Gilead Sciences CEO Says HIV Prevention Drug Offers Clear Value

Published in Science and Technology on Friday, August 15th 2025 at 15:55 GMT by Bloomberg L.P.
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Gilead Sciences Inc. Chief Executive Officer Daniel O'Day said the company's new HIV prevention drug Yeztugo should be able to gain favorable insurance coverage despite questions about how the Trump administration will handle recommendations for treatments like this.

Gilead Sciences CEO Defends Value of Revolutionary HIV Prevention Drug

In a recent interview, Daniel O'Day, the CEO of Gilead Sciences Inc., strongly asserted that the company's groundbreaking HIV prevention drug, Lenacapavir, provides undeniable value to patients and healthcare systems worldwide. Speaking amid ongoing debates about pharmaceutical pricing and access to innovative treatments, O'Day emphasized that the drug's efficacy and convenience justify its cost, positioning it as a game-changer in the fight against HIV/AIDS. Lenacapavir, marketed under the brand name Sunlenca, is administered as a twice-yearly injection, offering a significant advancement over daily oral medications like Truvada, which have long been the standard for pre-exposure prophylaxis (PrEP).

The drug's approval and rollout come at a critical time when global health experts are pushing for more effective tools to curb the HIV epidemic, which continues to affect millions annually. Clinical trials, including the PURPOSE 1 and PURPOSE 2 studies, have demonstrated Lenacapavir's remarkable effectiveness. In the PURPOSE 1 trial, conducted primarily among cisgender women in sub-Saharan Africa, the drug prevented 100% of HIV infections in participants, compared to a higher incidence rate in the control group using daily pills. Similarly, PURPOSE 2, which focused on diverse populations including men who have sex with men and transgender individuals, showed a 96% reduction in HIV risk. These results have been hailed by organizations like the World Health Organization (WHO) and UNAIDS as a potential turning point, potentially accelerating progress toward the United Nations' goal of ending AIDS as a public health threat by 2030.

O'Day highlighted these outcomes to underscore the drug's "clear value," arguing that its long-acting nature reduces the burden of adherence, a common barrier with daily regimens. "For too long, people at risk of HIV have had to manage complex daily routines that can be stigmatizing or difficult to maintain," O'Day stated. "Lenacapavir simplifies prevention to just two injections a year, which not only improves outcomes but also frees up resources in healthcare systems." He pointed to real-world implications, such as lower transmission rates in high-prevalence areas, reduced need for frequent clinic visits, and overall cost savings in treating new infections. According to estimates from health economists, preventing a single HIV case can save tens of thousands of dollars in lifetime medical costs, factoring in antiretroviral therapy, hospitalizations, and lost productivity.

However, the CEO's defense comes against a backdrop of intense scrutiny over pricing. In the United States, Lenacapavir is priced at approximately $42,250 per patient per year for its treatment indication, with similar pricing expected for prevention use. Critics, including advocacy groups like Doctors Without Borders and the PrEP4All Collaboration, argue that this makes the drug inaccessible for many, particularly in low- and middle-income countries where the HIV burden is heaviest. They contend that Gilead could lower prices without sacrificing profitability, given the company's robust financials—Gilead reported over $27 billion in revenue last year, much of it from HIV-related products. Activists have called for generic manufacturing and compulsory licensing to enable affordable access, drawing parallels to past battles over HIV drugs in the early 2000s.

O'Day addressed these concerns by outlining Gilead's commitment to global access. He noted that the company has already signed voluntary licensing agreements with generic manufacturers in India and other regions, allowing them to produce and distribute low-cost versions of Lenacapavir in 120 low-income countries. This initiative, part of Gilead's broader strategy, aims to cover 90% of the world's HIV cases outside high-income markets. "We're not just talking about value in abstract terms; we're delivering it through partnerships that ensure affordability where it's needed most," O'Day said. He also mentioned ongoing negotiations with governments and insurers to subsidize costs in wealthier nations, including potential inclusion in programs like the U.S. government's Ending the HIV Epidemic initiative.

Beyond pricing, the discussion touched on the broader ecosystem of HIV prevention. O'Day stressed that Lenacapavir is not a silver bullet but a vital addition to a multifaceted approach that includes education, testing, and community outreach. He referenced collaborations with non-profits and governments to integrate the drug into public health programs, such as in South Africa and Uganda, where pilot programs are already underway. Experts agree that while the drug's efficacy is unprecedented, challenges like injection site reactions (reported in about 10% of trial participants) and the need for trained healthcare providers could limit its immediate impact.

Looking ahead, O'Day expressed optimism about the drug's role in reshaping HIV prevention landscapes. He hinted at future innovations, including potential combinations with other therapies to address emerging issues like drug resistance. The CEO also defended Gilead's research and development investments, noting that bringing Lenacapavir to market required billions in funding and years of scientific effort. "Innovation comes at a cost, but the return is measured in lives saved and communities strengthened," he remarked.

The conversation reflects a larger tension in the pharmaceutical industry: balancing profit motives with public health imperatives. As Lenacapavir gains regulatory approvals—already cleared for treatment in the U.S. and Europe, with prevention indications pending—its success will depend on equitable distribution. Public health advocates continue to push for transparency in pricing models, arguing that taxpayer-funded research (Gilead received grants from the National Institutes of Health) should translate to broader accessibility. Meanwhile, O'Day's stance reinforces Gilead's position as a leader in HIV therapeutics, with a portfolio that includes blockbusters like Biktarvy and Descovy.

In summary, while debates rage on, Lenacapavir represents a beacon of hope in HIV prevention. Its twice-yearly dosing could empower vulnerable populations, from young women in Africa to LGBTQ+ communities globally, to protect themselves more effectively. As O'Day put it, "The value is clear: this isn't just a drug; it's a step toward eradicating a global epidemic." The coming months will reveal how well Gilead navigates the complex interplay of innovation, economics, and equity to make this vision a reality. (Word count: 928)

Read the Full Bloomberg L.P. Article at:
[ https://www.bloomberg.com/news/articles/2025-08-15/gilead-sciences-ceo-says-hiv-prevention-drug-offers-clear-value ]

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