After the FDA placed two of its next-gen HIV drugs on clinical hold last June, Gilead Sciences has now terminated one of the affected trials.
After discussions with the FDA, Gilead has “discontinued safety follow-up” for the phase 2/3 Wonders-2 trial, “effectively terminating the study,” a company spokesperson confirmed to Fierce Biotech.
Wonders-2 and its sibling phase 2/3 study Wonders-1, also paused, were testing GS-1720, an integrase strand transfer inhibitor, and GS-4182, a capsid inhibitor, against Gilead’s approved HIV med Biktarvy. Wonders-2 had enrolled 73 people with HIV, while Wonders-1 has around 675 participants.
The two trials, alongside three phase 1 studies testing either one of the investigational compounds alone or in combination, were placed on hold last June after some patients given the combo developed low levels of CD4+ T-cells and a reduced count of total white blood cells.
Measures of these cells have since “returned to baseline or are within normal ranges” for all Wonder-2 participants, the Gilead spokesperson added.
The FDA’s hold on these trials remains in place, the spokesperson confirmed.
“We continue to work closely with study investigators to ensure a smooth transition for participants to standard of care HIV treatment options,” the spokesperson added.
Gilead had been testing the ability of weekly oral GS-1720 and GS-4182 to best Biktarvy at suppressing virus levels. GS-4182 is a prodrug of lenacapavir, the twice-yearly HIV preventative that was approved as Yeztugo around the same time the clinical hold was placed.
Lenacapavir had previously been okayed to treat HIV in 2022 as Sunlenca, and Gilead is now working to turn the game-changing drug into a long-acting treatment in partnership with another integrase strand transfer inhibitor called GS-3242.