In the global fight against HIV, a twice-yearly injection could represent 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 healthcare access.
"With clinical trials showing a 100% prevention rate among cisgender women in the PURPOSE 1 trial and a 96% reduction in infection rates among cisgender men and gender-diverse people in the PURPOSE 2 trial, the therapy offers hope for individuals and overburdened healthcare systems worldwide," says Daniel O'Day, Chairman and CEO of Gilead.
According to Mitchell Warren, Executive Director of AVAC, an international non-profit organization working to accelerate 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've seen to date of any HIV prevention option. Adding this additional HIV prevention options means more people may find an option that is right for them. Beyond expanded choice, a twice-yearly 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 decreased burden on healthcare systems that are stretched to the limit."
It represents a big swing in a competitive space. In late 2021, Viiv Healthcare, owned by GlaxoSmithKline (NYSE: GSK), saw its Apretude (cabotegravir) approved for PrEP. At the time, it became the first long-acting PrEP treatment: the injection was administered as few as six times per year. Lenacapavir cuts the number of needed injections to two, serving as another testament to the power of competition in pharma. When companies compete, innovation thrives - 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 into oncology, immunology and transformative global health initiatives. Gilead was already renowned for its breakthroughs in virology - particularly in HIV, where it held an industry-leading portfolio.
O'Day, however, saw the bigger picture. He aimed to position Gilead as not only a scientific powerhouse but as an advocate for global health equity. Four years in, the company's transformation is well underway, with Gilead doubling the breadth of its pipeline, launching six innovative therapies and advancing initiatives designed to redefine the company's role in the healthcare landscape.
Not surprisingly, after spearheading advances in HIV treatment and prevention, Gilead's commitment to combatting HIV remains at the core of its mission.
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-limited countries - an unprecedented step taken even before the product's global regulatory approval.
For many people, the additional treatment options cannot come soon enough. "We have very effective treatment regimens in the developed world, but about 30% of people that know they have HIV are not virologically suppressed," O'Day notes. "We talk about having person-centric innovation when it comes to HIV and lenacapavir is a perfect example of that. We're going to have a variety of options to help that 30% of people."
This proactive approach, he says, is emblematic of Gilead's commitment to equitable healthcare access and addresses what he calls "the gaps between innovation and real-world impact." In 2023 alone, Gilead's therapeutics enabled over 120 million treatments for HIV and hepatitis B patients in low-and middle-income countries, the company reports.
For O'Day, the drive for health equity is personal. The company's decades-long advocacy for equitable treatment access in HIV prevention and care established an industry precedent. Programs like RADIAN, operated in partnership with the Elton John AIDS Foundation, have delivered critical support to underserved populations in Eastern Europe and Central Asia, where the volume of HIV diagnoses and AIDS-related deaths continues to rise.
According to the foundation, RADIAN has reached more than 270,000 people with HIV services, given more than 14,000 frontline workers training about stigma and discrimination, and provided 114,000 HIV tests. But according to foundation CEO Anne Aslett, the statistics tell only a small percentage of the larger story.
"Behind these numbers there are real people, whose lives have been saved and transformed thanks to the local organizations and programs we are helping to support," she says.
Aslett adds that the RADIAN program has set ambitious goals 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 - which has one of the fastest-growing HIV epidemics in 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, localized solutions. Similarly, Gilead's COMPASS initiative in the United States, backed by a $100 million commitment over 10 years, seeks to address disproportionately high HIV rates in Southern states.
Gilead believes its approach to patient-centered innovation resonates beyond clinical efficacy. The company's work in providing a range of HIV treatment options, such as one-pill-a-week or quarterly injections, reflects a nuanced understanding of patient needs. This level of personalization is vital 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 lower overall incidence, particularly in high-risk and hard-to-reach populations. With regulatory filings for lenacapavir expected to begin at the end of 2024, the product could be available to patients in 2025. The urgency of the situation is not lost on O'Day and his team, which understands that "ending the HIV epidemic for everyone, everywhere" will require Gilead not only to deliver innovative therapies but also to ensure that its products reach the communities most affected.
"We were the very first company to think about voluntary licensing for a patented medicine," O'Day recalls. The move initially faced industry skepticism but came to be regarded as a model of responsible innovation.