricitabine/Tenofovir Alafenamide in Adolescent Girls and Young Women at Risk of HIV Infection

Study of Lenacapavir for HIV Pre-Exposure Prophylaxis in People Who Are at Risk for HIV Infection

Study to Evaluate the Safety and Efficacy of Bictegravir/Emtricitabine/Tenofovir Alafenamide Versus Abacavir/Dolutegravir/Lamivudine in Human Immunodeficiency Virus-1 (HIV-1) Infected, Antiretroviral Treatment-Naive Adults

Study to Evaluate the Safety and Efficacy of Bictegravir/Emtricitabine/Tenofovir Alafenamide Versus Dolutegravir + Emtricitabine/Tenofovir Alafenamide in Human Immunodeficiency Virus (HIV-1) Infected, Antiretroviral Treatment-Naive Adults

Study to Evaluate the Safety and Efficacy of Lenacapavir (GS-6207) in Combination With an Optimized Background Regimen (OBR) in Heavily Treatment Experienced Participants Living With HIV-1 Infection With Multidrug Resistance

Study of Obeldesivir in Participants With COVID-19 Who Have a High Risk of Developing Serious or Severe Illness

Study of Obeldesivir in Nonhospitalized Participants With COVID-19

Study of Obeldesivir to Treat Nonhospitalized Adults With Acute Respiratory Syncytial Virus (RSV) Infection

Gilead Urged To Expand Voluntary Licences For Its Breakthrough HIV Treatment

FDA Approves First-in-Class HIV-1 Treatment

Drug Development Updates