Gilead’s HIV combo trials halted by FDA amid safety concerns

Gilead Sciences (Nasdaq: GILD) has paused five clinical trials of its investigational HIV drugs GS-1720 and GS-4182 after the American medicines regulator raised safety concerns. The once-weekly oral regimen was being studied as an alternative to the company’s blockbuster daily pill, Biktarvy (bictegravir/emtricitabine/tenofovir alafenamide).

The California-based biopharma said the trials were placed on full clinical hold following the discovery of a safety signal linked to declining CD4+ T-cell and absolute lymphocyte counts in some participants who received the drug combination.

Two of the halted studies, known as WONDERS-1 and WONDERS-2, were Phase II/III trials evaluating the safety and efficacy of the combo regimen. The former enrolled people with HIV who had already achieved viral suppression, while the latter focused on newly diagnosed, treatment-naive individuals.