Gilead and Merck Report Successful Phase 2 Results for Investigational Once-Weekly HIV Treatment
The combination of the antiviral agents islatravir and lenacapavir demonstrates both efficacy and safety, leading to advancement into Phase 3 trials.
Gilead Sciences and Merck have announced promising Phase 2 clinical trial results for an investigational weekly oral combination regimen of islatravir and lenacapavir, demonstrating sustained viral suppression in adults living with HIV after 48 weeks. This innovative regimen could become the first once-weekly oral treatment for HIV.
In the study presented at IDWeek, 94.2% of participants who switched from a daily regimen of Biktarvy to the new treatment maintained viral suppression, defined as HIV-1 RNA levels below 50 copies/mL. Importantly, no participants had detectable viral loads at this benchmark.
In our interview with Jared Baeten, Gilead’s Senior Vice President of Virology, he stated, “The study showed promising results for maintaining viral suppression in individuals with HIV. The primary outcome at week 48...indicated that the regimen is poised to advance to Phase 3 trials.” This underscores the significance of the trial's findings, highlighting that the treatment not only achieved its primary outcome but also sets the stage for further clinical evaluation in Phase 3 trials, a critical step toward potential approval.
The open-label study involved 104 virologically suppressed adults randomized to either the once-weekly regimen (n=52) or continued daily Biktarvy (n=52). Participants' median age was 40, with diverse representation. Secondary endpoints showed comparable rates of viral suppression between the two groups.
Baeten emphasizes the effectiveness of the investigational regimen by stating, “The study showed promising results for maintaining viral suppression in individuals with HIV. The primary outcome at week 48...indicated that the regimen is poised to advance to Phase 3 trials.” This underscores the significance of the trial's findings, highlighting that the treatment not only achieved its primary outcome but also sets the stage for further clinical evaluation in Phase 3 trials, which is a critical step toward potential approval.
Adverse events were reported in 19.2% of the islatravir-lenacapavir group, primarily mild, with dry mouth and nausea being the most common. In contrast, only 5.8% of participants on Biktarvy reported treatment-related adverse events, and no severe events related to the study drugs occurred. Baeten notes, “This combination demonstrated a favorable safety and tolerability profile, further supporting its progression.”
This combination regimen is under further investigation in two Phase 3 studies aimed at evaluating its safety and efficacy in a broader population of virologically suppressed individuals. Both islatravir and lenacapavir remain investigational compounds, with ongoing studies assessing their long-term potential as treatment options.
Baeten stated, “Additionally, the collaboration with Merck reinforces the development and potential commercialization of this HIV treatment regimen, with both organizations dedicated to advancing new and effective options for HIV treatment.” This highlights the strategic partnership between Gilead and Merck, essential for the successful development and commercialization of the treatment, addressing public health challenges. As HIV continues to pose public health challenges, these developments offer hope for more flexible and accessible treatment solutions for those living with the virus.
