FDA Greenlights Gilead’s twice-Yearly Injection for HIV Prevention, Ushering in a New Chapter

The Food and Drug Governance has granted approval to Gilead’s groundbreaking antiviral injection, designed to be administered biannually as a preventive strategy against HIV. This milestone marks a transformative step forward in the global effort to combat the persistent HIV epidemic.

Extended-Interval Dosing: A Game-Changer in HIV Prevention

Recent 2024 clinical trials revealed that Gilead’s lenacapavir injection offers nearly complete protection from new HIV infections when given every six months. this regimen is significantly less frequent than current alternatives such as daily oral PrEP pills or GSK’s injectable Apretude, which requires dosing every two months following an initial monthly loading phase.

This longer dosing interval not only enhances convenience but also holds promise for improving adherence among high-risk groups. In 2023 alone, approximately 1.3 million people worldwide contracted HIV, with over 630,000 fatalities attributed to the virus-highlighting the urgent need for more effective prevention tools.

HIV in the United States: Ongoing Disparities and Challenges

The U.S. continues to face significant hurdles with roughly 700 new HIV diagnoses each week and about 100 deaths related to the disease during that same period. The epidemic disproportionately impacts communities of color, gay and bisexual men, other men who have sex with men (MSM), and transgender women.

“This approval represents a critical turning point for public health globally,” stated Daniel O’Day, CEO of Gilead. “Making this twice-yearly injection widely available could dramatically shift how we control the epidemic.”

Tackling Adherence Barriers Through Injectable Convenience

Pill-based PrEP has been accessible for over a decade; however, inconsistent use driven by stigma or inconvenience remains a major obstacle-especially outside predominantly white MSM populations-leading infection rates either to plateau or rise in many areas.

• Disproportionate impact: Black Americans account for nearly 39% of new U.S. diagnoses but represent only about 14% of PrEP users;
• Diverse challenges: Hispanic individuals make up around 31% of new cases yet comprise just approximately 18% of those utilizing PrEP;

“Stigma continues to be one of our greatest barriers,” explained Johanna Mercier from Gilead. “A biannual injection provides discreet protection that many have long desired.”

Efficacy Proven Across Varied Populations

A pivotal late-stage trial involving over two thousand participants-including cisgender men; transgender women; transgender men; and gender nonbinary individuals engaging sexually with partners assigned male at birth-showed only two infections occurred among those receiving lenacapavir injections. This corresponds to an approximate risk reduction of 96%,surpassing daily Truvada pills’ effectiveness by nearly nine times (89%). Another study focusing on more than five thousand cisgender women reported zero infections during follow-up periods among those treated with injections, indicating full efficacy within this group as well.

The Financial Landscape: Pricing and Accessibility concerns

The annual list price for lenacapavir (marketed as Yeztugo) is $28,218 before insurance coverage in the United States-a figure comparable with branded oral PrEP medications like Truvada and Descovy priced near $24,000 annually without insurance-and higher than Apretude’s approximate $4,000 per dose cost prior to insurance adjustments.

A representative from gilead highlighted ongoing efforts aimed at securing broad insurance acceptance for Yeztugo alongside existing prevention options. Copay assistance programs are available that can reduce out-of-pocket costs down to zero for eligible insured patients; uninsured individuals may also qualify for free access through company-supported initiatives.

Global Access Strategies Through Licensing Agreements

Lenacapavir is already approved under Sunlenca branding as treatment for active HIV infection at an annual cost exceeding $42,200 but can be produced generically at drastically lower prices-estimated between $26 and $40 per year according to recent economic analyses.

Mizuho analysts forecast combined sales from both treatment and prevention uses could reach around $4 billion worldwide during peak years.

Acknowledging that “HIV knows no borders,” Gilead has licensed six generic manufacturers across more than 120 low- and lower-middle-income countries enabling affordable production of lenacapavir injections while pledging up to two million doses on a no-profit basis before generic versions become widely accessible globally.

The Risk Posed by Potential Federal Funding Cuts

Sustaining equitable access within underserved populations depends heavily on complete insurance coverage including Medicaid-the largest insurer covering roughly four out of every ten nonelderly adults diagnosed with HIV nationwide-and also commercial plans used by most current PrEP recipients.

“The foundation supporting America’s progress against HIV faces unprecedented threats,” says Jeremiah Johnson from advocacy group PrEP4All.“Proposed budget cuts targeting CDC programs endanger vital infrastructure essential for physician outreach and patient care.”

If these funding reductions proceed without congressional intervention starting fiscal year cycles in October 2025-26, a resurgence in infections may occur due partly to disruptions affecting people currently adhering successfully to preventive treatments like Yeztugo or other forms of PrEP medication.^*