How Gilead is driving global health equity and innovation

In the global fight against HIV, a biennial shot could mark a seismic shift in prevention efforts. Lenacapavir, Gilead Sciences’ (NASDAQ: GILD) innovative therapy for HIV pre-exposure prophylaxis (PrEP), is not only a breakthrough in clinical efficacy but also a model for advancing equitable access to healthcare.

“With clinical trials showing a 100% prevention rate among cisgender women in the PURPOSE 1 study and a 96% reduction in infection rates among cisgender men and gender diverse people in the PURPOSE 2 study, the therapy offers hope for individuals and overburdened healthcare systems . worldwide,” said Daniel O’Day, chairman and CEO of Gilead.

According to Mitchell Warren, executive director of AVAC, an international nonprofit organization committed to accelerating effective HIV prevention options in high-burden countries and communities, “the recent results of injectable lenacapavir for PrEP are among the most important results we have seen. of any option for HIV prevention so far. Adding these additional HIV prevention options will help more people find an option that’s right for them. In addition to increasing choice, a biannual injection has the potential to transform the way we deliver HIV prevention to people who need and want it most – from an easier-to-follow regimen for individuals to a reduced burden on healthcare systems that need to are stretched to their limits. .”

It represents a major change in a competitive space. In late 2021, GlaxoSmithKline-owned Viiv Healthcare (NYSE: GSK) saw its Apretude (cabotegravir) approved for PrEP. At the time, it became the first long-acting PrEP treatment: the injection was administered only six times a year. Lenacapavir reduces the number of injections needed to two, providing further evidence of the power of competition in the pharmaceutical sector. When companies compete, innovation flourishes – and people benefit.

When O’Day joined Gilead Sciences in 2019, he brought with him a clear vision: to leverage Gilead’s expertise in HIV and expand it into oncology, immunology and transformative global health initiatives. Gilead was already known for its breakthroughs in virology – especially in the field of HIV, where it had a leading portfolio.

However, O’Day saw the bigger picture. He wanted to position Gilead not only as a scientific powerhouse, but also as an advocate for global health equity. Four years later, the company’s transformation is well underway, with Gilead doubling the breadth of its pipeline, launching six innovative therapies and developing initiatives designed to redefine the company’s role in the healthcare landscape.

Not surprisingly, after leading the way in advances in HIV treatment and prevention, Gilead’s commitment to fighting HIV remains core to its mission.

“With lenacapavir, we have developed the first biennial HIV pre-exposure prophylaxis (PrEP) therapy, a potential game changer for many at-risk populations worldwide,” says O’Day.

The breadth of Gilead’s ambition extends beyond medical innovation and into the realm of public health. By pioneering royalty-free, voluntary licensing agreements for lenacapavir with six pharmaceutical manufacturers, Gilead is ensuring access to the therapy in 120 high-incidence, resource-constrained countries – an unprecedented step that comes even before the product’s global regulatory approval has been set.

For many people, additional treatment options can’t come soon enough. “We have very effective treatment regimens in the developed world, but about 30% of people who know they have HIV are not virologically suppressed,” O’Day notes. “We talk about person-centred innovation when it comes to HIV and lenacapavir is a perfect example of that. We will have different options to help those 30% of people.”

This proactive approach, he says, is emblematic of Gilead’s commitment to equitable access to healthcare and addresses what he calls “the gap between innovation and real-world impact.” In 2023 alone, Gilead’s therapies enabled more than 120 million treatments for HIV and hepatitis B patients in low- and middle-income countries, the company reports.

For O’Day, the pursuit of healthcare equity is personal. The company’s decades-long advocacy for equal access to treatment in HIV prevention and care has set an industry precedent. Programs like RADIAN, run in partnership with the Elton John AIDS Foundation, have provided critical support to underserved populations in Eastern Europe and Central Asia, where HIV diagnoses and AIDS-related deaths continue to rise.

According to the foundation, RADIAN has reached more than 270,000 people with HIV services, trained more than 14,000 frontline workers on stigma and discrimination, and provided 114,000 HIV tests. But according to Anne Aslett, CEO of the foundation, the statistics only tell a small percentage of the bigger story.

“Behind these numbers are real people, whose lives have been saved and transformed thanks to the local organizations and programs we help support,” she says.

Aslett adds that the RADIAN program has set ambitious targets for the next half decade: “It will continue to help meet the needs of people most affected by HIV in Eastern Europe and Central Asia – where a one of the fastest growing HIV epidemics in the world. the world and is too often overlooked in the global response – through innovative, scalable solutions that will create real long-lasting impact in the region.”

According to O’Day, the initiative has made a tangible difference in regions where HIV-related challenges persist and require immediate, local solutions. Similarly, Gilead’s COMPASS initiative in the United States, backed by a $100 million commitment over ten years, seeks to address disproportionately high HIV rates in the southern states.

Gilead believes its approach to patient-centered innovation resonates beyond clinical efficacy. The company’s work in offering a range of HIV treatment options, such as one pill per week or three-monthly injections, reflects a nuanced understanding of patients’ needs. This level of personalization is critical in HIV care, where, as O’Day notes, the industry is “entering an era with a variety of options to help the 30% of people who are not yet virologically suppressed.”

The company is also targeting the root of the HIV epidemic with prevention efforts designed to reduce overall incidence, especially in high-risk and hard-to-reach populations. With regulatory applications for lenacapavir expected to begin in late 2024, the product could be available to patients in 2025. The urgency of the situation is not lost on O’Day and his team, who understand that “ending the HIV epidemic for everyone, everywhere” requires that Gilead not only deliver innovative therapies, but also that its products reach the communities most affected reaches.

“We were the very first company to think about voluntary licensing of a patented drug,” O’Day recalls. This move was initially met with skepticism in the industry, but was considered a model of responsible innovation.