Game-Changing HIV Injection by Gilead Promises to Curb New Infections with Just Two Doses a Year

 

The fight against HIV has taken a major leap forward with a landmark decision by the U.S. Food and Drug Administration. Gilead Sciences, a leading biopharmaceutical company, has received approval for a long-acting injectable medication aimed at preventing HIV infection. Branded as Yeztugo, the injection is designed to be taken just twice a year, making it the least frequent dosage schedule among all existing HIV prevention options.

The approval is backed by two pivotal clinical trials conducted in 2024. According to findings highlighted by CNBC, the trials showed that Yeztugo was able to virtually eliminate new HIV infections when used as prescribed every six months. The injection contains the drug Lenacapavir, which has already been used under the brand name Sunlenca for treating HIV, although at a significantly higher annual cost.

Unlike daily pills such as Truvada and Descovy, or even GSK’s Apretude, which requires an injection every other month, Yeztugo’s biannual regimen is expected to dramatically ease adherence challenges. Experts believe this lower frequency can be a game-changer in combating the virus, particularly in communities where access to healthcare remains inconsistent or stigmatized.

Gilead’s CEO, Daniel O’Day, emphasized the potential public health impact of this new tool. Speaking ahead of the FDA’s announcement, O’Day pointed out that the United States continues to report approximately 700 new HIV cases and 100 HIV-related deaths each week. He stressed that certain groups continue to bear the brunt of the epidemic, including people of color, gay and bisexual men, and transgender women.

O’Day expressed optimism that Yeztugo will significantly change the trajectory of the epidemic, especially as it becomes more widely available worldwide. “This really will bend the arc of the epidemic as we roll this out across the globe,” he stated.

Despite the promise, there are challenges ahead. The anticipated rollout of Yeztugo could face hurdles stemming from political and economic developments. CNBC reported that the Trump administration has floated proposals to slash federal funding for HIV prevention, a move that could complicate nationwide access efforts.

Advocacy groups are already voicing concerns about equity and accessibility. Jeremiah Johnson, Executive Director of PrEP4All, a nonprofit organization working to expand access to HIV prevention tools, highlighted that the impact of Yeztugo will largely depend on how easily it can be accessed by those who need it most.

Johnson’s comments underscore longstanding barriers to HIV prevention: affordability, healthcare infrastructure, and social stigma. Although the drug has an annual list price of $28,218 in the United States, Gilead has announced multiple assistance programs to reduce or eliminate out-of-pocket costs for eligible patients.

According to a Gilead spokesperson, insured individuals may qualify for a copay savings program that could bring their payment down to zero. Additionally, the company has committed to offering the drug for free to uninsured individuals who meet eligibility criteria.

Pricing for Yeztugo aligns with other branded PrEP (pre-exposure prophylaxis) options currently on the market. For context, Gilead’s Truvada and Descovy pills cost about $2,000 per month without insurance, adding up to approximately $24,000 per year. GSK’s injectable Apretude, while not as frequent as daily pills, still requires multiple injections annually, each costing around $4,000 before insurance.

Yeztugo’s less burdensome dosing schedule might also improve medication adherence, a key issue in HIV prevention. Missed doses or inconsistent use of daily PrEP medications has long been a factor in new HIV transmissions, particularly in marginalized communities.

Global health organizations and experts are hailing the FDA’s approval as a monumental advancement. The World Health Organization reported that 1.3 million new HIV infections were recorded globally in 2023, alongside an estimated 630,000 HIV-related deaths. A twice-yearly preventive measure could significantly reduce those numbers, especially when integrated with broader public health strategies.

Beyond its role in prevention, Lenacapavir remains available under the brand name Sunlenca for individuals already living with HIV. The annual cost for that treatment stands at over $42,000, making affordability and access critical issues not only for prevention, but also for ongoing treatment.

While the approval of Yeztugo signals immense promise, the ultimate impact of this innovation will depend on political will, equitable distribution, and continued investment in public health. The next chapter in the fight against HIV may have just begun, but the potential to end the decades-long epidemic has never felt more tangible.