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HIV prevention through semi-annual injections given approval in the US

Clinical trials show nearly complete immune shield against yeztugo, particularly for the drug lenacapavir.

HIV prevention receives semi-annual injection approval by U.S. authorities
HIV prevention receives semi-annual injection approval by U.S. authorities

HIV prevention through semi-annual injections given approval in the US

In a significant milestone for HIV prevention, Gilead's Yeztugo, marketed as lenacapavir, has been approved by the US Food and Drug Administration (FDA) for preventing HIV infection. This twice-yearly long-acting pre-exposure prophylaxis (PrEP) injection, launched in June 2025, is rapidly gaining market traction with strong initial sales and promising future projections.

Yeztugo has demonstrated over 99.9% efficacy in clinical trials, making it the first twice-yearly injectable PrEP option. This improvement in adherence over daily oral or monthly injectable alternatives is a significant advantage, especially in regions with high HIV burden.

The World Health Organization endorsed Yeztugo in July 2025, facilitating accelerated access through partnerships like Unitaid's $25 million funding for rollout in Africa and voluntary licensing agreements for generics in over 120 low-income countries. This global endorsement expands Yeztugo's competitive edge.

Early 2025 sales surpassed expectations, hitting around $107 million in debut sales, with forecasts projecting global sales to reach between $3 billion and $5 billion by 2030–2031. Analysts recently upgraded projections with 2025 sales expected between $173 million to $200 million+, reflecting Yeztugo's contribution and market strength.

Yeztugo's long duration and high levels of protection contributed to it being named Science's breakthrough of the year in 2024. The journal Science also named lenacapavir as its 2024 breakthrough of the year.

While work continues on potential vaccines, they remain a long way from clinical success. In the meantime, Yeztugo offers a promising solution, particularly for younger, healthier patients who aren't on a lot of other therapies.

However, it's important to note that lenacapavir is expected to be more expensive than other PrEP combinations at least initially. Some serious side effects such as joint pain after the injections and about 100 listed drug-drug interactions have also been reported.

Yeztugo works by interfering with HIV's ability to form its outer protein shell (capsid) and affects multiple stages of the virus's replication. This mechanism makes it superior to other PrEP medications, offering a more convenient and effective solution for HIV prevention.

Gilead has invested so much in PrEP medicines that competitors are unlikely to enter the marketplace very quickly, meaning prices are unlikely to fall substantially before Gilead’s patents expire. Nevertheless, advances in HIV treatments in recent decades have drastically improved the lives of patients with HIV-Aids, and Yeztugo represents a significant step forward in long-term infection prevention.

In summary, Yeztugo is establishing itself as a market-leading, long-acting HIV prevention therapy with strong initial sales and multi-billion dollar future revenue potential, supported by regulatory endorsements and broad global access initiatives. Gilead’s integrated public health and commercialization strategy is set to sustain Yeztugo’s growth despite competitive and patent-related challenges.

  1. The medical-conditions sector witnessed a major advancement with the US Food and Drug Administration's approval of Gilead's HIV prevention drug Yeztugo.
  2. As a long-acting pre-exposure prophylaxis (PrEP) for HIV infection, Yeztugo offers a twice-yearly injection and is rapidly gaining market traction.
  3. The industry has taken notice of Yeztugo's promise, with predictions for global sales reaching between $3 billion and $5 billion by 2030–2031.
  4. Nutrition and healthcare analysts have recently upgraded their projections, as 2025 sales are expected to exceed $173 million.
  5. Science magazine recognized Yeztugo's impact in 2024 by naming it their breakthrough of the year.
  6. Despite ongoing research for vaccines, Yeztugo offers a promising solution, particularly for young, healthier patients who aren't on multiple therapies.
  7. However, some concerns surround its higher cost and potential drug-drug interactions, while reports of joint pain after injections have been noted.
  8. Yeztugo's efficacy comes from its mechanism that interferes with HIV's ability to form its outer shell and affects multiple stages of the virus's replication.
  9. The financing sector is closely watching Gilead's investments in PrEP medicines, as competitors are unlikely to enter the market soon due to patent-related challenges.
  10. Meanwhile, the advancements in HIV treatments in recent decades have significantly improved patients' lives, with Yeztugo representing a major step forward in long-term infection prevention.
  11. In the world of health-and-wellness, Yeztugo is establishing itself as a market-leading long-acting HIV prevention therapy, supported by regulatory endorsements and broad global access initiatives.
  12. The business landscape will continue to adapt to this new medical innovation, as industries such as lifestyle, fashion-and-beauty, food-and-drink, investing, home-and-garden, and real-estate may integrate treatments like Yeztugo into their offerings.
  13. As the implications of Yeztugo's approval will likely impact the general-news sphere, advancements in science, technology, and career-development in healthcare will continue to be of interest to a broad audience.

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