The approvals have been put on hold for two major new long-acting HIV therapies, lenacapavir (LEN, Gilead) and islatravir (ISL, Merck)—for two very different reasons, and likely with very different long-term results.
On March 3, 2022, the FDA issued a complete response letter for the New Drug Application for LEN, an investigational, long-acting treatment for people with multidrug-resistant HIV infection that is administered subcutaneously every six months. The FDA cited issues