FDA placed clinical hold on Gilead HIV treatment trials of GS-1720

The Food and Drug Administration has placed a clinical hold on Gilead’s (GILD) HIV treatment trials of GS-1720 and/or GS-4182, the company said in a statement. The clinical hold is due to the identification of a safety signal of decreases in CD4+T-cell and absolute lymphocyte counts in a subset of participants receiving the combination of GS-1720 and GS-4182, the company explained. It added, “Clinical trial investigators involved in the trials have been informed of these actions. GS-1720 and GS-1482 are investigational agents and have not been approved anywhere globally. We intend to investigate and pursue the potential of both agents and are committed to working with regulatory authorities to resolve the issues underlying the clinical hold. Gilead has multiple other long-acting oral and injectable investigational HIV treatment combinations under evaluation in clinical and preclinical studies, including combinations with weekly, monthly, quarterly, and twice-yearly dosing. This hold does not impact these combinations or their respective clinical or pre-clinical development programs.”