Gilead and GSK-ViiV Make Strides in Long-Acting HIV Therapies

Significant advancements in long-acting HIV treatments have been unveiled at the 2025 Conference on Retroviruses and Opportunistic Infections in San Francisco, with pharmaceutical giants Gilead Sciences and the GSK-ViiV Healthcare partnership presenting promising data for their respective drug candidates.

Gilead's Lenacapavir Shows Promise for Once-Yearly PrEP

Gilead Sciences has announced groundbreaking Phase I results for two novel formulations of lenacapavir, potentially paving the way for once-yearly injections in HIV prevention. The data, simultaneously published in The Lancet, demonstrated that once-yearly pre-exposure prophylaxis (PrEP) led to median plasma lenacapavir concentrations surpassing the efficacy threshold established in previous Phase III trials using twice-yearly administration.

Building on the success of the PURPOSE 1 and PURPOSE 2 studies from June 2024, which showed impressive efficacy rates in preventing HIV transmission across diverse populations, Gilead is now planning to fast-track the development of once-yearly lenacapavir. The company intends to bypass Phase II trials and proceed directly to Phase III studies later this year.

Dr. Jared Baeten, Gilead's Virology Therapeutic Area head, emphasized the potential impact of this development, stating, "Once-yearly lenacapavir, if approved, could become an important new HIV prevention option that could help address PrEP adherence and persistence challenges for individuals who need or want PrEP around the world."

GSK-ViiV Healthcare Advances Long-Acting Antivirals

GSK and its HIV-focused joint venture ViiV Healthcare have also made significant strides in the development of long-acting HIV treatments. The partners presented data on two promising candidates: VH499 and VH184.

VH499, at its highest investigational dose of 250 mg, demonstrated a strong reduction in viral load while maintaining a favorable safety and tolerability profile. Despite one patient developing a genetic mutation associated with reduced susceptibility to capsid inhibitors, the overall results support further development of VH499 as a potential long-acting antiretroviral for HIV treatment.

Complementing these findings, GSK and ViiV also reported positive outcomes for VH184. All tested doses of this candidate resulted in a marked reduction in HIV-1 viral load after 10 days of monotherapy, with no resistance mutations detected.

These developments from both Gilead and GSK-ViiV underscore the rapid progress being made in long-acting HIV therapies, potentially offering patients more convenient and effective treatment options in the near future. As these candidates move through advanced clinical trials, the pharmaceutical industry continues to demonstrate its commitment to improving the lives of individuals affected by HIV worldwide.