FDA Approves First-in-Class Drug for HIV

The US Food and Drug Administration (FDA) has approved the medication lenacapavir (Sunlenca) for adults living with multi-drug resistant HIV-1 infection. After the initial doses are completed — given both orally and via subcutaneous injection — the drug is administered by injection every 6 months. 

“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,” said site principal investigator Sorana Segal-Maurer, MD, a professor of clinical medicine at Weill Cornell Medicine, New York City, in a statement.

HIV drug regimens generally consist of two or three HIV medicines combined in a daily pill. In 2021, the FDA approved the first injectable complete drug regimen for HIV-1, Cabenuva, which can be administered monthly or every other month. Lenacapavir is administered only twice annually, but it is also combined with other antiretrovirals. The injections and oral tablets of lenacapavir are estimated to cost $42,250 in the first year of treatment and then $39,000 annually in the subsequent years, Reuters reported.

Lenacapavir is the first of a new class of drug called capsid inhibitors to be FDA-approved for treating HIV-1. The drug blocks the HIV-1 virus’ protein shell and interferes with essential steps of the virus’ evolution. The approval, announced today, was based on a multicenter clinical trial of 72 patients with multidrug resistant HIV-1 infection. After a year of the medication, 30 (83%) of the 36 patients randomly assigned to take lenacapavir, in combination with other HIV medications, had undetectable viral loads. 

“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, MD, director of the Division of Antivirals in the FDA’s Center for Drug Evaluation and Research, in a press release. “The availability of new classes of antiretroviral medications may possibly help these patients live longer, healthier lives.”

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