FDA Approves First-In-Class Twice-Yearly Treatment for HIV


Lenacapavir was approved with the FDA's Breakthrough Therapy Designation.

The FDA has approved lenacapavir (Sunlenca) as a first-in-class, twice-yearly treatment option for heavily treatment-experienced adults with multidrug resistant HIV-1, according to a press release.1 Lenacapavir works through a multi-stage mechanism of action “distinguishable from other currently approved classes of antiviral agents.”1

Although there have been significant advances in antiretroviral therapy, there are still multiple pressing unmet needs for individuals living with HIV—especially those considered heavily treatment experienced. Globally, this population accounts for an estimated 2% of adults who are unable to maintain virologic suppression for reasons such as resistance, intolerance, or safety considerations.

“An effective antiviral regimen can be devised for most people living with the virus; however, some people living with HIV no longer have durable viral suppression due to resistance to multiple classes of antiretroviral therapies,” said Sorana Segal-Maurer, MD, director of the Dr. James J. Rahal Jr. Division of Infectious Diseases at NewYork-Presbyterian Queens and professor of clinical medicine at Weill Cornell. “The availability of new classes of antiretroviral drugs is critical for heavily treatment-experienced people with multidrug 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,” Segal-Maurer added. Segal-Maurer is also the site principla investigator of the CAPELLA clinical trial (NCT04150068).

“This news is an important milestone in the work to help end the HIV epidemic,” said Daniel O’Day, chairman and CEO of Gilead Sciences. “Our goal is to devlier multiple long-acting options for treatment and prevention that are tailored to the needs of people living with HIV and people who could benefit from PrEP medicines.”

Lenacapavir approval was supported by data from the CAPELLA clinical trial, a phase 2/3, double blinded, placebo controlled, global multicenter study that evaluated lenacapavir in combination with an optimized background regimen in adults with multidrug resistant HIV-1. In the study population, 83% of adults randomly assigned to the treatment group achieved an undetectable viral load, defined as <50 copies/mL, at week 52, as well as a mean increase in CD4 count of 82 cells/µL.

Lenacapavir was reviewed and approved with the FDA’s Breakthrough Therapy Designation.


  1. Sunlenca (lenacapavir) receives FDA approval as a first-in-class, twice-yearly treatment option for people living with multi-drug resistant HIV. News release. Gilead Sciences. December 22, 2022. Accessed December 22, 2022. https://www.gilead.com/news-and-press/press-room/press-releases/2022/12/sunlenca-lenacapavir-receives-fda-approval-as-a-firstinclass-twiceyearly-treatment-option-for-people-living-with-multidrug-resistant-hiv

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