Gilead's Yeztugo Receives WHO HIV Prevention Recommendation as Merck Challenges with Monthly Oral PrEP Candidate

On July 14, Merck stated in a declaration that,EXPrESSIVE-10 TrialWill begin recruiting participants in 31 trial sites across Kenya, South Africa, and Uganda in the coming months.EXPrESSIVE-11 Trial, will begin recruiting sexually active populations in 16 countries starting in August.

Both trials are planned to recruit approximately 4,400 people, aiming to test Merck'sMK-8527Compared with Gilead's once-daily Truvada (emtricitabine/tenofovir), can it reduce the infection rate of HIV?

The statement said that the Gates Foundation provided donations to support the EXPrESSIVE-10 trial. It also funded the community advisory group for the EXPrESSIVE-11 trial, as well as patient recruitment and retention materials.

The statement pointed out,MK-8527 is able to inhibit the reverse transcriptase required for HIV replication.Merck recently completed the Phase II trial of the drug, which showed a similar incidence of adverse events between the treatment and placebo groups. The company plans to share more data from the study at the HIV Science Conference to be held in Rwanda on July 16.

Since Gilead announced its twice-yearly injectable lenacapavir (Yeztugo), the HIV field has garnered significant attention, being hailed as a scientific breakthrough. An HIV specialist doctor stated that she expects most of her patients to switch to Yeztugo within the next year, and Gilead anticipates that the drug's annual peak sales may reach$80 billion。

WHO Updated HIV Prevention Guidelines Yesterday, Explicitly Recommending YeztugoDr. Tedros Adhanom Ghebreyesus, WHO Director-General, stated that in the absence of an HIV vaccine, lenacapavir is "the next best option."

WHO Updates HIV Prevention Guidelines

Facing the market's enthusiasm for Gilead Sciences, Merck believes that compared to injectable drugs, there will still be a large population favoring oral medications. Therefore, its drug MK-8527 has broad market prospects.

Dr. Trevor Mundel, President of Global Health at the Gates Foundation, said in a statement: "Scientific advances in the fight against HIV have led to unimaginable achievements and are ushering us into a new era of HIV prevention. Currently, only 18% of the global demand for PrEP is being met, so there is an urgent need for options like MK-8527 that may have the potential to prevent infection. These Phase III trials are a crucial step in turning scientific progress into longer-lasting prevention solutions, with the potential to reverse the trend of the HIV epidemic."

Reference News:

https://www.businesswire.com/news/home/20250714554719/en/Merck-to-Initiate-Phase-3-Trials-for-Investigational-Once-Monthly-HIV-Prevention-Pill

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