FDA Approves First-in-Class HIV-1 Treatment

The FDA cleared Gilead Sciences’ Sunlenca (lenacapavir), in combination with other antiretrovirals, to treat HIV-1 infection in heavily treated adults with multi-drug resistant (MDR) HIV-1 infection. The twice-yearly treatment is for patients whose HIV is not adequately controlled by their current treatment regimen, Gilead said in a news release. Sunlenca has a multi-stage mechanism of action distinguishable from other currently approved classes of antiviral agents and no known cross resistance exhibited in vitro to other existing drug classes.

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, a Gilead spokesperson told Formulary Watch. “It is important to note that the actual costs to patients can vary, based on insurance coverage, copay support or financial assistance from Gilead and external support programs,” the spokesperson said.

Gilead expects U.S. commercial supply to be available in January 2023.

“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, in a news release. “The availability of new classes of antiretroviral medications may possibly help these patients live longer, healthier lives.”

Sunlenca is the first of a new class of drugs called capsid inhibitors. Sunlenca works by blocking the HIV-1 virus’ protein shell (the capsid), thereby interfering with multiple essential steps of the viral lifecycle, FDA said.

Sorana Segal-Maurer, M.D.

“The availability of new classes of antiretroviral drugs is critical for heavily treatment-experienced people with multi-drug resistant HIV,” Sorana Segal-Maurer, M.D., said in a press release. “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.” Segal-Maurer is director of the Dr. James J. Rahal Jr. Division of Infectious Diseases at NewYork-Presbyterian Queens, Professor of Clinical Medicine at Weill Cornell Medicine and the site principal investigator for the CAPELLA trial.

Patients who are heavily treated account for an estimated 2% of adults living with HIV who are on treatment globally, according to Gilead. “This type of complexity further increases the chance of treatment failure, underscoring the need for new treatment options that are active against resistant variants of the virus with a novel mechanism of action,” the pharma maker said.

The FDA approval for Sunlenca is supported by data from the phase 2/3 CAPELLA trial, which evaluated lenacapavir in combination with an optimized background regimen in people with multi-drug resistant HIV-1 who are heavily treatment experienced. Trial participants had undergone previous treatment with a median of nine antiretroviral medications. In this patient population with, 83% of participants randomly allocated to receive lenacapavir in addition to an optimized background regimen achieved an undetectable viral load at Week 52. In addition, patients achieved a mean increase in CD4 count of 82 cells/µL.

These data were presented at the 29th Conference on Retroviruses and Opportunistic Infections (virtual CROI 2022).