Byanyima Wants Trump to Fund Injectable Lenacapavir for PrEP

Food and Drug Administration (FDA) approval of injectable lenacapavir (LEN) for the prevention of HIV as pre-exposure prophylaxis (PrEP). 

LEN, developed by Gilead Sciences, is a twice-yearly injectable PrEP option that showed nearly complete protection against HIV in the landmark PURPOSE 1 and 2 trials.     

In 2024, Gilead Sciences released findings from the PURPOSE 1 and PURPOSE 2 trials testing lenacapavir (LEN) as HIV prevention.         

The PURPOSE 1 trial found 100% efficacy in preventing HIV in 5,300 cisgender women in Uganda and South Africa, and the PURPOSE 2 trial showed a 96% reduction in HIV incidence among cisgender men, trans, and non-binary individuals across multiple countries. Both trials demonstrated LEN’s safety and effectiveness in reducing HIV transmission.   

Science Magazine named LEN the “Breakthrough of the Year” in 2024, a recognition that reflects its enormous potential. But that promise will only be realized if it is rolled out with speed, scale, and equity.       

Mitchell Warren, executive director of AVAC said the approval of LEN is a much-needed boost for HIV prevention given the strength of the science and the simultaneous disruption in HIV programs globally.

“But US FDA approval is just one in a series of steps needed to ensure that injectable LEN can help reduce the 1.3 million new HIV infections that occur each year. Scientific progress only matters if innovation actually reaches people. LEN for PrEP is poised to re-shape 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.” said Warren

AVAC uses  its independent voice and global partnerships advocate for acceleration  ethical development and equitable delivery of effective HIV prevention options, as part of a comprehensive and integrated pathway to global health equity.       

In December, PEPFAR and the Global Fund announced a coordinated ambition to reach two million people within three years of product launch.      

This commitment signals an unprecedented opportunity to make PrEP access a reality. But translating this ambition into impact, especially now amid the current political environment, is not without considerable challenges. 

“Political will, programmatic implementation, and sustainable funding are needed to truly accelerate equitable and impactful introduction of LEN worldwide,” said Wawira Nyagah, AVAC’s director of product introduction and access.    

  “We have over a decade of hard-won lessons on what it takes to rollout PrEP effectively, and the field cannot afford the delays we have seen with the past launches of daily oral PrEP, the monthly dapivirine vaginal ring (DVR), and every-two-month injectable cabotegravir (CAB). Lives depend on speed, scale and equity.”

  UNAIDS Executive Director, Winnie Byanyima las week met the South African President, Cyril Ramaphosa as part of her efforts to mobilise funding to HIV/AIDS following disruption caused by President Donald Trump’s aid cuts to USAID.

South Africa will also be co-hosting with the UK the upcoming Global Fund to Fight AIDS, Tuberculosis and Malaria (the Global Fund) replenishment meeting.

  Byanyima expected Ramaphosa to use the G20 meeting he will host in South Africa to convince Donald Trump to provide more funding to HIV/AIDs prevention especially the roll out of injectable lenacapavir (LEN) for the prevention of HIV as pre-exposure prophylaxis (PrEP).

  While LEN is now approved, Byanyima has expressed fear that its price will be out of reach for many countries in Africa.

///Cue In “ Our friends……

Cue Out….that here is the deal .”////    

“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 make profits, pay its taxes be assured of a market, give jobs to the American people and prevent HIV,”  said Byanyima.     

Byanyima says with Lencapvir in place, the world would be able to bring down new HIV/AIDS infections. 

“We could end this disease by bringing down new infections to zero. This is an opportunity to say there is a win-win for the American government which has lead in support to HIV and here is an opportunity for their company to make its millions and the opportunity to end this disease,” she said.     

The World Health Organization (WHO) is expected to release updated PrEP guidelines for LEN in July, and regulatory agencies in Brazil, Europe and South Africa are simultaneously reviewing the product.       

But the current political context, including a shuttered USAID and further disruptions across global health, demands an urgent and courageous response. In January, the US Administration issued a stop-work on all USAID-funded grants, nearly paralyzing HIV treatment and prevention by PEPFAR, the primary funder of programs in HIV-burdened countries (and administered by USAID).      

In February, PrEP was broadly excluded from a waiver that allowed HIV treatment to continue and allowed PrEP only for pregnant and breastfeeding women. These policies could not only undercut LEN’s promise but roll back years of progress in HIV prevention.           

It will take new, re-vitalized and committed partnerships to work together to sustain past progress and advance HIV prevention to deliver on the UN targets for epidemic control.              

“No one donor, national government or manufacturer can realize this ambition alone,” said Warren. “All stakeholders—including Gilead, PEPFAR, and the Gates Foundation—must act decisively to seize this opportunity, ensuring that all populations—regardless of geography, income, or identity—benefit from this innovative prevention option.”     

Gilead to set a cost-effective price that compares to generic daily oral TDF/FTC. Achieving this will require a low launch price from Gilead, significant volume procurement from donors, and the entry of multiple generic manufacturers into a competitive, multi-million-user market. 

While this low price is not expected at launch, stakeholders must act now to reach this price point as quickly as possible by building volume with supplies from Gilead at no more than $100 per person per year and to support multiple generic manufacturers to enable production at larger scale and lower prices as quickly as possible.          

A mobilized civil society in high-burden countries pushing national governments to expedite regulatory approvals, integrate LEN into HIV and national health programs with domestic resources, and develop national guidelines without delay.

Civil society also demanding transparent pricing and a clear, accelerated pathway to sustainable PrEP programs—so that by the time generic LEN becomes available around 2028, the market is primed for rapid scale-up, with multiple producers driving down prices through competition.

“This is the moment to build on the momentum of science, which has brought the field to this day, when LEN for PrEP is speeding through regulatory review faster than any prevention product to date,” said Nyagah. “Translating this success into real impact on the epidemic, led by communities around the world, must be a top priority among all stakeholders.”