FDA Approval of Long-Acting PrEP Marks Milestone in HIV Prevention—But Raises Urgent Questions About Access and Equity

FDA Approval of Long-Acting PrEP Marks Milestone in HIV Prevention—But Raises Urgent Questions About Access and Equity

WASHINGTON, DC, UNITED STATES, June 19, 2025 /EINPresswire.com/ -- This week marks a pivotal development in the fight against HIV with the U.S. Food and Drug Administration’s approval of Lenacapavir (Sunlenca), a long-acting injectable PrEP (pre-exposure prophylaxis) that requires just two injections per year. Hailed as a groundbreaking innovation, this biannual regimen has the potential to transform HIV prevention—especially for communities historically marginalized in the healthcare system.

“This moment is bittersweet,” said Kenya Hutton (he/him/his), CEO and President of the Center for Black Equity. “On the same day this life-saving medication was approved, the Supreme Court upheld Tennessee’s ban on gender-affirming care for transgender youth. While we celebrate progress for one community, we witness another face a devastating setback. These issues are deeply interconnected—they’re all about who gets to access care, who gets to live fully, and who is left behind.”

Hutton continued: “The idea that someone can receive two injections a year and be protected from HIV is revolutionary. But we must ensure this advancement doesn’t follow the same pattern of exclusion that has plagued so many other medical innovations.”
While the approval of injectable PrEP is a cause for celebration, it also underscores the ongoing disparities in healthcare access—particularly for Black Queer individuals, Black cisgender women, and Black transgender women. These communities remain disproportionately impacted by new HIV diagnoses, yet too often face systemic barriers to accessing preventative care.

Black women alone account for more than half of new HIV infections among women in the U.S., yet remain largely overlooked in public health strategies centered on PrEP. Structural racism, stigma, misinformation, transportation challenges, cost, and provider bias all contribute to the ongoing gap in PrEP uptake.

Now, just as this long-acting option becomes available, millions across the U.S. face potential loss of Medicaid coverage, and many employer-based insurance plans remain unstable and unaffordable—making it even harder for the most impacted communities to benefit from this innovation.

Advocates are urging pharmaceutical companies, policymakers, and philanthropic leaders to go beyond drug approval and put equity at the center of rollout plans. Community-based clinics and nonprofit organizations—often serving as the only touchpoints for marginalized individuals—must be properly funded and supported. Reform to the federal 340B drug pricing program is also critical to ensure that resources generated through discounted medications are reinvested directly into the communities they are intended to serve.

“Healthcare in America is still treated as a privilege, not a right,” said Hutton. “Approving innovative medicine is a first step. Ensuring it reaches the people who need it most—that’s the real test of progress.”

This milestone comes just one day before Juneteenth, a date that commemorates delayed freedom and the enduring struggle for Black liberation—a timing that is no coincidence. It serves as a powerful reminder that medical breakthroughs alone are not enough. We must actively dismantle the systemic barriers that continue to block equitable access to care. And it arrives as Pride Month comes to a close—a time meant to honor the resilience, resistance, and visibility of LGBTQ+ communities worldwide. The convergence of these moments reinforces a truth we cannot ignore: Pride has never been just a celebration—it has always been a protest, a call for dignity, equity, and justice. Until healthcare is truly a right for all—especially for Black LGBTQ+ communities, Black women, and transgender youth—our work remains far from over.

Karine Delage
Center for Black Equity
+1 416-876-3329
karine@karyzmaagency.com

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