Merck to Start Studying Lower Dose of HIV Drug After FDA Hold

Reuters staff

September 21, 2022

(Reuters) -Merck & Co Inc said on Tuesday it would start fresh late-stage studies of its HIV treatment, islatravir, months after the U.S. Food and Drug Administration put the trials on hold, citing safety concerns.

The FDA has reviewed and agreed with the plan to study lower-dose versions of the once-daily pill for treating HIV patients, the company said.

The drugmaker, however, said it was discontinuing development of a once-a-month dose of islatravir for preventing HIV infection.

The FDA in December last year placed six studies related to the treatment on full clinical hold and seven on partial clinical hold, saying immune system component that helps fight infections was at a lower level in some patients.

Merck said a mid-stage trial testing a low dose of islatravir and Gilead Sciences lenacapavir in adults with HIV-1 infections would also be resumed.

Some studies using a higher-dose version of islatravir remain under clinical hold.

(Reporting by Manas Mishra and Khushi Mandowara in Bengaluru; Editing by Anil D'Silva)

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