Merck, known as MSD outside of the United States and Canada, announced that the company will initiate a new phase 3 clinical programme with once-daily islatravir for the treatment of people with HIV-1 infection. These new phase 3 studies will evaluate a once-daily oral combination of doravirine 100 mg and a lower dose of islatravir (DOR/ISL). One study will evaluate DOR/ISL in previously untreated adults with HIV-1 infection and two studies will evaluate DOR/ISL as a switch in antiretroviral therapy (ART) in adults with HIV-1 infection who are virologically suppressed. Certain study participants currently enrolled in once-daily treatment studies with DOR 100 mg/ISL 0.75 mg will have the option of transitioning to a new study with the lower islatravir dose. The US Food and Drug Administration (FDA) has reviewed and agreed with this plan. The investigational new drug application (IND) for the once-daily oral DOR/ISL treatment programme remains under a partial clinical hold for any studies that would use doses higher than the dose to be studied in the new phase 3 programme. Refer here for more information on the islatravir clinical hold.
The phase 2 clinical trial (NCT05052996) evaluating an investigational oral once-weekly combination treatment regimen of islatravir and Gilead
