Byanyima urges realistic price cut on Shs 100m/yr HIV prevention drug  

UNAIDS executive director and United Nations Undersecretary-General, Winnie Byanyima, has called for a drastic and transparent reduction in the cost of lenacapavir, a twice-yearly injectable drug recently approved for HIV prevention, saying the current price of $28,218 (about Shs 101m) per person per year risks undermining global efforts to end the HIV/AIDS epidemic.

Byanyima made the appeal following the United States Food and Drug Administration (FDA)’s approval of lenacapavir (LEN) as a long-acting pre-exposure prophylaxis (PrEP) after promising results from the PURPOSE 1 and PURPOSE 2 clinical trials.

In 2024, Gilead Sciences announced the findings of both trials, showing that PURPOSE 1 demonstrated 100% efficacy 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 individuals across several countries.

Despite the breakthrough, Gilead has set a US list price of $28,218 per person per year for LEN, an amount Byanyima says is “beyond comprehension.” She argues the drug should cost no more than $40 per person annually to ensure equitable access, especially for low-income countries with high HIV prevalence.

“UNAIDS has seen research that lenacapavir can be produced for just $40 per person per year, falling to $25 within a year of rollout. It is beyond comprehension how Gilead can justify a price of $28,218. If this game-changing medicine remains unaffordable, it will change nothing,” said Byanyima.

“I urge Gilead to do the right thing. Drop the price, expand production, and ensure the world has a shot at ending AIDS.”

Byanyima called on South African President Cyril Ramaphosa to use the upcoming G20 summit in November to push global leaders, including US President Donald Trump, for financial support to lower the cost of LEN ahead of its anticipated global rollout in 2028.

She warned that without urgent action, the drug would be out of reach for African nations already grappling with cuts to HIV funding. Byanyima pointed to the ongoing freeze in USAID funding, including disruptions to PEPFAR (President’s Emergency Plan for AIDS Relief), which has left many HIV programs stalled.

“If PEPFAR, the American program and Global Fund are fully funded, then they will be able to purchase lencapvir from Gilead, assuring Gilead a market and by selling their product, Gilead would makeprofits, pay its taxes be assured of a market, give jobs to the American peopleand prevent HIV,” she noted.

Experts demand urgency, equity Mitchell Warren, executive director of AVAC, welcomed the FDA approval as a significant scientific milestone but warned that its impact hinges on timely, equitable rollout. Warren said scientific progress only matters if innovation actually reaches people and that LEN for PrEP could reshape HIV prevention, but only if bold, strategic, and equitable rollout accompanies its approval.

“Scientific progress only matters if innovation actually reaches people. LEN for PrEP is poised to reshape the HIV response, but only if today’s approval is accompanied by bold, strategic, effective and equitable rollout that reaches the populations that need access. Otherwise, the world risks squandering this PrEP opportunity, as it has with other PrEP options too often over the past 12 years.”

He cautioned that failure to act swiftly could repeat the mistakes seen with earlier PrEP options, including the monthly dapivirine vaginal ring (DVR) and the every-two-month injectable cabotegravir (CAB), which faced delays in access and limited uptake in high-burden areas.

Wawira Nyagah, AVAC’s director of product introduction and access, echoed the concern, saying: “Lives depend on speed, scale, and equity. We’ve learned hard lessons over the past decade we can’t afford to delay LEN the same way.”

The World Health Organization (WHO) is expected to release updated PrEP guidelines for LEN in July, while regulatory reviews are ongoing in Brazil, South Africa, and Europe.

Politics and policy hurdles

However, the political climate remains fragile. In January, the US Administration issued a stop-work order on all USAID-funded grants, severely affecting HIV prevention and treatment in recipient countries.

A February policy shift excluded most PrEP services from a waiver allowing HIV treatment to continue, limiting PrEP use to pregnant and breastfeeding women only. Despite the setbacks, PEPFAR and the Global Fund have set an ambitious target to reach two million people with LEN within three years of launch.

But turning that ambition into reality will require serious political will, funding, and partnerships. No single donor, government, or manufacturer can achieve this alone. Gilead, PEPFAR, the Gates Foundation, and others must act now to ensure all populations, regardless of geography, income, or identity, benefit from this innovation, said Warren.

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