Winnie Byanyima Urges Affordable Pricing for Breakthrough HIV Prevention Drug Lenacapavir

UNAIDS Executive Director and UN Undersecretary-General Winnie Byanyima has called for a major and transparent reduction in the price of lenacapavir, a newly approved long-acting injectable for HIV prevention. The drug, which requires only two doses a year, currently carries a U.S. list price of $28,218—around Shs 101 million—per person annually, a figure Byanyima says could jeopardize global goals to end the HIV/AIDS epidemic.

Following the recent approval of lenacapavir (LEN) by the U.S. Food and Drug Administration (FDA) as a pre-exposure prophylaxis (PrEP), Byanyima stressed that such life-changing medical advances must be accessible. The approval was based on positive results from two large-scale trials—PURPOSE 1 and PURPOSE 2—conducted by Gilead Sciences. In PURPOSE 1, LEN showed 100% effectiveness in preventing HIV among over 5,300 cisgender women in Uganda and South Africa. PURPOSE 2 showed a 96% drop in HIV incidence among cisgender men, transgender, and non-binary individuals across several countries.

Despite the promising results, Gilead’s pricing has sparked criticism. Byanyima cited research indicating that LEN can be manufactured for as little as $40 per person per year, with that figure potentially falling to $25 within the first year of distribution. She condemned the $28,218 price tag as unjustifiable and unaffordable for countries most in need.

“This is a medicine that can change the course of the epidemic, yet its current cost makes it inaccessible to the people who need it most,” she said. “I urge Gilead to lower the price, ramp up production, and give the world a real chance to end AIDS.”

She also urged South African President Cyril Ramaphosa to use the G20 summit in November to advocate for international funding, including support from U.S. President Donald Trump, to make LEN more affordable ahead of its global rollout anticipated in 2028. Her appeal comes amid cuts to HIV funding and a pause in USAID disbursements, which have disrupted programs including the President’s Emergency Plan for AIDS Relief (PEPFAR).

Byanyima argued that a well-supported rollout of LEN would benefit all parties involved. “If PEPFAR and the Global Fund are fully financed, they can procure LEN in bulk, giving Gilead guaranteed returns, sustaining jobs, and saving lives,” she said.

Health advocates echoed her concerns. Mitchell Warren, Executive Director of AVAC, described LEN’s FDA approval as a milestone, but emphasized that its impact depends entirely on rapid and equitable access. “Science is only transformative if it reaches the people it’s meant for. Without an inclusive and strategic rollout, LEN risks becoming another missed opportunity,” he warned.

Wawira Nyagah, AVAC’s Director of Product Introduction and Access, underscored the urgency of implementation. “We’ve seen delays and poor uptake with previous PrEP options. Lives depend on how fast and fairly we act now,” she said.

The World Health Organization is expected to issue updated PrEP guidelines for LEN in July. Regulatory reviews are also underway in Brazil, South Africa, and Europe. However, political and policy obstacles continue to stall progress. In January, the U.S. government froze all USAID HIV-related grants, and a February policy shift further restricted PrEP access, limiting its use to pregnant and breastfeeding women.

Despite these challenges, the Global Fund and PEPFAR aim to reach two million people with LEN within three years of its launch. Experts say this goal can only be achieved through collaboration, adequate funding, and policy reform.

“No single organization or government can do this alone,” said Warren. “It’s time for Gilead, PEPFAR, the Gates Foundation, and others to act decisively so that everyone—regardless of geography or income—can benefit from this groundbreaking innovation.”