FDA Places Clinical Hold on Five Gilead HIV Studies Due to Safety Concerns
The FDA placed a clinical hold on five of Gilead Sciences' clinical trials involving a once-weekly investigational HIV pill combination (GS-1720 and GS-4182) after discovering safety signals, specifically decreases in CD4+ T-cell and absolute lymphocyte counts in some participants123.
The affected studies include two Phase 2/3 trials comparing the GS-1720/GS-4182 combination to Gilead's approved HIV treatment Biktarvy, as well as three Phase 1 studies1.
This clinical hold does not impact Gilead's other ongoing HIV programs, including its highly anticipated lenacapavir regimens, which are under separate FDA review12.
Analysts see the setback as minor for Gilead's broader HIV pipeline, as the restriction is limited to these five studies and does not threaten the company's other late-stage or priority HIV candidates1.
Gilead is collaborating with regulatory authorities to address the safety concerns and resume the affected studies as soon as possible1.
Sources:
1. https://www.morningstar.com/news/dow-jones/202506105797/gilead-fda-places-clinical-hold-on-hiv-treatment-trials-of-gs-1720-gs-4182
2. https://www.biospace.com/drug-development/gileads-hiv-combo-on-hold-with-no-impact-on-fdas-pending-lenacapavir-decision