Breakthrough in HIV Prevention: WHO Recommends Injectable Lenacapavir

A significant development in global health has emerged with the World Health Organization's (WHO) recent endorsement of injectable lenacapavir (LEN) for pre-exposure prophylaxis (PrEP) against HIV. This landmark policy, unveiled at the 13th International AIDS Society Conference (IAS 2025) in Kigali, Rwanda, signals a pivotal shift in how the world approaches HIV prevention, offering a novel, long-acting option that could revolutionize adherence and accessibility for at-risk populations.

This innovative injectable, requiring only two doses annually, presents a powerful alternative to existing daily oral medications and other shorter-acting regimens. Its introduction is particularly impactful for individuals who encounter difficulties with consistent daily pill intake, experience social stigma, or face barriers in accessing healthcare services. Dr. Tedros Adhanom Ghebreyesus, WHO Director-General, highlighted its importance, stating that while a vaccine remains elusive, lenacapavir represents a critical next step, proving nearly universally effective in preventing HIV infections among those susceptible. The WHO is committed to collaborating with nations and partners to ensure this breakthrough reaches communities swiftly and safely, emphasizing its potential to address the 1.3 million new HIV infections recorded in 2024, which disproportionately affect vulnerable groups such as sex workers, men who have sex with men, transgender individuals, and people who inject drugs.

Furthermore, these new guidelines simplify the testing protocols necessary for long-acting injectable PrEP, including both LEN and cabotegravir (CAB-LA), by recommending a public health approach utilizing rapid HIV tests. This strategic simplification removes significant logistical and financial hurdles, paving the way for broader community-level distribution through various channels like pharmacies, clinics, and telehealth services. LEN now complements a growing array of WHO-approved PrEP options, alongside daily oral PrEP, injectable cabotegravir, and the dapivirine vaginal ring, strengthening the arsenal against the epidemic. Despite current limitations in its availability outside clinical trials, the WHO is urging governments, donors, and global health organizations to expedite the implementation of LEN within national HIV prevention programs. This push includes the vital collection of data on uptake, adherence, and real-world impact to refine strategies and ensure the broadest possible reach of this transformative intervention. Additionally, the updated guidelines integrate HIV services with care for noncommunicable diseases like hypertension and diabetes, as well as mental health support, and recommend screening for gonorrhoea and chlamydia in key populations. Rapid antiretroviral therapy (ART) initiation is advised for HIV-positive individuals with mpox who are ART-naive or have had prolonged ART interruptions, alongside early HIV and syphilis testing for all suspected or confirmed mpox cases.

In a world grappling with persistent public health challenges and evolving funding landscapes, these comprehensive and forward-thinking guidelines represent a beacon of hope. By diversifying prevention and treatment avenues, streamlining healthcare delivery, and fostering integrated care, the global community can forge more efficient, equitable, and resilient responses to HIV. The moment calls for decisive action and bold implementation, translating these advancements into tangible improvements in global health outcomes and upholding the dignity and well-being of all individuals.