How Often Is Lenacapavir Given for HIV Prevention?
Yeztugo (lenacapavir) HIV PrEP uses initiation injections plus oral tablets, followed by maintenance injections every 26 weeks, with a two-week scheduling window. HIV testing before initiation and every later injection is essential because undiagnosed infection can lead to drug resistance.
Timeline
- 2025-06-18: FDA approved Yeztugo for prevention of sexually acquired HIV-1 in eligible adults and adolescents weighing at least 35 kg.
- Day 1 and Day 2: The labeled initiation phase combines injections with oral tablets on day 1 and oral tablets on day 2.
- Every 26 weeks: The labeled maintenance dose is administered every six months, within a plus-or-minus two-week window.
Lenacapavir for HIV pre-exposure prophylaxis is sold under the brand name Yeztugo. The FDA approved it in June 2025 to reduce the risk of sexually acquired HIV-1 in adults and adolescents weighing at least 35 kilograms who are at risk of acquisition. CDC subsequently recommended injectable lenacapavir as a PrEP option for people meeting that weight threshold who would benefit from prevention. [1][2]
“Every six months” describes the maintenance interval, not the entire starting schedule. The FDA label begins with two subcutaneous injections totaling 927 mg plus 600 mg of oral tablets on day 1, then 600 mg orally on day 2. Continuation is 927 mg by two subcutaneous injections every 26 weeks, with a scheduling window of two weeks before or after the due date. [1][2]
The injections must be administered by a health professional, and the schedule should be planned rather than improvised. The label provides special instructions for an anticipated delay and for a missed injection beyond the permitted window. A patient should contact the PrEP clinic before a late visit because interim tablets or re-initiation may be needed under the prescribing information. [1][2]
HIV testing is a central safety requirement. Yeztugo has a boxed warning about drug resistance if it is used by someone with undiagnosed HIV-1. The label requires testing before initiation, before every later injection and additionally when clinically appropriate. A person who acquires HIV while receiving PrEP needs prompt transition to a complete HIV treatment regimen rather than lenacapavir PrEP alone. [2]
CDC’s recommendation followed two randomized trials. The agency reported efficacy against HIV infection of 100% among females in one trial and 96% in a primarily male population in another, compared with estimated background incidence over 52 weeks. Those results support prevention efficacy in the studied populations but do not mean an individual can skip injections, testing or other indicated prevention services. [1]
The most common adverse effects in the FDA label include injection-site reactions, headache and nausea. Lenacapavir also has important drug-interaction considerations, and measurable drug can remain in the body for a year or longer after the last injection. That long pharmacologic “tail” makes follow-up planning important if PrEP is stopped or interrupted. [1][2]
Lenacapavir PrEP reduces risk of sexually acquired HIV-1 but does not prevent other sexually transmitted infections. CDC recommends follow-up that includes HIV testing, review of symptoms and interactions, injection-site assessment, reassessment of prevention needs and appropriate STI screening. People interested in the six-month option should discuss eligibility, testing, medicines and reliable return visits with a qualified PrEP clinician. [1][2]
Sources
- CDC MMWR — Clinical recommendation for injectable lenacapavir as HIV PrEP
- FDA — Yeztugo prescribing information