Merck & Co Resumes Islatravir HIV Studies After Safety Concerns, But Abandons PrEP Approach
Maintains Belief In Oral Long-Acting Regimen
After a nine-month US FDA-imposed pause, Merck is relaunching its studies of islatravir with a lower dose, while also abandoning its use in PrEP studies.
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Merck has already paused other studies testing the potential first-in-class NRTTI and is adding additional monitoring of lymphocyte and CD4+ T-cell assessments.
Merck & Co. is looking to compete in the burgeoning long-acting HIV market, but a safety halt to a Phase II trial could disrupt those plans.