WHO Approves Kenya To Roll Out Twice-yearly Lenacapavir Injectable HIV Preventive Drug Starting January 2026

Kenya Selected Among Nine Early Adopter Countries for Revolutionary HIV Prevention Treatment

Kenya has been selected as one of nine early adopter countries to implement lenacapavir (LEN), a groundbreaking twice-yearly injectable HIV prevention drug approved by the World Health Organization in a landmark policy decision that could reshape the global HIV response.

The National AIDS and STI Control Program (NASCOP) announced that the revolutionary HIV prevention medication will be available to Kenyans by January 2026, marking a significant milestone in the country’s fight against HIV/AIDS.

The WHO’s approval of lenacapavir represents the first twice-yearly injectable pre-exposure prophylaxis (PrEP) option for HIV prevention.

Unlike daily oral pills that many people struggle to take consistently, lenacapavir offers protection with just two injections per year, administered under the skin every six months.

“While an HIV vaccine remains elusive, lenacapavir is the next best thing: a long-acting antiretroviral shown in trials to prevent almost all HIV infections among those at risk,” stated WHO Director-General Dr. Tedros Adhanom Ghebreyesus during the announcement at the 13th International AIDS Society Conference in Kigali, Rwanda.

The drug has demonstrated remarkable efficacy in clinical trials, with some studies showing a 100 percent effectiveness rate and zero infections among participants.

This breakthrough comes at a critical time when global HIV prevention efforts have stagnated, with 1.3 million new infections recorded in 2024.

The approval addresses significant barriers that have hindered traditional HIV prevention methods.

Many people at risk struggle with daily adherence to oral PrEP due to various factors including inconvenience, cost, stigma, and side effects.

How it works

The twice-yearly injection offers a discreet, long-acting alternative that eliminates the need for daily pills.

“LEN represents a transformative step in protecting people at risk of HIV—particularly those who face challenges with daily adherence, stigma, or limited access to health care,” the WHO stated in its guidelines.

The drug works by attacking HIV’s protective shell, stopping the virus from copying itself at multiple stages.

Users take pills for a short period—either two weeks before the injection or for the first days after—to ensure protection while the injection begins working.

The Ministry of Health, through NASCOP and in collaboration with various partners, is actively working to ensure the availability of this innovative product for Kenyans.

The January 2026 rollout timeline demonstrates Kenya’s commitment to adopting cutting-edge HIV prevention technologies.

Kenya’s selection as an early adopter country reflects its strong healthcare infrastructure and commitment to HIV prevention.

The country has made significant strides in HIV treatment and prevention, making it an ideal testing ground for this new intervention.

The WHO’s recommendation comes as approximately 40.8 million people worldwide are living with HIV, with about 65% of cases in the WHO African Region. Globally, around 630,000 people died from HIV-related causes in 2024, with an estimated 1.3 million new infections, including 120,000 children.

Lenacapavir now joins other WHO-recommended PrEP options such as daily oral PrEP, injectable cabotegravir, and the dapivirine vaginal ring, expanding the arsenal of tools available to combat HIV.

However, the drug’s high cost—currently priced at around $28,000 per year in the United States—presents a significant barrier to widespread global access.

Researchers estimate that generic manufacturers could potentially produce lenacapavir for as little as $25 per year if manufactured in large quantities, but this would require substantial investment and coordination.

Safety and effectiveness

Clinical trials have shown that lenacapavir is generally well-tolerated, with the most common side effect being mild discomfort at the injection site, including redness, swelling, or soreness that typically resolves quickly.

Some users have reported nausea, though this is uncommon.

Two breakthrough HIV cases in pivotal studies were linked to virus mutations that made it resistant to the drug, highlighting the importance of regular medical monitoring to ensure continued effectiveness.

The WHO has also recommended a simplified public health approach to HIV testing using rapid tests to support the delivery of long-acting injectable PrEP, removing major access barriers and enabling community-based delivery through pharmacies, clinics, and telehealth services.

While lenacapavir offers unprecedented protection against HIV, health experts emphasize that it doesn’t protect against other sexually transmitted infections. The use of condoms and regular screening for STDs remains crucial for comprehensive sexual health protection.

The approval of lenacapavir represents a significant advancement in HIV prevention, offering hope for more accessible and effective protection, particularly for high-risk populations including sex workers, men who have sex with men, transgender people, people who inject drugs, and those in prison settings.

As Kenya prepares for the January 2026 rollout, the country stands poised to lead the way in implementing this revolutionary HIV prevention tool, potentially serving as a model for other nations in the region and beyond.