The U.S. Food and Drug Administration (FDA) has granted approval to Gilead Sciences' Sunlenca (lenacapavir), a first-in-class capsid inhibitor, for the treatment of HIV-1 infection in heavily treatment-experienced adults with multi-drug resistant (MDR) HIV-1. This twice-yearly treatment is indicated for patients whose HIV is not adequately controlled by their current antiretroviral regimen.
Novel Mechanism of Action
Sunlenca distinguishes itself through a multi-stage mechanism of action, targeting the HIV-1 capsid, the virus's protein shell. By disrupting the capsid, lenacapavir interferes with multiple essential steps of the viral lifecycle, offering a novel approach to combating HIV-1. It exhibits no known cross-resistance to other existing drug classes in vitro.
Clinical Evidence from the CAPELLA Trial
The FDA approval is supported by data from the Phase 2/3 CAPELLA trial, which evaluated lenacapavir in combination with an optimized background regimen in heavily treatment-experienced individuals with multi-drug resistant HIV-1. Participants in the trial had previously undergone treatment with a median of nine antiretroviral medications.
The results showed that 83% of participants randomly assigned to receive lenacapavir in addition to an optimized background regimen achieved an undetectable viral load at Week 52. Furthermore, patients experienced a mean increase in CD4 count of 82 cells/µL.
Addressing Unmet Needs
"Today’s approval ushers in a new class of antiretroviral drugs that may help patients with HIV who have run out of treatment options,” said Debra Birnkrant, M.D., director of the Division of Antivirals in the FDA’s Center for Drug Evaluation and Research. "The availability of new classes of antiretroviral medications may possibly help these patients live longer, healthier lives."
Sorana Segal-Maurer, M.D., director of the Dr. James J. Rahal Jr. Division of Infectious Diseases at NewYork-Presbyterian Queens, emphasized the importance of new antiretroviral drug classes for heavily treatment-experienced individuals with multi-drug resistant HIV. "Following today’s decision from the FDA, lenacapavir helps to fill a critical unmet need for people with complex prior treatment histories and offers physicians a long-awaited twice-yearly option for these patients who otherwise have limited therapy choices."
Market and Availability
Gilead anticipates U.S. commercial supply to be available in January 2023. The anticipated wholesale acquisition cost (WAC) for Sunlenca injection and tablets is $42,250 per year during the initial year of therapy, and then $39,000 annually for maintenance years. Actual costs to patients can vary based on insurance coverage, copay support, or financial assistance programs.
