In June of 2025, FDA approval was given for injectable lenacapavir, a twice-yearly HIV infection prevention injection that experts believe could be a “game changer in the fight against HIV.” Even as those who have worked for years to slow the spread of HIV and work towards an eventual cure celebrate this breakthrough, there remains a persistent concern that this breakthrough preventative medication will fail to reach the communities that need it the most.
As the medical community and healthcare advocates plan the rollout of lenacapavir, offered under the brand name Yeztugo, a stark gap remains between scientific breakthroughs and societal disparities. The vulnerable communities at highest risk of HIV that continue to face stigmas, economic instability, and barriers in the ever-evolving health system will need support to access lenacapavir swiftly and affordably.
Long-acting injectable: the promise of innovation
While there have been HIV prevention medications released in the past few years that have seen success, lenacapavir stands out as the only medication approved that only needs to be taken twice a year. This difference allows people to avoid the burden of daily pills, frequent health visits, and challenges with medication adherence.
The medicine acts by blocking HIV’s protective capsid shell, preventing it from infecting cells. Clinical trials PURPOSE 1 and PURPOSE 2 showed that over 99.9% of participants receiving the shot remained HIV negative, marking it as “one of the best HIV prevention options available since the beginning of the epidemic,” according to UC Davis infectious disease expert Sarah Waldman. These positive initial reports have led to the European Medicines Agency recommending the medication for easier prevention of HIV. 6
“Unlike oral pre-exposure prophylaxis (PrEP), which must be taken once a day, every day, around the same time of day, lenacapavir is only taken twice a year,” explains Thresa Giles, CEO of Hope and Help of Central Florida, a non-profit that offers HIV prevention services such as free HIV testing and community support resources. “In addition, there have been very few side effects reported with the new drug, and it makes it all attractive for a broad application for a diverse collection of communities.”
Barriers to access for lenacapavir
“Though lenacapavir is a major breakthrough, equitable access to the medication remains a concern,” says Giles. Communities that are most impacted by HIV, such as Black and Latino gay and bisexual men or those who use injectable drugs, face ongoing barriers to access to breakthrough medications and treatments.
Geographic barriers can mean that healthcare providers and infrastructure are lacking for vulnerable populations. Rural and underserved poor urban areas may be lacking in provider network coverage and access to the latest medications for people at risk.
Stigmas and discrimination also stand in the way of progress for preventative medications. The ongoing stigma that surrounds HIV and the discrimination that many vulnerable populations face may keep them from seeking preventative help or services like testing.
Cost also remains a substantial barrier for many. The cost of Yeztugo, the brand name for lenacapavir, can be astronomical without insurance coverage, reaching nearly $29,000 per year for use.
“However, a generic lenacapavir has been authorized by Gilead Sciences that will be available for about $40 per person by 2027, though it remains to be seen if this cheaper option will be available in the United States initially,” explains Giles.
What also remains to be seen is how insurance companies will handle this new preventative medication offering. It is expected that, at least early on, the medication will need to be administered in specialty infectious disease clinics, limiting access even further for people in rural healthcare deserts or poverty-stricken areas.
The critical role of community organizations in the prevention of new HIV infections
Part of the role of organizations like Hope and Help of Central Florida is outreach and making treatments such as antiretroviral medicines and preventative measures more accessible. Local nonprofits and other organizations play a crucial role in bridging the gaps between innovation in the HIV space and access.
“There’s power in community,” says Giles. “Staff, volunteers, partners, and supporters can break down barriers and inspire healthier futures.”
As breakthroughs like lenacapavir become available, the role of community organizations will shift to primarily focus on disseminating information, continuing to offer services such as free HIV testing, and being at the forefront of accessibility for those they serve. Outreach campaigns can keep people informed of their preventative options, advocacy can help influence policy surrounding medication innovation and accessibility, and partnerships can help ensure that distribution channels are not hindered.
A powerful new path forward
“New medications like lenacapavir represent hope for people,” says Giles. “The challenge remains making these scientific breakthroughs equitably available.”
The development of lenacapavir is an incredible step forward in the push to eliminate HIV and end the AIDS epidemic. Through the critical work of community organizations, healthcare providers, and advocates, the communities that need the medication the most can gain access and benefit from the scientific breakthrough.
