Winnie Byanyima, Executive Director of UNAIDS and United Nations Undersecretary-General, has urged Gilead Sciences to drastically cut the price of lenacapavir, a newly approved injectable HIV prevention drug, citing its current cost of $28,218 (about Shs 101 million) per person per year as a major barrier to global HIV response efforts.
Her appeal came after the U.S. Food and Drug Administration (FDA) approved lenacapavir (LEN) for use as long-acting pre-exposure prophylaxis (PrEP), following strong results from the PURPOSE 1 and PURPOSE 2 trials. In these trials, PURPOSE 1 showed 100% effectiveness in preventing HIV among 5,300 cisgender women in Uganda and South Africa, while PURPOSE 2 reported a 96% reduction in HIV incidence among cisgender men, transgender, and non-binary people across several countries.
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Despite these promising outcomes, Byanyima criticized Gilead’s pricing strategy, stressing that the drug could be produced for as little as $40 per year, dropping to $25 with broader distribution. She warned that keeping the price so high would make the drug inaccessible to many in low-income, high-HIV-burden countries.
“It’s unacceptable to price a life-saving drug so far out of reach,” she said. “I call on Gilead to lower the price, scale up manufacturing, and make it available to all who need it. Otherwise, this innovation will mean nothing.”
Byanyima also urged South African President Cyril Ramaphosa to raise the issue at the upcoming G20 summit and called on world leaders—including U.S. President Joe Biden—to step up financial support to ensure affordability of LEN, particularly in light of cuts to key HIV funding streams such as USAID and PEPFAR.
She stressed that if major donors like PEPFAR and the Global Fund are fully funded, they can purchase LEN in large quantities, guaranteeing Gilead a sustainable market while ensuring access for the most vulnerable.
Access Delays Could Undermine Impact
Mitchell Warren, Executive Director of AVAC, welcomed the FDA’s green light as a critical scientific breakthrough but warned that it would only have an impact if there is an urgent and fair rollout. He pointed to past delays with other PrEP options, such as the monthly dapivirine vaginal ring and injectable cabotegravir, as cautionary tales.
“Scientific advances only matter if they reach the people who need them. If we fail to roll out LEN boldly and equitably, we risk repeating the same mistakes,” said Warren.
AVAC’s Wawira Nyagah agreed, emphasizing the need for speed, scale, and inclusivity. “People’s lives are at stake. We can’t afford to stall LEN like we did with previous PrEP innovations,” she said.
The World Health Organization (WHO) is expected to issue updated guidelines for LEN in July, with regulatory reviews already underway in Brazil, South Africa, and the EU.
Funding and Political Roadblocks
However, political and funding challenges persist. In early 2024, the U.S. government halted work on all USAID-funded grants, significantly affecting HIV-related services globally. A subsequent policy change in February limited access to PrEP under treatment waivers, narrowing its availability to pregnant and breastfeeding women.
Despite these challenges, both PEPFAR and the Global Fund remain committed to making LEN accessible to at least two million people within three years of its global launch.
Warren concluded by urging unified action: “No single player can do this alone. It will take governments, donors, and manufacturers working together to make sure LEN reaches everyone—regardless of income, geography, or identity.”
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