Gilead ended a Phase 2/3 trial of two long-acting HIV pills after FDA concerns led to a clinical hold that remained in place. The company discontinued safety follow-up for the Wonders-2 study, effectively terminating it, while Wonders-1 had already been paused. The paused combination regimen tested weekly oral GS-1720 (integrase strand transfer inhibitor) plus GS-4182 (capsid inhibitor) against Gilead’s approved Biktarvy. The FDA’s original hold was triggered by reports of reduced CD4+ T-cell levels and lower total white blood cell counts in some participants. Gilead said measures for Wonder-2 participants have returned to baseline or normal ranges, but the FDA hold itself was not lifted, leaving trial resumption uncertain. The company also referenced work to turn lenacapavir into longer-acting treatment options through partnerships and additional investigational combinations. For biotech leaders, the action highlights how safety signals can become program-level constraints when regulatory timelines and clinical-hold conditions don’t move in parallel with cohort improvements.