The Food and Drug Administration (FDA) has approved Yeztugo (aka. lenacapavir or LEN), a twice-a-year injection that stops HIV from replicating inside cells, thereby reducing the risk of transmitting the virus to other people by 96%. HIV advocates hope it will help reduce national transmission rates because the medication is easier to take than the many current once-a-day medications.
“This is the single best opportunity in 44 years of HIV prevention,” said Mitchell Warren, executive director of the AIDS Vaccine Advocacy Coalition (AVAC), an HIV advocacy nonprofit group, according to NBC News. The FDA approved the drug after Gilead Sciences, the drug’s developer, found it to be overwhelmingly successful early into Phase 3 clinical trials last September.
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“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,” Warren added. “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.”
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Colleen Kelley, MD, one of the principal researchers in Phase 3 trials, said, “Because adherence to oral products can be challenging for some people, twice-yearly injectable lenacapavir for PrEP has the potential to be one of the most impactful interventions we could have to drive down new infections and bring us closer to ending HIV in the United States.”
However, AVAC said it will take urgent and decisive action to ensure that the drug will reduce global HIV rates. Lenacapavir’s current price as an HIV treatment is $3,450 per month, NBC News reported. AVAC has called on Gilead to provide the drug for $100 or below and to allow companies to develop generic forms of the drug.
The group has also urged governments to quickly integrate the drug into their national health programs, and encouraged funders to join the Global Fund’s Children’s Investment Fund Foundation to provide at least enough of the drug to treat two million people globally through 2027.
However, the drug arrives at a time when the current presidential administration has widely cancelled HIV research grants; slashed medical programs benefitting Black, Latino, and LGBTQ+ people most at-risk for contracting the virus; and also made severe reductions to the U.S. Agency for International Development (which oversaw HIV-prevention programs abroad).
“No one donor, national government, or manufacturer can realize this ambition alone,” Warren said in a statement. “All stakeholders—including Gilead, [the U.S. President’s Emergency Plan for AIDS Relief], 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.”
“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 Wawira Nyagah, AVAC’s director of product introduction & access. “Translating this success into real impact on [global HIV reduction], led by communities around the world, must be a top priority among all stakeholders.”
In 2023, there were an estimated 1.3 million new HIV infections worldwide, according to UNAIDS, a significant decrease from the peak of 3.3 million new infections in 1995. The availability of pre-exposure prophylactics (PrEP), a daily medication that can reduce the chance of transmission up to 99%, has been largely credited for the global reduction.
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