On December 22, the Federal Food and Drug Administration approved Gilead Sciences’ Sunlenca (lenacapavir), offering hope for heavily treatment-experienced individuals.

Via EDGE: Sunlenca, the first HIV capsid inhibitor, is indicated for people who are unable to maintain an undetectable viral load on their current antiretroviral regimen due to resistance, intolerance, or safety considerations. This group includes long-term survivors who may have used early HIV drugs one at a time or in suboptimal combinations. This approval does not include first-time HIV treatment, but ongoing studies show Sunlenca also looks promising for that indication. “Today’s approval ushers in a new class of antiretroviral drugs that may help patients with HIV who have run out of treatment options,” Dr. Debra Birnkrant, director of the Division of Antivirals in the FDA’s Center for Drug Evaluation and Research, said in an agency press release. “The availability of new classes of antiretroviral medications may possibly help these patients live longer, healthier lives.”

Previously, the longest-acting treatment was ViiV Healthcare’s Cabenuva (injectable cabotegravir and rilpivirine), which can be administered every one or two months. 

“The availability of new classes of antiretroviral drugs is critical for heavily treatment-experienced people with multi-drug resistant HIV,” CAPELLA investigator Dr. Sorana Segal-Maurer of Weill Cornell Medicine said in a Gilead press release. “[L]enacapavir 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.”