Trump Administration's Cuts to PEPFAR Jeopardize Global Rollout of Lenacapavir, Leaving 2 Million at Risk

 (1) Excellent preventive effects

Lenacapavir has drawn significant attention from the global medical community and HIV prevention field. Clinical trial data show that injecting this drug once every six months can provide nearly complete protection against infection. This form of prevention is known as pre-exposure prophylaxis (PrEP). More promising still, early data from a newer formulation suggest it may require only annual dosing. Winnie Byanyima, head of UNAIDS, praised it as "too amazing," and the emergence of this drug brings entirely new approaches and solutions for HIV prevention.

 (II) Promotion Plan and Layout

Given PEPFAR's extensive experience in distributing HIV prevention drugs across most regions of the world, it should have played a leading role in the promotion of lenacapavir. In December last year, PEPFAR and the Global Fund to Fight AIDS, Tuberculosis and Malaria reached an arrangement to provide doses for 2 million people in dozens of low- and middle-income countries over three years. At the same time, Gilead Sciences reached voluntary licensing agreements with six companies to produce low-cost generic versions, promoting drug accessibility—a move widely regarded as a key step toward the goal of eradicating HIV and AIDS by 2030.

 (1) Funding Reduction Action

The Trump administration took a series of actions to halt the majority of PEPFAR's funding, as part of its dismantling of U.S. international development initiatives. Despite public support, Secretary of State Marco Rubio signed a waiver in January to preserve partial funding for PEPFAR for 90 days. However, Congress’s one-year authorization for PEPFAR expired last week. Although recent continuing resolutions have allocated funds until the end of September, the future of PEPFAR remains uncertain until the Trump administration completes its review by April 20.

 (II) Direct Impact on Drug Promotion

1. Promotion Plan Hindered: A significant reduction in funding has made it difficult for PEPFAR to lead the promotion of lenacapavir as originally planned. A PEPFAR official, speaking anonymously, stated that if the government adopts similar policies in the future, this would greatly limit the distribution scope of the drug. Chris Beyrer, Director of the Duke Global Health Institute, pointed out that this situation might allow wealthy countries to access the drug, but in areas with high HIV infection rates, the promotion plan for lenacapavir cannot be effectively implemented.

2. Imbalance in Resource Allocation: The Rubio waiver specifically stipulates that PEPFAR only funds prevention for pregnant and breastfeeding women, excluding vulnerable groups such as adolescent girls and young men who have sex with men. This severely disrupts the equitable distribution of HIV prevention resources, weakens the availability of medication among high-risk populations, and impacts overall prevention and control efforts.

 (III) The Wide-Ranging Impact on Global AIDS Prevention and Control Efforts

1. Endangering Millions of Lives: PEPFAR invests $6 to $7 billion annually in antiretroviral drugs, outreach workers, education, and other services. Since its launch in 2003, the program has saved 26 million lives. However, the sudden and chaotic funding cuts have endangered the lives of millions in Africa and the Caribbean.

2. Obstructing the Achievement of Global AIDS Prevention Goals: Global health advocates have warned that the U.S. withdrawal of PEPFAR funding could squander the progress made during a critical moment in AIDS prevention and treatment. With 1 million new infections occurring annually, the United Nations' AIDS prevention targets will be difficult to achieve if preventive drugs like lenacapavir cannot be effectively promoted.

 (1) Response of pharmaceutical companies and organizations

1. Gilead Sciences: A spokesperson for Gilead stated that the company is closely monitoring current developments and supports continued prioritization of ensuring access to critical tools like HIV prevention medications to achieve the goal of ending the global AIDS epidemic.

2. The Global Fund to Fight AIDS, Tuberculosis and Malaria: Despite the challenge of reduced PEPFAR funding, the Global Fund still aims to find ways to continue advancing the rollout of lenacapavir. Peter Sands, in charge of public-private partnerships, stated that even with limited scale, they remain ambitious about promoting lenacapavir, emphasizing the importance of not missing this game-changing opportunity. However, the Global Fund is attempting to raise $18 billion to sustain its mission over the next three years, and whether donors will provide sufficient funds to offset the PEPFAR cuts remains highly uncertain.

 (II) Calls from Experts and Officials

1. UNAIDS: Winnie Byanyima emphasized that ensuring the supply of lenacapavir is a "deal that cannot be missed." She noted that the drug is an American innovation, and if successfully promoted, it could not only create jobs in the U.S. but also save millions of lives in poor countries. However, she warned that U.S. funding accounts for about 45% of UNAIDS' core budget, and other donors are unlikely to fill this funding gap. European donors have already indicated they will cut support, and if HIV prevention efforts are not restored, it could result in an additional 6.3 million deaths.

2. Industry Expert: Alan Whiteside, an AIDS researcher at the University of KwaZulu-Natal in South Africa, said that people now have to reassess priorities, but if PEPFAR is destroyed, it cannot complete its mission. John Nkengasong, who once led PEPFAR, called lenacapavir a unique opportunity to reverse the tide in the fight against HIV/AIDS, stating that science has provided us with the tools, and we cannot give up at the final stage.

 (1) Research Conclusions

The Trump administration's significant cuts to PEPFAR severely threaten the promotion of lenacapavir and the progress of global AIDS prevention efforts. The shortage of funds not only hinders the drug's accessibility among high-risk populations but also disrupts the rational allocation of global HIV prevention resources, making the goal of eradicating AIDS by 2030 even more distant. Despite active efforts from all parties to seek solutions, the prospects for promoting lenacapavir remain challenging given the substantial funding gap and uncertain donor attitudes.

 (II) Future Prospects

1. Policy Adjustment: It is hoped that the U.S. government will reconsider its funding policy for PEPFAR, recognize the importance of global AIDS prevention and control efforts, restore reasonable financial support for PEPFAR, and ensure the smooth promotion of key anti-AIDS drugs such as lenacapavir.

2. International Cooperation: Countries around the world should strengthen collaboration in the field of HIV/AIDS prevention and treatment to jointly address issues such as funding shortages. Other countries and international organizations should, within their capabilities, fill the gap left by the reduction in PEPFAR funding and continue to advance global HIV/AIDS prevention and treatment efforts.

3. Continuous Attention: All sectors of society should continuously pay attention to the progress of global AIDS prevention and control efforts, monitor the use of funds and the promotion of drugs, ensuring that limited resources are truly used to save lives and achieve the goal of ending the global AIDS epidemic.