Gilead Advances Once-Yearly Lenacapavir into Phase III for HIV PrEP, Skipping Phase II; GSK and ViiV Report Promising Early Data on Long-Acting Candidates VH499 and VH184

Mar 13, 2025 07:10 CST Updated 07:10

Gilead Sciences

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Gilead Sciences Plans to Skip Phase II Study, Directly Launching Phase III Clinical Trial of Lenacapavir with Once-Yearly Injection; GSK and ViiV Healthcare Announce Advancement in Development Following Positive Early Data on Long-Acting Antiviral Drugs.

Held in San FranciscoConference on Retroviruses and Opportunistic Infections 2025Above, long-acting HIV therapies take the spotlight. Gilead Sciences, GSK, and its partner ViiV Healthcare respectively presented promising data on their respective drug candidates, laying the groundwork for future development.

Gilead Sciences Presents First-in-Human Phase I Results for Two Novel Formulations of Lenacapavir, a Potential Once-Yearly Injection for HIV Prevention, Published in The LancetThe Lancet) Data shows,Annual pre-exposure prophylaxis (PrEP) results in median lenacapavir plasma concentrations higher than the effective concentration required in Phase III trials for patients treated every six months.。

The results of the PURPOSE 1 study, announced in June 2024, showed thatLenacapavir Administered Every Six Months Can 100% Prevent HIV Infection in Cisgender Women; while the PURPOSE 2 study found that the risk of HIV infection was reduced by 96% among cisgender men, transgender men, transgender women, and non-binary individuals who have sex with men.

Based on these Phase I study results,Gilead Sciences Plans to Skip Phase II and Directly Initiate Phase III Development of Lenacapavir for Once-Yearly PrEPRelevant research will be launched later this year.

Jared Baeten, head of Gilead’s virology therapeutic area, said in a statement: "If approved, once-a-year lenacapavir could become an important new HIV prevention option, helping to address adherence and persistence challenges for people who need or want PrEP globally."

Also on Tuesday, GSK and ViiV released data on their long-acting antiviral drug VH499. The results showed that at the highest study dose of 250 milligrams,The candidate drug significantly reduced the viral load.VH499 demonstrated good safety and tolerability, with no instances of discontinuation due to side effects.

GSK and ViiV reported that a patient receiving 25 mg of VH499 developed a "mutation associated with reduced capsid inhibitor sensitivity" on day 11, but noted in the statement that these data, together with the positive Phase I results confirming the efficacy and tolerability of VH499, "support the further development of VH499 as a potential long-acting antiretroviral HIV treatment."

In addition, GSK and ViiV also announced data on another long-acting antiviral drug, VH184. All doses of the candidate drug "significantly" reduced HIV-1 viral load after 10 days of monotherapy, with no detected resistance mutations.

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