Gilead discontinued the phase 2/3 Wonders-2 trial after FDA placed a clinical hold on trials testing the combination of GS-1720 (an integrase strand transfer inhibitor) and GS-4182 (a capsid inhibitor)1
The FDA clinical hold was instituted in June 2025 due to a safety signal showing decreases in CD4+ T-cell and absolute lymphocyte counts in some patients receiving the drug combination12
Wonders-2 had enrolled 73 people with HIV, while the related Wonders-1 trial (also paused) had approximately 675 participants1
CD4+ T-cell and lymphocyte measures have since returned to baseline or are within normal ranges for all Wonders-2 participants1
The FDA's clinical hold on these trials remains in place despite the improved cell count measurements1
The trials were comparing the experimental combination against Biktarvy, an approved HIV medication, to test the ability of weekly oral GS-1720 and GS-4182 to suppress virus levels1
Gilead's other long-acting oral and injectable investigational HIV treatment combinations under development are not impacted by this clinical hold4
Sources:
1. https://www.fiercebiotech.com/biotech/gilead-cancels-midstage-hiv-trial-fdas-clinical-hold-remains-intact
2. https://www.infectiousdiseaseadvisor.com/news/fda-puts-clinical-hold-on-gileads-trials-for-two-hiv-drug-candidates/
4. https://www.gilead.com/company/company-statements/2025/gilead-provides-update-on-clinical-studies-evaluating-gs-1720-and-or-gs-4182-for-the-treatment-of-hiv-1-infection