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 combination 1 2 Wonders-2 had enrolled 73 people with HIV, while the related Wonders-1 trial (also paused) had approximately 675 participants 1 CD4+ T-cell and lymphocyte measures have since returned to baseline or are within normal ranges for all Wonders-2 participants 1 The FDA's clinical hold on these trials remains in place despite the improved cell count measurements 1 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 levels 1 Gilead's other long-acting oral and injecta...
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