WHO Endorses Lenacapavir for Twice-Yearly HIV Prevention in Landmark Update

In a transformative moment for the global fight against HIV, the World Health Organization (WHO) has released new guidelines recommending the use of injectable lenacapavir (LEN) as a twice-yearly pre-exposure prophylaxis (PrEP) option. The announcement, made at the 13th International AIDS Society (IAS) Conference on HIV Science in Kigali, Rwanda, positions LEN as a groundbreaking addition to the world’s HIV prevention toolkit. Its potential to revolutionize prevention strategies, particularly among high-risk populations, comes at a time when global progress in reducing HIV infections has slowed.

A Game-Changing Prevention Tool: Twice-Yearly Protection

LEN is the first long-acting PrEP product that requires only two injections per year, offering an appealing alternative to daily oral regimens or shorter-acting injectables. Its clinical trials have demonstrated near-complete protection against HIV transmission among at-risk populations.

“While an HIV vaccine remains elusive, lenacapavir is the next best thing,” said WHO Director-General Dr. Tedros Adhanom Ghebreyesus. “The launch of WHO’s new guidelines, alongside the FDA’s recent approval, marks a critical step forward in expanding access to this powerful tool.”

LEN’s benefits go beyond its biological efficacy. For many individuals—especially those who experience stigma, have limited healthcare access, or struggle with daily adherence—LEN represents a more practical, discreet, and sustainable option. By requiring just two injections annually, LEN simplifies HIV prevention and broadens the spectrum of choices available to people at risk.

Addressing Stalled Prevention Amid Rising Infections

The recommendation comes at a crucial juncture. In 2024, an estimated 1.3 million people were newly infected with HIV, with 120,000 of these infections occurring among children. Alarmingly, key populations—such as men who have sex with men, sex workers, transgender individuals, people who inject drugs, incarcerated individuals, and adolescents—continue to bear a disproportionate burden of new infections.

By end-2024, approximately 40.8 million people were living with HIV globally, and 630,000 people died from HIV-related causes. Although 31.6 million individuals are now on antiretroviral therapy (ART), representing progress from 30.3 million in 2023, treatment expansion alone is not enough to eliminate transmission risks—underscoring the urgent need to boost prevention efforts.

Simplified Testing and Community Delivery: Removing Barriers

One of the most significant elements of WHO’s updated guidance is the simplification of HIV testing protocols for long-acting PrEP delivery. The organization now recommends the use of rapid HIV tests to facilitate community-based delivery of LEN and other long-acting options like injectable cabotegravir (CAB-LA). This removes logistical and cost-related barriers posed by complex testing procedures and paves the way for implementation via local clinics, pharmacies, and tele-health platforms.

By decentralizing PrEP access and simplifying entry into care, WHO hopes to reach populations that have traditionally been underserved by formal health systems.

Expanding the Arsenal: PrEP, ART, and STI Management

LEN is now part of a comprehensive menu of WHO-approved PrEP options that includes daily oral PrEP, injectable CAB-LA, and the dapivirine vaginal ring. Each offers a unique route of administration and dosing schedule, helping individuals tailor their HIV prevention plans to their lifestyle and risk profile.

In parallel, WHO released updated treatment guidelines recommending the use of long-acting injectable cabotegravir and rilpivirine (CAB/RPV) for HIV-positive individuals who have achieved viral suppression on oral ART. This marks a crucial new strategy for maintaining viral suppression in people who face adherence challenges with daily pills and do not have active hepatitis B infection.

Additionally, WHO has updated service delivery guidance to promote integration of HIV services with noncommunicable disease (NCD) care—including hypertension, diabetes, and mental health disorders. Recommendations also call for enhanced screening and management of asymptomatic sexually transmitted infections (STIs), particularly gonorrhoea and chlamydia, among key populations.

Responding to Emerging Co-Infections and Global Challenges

In light of growing evidence linking HIV and mpox co-infections, WHO now recommends the rapid initiation of ART for individuals diagnosed with mpox who are either ART-naive or have experienced prolonged treatment interruptions. Early HIV testing is also advised for all patients presenting with mpox symptoms. These measures aim to reduce the severity of co-infections and prevent delayed diagnoses.

Beyond clinical updates, WHO has issued new operational guidance to help countries sustain priority HIV services amid shrinking donor support and rising global instability. This framework advises countries on how to assess health system risks, maintain continuity of care, and adapt to evolving funding landscapes.

Call to Action: Bold Implementation Required

“The tools and knowledge to end AIDS as a public health threat already exist,” said Dr. Meg Doherty, Director of WHO’s Department of Global HIV, Hepatitis and STI Programmes. “What we need now is bold implementation of these recommendations, grounded in equity and powered by communities.”

The WHO’s comprehensive policy update calls on governments, donors, and international partners to:

• Begin national rollout of LEN and other long-acting PrEP options, especially in high-burden areas;

• Ensure community-level distribution by supporting simplified HIV testing and expanding service delivery networks;

• Invest in prevention-focused infrastructure, including education, outreach, and stigma reduction;

• Prioritize funding for integrated HIV-NCD care models;

• Monitor real-world effectiveness and adherence to guide implementation and future guidelines.

Toward a Future Without AIDS

As the HIV epidemic enters its fifth decade, the path forward lies in innovation, equity, and integration. The addition of lenacapavir to the prevention arsenal is a major breakthrough—but without strong, equity-focused implementation, its potential may remain unrealized.

With political will, sustained investment, and community leadership, these new WHO guidelines offer a roadmap toward ending AIDS as a public health threat by 2030. The opportunity is clear, and the time to act is now.