In a landmark development, the U.S. Food and Drug Administration (FDA) approved Yeztugo (generic name: lenacapavir) on June 18, 2025—the first injectable HIV pre-exposure prophylaxis (PrEP) that requires only two shots per year . This biannual regimen represents a remarkable shift from the daily pill routines—and even the two-monthly injections—that have dominated HIV prevention for years.
Clinical Breakthroughs
Yeztugo’s clinical trials revealed nearly flawless efficacy: Phase III results from the PURPOSE 1 and PURPOSE 2 studies showed ≥99.9% effectiveness in preventing HIV infection, outperforming daily pills like Truvada and Descovy . In one trial among cisgender women, there were zero HIV cases among participants, prompting the early termination of the study .
Access, Pricing, and Equity
The annual list price in the U.S. stands at approximately $28,218, comparable to other branded PrEP options . In contrast, generic daily pills can cost as little as $1 per dose, and Apretude (a two-month injectable) runs around $24,000 annually .
To improve affordability, Gilead has established co-pay assistance programs, aims for 90% insurance coverage, and offers a no-profit pricing model enabling cheaper, generic manufacturing across 120 low- and middle-income countries . However, inclusion gaps persist—many middle-income countries are currently excluded, raising concern that those in need may be left behind .
Global Implications and Challenges
Gilead’s CEO, Daniel O’Day, hailed Yeztugo as “one of the most important scientific breakthroughs of our time,” positioning it as a tool that could potentially “bend the arc of the [HIV] epidemic” . The convenience of biannual dosing may improve adherence, reduce stigma, and better serve underserved communities .
In parallel, the European Medicines Agency (EMA) has recommended approving lenacapavir—under the brand name Yeytuo—for HIV prevention, heralding potential regulatory synchronization across Europe .
Still, hurdles such as funding cuts to prevention programs, delays in global rollout, and insurance access, particularly in low-resource settings, may limit reach .
Opinion Section
Yeztugo’s emergence is nothing short of revolutionary. Requiring two injections a year rather than daily pills or frequent clinic visits, it could significantly lower barriers to PrEP access and adherence—especially for populations burdened by stigma, inconsistent healthcare access, or daily pill fatigue.
However, the promise of exceptional efficacy must be met with inclusive access strategies. While Gilead’s pricing and licensing initiatives are promising, the high launch cost in wealthier markets and exclusion of many middle-income countries remain troubling gaps. Equitable distribution is imperative—not just to curb infections, but to ensure justice in global health.
In my view, for Yeztugo to fulfill its transformative potential, stakeholders—including governments, donors, and industry—must prioritize affordability, streamline regulatory approvals, and establish robust community delivery models. Only then can this breakthrough truly shift the trajectory of the HIV epidemic.
Summary Table
|
Feature |
Details |
|
Drug |
Yeztugo (lenacapavir) |
|
Approval Date |
June 18, 2025 (FDA) |
|
Dosing Frequency |
Twice per year |
|
Efficacy |
≥99.9% in trials |
|
List Price (U.S.) |
~$28,218/year |
|
Access Initiatives |
Insurance coverage, co-pay assistance, generic licensing in 120 countries |
|
Key Challenges |
Cost, insurance uptake, global rollout, equity gaps |
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