Gilead Sciences received approval from the U.S. Food and Drug Administration (FDA) on Dec. 22, 2022, for Sunlenca^® (lenacapavir) 300mg tablets and 463.5mg/1.5mL injection solution. It is a first-in-class HIV capsid inhibitor indicated to be used along with other antiretroviral(s) (ARV) for treating adults with heavily-treated, multi-drug resistant HIV-1 who are failing on their current antiviral drug regimen. Initial treatment with Sunlenca has two scheduling options. In one, patients receive two subcutaneous (SC) injections (927mg) and two tablets (600mg) of Sunlenca on the first day and then only two tablets on the second day. For the alternate option, patients take two tablets on each of the first two days and then one tablet on the eighth day, followed by two injections seven days later. For either option, maintenance treatment begins between 24 and 28 weeks after the injection date and continues at two SC injections once every six months. Injections are given by a healthcare provider. Gilead plans to release Sunlenca to the United States market in January 2023. Its wholesale acquisition cost (WAC) is about $42,250 for the first year of treatment and $39,000 annually for subsequent years. For its full prescribing information, look here.

u  At a Glance

• Brand (Generic) Name: Sunlenca^® (lenacapavir)
• Manufacturer: Gilead Sciences
• Date Approved: Dec. 22, 2022
• Indication: for the treatment of HIV-1 infection in heavily treatment-experienced adults who have multi-drug resistant HIV-1 infection and who are failing their current ARV regimen due to resistance, intolerance or safety considerations
• Dosage Forms Available: 300mg oral tablets and 463.5mg/1.5mL solution for SC injection
• Launch Date: January 2023
• Estimated Annual Cost: WAC for the first year will be $42,250 followed by $39,000 per year for maintenance
• Although the incidence of diagnosed cases is decreasing (to about 35,000 in 2020), the Centers for Disease Control and Prevention (CDC) estimates that about 1.2 million Americans who are at least 13 years old have HIV-1.
• Treatment with combination ARV therapy has significantly decreased mortality of HIV-1. However, individuals on long-term ARV therapy continue to develop drug resistance, which increases the risk of the HIV-1 infection transforming into AIDS. 
• Approximately 2% of adults (roughly 10,000 patients in the U.S.) who have HIV-1 have tried numerous drugs without long-term success in achieving viral suppression.
• Sunlenca interferes with the protein coverings (capsids) of HIV-1 particles to interrupt different stages of their growth and spread.
• In the CAPELLA clinical study of 72 patients who still had high viral loads of HIV-1 even though they were being treated, 87.5% of actively treated patients achieved the targeted reduction of the virus within two weeks versus only 16.7% of patients using a placebo. At six months, 81% of participants on Sunlenca had reached undetectable levels of HIV-1, rising to 83% at one year. All patients continued with their previous HIV-1 treatments during the study.
• By far the most common adverse effect among patients was injection site reactions, including pain, redness, and swelling.
• On July 2, 2020, the FDA approved Rukobia^™ (fostemsavir – ViiV Healthcare) for the same patient population as Sunlenca. A glycoprotein 120 (gp120) attachment inhibitor, it works by binding to the viral envelope protein, preventing viral attachment and entry into T-cells. Available in 600mg extended-release tablets, it is taken 600mg orally twice per day.
• A Breakthrough Therapy, Sunlenca was approved through the FDA’s Fast Track and Priority Review pathways.