Clinical Recommendation for the Use of Injectable Lenacapavir as HIV Preexposure Prophylaxis — United States, 2025
MMWR. Morbidity and Mortality Weekly Report·
- DOI
- 10.15585/mmwr.mm7435a1
- PMID
- 40966169
- PMCID
- PMC12445877
- OpenAlex
- W4414330763
- Study type
- Guideline
- Publisher
- Centers for Disease Control MMWR Office
- Article type
- journal-article
- Integrity
- current
Why this research matters now
With approximately 39,000 new HIV diagnoses annually in the United States and suboptimal adherence to existing oral and injectable PrEP regimens, a strongly recommended 6-month injectable option may improve adherence and strengthen HIV prevention efforts.
Structured evidence summary
Research question
The work group evaluated the efficacy and safety of injectable lenacapavir administered every 6 months for HIV preexposure prophylaxis following FDA approval in June 2025.
Study design
CDC applied the GRADE methodology to assess evidence from two randomized controlled trials (PURPOSE 1 and PURPOSE 2) with 52 weeks of follow-up.
Population and setting
The trials enrolled females in one study and a primarily male population in the other. The clinical recommendation applies to persons weighing 35 kg or more in the United States who would benefit from PrEP.
Main findings
Lenacapavir reduced HIV infection by 100% among females and 96% among the primarily male population compared with estimated background incidence. The most frequent adverse events were mild to moderate injection site reactions, and no significant safety concerns emerged.
Public-health relevance
With approximately 39,000 new HIV diagnoses annually in the United States and suboptimal adherence to existing oral and injectable PrEP regimens, a strongly recommended 6-month injectable option may improve adherence and strengthen HIV prevention efforts.
Important limitations
This summary relies on the supplied single-article abstract and metadata. Full interpretation of the GRADE assessment, detailed trial methodology, subgroup analyses, and safety profiles requires review of the original guideline document.
GIDS interpretation
The classifier links identify this guideline as relevant to HIV infection, AIDS, health policy, and treatment in the United States, supporting discoverability for those monitoring PrEP recommendations and HIV prevention policy updates.
Related GIDS surveillance
Literature context does not validate, explain, or change a surveillance signal. Exact and contextual relationships are shown separately.
Evidence relationships
This article has 10 auditable classifier relationships to diseases, places, topics, and study design.