US FDA pauses Gilead trials testing experimental HIV pill combination
By Sneha S K
(Reuters) -The U.S. Food and Drug Administration has paused Gilead Sciences' trials testing a combination of two of its experimental HIV treatments due to low levels of a type of white blood cell in some patients, the company said on Tuesday.
Shares of the company, a global leader in HIV drugs, were down 2.3% at $110.35.
The agency placed the trials on hold after some patients who received the combination of the drugs, GS-1720 and GS-4182, were found to have low levels of a type of white blood cell called CD4+T-cell, the company said.
Gilead did not provide more information on what caused the decline in the type of white blood cell, which is a key measurement in HIV management and serves as a guide for treatment.
The company said it plans to investigate and will work with regulatory authorities to resolve the issues.
The paused trials included two mid-to-late studies, and three more in the early phase, the company said. The mid-to-late stage trials were testing the oral combination treatment against Biktarvy, Gilead's once-a-day pill to treat HIV.
"Today's update underscores the difficulties of improving upon the profile of Gilead's once-daily Biktarvy," said BMO Capital Markets analyst Evan Seigerman.
GS-4182 is an experimental pill version of the company's approved HIV drug lenacapavir, while GS-1720 is a once-weekly therapy in development for treatment of HIV.
The company said the hold is not related to Gilead's application seeking FDA's approval for lenacapavir in preventing HIV. The agency is set to decide on the application by June 19.
The FDA had approved lenacapavir for HIV treatment in 2022 and is sold under the brand Sunlenca.
Gilead has multiple other long-acting oral and injectable HIV treatment combinations under development, and this clinical hold does not impact those combinations, the drugmaker said.
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