FDA Approves New HIV Medication

Leigh Precopio

The FDA has approved a new antiretroviral medication, lenacapavir, for use in adults living with HIV type 1 (HIV-1).

Individuals with HIV-1 are often unable to be successfully treated with other previously approved medications due to concerns of resistance, intolerance, or safety. This medication is the first of a new class of capsid inhibitors to be approved for the treatment of HIV-1.

The approval was based on a multicenter clinical trial that included 72 patients with high levels of HIV in their blood despite the use of multiple classes of HIV medications, including antiretroviral drugs. The results indicated that 87.5% of the medication group had a decrease in the virus compared with 16.7% of the placebo group. Further, 81% of participants achieved HIV RNA suppression at 26 weeks, of which 83% continued to have at 52 weeks.

Following a starting combination dose of oral tablets and subcutaneous injections, lenacapavir is to be administered subcutaneously once every 6 months. Lenacapavir may be used in combination with other antiretroviral medications. However, patients on other medications that cause reduced levels of lenacapavir should not receive this medication as this may result in lost virologic response or the development of viral resistance.

Common adverse effects include injection site reactions (swelling, pain, or redness) and nausea. Individuals may develop immune reconstitution syndrome. Residual amounts of medication may remain in the body for a year or longer and may cause potential drug interactions. Patients may be at an increased risk of viral resistance development if doses are missed.



FDA approves new HIV drug for adults with limited treatment options. News release. US Food and Drug Administration; December 22, 2022. Accessed January 4, 2023.